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| ID | Type | Description | Link |
|---|---|---|---|
| 12007 | Registry Identifier | DAIDS-ES Registry Number |
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This study will evaluate the safety and immune response to the DNA-HIV-PT123 vaccine used in combination with one of two protein vaccines (Bivalent Subtype C gp120/MF59 or Bivalent Subtype C gp120/AS01B) in healthy, HIV-uninfected adults.
The purpose of this study is to evaluate the safety, tolerability, and immune response of the DNA-HIV-PT123 vaccine when used in combination with one of two protein vaccines: Bivalent Subtype C gp120/MF59 (Protein/MF59) or Bivalent Subtype C gp120/AS01B (Protein/AS01B). These protein vaccines may boost the immune response to the DNA vaccine.
The study will enroll healthy, HIV-uninfected adults. Participants will be randomly assigned to one of eight groups, and each group will receive a different sequence of vaccines during the study. Groups 1 and 4 will receive the DNA-HIV-PT123 vaccine, the Protein/MF59 vaccine, and placebo. Groups 2, 3, 5, 6, and 7 will receive the DNA-HIV-PT123 vaccine, the Protein/AS01B vaccine, and placebo. Group 8 will only receive placebo.
All participants will receive their assigned vaccines at Months 0, 1, 3, and 6. Each of these visits will include three injections. Follow-up visits will occur at Week 2 and Months 1.5, 3.5, 6.25, 6.5, 9, and 12.
Study visits will include a physical examination, an interview and/or questionnaire, HIV testing and HIV risk reduction counseling, and urine and blood collection. Participants may optionally choose to provide stool, rectal fluid, cervical fluid, or semen samples. Participants will be contacted 6 months after the last scheduled visit by phone, text message, or e-mail for information about their health.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59 | Experimental | Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo in their right deltoid at Months 0 and 1, and placebo and the Protein/MF59 vaccine in their right deltoid at Months 3 and 6. |
|
| Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01B | Experimental | Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo in their right deltoid at Months 0 and 1, and placebo and the Protein/AS01B vaccine in their right deltoid at Months 3 and 6. |
|
| Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01B | Experimental | Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo in their right deltoid at Months 0 and 1, and placebo and the Protein/AS01B vaccine in their right deltoid at Months 3 and 6. |
|
| Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59 | Experimental | Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, and 6 and placebo in their left deltoid at Month 3. They will receive placebo and the Protein/MF59 vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DNA-HIV-PT123 vaccine | Biological | Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 [March 2017]. The maximum grade observed for each symptom over the time frame is presented. | Measured through 7 days after each vaccine dose at Month 0, 1, 3, and 6 |
| Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 [March 2017]. The maximum grade observed for each symptom over the time frame is presented. | Measured through 7 days after each vaccine dose at Month 0, 1, 3, and 6 |
| Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 [March 2017]. The following symptoms are considered as systemic reactogenicity if the onset date was within the periods of assessment specified in the protocol: malaise and/or fatigue, myalgia, headache, nausea, vomiting, chills, arthralgia, and body temperature. The item Max. Systemic Reaction is the maximum of the individual systemic variables for a participant. It does not include temperature. | Measured through 7 days after each vaccination at Month 0, 1, 3, and 6 |
| Number of Participants Reporting Adverse Events (AEs), by Relationship to Study Product | For participants reporting multiple AEs over the time frame, the maximum relationship is counted. | Measured through 30 days after each vaccination at Month 0, 1, 3, and 6 |
| Number of Participants Reporting Adverse Events (AEs), by Severity Grade |
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Inclusion Criteria:
General and Demographic Criteria
HIV-Related Criteria:
Laboratory Inclusion Values:
Hemogram/Complete Blood Count (CBC)
Chemistry
Virology
Urine
Normal urine:
Reproductive Status
Reproductive status:
United States
A volunteer who was born female must:
Agree to consistently use effective contraception (see the protocol for more information) for sexual activity that could lead to pregnancy from at least 21 days prior to enrollment through the last required protocol clinic visit. Effective contraception for participants in the United States is defined as using any 1 or more of the following methods:
Or not be of reproductive potential, such as having reached menopause (no menses for 1 year) or having undergone hysterectomy, bilateral oophorectomy, or tubal ligation;
Or be sexually abstinent.
Southern Africa
A volunteer who was born female must:
Agree to consistently use effective contraception (see the protocol for more information) for sexual activity that could lead to pregnancy from at least 21 days prior to enrollment through the last required protocol clinic visit. Effective contraception for participants in Southern Africa is defined as using 2 methods of birth control. These include 1 of the following methods:
PLUS 1 of the following methods:
Or not be of reproductive potential, such as having reached menopause (no menses for 1 year) or having undergone hysterectomy, bilateral oophorectomy, or tubal ligation;
Or be sexually abstinent.
Volunteers who were born female must also agree not to seek pregnancy through alternative methods, such as artificial insemination or in vitro fertilization until after the last required protocol clinic visit
Other
Volunteers 21 years of age and older who were born female consenting to provide cervical samples:
Pap smear within:
If no pap smear was done within the last 3 years (or within the last 5 years, if high risk HPV testing was performed), the volunteer must be willing to undergo a pap smear with the result reported as normal or ASCUS prior to sample collection.
Exclusion Criteria:
General
Vaccines and Other Injections
Immune System
Clinically significant medical conditions
Untreated or incompletely treated syphilis infection
Clinically significant medical condition, physical examination findings, clinically significant abnormal laboratory results, or past medical history with clinically significant implications for current health. A clinically significant condition or process includes but is not limited to:
Any medical, psychiatric, occupational, or other condition that, in the judgment of the investigator, would interfere with, or serve as a contraindication to, protocol adherence, assessment of safety or reactogenicity, or a volunteer's ability to give informed consent
Psychiatric condition that precludes compliance with the protocol. Specifically excluded are persons with psychoses within the past 3 years, ongoing risk for suicide, or history of suicide attempt or gesture within the past 3 years.
Current anti-tuberculosis (TB) prophylaxis or therapy
Asthma other than mild, well-controlled asthma. (Symptoms of asthma severity as defined in the most recent US National Asthma Education and Prevention Program (NAEPP) Expert Panel report). Exclude a volunteer who:
Diabetes mellitus type 1 or type 2, including cases controlled with diet alone. (Not excluded: history of isolated gestational diabetes.)
Thyroidectomy, or thyroid disease requiring medication during the last 12 months
Hypertension:
Bleeding disorder diagnosed by a doctor (eg, factor deficiency, coagulopathy, or platelet disorder requiring special precautions)
Malignancy (Not excluded from participation: Volunteer who has had malignancy excised surgically and who, in the investigator's estimation, has a reasonable assurance of sustained cure, or who is unlikely to experience recurrence of malignancy during the period of the study)
Seizure disorder: History of seizure(s) within past 3 years. Also exclude if volunteer has used medications in order to prevent or treat seizure(s) at any time within the past 3 years.
Asplenia: any condition resulting in the absence of a functional spleen
History of hereditary angioedema, acquired angioedema, or idiopathic angioedema.
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| Name | Affiliation | Role |
|---|---|---|
| Nigel Garrett | Centre for the AIDS Programme of Research in South Africa | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alabama CRS | Birmingham | Alabama | 35294 | United States | ||
| Brigham and Women's Hospital Vaccine CRS (BWH VCRS) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40704585 | Derived | Conley HE, Oh SY, Garrett N, Kublin J, Monaco CL, Watts S, Jha S, Ferrari G, Tomaras GD, Geraghty DE, Chan C, Pollara J. IgG and Fc Receptor Genetic Variation Associates With Functional Antibody Responses in a DNA and Protein Candidate HIV Vaccine Trial. J Acquir Immune Defic Syndr. 2025 Dec 1;100(4):371-375. doi: 10.1097/QAI.0000000000003734. | |
| 40190112 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59 | Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo in their right deltoid at Months 0 and 1, and placebo and the Protein/MF59 vaccine in their right deltoid at Months 3 and 6. DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose. Bivalent Subtype C gp120/MF59 vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, each at a dose of 100 mcg, mixed with MF59 adjuvant, administered by IM injection to the right deltoid as a single 0.5 mL dose. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Aug 8, 2016 |
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| Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01B | Experimental | Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, and 6 and placebo in their left deltoid at Month 3. They will receive placebo and the Protein/AS01B vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3. |
|
| Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01B | Experimental | Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, and 6 and placebo in their left deltoid at Month 3. They will receive placebo and the Protein/AS01B vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3. |
|
| Group 7: Placebo + Protein/AS01B | Experimental | Participants will receive placebo in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo and the Protein/AS01B vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3. |
|
| Group 8: Placebo | Placebo Comparator | Participants will receive placebo in both their right and left deltoids at Months 0, 1, 3, and 6. |
|
|
| Bivalent Subtype C gp120/MF59 vaccine | Biological | Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, each at a dose of 100 mcg, mixed with MF59 adjuvant, administered by IM injection to the right deltoid as a single 0.5 mL dose. |
|
|
| Bivalent Subtype C gp120/AS01B vaccine | Biological | Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose. Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose. |
|
|
| Placebo | Biological | Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products. |
|
For participants reporting multiple AEs over the time frame, the maximum severity grade is counted. |
| Measured through 30 days after each vaccination at Month 0, 1, 3, and 6 |
| Number of Participants Reporting Serious Adverse Events (SAEs) | Measured as outlined in Version 2.0 (January 2010) of the Manual for Expedited Reporting of Adverse Events to DAIDS (DAIDS EAE Manual) | Measured through Month 12 |
| Number of Participants Reporting Adverse Events of Special Interest (AESIs) | There were no adverse events of special interest reported by any participant. | Measured through Month 18 |
| Number of Participants Reporting New Chronic Conditions (Requiring Medical Intervention for ≥ 30 Days) | There were no new chronic conditions (requiring medical intervention for ≥ 30 days) reported by any participant. | Measured through Month 12 |
| Number of Participants With Early Study Termination Associated With an AE or Reactogenicity | There were no early study terminations associated with an AE or reactogenicity reported by any participant. | Measured through Month 12 |
| Number of Participants With Study Product Discontinuation Associated With an AE or Reactogenicity | From the study product discontinuation form, study product administration reasons are tabulated by treatment arm. | Measured through Month 6.5 |
| Chemistry and Hematology Laboratory Measures - ALT(SGPT), AST, Alkaline Phosphatase. | For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population. | Measured during screening, and 2 weeks after each vaccination at Month 0, 1, 3, and 6 |
| Chemistry and Hematology Laboratory Measures - Creatinine. | For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population. | Measured during screening, and 2 weeks after each vaccination at Month 0, 1, 3, and 6 |
| Chemistry and Hematology Laboratory Measures - Hemoglobin. | For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population. | Measured during screening, and 2 weeks after each vaccination at Month 0, 1, 3, and 6 |
| Chemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils. | For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population. | Measured during screening, and 2 weeks after each vaccination at Month 0, 1, 3, and 6 |
| Chemistry and Hematology Laboratory Measures - Platelets, WBC. | For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population. | Measured during screening, and 2 weeks after each vaccination at Month 0, 1, 3, and 6 |
| Numbers of Participants With Grade 1 or Higher Local Laboratory Results. | The numbers (percentages) of participants with local laboratory values recorded as meeting Grade 1 AE criteria or above as specified in the DAIDS AE Grading Table were tabulated by treatment group for each post vaccination timepoint. | Measured during screening, and 2 weeks after each vaccination at Month 0, 1, 3, and 6 |
| Occurrence and Level of HIV-specific Total IgG Binding Antibody Response Breadth and Magnitude - Positive Response Rates. | IgG binding antibody breadth assays were not run. Instead, IgG was assayed against a smaller panel of antigens. Serum IgG responses were measured on a Bio-Plex instrument using a custom Luminex assay, run at 1:50 dilution. The readout is background-subtracted mean fluorescent intensity (MFI), with background adjustment for an antigen-specific plate level control. For each sample, response magnitude is net MFI, defined as experimental antigen minus reference antigen MFI. Net MFI below 1 is set to 1, and Net MFI above 22,000 is set to 22,000. Samples from post-baseline visits have positive responses if they meet three criteria: (1) net MFI >= antigen-specific threshold (defined as the maximum of 100 and the 95th percentile of baseline net MFI), (2) net MFI > 3 times baseline net MFI, and (3) experimental antigen MFI > 3 times baseline MFI. Data are excluded if the blood draw date was outside the allowable window, a participant was HIV-infected, or the reference antigen exceeds 5000 MFI. | Measured at Month 6.5 |
| Occurrence and Level of HIV-specific Total IgG Binding Antibody Response Breadth and Magnitude - Magnitudes. | IgG binding antibody breadth assays were not run. Instead, IgG was assayed against a smaller panel of antigens.Serum IgG responses were measured on a Bio-Plex instrument using a custom Luminex assay, run at 1:50 dilution. The readout is background-subtracted mean fluorescent intensity (MFI), with background adjustment for an antigen-specific plate level control. For each sample, response magnitude is net MFI, defined as experimental antigen minus reference antigen MFI. Net MFI below 1 is set to 1, and Net MFI above 22,000 is set to 22,000. Samples from post-baseline visits have positive responses if they meet three criteria: (1) net MFI >= antigen-specific threshold (defined as the maximum of 100 and the 95th percentile of baseline net MFI), (2) net MFI > 3 times baseline net MFI, and (3) experimental antigen MFI > 3 times baseline MFI. Data are excluded if the blood draw date was outside the allowable window, a participant was HIV-infected, or the reference antigen exceeds 5000 MFI. | Measured at Month 6.5 |
| Occurrence and Level of Anti -V1/V2 Scaffold IgG Binding Antibody Responses - Positive Response Rates. | Serum IgG responses were measured on a Bio-Plex instrument using a custom Luminex assay, run at 1:50 dilution. The readout is background-subtracted mean fluorescent intensity (MFI), with background adjustment for an antigen-specific plate level control. For each sample, response magnitude is net MFI, defined as experimental antigen minus reference antigen MFI. Net MFI below 1 is set to 1, and Net MFI above 22,000 is set to 22,000. Samples from post-baseline visits have positive responses if they meet three criteria: (1) net MFI >= antigen-specific threshold (defined as the maximum of 100 and the 95th percentile of baseline net MFI), (2) net MFI > 3 times baseline net MFI, and (3) experimental antigen MFI > 3 times baseline MFI. Data are excluded if the blood draw date was outside the allowable window, a participant was HIV-infected, or the reference antigen exceeds 5000 MFI. | Measured at Month 6.5 |
| Occurrence and Level of Anti -V1/V2 Scaffold IgG Binding Antibody Response - Magnitudes. | Serum IgG responses were measured on a Bio-Plex instrument using a custom Luminex assay, run at 1:50 dilution. The readout is background-subtracted mean fluorescent intensity (MFI), with background adjustment for an antigen-specific plate level control. For each sample, response magnitude is net MFI, defined as experimental antigen minus reference antigen MFI. Net MFI below 1 is set to 1, and Net MFI above 22,000 is set to 22,000. Samples from post-baseline visits have positive responses if they meet three criteria: (1) net MFI >= antigen-specific threshold (defined as the maximum of 100 and the 95th percentile of baseline net MFI), (2) net MFI > 3 times baseline net MFI, and (3) experimental antigen MFI > 3 times baseline MFI. Data are excluded if the blood draw date was outside the allowable window, a participant was HIV-infected, or the reference antigen exceeds 5000 MFI. | Measured at Month 6.5 |
| Occurrence and Level of Neutralizing Antibody Responses Against HIV-1 Isolates. | The neutralizing antibody assay was not run. Therefore this dataset doesn't exist | Measured at Month 6.5 |
| Occurrence and Level of HIV-specific CD4+ T-cell Responses - Positive Response Rates. | PBMC samples are stimulated with synthetic peptide pools or left unstimulated as a negative control. For each sample, T-cell subset, and peptide pool, response magnitude is % cells expressing markers after peptide stimulation minus % cells expressing markers after no stimulation. A contingency table is constructed to assess response: stimulation (peptide/none) vs. marker expression (yes/no). A one-sided Fisher's exact test is applied, testing if the number of cells positive for the marker is equal in the stimulated vs. unstimulated cells. A discrete Bonferroni adjustment is made over the peptide pools. Response is positive if p<=0.00001. Any Env magnitude is the maximum of gp120 and Env ZM96 magnitude; Any Pol is the sum of CN54 magnitude; and Any HIV is the sum of Gag ZM96, Nef CN54, Any Pol, and Any Env. Data are excluded if the blood draw date was outside the visit window, the participant was HIV-infected, PBMC viability or T-cell count were low, or negative control was high. | Measured at Month 6.5 |
| Occurrence and Level of HIV-specific CD4+ T-cell Responses - Magnitudes. | PBMC samples are stimulated with synthetic peptide pools or left unstimulated as a negative control. For each sample, T-cell subset, and peptide pool, response magnitude is % cells expressing markers after peptide stimulation minus % cells expressing markers after no stimulation. A contingency table is constructed to assess response: stimulation (peptide/none) vs. marker expression (yes/no). A one-sided Fisher's exact test is applied, testing if the number of cells positive for the marker is equal in the stimulated vs. unstimulated cells. A discrete Bonferroni adjustment is made over the peptide pools. Response is positive if p<=0.00001. Any Env magnitude is the maximum of gp120 and Env ZM96 magnitude; Any Pol is the sum of CN54 magnitude; and Any HIV is the sum of Gag ZM96, Nef CN54, Any Pol, and Any Env. Data are excluded if the blood draw date was outside the visit window, the participant was HIV-infected, PBMC viability or T-cell count were low, or negative control was high. | Measured at Month 6.5 |
| Occurrence and Level of HIV-specific CD8+ T-cell Responses - Positive Response Rates. | PBMC samples are stimulated with synthetic peptide pools or left unstimulated as a negative control. For each sample, T-cell subset, and peptide pool, response magnitude is % cells expressing markers after peptide stimulation minus % cells expressing markers after no stimulation. A contingency table is constructed to assess response: stimulation (peptide/none) vs. marker expression (yes/no). A one-sided Fisher's exact test is applied, testing if the number of cells positive for the marker is equal in the stimulated vs. unstimulated cells. A discrete Bonferroni adjustment is made over the peptide pools. Response is positive if p<=0.00001. Any Env magnitude is the maximum of gp120 and Env ZM96 magnitude; Any Pol is the sum of CN54 magnitude; and Any HIV is the sum of Gag ZM96, Nef CN54, Any Pol, and Any Env. Data are excluded if the blood draw date was outside the visit window, the participant was HIV-infected, PBMC viability or T-cell count were low, or negative control was high. | Measured at Month 6.5 |
| Occurrence and Level of HIV-specific CD8+ T-cell Responses - Magnitudes. | PBMC samples are stimulated with synthetic peptide pools or left unstimulated as a negative control. For each sample, T-cell subset, and peptide pool, response magnitude is % cells expressing markers after peptide stimulation minus % cells expressing markers after no stimulation. A contingency table is constructed to assess response: stimulation (peptide/none) vs. marker expression (yes/no). A one-sided Fisher's exact test is applied, testing if the number of cells positive for the marker is equal in the stimulated vs. unstimulated cells. A discrete Bonferroni adjustment is made over the peptide pools. Response is positive if p<=0.00001. Any Env magnitude is the maximum of gp120 and Env ZM96 magnitude; Any Pol is the sum of CN54 magnitude; and Any HIV is the sum of Gag ZM96, Nef CN54, Any Pol, and Any Env. Data are excluded if the blood draw date was outside the visit window, the participant was HIV-infected, PBMC viability or T-cell count were low, or negative control was high. | Measured at Month 6.5 |
| Boston |
| Massachusetts |
| 02115-6110 |
| United States |
| Fenway Health (FH) CRS | Boston | Massachusetts | 02215-4302 | United States |
| Columbia P&S CRS | New York | New York | 10032-3732 | United States |
| New York Blood Center CRS | New York | New York | 10065 | United States |
| University of Rochester Vaccines to Prevent HIV Infection CRS | Rochester | New York | 14642 | United States |
| Vanderbilt Vaccine (VV) CRS | Nashville | Tennessee | 37232-2582 | United States |
| Seattle Vaccine and Prevention CRS | Seattle | Washington | 98109-1024 | United States |
| Kliptown Soweto CRS | Johannesburg | Gauteng | 1409 | South Africa |
| The Aurum Institute Tembisa Clinical Research Centre CRS | Johannesburg | Gauteng | 1632 | South Africa |
| Soweto HVTN CRS | Johannesburg | Gauteng | 1862 | South Africa |
| Setshaba Research Centre CRS | Soshanguve | Gauteng | 0152 | South Africa |
| CAPRISA eThekwini CRS | Durban | KwaZulu-Natal | 4013 | South Africa |
| Qhakaza Mbokodo Research Clinic CRS | Ladysmith | KwaZulu-Natal | 3370 | South Africa |
| Verulam CRS | Verulam | KwaZulu-Natal | 4340 | South Africa |
| Aurum Institute Klerksdorp CRS | Klerksdorp | North West | 2571 | South Africa |
| Emavundleni CRS | Cape Town | Western Cape | 7750 | South Africa |
| Moodie Z, Li SS, Giorgi EE, Williams LD, Dintwe O, Carpp LN, Chen S, Seaton KE, Sawant SS, Zhang L, Heptinstall J, Liu S, Grunenberg N, Tomaka F, Rerks-Ngarm S, Pitisuttithum P, Nitayaphan S, Ake JA, Vasan S, Pantaleo G, Frank I, Baden LR, Goepfert PA, Keefer M, Chirenje M, Hosseinipour MC, Mngadi K, Laher F, Garrett N, Bekker LG, De Rosa S, Andersen-Nissen E, Kublin JG, Lu S, Gilbert PB, Gray GE, Corey L, McElrath MJ, Tomaras GD. A polyvalent DNA prime with matched polyvalent protein/GLA-SE boost regimen elicited the most robust and broad IgG and IgG3 V1V2 binding antibody and CD4+ T cell responses among 13 HIV vaccine trials. Emerg Microbes Infect. 2025 Dec;14(1):2485317. doi: 10.1080/22221751.2025.2485317. Epub 2025 Apr 7. |
| 38916429 | Derived | Garrett N, Dintwe O, Monaco CL, Jones M, Seaton KE, Church EC, Grunenberg N, Hutter J, deCamp A, Huang Y, Lu H, Mann P, Robinson ST, Heptinstall J, Jensen RL, Pantaleo G, Ding S, Koutsoukos M, Hosseinipour MC, Van Der Meeren O, Gilbert PB, Ferrari G, Andersen-Nissen E, McElrath MJ, Tomaras GD, Gray GE, Corey L, Kublin JG; HVTN 108 and HVTN 111 Study Teams. Safety and Immunogenicity of a DNA Vaccine With Subtype C gp120 Protein Adjuvanted With MF59 or AS01B: A Phase 1/2a HIV-1 Vaccine Trial. J Acquir Immune Defic Syndr. 2024 Aug 1;96(4):350-360. doi: 10.1097/QAI.0000000000003438. Epub 2024 Jun 21. |
| 34895272 | Derived | Hanass-Hancock J, Carpenter B, Reddy T, Nzuza A, Gaffoor Z, Goga A, Andrasik M. Participants' characteristics and motivations to screen for HIV vaccine and monoclonal antibody trials in KwaZulu-Natal, South Africa. Trials. 2021 Dec 11;22(1):897. doi: 10.1186/s13063-021-05792-7. |
| 30282622 | Derived | Mngadi KT, Maharaj B, Duki Y, Grove D, Andriesen J. Using Mobile Technology (pMOTAR) to Assess Reactogenicity: Protocol for a Pilot Randomized Controlled Trial. JMIR Res Protoc. 2018 Oct 3;7(10):e175. doi: 10.2196/resprot.9396. |
| FG001 | Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01B | Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo in their right deltoid at Months 0 and 1, and placebo and the Protein/AS01B vaccine in their right deltoid at Months 3 and 6. DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose. Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose. Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products. |
| FG002 | Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01B | Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo in their right deltoid at Months 0 and 1, and placebo and the Protein/AS01B vaccine in their right deltoid at Months 3 and 6. DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose. Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose. Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products. |
| FG003 | Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59 | Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, and 6 and placebo in their left deltoid at Month 3. They will receive placebo and the Protein/MF59 vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3. DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose. Bivalent Subtype C gp120/MF59 vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, each at a dose of 100 mcg, mixed with MF59 adjuvant, administered by IM injection to the right deltoid as a single 0.5 mL dose. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products. |
| FG004 | Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01B | Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, and 6 and placebo in their left deltoid at Month 3. They will receive placebo and the Protein/AS01B vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3. DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose. Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose. Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products. |
| FG005 | Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01B | Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, and 6 and placebo in their left deltoid at Month 3. They will receive placebo and the Protein/AS01B vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3. DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose. Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose. Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products. |
| FG006 | Group 7: Placebo + Protein/AS01B | Participants will receive placebo in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo and the Protein/AS01B vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3. Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose. Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products. |
| FG007 | Group 8: Placebo | Participants will receive placebo in both their right and left deltoids at Months 0, 1, 3, and 6. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products. |
| Month 6.5 Immunogenicity Timepoint | HIV uninfected at Month 6.5 and specimen available for assays |
|
| COMPLETED |
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| NOT COMPLETED |
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|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59 | Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo in their right deltoid at Months 0 and 1, and placebo and the Protein/MF59 vaccine in their right deltoid at Months 3 and 6. DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose. Bivalent Subtype C gp120/MF59 vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, each at a dose of 100 mcg, mixed with MF59 adjuvant, administered by IM injection to the right deltoid as a single 0.5 mL dose. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products. |
| BG001 | Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01B | Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo in their right deltoid at Months 0 and 1, and placebo and the Protein/AS01B vaccine in their right deltoid at Months 3 and 6. DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose. Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose. Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products. |
| BG002 | Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01B | Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo in their right deltoid at Months 0 and 1, and placebo and the Protein/AS01B vaccine in their right deltoid at Months 3 and 6. DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose. Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose. Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products. |
| BG003 | Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59 | Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, and 6 and placebo in their left deltoid at Month 3. They will receive placebo and the Protein/MF59 vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3. DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose. Bivalent Subtype C gp120/MF59 vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, each at a dose of 100 mcg, mixed with MF59 adjuvant, administered by IM injection to the right deltoid as a single 0.5 mL dose. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products. |
| BG004 | Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01B | Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, and 6 and placebo in their left deltoid at Month 3. They will receive placebo and the Protein/AS01B vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3. DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose. Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose. Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products. |
| BG005 | Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01B | Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, and 6 and placebo in their left deltoid at Month 3. They will receive placebo and the Protein/AS01B vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3. DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose. Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose. Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products. |
| BG006 | Group 7: Placebo + Protein/AS01B | Participants will receive placebo in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo and the Protein/AS01B vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3. Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose. Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products. |
| BG007 | Group 8: Placebo | Participants will receive placebo in both their right and left deltoids at Months 0, 1, 3, and 6. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products. |
| BG008 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
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| Age, Customized | Count of Participants | Participants |
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| Sex: Female, Male | Sex assigned at birth | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||
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| Primary | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 [March 2017]. The maximum grade observed for each symptom over the time frame is presented. | Posted | Count of Participants | Participants | Measured through 7 days after each vaccine dose at Month 0, 1, 3, and 6 |
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| Primary | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 [March 2017]. The maximum grade observed for each symptom over the time frame is presented. | Posted | Count of Participants | Participants | Measured through 7 days after each vaccine dose at Month 0, 1, 3, and 6 |
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| Primary | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 [March 2017]. The following symptoms are considered as systemic reactogenicity if the onset date was within the periods of assessment specified in the protocol: malaise and/or fatigue, myalgia, headache, nausea, vomiting, chills, arthralgia, and body temperature. The item Max. Systemic Reaction is the maximum of the individual systemic variables for a participant. It does not include temperature. | Posted | Count of Participants | Participants | Measured through 7 days after each vaccination at Month 0, 1, 3, and 6 |
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| Primary | Number of Participants Reporting Adverse Events (AEs), by Relationship to Study Product | For participants reporting multiple AEs over the time frame, the maximum relationship is counted. | Posted | Count of Participants | Participants | Measured through 30 days after each vaccination at Month 0, 1, 3, and 6 |
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| Primary | Number of Participants Reporting Adverse Events (AEs), by Severity Grade | For participants reporting multiple AEs over the time frame, the maximum severity grade is counted. | Posted | Count of Participants | Participants | Measured through 30 days after each vaccination at Month 0, 1, 3, and 6 |
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| Primary | Number of Participants Reporting Serious Adverse Events (SAEs) | Measured as outlined in Version 2.0 (January 2010) of the Manual for Expedited Reporting of Adverse Events to DAIDS (DAIDS EAE Manual) | Posted | Count of Participants | Participants | Measured through Month 12 |
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| Primary | Number of Participants Reporting Adverse Events of Special Interest (AESIs) | There were no adverse events of special interest reported by any participant. | Posted | Count of Participants | Participants | Measured through Month 18 |
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| Primary | Number of Participants Reporting New Chronic Conditions (Requiring Medical Intervention for ≥ 30 Days) | There were no new chronic conditions (requiring medical intervention for ≥ 30 days) reported by any participant. | Posted | Count of Participants | Participants | Measured through Month 12 |
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| Primary | Number of Participants With Early Study Termination Associated With an AE or Reactogenicity | There were no early study terminations associated with an AE or reactogenicity reported by any participant. | Posted | Count of Participants | Participants | Measured through Month 12 |
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| Primary | Number of Participants With Study Product Discontinuation Associated With an AE or Reactogenicity | From the study product discontinuation form, study product administration reasons are tabulated by treatment arm. | Posted | Count of Participants | Participants | Measured through Month 6.5 |
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| Primary | Chemistry and Hematology Laboratory Measures - ALT(SGPT), AST, Alkaline Phosphatase. | For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population. | Posted | Median | Inter-Quartile Range | U/L | Measured during screening, and 2 weeks after each vaccination at Month 0, 1, 3, and 6 |
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| Primary | Chemistry and Hematology Laboratory Measures - Creatinine. | For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population. | Posted | Median | Inter-Quartile Range | mg/dL | Measured during screening, and 2 weeks after each vaccination at Month 0, 1, 3, and 6 |
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| Primary | Chemistry and Hematology Laboratory Measures - Hemoglobin. | For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population. | Posted | Median | Inter-Quartile Range | g/dL | Measured during screening, and 2 weeks after each vaccination at Month 0, 1, 3, and 6 |
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| Primary | Chemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils. | For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population. | Posted | Median | Inter-Quartile Range | cells/cubic mm | Measured during screening, and 2 weeks after each vaccination at Month 0, 1, 3, and 6 |
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| Primary | Chemistry and Hematology Laboratory Measures - Platelets, WBC. | For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population. | Posted | Median | Inter-Quartile Range | x1000/cubic mm | Measured during screening, and 2 weeks after each vaccination at Month 0, 1, 3, and 6 |
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| Primary | Numbers of Participants With Grade 1 or Higher Local Laboratory Results. | The numbers (percentages) of participants with local laboratory values recorded as meeting Grade 1 AE criteria or above as specified in the DAIDS AE Grading Table were tabulated by treatment group for each post vaccination timepoint. | Posted | Count of Participants | Participants | Measured during screening, and 2 weeks after each vaccination at Month 0, 1, 3, and 6 |
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| Primary | Occurrence and Level of HIV-specific Total IgG Binding Antibody Response Breadth and Magnitude - Positive Response Rates. | IgG binding antibody breadth assays were not run. Instead, IgG was assayed against a smaller panel of antigens. Serum IgG responses were measured on a Bio-Plex instrument using a custom Luminex assay, run at 1:50 dilution. The readout is background-subtracted mean fluorescent intensity (MFI), with background adjustment for an antigen-specific plate level control. For each sample, response magnitude is net MFI, defined as experimental antigen minus reference antigen MFI. Net MFI below 1 is set to 1, and Net MFI above 22,000 is set to 22,000. Samples from post-baseline visits have positive responses if they meet three criteria: (1) net MFI >= antigen-specific threshold (defined as the maximum of 100 and the 95th percentile of baseline net MFI), (2) net MFI > 3 times baseline net MFI, and (3) experimental antigen MFI > 3 times baseline MFI. Data are excluded if the blood draw date was outside the allowable window, a participant was HIV-infected, or the reference antigen exceeds 5000 MFI. | In this report, the "overall number of participants analyzed" represents the HIV uninfected participants with specimens at Month6.5. The "Number Analyzed" in the Outcome Measure Data Table shows the number of participants with available BAMA data after filtering for assay specific quality control criteria. | Posted | Count of Participants | Participants | Measured at Month 6.5 |
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| Primary | Occurrence and Level of HIV-specific Total IgG Binding Antibody Response Breadth and Magnitude - Magnitudes. | IgG binding antibody breadth assays were not run. Instead, IgG was assayed against a smaller panel of antigens.Serum IgG responses were measured on a Bio-Plex instrument using a custom Luminex assay, run at 1:50 dilution. The readout is background-subtracted mean fluorescent intensity (MFI), with background adjustment for an antigen-specific plate level control. For each sample, response magnitude is net MFI, defined as experimental antigen minus reference antigen MFI. Net MFI below 1 is set to 1, and Net MFI above 22,000 is set to 22,000. Samples from post-baseline visits have positive responses if they meet three criteria: (1) net MFI >= antigen-specific threshold (defined as the maximum of 100 and the 95th percentile of baseline net MFI), (2) net MFI > 3 times baseline net MFI, and (3) experimental antigen MFI > 3 times baseline MFI. Data are excluded if the blood draw date was outside the allowable window, a participant was HIV-infected, or the reference antigen exceeds 5000 MFI. | In this report, the "overall number of participants analyzed" represents the HIV uninfected participants with specimens at Month6.5. The "Number Analyzed" in the Outcome Measure Data Table shows the number of participants with available BAMA data after filtering for assay specific quality control criteria. | Posted | Median | Inter-Quartile Range | relative fluorescence units | Measured at Month 6.5 |
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| Primary | Occurrence and Level of Anti -V1/V2 Scaffold IgG Binding Antibody Responses - Positive Response Rates. | Serum IgG responses were measured on a Bio-Plex instrument using a custom Luminex assay, run at 1:50 dilution. The readout is background-subtracted mean fluorescent intensity (MFI), with background adjustment for an antigen-specific plate level control. For each sample, response magnitude is net MFI, defined as experimental antigen minus reference antigen MFI. Net MFI below 1 is set to 1, and Net MFI above 22,000 is set to 22,000. Samples from post-baseline visits have positive responses if they meet three criteria: (1) net MFI >= antigen-specific threshold (defined as the maximum of 100 and the 95th percentile of baseline net MFI), (2) net MFI > 3 times baseline net MFI, and (3) experimental antigen MFI > 3 times baseline MFI. Data are excluded if the blood draw date was outside the allowable window, a participant was HIV-infected, or the reference antigen exceeds 5000 MFI. | In this report, the "overall number of participants analyzed" represents the HIV uninfected participants with specimens at Month6.5. The "Number Analyzed" in the Outcome Measure Data Table shows the number of participants with available BAMA data after filtering for assay specific quality control criteria. | Posted | Count of Participants | Participants | Measured at Month 6.5 |
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| Primary | Occurrence and Level of Anti -V1/V2 Scaffold IgG Binding Antibody Response - Magnitudes. | Serum IgG responses were measured on a Bio-Plex instrument using a custom Luminex assay, run at 1:50 dilution. The readout is background-subtracted mean fluorescent intensity (MFI), with background adjustment for an antigen-specific plate level control. For each sample, response magnitude is net MFI, defined as experimental antigen minus reference antigen MFI. Net MFI below 1 is set to 1, and Net MFI above 22,000 is set to 22,000. Samples from post-baseline visits have positive responses if they meet three criteria: (1) net MFI >= antigen-specific threshold (defined as the maximum of 100 and the 95th percentile of baseline net MFI), (2) net MFI > 3 times baseline net MFI, and (3) experimental antigen MFI > 3 times baseline MFI. Data are excluded if the blood draw date was outside the allowable window, a participant was HIV-infected, or the reference antigen exceeds 5000 MFI. | In this report, the "overall number of participants analyzed" represents the HIV uninfected participants with specimens at Month6.5. The "Number Analyzed" in the Outcome Measure Data Table shows the number of participants with available BAMA data after filtering for assay specific quality control criteria. | Posted | Median | Inter-Quartile Range | relative fluorescence units | Measured at Month 6.5 |
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| Primary | Occurrence and Level of Neutralizing Antibody Responses Against HIV-1 Isolates. | The neutralizing antibody assay was not run. Therefore this dataset doesn't exist | Data were not collected | Posted | Measured at Month 6.5 |
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| Primary | Occurrence and Level of HIV-specific CD4+ T-cell Responses - Positive Response Rates. | PBMC samples are stimulated with synthetic peptide pools or left unstimulated as a negative control. For each sample, T-cell subset, and peptide pool, response magnitude is % cells expressing markers after peptide stimulation minus % cells expressing markers after no stimulation. A contingency table is constructed to assess response: stimulation (peptide/none) vs. marker expression (yes/no). A one-sided Fisher's exact test is applied, testing if the number of cells positive for the marker is equal in the stimulated vs. unstimulated cells. A discrete Bonferroni adjustment is made over the peptide pools. Response is positive if p<=0.00001. Any Env magnitude is the maximum of gp120 and Env ZM96 magnitude; Any Pol is the sum of CN54 magnitude; and Any HIV is the sum of Gag ZM96, Nef CN54, Any Pol, and Any Env. Data are excluded if the blood draw date was outside the visit window, the participant was HIV-infected, PBMC viability or T-cell count were low, or negative control was high. | In this report, the "overall number of participants analyzed" represents the HIV uninfected participants with specimens at Month6.5. The "Number Analyzed" in the Outcome Measure Data Table shows the number of participants with available ICS data after filtering for assay specific quality control criteria. | Posted | Count of Participants | Participants | Measured at Month 6.5 |
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| Primary | Occurrence and Level of HIV-specific CD4+ T-cell Responses - Magnitudes. | PBMC samples are stimulated with synthetic peptide pools or left unstimulated as a negative control. For each sample, T-cell subset, and peptide pool, response magnitude is % cells expressing markers after peptide stimulation minus % cells expressing markers after no stimulation. A contingency table is constructed to assess response: stimulation (peptide/none) vs. marker expression (yes/no). A one-sided Fisher's exact test is applied, testing if the number of cells positive for the marker is equal in the stimulated vs. unstimulated cells. A discrete Bonferroni adjustment is made over the peptide pools. Response is positive if p<=0.00001. Any Env magnitude is the maximum of gp120 and Env ZM96 magnitude; Any Pol is the sum of CN54 magnitude; and Any HIV is the sum of Gag ZM96, Nef CN54, Any Pol, and Any Env. Data are excluded if the blood draw date was outside the visit window, the participant was HIV-infected, PBMC viability or T-cell count were low, or negative control was high. | In this report, the "overall number of participants analyzed" represents the HIV uninfected participants with specimens at Month6.5. The "Number Analyzed" in the Outcome Measure Data Table shows the number of participants with available ICS data after filtering for assay specific quality control criteria. | Posted | Median | Inter-Quartile Range | percent T-cells | Measured at Month 6.5 |
| ||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Occurrence and Level of HIV-specific CD8+ T-cell Responses - Positive Response Rates. | PBMC samples are stimulated with synthetic peptide pools or left unstimulated as a negative control. For each sample, T-cell subset, and peptide pool, response magnitude is % cells expressing markers after peptide stimulation minus % cells expressing markers after no stimulation. A contingency table is constructed to assess response: stimulation (peptide/none) vs. marker expression (yes/no). A one-sided Fisher's exact test is applied, testing if the number of cells positive for the marker is equal in the stimulated vs. unstimulated cells. A discrete Bonferroni adjustment is made over the peptide pools. Response is positive if p<=0.00001. Any Env magnitude is the maximum of gp120 and Env ZM96 magnitude; Any Pol is the sum of CN54 magnitude; and Any HIV is the sum of Gag ZM96, Nef CN54, Any Pol, and Any Env. Data are excluded if the blood draw date was outside the visit window, the participant was HIV-infected, PBMC viability or T-cell count were low, or negative control was high. | In this report, the "overall number of participants analyzed" represents the HIV uninfected participants with specimens at Month6.5. The "Number Analyzed" in the Outcome Measure Data Table shows the number of participants with available ICS data after filtering for assay specific quality control criteria. | Posted | Count of Participants | Participants | Measured at Month 6.5 |
| |||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Occurrence and Level of HIV-specific CD8+ T-cell Responses - Magnitudes. | PBMC samples are stimulated with synthetic peptide pools or left unstimulated as a negative control. For each sample, T-cell subset, and peptide pool, response magnitude is % cells expressing markers after peptide stimulation minus % cells expressing markers after no stimulation. A contingency table is constructed to assess response: stimulation (peptide/none) vs. marker expression (yes/no). A one-sided Fisher's exact test is applied, testing if the number of cells positive for the marker is equal in the stimulated vs. unstimulated cells. A discrete Bonferroni adjustment is made over the peptide pools. Response is positive if p<=0.00001. Any Env magnitude is the maximum of gp120 and Env ZM96 magnitude; Any Pol is the sum of CN54 magnitude; and Any HIV is the sum of Gag ZM96, Nef CN54, Any Pol, and Any Env. Data are excluded if the blood draw date was outside the visit window, the participant was HIV-infected, PBMC viability or T-cell count were low, or negative control was high. | In this report, the "overall number of participants analyzed" represents the HIV uninfected participants with specimens at Month6.5. The "Number Analyzed" in the Outcome Measure Data Table shows the number of participants with available ICS data after filtering for assay specific quality control criteria. | Posted | Median | Inter-Quartile Range | percent T-cells | Measured at Month 6.5 |
|
Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.
Adverse events of special interest were described in the protocol Appendix J. AESI for this protocol include but are not limited to potential immune-mediated diseases.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59 | Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo in their right deltoid at Months 0 and 1, and placebo and the Protein/MF59 vaccine in their right deltoid at Months 3 and 6. DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose. Bivalent Subtype C gp120/MF59 vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, each at a dose of 100 mcg, mixed with MF59 adjuvant, administered by IM injection to the right deltoid as a single 0.5 mL dose. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products. | 0 | 30 | 0 | 30 | 24 | 30 |
| EG001 | Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01B | Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo in their right deltoid at Months 0 and 1, and placebo and the Protein/AS01B vaccine in their right deltoid at Months 3 and 6. DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose. Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose. Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products. | 0 | 50 | 1 | 50 | 33 | 50 |
| EG002 | Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01B | Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo in their right deltoid at Months 0 and 1, and placebo and the Protein/AS01B vaccine in their right deltoid at Months 3 and 6. DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose. Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose. Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products. | 0 | 50 | 0 | 50 | 34 | 50 |
| EG003 | Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59 | Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, and 6 and placebo in their left deltoid at Month 3. They will receive placebo and the Protein/MF59 vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3. DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose. Bivalent Subtype C gp120/MF59 vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, each at a dose of 100 mcg, mixed with MF59 adjuvant, administered by IM injection to the right deltoid as a single 0.5 mL dose. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products. | 0 | 30 | 1 | 30 | 20 | 30 |
| EG004 | Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01B | Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, and 6 and placebo in their left deltoid at Month 3. They will receive placebo and the Protein/AS01B vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3. DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose. Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose. Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products. | 0 | 50 | 1 | 50 | 39 | 50 |
| EG005 | Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01B | Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, and 6 and placebo in their left deltoid at Month 3. They will receive placebo and the Protein/AS01B vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3. DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose. Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose. Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products. | 0 | 50 | 1 | 50 | 31 | 50 |
| EG006 | Group 7: Placebo + Protein/AS01B | Participants will receive placebo in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo and the Protein/AS01B vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3. Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose. Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products. | 0 | 50 | 0 | 50 | 27 | 50 |
| EG007 | Group 8: Placebo | Participants will receive placebo in both their right and left deltoids at Months 0, 1, 3, and 6. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products. | 0 | 24 | 0 | 24 | 13 | 24 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Any SOC | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Obstructive pancreatitis | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Any SOC | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Any SOC | Injury, poisoning and procedural complications | MedDRA 23.0 | Non-systematic Assessment |
| |
| Facial bones fracture | Injury, poisoning and procedural complications | MedDRA 23.0 | Non-systematic Assessment |
| |
| Any SOC | Reproductive system and breast disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Dysfunctional uterine bleeding | Reproductive system and breast disorders | MedDRA 23.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Any SOC | Blood and lymphatic system disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Lymph node pain | Blood and lymphatic system disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Any SOC | Ear and labyrinth disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Any SOC | Eye disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Eye irritation | Eye disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Eye pruritus | Eye disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Any SOC | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Dental caries | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Peptic ulcer | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Any SOC | General disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Axillary pain | General disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Hangover | General disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Injection site pruritus | General disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Injection site warmth | General disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Peripheral swelling | General disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Any SOC | Immune system disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Seasonal allergy | Immune system disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Any SOC | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Acarodermatitis | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Acute sinusitis | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Bacterial vaginosis | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Body tinea | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Ear infection | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Folliculitis | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Fungal infection | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Furuncle | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Genital herpes | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Genitourinary chlamydia infection | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Genitourinary tract gonococcal infection | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Gingivitis | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Hordeolum | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Infectious mononucleosis | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Molluscum contagiosum | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Mycetoma mycotic | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Otitis externa | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Pharyngitis streptococcal | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Proctitis chlamydial | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Sexually transmitted disease | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Skin bacterial infection | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Tinea pedis | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Tinea versicolour | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Tonsillitis bacterial | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Tooth abscess | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Tooth infection | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Urethritis | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Vaginitis chlamydial | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Viral rhinitis | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Vulvovaginal candidiasis | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Vulvovaginal mycotic infection | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Vulvovaginitis trichomonal | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Any SOC | Injury, poisoning and procedural complications | MedDRA 23.0 | Non-systematic Assessment |
| |
| Animal bite | Injury, poisoning and procedural complications | MedDRA 23.0 | Non-systematic Assessment |
| |
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA 23.0 | Non-systematic Assessment |
| |
| Chemical burn of skin | Injury, poisoning and procedural complications | MedDRA 23.0 | Non-systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 23.0 | Non-systematic Assessment |
| |
| Foot fracture | Injury, poisoning and procedural complications | MedDRA 23.0 | Non-systematic Assessment |
| |
| Head injury | Injury, poisoning and procedural complications | MedDRA 23.0 | Non-systematic Assessment |
| |
| Joint injury | Injury, poisoning and procedural complications | MedDRA 23.0 | Non-systematic Assessment |
| |
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA 23.0 | Non-systematic Assessment |
| |
| Limb injury | Injury, poisoning and procedural complications | MedDRA 23.0 | Non-systematic Assessment |
| |
| Muscle strain | Injury, poisoning and procedural complications | MedDRA 23.0 | Non-systematic Assessment |
| |
| Nasal injury | Injury, poisoning and procedural complications | MedDRA 23.0 | Non-systematic Assessment |
| |
| Scratch | Injury, poisoning and procedural complications | MedDRA 23.0 | Non-systematic Assessment |
| |
| Skin laceration | Injury, poisoning and procedural complications | MedDRA 23.0 | Non-systematic Assessment |
| |
| Stab wound | Injury, poisoning and procedural complications | MedDRA 23.0 | Non-systematic Assessment |
| |
| Thermal burn | Injury, poisoning and procedural complications | MedDRA 23.0 | Non-systematic Assessment |
| |
| Wound | Injury, poisoning and procedural complications | MedDRA 23.0 | Non-systematic Assessment |
| |
| Any SOC | Investigations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Blood pressure increased | Investigations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Any SOC | Metabolism and nutrition disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Any SOC | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Limb mass | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Synovial cyst | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Tendonitis | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Any SOC | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Non-systematic Assessment |
| |
| Lipoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Non-systematic Assessment |
| |
| Any SOC | Nervous system disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Any SOC | Pregnancy, puerperium and perinatal conditions | MedDRA 23.0 | Non-systematic Assessment |
| |
| Ectopic pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA 23.0 | Non-systematic Assessment |
| |
| Any SOC | Psychiatric disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Alcoholic hangover | Psychiatric disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Attention deficit hyperactivity disorder | Psychiatric disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Any SOC | Renal and urinary disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Glycosuria | Renal and urinary disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Any SOC | Reproductive system and breast disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Cervical dysplasia | Reproductive system and breast disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Menstruation irregular | Reproductive system and breast disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Polycystic ovaries | Reproductive system and breast disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Testicular pain | Reproductive system and breast disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Vulvovaginal pruritus | Reproductive system and breast disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Any SOC | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Pleuritic pain | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Respiratory symptom | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Sinus pain | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Any SOC | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Dermal cyst | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Miliaria | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Neurodermatitis | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Rash erythematous | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Rash macular | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Rash papular | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Rash pruritic | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Seborrhoeic dermatitis | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Xeroderma | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Any SOC | Vascular disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Peripheral coldness | Vascular disorders | MedDRA 23.0 | Non-systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jessica Andriesen, PhD, Associate Director of HVTN SDMC Operations | Fred Hutchinson Cancer Research Center | 206-667-5812 | jandries@fredhutch.org |
| Aug 7, 2020 |
| Prot_SAP_ICF_000.pdf |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D011506 | Proteins |
| ID | Term |
|---|---|
| D000602 | Amino Acids, Peptides, and Proteins |
Not provided
Not provided
| 18 - 20 years |
|
| 21 - 30 years |
|
| 31 - 40 years |
|
| 41 - 50 years |
|
| Over 50 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Africa |
|
| Mild |
|
| Moderate |
|
| Severe |
|
| Life Threatening |
|
| Tenderness |
|
| Pain and/or Tenderness |
|
| OG002 | Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01B | Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo in their right deltoid at Months 0 and 1, and placebo and the Protein/AS01B vaccine in their right deltoid at Months 3 and 6. DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose. Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose. Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products. |
| OG003 | Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59 | Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, and 6 and placebo in their left deltoid at Month 3. They will receive placebo and the Protein/MF59 vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3. DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose. Bivalent Subtype C gp120/MF59 vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, each at a dose of 100 mcg, mixed with MF59 adjuvant, administered by IM injection to the right deltoid as a single 0.5 mL dose. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products. |
| OG004 | Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01B | Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, and 6 and placebo in their left deltoid at Month 3. They will receive placebo and the Protein/AS01B vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3. DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose. Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose. Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products. |
| OG005 | Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01B | Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, and 6 and placebo in their left deltoid at Month 3. They will receive placebo and the Protein/AS01B vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3. DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose. Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose. Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products. |
| OG006 | Group 7: Placebo + Protein/AS01B | Participants will receive placebo in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo and the Protein/AS01B vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3. Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose. Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products. |
| OG007 | Group 8: Placebo | Participants will receive placebo in both their right and left deltoids at Months 0, 1, 3, and 6. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products. |
|
|
| OG001 |
| Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01B |
Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo in their right deltoid at Months 0 and 1, and placebo and the Protein/AS01B vaccine in their right deltoid at Months 3 and 6. DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose. Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose. Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products. |
| OG002 | Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01B | Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo in their right deltoid at Months 0 and 1, and placebo and the Protein/AS01B vaccine in their right deltoid at Months 3 and 6. DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose. Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose. Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products. |
| OG003 | Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59 | Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, and 6 and placebo in their left deltoid at Month 3. They will receive placebo and the Protein/MF59 vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3. DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose. Bivalent Subtype C gp120/MF59 vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, each at a dose of 100 mcg, mixed with MF59 adjuvant, administered by IM injection to the right deltoid as a single 0.5 mL dose. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products. |
| OG004 | Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01B | Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, and 6 and placebo in their left deltoid at Month 3. They will receive placebo and the Protein/AS01B vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3. DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose. Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose. Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products. |
| OG005 | Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01B | Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, and 6 and placebo in their left deltoid at Month 3. They will receive placebo and the Protein/AS01B vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3. DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose. Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose. Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products. |
| OG006 | Group 7: Placebo + Protein/AS01B | Participants will receive placebo in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo and the Protein/AS01B vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3. Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose. Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products. |
| OG007 | Group 8: Placebo | Participants will receive placebo in both their right and left deltoids at Months 0, 1, 3, and 6. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products. |
|
|
| OG002 | Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01B | Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo in their right deltoid at Months 0 and 1, and placebo and the Protein/AS01B vaccine in their right deltoid at Months 3 and 6. DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose. Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose. Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products. |
| OG003 | Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59 | Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, and 6 and placebo in their left deltoid at Month 3. They will receive placebo and the Protein/MF59 vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3. DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose. Bivalent Subtype C gp120/MF59 vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, each at a dose of 100 mcg, mixed with MF59 adjuvant, administered by IM injection to the right deltoid as a single 0.5 mL dose. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products. |
| OG004 | Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01B | Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, and 6 and placebo in their left deltoid at Month 3. They will receive placebo and the Protein/AS01B vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3. DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose. Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose. Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products. |
| OG005 | Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01B | Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, and 6 and placebo in their left deltoid at Month 3. They will receive placebo and the Protein/AS01B vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3. DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose. Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose. Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products. |
| OG006 | Group 7: Placebo + Protein/AS01B | Participants will receive placebo in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo and the Protein/AS01B vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3. Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose. Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products. |
| OG007 | Group 8: Placebo | Participants will receive placebo in both their right and left deltoids at Months 0, 1, 3, and 6. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products. |
|
|
| OG002 | Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01B | Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo in their right deltoid at Months 0 and 1, and placebo and the Protein/AS01B vaccine in their right deltoid at Months 3 and 6. DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose. Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose. Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products. |
| OG003 | Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59 | Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, and 6 and placebo in their left deltoid at Month 3. They will receive placebo and the Protein/MF59 vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3. DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose. Bivalent Subtype C gp120/MF59 vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, each at a dose of 100 mcg, mixed with MF59 adjuvant, administered by IM injection to the right deltoid as a single 0.5 mL dose. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products. |
| OG004 | Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01B | Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, and 6 and placebo in their left deltoid at Month 3. They will receive placebo and the Protein/AS01B vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3. DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose. Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose. Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products. |
| OG005 | Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01B | Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, and 6 and placebo in their left deltoid at Month 3. They will receive placebo and the Protein/AS01B vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3. DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose. Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose. Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products. |
| OG006 | Group 7: Placebo + Protein/AS01B | Participants will receive placebo in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo and the Protein/AS01B vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3. Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose. Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products. |
| OG007 | Group 8: Placebo | Participants will receive placebo in both their right and left deltoids at Months 0, 1, 3, and 6. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products. |
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| OG002 | Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01B | Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo in their right deltoid at Months 0 and 1, and placebo and the Protein/AS01B vaccine in their right deltoid at Months 3 and 6. DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose. Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose. Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products. |
| OG003 | Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59 | Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, and 6 and placebo in their left deltoid at Month 3. They will receive placebo and the Protein/MF59 vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3. DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose. Bivalent Subtype C gp120/MF59 vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, each at a dose of 100 mcg, mixed with MF59 adjuvant, administered by IM injection to the right deltoid as a single 0.5 mL dose. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products. |
| OG004 | Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01B | Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, and 6 and placebo in their left deltoid at Month 3. They will receive placebo and the Protein/AS01B vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3. DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose. Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose. Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products. |
| OG005 | Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01B | Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, and 6 and placebo in their left deltoid at Month 3. They will receive placebo and the Protein/AS01B vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3. DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose. Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose. Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products. |
| OG006 | Group 7: Placebo + Protein/AS01B | Participants will receive placebo in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo and the Protein/AS01B vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3. Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose. Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products. |
| OG007 | Group 8: Placebo | Participants will receive placebo in both their right and left deltoids at Months 0, 1, 3, and 6. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products. |
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| OG002 | Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01B | Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo in their right deltoid at Months 0 and 1, and placebo and the Protein/AS01B vaccine in their right deltoid at Months 3 and 6. DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose. Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose. Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products. |
| OG003 | Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59 | Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, and 6 and placebo in their left deltoid at Month 3. They will receive placebo and the Protein/MF59 vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3. DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose. Bivalent Subtype C gp120/MF59 vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, each at a dose of 100 mcg, mixed with MF59 adjuvant, administered by IM injection to the right deltoid as a single 0.5 mL dose. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products. |
| OG004 | Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01B | Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, and 6 and placebo in their left deltoid at Month 3. They will receive placebo and the Protein/AS01B vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3. DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose. Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose. Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products. |
| OG005 | Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01B | Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, and 6 and placebo in their left deltoid at Month 3. They will receive placebo and the Protein/AS01B vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3. DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose. Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose. Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products. |
| OG006 | Group 7: Placebo + Protein/AS01B | Participants will receive placebo in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo and the Protein/AS01B vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3. Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose. Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products. |
| OG007 | Group 8: Placebo | Participants will receive placebo in both their right and left deltoids at Months 0, 1, 3, and 6. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products. |
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| OG002 | Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01B | Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo in their right deltoid at Months 0 and 1, and placebo and the Protein/AS01B vaccine in their right deltoid at Months 3 and 6. DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose. Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose. Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products. |
| OG003 | Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59 | Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, and 6 and placebo in their left deltoid at Month 3. They will receive placebo and the Protein/MF59 vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3. DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose. Bivalent Subtype C gp120/MF59 vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, each at a dose of 100 mcg, mixed with MF59 adjuvant, administered by IM injection to the right deltoid as a single 0.5 mL dose. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products. |
| OG004 | Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01B | Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, and 6 and placebo in their left deltoid at Month 3. They will receive placebo and the Protein/AS01B vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3. DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose. Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose. Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products. |
| OG005 | Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01B | Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, and 6 and placebo in their left deltoid at Month 3. They will receive placebo and the Protein/AS01B vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3. DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose. Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose. Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products. |
| OG006 | Group 7: Placebo + Protein/AS01B | Participants will receive placebo in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo and the Protein/AS01B vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3. Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose. Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products. |
| OG007 | Group 8: Placebo | Participants will receive placebo in both their right and left deltoids at Months 0, 1, 3, and 6. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products. |
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| OG002 | Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01B | Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo in their right deltoid at Months 0 and 1, and placebo and the Protein/AS01B vaccine in their right deltoid at Months 3 and 6. DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose. Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose. Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products. |
| OG003 | Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59 | Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, and 6 and placebo in their left deltoid at Month 3. They will receive placebo and the Protein/MF59 vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3. DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose. Bivalent Subtype C gp120/MF59 vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, each at a dose of 100 mcg, mixed with MF59 adjuvant, administered by IM injection to the right deltoid as a single 0.5 mL dose. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products. |
| OG004 | Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01B | Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, and 6 and placebo in their left deltoid at Month 3. They will receive placebo and the Protein/AS01B vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3. DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose. Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose. Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products. |
| OG005 | Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01B | Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, and 6 and placebo in their left deltoid at Month 3. They will receive placebo and the Protein/AS01B vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3. DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose. Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose. Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products. |
| OG006 | Group 7: Placebo + Protein/AS01B | Participants will receive placebo in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo and the Protein/AS01B vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3. Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose. Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products. |
| OG007 | Group 8: Placebo | Participants will receive placebo in both their right and left deltoids at Months 0, 1, 3, and 6. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products. |
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| OG002 | Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01B | Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo in their right deltoid at Months 0 and 1, and placebo and the Protein/AS01B vaccine in their right deltoid at Months 3 and 6. DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose. Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose. Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products. |
| OG003 | Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59 | Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, and 6 and placebo in their left deltoid at Month 3. They will receive placebo and the Protein/MF59 vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3. DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose. Bivalent Subtype C gp120/MF59 vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, each at a dose of 100 mcg, mixed with MF59 adjuvant, administered by IM injection to the right deltoid as a single 0.5 mL dose. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products. |
| OG004 | Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01B | Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, and 6 and placebo in their left deltoid at Month 3. They will receive placebo and the Protein/AS01B vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3. DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose. Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose. Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products. |
| OG005 | Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01B | Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, and 6 and placebo in their left deltoid at Month 3. They will receive placebo and the Protein/AS01B vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3. DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose. Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose. Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products. |
| OG006 | Group 7: Placebo + Protein/AS01B | Participants will receive placebo in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo and the Protein/AS01B vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3. Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose. Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products. |
| OG007 | Group 8: Placebo | Participants will receive placebo in both their right and left deltoids at Months 0, 1, 3, and 6. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products. |
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| OG002 | Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01B | Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo in their right deltoid at Months 0 and 1, and placebo and the Protein/AS01B vaccine in their right deltoid at Months 3 and 6. DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose. Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose. Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products. |
| OG003 | Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59 | Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, and 6 and placebo in their left deltoid at Month 3. They will receive placebo and the Protein/MF59 vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3. DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose. Bivalent Subtype C gp120/MF59 vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, each at a dose of 100 mcg, mixed with MF59 adjuvant, administered by IM injection to the right deltoid as a single 0.5 mL dose. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products. |
| OG004 | Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01B | Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, and 6 and placebo in their left deltoid at Month 3. They will receive placebo and the Protein/AS01B vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3. DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose. Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose. Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products. |
| OG005 | Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01B | Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, and 6 and placebo in their left deltoid at Month 3. They will receive placebo and the Protein/AS01B vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3. DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose. Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose. Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products. |
| OG006 | Group 7: Placebo + Protein/AS01B | Participants will receive placebo in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo and the Protein/AS01B vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3. Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose. Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products. |
| OG007 | Group 8: Placebo | Participants will receive placebo in both their right and left deltoids at Months 0, 1, 3, and 6. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products. |
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| OG002 | Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01B | Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo in their right deltoid at Months 0 and 1, and placebo and the Protein/AS01B vaccine in their right deltoid at Months 3 and 6. DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose. Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose. Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products. |
| OG003 | Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59 | Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, and 6 and placebo in their left deltoid at Month 3. They will receive placebo and the Protein/MF59 vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3. DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose. Bivalent Subtype C gp120/MF59 vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, each at a dose of 100 mcg, mixed with MF59 adjuvant, administered by IM injection to the right deltoid as a single 0.5 mL dose. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products. |
| OG004 | Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01B | Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, and 6 and placebo in their left deltoid at Month 3. They will receive placebo and the Protein/AS01B vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3. DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose. Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose. Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products. |
| OG005 | Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01B | Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, and 6 and placebo in their left deltoid at Month 3. They will receive placebo and the Protein/AS01B vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3. DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose. Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose. Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products. |
| OG006 | Group 7: Placebo + Protein/AS01B | Participants will receive placebo in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo and the Protein/AS01B vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3. Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose. Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products. |
| OG007 | Group 8: Placebo | Participants will receive placebo in both their right and left deltoids at Months 0, 1, 3, and 6. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products. |
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| OG002 | Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01B | Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo in their right deltoid at Months 0 and 1, and placebo and the Protein/AS01B vaccine in their right deltoid at Months 3 and 6. DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose. Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose. Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products. |
| OG003 | Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59 | Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, and 6 and placebo in their left deltoid at Month 3. They will receive placebo and the Protein/MF59 vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3. DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose. Bivalent Subtype C gp120/MF59 vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, each at a dose of 100 mcg, mixed with MF59 adjuvant, administered by IM injection to the right deltoid as a single 0.5 mL dose. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products. |
| OG004 | Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01B | Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, and 6 and placebo in their left deltoid at Month 3. They will receive placebo and the Protein/AS01B vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3. DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose. Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose. Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products. |
| OG005 | Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01B | Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, and 6 and placebo in their left deltoid at Month 3. They will receive placebo and the Protein/AS01B vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3. DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose. Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose. Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products. |
| OG006 | Group 7: Placebo + Protein/AS01B | Participants will receive placebo in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo and the Protein/AS01B vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3. Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose. Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products. |
| OG007 | Group 8: Placebo | Participants will receive placebo in both their right and left deltoids at Months 0, 1, 3, and 6. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products. |
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| OG002 | Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01B | Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo in their right deltoid at Months 0 and 1, and placebo and the Protein/AS01B vaccine in their right deltoid at Months 3 and 6. DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose. Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose. Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products. |
| OG003 | Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59 | Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, and 6 and placebo in their left deltoid at Month 3. They will receive placebo and the Protein/MF59 vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3. DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose. Bivalent Subtype C gp120/MF59 vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, each at a dose of 100 mcg, mixed with MF59 adjuvant, administered by IM injection to the right deltoid as a single 0.5 mL dose. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products. |
| OG004 | Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01B | Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, and 6 and placebo in their left deltoid at Month 3. They will receive placebo and the Protein/AS01B vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3. DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose. Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose. Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products. |
| OG005 | Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01B | Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, and 6 and placebo in their left deltoid at Month 3. They will receive placebo and the Protein/AS01B vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3. DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose. Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose. Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products. |
| OG006 | Group 7: Placebo + Protein/AS01B | Participants will receive placebo in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo and the Protein/AS01B vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3. Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose. Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products. |
| OG007 | Group 8: Placebo | Participants will receive placebo in both their right and left deltoids at Months 0, 1, 3, and 6. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products. |
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| OG002 | Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01B | Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo in their right deltoid at Months 0 and 1, and placebo and the Protein/AS01B vaccine in their right deltoid at Months 3 and 6. DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose. Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose. Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products. |
| OG003 | Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59 | Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, and 6 and placebo in their left deltoid at Month 3. They will receive placebo and the Protein/MF59 vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3. DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose. Bivalent Subtype C gp120/MF59 vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, each at a dose of 100 mcg, mixed with MF59 adjuvant, administered by IM injection to the right deltoid as a single 0.5 mL dose. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products. |
| OG004 | Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01B | Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, and 6 and placebo in their left deltoid at Month 3. They will receive placebo and the Protein/AS01B vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3. DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose. Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose. Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products. |
| OG005 | Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01B | Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, and 6 and placebo in their left deltoid at Month 3. They will receive placebo and the Protein/AS01B vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3. DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose. Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose. Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products. |
| OG006 | Group 7: Placebo + Protein/AS01B | Participants will receive placebo in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo and the Protein/AS01B vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3. Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose. Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products. |
| OG007 | Group 8: Placebo | Participants will receive placebo in both their right and left deltoids at Months 0, 1, 3, and 6. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products. |
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| OG002 | Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01B | Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo in their right deltoid at Months 0 and 1, and placebo and the Protein/AS01B vaccine in their right deltoid at Months 3 and 6. DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose. Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose. Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products. |
| OG003 | Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59 | Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, and 6 and placebo in their left deltoid at Month 3. They will receive placebo and the Protein/MF59 vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3. DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose. Bivalent Subtype C gp120/MF59 vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, each at a dose of 100 mcg, mixed with MF59 adjuvant, administered by IM injection to the right deltoid as a single 0.5 mL dose. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products. |
| OG004 | Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01B | Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, and 6 and placebo in their left deltoid at Month 3. They will receive placebo and the Protein/AS01B vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3. DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose. Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose. Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products. |
| OG005 | Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01B | Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, and 6 and placebo in their left deltoid at Month 3. They will receive placebo and the Protein/AS01B vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3. DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose. Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose. Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products. |
| OG006 | Group 7: Placebo + Protein/AS01B | Participants will receive placebo in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo and the Protein/AS01B vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3. Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose. Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products. |
| OG007 | Group 8: Placebo | Participants will receive placebo in both their right and left deltoids at Months 0, 1, 3, and 6. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products. |
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| OG001 | Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01B | Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo in their right deltoid at Months 0 and 1, and placebo and the Protein/AS01B vaccine in their right deltoid at Months 3 and 6. DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose. Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose. Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products. |
| OG002 | Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01B | Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo in their right deltoid at Months 0 and 1, and placebo and the Protein/AS01B vaccine in their right deltoid at Months 3 and 6. DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose. Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose. Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products. |
| OG003 | Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59 | Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, and 6 and placebo in their left deltoid at Month 3. They will receive placebo and the Protein/MF59 vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3. DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose. Bivalent Subtype C gp120/MF59 vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, each at a dose of 100 mcg, mixed with MF59 adjuvant, administered by IM injection to the right deltoid as a single 0.5 mL dose. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products. |
| OG004 | Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01B | Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, and 6 and placebo in their left deltoid at Month 3. They will receive placebo and the Protein/AS01B vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3. DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose. Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose. Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products. |
| OG005 | Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01B | Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, and 6 and placebo in their left deltoid at Month 3. They will receive placebo and the Protein/AS01B vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3. DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose. Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose. Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products. |
| OG006 | Group 7: Placebo + Protein/AS01B | Participants will receive placebo in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo and the Protein/AS01B vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3. Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose. Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products. |
| OG007 | Group 8: Placebo | Participants will receive placebo in both their right and left deltoids at Months 0, 1, 3, and 6. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products. |
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| OG001 | Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01B | Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo in their right deltoid at Months 0 and 1, and placebo and the Protein/AS01B vaccine in their right deltoid at Months 3 and 6. DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose. Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose. Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products. |
| OG002 | Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01B | Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo in their right deltoid at Months 0 and 1, and placebo and the Protein/AS01B vaccine in their right deltoid at Months 3 and 6. DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose. Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose. Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products. |
| OG003 | Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59 | Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, and 6 and placebo in their left deltoid at Month 3. They will receive placebo and the Protein/MF59 vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3. DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose. Bivalent Subtype C gp120/MF59 vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, each at a dose of 100 mcg, mixed with MF59 adjuvant, administered by IM injection to the right deltoid as a single 0.5 mL dose. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products. |
| OG004 | Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01B | Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, and 6 and placebo in their left deltoid at Month 3. They will receive placebo and the Protein/AS01B vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3. DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose. Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose. Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products. |
| OG005 | Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01B | Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, and 6 and placebo in their left deltoid at Month 3. They will receive placebo and the Protein/AS01B vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3. DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose. Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose. Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products. |
| OG006 | Group 7: Placebo + Protein/AS01B | Participants will receive placebo in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo and the Protein/AS01B vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3. Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose. Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products. |
| OG007 | Group 8: Placebo | Participants will receive placebo in both their right and left deltoids at Months 0, 1, 3, and 6. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products. |
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| OG001 | Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01B | Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo in their right deltoid at Months 0 and 1, and placebo and the Protein/AS01B vaccine in their right deltoid at Months 3 and 6. DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose. Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose. Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products. |
| OG002 | Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01B | Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo in their right deltoid at Months 0 and 1, and placebo and the Protein/AS01B vaccine in their right deltoid at Months 3 and 6. DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose. Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose. Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products. |
| OG003 | Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59 | Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, and 6 and placebo in their left deltoid at Month 3. They will receive placebo and the Protein/MF59 vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3. DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose. Bivalent Subtype C gp120/MF59 vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, each at a dose of 100 mcg, mixed with MF59 adjuvant, administered by IM injection to the right deltoid as a single 0.5 mL dose. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products. |
| OG004 | Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01B | Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, and 6 and placebo in their left deltoid at Month 3. They will receive placebo and the Protein/AS01B vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3. DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose. Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose. Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products. |
| OG005 | Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01B | Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, and 6 and placebo in their left deltoid at Month 3. They will receive placebo and the Protein/AS01B vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3. DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose. Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose. Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products. |
| OG006 | Group 7: Placebo + Protein/AS01B | Participants will receive placebo in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo and the Protein/AS01B vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3. Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose. Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products. |
| OG007 | Group 8: Placebo | Participants will receive placebo in both their right and left deltoids at Months 0, 1, 3, and 6. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products. |
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| OG001 | Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01B | Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo in their right deltoid at Months 0 and 1, and placebo and the Protein/AS01B vaccine in their right deltoid at Months 3 and 6. DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose. Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose. Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products. |
| OG002 | Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01B | Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo in their right deltoid at Months 0 and 1, and placebo and the Protein/AS01B vaccine in their right deltoid at Months 3 and 6. DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose. Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose. Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products. |
| OG003 | Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59 | Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, and 6 and placebo in their left deltoid at Month 3. They will receive placebo and the Protein/MF59 vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3. DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose. Bivalent Subtype C gp120/MF59 vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, each at a dose of 100 mcg, mixed with MF59 adjuvant, administered by IM injection to the right deltoid as a single 0.5 mL dose. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products. |
| OG004 | Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01B | Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, and 6 and placebo in their left deltoid at Month 3. They will receive placebo and the Protein/AS01B vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3. DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose. Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose. Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products. |
| OG005 | Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01B | Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, and 6 and placebo in their left deltoid at Month 3. They will receive placebo and the Protein/AS01B vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3. DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose. Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose. Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products. |
| OG006 | Group 7: Placebo + Protein/AS01B | Participants will receive placebo in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo and the Protein/AS01B vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3. Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose. Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products. |
| OG007 | Group 8: Placebo | Participants will receive placebo in both their right and left deltoids at Months 0, 1, 3, and 6. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products. |
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| OG002 | Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01B | Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo in their right deltoid at Months 0 and 1, and placebo and the Protein/AS01B vaccine in their right deltoid at Months 3 and 6. DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose. Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose. Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products. |
| OG003 | Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59 | Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, and 6 and placebo in their left deltoid at Month 3. They will receive placebo and the Protein/MF59 vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3. DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose. Bivalent Subtype C gp120/MF59 vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, each at a dose of 100 mcg, mixed with MF59 adjuvant, administered by IM injection to the right deltoid as a single 0.5 mL dose. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products. |
| OG004 | Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01B | Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, and 6 and placebo in their left deltoid at Month 3. They will receive placebo and the Protein/AS01B vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3. DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose. Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose. Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products. |
| OG005 | Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01B | Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, and 6 and placebo in their left deltoid at Month 3. They will receive placebo and the Protein/AS01B vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3. DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose. Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose. Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products. |
| OG006 | Group 7: Placebo + Protein/AS01B | Participants will receive placebo in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo and the Protein/AS01B vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3. Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose. Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products. |
| OG007 | Group 8: Placebo | Participants will receive placebo in both their right and left deltoids at Months 0, 1, 3, and 6. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products. |
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| OG001 | Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01B | Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo in their right deltoid at Months 0 and 1, and placebo and the Protein/AS01B vaccine in their right deltoid at Months 3 and 6. DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose. Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose. Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products. |
| OG002 | Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01B | Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo in their right deltoid at Months 0 and 1, and placebo and the Protein/AS01B vaccine in their right deltoid at Months 3 and 6. DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose. Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose. Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products. |
| OG003 | Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59 | Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, and 6 and placebo in their left deltoid at Month 3. They will receive placebo and the Protein/MF59 vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3. DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose. Bivalent Subtype C gp120/MF59 vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, each at a dose of 100 mcg, mixed with MF59 adjuvant, administered by IM injection to the right deltoid as a single 0.5 mL dose. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products. |
| OG004 | Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01B | Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, and 6 and placebo in their left deltoid at Month 3. They will receive placebo and the Protein/AS01B vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3. DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose. Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose. Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products. |
| OG005 | Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01B | Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, and 6 and placebo in their left deltoid at Month 3. They will receive placebo and the Protein/AS01B vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3. DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose. Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose. Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products. |
| OG006 | Group 7: Placebo + Protein/AS01B | Participants will receive placebo in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo and the Protein/AS01B vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3. Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose. Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products. |
| OG007 | Group 8: Placebo | Participants will receive placebo in both their right and left deltoids at Months 0, 1, 3, and 6. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products. |
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| OG001 | Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01B | Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo in their right deltoid at Months 0 and 1, and placebo and the Protein/AS01B vaccine in their right deltoid at Months 3 and 6. DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose. Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose. Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products. |
| OG002 | Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01B | Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo in their right deltoid at Months 0 and 1, and placebo and the Protein/AS01B vaccine in their right deltoid at Months 3 and 6. DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose. Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose. Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products. |
| OG003 | Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59 | Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, and 6 and placebo in their left deltoid at Month 3. They will receive placebo and the Protein/MF59 vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3. DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose. Bivalent Subtype C gp120/MF59 vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, each at a dose of 100 mcg, mixed with MF59 adjuvant, administered by IM injection to the right deltoid as a single 0.5 mL dose. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products. |
| OG004 | Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01B | Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, and 6 and placebo in their left deltoid at Month 3. They will receive placebo and the Protein/AS01B vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3. DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose. Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose. Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products. |
| OG005 | Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01B | Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, and 6 and placebo in their left deltoid at Month 3. They will receive placebo and the Protein/AS01B vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3. DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose. Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose. Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products. |
| OG006 | Group 7: Placebo + Protein/AS01B | Participants will receive placebo in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo and the Protein/AS01B vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3. Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose. Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products. |
| OG007 | Group 8: Placebo | Participants will receive placebo in both their right and left deltoids at Months 0, 1, 3, and 6. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products. |
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| OG001 | Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01B | Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo in their right deltoid at Months 0 and 1, and placebo and the Protein/AS01B vaccine in their right deltoid at Months 3 and 6. DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose. Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose. Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products. |
| OG002 | Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01B | Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo in their right deltoid at Months 0 and 1, and placebo and the Protein/AS01B vaccine in their right deltoid at Months 3 and 6. DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose. Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose. Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products. |
| OG003 | Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59 | Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, and 6 and placebo in their left deltoid at Month 3. They will receive placebo and the Protein/MF59 vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3. DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose. Bivalent Subtype C gp120/MF59 vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, each at a dose of 100 mcg, mixed with MF59 adjuvant, administered by IM injection to the right deltoid as a single 0.5 mL dose. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products. |
| OG004 | Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01B | Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, and 6 and placebo in their left deltoid at Month 3. They will receive placebo and the Protein/AS01B vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3. DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose. Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose. Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products. |
| OG005 | Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01B | Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, and 6 and placebo in their left deltoid at Month 3. They will receive placebo and the Protein/AS01B vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3. DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose. Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose. Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products. |
| OG006 | Group 7: Placebo + Protein/AS01B | Participants will receive placebo in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo and the Protein/AS01B vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3. Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose. Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products. |
| OG007 | Group 8: Placebo | Participants will receive placebo in both their right and left deltoids at Months 0, 1, 3, and 6. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products. |
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| OG001 | Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01B | Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo in their right deltoid at Months 0 and 1, and placebo and the Protein/AS01B vaccine in their right deltoid at Months 3 and 6. DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose. Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose. Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products. |
| OG002 | Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01B | Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo in their right deltoid at Months 0 and 1, and placebo and the Protein/AS01B vaccine in their right deltoid at Months 3 and 6. DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose. Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose. Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products. |
| OG003 | Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59 | Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, and 6 and placebo in their left deltoid at Month 3. They will receive placebo and the Protein/MF59 vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3. DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose. Bivalent Subtype C gp120/MF59 vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, each at a dose of 100 mcg, mixed with MF59 adjuvant, administered by IM injection to the right deltoid as a single 0.5 mL dose. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products. |
| OG004 | Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01B | Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, and 6 and placebo in their left deltoid at Month 3. They will receive placebo and the Protein/AS01B vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3. DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose. Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose. Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products. |
| OG005 | Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01B | Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, and 6 and placebo in their left deltoid at Month 3. They will receive placebo and the Protein/AS01B vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3. DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose. Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose. Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products. |
| OG006 | Group 7: Placebo + Protein/AS01B | Participants will receive placebo in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo and the Protein/AS01B vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3. Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose. Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products. |
| OG007 | Group 8: Placebo | Participants will receive placebo in both their right and left deltoids at Months 0, 1, 3, and 6. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products. |
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| Not gradable |
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| Grade 1: Less than 5 cm diameter |
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| Grade 1: Between 6.25 to 25 cm sq area |
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| Grade 2: Between 5 to 10 cm diameter |
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| Grade 2: Between 25 to 100 cm sq area |
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| Grade 3: Greater or equal to 10 cm |
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| Grade 3: Greater or equal to 100 cm sq |
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| Grade 3: complications |
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| Grade 4: complications |
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| Not gradable |
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| Grade 1: Less than 5 cm diameter |
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| Grade 1: Between 6.25 to 25 cm sq area |
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| Grade 2: Between 5 to 10 cm diameter |
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| Grade 2: Between 25 to 100 cm sq area |
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| Grade 3: Greater or equal to 10 cm |
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| Grade 3: Greater or equal to 100 cm sq |
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| Grade 3: complications |
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| Grade 4: complications |
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| Mild |
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| Moderate |
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| Severe |
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| Potentially Life-threatening |
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| Mild |
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| Moderate |
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| Severe |
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| Potentially Life-threatening |
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| Mild |
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| Moderate |
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| Severe |
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| Potentially Life-threatening |
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| Mild |
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| Moderate |
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| Severe |
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| Potentially Life-threatening |
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| Mild |
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| Moderate |
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| Severe |
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| Potentially Life-threatening |
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| Mild |
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| Moderate |
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| Severe |
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| Potentially Life-threatening |
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| Mild |
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| Moderate |
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| Severe |
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| Potentially Life-threatening |
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| Mild |
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| Moderate |
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| Severe |
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| Potentially Life-threatening |
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