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| Name | Class |
|---|---|
| HIV Vaccine Trials Network | NETWORK |
| Sanofi Pasteur, a Sanofi Company | INDUSTRY |
| GlaxoSmithKline | INDUSTRY |
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The purpose of this study is to evaluate the safety and immune response to an HIV clade C vaccine and to an MF59- or alum-adjuvanted clade C Env protein in healthy, HIV-uninfected adults.
This study will evaluate the safety, tolerability, and immunogenicity to vCP2438 (an HIV clade C vaccine) and to an unadjuvanted or MF59- or alum-adjuvanted bivalent clade C gp120 in healthy, HIV-uninfected adults.
The study will enroll healthy, HIV-uninfected participants aged 18 to 40 years. Participants will be randomly assigned to one of 4 groups. [describe further]
Study visits will include a physical examination, an interview and/or questionnaire, HIV testing and HIV risk-reduction counseling, and urine and blood collection. A subset of participants will provide rectal fluid, cervical fluid, semen, or stool samples.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: ALVAC-HIV + gp120/MF59 | Active Comparator | Participants will receive the ALVAC-HIV (vCP2438) vaccine in the left deltoid at months 0, 1, 3, 6, and 12, and Bivalent Subtype C gp120/MF59 in the right deltoid at months 3, 6, and 12. All injections are via needle and syringe. |
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| Group 2: ALVAC-HIV + gp120/Al(OH)3 | Active Comparator | Participants will receive the ALVAC-HIV (vCP2438) vaccine in the left deltoid at months 0, 1, 3, 6, and 12, and Bivalent Subtype C gp120 admixed with Al(OH)3 Suspension in the right deltoid at months 3, 6, and 12. All injections are via needle and syringe. |
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| Group 3: ALVAC-HIV + gp120/MF59 | Active Comparator | Participants will receive the ALVAC-HIV (vCP2438) vaccine in the left deltoid and Bivalent Subtype C gp120/MF59 in the right deltoid at months 0, 1, 6, and 12. All injections are via needle and syringe. |
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| Group 4: ALVAC-HIV + gp120 | Active Comparator | Participants will receive the ALVAC-HIV (vCP2438) vaccine in the left deltoid at months 0, 1, 3, 6, and 12, and Bivalent Subtype C gp120 in the right deltoid at months 3, 6, and 12. All injections are via needle and syringe. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ALVAC-HIV (vCP2438) | Biological | Expresses the gene products ZM96 gp120 (clade C strain) linked to the sequences encoding the HIV-1 transmembrane (TM) anchor sequence of gp41 (28 amino acids clade B LAI strain) and gag and pro (clade B LAI strain); formulated as a lyophilized vaccine for injection at a viral titer ≥ 1 × 10^6 cell culture infectious dose (CCID)50 and < 1 × 10^8 CCID50 (nominal dose of 10^7 CCID50) and reconstituted with 1mL of sterile sodium chloride solution (NaCl 0.4%) for intramuscular (IM) injection as a single dose |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of Vaccine-induced Systemic IgG Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C) in Group 1 and Group 2 | Serum IgG responses were measured on a Bio-Plex instrument using a standardized 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 MFI minus reference antigen MFI. Net MFI < 1 is set to 1, and net MFI > 22,000 is set to 22,000. Data are excluded if blood draw date was outside the allowable window, a participant was HIV-infected, reference antigen > 5,000 MFI, or baseline net MFI > 6,500. Samples from post-enrollment visits have positive responses if they meet three criteria: (1) net MFI greater than or equal to an antigen-specific response threshold (defined as the maximum of 100 and the 95th percentile of baseline net MFI), (2) net MFI values are greater than 3 times baseline net MFI, and (3) experimental antigen MFI values are greater than 3 times baseline MFI. | Measured at Month 6.5 |
| Level of Vaccine-induced Systemic IgG Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C) in Group 1 and Group 2 | Serum IgG responses were measured on a Bio-Plex instrument using a standardized 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 MFI minus reference antigen MFI. Net MFI < 1 is set to 1, and net MFI > 22,000 is set to 22,000. Data are excluded if blood draw date was outside the allowable window, a participant was HIV-infected, reference antigen > 5,000 MFI, or baseline net MFI > 6,500. Comparisons were performed among positive responders only (positivity criteria are described in Outcome 1). | Measured at Month 6.5 |
| Occurrence of Vaccine-induced Serum IgA Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C) in Group 1 and Group 3 | Serum IgA responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay, run at 1:10 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 MFI minus reference antigen MFI. Net MFI < 1 is set to 1, and net MFI > 22,000 is set to 22,000. Data are excluded if blood draw date was outside the allowable window, a participant was HIV-infected, reference antigen > 5,000 MFI, or baseline net MFI > 6,500. Samples from post-enrollment visits have positive responses if they meet three criteria: (1) net MFI greater than or equal to an antigen-specific response threshold (defined as the maximum of 100 and the 95th percentile of baseline net MFI), (2) net MFI values are greater than 3 times baseline net MFI, and (3) experimental antigen MFI values are greater than 3 times baseline MFI. |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of Vaccine-induced Serum IgG Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C) | Serum IgG responses were measured on a Bio-Plex instrument using a standardized 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 MFI minus reference antigen MFI. Net MFI < 1 is set to 1, and net MFI > 22,000 is set to 22,000. Data are excluded if blood draw date was outside the allowable window, a participant was HIV-infected, reference antigen > 5,000 MFI, or baseline net MFI > 6,500. Samples from post-enrollment visits have positive responses if they meet three criteria: (1) net MFI greater than or equal to an antigen-specific response threshold (defined as the maximum of 100 and the 95th percentile of baseline net MFI), (2) net MFI values are greater than 3 times baseline net MFI, and (3) experimental antigen MFI values are greater than 3 times baseline MFI. |
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Inclusion Criteria:
General and Demographic Criteria
Age of 18 to 40 years
Access to a participating HVTN CRS and willingness to be followed for the planned duration of the study
Ability and willingness to provide informed consent
Assessment of understanding: volunteer demonstrates understanding of this study; completes a questionnaire prior to first vaccination with verbal demonstration of understanding of all questionnaire items answered incorrectly
Agrees not to enroll in another study of an investigational research agent
Good general health as shown by medical history, physical exam, and screening laboratory tests
HIV-Related Criteria:
Willingness to receive HIV test results
Willingness to discuss HIV infection risks and amenable to HIV risk reduction counseling.
Assessed by the clinic staff as being at "low risk" for HIV infection and committed to maintaining behavior consistent with low risk of HIV exposure through the last required protocol clinic visit.
Laboratory Inclusion Values
Hemogram/Complete blood count (CBC)
Hemoglobin ≥ 11.0 g/dL for volunteers who were born female, ≥ 13.0 g/dL for volunteers who were born male
White blood cell count = 3,300 to 12,000 cells/mm^3
Total lymphocyte count ≥ 800 cells/mm^3
Remaining differential either within institutional normal range or with site physician approval
Platelets = 125,000 to 550,000/mm^3
Chemistry
Chemistry panel: ALT, AST, and ALP < 1.25 times the institutional upper limit of normal; creatinine ≤ institutional upper limit of normal.
Virology
Negative HIV-1 and -2 blood test: Sites may use locally available assays that have been approved by HVTN Laboratory Operations.
Negative Hepatitis B surface antigen (HBsAg)
Negative anti-Hepatitis C virus antibodies (anti-HCV), or negative HCV polymerase chain reaction (PCR) if the anti-HCV is positive Urine
Normal urine:
Reproductive Status
Volunteers who were born female: negative serum or urine beta human chorionic gonadotropin (β-HCG) pregnancy test performed prior to vaccination on the day of initial vaccination. Persons who are NOT of reproductive potential due to having undergone total hysterectomy or bilateral oophorectomy (verified by medical records), are not required to undergo pregnancy testing.
Reproductive status: A volunteer who was born female must:
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 who were born female consenting to provide cervical samples: pap smear within the 3 years prior to enrollment, with the latest result reported as normal or ASCUS (atypical squamous cells of undetermined significance); for those 21 years and older that have not had a pap smear within the last 3 years prior to enrollment, must be willing to undergo a pap smear with the result reported as normal or ASCUS prior to sample collection.
Exclusion Criteria:
General
Blood products received within 120 days before first vaccination
Investigational research agents received within 30 days before first vaccination
Body mass index (BMI) ≥ 40; or BMI ≥ 35 with 2 or more of the following: systolic blood pressure > 140 mm Hg, diastolic blood pressure > 90 mm Hg, current smoker, known hyperlipidemia
Intent to participate in another study of an investigational research agent or any other study that requires non-HVTN HIV antibody testing during the planned duration of the HVTN 107 study
Pregnant or breastfeeding
Vaccines and other Injections
HIV vaccine(s) received in a prior HIV vaccine trial. For volunteers who have received control/placebo in an HIV vaccine trial, the HVTN 107 PSRT will determine eligibility on a case-by-case basis.
Non-HIV experimental vaccine(s) received within the last 5 years in a prior vaccine trial. Exceptions may be made for vaccines that have subsequently undergone licensure in a volunteer's country of residence. For volunteers who have received control/placebo in an experimental vaccine trial, the HVTN 107 PSRT will determine eligibility on a case-by-case basis. For volunteers who have received an experimental vaccine(s) greater than 5 years ago, eligibility for enrollment will be determined by the HVTN 107 PSRT on a case-by-case basis.
Live attenuated vaccines other than influenza vaccine received within 30 days before first vaccination or scheduled within 14 days after injection (eg, measles, mumps, and rubella [MMR]; oral polio vaccine [OPV]; varicella; yellow fever)
Influenza vaccine or any vaccines that are not live attenuated vaccines and were received within 14 days prior to first vaccination (eg, tetanus, pneumococcal, Hepatitis A or B)
Allergy treatment with antigen injections within 30 days before first vaccination or that are scheduled within 14 days after first vaccination
Immune System
Immunosuppressive medications received within 168 days before first vaccination. (Not exclusionary: [1] corticosteroid nasal spray; [2] inhaled corticosteroids; [3] topical corticosteroids for mild, uncomplicated dermatitis; or [4] a single course of oral/parenteral corticosteroids at doses < 2 mg/kg/day and length of therapy < 11 days with completion at least 30 days prior to enrollment.)
Serious adverse reactions to vaccines or to vaccine components such as eggs, egg products, or neomycin, including history of anaphylaxis and related symptoms such as hives, respiratory difficulty, angioedema, and/or abdominal pain. (Not excluded from participation: a volunteer who had a nonanaphylactic adverse reaction to pertussis vaccine as a child.)
Immunoglobulin received within 60 days before first vaccination
Autoimmune disease
Immunodeficiency
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 National Asthma Education and Prevention Program (NAEPP) Expert Panel report).
Exclude a volunteer who:
Uses a short-acting rescue inhaler (typically a beta 2 agonist) daily, or
Uses moderate/high dose inhaled corticosteroids, or
In the past year has either of the following:
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 three 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 |
|---|---|---|
| Paul Goepfert | University of Alabama at Birmingham | Study Chair |
| Kathy Mngadi | Centre for the AIDS Programme of Research in South Africa | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Polana Canico Health Research and Training Center (CISPOC), National Institute of Health (INS) CRS | Maputo | Mozambique | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40190112 | Derived | 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. | |
| 38502656 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, and 12 AND Bivalent Subtype C gp120/MF59 (an admixture of 100 mcg of TV1.C gp120, 100 mcg of 1086.C gp120, and MF59C.1) to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, and 12 |
| 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 | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 4, 2017 |
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| Bivalent Subtype C gp120/MF59 | Biological | Consists of 2 subtype C recombinant monomeric proteins, TV1.C gp120 Env and 1086.C gp120 Env, each at a dose of 100 mcg, mixed with MF59 adjuvant (an oil-in-water emulsion); delivered as a 0.5 mL IM injection |
|
| Bivalent Subtype C gp120 admixed with Al(OH)3 Suspension | Biological | Consists of 2 subtype C recombinant monomeric proteins, TV1.C gp120 Env and 1086.C gp120 Env, each at a dose of 100 mcg, admixed with Aluminum Hydroxide Suspension (~625 mcg aluminum content); delivered as a 0.5 mL IM injection |
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| Bivalent Subtype C gp120 | Biological | Consists of 2 subtype C recombinant monomeric proteins, TV1.C gp120 Env and 1086.C gp120 Env, each at a dose of 100 mcg, mixed with sodium chloride for injection, 0.9%; delivered as a 0.5 mL IM injection |
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| Measured at Month 6.5 |
| Level of Vaccine-induced Serum IgA Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C) in Group 1 and Group 3 | Serum IgA responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay, run at 1:10 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 MFI minus reference antigen MFI. Net MFI < 1 is set to 1, and net MFI > 22,000 is set to 22,000. Data are excluded if blood draw date was outside the allowable window, a participant was HIV-infected, reference antigen > 5,000 MFI, or baseline net MFI > 6,500. Comparisons were performed among positive responders only (positivity criteria are described in Outcome 1). | Measured at Month 6.5 |
| 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 [July 2017]. The maximum grade observed for each symptom over the time frame is presented. | Measured through Month Measured through 3 days after each vaccine dose at Months 0, 1, 3, 6, and 12 |
| 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 [July 2017]. The maximum grade observed for each symptom over the time frame is presented. | Measured through Month Measured through 3 days after each vaccine dose at Months 0, 1, 3, 6, and 12 |
| 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 [July 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 Symptoms is the maximum of the individual systemic reactogenicities excluding body temperature for a participant. | Measured through Month Measured through 3 days after each vaccine dose at Months 0, 1, 3, 6, and 12 |
| 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 vaccine dose at Months 0, 1, 3, 6, and 12 |
| 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. | Measured through 30 days after each vaccine dose at Months 0, 1, 3, 6, and 12 |
| 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 18 |
| 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) | New chronic conditions are adverse events that require medical intervention for >= 30 days. | Measured through Month 18 |
| 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, Days 7, 42, 98, 182, 378, and 455 |
| 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, Days 7, 42, 98, 182, 378, and 455 |
| 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, Days 7, 42, 98, 182, 378, and 455 |
| 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, Days 0, 1, 3, 7, 42, 84, 85, 87, 91, 98, 182, 378, and 455 |
| 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, Days 0, 1, 3, 7, 42, 84, 85, 87, 91, 98, 182, 378, and 455 |
| Numbers of Participants With Grade 1 or Higher Local Laboratory Results | The number (percentage) 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 arm for each post-vaccination time point. | Measured during screening, Days 0, 1, 3, 7, 42, 84, 85, 87, 91, 98, 182, 378, and 455 |
| 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 18 |
| Number of Participants With Study Product Discontinuation Associated With an AE or Reactogenicity | From the study product discontinuation form, study product discontinuation reasons are tabulated by treatment arm. | Measured through Month 18 |
| Measured at Months 6.5 and 12. |
| Level of Vaccine-induced Serum IgG Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C) | Serum IgG responses were measured on a Bio-Plex instrument using a standardized 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 MFI minus reference antigen MFI. Net MFI < 1 is set to 1, and net MFI > 22,000 is set to 22,000. Data are excluded if blood draw date was outside the allowable window, a participant was HIV-infected, reference antigen > 5,000 MFI, or baseline net MFI > 6,500. Summary was calculated among positive responders only (positivity criteria are described in Outcome 1). | Measured at Months 6.5 and 12. |
| Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | Serum IgG responses were measured on a Bio-Plex instrument using a standardized 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 MFI minus reference antigen MFI. Net MFI < 1 is set to 1, and net MFI > 22,000 is set to 22,000. Data are excluded if blood draw date was outside the allowable window, a participant was HIV-infected, reference antigen > 5,000 MFI, or baseline net MFI > 6,500. Samples from post-enrollment visits have positive responses if they meet three criteria: (1) net MFI greater than or equal to an antigen-specific response threshold (defined as the maximum of 100 and the 95th percentile of baseline net MFI), (2) net MFI values are greater than 3 times baseline net MFI, and (3) experimental antigen MFI values are greater than 3 times baseline MFI. | Measured at Months 6.5 and 12. |
| Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | Serum IgG responses were measured on a Bio-Plex instrument using a standardized 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 MFI minus reference antigen MFI. Net MFI < 1 is set to 1, and net MFI > 22,000 is set to 22,000. Data are excluded if blood draw date was outside the allowable window, a participant was HIV-infected, reference antigen > 5,000 MFI, or baseline net MFI > 6,500. Summary was calculated among positive responders only (positivity criteria are described in Outcome 1). | Measured at Months 6.5 and 12. |
| Vaccine-induced Occurrence of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | 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 (IFNg and/or IL-2) 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 adjusted p-value <=0.00001. Any Env magnitude is the maximum of 1086 gp120, TV1 gp120, and Env ZM96 magnitudes. Any HIV magnitude is the sum of Any Env and LAI Gag magnitudes. Data are excluded if blood draw date was outside the visit window, participant was HIV-infected, PBMC viability or T-cell count were low, or negative control was high. | Measured at Months 6.5, 12, 12.5, and 18 |
| Vaccine-induced Percentage of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | 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 (IFNg and/or IL-2) 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 adjusted p-value <=0.00001. Any Env magnitude is the maximum of 1086 gp120, TV1 gp120, and Env ZM96 magnitudes. Any HIV magnitude is the sum of Any Env and LAI Gag magnitudes. Data are excluded if blood draw date was outside the visit window, participant was HIV-infected, PBMC viability or T-cell count were low, or negative control was high. | Measured at Months 6.5, 12, 12.5, and 18 |
| Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | Serum IgG3 responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay, run at 1:40 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 MFI minus reference antigen MFI. Net MFI < 1 is set to 1, and net MFI > 22,000 is set to 22,000. Data are excluded if blood draw date was outside the allowable window, a participant was HIV-infected, reference antigen > 5,000 MFI, or baseline net MFI > 6,500. Samples from post-enrollment visits have positive responses if they meet three criteria: (1) net MFI greater than or equal to an antigen-specific response threshold (defined as the maximum of 100 and the 95th percentile of baseline net MFI), (2) net MFI values are greater than 3 times baseline net MFI, and (3) experimental antigen MFI values are greater than 3 times baseline MFI. | Measured at Months 6.5 and 12. |
| Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | Serum IgG3 responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay, run at 1:40 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 MFI minus reference antigen MFI. Net MFI < 1 is set to 1, and net MFI > 22,000 is set to 22,000. Data are excluded if blood draw date was outside the allowable window, a participant was HIV-infected, reference antigen > 5,000 MFI, or baseline net MFI > 6,500. Summary was calculated among positive responders only (positivity criteria are described in Outcome 1). | Measured at Months 6.5 and 12. |
| Occurrence of Vaccine-induced Serum IgA Ab Binding to Env Proteins | Serum IgA responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay, run at 1:10 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 MFI minus reference antigen MFI. Net MFI < 1 is set to 1, and net MFI > 22,000 is set to 22,000. Data are excluded if blood draw date was outside the allowable window, a participant was HIV-infected, reference antigen > 5,000 MFI, or baseline net MFI > 6,500. Samples from post-enrollment visits have positive responses if they meet three criteria: (1) net MFI greater than or equal to an antigen-specific response threshold (defined as the maximum of 100 and the 95th percentile of baseline net MFI), (2) net MFI values are greater than 3 times baseline net MFI, and (3) experimental antigen MFI values are greater than 3 times baseline MFI. | Measured at Months 6.5 and 12. |
| Level of Vaccine-induced Serum IgA Ab Binding to Env Proteins | Serum IgA responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay, run at 1:10 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 MFI minus reference antigen MFI. Net MFI < 1 is set to 1, and net MFI > 22,000 is set to 22,000. Data are excluded if blood draw date was outside the allowable window, a participant was HIV-infected, reference antigen > 5,000 MFI, or baseline net MFI > 6,500. Summary was calculated among positive responders only (positivity criteria are described in Outcome 1). | Measured at Months 6.5 and 12. |
| HIV-specific CD4+ T Cell Polyfunctionality by ICS - Functionality Scores | COMPASS uses a Bayesian hierarchical framework to model all observed functional cell subsets and select those most likely to exhibit antigen-specific responses. Cell-subset responses are quantified by posterior probabilities. The functionality score (FS) summarizes, as a single number for each participant, the proportion of antigen-specific cell subsets among all measured subsets, irrespective of degree of functionality. FS ranges from zero to one. FS will assign a higher score to participants that exhibit antigen specificity in more cell subsets irrespective of their degree of functionality. | Measured at Months 6.5, 12, 12.5, and 18 |
| HIV-specific CD4+ T Cell Polyfunctionality by ICS - Polyfunctionality Scores | COMPASS uses a Bayesian hierarchical framework to model all observed functional cell subsets and select those most likely to exhibit antigen-specific responses. Cell-subset responses are quantified by posterior probabilities. The polyfunctionality score (PFS) summarizes, as a single number for each participant, the proportion of antigen-specific cell subsets among all measured subsets, weighted by the degree of functionality of the corresponding subset. PFS ranges from zero to one. PFS will assign a higher score to participants with antigen-specific cell subsets of higher degree. | Measured at Months 6.5, 12, 12.5, and 18 |
| Occurrence of Vaccine-induced Serum IgG Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C) | Serum IgG responses were measured on a Bio-Plex instrument using a standardized 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 MFI minus reference antigen MFI. Net MFI < 1 is set to 1, and net MFI > 22,000 is set to 22,000. Data are excluded if blood draw date was outside the allowable window, a participant was HIV-infected, reference antigen > 5,000 MFI, or baseline net MFI > 6,500. Samples from post-enrollment visits have positive responses if they meet three criteria: (1) net MFI greater than or equal to an antigen-specific response threshold (defined as the maximum of 100 and the 95th percentile of baseline net MFI), (2) net MFI values are greater than 3 times baseline net MFI, and (3) experimental antigen MFI values are greater than 3 times baseline MFI. | Measured at Months 12.5 and 18. |
| Level of Vaccine-induced Serum IgG Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C) | Serum IgG responses were measured on a Bio-Plex instrument using a standardized 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 MFI minus reference antigen MFI. Net MFI < 1 is set to 1, and net MFI > 22,000 is set to 22,000. Data are excluded if blood draw date was outside the allowable window, a participant was HIV-infected, reference antigen > 5,000 MFI, or baseline net MFI > 6,500. Summary was calculated among positive responders only (positivity criteria are described in Outcome 1). | Measured at Months 12.5 and 18. |
| Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | Serum IgG responses were measured on a Bio-Plex instrument using a standardized 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 MFI minus reference antigen MFI. Net MFI < 1 is set to 1, and net MFI > 22,000 is set to 22,000. Data are excluded if blood draw date was outside the allowable window, a participant was HIV-infected, reference antigen > 5,000 MFI, or baseline net MFI > 6,500. Samples from post-enrollment visits have positive responses if they meet three criteria: (1) net MFI greater than or equal to an antigen-specific response threshold (defined as the maximum of 100 and the 95th percentile of baseline net MFI), (2) net MFI values are greater than 3 times baseline net MFI, and (3) experimental antigen MFI values are greater than 3 times baseline MFI. | Measured at Months 12.5 and 18. |
| Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | Serum IgG responses were measured on a Bio-Plex instrument using a standardized 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 MFI minus reference antigen MFI. Net MFI < 1 is set to 1, and net MFI > 22,000 is set to 22,000. Data are excluded if blood draw date was outside the allowable window, a participant was HIV-infected, reference antigen > 5,000 MFI, or baseline net MFI > 6,500. Summary was calculated among positive responders only (positivity criteria are described in Outcome 1). | Measured at Months 12.5 and 18. |
| Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | Serum IgG3 responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay, run at 1:40 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 MFI minus reference antigen MFI. Net MFI < 1 is set to 1, and net MFI > 22,000 is set to 22,000. Data are excluded if blood draw date was outside the allowable window, a participant was HIV-infected, reference antigen > 5,000 MFI, or baseline net MFI > 6,500. Samples from post-enrollment visits have positive responses if they meet three criteria: (1) net MFI greater than or equal to an antigen-specific response threshold (defined as the maximum of 100 and the 95th percentile of baseline net MFI), (2) net MFI values are greater than 3 times baseline net MFI, and (3) experimental antigen MFI values are greater than 3 times baseline MFI. | Measured at Months 12.5 and 18. |
| Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | Serum IgG3 responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay, run at 1:40 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 MFI minus reference antigen MFI. Net MFI < 1 is set to 1, and net MFI > 22,000 is set to 22,000. Data are excluded if blood draw date was outside the allowable window, a participant was HIV-infected, reference antigen > 5,000 MFI, or baseline net MFI > 6,500. Summary was calculated among positive responders only (positivity criteria are described in Outcome 1). | Measured at Months 12.5 and 18. |
| Aurum Tembisa CRS |
| Johannesburg |
| Gauteng |
| 1632 |
| South Africa |
| Soweto HVTN CRS | Johannesburg | Gauteng | 1862 | South Africa |
| eThekwini CRS | Durban | KwaZulu-Natal | 4013 | South Africa |
| Emavundleni CRS | Cape Town | Western Cape | 7750 | South Africa |
| Seke South CRS | Chitungwiza | Mashonaland East Province | Zimbabwe |
| Derived |
| Moodie Z, Andersen-Nissen E, Grunenberg N, Dintwe OB, Omar FL, Kee JJ, Bekker LG, Laher F, Naicker N, Jani I, Mgodi NM, Hunidzarira P, Sebe M, Miner MD, Polakowski L, Ramirez S, Nebergall M, Takuva S, Sikhosana L, Heptinstall J, Seaton KE, De Rosa S, Diazgranados CA, Koutsoukos M, Van Der Meeren O, Barnett SW, Kanesa-Thasan N, Kublin JG, Tomaras GD, McElrath MJ, Corey L, Mngadi K, Goepfert P; HVTN 107 Protocol Team. Safety and immunogenicity of a subtype C ALVAC-HIV (vCP2438) vaccine prime plus bivalent subtype C gp120 vaccine boost adjuvanted with MF59 or alum in healthy adults without HIV (HVTN 107): A phase 1/2a randomized trial. PLoS Med. 2024 Mar 19;21(3):e1004360. doi: 10.1371/journal.pmed.1004360. eCollection 2024 Mar. |
| FG001 | Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, and 12 AND Bivalent Subtype C gp120 (an admixture of 100 mcg of TV1.C gp120 and 100 mcg of 1806.C gp120) admixed with Aluminum Hydroxide Suspension to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, and 12 |
| FG002 | Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 6, and 12 AND Bivalent Subtype C gp120/MF59 (an admixture of 100 mcg of TV1.C gp120, 100 mcg of 1086.C gp120, and MF59C.1) to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 0, 1, 6, and 12 |
| FG003 | Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, and 12 AND Bivalent Subtype C gp120 (an admixture of 100 mcg of TV1.C gp120 and 100 mcg of 1806.C gp120) admixed with Sodium Chloride for Injection, 0.9% to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, and 12 |
| Month 6.5 Immunogenicity Timepoint |
|
| Month 12 Immunogenicity Timepoint |
|
| Month 12.5 Immunogenicity Timepoint |
|
| Month 18 Immunogenicity Timepoint |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, and 12 AND Bivalent Subtype C gp120/MF59 (an admixture of 100 mcg of TV1.C gp120, 100 mcg of 1086.C gp120, and MF59C.1) to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, and 12 |
| BG001 | Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, and 12 AND Bivalent Subtype C gp120 (an admixture of 100 mcg of TV1.C gp120 and 100 mcg of 1806.C gp120) admixed with Aluminum Hydroxide Suspension to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, and 12 |
| BG002 | Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 6, and 12 AND Bivalent Subtype C gp120/MF59 (an admixture of 100 mcg of TV1.C gp120, 100 mcg of 1086.C gp120, and MF59C.1) to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 0, 1, 6, and 12 |
| BG003 | Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, and 12 AND Bivalent Subtype C gp120 (an admixture of 100 mcg of TV1.C gp120 and 100 mcg of 1806.C gp120) admixed with Sodium Chloride for Injection, 0.9% to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, and 12 |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||
| Age, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
|
| 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Occurrence of Vaccine-induced Systemic IgG Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C) in Group 1 and Group 2 | Serum IgG responses were measured on a Bio-Plex instrument using a standardized 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 MFI minus reference antigen MFI. Net MFI < 1 is set to 1, and net MFI > 22,000 is set to 22,000. Data are excluded if blood draw date was outside the allowable window, a participant was HIV-infected, reference antigen > 5,000 MFI, or baseline net MFI > 6,500. Samples from post-enrollment visits have positive responses if they meet three criteria: (1) net MFI greater than or equal to an antigen-specific response threshold (defined as the maximum of 100 and the 95th percentile of baseline net MFI), (2) net MFI values are greater than 3 times baseline net MFI, and (3) experimental antigen MFI values are greater than 3 times baseline MFI. | Overall Number of Participants Analyzed represents the HIV uninfected participants with specimens at Month 6.5. "Number Analyzed" shows the number of participants with available BAMA data after filtering for assay specific quality control criteria at each timepoint. | Posted | Count of Participants | Participants | Measured at Month 6.5 |
|
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| Primary | Level of Vaccine-induced Systemic IgG Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C) in Group 1 and Group 2 | Serum IgG responses were measured on a Bio-Plex instrument using a standardized 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 MFI minus reference antigen MFI. Net MFI < 1 is set to 1, and net MFI > 22,000 is set to 22,000. Data are excluded if blood draw date was outside the allowable window, a participant was HIV-infected, reference antigen > 5,000 MFI, or baseline net MFI > 6,500. Comparisons were performed among positive responders only (positivity criteria are described in Outcome 1). | "Overall Number of Participants Analyzed" represents the HIV uninfected participants with specimens at Month 6.5. "Number Analyzed" shows the number of participants with available BAMA data after filtering for assay specific quality control criteria at each timepoint. | Posted | Median | Inter-Quartile Range | relative fluorescence units | Measured at Month 6.5 |
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| Primary | Occurrence of Vaccine-induced Serum IgA Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C) in Group 1 and Group 3 | Serum IgA responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay, run at 1:10 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 MFI minus reference antigen MFI. Net MFI < 1 is set to 1, and net MFI > 22,000 is set to 22,000. Data are excluded if blood draw date was outside the allowable window, a participant was HIV-infected, reference antigen > 5,000 MFI, or baseline net MFI > 6,500. Samples from post-enrollment visits have positive responses if they meet three criteria: (1) net MFI greater than or equal to an antigen-specific response threshold (defined as the maximum of 100 and the 95th percentile of baseline net MFI), (2) net MFI values are greater than 3 times baseline net MFI, and (3) experimental antigen MFI values are greater than 3 times baseline MFI. | "Overall Number of Participants Analyzed" represents the HIV uninfected participants with specimens at Month 6.5. "Number Analyzed" shows the number of participants with available BAMA data after filtering for assay specific quality control criteria at each timepoint. | Posted | Count of Participants | Participants | Measured at Month 6.5 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Level of Vaccine-induced Serum IgA Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C) in Group 1 and Group 3 | Serum IgA responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay, run at 1:10 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 MFI minus reference antigen MFI. Net MFI < 1 is set to 1, and net MFI > 22,000 is set to 22,000. Data are excluded if blood draw date was outside the allowable window, a participant was HIV-infected, reference antigen > 5,000 MFI, or baseline net MFI > 6,500. Comparisons were performed among positive responders only (positivity criteria are described in Outcome 1). | "Overall Number of Participants Analyzed" represents the HIV uninfected participants with specimens at Month 6.5. "Number Analyzed" shows the number of participants with available BAMA data after filtering for assay specific quality control criteria at each timepoint. | Posted | Median | Inter-Quartile Range | relative fluorescence units | Measured at Month 6.5 |
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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 [July 2017]. The maximum grade observed for each symptom over the time frame is presented. | Posted | Count of Participants | Participants | Measured through Month Measured through 3 days after each vaccine dose at Months 0, 1, 3, 6, and 12 |
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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 [July 2017]. The maximum grade observed for each symptom over the time frame is presented. | Posted | Count of Participants | Participants | Measured through Month Measured through 3 days after each vaccine dose at Months 0, 1, 3, 6, and 12 |
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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 [July 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 Symptoms is the maximum of the individual systemic reactogenicities excluding body temperature for a participant. | Posted | Count of Participants | Participants | Measured through Month Measured through 3 days after each vaccine dose at Months 0, 1, 3, 6, and 12 |
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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 vaccine dose at Months 0, 1, 3, 6, and 12 |
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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 vaccine dose at Months 0, 1, 3, 6, and 12 |
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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 18 |
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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) | New chronic conditions are adverse events that require medical intervention for >= 30 days. | Posted | Count of Participants | Participants | Measured through Month 18 |
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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. | "Overall Number of Participants Analyzed" represents participants enrolled and eligible for laboratory assessment. Participants do not have laboratory assessments if they attended the visit but laboratory specimens were not collected, missed the scheduled visit, or terminated participation in the study prior to the scheduled visit. | Posted | Median | Inter-Quartile Range | U/L | Measured during screening, Days 7, 42, 98, 182, 378, and 455 |
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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. | "Overall Number of Participants Analyzed" represents participants enrolled and eligible for laboratory assessment. Participants do not have laboratory assessments if they attended the visit but laboratory specimens were not collected, missed the scheduled visit, or terminated participation in the study prior to the scheduled visit. | Posted | Median | Inter-Quartile Range | g/dL | Measured during screening, Days 7, 42, 98, 182, 378, and 455 |
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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. | "Overall Number of Participants Analyzed" represents participants enrolled and eligible for laboratory assessment. Participants do not have laboratory assessments if they attended the visit but laboratory specimens were not collected, missed the scheduled visit, or terminated participation in the study prior to the scheduled visit. | Posted | Median | Inter-Quartile Range | g/dL | Measured during screening, Days 7, 42, 98, 182, 378, and 455 |
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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. | "Overall Number of Participants Analyzed" represents participants enrolled and eligible for laboratory assessment. Participants do not have laboratory assessments if they attended the visit but laboratory specimens were not collected, missed the scheduled visit, or terminated participation in the study prior to the scheduled visit. | Posted | Median | Inter-Quartile Range | thousand cells/cubic mm | Measured during screening, Days 0, 1, 3, 7, 42, 84, 85, 87, 91, 98, 182, 378, and 455 |
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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. | "Overall Number of Participants Analyzed" represents participants enrolled and eligible for laboratory assessment. Participants do not have laboratory assessments if they attended the visit but laboratory specimens were not collected, missed the scheduled visit, or terminated participation in the study prior to the scheduled visit. | Posted | Median | Inter-Quartile Range | thousand cells/cubic mm | Measured during screening, Days 0, 1, 3, 7, 42, 84, 85, 87, 91, 98, 182, 378, and 455 |
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| Primary | Numbers of Participants With Grade 1 or Higher Local Laboratory Results | The number (percentage) 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 arm for each post-vaccination time point. | "Overall Number of Participants Analyzed" represents participants enrolled and eligible for laboratory assessment. Participants do not have laboratory assessments if they attended the visit but laboratory specimens were not collected, missed the scheduled visit, or terminated participation in the study prior to the scheduled visit. | Posted | Count of Participants | Participants | Measured during screening, Days 0, 1, 3, 7, 42, 84, 85, 87, 91, 98, 182, 378, and 455 |
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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 18 |
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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 discontinuation reasons are tabulated by treatment arm. | Posted | Count of Participants | Participants | Measured through Month 18 |
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| Secondary | Occurrence of Vaccine-induced Serum IgG Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C) | Serum IgG responses were measured on a Bio-Plex instrument using a standardized 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 MFI minus reference antigen MFI. Net MFI < 1 is set to 1, and net MFI > 22,000 is set to 22,000. Data are excluded if blood draw date was outside the allowable window, a participant was HIV-infected, reference antigen > 5,000 MFI, or baseline net MFI > 6,500. Samples from post-enrollment visits have positive responses if they meet three criteria: (1) net MFI greater than or equal to an antigen-specific response threshold (defined as the maximum of 100 and the 95th percentile of baseline net MFI), (2) net MFI values are greater than 3 times baseline net MFI, and (3) experimental antigen MFI values are greater than 3 times baseline MFI. | Overall Number of Participants Analyzed represents the number of enrolled participants with available specimens. "Number Analyzed" shows the number of HIV uninfected participants with available BAMA data after filtering for assay specific quality control criteria at each timepoint. | Posted | Count of Participants | Participants | Measured at Months 6.5 and 12. |
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| Secondary | Level of Vaccine-induced Serum IgG Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C) | Serum IgG responses were measured on a Bio-Plex instrument using a standardized 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 MFI minus reference antigen MFI. Net MFI < 1 is set to 1, and net MFI > 22,000 is set to 22,000. Data are excluded if blood draw date was outside the allowable window, a participant was HIV-infected, reference antigen > 5,000 MFI, or baseline net MFI > 6,500. Summary was calculated among positive responders only (positivity criteria are described in Outcome 1). | "Overall Number of Participants Analyzed" represents the number of enrolled participants with available specimens. "Number Analyzed" shows the number of HIV uninfected participants with available BAMA data after filtering for assay specific quality control criteria at each timepoint. | Posted | Median | Inter-Quartile Range | relative fluorescence units | Measured at Months 6.5 and 12. |
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| Secondary | Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | Serum IgG responses were measured on a Bio-Plex instrument using a standardized 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 MFI minus reference antigen MFI. Net MFI < 1 is set to 1, and net MFI > 22,000 is set to 22,000. Data are excluded if blood draw date was outside the allowable window, a participant was HIV-infected, reference antigen > 5,000 MFI, or baseline net MFI > 6,500. Samples from post-enrollment visits have positive responses if they meet three criteria: (1) net MFI greater than or equal to an antigen-specific response threshold (defined as the maximum of 100 and the 95th percentile of baseline net MFI), (2) net MFI values are greater than 3 times baseline net MFI, and (3) experimental antigen MFI values are greater than 3 times baseline MFI. | "Overall Number of Participants Analyzed" represents the number of enrolled participants with available specimens. "Number Analyzed" shows the number of HIV uninfected participants with available BAMA data after filtering for assay specific quality control criteria at each timepoint. | Posted | Count of Participants | Participants | Measured at Months 6.5 and 12. |
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| Secondary | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | Serum IgG responses were measured on a Bio-Plex instrument using a standardized 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 MFI minus reference antigen MFI. Net MFI < 1 is set to 1, and net MFI > 22,000 is set to 22,000. Data are excluded if blood draw date was outside the allowable window, a participant was HIV-infected, reference antigen > 5,000 MFI, or baseline net MFI > 6,500. Summary was calculated among positive responders only (positivity criteria are described in Outcome 1). | "Overall Number of Participants Analyzed" represents the number of enrolled participants with available specimens. "Number Analyzed" shows the number of HIV uninfected participants with available BAMA data after filtering for assay specific quality control criteria at each timepoint. | Posted | Median | Inter-Quartile Range | relative fluorescence units | Measured at Months 6.5 and 12. |
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| Secondary | Vaccine-induced Occurrence of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | 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 (IFNg and/or IL-2) 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 adjusted p-value <=0.00001. Any Env magnitude is the maximum of 1086 gp120, TV1 gp120, and Env ZM96 magnitudes. Any HIV magnitude is the sum of Any Env and LAI Gag magnitudes. Data are excluded if blood draw date was outside the visit window, participant was HIV-infected, PBMC viability or T-cell count were low, or negative control was high. | "Overall Number of Participants Analyzed" represents the number of enrolled participants with available specimens. "Number Analyzed" shows the number of HIV uninfected participants with available ICS data after filtering for assay specific quality control criteria at each timepoint. | Posted | Count of Participants | Participants | Measured at Months 6.5, 12, 12.5, and 18 |
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| Secondary | Vaccine-induced Percentage of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | 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 (IFNg and/or IL-2) 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 adjusted p-value <=0.00001. Any Env magnitude is the maximum of 1086 gp120, TV1 gp120, and Env ZM96 magnitudes. Any HIV magnitude is the sum of Any Env and LAI Gag magnitudes. Data are excluded if blood draw date was outside the visit window, participant was HIV-infected, PBMC viability or T-cell count were low, or negative control was high. | "Overall Number of Participants Analyzed" represents the number of enrolled participants with available specimens. "Number Analyzed" shows the number of HIV uninfected participants with available ICS data after filtering for assay specific quality control criteria at each timepoint. | Posted | Median | Inter-Quartile Range | % CD4+ T-cells | Measured at Months 6.5, 12, 12.5, and 18 |
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| Secondary | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | Serum IgG3 responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay, run at 1:40 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 MFI minus reference antigen MFI. Net MFI < 1 is set to 1, and net MFI > 22,000 is set to 22,000. Data are excluded if blood draw date was outside the allowable window, a participant was HIV-infected, reference antigen > 5,000 MFI, or baseline net MFI > 6,500. Samples from post-enrollment visits have positive responses if they meet three criteria: (1) net MFI greater than or equal to an antigen-specific response threshold (defined as the maximum of 100 and the 95th percentile of baseline net MFI), (2) net MFI values are greater than 3 times baseline net MFI, and (3) experimental antigen MFI values are greater than 3 times baseline MFI. | "Overall Number of Participants Analyzed" represents the number of enrolled participants with available specimens. "Number Analyzed" shows the number of HIV uninfected participants with available BAMA data after filtering for assay specific quality control criteria at each timepoint. | Posted | Count of Participants | Participants | Measured at Months 6.5 and 12. |
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| Secondary | Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | Serum IgG3 responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay, run at 1:40 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 MFI minus reference antigen MFI. Net MFI < 1 is set to 1, and net MFI > 22,000 is set to 22,000. Data are excluded if blood draw date was outside the allowable window, a participant was HIV-infected, reference antigen > 5,000 MFI, or baseline net MFI > 6,500. Summary was calculated among positive responders only (positivity criteria are described in Outcome 1). | "Overall Number of Participants Analyzed" represents the number of enrolled participants with available specimens. "Number Analyzed" shows the number of HIV uninfected participants with available BAMA data after filtering for assay specific quality control criteria at each timepoint. | Posted | Median | Inter-Quartile Range | relative fluorescence units | Measured at Months 6.5 and 12. |
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| Secondary | Occurrence of Vaccine-induced Serum IgA Ab Binding to Env Proteins | Serum IgA responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay, run at 1:10 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 MFI minus reference antigen MFI. Net MFI < 1 is set to 1, and net MFI > 22,000 is set to 22,000. Data are excluded if blood draw date was outside the allowable window, a participant was HIV-infected, reference antigen > 5,000 MFI, or baseline net MFI > 6,500. Samples from post-enrollment visits have positive responses if they meet three criteria: (1) net MFI greater than or equal to an antigen-specific response threshold (defined as the maximum of 100 and the 95th percentile of baseline net MFI), (2) net MFI values are greater than 3 times baseline net MFI, and (3) experimental antigen MFI values are greater than 3 times baseline MFI. | "Overall Number of Participants Analyzed" represents the number of enrolled participants with available specimens. "Number Analyzed" shows the number of HIV uninfected participants with available BAMA data after filtering for assay specific quality control criteria at each timepoint. | Posted | Count of Participants | Participants | Measured at Months 6.5 and 12. |
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| Secondary | Level of Vaccine-induced Serum IgA Ab Binding to Env Proteins | Serum IgA responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay, run at 1:10 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 MFI minus reference antigen MFI. Net MFI < 1 is set to 1, and net MFI > 22,000 is set to 22,000. Data are excluded if blood draw date was outside the allowable window, a participant was HIV-infected, reference antigen > 5,000 MFI, or baseline net MFI > 6,500. Summary was calculated among positive responders only (positivity criteria are described in Outcome 1). | "Overall Number of Participants Analyzed" represents the number of enrolled participants with available specimens. "Number Analyzed" shows the number of HIV uninfected participants with available BAMA data after filtering for assay specific quality control criteria at each timepoint. | Posted | Median | Inter-Quartile Range | relative fluorescence units | Measured at Months 6.5 and 12. |
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| Secondary | HIV-specific CD4+ T Cell Polyfunctionality by ICS - Functionality Scores | COMPASS uses a Bayesian hierarchical framework to model all observed functional cell subsets and select those most likely to exhibit antigen-specific responses. Cell-subset responses are quantified by posterior probabilities. The functionality score (FS) summarizes, as a single number for each participant, the proportion of antigen-specific cell subsets among all measured subsets, irrespective of degree of functionality. FS ranges from zero to one. FS will assign a higher score to participants that exhibit antigen specificity in more cell subsets irrespective of their degree of functionality. | "Overall Number of Participants Analyzed" represents the number of participants in the per-protocol population. "Number Analyzed" shows the number of HIV uninfected participants with available COMPASS data after filtering for assay specific quality control criteria at each timepoint. | Posted | Median | Inter-Quartile Range | Functionality Score | Measured at Months 6.5, 12, 12.5, and 18 |
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| Secondary | HIV-specific CD4+ T Cell Polyfunctionality by ICS - Polyfunctionality Scores | COMPASS uses a Bayesian hierarchical framework to model all observed functional cell subsets and select those most likely to exhibit antigen-specific responses. Cell-subset responses are quantified by posterior probabilities. The polyfunctionality score (PFS) summarizes, as a single number for each participant, the proportion of antigen-specific cell subsets among all measured subsets, weighted by the degree of functionality of the corresponding subset. PFS ranges from zero to one. PFS will assign a higher score to participants with antigen-specific cell subsets of higher degree. | "Overall Number of Participants Analyzed" represents the number of participants in the per-protocol population. "Number Analyzed" shows the number of HIV uninfected participants with available COMPASS data after filtering for assay specific quality control criteria at each timepoint. | Posted | Median | Inter-Quartile Range | Polyfunctionality Score | Measured at Months 6.5, 12, 12.5, and 18 |
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| Secondary | Occurrence of Vaccine-induced Serum IgG Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C) | Serum IgG responses were measured on a Bio-Plex instrument using a standardized 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 MFI minus reference antigen MFI. Net MFI < 1 is set to 1, and net MFI > 22,000 is set to 22,000. Data are excluded if blood draw date was outside the allowable window, a participant was HIV-infected, reference antigen > 5,000 MFI, or baseline net MFI > 6,500. Samples from post-enrollment visits have positive responses if they meet three criteria: (1) net MFI greater than or equal to an antigen-specific response threshold (defined as the maximum of 100 and the 95th percentile of baseline net MFI), (2) net MFI values are greater than 3 times baseline net MFI, and (3) experimental antigen MFI values are greater than 3 times baseline MFI. | Overall Number of Participants Analyzed represents the number of enrolled participants with available specimens. "Number Analyzed" shows the number of HIV uninfected participants with available BAMA data after filtering for assay specific quality control criteria at each timepoint. | Posted | Count of Participants | Participants | Measured at Months 12.5 and 18. |
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| Secondary | Level of Vaccine-induced Serum IgG Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C) | Serum IgG responses were measured on a Bio-Plex instrument using a standardized 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 MFI minus reference antigen MFI. Net MFI < 1 is set to 1, and net MFI > 22,000 is set to 22,000. Data are excluded if blood draw date was outside the allowable window, a participant was HIV-infected, reference antigen > 5,000 MFI, or baseline net MFI > 6,500. Summary was calculated among positive responders only (positivity criteria are described in Outcome 1). | "Overall Number of Participants Analyzed" represents the number of enrolled participants with available specimens. "Number Analyzed" shows the number of HIV uninfected participants with available BAMA data after filtering for assay specific quality control criteria at each timepoint. | Posted | Median | Inter-Quartile Range | relative fluorescence units | Measured at Months 12.5 and 18. |
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| Secondary | Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | Serum IgG responses were measured on a Bio-Plex instrument using a standardized 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 MFI minus reference antigen MFI. Net MFI < 1 is set to 1, and net MFI > 22,000 is set to 22,000. Data are excluded if blood draw date was outside the allowable window, a participant was HIV-infected, reference antigen > 5,000 MFI, or baseline net MFI > 6,500. Samples from post-enrollment visits have positive responses if they meet three criteria: (1) net MFI greater than or equal to an antigen-specific response threshold (defined as the maximum of 100 and the 95th percentile of baseline net MFI), (2) net MFI values are greater than 3 times baseline net MFI, and (3) experimental antigen MFI values are greater than 3 times baseline MFI. | "Overall Number of Participants Analyzed" represents the number of enrolled participants with available specimens. "Number Analyzed" shows the number of HIV uninfected participants with available BAMA data after filtering for assay specific quality control criteria at each timepoint. | Posted | Count of Participants | Participants | Measured at Months 12.5 and 18. |
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| Secondary | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | Serum IgG responses were measured on a Bio-Plex instrument using a standardized 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 MFI minus reference antigen MFI. Net MFI < 1 is set to 1, and net MFI > 22,000 is set to 22,000. Data are excluded if blood draw date was outside the allowable window, a participant was HIV-infected, reference antigen > 5,000 MFI, or baseline net MFI > 6,500. Summary was calculated among positive responders only (positivity criteria are described in Outcome 1). | "Overall Number of Participants Analyzed" represents the number of enrolled participants with available specimens. "Number Analyzed" shows the number of HIV uninfected participants with available BAMA data after filtering for assay specific quality control criteria at each timepoint. | Posted | Median | Inter-Quartile Range | relative fluorescence units | Measured at Months 12.5 and 18. |
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| Secondary | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | Serum IgG3 responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay, run at 1:40 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 MFI minus reference antigen MFI. Net MFI < 1 is set to 1, and net MFI > 22,000 is set to 22,000. Data are excluded if blood draw date was outside the allowable window, a participant was HIV-infected, reference antigen > 5,000 MFI, or baseline net MFI > 6,500. Samples from post-enrollment visits have positive responses if they meet three criteria: (1) net MFI greater than or equal to an antigen-specific response threshold (defined as the maximum of 100 and the 95th percentile of baseline net MFI), (2) net MFI values are greater than 3 times baseline net MFI, and (3) experimental antigen MFI values are greater than 3 times baseline MFI. | "Overall Number of Participants Analyzed" represents the number of enrolled participants with available specimens. "Number Analyzed" shows the number of HIV uninfected participants with available BAMA data after filtering for assay specific quality control criteria at each timepoint. | Posted | Count of Participants | Participants | Measured at Months 12.5 and 18. |
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| Secondary | Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | Serum IgG3 responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay, run at 1:40 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 MFI minus reference antigen MFI. Net MFI < 1 is set to 1, and net MFI > 22,000 is set to 22,000. Data are excluded if blood draw date was outside the allowable window, a participant was HIV-infected, reference antigen > 5,000 MFI, or baseline net MFI > 6,500. Summary was calculated among positive responders only (positivity criteria are described in Outcome 1). | "Overall Number of Participants Analyzed" represents the number of enrolled participants with available specimens. "Number Analyzed" shows the number of HIV uninfected participants with available BAMA data after filtering for assay specific quality control criteria at each timepoint. | Posted | Median | Inter-Quartile Range | relative fluorescence units | Measured at Months 12.5 and 18. |
|
Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).
Adverse events of special interest were described in Appendix N of the protocol. 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: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, and 12 AND Bivalent Subtype C gp120/MF59 (an admixture of 100 mcg of TV1.C gp120, 100 mcg of 1086.C gp120, and MF59C.1) to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, and 12 | 0 | 36 | 1 | 36 | 28 | 36 |
| EG001 | Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, and 12 AND Bivalent Subtype C gp120 (an admixture of 100 mcg of TV1.C gp120 and 100 mcg of 1806.C gp120) admixed with Aluminum Hydroxide Suspension to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, and 12 | 0 | 36 | 0 | 36 | 28 | 36 |
| EG002 | Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 6, and 12 AND Bivalent Subtype C gp120/MF59 (an admixture of 100 mcg of TV1.C gp120, 100 mcg of 1086.C gp120, and MF59C.1) to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 0, 1, 6, and 12 | 0 | 36 | 0 | 36 | 26 | 36 |
| EG003 | Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, and 12 AND Bivalent Subtype C gp120 (an admixture of 100 mcg of TV1.C gp120 and 100 mcg of 1806.C gp120) admixed with Sodium Chloride for Injection, 0.9% to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, and 12 | 0 | 24 | 1 | 24 | 15 | 24 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Any Event in SOC | Injury, poisoning and procedural complications | MedDRA 23.0 | Non-systematic Assessment |
| |
| Skin laceration | Injury, poisoning and procedural complications | MedDRA 23.0 | Non-systematic Assessment |
| |
| Traumatic haemothorax | Injury, poisoning and procedural complications | MedDRA 23.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Any Event in SOC | Blood and lymphatic system disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Microcytic anaemia | Blood and lymphatic system disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Any Event in SOC | Ear and labyrinth disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Ear pain | Ear and labyrinth disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Any Event in SOC | Eye disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Conjunctivitis allergic | Eye disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Eye pain | Eye disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Any Event in SOC | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Constipation | 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 |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Any Event in SOC | General disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Peripheral swelling | General disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Vessel puncture site phlebitis | General disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Any Event in SOC | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Acarodermatitis | 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 |
| |
| Conjunctivitis | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Fungal skin 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 |
| |
| Gastroenteritis viral | 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 |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Malaria | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Orchitis | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Otitis externa | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Pelvic inflammatory disease | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Subcutaneous abscess | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Tonsillitis | 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 |
| |
| Urinary tract infection | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Urinary tract infection bacterial | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Vulvovaginal candidiasis | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Vulvovaginitis gonococcal | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Vulvovaginitis trichomonal | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Any Event in SOC | Injury, poisoning and procedural complications | MedDRA 23.0 | Non-systematic Assessment |
| |
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA 23.0 | Non-systematic Assessment |
| |
| Arthropod sting | Injury, poisoning and procedural complications | MedDRA 23.0 | Non-systematic Assessment |
| |
| Eye injury | Injury, poisoning and procedural complications | MedDRA 23.0 | Non-systematic Assessment |
| |
| Human bite | 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 |
| |
| Skin abrasion | Injury, poisoning and procedural complications | MedDRA 23.0 | Non-systematic Assessment |
| |
| Skin laceration | Injury, poisoning and procedural complications | MedDRA 23.0 | Non-systematic Assessment |
| |
| Sunburn | Injury, poisoning and procedural complications | MedDRA 23.0 | Non-systematic Assessment |
| |
| Any Event in 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 bicarbonate decreased | 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 |
| |
| Cardiac murmur | Investigations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 23.0 | Non-systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Any Event in SOC | Metabolism and nutrition disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Abnormal loss of weight | Metabolism and nutrition disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Gout | Metabolism and nutrition disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Any Event in 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 |
| |
| 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 |
| |
| Myalgia | 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 |
| |
| Any Event in 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 |
| |
| Syncope | Nervous system disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Any Event in SOC | Renal and urinary disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Dysuria | 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 Event in 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 |
| |
| Prostatitis | Reproductive system and breast disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Vaginal discharge | Reproductive system and breast disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Vulvovaginal rash | Reproductive system and breast disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Any Event in SOC | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Rhinalgia | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Any Event in SOC | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Acne | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Hand dermatitis | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Ingrowing nail | 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 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 |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Any Event in SOC | Vascular disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 23.0 | Non-systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Yunda Huang, PhD, Multiple Principal Investigator, HVTN Statistical and Data Management Center | Fred Hutchinson Cancer Center | 206-667-5780 | hvtn.covpn.sdmc@hvtn.org |
| Nov 10, 2020 |
| Prot_SAP_000.pdf |
Not provided
| 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 |
|---|---|
| C112734 | AIDSVAX |
Not provided
Not provided
Not provided
| 18 - 20 years |
|
| 21 - 30 years |
|
| 31 - 40 years |
|
| 41 - 50 years |
|
| Above 50 years |
|
| Unknown or Not Reported |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| South Africa |
|
| Zimbabwe |
|
| 96ZM651.D11gp120.avi |
|
|
| TV1c8_D11gp120.avi/293F |
|
|
| Barnard's test |
| 1.000 |
The threshold for statistical significance was p = 0.05. |
| Other |
| IgGAb binding to TV1c8_D11gp120.avi/293F in Group 1 versus Group 2 | Barnard's test | 0.361 | The threshold for statistical significance was p = 0.05. | Other |
| OG001 | Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, and 12 AND Bivalent Subtype C gp120 (an admixture of 100 mcg of TV1.C gp120 and 100 mcg of 1806.C gp120) admixed with Aluminum Hydroxide Suspension to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, and 12 |
|
|
|
| OG001 | Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 6, and 12 AND Bivalent Subtype C gp120/MF59 (an admixture of 100 mcg of TV1.C gp120, 100 mcg of 1086.C gp120, and MF59C.1) to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 0, 1, 6, and 12 |
|
|
|
| OG001 | Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 6, and 12 AND Bivalent Subtype C gp120/MF59 (an admixture of 100 mcg of TV1.C gp120, 100 mcg of 1086.C gp120, and MF59C.1) to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 0, 1, 6, and 12 |
|
|
|
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) |
ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 6, and 12 AND Bivalent Subtype C gp120/MF59 (an admixture of 100 mcg of TV1.C gp120, 100 mcg of 1086.C gp120, and MF59C.1) to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 0, 1, 6, and 12 |
| OG003 | Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, and 12 AND Bivalent Subtype C gp120 (an admixture of 100 mcg of TV1.C gp120 and 100 mcg of 1806.C gp120) admixed with Sodium Chloride for Injection, 0.9% to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, and 12 |
|
|
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) |
ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 6, and 12 AND Bivalent Subtype C gp120/MF59 (an admixture of 100 mcg of TV1.C gp120, 100 mcg of 1086.C gp120, and MF59C.1) to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 0, 1, 6, and 12 |
| OG003 | Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, and 12 AND Bivalent Subtype C gp120 (an admixture of 100 mcg of TV1.C gp120 and 100 mcg of 1806.C gp120) admixed with Sodium Chloride for Injection, 0.9% to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, and 12 |
|
|
| OG002 | Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 6, and 12 AND Bivalent Subtype C gp120/MF59 (an admixture of 100 mcg of TV1.C gp120, 100 mcg of 1086.C gp120, and MF59C.1) to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 0, 1, 6, and 12 |
| OG003 | Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, and 12 AND Bivalent Subtype C gp120 (an admixture of 100 mcg of TV1.C gp120 and 100 mcg of 1806.C gp120) admixed with Sodium Chloride for Injection, 0.9% to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, and 12 |
|
|
ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 6, and 12 AND Bivalent Subtype C gp120/MF59 (an admixture of 100 mcg of TV1.C gp120, 100 mcg of 1086.C gp120, and MF59C.1) to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 0, 1, 6, and 12
| OG003 | Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, and 12 AND Bivalent Subtype C gp120 (an admixture of 100 mcg of TV1.C gp120 and 100 mcg of 1806.C gp120) admixed with Sodium Chloride for Injection, 0.9% to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, and 12 |
|
|
ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 6, and 12 AND Bivalent Subtype C gp120/MF59 (an admixture of 100 mcg of TV1.C gp120, 100 mcg of 1086.C gp120, and MF59C.1) to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 0, 1, 6, and 12
| OG003 | Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, and 12 AND Bivalent Subtype C gp120 (an admixture of 100 mcg of TV1.C gp120 and 100 mcg of 1806.C gp120) admixed with Sodium Chloride for Injection, 0.9% to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, and 12 |
|
|
ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 6, and 12 AND Bivalent Subtype C gp120/MF59 (an admixture of 100 mcg of TV1.C gp120, 100 mcg of 1086.C gp120, and MF59C.1) to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 0, 1, 6, and 12
| OG003 | Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, and 12 AND Bivalent Subtype C gp120 (an admixture of 100 mcg of TV1.C gp120 and 100 mcg of 1806.C gp120) admixed with Sodium Chloride for Injection, 0.9% to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, and 12 |
|
|
| OG003 | Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, and 12 AND Bivalent Subtype C gp120 (an admixture of 100 mcg of TV1.C gp120 and 100 mcg of 1806.C gp120) admixed with Sodium Chloride for Injection, 0.9% to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, and 12 |
|
|
ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 6, and 12 AND Bivalent Subtype C gp120/MF59 (an admixture of 100 mcg of TV1.C gp120, 100 mcg of 1086.C gp120, and MF59C.1) to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 0, 1, 6, and 12
| OG003 | Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, and 12 AND Bivalent Subtype C gp120 (an admixture of 100 mcg of TV1.C gp120 and 100 mcg of 1806.C gp120) admixed with Sodium Chloride for Injection, 0.9% to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, and 12 |
|
|
| OG002 | Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 6, and 12 AND Bivalent Subtype C gp120/MF59 (an admixture of 100 mcg of TV1.C gp120, 100 mcg of 1086.C gp120, and MF59C.1) to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 0, 1, 6, and 12 |
| OG003 | Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, and 12 AND Bivalent Subtype C gp120 (an admixture of 100 mcg of TV1.C gp120 and 100 mcg of 1806.C gp120) admixed with Sodium Chloride for Injection, 0.9% to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, and 12 |
|
|
| OG002 | Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 6, and 12 AND Bivalent Subtype C gp120/MF59 (an admixture of 100 mcg of TV1.C gp120, 100 mcg of 1086.C gp120, and MF59C.1) to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 0, 1, 6, and 12 |
| OG003 | Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, and 12 AND Bivalent Subtype C gp120 (an admixture of 100 mcg of TV1.C gp120 and 100 mcg of 1806.C gp120) admixed with Sodium Chloride for Injection, 0.9% to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, and 12 |
|
|
| OG002 | Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 6, and 12 AND Bivalent Subtype C gp120/MF59 (an admixture of 100 mcg of TV1.C gp120, 100 mcg of 1086.C gp120, and MF59C.1) to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 0, 1, 6, and 12 |
| OG003 | Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, and 12 AND Bivalent Subtype C gp120 (an admixture of 100 mcg of TV1.C gp120 and 100 mcg of 1806.C gp120) admixed with Sodium Chloride for Injection, 0.9% to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, and 12 |
|
|
| OG002 | Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 6, and 12 AND Bivalent Subtype C gp120/MF59 (an admixture of 100 mcg of TV1.C gp120, 100 mcg of 1086.C gp120, and MF59C.1) to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 0, 1, 6, and 12 |
| OG003 | Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, and 12 AND Bivalent Subtype C gp120 (an admixture of 100 mcg of TV1.C gp120 and 100 mcg of 1806.C gp120) admixed with Sodium Chloride for Injection, 0.9% to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, and 12 |
|
|
| OG002 | Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 6, and 12 AND Bivalent Subtype C gp120/MF59 (an admixture of 100 mcg of TV1.C gp120, 100 mcg of 1086.C gp120, and MF59C.1) to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 0, 1, 6, and 12 |
| OG003 | Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, and 12 AND Bivalent Subtype C gp120 (an admixture of 100 mcg of TV1.C gp120 and 100 mcg of 1806.C gp120) admixed with Sodium Chloride for Injection, 0.9% to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, and 12 |
|
|
| OG002 | Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 6, and 12 AND Bivalent Subtype C gp120/MF59 (an admixture of 100 mcg of TV1.C gp120, 100 mcg of 1086.C gp120, and MF59C.1) to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 0, 1, 6, and 12 |
| OG003 | Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, and 12 AND Bivalent Subtype C gp120 (an admixture of 100 mcg of TV1.C gp120 and 100 mcg of 1806.C gp120) admixed with Sodium Chloride for Injection, 0.9% to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, and 12 |
|
|
ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 6, and 12 AND Bivalent Subtype C gp120/MF59® (an admixture of 100 mcg of TV1.C gp120, 100 mcg of 1086.C gp120, and MF59C.1) to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 0, 1, 6, and 12 |
| OG003 | Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) gp120 mo(3,6,12) | ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, and 12 AND Bivalent Subtype C gp120 (an admixture of 100 mcg of TV1.C gp120 and 100 mcg of 1806.C gp120) admixed with Sodium Chloride for Injection, 0.9% to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, and 12 |
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ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 6, and 12 AND Bivalent Subtype C gp120/MF59 (an admixture of 100 mcg of TV1.C gp120, 100 mcg of 1086.C gp120, and MF59C.1) to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 0, 1, 6, and 12
| OG003 | Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, and 12 AND Bivalent Subtype C gp120 (an admixture of 100 mcg of TV1.C gp120 and 100 mcg of 1806.C gp120) admixed with Sodium Chloride for Injection, 0.9% to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, and 12 |
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| OG001 | Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, and 12 AND Bivalent Subtype C gp120 (an admixture of 100 mcg of TV1.C gp120 and 100 mcg of 1806.C gp120) admixed with Aluminum Hydroxide Suspension to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, and 12 |
| OG002 | Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 6, and 12 AND Bivalent Subtype C gp120/MF59 (an admixture of 100 mcg of TV1.C gp120, 100 mcg of 1086.C gp120, and MF59C.1) to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 0, 1, 6, and 12 |
| OG003 | Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, and 12 AND Bivalent Subtype C gp120 (an admixture of 100 mcg of TV1.C gp120 and 100 mcg of 1806.C gp120) admixed with Sodium Chloride for Injection, 0.9% to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, and 12 |
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| OG001 | Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, and 12 AND Bivalent Subtype C gp120 (an admixture of 100 mcg of TV1.C gp120 and 100 mcg of 1806.C gp120) admixed with Aluminum Hydroxide Suspension to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, and 12 |
| OG002 | Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 6, and 12 AND Bivalent Subtype C gp120/MF59 (an admixture of 100 mcg of TV1.C gp120, 100 mcg of 1086.C gp120, and MF59C.1) to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 0, 1, 6, and 12 |
| OG003 | Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, and 12 AND Bivalent Subtype C gp120 (an admixture of 100 mcg of TV1.C gp120 and 100 mcg of 1806.C gp120) admixed with Sodium Chloride for Injection, 0.9% to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, and 12 |
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| OG001 | Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, and 12 AND Bivalent Subtype C gp120 (an admixture of 100 mcg of TV1.C gp120 and 100 mcg of 1806.C gp120) admixed with Aluminum Hydroxide Suspension to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, and 12 |
| OG002 | Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 6, and 12 AND Bivalent Subtype C gp120/MF59 (an admixture of 100 mcg of TV1.C gp120, 100 mcg of 1086.C gp120, and MF59C.1) to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 0, 1, 6, and 12 |
| OG003 | Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, and 12 AND Bivalent Subtype C gp120 (an admixture of 100 mcg of TV1.C gp120 and 100 mcg of 1806.C gp120) admixed with Sodium Chloride for Injection, 0.9% to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, and 12 |
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| OG001 |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) |
ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, and 12 AND Bivalent Subtype C gp120 (an admixture of 100 mcg of TV1.C gp120 and 100 mcg of 1806.C gp120) admixed with Aluminum Hydroxide Suspension to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, and 12 |
| OG002 | Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 6, and 12 AND Bivalent Subtype C gp120/MF59 (an admixture of 100 mcg of TV1.C gp120, 100 mcg of 1086.C gp120, and MF59C.1) to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 0, 1, 6, and 12 |
| OG003 | Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, and 12 AND Bivalent Subtype C gp120 (an admixture of 100 mcg of TV1.C gp120 and 100 mcg of 1806.C gp120) admixed with Sodium Chloride for Injection, 0.9% to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, and 12 |
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| OG001 | Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, and 12 AND Bivalent Subtype C gp120 (an admixture of 100 mcg of TV1.C gp120 and 100 mcg of 1806.C gp120) admixed with Aluminum Hydroxide Suspension to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, and 12 |
| OG002 | Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 6, and 12 AND Bivalent Subtype C gp120/MF59 (an admixture of 100 mcg of TV1.C gp120, 100 mcg of 1086.C gp120, and MF59C.1) to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 0, 1, 6, and 12 |
| OG003 | Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, and 12 AND Bivalent Subtype C gp120 (an admixture of 100 mcg of TV1.C gp120 and 100 mcg of 1806.C gp120) admixed with Sodium Chloride for Injection, 0.9% to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, and 12 |
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| OG001 | Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, and 12 AND Bivalent Subtype C gp120 (an admixture of 100 mcg of TV1.C gp120 and 100 mcg of 1806.C gp120) admixed with Aluminum Hydroxide Suspension to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, and 12 |
| OG002 | Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 6, and 12 AND Bivalent Subtype C gp120/MF59 (an admixture of 100 mcg of TV1.C gp120, 100 mcg of 1086.C gp120, and MF59C.1) to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 0, 1, 6, and 12 |
| OG003 | Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, and 12 AND Bivalent Subtype C gp120 (an admixture of 100 mcg of TV1.C gp120 and 100 mcg of 1806.C gp120) admixed with Sodium Chloride for Injection, 0.9% to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, and 12 |
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| OG001 | Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, and 12 AND Bivalent Subtype C gp120 (an admixture of 100 mcg of TV1.C gp120 and 100 mcg of 1806.C gp120) admixed with Aluminum Hydroxide Suspension to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, and 12 |
| OG002 | Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 6, and 12 AND Bivalent Subtype C gp120/MF59 (an admixture of 100 mcg of TV1.C gp120, 100 mcg of 1086.C gp120, and MF59C.1) to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 0, 1, 6, and 12 |
| OG003 | Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, and 12 AND Bivalent Subtype C gp120 (an admixture of 100 mcg of TV1.C gp120 and 100 mcg of 1806.C gp120) admixed with Sodium Chloride for Injection, 0.9% to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, and 12 |
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| OG001 |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) |
ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, and 12 AND Bivalent Subtype C gp120 (an admixture of 100 mcg of TV1.C gp120 and 100 mcg of 1806.C gp120) admixed with Aluminum Hydroxide Suspension to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, and 12 |
| OG002 | Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 6, and 12 AND Bivalent Subtype C gp120/MF59 (an admixture of 100 mcg of TV1.C gp120, 100 mcg of 1086.C gp120, and MF59C.1) to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 0, 1, 6, and 12 |
| OG003 | Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, and 12 AND Bivalent Subtype C gp120 (an admixture of 100 mcg of TV1.C gp120 and 100 mcg of 1806.C gp120) admixed with Sodium Chloride for Injection, 0.9% to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, and 12 |
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| OG001 | Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, and 12 AND Bivalent Subtype C gp120 (an admixture of 100 mcg of TV1.C gp120 and 100 mcg of 1806.C gp120) admixed with Aluminum Hydroxide Suspension to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, and 12 |
| OG002 | Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 6, and 12 AND Bivalent Subtype C gp120/MF59 (an admixture of 100 mcg of TV1.C gp120, 100 mcg of 1086.C gp120, and MF59C.1) to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 0, 1, 6, and 12 |
| OG003 | Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, and 12 AND Bivalent Subtype C gp120 (an admixture of 100 mcg of TV1.C gp120 and 100 mcg of 1806.C gp120) admixed with Sodium Chloride for Injection, 0.9% to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, and 12 |
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| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) |
ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, and 12 AND Bivalent Subtype C gp120 (an admixture of 100 mcg of TV1.C gp120 and 100 mcg of 1806.C gp120) admixed with Aluminum Hydroxide Suspension to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, and 12 |
| OG002 | Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 6, and 12 AND Bivalent Subtype C gp120/MF59 (an admixture of 100 mcg of TV1.C gp120, 100 mcg of 1086.C gp120, and MF59C.1) to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 0, 1, 6, and 12 |
| OG003 | Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, and 12 AND Bivalent Subtype C gp120 (an admixture of 100 mcg of TV1.C gp120 and 100 mcg of 1806.C gp120) admixed with Sodium Chloride for Injection, 0.9% to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, and 12 |
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ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, and 12 AND Bivalent Subtype C gp120 (an admixture of 100 mcg of TV1.C gp120 and 100 mcg of 1806.C gp120) admixed with Aluminum Hydroxide Suspension to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, and 12 |
| OG002 | Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 6, and 12 AND Bivalent Subtype C gp120/MF59 (an admixture of 100 mcg of TV1.C gp120, 100 mcg of 1086.C gp120, and MF59C.1) to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 0, 1, 6, and 12 |
| OG003 | Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, and 12 AND Bivalent Subtype C gp120 (an admixture of 100 mcg of TV1.C gp120 and 100 mcg of 1806.C gp120) admixed with Sodium Chloride for Injection, 0.9% to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, and 12 |
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ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, and 12 AND Bivalent Subtype C gp120 (an admixture of 100 mcg of TV1.C gp120 and 100 mcg of 1806.C gp120) admixed with Aluminum Hydroxide Suspension to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, and 12 |
| OG002 | Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 6, and 12 AND Bivalent Subtype C gp120/MF59 (an admixture of 100 mcg of TV1.C gp120, 100 mcg of 1086.C gp120, and MF59C.1) to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 0, 1, 6, and 12 |
| OG003 | Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, and 12 AND Bivalent Subtype C gp120 (an admixture of 100 mcg of TV1.C gp120 and 100 mcg of 1806.C gp120) admixed with Sodium Chloride for Injection, 0.9% to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, and 12 |
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| OG001 | Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, and 12 AND Bivalent Subtype C gp120 (an admixture of 100 mcg of TV1.C gp120 and 100 mcg of 1806.C gp120) admixed with Aluminum Hydroxide Suspension to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, and 12 |
| OG002 | Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 6, and 12 AND Bivalent Subtype C gp120/MF59 (an admixture of 100 mcg of TV1.C gp120, 100 mcg of 1086.C gp120, and MF59C.1) to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 0, 1, 6, and 12 |
| OG003 | Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, and 12 AND Bivalent Subtype C gp120 (an admixture of 100 mcg of TV1.C gp120 and 100 mcg of 1806.C gp120) admixed with Sodium Chloride for Injection, 0.9% to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, and 12 |
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| OG001 | Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, and 12 AND Bivalent Subtype C gp120 (an admixture of 100 mcg of TV1.C gp120 and 100 mcg of 1806.C gp120) admixed with Aluminum Hydroxide Suspension to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, and 12 |
| OG002 | Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 6, and 12 AND Bivalent Subtype C gp120/MF59 (an admixture of 100 mcg of TV1.C gp120, 100 mcg of 1086.C gp120, and MF59C.1) to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 0, 1, 6, and 12 |
| OG003 | Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, and 12 AND Bivalent Subtype C gp120 (an admixture of 100 mcg of TV1.C gp120 and 100 mcg of 1806.C gp120) admixed with Sodium Chloride for Injection, 0.9% to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, and 12 |
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| OG001 | Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, and 12 AND Bivalent Subtype C gp120 (an admixture of 100 mcg of TV1.C gp120 and 100 mcg of 1806.C gp120) admixed with Aluminum Hydroxide Suspension to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, and 12 |
| OG002 | Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 6, and 12 AND Bivalent Subtype C gp120/MF59 (an admixture of 100 mcg of TV1.C gp120, 100 mcg of 1086.C gp120, and MF59C.1) to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 0, 1, 6, and 12 |
| OG003 | Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, and 12 AND Bivalent Subtype C gp120 (an admixture of 100 mcg of TV1.C gp120 and 100 mcg of 1806.C gp120) admixed with Sodium Chloride for Injection, 0.9% to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, and 12 |
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| OG001 |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) |
ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, and 12 AND Bivalent Subtype C gp120 (an admixture of 100 mcg of TV1.C gp120 and 100 mcg of 1806.C gp120) admixed with Aluminum Hydroxide Suspension to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, and 12 |
| OG002 | Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 6, and 12 AND Bivalent Subtype C gp120/MF59 (an admixture of 100 mcg of TV1.C gp120, 100 mcg of 1086.C gp120, and MF59C.1) to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 0, 1, 6, and 12 |
| OG003 | Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, and 12 AND Bivalent Subtype C gp120 (an admixture of 100 mcg of TV1.C gp120 and 100 mcg of 1806.C gp120) admixed with Sodium Chloride for Injection, 0.9% to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, and 12 |
|
|
| OG001 | Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, and 12 AND Bivalent Subtype C gp120 (an admixture of 100 mcg of TV1.C gp120 and 100 mcg of 1806.C gp120) admixed with Aluminum Hydroxide Suspension to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, and 12 |
| OG002 | Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 6, and 12 AND Bivalent Subtype C gp120/MF59 (an admixture of 100 mcg of TV1.C gp120, 100 mcg of 1086.C gp120, and MF59C.1) to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 0, 1, 6, and 12 |
| OG003 | Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, and 12 AND Bivalent Subtype C gp120 (an admixture of 100 mcg of TV1.C gp120 and 100 mcg of 1806.C gp120) admixed with Sodium Chloride for Injection, 0.9% to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, and 12 |
|
|
| OG001 |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) |
ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, and 12 AND Bivalent Subtype C gp120 (an admixture of 100 mcg of TV1.C gp120 and 100 mcg of 1806.C gp120) admixed with Aluminum Hydroxide Suspension to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, and 12 |
| OG002 | Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 6, and 12 AND Bivalent Subtype C gp120/MF59 (an admixture of 100 mcg of TV1.C gp120, 100 mcg of 1086.C gp120, and MF59C.1) to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 0, 1, 6, and 12 |
| OG003 | Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, and 12 AND Bivalent Subtype C gp120 (an admixture of 100 mcg of TV1.C gp120 and 100 mcg of 1806.C gp120) admixed with Sodium Chloride for Injection, 0.9% to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, and 12 |
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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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| Not gradable |
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| Mild |
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| Moderate |
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| Potentially Life-threatening |
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| Not gradable |
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| Mild |
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| Moderate |
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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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| Mild |
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| Moderate |
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| Severe |
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| Potentially Life-threatening |
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