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| ID | Type | Description | Link |
|---|---|---|---|
| UM1AI068614 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Allergy and Infectious Diseases (NIAID) | NIH |
| National Institutes of Health (NIH) | NIH |
| Department of Health and Human Services | FED |
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The purpose of this study is to evaluate the safety and immunogenicity of HIV-1 vaccines based on chimpanzee serotypes of adenovirus expressing clade C gp140 and a CH505TF gp120 protein boost in healthy, HIV- uninfected adult participants.
This study will evaluate the safety and tolerability of AdC6-HIVgp140 and AdC7-HIVgp140 at doses of 1 x 10^10 virus particles (vp) and 5 x 10^10 vp, alone and in combination with CH505TF gp120 adjuvanted with GLA-SE in HIV- uninfected adults.
Participants will be randomly assigned to 6 groups, separated into low dose (Part A; Groups 1-3) and high dose (Part B; Groups 4-6).
Participants in Group 1 (Groups 1-3) will receive 1 x 10^10 vp of AdC6-HIVgp140. Participants in Group 2 will receive 1 x 10^10 vp of AdC7-HIVgp140. Participants in Group 3 will receive Placebo control.
Part A participants will undergo 6 months of scheduled clinic visits (main study) followed by AESI (Adverse Events of Special Interest) health contacts at month 12, and then annual health contacts at month 24 and 36.
Participants in Group 4 will receive 5 x 10^10 vp of AdC6-HIVgp140 followed by 5 x 10^10 vp of AdC7-HIVgp140 (month 3) and 400 mcg CH505TF with 10 mcg GLA-SE (month 6). Participants in Group 5 will receive 5 x 10^10 vp of AdC7-HIVgp140 followed by 5 x 10^10 vp of AdC6-HIVgp140 (month 3) and 400 mcg CH505TF with 10 mcg GLA-SE (month 6). Participants in Group 6 will receive Placebo control.
Part B participants (Group 4-6) will undergo 12 months of scheduled clinic visits (main study) followed by an AESI health contact at month 18, and then annual health contacts at month 24 and 36.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A, Group 1: AdC6-HIVgp140 | Experimental | Participants will receive 1 x 10^10 vp AdC6-HIVgp140 to be administered as two separate 1 mL IM injections into the deltoid of the non-dominant arm unless medically contraindicated at month 0. |
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| Part A, Group 2: AdC7-HIVgp140 | Experimental | Participants will receive 1 x 10^10 vp AdC7-HIVgp140 to be administered as two separate 1 mL IM injections into the deltoid of the non-dominant arm unless medically contraindicated at month 0. |
|
| Part A, Group 3: Placebo | Placebo Comparator | Participants will receive placebo for AdC6-HIVgp140 or AdC7-HIVgp140 (labeled as Sodium Chloride for Injection, 0.9%) to be administered as two separate 1 mL IM injections into the deltoid of the non-dominant arm unless medically contraindicated at month 0. |
|
| Part B, Group 4: AdC6-HIVgp140 + AdC7-HIVgp140 + 400 mcg CH505TF gp120/GLA-SE | Experimental | Participants will receive 5 x 10^10 vp AdC6-HIVgp140 to be administered as two separate 1 mL IM injections into the deltoid of the non-dominant arm unless medically contraindicated at month 0. Then 5 x 10^10 vp AdC7-HIVgp140 to be administered as two separate 1 mL IM injections into the deltoid of the non-dominant arm unless medically contraindicated at month 3. Then 400 mcg CH505TF gp120 admixed with 10 mcg GLA-SE administered as a 1mL IM injection into either thigh unless medically contraindicated at month 6. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AdC6-HIVgp140 | Biological | The product is diluted in 2.5% Glycerol/25 mM NaCl/20 mM TRIS [tris(hydroxymethyl)aminomethane], pH 8.0 formulation buffer to a concentration of 1.2 x 10^11 vp/mL and filled at 0.3 mL for AdC6-HIVgp140 into a 2 mL Type 1 glass vial and stoppered with a gray chlorobutyl rubber stopper. The product is clear to slightly cloudy liquid, essentially free of visible particles. AdC6-HIVgp140 should be stored at ≤ -65°C prior to use/preparation. The study product is described in further detail in the Investigator's Brochure (IB). |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Reporting Local Reactogenicity Events 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 7 days after each study product administration at Study Day 0 (Month 0) for Part A (T1, T2, and C3) and at Study Days 0 (Month 0), 84 (Month 3) and 168 (Month 6) for Part B (T4, T5, and C6). |
| 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 7 days after each study product administration at Study Day 0 (Month 0) for Part A (T1, T2, and C3) and at Study Days 0 (Month 0), 84 (Month 3) and 168 (Month 6) for Part B (T4, T5, and C6). |
| 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 maximum grade observed for each symptom over the time frame is presented. | Measured through 7 days after each study product administration at Study Day 0 (Month 0) for Part A (T1, T2, and C3) and at Study Days 0 (Month 0), 84 (Month 3) and 168 (Month 6) for Part B (T4, T5, and C6). |
| Numbers of Participant With Early Study Termination Associated With Reactogenicity, AE, or Death During Main Study and AESI Visits. | From the termination and adverse event forms that were collected during main study clinical visits period and AESI contact visits. Counts are tabulated by treatment arm. | Early study termination reason was collected through 7 days for reactogenicity, 30 days for AEs and 12 months for deaths following any receipt of study product (up to 18 months). |
| Measure | Description | Time Frame |
|---|---|---|
| Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | Serum HIV-1-specific IgG responses (dilution 1:50) against gp120, gp140, gp70-V1V2 and gp41 antigens were measured on a Bio-Plex instrument (Bio-Rad) using a standardized custom HIV-1 Luminex assay. The readout was background-subtracted mean fluorescence intensity (MFI), where background referred to a plate level control (i.e., a blank well run on each plate). Samples from post-enrollment visits were declared to have positive responses if they met three conditions: (1) the mean fluorescence intensity (MFI) minus blank (MFI*) values were ≥ antigen-specific cutoff at the 1:50 dilution level (based on the 95th percentile of baseline samples as calculated by SAS PROC UNIVARIATE default method, and at least 100 MFI minus blank), (2) the MFI minus blank values were greater than 3 times the baseline (day 0) MFI minus blank values, and (3) the MFI values were greater than 3 times the baseline MFI values. |
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Inclusion Criteria:
General and Demographic Criteria
HIV-Related Criteria
Laboratory Inclusion Values
Hemogram/Complete blood count (CBC)
Hemoglobin
For transgender participants who have been on hormone therapy for less than 6 consecutive months, determine hemoglobin eligibility based on the sex assigned at birth
Chemistry
Virology
Urine
Normal urine:
Reproductive Status
Volunteers who were assigned female sex at birth: negative serum or urine beta human chorionic gonadotropin (β-HCG) pregnancy test at screening (ie, prior to randomization) and prior to study product administration on the day of study product administration. Persons who are NOT of reproductive potential due to having undergone hysterectomy or bilateral oophorectomy (verified by medical records), are not required to undergo pregnancy testing.
Reproductive status: A volunteer who was assigned female sex at birth must agree to use effective contraception for sexual activity that could lead to pregnancy from at least 21 days prior to enrollment until two months following final product administration.
Volunteers who were assigned female sex at birth must also agree not to seek pregnancy through alternative methods, such as artificial insemination or in vitro fertilization until two months after the last product administration
Exclusion Criteria:
Vaccines and other Injections
Immune System
Volunteers who currently have, or have a history of, any condition that could be considered an AESI for the products administered in this protocol (representative examples are listed in Appendix N). The exception to Appendix N is well-controlled psoriasis, which is not exclusionary (as above)
Clinical significant medical conditions
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 exclusion criteria: Asthma is excluded if the participant has ANY of the following:
Diabetes mellitus type 1 or type 2. (Not exclusionary: type 2 cases controlled with diet alone or a history of isolated gestational diabetes)
Thyroidectomy, or thyroid disease (Not exclusionary: well-controlled non-autoimmune thyroid disease as defined in HVTN 139 Study Specific Procedures (SSP))
Hypertension:
If a person has been found to have elevated blood pressure or hypertension during screening or previously, exclude for blood pressure that is not well controlled. Well-controlled blood pressure is defined in this protocol as consistently < 140 mm Hg systolic and < 90 mm Hg diastolic, with or without medication, with only isolated, brief instances of higher readings, which must be ≤ 150 mm Hg systolic and ≤ 100 mm Hg diastolic. For these volunteers, blood pressure must be < 140 mm Hg systolic and < 90 mm Hg diastolic at enrollment.
If a person has NOT been found to have elevated blood pressure or hypertension during screening or previously, exclude for systolic blood pressure ≥ 150 mm Hg at enrollment or diastolic blood pressure ≥ 100 mm Hg at enrollment.
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| Name | Affiliation | Role |
|---|---|---|
| Ameena Goga | HIV Prevention Research Unit, South African Medical Research Council | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emavundleni CRS | Cape Town | South Africa | ||||
| CAPRISA eThekwini CRS |
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| ID | Title | Description |
|---|---|---|
| FG000 | Part A, Group 1: Vaccine | AdC6-HIVgp140 1 x 10^10 vp to be administrated IM at Month 0 |
| FG001 | Part A, Group 2: Vaccine | AdC7-HIVgp140 1 x 10^10 vp to be administrated IM at Month 0 |
| 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 | Yes | No | No | Study Protocol: Protocol Version 1 | Feb 23, 2021 |
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| Part B, Group 5: AdC7-HIVgp140 + AdC6-HIVgp140 + 400 mcg CH505TF gp120/GLA-SE | Experimental | Participants will receive 5 x 10^10 vp AdC7-HIVgp140 to be administered as two separate 1 mL IM injections into the deltoid of the non-dominant arm unless medically contraindicated at month 0. Then 5 x 10^10 vp AdC6-HIVgp140 to be administered as two separate 1 mL IM injections into the deltoid of the non-dominant arm unless medically contraindicated at month 3. Then 400 mcg CH505TF gp120 admixed with 10 mcg GLA-SE administered as a 1mL IM injection into either thigh unless medically contraindicated at month 6. |
|
| Part B, Group 6: Placebo + Placebo + Placebo | Placebo Comparator | Participants will receive placebo for AdC6-HIVgp140and AdC7-HIVgp140 (labeled as Sodium Chloride for Injection, 0.9%) to be administered as two separate 1 mL IM injections into the deltoid of the non-dominant arm unless medically contraindicated at month 0 and 3. Placebo for CH505TF/GLA-SE (labeled as Sodium Chloride for Injection, 0.9% ) to be administered as 1 mL IM injection into either thigh at month 6. |
|
|
| AdC7-HIVgp140 | Biological | The products is diluted in 2.5% Glycerol/25 mM NaCl/20 mM TRIS [tris(hydroxymethyl)aminomethane], pH 8.0 formulation buffer to a concentration of 1.2 x 10^11 vp/mL and filled at 0.6 mL for AdC7-HIVgp140 into a 2 mL Type 1 glass vial and stoppered with a gray chlorobutyl rubber stopper. The product is clear to slightly cloudy liquid, essentially free of visible particles. AdC7-HIVgp140 should be stored at ≤ -65°C prior to use/preparation. The study product is described in further detail in the IB. |
|
| CH505TF gp120 | Biological | CH505TF gp120 is formulated in 20 mM sodium phosphate, 150 mM NaCl, 0.02% polysorbate 80 (PS80), pH 6.5, supplied as a frozen liquid in 2 mL glass vials. Each 2 mL vial contains 0.75 mL of formulated gp120 at a concentration of 0.8 mg/mL and is stored at ≤ -65°C. The study product is described in further detail in the IB. |
|
| GLA-SE (glucopyranosyl lipid A - stable emulsion; [labeled as AP 10-201]) | Biological | The GLA-SE adjuvant will be provided as vials containing 20 mcg/mL GLA in a 4% oil-in-water emulsion. Each sterile, single use vial contains 0.4 mL of product. Product appears as a milky-white liquid. GLA-SE must be stored at 2° to 8°C and must not be frozen. The study product is described in further detail within the IB. |
|
| Placebo | Biological | Placebo will be Sodium Chloride for Injection, 0.9%, will be used as the placebo. It must be stored as recommended by the manufacturer. |
|
| Number of Participants Reporting Serious Adverse Events (SAEs) | From adverse event (AE) forms, counts are tabulated by treatment arm. AE forms were collected during main study clinical visits and AESI contact visits | Measured through 12 months following any receipt of study product(up to 18 months). Study products were given at Study Day 0 (Month 0) for Part A (T1, T2, and C3) and at Study Days 0 (Month 0), 84 (Month 3) and 168 (Month 6) for Part B (T4, T5, and C6). |
| Number of Participants Reporting Medically Attended Adverse Events (MAAEs) | From adverse event (AE) forms, counts are tabulated by treatment arm. AE forms were collected during main study clinical visits and AESI contact visits | Measured through 12 months following any receipt of study product(up to 18 months). Study products were given at Study Day 0 (Month 0) for Part A (T1, T2, and C3) and at Study Days 0 (Month 0), 84 (Month 3) and 168 (Month 6) for Part B (T4, T5, and C6). |
| Number of Participants Reporting Adverse Event of Special Interests (AESIs) | From adverse event (AE) forms, counts are tabulated by treatment arm. AE forms were collected during main study clinical visits and AESI contact visits | Measured through 12 months following any receipt of study product(up to 18 months). Study products were given at Study Day 0 (Month 0) for Part A (T1, T2, and C3) and at Study Days 0 (Month 0), 84 (Month 3) and 168 (Month 6) for Part B (T4, T5, and C6). |
| Measured at Month 1 for both Part A and Part B |
| Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | Serum HIV-1-specific IgG responses (dilution 1:50) against gp120, gp140, gp70-V1V2 and gp41 antigens were measured on a Bio-Plex instrument (Bio-Rad) using a standardized custom HIV-1 Luminex assay. The readout was background-subtracted mean fluorescence intensity (MFI), where background referred to a plate level control (i.e., a blank well run on each plate). | Measured at Month 1 for both Part A and Part B |
| HIV-specific Serum IgG Binding Antibodies Magnitude Breadth of AUC (AUC--MB) by Panel and Treatment Arm Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | The area under the magnitude-breadth curve (AUC-MB) was calculated by first measuring the mean fluorescence intensity (MFI) of antibody binding to each antigen at 1:50 dilution. For each sample, a magnitude-breadth curve is generated by plotting the number of antigens (breadth) that exceed a series of MFI thresholds (MFI >100). The area under this curve (AUC) is then computed by the trapezoidal rule to summarize both the strength and diversity of the antibody response in a single value, which is equivalent to the average of the log10 net MFI over the panel of antigens | Measured at Month 1 for both Part A and Part B |
| Response Rate of HIV-specific CD4+ and CD8+ T-cell Responses Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | The four entries in each table were the number of cells positive for IFN-γ and/or IL-2 for both the stimulated and the negative control data. If both negative control replicates were included, then the average number of total cells and the average number of positive cells were used. A one-sided Fisher's exact test was applied to the table, testing whether the number of cytokine-producing cells for the stimulated data was equal to that for the negative control data. Since multiple individual tests (for each peptide pool) were conducted simultaneously, a multiplicity adjustment was made to the two individual peptide pool p-values considered, using the Bonferroni-Holm adjustment method. If the adjusted p-value for a peptide pool was ≤ 0.00001, the response to the peptide pool for the T-cell subset was considered positive. If at least one peptide pool for a specific HIV-1 protein was positive, then the overall response to the protein was considered positive. | Measured at Month 1 for both Part A and Part B |
| Magnitude of HIV-specific CD4+ and CD8+ T-cell by Cytokine, T-cell Subset, Antigen and Treatment Group Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | PBMC samples were 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 cytokines (IFNy and/or IL-2) after peptide stimulation minus % cells expressing markers after no stimulation. Reported responses magnitude for Any Env are the sum of ENV-1-PTEG-SEQ and ENV-2-PTEG-SEQ | Measured at Month 1 for both Part A and Part B |
| Response Rate of Serum Neutralizing Antibodies Against Env-pseudotyped Vaccine Strains (Du422.1, Du172.17 and CH505TF) and a Tier 1A Neutralization Phenotype (MW965.26) Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | Neutralizing antibodies against strains of HIV-1 were measured as a function of reductions in Tat-induced luciferase (Luc) reporter gene expression in TZMbl cells. A serum neutralization titer was defined as the serum dilution that reduced relative luminescence units (RLUs) by 50% and 80% (ID50 and ID80) relative to the RLUs in virus control wells (cells + virus only) after subtraction of background RLU (cells only). The assay performed in TZM-bl cells measured neutralization titers against the Env-pseudotyped vaccine strains (Du422.1, Du172.17 and CH505TF) and a virus that exhibits a tier 1A neutralization phenotype (MW965.26). Response to a virus/isolate was considered positive if the neutralization titer was at or above a pre-specified cutoff of 10. | Measured at Month 1 for both Part A and Part B |
| Magnitude of Serum Neutralizing Antibodies Against Env-pseudotyped Vaccine Strains (Du422.1, Du172.17 and CH505TF) and a Tier 1A Neutralization Phenotype (MW965.26) Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | Neutralizing antibodies against strains of HIV-1 were measured as a function of reductions in Tat-induced luciferase (Luc) reporter gene expression in TZMbl cells. A serum neutralization titer was defined as the serum dilution that reduced relative luminescence units (RLUs) by 50% and 80% (ID50 and ID80) relative to the RLUs in virus control wells (cells + virus only) after subtraction of background RLU (cells only). The assay performed in TZM-bl cells measured neutralization titers against the Env-pseudotyped vaccine strains (Du422.1, Du172.17 and CH505TF) and a virus that exhibits a tier 1A neutralization phenotype (MW965.26). | Measured at Month 1 for both Part A and Part B |
| Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination | Serum HIV-1-specific IgG responses (dilution 1:50) against gp120, gp140, gp70-V1V2 and gp41 antigens were measured on a Bio-Plex instrument (Bio-Rad) using a standardized custom HIV-1 Luminex assay. The readout was background-subtracted mean fluorescence intensity (MFI), where background referred to a plate level control (i.e., a blank well run on each plate). Samples from post-enrollment visits were declared to have positive responses if they met three conditions: (1) the mean fluorescence intensity (MFI) minus blank (MFI*) values were ≥ antigen-specific cutoff at the 1:50 dilution level (based on the 95th percentile of baseline samples as calculated by SAS PROC UNIVARIATE default method, and at least 100 MFI minus blank), (2) the MFI minus blank values were greater than 3 times the baseline (day 0) MFI minus blank values, and (3) the MFI values were greater than 3 times the baseline MFI values. | Measured at Month 4 for Part B |
| Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination | Serum HIV-1-specific IgG responses (dilution 1:50) against gp120, gp140, gp70-V1V2 and gp41 antigens were measured on a Bio-Plex instrument (Bio-Rad) using a standardized custom HIV-1 Luminex assay. The readout was background-subtracted mean fluorescence intensity (MFI), where background referred to a plate level control (i.e., a blank well run on each plate). | Measured at Month 4 for Part B |
| Part B: HIV-specific Serum IgG Binding Antibodies Magnitude Breadth of AUC by Panel and Treatment Arm Assessed 4 Weeks After the Second Vaccination | The area under the magnitude-breadth curve (AUC-MB) was calculated by first measuring the mean fluorescence intensity (MFI) of antibody binding to each antigen at 1:50 dilution. For each sample, a magnitude-breadth curve is generated by plotting the number of antigens (breadth) that exceed a series of MFI thresholds (MFI >100). The area under this curve (AUC) is then computed by the trapezoidal rule to summarize both the strength and diversity of the antibody response in a single value, which is equivalent to the average of the log10 net MFI over the panel of antigens | Measured at Month 4 for Part B |
| Part B: Response Rate of HIV-specific CD4+ and CD8+ T-cell Responses Assessed 4 Weeks After the Second Vaccination | The four entries in each table were the number of cells positive for IFN-γ and/or IL-2 for both the stimulated and the negative control data. If both negative control replicates were included, then the average number of total cells and the average number of positive cells were used. A one-sided Fisher's exact test was applied to the table, testing whether the number of cytokine-producing cells for the stimulated data was equal to that for the negative control data. Since multiple individual tests (for each peptide pool) were conducted simultaneously, a multiplicity adjustment was made to the two individual peptide pool p-values considered, using the Bonferroni-Holm adjustment method. If the adjusted p-value for a peptide pool was ≤ 0.00001, the response to the peptide pool for the T-cell subset was considered positive. If at least one peptide pool for a specific HIV-1 protein was positive, then the overall response to the protein was considered positive. | Measured at Month 4 for Part B |
| Part B: Magnitude of HIV-specific CD4+ and CD8+ T-cell by Cytokine, T-cell Subset, Antigen and Treatment Group Assessed 4 Weeks After the Second Vaccination | PBMC samples were 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 cytokines (IFNy and/or IL-2) after peptide stimulation minus % cells expressing markers after no stimulation. Reported responses magnitude for Any Env are the sum of ENV-1-PTEG-SEQ and ENV-2-PTEG-SEQ | Measured at Month 4 for Part B |
| Part B: Response Rate of Serum Neutralizing Antibodies Against Env-pseudotyped Vaccine Strains (Du422.1, Du172.17 and CH505TF) and a Tier 1A Neutralization Phenotype (MW965.26) Assessed 4 Weeks After the Second Vaccination | Neutralizing antibodies against strains of HIV-1 were measured as a function of reductions in Tat-induced luciferase (Luc) reporter gene expression in TZMbl cells. A serum neutralization titer was defined as the serum dilution that reduced relative luminescence units (RLUs) by 50% and 80% (ID50 and ID80) relative to the RLUs in virus control wells (cells + virus only) after subtraction of background RLU (cells only). The assay performed in TZM-bl cells measured neutralization titers against the Env-pseudotyped vaccine strains (Du422.1, Du172.17 and CH505TF) and a virus that exhibits a tier 1A neutralization phenotype (MW965.26). Response to a virus/isolate was considered positive if the neutralization titer was at or above a pre-specified cutoff of 10. | Measured at Month 4 for Part B |
| Part B: Magnitude of Serum Neutralizing Antibodies Against Env-pseudotyped Vaccine Strains (Du422.1, Du172.17 and CH505TF) and a Tier 1A Neutralization Phenotype (MW965.26) Assessed 4 Weeks After the Second Vaccination | Neutralizing antibodies against strains of HIV-1 were measured as a function of reductions in Tat-induced luciferase (Luc) reporter gene expression in TZMbl cells. A serum neutralization titer was defined as the serum dilution that reduced relative luminescence units (RLUs) by 50% and 80% (ID50 and ID80) relative to the RLUs in virus control wells (cells + virus only) after subtraction of background RLU (cells only). The assay performed in TZM-bl cells measured neutralization titers against the Env-pseudotyped vaccine strains (Du422.1, Du172.17 and CH505TF) and a virus that exhibits a tier 1A neutralization phenotype (MW965.26). A titer was defined as the serum dilution that reduced relative luminescence units (RLUs) by 50% and 80% relative to the RLUs in virus control wells (cells + virus only) after subtraction of background RLU (cells only). | Measured at Month 4 for Part B |
| Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination | Serum HIV-1-specific IgG responses (dilution 1:50) against gp120, gp140, gp70-V1V2 and gp41 antigens were measured on a Bio-Plex instrument (Bio-Rad) using a standardized custom HIV-1 Luminex assay. The readout was background-subtracted mean fluorescence intensity (MFI), where background referred to a plate level control (i.e., a blank well run on each plate). Samples from post-enrollment visits were declared to have positive responses if they met three conditions: (1) the mean fluorescence intensity (MFI) minus blank (MFI*) values were ≥ antigen-specific cutoff at the 1:50 dilution level (based on the 95th percentile of baseline samples as calculated by SAS PROC UNIVARIATE default method, and at least 100 MFI minus blank), (2) the MFI minus blank values were greater than 3 times the baseline (day 0) MFI minus blank values, and (3) the MFI values were greater than 3 times the baseline MFI values. | Measured at Month 6.5 for Part B |
| Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination | Serum HIV-1-specific IgG responses (dilution 1:50) against gp120, gp140, gp70-V1V2 and gp41 antigens were measured on a Bio-Plex instrument (Bio-Rad) using a standardized custom HIV-1 Luminex assay. The readout was background-subtracted mean fluorescence intensity (MFI), where background referred to a plate level control (i.e., a blank well run on each plate). | Measured at Month 6.5 for Part B |
| Part B: HIV-specific Serum IgG Binding Antibodies Magnitude Breadth of AUC by Panel and Treatment Arm Assessed 2 Weeks After the Third Vaccination | The area under the magnitude-breadth curve (AUC-MB) was calculated by first measuring the mean fluorescence intensity (MFI) of antibody binding to each antigen at 1:50 dilution. For each sample, a magnitude-breadth curve is generated by plotting the number of antigens (breadth) that exceed a series of MFI thresholds (MFI >100). The area under this curve (AUC) is then computed by the trapezoidal rule to summarize both the strength and diversity of the antibody response in a single value, which is equivalent to the average of the log10 net MFI over the panel of antigens | Measured at Month 6.5 for Part B |
| Part B: Response Rate of HIV-specific CD4+ and CD8+ T-cell Responses Assessed 2 Weeks After the Third Vaccination | The four entries in each table were the number of cells positive for IFN-γ and/or IL-2 for both the stimulated and the negative control data. If both negative control replicates were included, then the average number of total cells and the average number of positive cells were used. A one-sided Fisher's exact test was applied to the table, testing whether the number of cytokine-producing cells for the stimulated data was equal to that for the negative control data. Since multiple individual tests (for each peptide pool) were conducted simultaneously, a multiplicity adjustment was made to the two individual peptide pool p-values considered, using the Bonferroni-Holm adjustment method. If the adjusted p-value for a peptide pool was ≤ 0.00001, the response to the peptide pool for the T-cell subset was considered positive. If at least one peptide pool for a specific HIV-1 protein was positive, then the overall response to the protein was considered positive. | Measured at Month 6.5 for Part B |
| Part B: Magnitude of HIV-specific CD4+ and CD8+ T-cell by Cytokine, T-cell Subset, Antigen and Treatment Group Assessed 2 Weeks After the Third Vaccination | PBMC samples were 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 cytokines (IFNy and/or IL-2) after peptide stimulation minus % cells expressing markers after no stimulation. Reported responses magnitude for Any Env are the sum of ENV-1-PTEG-SEQ and ENV-2-PTEG-SEQ | Measured at Month 6.5 for Part B |
| Part B: Response Rate of Serum Neutralizing Antibodies Against Env-pseudotyped Vaccine Strains (Du422.1, Du172.17 and CH505TF) and a Tier 1A Neutralization Phenotype (MW965.26) Assessed 2 Weeks After the Third Vaccination | Neutralizing antibodies against strains of HIV-1 were measured as a function of reductions in Tat-induced luciferase (Luc) reporter gene expression in TZMbl cells. A serum neutralization titer was defined as the serum dilution that reduced relative luminescence units (RLUs) by 50% and 80% (ID50 and ID80) relative to the RLUs in virus control wells (cells + virus only) after subtraction of background RLU (cells only). The assay performed in TZM-bl cells measured neutralization titers against the Env-pseudotyped vaccine strains (Du422.1, Du172.17 and CH505TF) and a virus that exhibits a tier 1A neutralization phenotype (MW965.26). Response to a virus/isolate was considered positive if the neutralization titer was at or above a pre-specified cutoff of 10. | Measured at Month 6.5 for Part B |
| Part B: Magnitude of Serum Neutralizing Antibodies Against Env-pseudotyped Vaccine Strains (Du422.1, Du172.17 and CH505TF) and a Tier 1A Neutralization Phenotype (MW965.26) Assessed 2 Weeks After the Third Vaccination | Neutralizing antibodies against strains of HIV-1 were measured as a function of reductions in Tat-induced luciferase (Luc) reporter gene expression in TZMbl cells. A serum neutralization titer was defined as the serum dilution that reduced relative luminescence units (RLUs) by 50% and 80% (ID50 and ID80) relative to the RLUs in virus control wells (cells + virus only) after subtraction of background RLU (cells only). The assay performed in TZM-bl cells measured neutralization titers against the Env-pseudotyped vaccine strains (Du422.1, Du172.17 and CH505TF) and a virus that exhibits a tier 1A neutralization phenotype (MW965.26). A titer was defined as the serum dilution that reduced relative luminescence units (RLUs) by 50% and 80% relative to the RLUs in virus control wells (cells + virus only) after subtraction of background RLU (cells only). | Measured at Month 6.5 for Part B |
| Durban |
| South Africa |
| Isipingo CRS | Isipingo | South Africa |
| Soweto HVTN CRS | Johannesburg | South Africa |
| Aurum Institute Klerksdorp CRS | Klerksdorp | South Africa |
| Setshaba Research Centre CRS | Soshanguve | South Africa |
| FG002 | Part A, Group 3: Placebo | Placebo Control for AdC6-HIVgp140 or AdC7-HIVgp140, Sodium Chloride for Injection, 0.9%. Control for CH505TF gp120/GLA-SE adjuvanted protein: Sodium Chloride for Injection, 0.9%. |
| FG003 | Part B, Group 4: Vaccine | AdC6-HIVgp140 5 x 10^10 vp at Month 0 and AdC7-HIVgp140 5 x 10^10 vp at Month 3 and CH505TF/GLA-SE 400mg at Month 6 |
| FG004 | Part B, Group 5: Vaccine | AdC7-HIVgp140 5 x 10^10 vp at Month 0 and AdC6-HIVgp140 5 x 10^10 vp at Month 3 and CH505TF/GLA-SE 400mg at Month 6 |
| FG005 | Part B, Group 6: Placebo | Placebo+Placebo+Placebo Control for AdC6-HIVgp140 or AdC7-HIVgp140, Sodium Chloride for Injection, 0.9%. Control for CH505TF gp120/GLA-SE adjuvanted protein: Sodium Chloride for Injection, 0.9%. |
|
| COMPLETED | Term form with reason = scheduled exit visit |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Part A, Group 1: Vaccine | AdC6-HIVgp140 1 x 10^10 vp to be administrated IM at Month 0 |
| BG001 | Part A, Group 2: Vaccine | AdC7-HIVgp140 1 x 10^10 vp to be administrated IM at Month 0 |
| BG002 | Part A, Group 3: Placebo | Placebo Control for AdC6-HIVgp140 or AdC7-HIVgp140, Sodium Chloride for Injection, 0.9%. Control for CH505TF gp120/GLA-SE adjuvanted protein: Sodium Chloride for Injection, 0.9%. |
| BG003 | Part B, Group 4: Vaccine | AdC6-HIVgp140 5 x 10^10 vp at Month 0 and AdC7-HIVgp140 5 x 10^10 vp at Month 3 and CH505TF/GLA-SE 400mg at Month 6 |
| BG004 | Part B, Group 5: Vaccine | AdC7-HIVgp140 5 x 10^10 vp at Month 0 and AdC6-HIVgp140 5 x 10^10 vp at Month 3 and CH505TF/GLA-SE 400mg at Month 6 |
| BG005 | Part B, Group 6: Placebo | Placebo+Placebo+Placebo Control for AdC6-HIVgp140 or AdC7-HIVgp140, Sodium Chloride for Injection, 0.9%. Control for CH505TF gp120/GLA-SE adjuvanted protein: Sodium Chloride for Injection, 0.9%. |
| BG006 | 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 |
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| Age, Customized | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (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 | Number of Participants Reporting Local Reactogenicity Events 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 7 days after each study product administration at Study Day 0 (Month 0) for Part A (T1, T2, and C3) and at Study Days 0 (Month 0), 84 (Month 3) and 168 (Month 6) for Part B (T4, T5, and C6). |
|
|
| ||||||||||||||||||||||||||||||||||||||||||
| 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 7 days after each study product administration at Study Day 0 (Month 0) for Part A (T1, T2, and C3) and at Study Days 0 (Month 0), 84 (Month 3) and 168 (Month 6) for Part B (T4, T5, and C6). |
| ||||||||||||||||||||||||||||||||||||||||||||
| 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 maximum grade observed for each symptom over the time frame is presented. | Posted | Count of Participants | Participants | Measured through 7 days after each study product administration at Study Day 0 (Month 0) for Part A (T1, T2, and C3) and at Study Days 0 (Month 0), 84 (Month 3) and 168 (Month 6) for Part B (T4, T5, and C6). |
| ||||||||||||||||||||||||||||||||||||||||||||
| Primary | Numbers of Participant With Early Study Termination Associated With Reactogenicity, AE, or Death During Main Study and AESI Visits. | From the termination and adverse event forms that were collected during main study clinical visits period and AESI contact visits. Counts are tabulated by treatment arm. | Safety population | Posted | Count of Participants | Participants | Early study termination reason was collected through 7 days for reactogenicity, 30 days for AEs and 12 months for deaths following any receipt of study product (up to 18 months). |
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| Primary | Number of Participants Reporting Serious Adverse Events (SAEs) | From adverse event (AE) forms, counts are tabulated by treatment arm. AE forms were collected during main study clinical visits and AESI contact visits | Safety population | Posted | Count of Participants | Participants | Measured through 12 months following any receipt of study product(up to 18 months). Study products were given at Study Day 0 (Month 0) for Part A (T1, T2, and C3) and at Study Days 0 (Month 0), 84 (Month 3) and 168 (Month 6) for Part B (T4, T5, and C6). |
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| Primary | Number of Participants Reporting Medically Attended Adverse Events (MAAEs) | From adverse event (AE) forms, counts are tabulated by treatment arm. AE forms were collected during main study clinical visits and AESI contact visits | Safety population | Posted | Count of Participants | Participants | Measured through 12 months following any receipt of study product(up to 18 months). Study products were given at Study Day 0 (Month 0) for Part A (T1, T2, and C3) and at Study Days 0 (Month 0), 84 (Month 3) and 168 (Month 6) for Part B (T4, T5, and C6). |
| |||||||||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants Reporting Adverse Event of Special Interests (AESIs) | From adverse event (AE) forms, counts are tabulated by treatment arm. AE forms were collected during main study clinical visits and AESI contact visits | Safety population | Posted | Count of Participants | Participants | Measured through 12 months following any receipt of study product(up to 18 months). Study products were given at Study Day 0 (Month 0) for Part A (T1, T2, and C3) and at Study Days 0 (Month 0), 84 (Month 3) and 168 (Month 6) for Part B (T4, T5, and C6). |
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| Secondary | Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | Serum HIV-1-specific IgG responses (dilution 1:50) against gp120, gp140, gp70-V1V2 and gp41 antigens were measured on a Bio-Plex instrument (Bio-Rad) using a standardized custom HIV-1 Luminex assay. The readout was background-subtracted mean fluorescence intensity (MFI), where background referred to a plate level control (i.e., a blank well run on each plate). Samples from post-enrollment visits were declared to have positive responses if they met three conditions: (1) the mean fluorescence intensity (MFI) minus blank (MFI*) values were ≥ antigen-specific cutoff at the 1:50 dilution level (based on the 95th percentile of baseline samples as calculated by SAS PROC UNIVARIATE default method, and at least 100 MFI minus blank), (2) the MFI minus blank values were greater than 3 times the baseline (day 0) MFI minus blank values, and (3) the MFI values were greater than 3 times the baseline MFI values. | Overall Number of Participants Analyzed represents the number participants with specimen at Month 1. Number Analyzed-shows the number of participants with available data after filtering for assay specific quality control criteria. | Posted | Count of Participants | Participants | Measured at Month 1 for both Part A and Part B |
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| Secondary | Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | Serum HIV-1-specific IgG responses (dilution 1:50) against gp120, gp140, gp70-V1V2 and gp41 antigens were measured on a Bio-Plex instrument (Bio-Rad) using a standardized custom HIV-1 Luminex assay. The readout was background-subtracted mean fluorescence intensity (MFI), where background referred to a plate level control (i.e., a blank well run on each plate). | Overall Number of Participants Analyzed represents the number participants with specimen at Month 1. Number Analyzed-shows the number of participants with available data after filtering for assay specific quality control criteria | Posted | Median | Inter-Quartile Range | Net MFI | Measured at Month 1 for both Part A and Part B |
| ||||||||||||||||||||||||||||||||||||||||||
| Secondary | HIV-specific Serum IgG Binding Antibodies Magnitude Breadth of AUC (AUC--MB) by Panel and Treatment Arm Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | The area under the magnitude-breadth curve (AUC-MB) was calculated by first measuring the mean fluorescence intensity (MFI) of antibody binding to each antigen at 1:50 dilution. For each sample, a magnitude-breadth curve is generated by plotting the number of antigens (breadth) that exceed a series of MFI thresholds (MFI >100). The area under this curve (AUC) is then computed by the trapezoidal rule to summarize both the strength and diversity of the antibody response in a single value, which is equivalent to the average of the log10 net MFI over the panel of antigens | Overall Number of Participants Analyzed represents the number participants with specimen at Month 1. Number Analyzed-shows the number of participants with available data after filtering for assay specific quality control criteria | Posted | Median | Inter-Quartile Range | log10(net MFI) | Measured at Month 1 for both Part A and Part B |
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| Secondary | Response Rate of HIV-specific CD4+ and CD8+ T-cell Responses Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | The four entries in each table were the number of cells positive for IFN-γ and/or IL-2 for both the stimulated and the negative control data. If both negative control replicates were included, then the average number of total cells and the average number of positive cells were used. A one-sided Fisher's exact test was applied to the table, testing whether the number of cytokine-producing cells for the stimulated data was equal to that for the negative control data. Since multiple individual tests (for each peptide pool) were conducted simultaneously, a multiplicity adjustment was made to the two individual peptide pool p-values considered, using the Bonferroni-Holm adjustment method. If the adjusted p-value for a peptide pool was ≤ 0.00001, the response to the peptide pool for the T-cell subset was considered positive. If at least one peptide pool for a specific HIV-1 protein was positive, then the overall response to the protein was considered positive. | Overall Number of Participants Analyzed represents the number participants with specimen at Month 1. Number Analyzed-shows the number of participants with available data after filtering for assay specific quality control criteria. | Posted | Count of Participants | Participants | Measured at Month 1 for both Part A and Part B |
| |||||||||||||||||||||||||||||||||||||||||||
| Secondary | Magnitude of HIV-specific CD4+ and CD8+ T-cell by Cytokine, T-cell Subset, Antigen and Treatment Group Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | PBMC samples were 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 cytokines (IFNy and/or IL-2) after peptide stimulation minus % cells expressing markers after no stimulation. Reported responses magnitude for Any Env are the sum of ENV-1-PTEG-SEQ and ENV-2-PTEG-SEQ | Overall Number of Participants Analyzed represents the number participants with specimen at Month 1. Number Analyzed-shows the number of participants with available data after filtering for assay specific quality control criteria | Posted | Median | Inter-Quartile Range | Percentage of cells | Measured at Month 1 for both Part A and Part B |
| ||||||||||||||||||||||||||||||||||||||||||
| Secondary | Response Rate of Serum Neutralizing Antibodies Against Env-pseudotyped Vaccine Strains (Du422.1, Du172.17 and CH505TF) and a Tier 1A Neutralization Phenotype (MW965.26) Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | Neutralizing antibodies against strains of HIV-1 were measured as a function of reductions in Tat-induced luciferase (Luc) reporter gene expression in TZMbl cells. A serum neutralization titer was defined as the serum dilution that reduced relative luminescence units (RLUs) by 50% and 80% (ID50 and ID80) relative to the RLUs in virus control wells (cells + virus only) after subtraction of background RLU (cells only). The assay performed in TZM-bl cells measured neutralization titers against the Env-pseudotyped vaccine strains (Du422.1, Du172.17 and CH505TF) and a virus that exhibits a tier 1A neutralization phenotype (MW965.26). Response to a virus/isolate was considered positive if the neutralization titer was at or above a pre-specified cutoff of 10. | Overall Number of Participants Analyzed represents the number participants with specimen at Month 1. Number Analyzed-shows the number of participants with available data after filtering for assay specific quality control criteria. | Posted | Count of Participants | Participants | Measured at Month 1 for both Part A and Part B |
| |||||||||||||||||||||||||||||||||||||||||||
| Secondary | Magnitude of Serum Neutralizing Antibodies Against Env-pseudotyped Vaccine Strains (Du422.1, Du172.17 and CH505TF) and a Tier 1A Neutralization Phenotype (MW965.26) Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | Neutralizing antibodies against strains of HIV-1 were measured as a function of reductions in Tat-induced luciferase (Luc) reporter gene expression in TZMbl cells. A serum neutralization titer was defined as the serum dilution that reduced relative luminescence units (RLUs) by 50% and 80% (ID50 and ID80) relative to the RLUs in virus control wells (cells + virus only) after subtraction of background RLU (cells only). The assay performed in TZM-bl cells measured neutralization titers against the Env-pseudotyped vaccine strains (Du422.1, Du172.17 and CH505TF) and a virus that exhibits a tier 1A neutralization phenotype (MW965.26). | Overall Number of Participants Analyzed represents the number participants with specimen at Month 1. Number Analyzed-shows the number of participants with available data after filtering for assay specific quality control criteria | Posted | Median | Inter-Quartile Range | titer | Measured at Month 1 for both Part A and Part B |
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| Secondary | Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination | Serum HIV-1-specific IgG responses (dilution 1:50) against gp120, gp140, gp70-V1V2 and gp41 antigens were measured on a Bio-Plex instrument (Bio-Rad) using a standardized custom HIV-1 Luminex assay. The readout was background-subtracted mean fluorescence intensity (MFI), where background referred to a plate level control (i.e., a blank well run on each plate). Samples from post-enrollment visits were declared to have positive responses if they met three conditions: (1) the mean fluorescence intensity (MFI) minus blank (MFI*) values were ≥ antigen-specific cutoff at the 1:50 dilution level (based on the 95th percentile of baseline samples as calculated by SAS PROC UNIVARIATE default method, and at least 100 MFI minus blank), (2) the MFI minus blank values were greater than 3 times the baseline (day 0) MFI minus blank values, and (3) the MFI values were greater than 3 times the baseline MFI values. | Overall Number of Participants Analyzed represents the number participants with specimen at Month 1. Number Analyzed-shows the number of participants with available data after filtering for assay specific quality control criteria. | Posted | Count of Participants | Participants | Measured at Month 4 for Part B |
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| Secondary | Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination | Serum HIV-1-specific IgG responses (dilution 1:50) against gp120, gp140, gp70-V1V2 and gp41 antigens were measured on a Bio-Plex instrument (Bio-Rad) using a standardized custom HIV-1 Luminex assay. The readout was background-subtracted mean fluorescence intensity (MFI), where background referred to a plate level control (i.e., a blank well run on each plate). | Overall Number of Participants Analyzed represents the number participants with specimen at Month 1. Number Analyzed-shows the number of participants with available data after filtering for assay specific quality control criteria | Posted | Median | Inter-Quartile Range | Net MFI | Measured at Month 4 for Part B |
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| Secondary | Part B: HIV-specific Serum IgG Binding Antibodies Magnitude Breadth of AUC by Panel and Treatment Arm Assessed 4 Weeks After the Second Vaccination | The area under the magnitude-breadth curve (AUC-MB) was calculated by first measuring the mean fluorescence intensity (MFI) of antibody binding to each antigen at 1:50 dilution. For each sample, a magnitude-breadth curve is generated by plotting the number of antigens (breadth) that exceed a series of MFI thresholds (MFI >100). The area under this curve (AUC) is then computed by the trapezoidal rule to summarize both the strength and diversity of the antibody response in a single value, which is equivalent to the average of the log10 net MFI over the panel of antigens | Overall Number of Participants Analyzed represents the number participants with specimen at Month 1. Number Analyzed-shows the number of participants with available data after filtering for assay specific quality control criteria | Posted | Median | Inter-Quartile Range | log10(net MFI) | Measured at Month 4 for Part B |
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| Secondary | Part B: Response Rate of HIV-specific CD4+ and CD8+ T-cell Responses Assessed 4 Weeks After the Second Vaccination | The four entries in each table were the number of cells positive for IFN-γ and/or IL-2 for both the stimulated and the negative control data. If both negative control replicates were included, then the average number of total cells and the average number of positive cells were used. A one-sided Fisher's exact test was applied to the table, testing whether the number of cytokine-producing cells for the stimulated data was equal to that for the negative control data. Since multiple individual tests (for each peptide pool) were conducted simultaneously, a multiplicity adjustment was made to the two individual peptide pool p-values considered, using the Bonferroni-Holm adjustment method. If the adjusted p-value for a peptide pool was ≤ 0.00001, the response to the peptide pool for the T-cell subset was considered positive. If at least one peptide pool for a specific HIV-1 protein was positive, then the overall response to the protein was considered positive. | Overall Number of Participants Analyzed represents the number participants with specimen at Month 1. Number Analyzed-shows the number of participants with available data after filtering for assay specific quality control criteria. | Posted | Count of Participants | Participants | Measured at Month 4 for Part B |
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| Secondary | Part B: Magnitude of HIV-specific CD4+ and CD8+ T-cell by Cytokine, T-cell Subset, Antigen and Treatment Group Assessed 4 Weeks After the Second Vaccination | PBMC samples were 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 cytokines (IFNy and/or IL-2) after peptide stimulation minus % cells expressing markers after no stimulation. Reported responses magnitude for Any Env are the sum of ENV-1-PTEG-SEQ and ENV-2-PTEG-SEQ | Overall Number of Participants Analyzed represents the number participants with specimen at Month 1. Number Analyzed-shows the number of participants with available data after filtering for assay specific quality control criteria | Posted | Median | Inter-Quartile Range | Percentage of cells | Measured at Month 4 for Part B |
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| Secondary | Part B: Response Rate of Serum Neutralizing Antibodies Against Env-pseudotyped Vaccine Strains (Du422.1, Du172.17 and CH505TF) and a Tier 1A Neutralization Phenotype (MW965.26) Assessed 4 Weeks After the Second Vaccination | Neutralizing antibodies against strains of HIV-1 were measured as a function of reductions in Tat-induced luciferase (Luc) reporter gene expression in TZMbl cells. A serum neutralization titer was defined as the serum dilution that reduced relative luminescence units (RLUs) by 50% and 80% (ID50 and ID80) relative to the RLUs in virus control wells (cells + virus only) after subtraction of background RLU (cells only). The assay performed in TZM-bl cells measured neutralization titers against the Env-pseudotyped vaccine strains (Du422.1, Du172.17 and CH505TF) and a virus that exhibits a tier 1A neutralization phenotype (MW965.26). Response to a virus/isolate was considered positive if the neutralization titer was at or above a pre-specified cutoff of 10. | Overall Number of Participants Analyzed represents the number participants with specimen at Month 1. Number Analyzed-shows the number of participants with available data after filtering for assay specific quality control criteria. | Posted | Count of Participants | Participants | Measured at Month 4 for Part B |
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| Secondary | Part B: Magnitude of Serum Neutralizing Antibodies Against Env-pseudotyped Vaccine Strains (Du422.1, Du172.17 and CH505TF) and a Tier 1A Neutralization Phenotype (MW965.26) Assessed 4 Weeks After the Second Vaccination | Neutralizing antibodies against strains of HIV-1 were measured as a function of reductions in Tat-induced luciferase (Luc) reporter gene expression in TZMbl cells. A serum neutralization titer was defined as the serum dilution that reduced relative luminescence units (RLUs) by 50% and 80% (ID50 and ID80) relative to the RLUs in virus control wells (cells + virus only) after subtraction of background RLU (cells only). The assay performed in TZM-bl cells measured neutralization titers against the Env-pseudotyped vaccine strains (Du422.1, Du172.17 and CH505TF) and a virus that exhibits a tier 1A neutralization phenotype (MW965.26). A titer was defined as the serum dilution that reduced relative luminescence units (RLUs) by 50% and 80% relative to the RLUs in virus control wells (cells + virus only) after subtraction of background RLU (cells only). | Overall Number of Participants Analyzed represents the number participants with specimen at Month 1. Number Analyzed-shows the number of participants with available data after filtering for assay specific quality control criteria | Posted | Median | Inter-Quartile Range | titer | Measured at Month 4 for Part B |
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| Secondary | Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination | Serum HIV-1-specific IgG responses (dilution 1:50) against gp120, gp140, gp70-V1V2 and gp41 antigens were measured on a Bio-Plex instrument (Bio-Rad) using a standardized custom HIV-1 Luminex assay. The readout was background-subtracted mean fluorescence intensity (MFI), where background referred to a plate level control (i.e., a blank well run on each plate). Samples from post-enrollment visits were declared to have positive responses if they met three conditions: (1) the mean fluorescence intensity (MFI) minus blank (MFI*) values were ≥ antigen-specific cutoff at the 1:50 dilution level (based on the 95th percentile of baseline samples as calculated by SAS PROC UNIVARIATE default method, and at least 100 MFI minus blank), (2) the MFI minus blank values were greater than 3 times the baseline (day 0) MFI minus blank values, and (3) the MFI values were greater than 3 times the baseline MFI values. | Overall Number of Participants Analyzed represents the number participants with specimen at Month 1. Number Analyzed-shows the number of participants with available data after filtering for assay specific quality control criteria. | Posted | Count of Participants | Participants | Measured at Month 6.5 for Part B |
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| Secondary | Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination | Serum HIV-1-specific IgG responses (dilution 1:50) against gp120, gp140, gp70-V1V2 and gp41 antigens were measured on a Bio-Plex instrument (Bio-Rad) using a standardized custom HIV-1 Luminex assay. The readout was background-subtracted mean fluorescence intensity (MFI), where background referred to a plate level control (i.e., a blank well run on each plate). | Overall Number of Participants Analyzed represents the number participants with specimen at Month 1. Number Analyzed-shows the number of participants with available data after filtering for assay specific quality control criteria | Posted | Median | Inter-Quartile Range | Net MFI | Measured at Month 6.5 for Part B |
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| Secondary | Part B: HIV-specific Serum IgG Binding Antibodies Magnitude Breadth of AUC by Panel and Treatment Arm Assessed 2 Weeks After the Third Vaccination | The area under the magnitude-breadth curve (AUC-MB) was calculated by first measuring the mean fluorescence intensity (MFI) of antibody binding to each antigen at 1:50 dilution. For each sample, a magnitude-breadth curve is generated by plotting the number of antigens (breadth) that exceed a series of MFI thresholds (MFI >100). The area under this curve (AUC) is then computed by the trapezoidal rule to summarize both the strength and diversity of the antibody response in a single value, which is equivalent to the average of the log10 net MFI over the panel of antigens | Overall Number of Participants Analyzed represents the number participants with specimen at Month 1. Number Analyzed-shows the number of participants with available data after filtering for assay specific quality control criteria | Posted | Median | Inter-Quartile Range | log10(net MFI) | Measured at Month 6.5 for Part B |
| ||||||||||||||||||||||||||||||||||||||||||
| Secondary | Part B: Response Rate of HIV-specific CD4+ and CD8+ T-cell Responses Assessed 2 Weeks After the Third Vaccination | The four entries in each table were the number of cells positive for IFN-γ and/or IL-2 for both the stimulated and the negative control data. If both negative control replicates were included, then the average number of total cells and the average number of positive cells were used. A one-sided Fisher's exact test was applied to the table, testing whether the number of cytokine-producing cells for the stimulated data was equal to that for the negative control data. Since multiple individual tests (for each peptide pool) were conducted simultaneously, a multiplicity adjustment was made to the two individual peptide pool p-values considered, using the Bonferroni-Holm adjustment method. If the adjusted p-value for a peptide pool was ≤ 0.00001, the response to the peptide pool for the T-cell subset was considered positive. If at least one peptide pool for a specific HIV-1 protein was positive, then the overall response to the protein was considered positive. | Overall Number of Participants Analyzed represents the number participants with specimen at Month 1. Number Analyzed-shows the number of participants with available data after filtering for assay specific quality control criteria. | Posted | Count of Participants | Participants | Measured at Month 6.5 for Part B |
| |||||||||||||||||||||||||||||||||||||||||||
| Secondary | Part B: Magnitude of HIV-specific CD4+ and CD8+ T-cell by Cytokine, T-cell Subset, Antigen and Treatment Group Assessed 2 Weeks After the Third Vaccination | PBMC samples were 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 cytokines (IFNy and/or IL-2) after peptide stimulation minus % cells expressing markers after no stimulation. Reported responses magnitude for Any Env are the sum of ENV-1-PTEG-SEQ and ENV-2-PTEG-SEQ | Overall Number of Participants Analyzed represents the number participants with specimen at Month 1. Number Analyzed-shows the number of participants with available data after filtering for assay specific quality control criteria | Posted | Median | Inter-Quartile Range | Percentage of cells | Measured at Month 6.5 for Part B |
| ||||||||||||||||||||||||||||||||||||||||||
| Secondary | Part B: Response Rate of Serum Neutralizing Antibodies Against Env-pseudotyped Vaccine Strains (Du422.1, Du172.17 and CH505TF) and a Tier 1A Neutralization Phenotype (MW965.26) Assessed 2 Weeks After the Third Vaccination | Neutralizing antibodies against strains of HIV-1 were measured as a function of reductions in Tat-induced luciferase (Luc) reporter gene expression in TZMbl cells. A serum neutralization titer was defined as the serum dilution that reduced relative luminescence units (RLUs) by 50% and 80% (ID50 and ID80) relative to the RLUs in virus control wells (cells + virus only) after subtraction of background RLU (cells only). The assay performed in TZM-bl cells measured neutralization titers against the Env-pseudotyped vaccine strains (Du422.1, Du172.17 and CH505TF) and a virus that exhibits a tier 1A neutralization phenotype (MW965.26). Response to a virus/isolate was considered positive if the neutralization titer was at or above a pre-specified cutoff of 10. | Overall Number of Participants Analyzed represents the number participants with specimen at Month 1. Number Analyzed-shows the number of participants with available data after filtering for assay specific quality control criteria. | Posted | Count of Participants | Participants | Measured at Month 6.5 for Part B |
| |||||||||||||||||||||||||||||||||||||||||||
| Secondary | Part B: Magnitude of Serum Neutralizing Antibodies Against Env-pseudotyped Vaccine Strains (Du422.1, Du172.17 and CH505TF) and a Tier 1A Neutralization Phenotype (MW965.26) Assessed 2 Weeks After the Third Vaccination | Neutralizing antibodies against strains of HIV-1 were measured as a function of reductions in Tat-induced luciferase (Luc) reporter gene expression in TZMbl cells. A serum neutralization titer was defined as the serum dilution that reduced relative luminescence units (RLUs) by 50% and 80% (ID50 and ID80) relative to the RLUs in virus control wells (cells + virus only) after subtraction of background RLU (cells only). The assay performed in TZM-bl cells measured neutralization titers against the Env-pseudotyped vaccine strains (Du422.1, Du172.17 and CH505TF) and a virus that exhibits a tier 1A neutralization phenotype (MW965.26). A titer was defined as the serum dilution that reduced relative luminescence units (RLUs) by 50% and 80% relative to the RLUs in virus control wells (cells + virus only) after subtraction of background RLU (cells only). | Overall Number of Participants Analyzed represents the number participants with specimen at Month 1. Number Analyzed-shows the number of participants with available data after filtering for assay specific quality control criteria | Posted | Median | Inter-Quartile Range | titer | Measured at Month 6.5 for Part B |
|
All adverse events were collected for 30 after any receipt of study vaccination (up to 7 months). All serious adverse events (SAEs), medically attended adverse events (MAAEs), and adverse events of special interest (AESIs) were collected for twelve months following any receipt of study product (up to 18 months). Study vaccinations were given at study Day 0 (Month 0) for Part A (T1, T2, and C3) and at study Days 0 (Month 0), 84 (Month 3) and 168 (Month 6) for Part B (T4, T5, and C6).
Not provided
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 | Part A, Group 1: Vaccine | AdC6-HIVgp140 1 x 10^10 vp to be administrated IM at Month 0 | 0 | 5 | 0 | 5 | 1 | 5 |
| EG001 | Part A, Group 2: Vaccine | AdC7-HIVgp140 1 x 10^10 vp to be administrated IM at Month 0 | 0 | 5 | 0 | 5 | 1 | 5 |
| EG002 | Part A, Group 3: Placebo | Placebo Control for AdC6-HIVgp140 or AdC7-HIVgp140, Sodium Chloride for Injection, 0.9%. Control for CH505TF gp120/GLA-SE adjuvanted protein: Sodium Chloride for Injection, 0.9%. | 0 | 2 | 0 | 2 | 1 | 2 |
| EG003 | Part B, Group 4: Vaccine | AdC6-HIVgp140 5 x 10^10 vp at Month 0 and AdC7-HIVgp140 5 x 10^10 vp at Month 3 and CH505TF/GLA-SE 400mg at Month 6 | 0 | 10 | 0 | 10 | 7 | 10 |
| EG004 | Part B, Group 5: Vaccine | AdC7-HIVgp140 5 x 10^10 vp at Month 0 and AdC6-HIVgp140 5 x 10^10 vp at Month 3 and CH505TF/GLA-SE 400mg at Month 6 | 1 | 10 | 1 | 10 | 3 | 10 |
| EG005 | Part B, Group 6: Placebo | Placebo+Placebo+Placebo Control for AdC6-HIVgp140 or AdC7-HIVgp140, Sodium Chloride for Injection, 0.9%. Control for CH505TF gp120/GLA-SE adjuvanted protein: Sodium Chloride for Injection, 0.9%. | 0 | 2 | 0 | 2 | 0 | 2 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Any Event in SOC | Injury, poisoning and procedural complications | MEDRA 26.1 | Non-systematic Assessment |
| |
| Stab wound | Injury, poisoning and procedural complications | MEDRA 26.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Any Event in SOC | Gastrointestinal disorders | MEDRA 26.1 | Non-systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | MEDRA 26.1 | Non-systematic Assessment |
| |
| Any Event in SOC | General disorders | MEDRA 26.1 | Non-systematic Assessment |
| |
| Influenza like illness | General disorders | MEDRA 26.1 | Non-systematic Assessment |
| |
| Any Event in SOC | Infections and infestations | MEDRA 26.1 | Non-systematic Assessment |
| |
| Body tinea | Infections and infestations | MEDRA 26.1 | Non-systematic Assessment |
| |
| Breast abscess | Infections and infestations | MEDRA 26.1 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MEDRA 26.1 | Non-systematic Assessment |
| |
| Urethritis | Infections and infestations | MEDRA 26.1 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MEDRA 26.1 | Non-systematic Assessment |
| |
| Any Event in SOC | Injury, poisoning and procedural complications | MEDRA 26.1 | Non-systematic Assessment |
| |
| Chest injury | Injury, poisoning and procedural complications | MEDRA 26.1 | Non-systematic Assessment |
| |
| Soft tissue injury | Injury, poisoning and procedural complications | MEDRA 26.1 | Non-systematic Assessment |
| |
| Any Event in SOC | Investigations | MEDRA 26.1 | Non-systematic Assessment |
| |
| Blood pressure increased | Investigations | MEDRA 26.1 | Non-systematic Assessment |
| |
| Any Event in SOC | Metabolism and nutrition disorders | MEDRA 26.1 | Non-systematic Assessment |
| |
| Abnormal loss of weight | Metabolism and nutrition disorders | MEDRA 26.1 | Non-systematic Assessment |
| |
| Any Event in SOC | Renal and urinary disorders | MEDRA 26.1 | Non-systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MEDRA 26.1 | Non-systematic Assessment |
| |
| Any Event in SOC | Reproductive system and breast disorders | MEDRA 26.1 | Non-systematic Assessment |
| |
| Balanoposthitis | Reproductive system and breast disorders | MEDRA 26.1 | Non-systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jessica Andriesen, PhD, Associate Director of HVTN SDMC Operations | Fred Hutchinson Cancer Center | 206-667-5812 | hvtn.covpn.sdmc@hvtn.org |
| Jun 20, 2024 |
| Prot_000.pdf |
| Prot | Yes | No | No | Study Protocol: Letter of Amendment | Nov 16, 2022 | Jul 7, 2025 | Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan: SAP for safety | Jul 25, 2024 | Aug 8, 2024 | SAP_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan: SAP for immunogenicity | Sep 11, 2024 | May 27, 2025 | SAP_003.pdf |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D011356 | Product Labeling |
| ID | Term |
|---|---|
| D019064 | Product Packaging |
| D007221 | Industry |
| D013676 | Technology, Industry, and Agriculture |
Not provided
Not provided
| 18-20 |
|
| 21-30 |
|
| 31-40 |
|
| 41-50 |
|
| Age Category : Above 50 |
|
| Unknown or Not Reported |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| White |
|
| Indian |
|
| Asian |
|
| Colored |
|
| Other |
|
| Unknown or Not Reported |
|
| Mild |
|
| Moderate |
|
| Severe |
|
| Potentially Life-threatening |
|
AdC6-HIVgp140 5 x 10^10 vp at Month 0 and AdC7-HIVgp140 5 x 10^10 vp at Month 3 and CH505TF/GLA-SE 400mg at Month 6
| OG004 | Part B, Group 5: Vaccine | AdC7-HIVgp140 5 x 10^10 vp at Month 0 and AdC6-HIVgp140 5 x 10^10 vp at Month 3 and CH505TF/GLA-SE 400mg at Month 6 |
| OG005 | Part B, Group 6: Placebo | Placebo+Placebo+Placebo Control for AdC6-HIVgp140 or AdC7-HIVgp140, Sodium Chloride for Injection, 0.9%. Control for CH505TF gp120/GLA-SE adjuvanted protein: Sodium Chloride for Injection, 0.9%. |
|
|
AdC6-HIVgp140 5 x 10^10 vp at Month 0 and AdC7-HIVgp140 5 x 10^10 vp at Month 3 and CH505TF/GLA-SE 400mg at Month 6
| OG004 | Part B, Group 5: Vaccine | AdC7-HIVgp140 5 x 10^10 vp at Month 0 and AdC6-HIVgp140 5 x 10^10 vp at Month 3 and CH505TF/GLA-SE 400mg at Month 6 |
| OG005 | Part B, Group 6: Placebo | Placebo+Placebo+Placebo Control for AdC6-HIVgp140 or AdC7-HIVgp140, Sodium Chloride for Injection, 0.9%. Control for CH505TF gp120/GLA-SE adjuvanted protein: Sodium Chloride for Injection, 0.9%. |
|
|
AdC6-HIVgp140 5 x 10^10 vp at Month 0 and AdC7-HIVgp140 5 x 10^10 vp at Month 3 and CH505TF/GLA-SE 400mg at Month 6 |
| OG004 | Part B, Group 5: Vaccine | AdC7-HIVgp140 5 x 10^10 vp at Month 0 and AdC6-HIVgp140 5 x 10^10 vp at Month 3 and CH505TF/GLA-SE 400mg at Month 6 |
| OG005 | Part B, Group 6: Placebo | Placebo+Placebo+Placebo Control for AdC6-HIVgp140 or AdC7-HIVgp140, Sodium Chloride for Injection, 0.9%. Control for CH505TF gp120/GLA-SE adjuvanted protein: Sodium Chloride for Injection, 0.9%. |
|
|
AdC6-HIVgp140 5 x 10^10 vp at Month 0 and AdC7-HIVgp140 5 x 10^10 vp at Month 3 and CH505TF/GLA-SE 400mg at Month 6
| OG004 | Part B, Group 5: Vaccine | AdC7-HIVgp140 5 x 10^10 vp at Month 0 and AdC6-HIVgp140 5 x 10^10 vp at Month 3 and CH505TF/GLA-SE 400mg at Month 6 |
| OG005 | Part B, Group 6: Placebo | Placebo+Placebo+Placebo Control for AdC6-HIVgp140 or AdC7-HIVgp140, Sodium Chloride for Injection, 0.9%. Control for CH505TF gp120/GLA-SE adjuvanted protein: Sodium Chloride for Injection, 0.9%. |
|
|
AdC6-HIVgp140 5 x 10^10 vp at Month 0 and AdC7-HIVgp140 5 x 10^10 vp at Month 3 and CH505TF/GLA-SE 400mg at Month 6 |
| OG004 | Part B, Group 5: Vaccine | AdC7-HIVgp140 5 x 10^10 vp at Month 0 and AdC6-HIVgp140 5 x 10^10 vp at Month 3 and CH505TF/GLA-SE 400mg at Month 6 |
| OG005 | Part B, Group 6: Placebo | Placebo+Placebo+Placebo Control for AdC6-HIVgp140 or AdC7-HIVgp140, Sodium Chloride for Injection, 0.9%. Control for CH505TF gp120/GLA-SE adjuvanted protein: Sodium Chloride for Injection, 0.9%. |
|
|
AdC6-HIVgp140 5 x 10^10 vp at Month 0 and AdC7-HIVgp140 5 x 10^10 vp at Month 3 and CH505TF/GLA-SE 400mg at Month 6 |
| OG004 | Part B, Group 5: Vaccine | AdC7-HIVgp140 5 x 10^10 vp at Month 0 and AdC6-HIVgp140 5 x 10^10 vp at Month 3 and CH505TF/GLA-SE 400mg at Month 6 |
| OG005 | Part B, Group 6: Placebo | Placebo+Placebo+Placebo Control for AdC6-HIVgp140 or AdC7-HIVgp140, Sodium Chloride for Injection, 0.9%. Control for CH505TF gp120/GLA-SE adjuvanted protein: Sodium Chloride for Injection, 0.9%. |
|
|
AdC7-HIVgp140 1 x 10^10 vp to be administrated IM at Month 0 |
| OG002 | Part A, Group 3: Placebo | Placebo Control for AdC6-HIVgp140 or AdC7-HIVgp140, Sodium Chloride for Injection, 0.9%. Control for CH505TF gp120/GLA-SE adjuvanted protein: Sodium Chloride for Injection, 0.9%. |
| OG003 | Part B, Group 4: Vaccine | AdC6-HIVgp140 5 x 10^10 vp at Month 0 and AdC7-HIVgp140 5 x 10^10 vp at Month 3 and CH505TF/GLA-SE 400mg at Month 6 |
| OG004 | Part B, Group 5: Vaccine | AdC7-HIVgp140 5 x 10^10 vp at Month 0 and AdC6-HIVgp140 5 x 10^10 vp at Month 3 and CH505TF/GLA-SE 400mg at Month 6 |
| OG005 | Part B, Group 6: Placebo | Placebo+Placebo+Placebo Control for AdC6-HIVgp140 or AdC7-HIVgp140, Sodium Chloride for Injection, 0.9%. Control for CH505TF gp120/GLA-SE adjuvanted protein: Sodium Chloride for Injection, 0.9%. |
|
|
| OG003 | Part B, Group 4: Vaccine | AdC6-HIVgp140 5 x 10^10 vp at Month 0 and AdC7-HIVgp140 5 x 10^10 vp at Month 3 and CH505TF/GLA-SE 400mg at Month 6 |
| OG004 | Part B, Group 5: Vaccine | AdC7-HIVgp140 5 x 10^10 vp at Month 0 and AdC6-HIVgp140 5 x 10^10 vp at Month 3 and CH505TF/GLA-SE 400mg at Month 6 |
| OG005 | Part B, Group 6: Placebo | Placebo+Placebo+Placebo Control for AdC6-HIVgp140 or AdC7-HIVgp140, Sodium Chloride for Injection, 0.9%. Control for CH505TF gp120/GLA-SE adjuvanted protein: Sodium Chloride for Injection, 0.9%. |
|
|
| Part A, Group 3: Placebo |
Placebo Control for AdC6-HIVgp140 or AdC7-HIVgp140, Sodium Chloride for Injection, 0.9%. Control for CH505TF gp120/GLA-SE adjuvanted protein: Sodium Chloride for Injection, 0.9%. |
| OG003 | Part B, Group 4: Vaccine | AdC6-HIVgp140 5 x 10^10 vp at Month 0 and AdC7-HIVgp140 5 x 10^10 vp at Month 3 and CH505TF/GLA-SE 400mg at Month 6 |
| OG004 | Part B, Group 5: Vaccine | AdC7-HIVgp140 5 x 10^10 vp at Month 0 and AdC6-HIVgp140 5 x 10^10 vp at Month 3 and CH505TF/GLA-SE 400mg at Month 6 |
| OG005 | Part B, Group 6: Placebo | Placebo+Placebo+Placebo Control for AdC6-HIVgp140 or AdC7-HIVgp140, Sodium Chloride for Injection, 0.9%. Control for CH505TF gp120/GLA-SE adjuvanted protein: Sodium Chloride for Injection, 0.9%. |
|
|
| Part A, Group 2: Vaccine |
AdC7-HIVgp140 1 x 10^10 vp to be administrated IM at Month 0 |
| OG002 | Part A, Group 3: Placebo | Placebo Control for AdC6-HIVgp140 or AdC7-HIVgp140, Sodium Chloride for Injection, 0.9%. Control for CH505TF gp120/GLA-SE adjuvanted protein: Sodium Chloride for Injection, 0.9%. |
| OG003 | Part B, Group 4: Vaccine | AdC6-HIVgp140 5 x 10^10 vp at Month 0 and AdC7-HIVgp140 5 x 10^10 vp at Month 3 and CH505TF/GLA-SE 400mg at Month 6 |
| OG004 | Part B, Group 5: Vaccine | AdC7-HIVgp140 5 x 10^10 vp at Month 0 and AdC6-HIVgp140 5 x 10^10 vp at Month 3 and CH505TF/GLA-SE 400mg at Month 6 |
| OG005 | Part B, Group 6: Placebo | Placebo+Placebo+Placebo Control for AdC6-HIVgp140 or AdC7-HIVgp140, Sodium Chloride for Injection, 0.9%. Control for CH505TF gp120/GLA-SE adjuvanted protein: Sodium Chloride for Injection, 0.9%. |
|
|
| OG003 | Part B, Group 4: Vaccine | AdC6-HIVgp140 5 x 10^10 vp at Month 0 and AdC7-HIVgp140 5 x 10^10 vp at Month 3 and CH505TF/GLA-SE 400mg at Month 6 |
| OG004 | Part B, Group 5: Vaccine | AdC7-HIVgp140 5 x 10^10 vp at Month 0 and AdC6-HIVgp140 5 x 10^10 vp at Month 3 and CH505TF/GLA-SE 400mg at Month 6 |
| OG005 | Part B, Group 6: Placebo | Placebo+Placebo+Placebo Control for AdC6-HIVgp140 or AdC7-HIVgp140, Sodium Chloride for Injection, 0.9%. Control for CH505TF gp120/GLA-SE adjuvanted protein: Sodium Chloride for Injection, 0.9%. |
|
|
AdC7-HIVgp140 1 x 10^10 vp to be administrated IM at Month 0
| OG002 | Part A, Group 3: Placebo | Placebo Control for AdC6-HIVgp140 or AdC7-HIVgp140, Sodium Chloride for Injection, 0.9%. Control for CH505TF gp120/GLA-SE adjuvanted protein: Sodium Chloride for Injection, 0.9%. |
| OG003 | Part B, Group 4: Vaccine | AdC6-HIVgp140 5 x 10^10 vp at Month 0 and AdC7-HIVgp140 5 x 10^10 vp at Month 3 and CH505TF/GLA-SE 400mg at Month 6 |
| OG004 | Part B, Group 5: Vaccine | AdC7-HIVgp140 5 x 10^10 vp at Month 0 and AdC6-HIVgp140 5 x 10^10 vp at Month 3 and CH505TF/GLA-SE 400mg at Month 6 |
| OG005 | Part B, Group 6: Placebo | Placebo+Placebo+Placebo Control for AdC6-HIVgp140 or AdC7-HIVgp140, Sodium Chloride for Injection, 0.9%. Control for CH505TF gp120/GLA-SE adjuvanted protein: Sodium Chloride for Injection, 0.9%. |
|
|
| OG002 | Part A, Group 3: Placebo | Placebo Control for AdC6-HIVgp140 or AdC7-HIVgp140, Sodium Chloride for Injection, 0.9%. Control for CH505TF gp120/GLA-SE adjuvanted protein: Sodium Chloride for Injection, 0.9%. |
| OG003 | Part B, Group 4: Vaccine | AdC6-HIVgp140 5 x 10^10 vp at Month 0 and AdC7-HIVgp140 5 x 10^10 vp at Month 3 and CH505TF/GLA-SE 400mg at Month 6 |
| OG004 | Part B, Group 5: Vaccine | AdC7-HIVgp140 5 x 10^10 vp at Month 0 and AdC6-HIVgp140 5 x 10^10 vp at Month 3 and CH505TF/GLA-SE 400mg at Month 6 Control for AdC6-HIVgp140 or AdC7-HIVgp140, Sodium Chloride for Injection, 0.9%. Control for CH505TF gp120/GLA-SE adjuvanted protein: Sodium Chloride for Injection, 0.9%. |
| OG005 | Part B, Group 6: Placebo | Placebo+Placebo+Placebo Control for AdC6-HIVgp140 or AdC7-HIVgp140, Sodium Chloride for Injection, 0.9%. Control for CH505TF gp120/GLA-SE adjuvanted protein: Sodium Chloride for Injection, 0.9%. |
|
|
AdC7-HIVgp140 5 x 10^10 vp at Month 0 and AdC6-HIVgp140 5 x 10^10 vp at Month 3 and CH505TF/GLA-SE 400mg at Month 6 |
| OG002 | Part B, Group 6: Placebo | Placebo+Placebo+Placebo Control for AdC6-HIVgp140 or AdC7-HIVgp140, Sodium Chloride for Injection, 0.9%. Control for CH505TF gp120/GLA-SE adjuvanted protein: Sodium Chloride for Injection, 0.9%. |
|
|
|
|
| OG002 |
| Part B, Group 6: Placebo |
Placebo+Placebo+Placebo Control for AdC6-HIVgp140 or AdC7-HIVgp140, Sodium Chloride for Injection, 0.9%. Control for CH505TF gp120/GLA-SE adjuvanted protein: Sodium Chloride for Injection, 0.9%. |
|
|
| Part B, Group 5: Vaccine |
AdC7-HIVgp140 5 x 10^10 vp at Month 0 and AdC6-HIVgp140 5 x 10^10 vp at Month 3 and CH505TF/GLA-SE 400mg at Month 6 |
| OG002 | Part B, Group 6: Placebo | Placebo+Placebo+Placebo Control for AdC6-HIVgp140 or AdC7-HIVgp140, Sodium Chloride for Injection, 0.9%. Control for CH505TF gp120/GLA-SE adjuvanted protein: Sodium Chloride for Injection, 0.9%. |
|
|
Placebo+Placebo+Placebo
Control for AdC6-HIVgp140 or AdC7-HIVgp140, Sodium Chloride for Injection, 0.9%. Control for CH505TF gp120/GLA-SE adjuvanted protein: Sodium Chloride for Injection, 0.9%.
|
|
AdC7-HIVgp140 5 x 10^10 vp at Month 0 and AdC6-HIVgp140 5 x 10^10 vp at Month 3 and CH505TF/GLA-SE 400mg at Month 6
| OG002 | Part B, Group 6: Placebo | Placebo+Placebo+Placebo Control for AdC6-HIVgp140 or AdC7-HIVgp140, Sodium Chloride for Injection, 0.9%. Control for CH505TF gp120/GLA-SE adjuvanted protein: Sodium Chloride for Injection, 0.9%. |
|
|
AdC7-HIVgp140 5 x 10^10 vp at Month 0 and AdC6-HIVgp140 5 x 10^10 vp at Month 3 and CH505TF/GLA-SE 400mg at Month 6 |
| OG002 | Part B, Group 6: Placebo | Placebo+Placebo+Placebo Control for AdC6-HIVgp140 or AdC7-HIVgp140, Sodium Chloride for Injection, 0.9%. Control for CH505TF gp120/GLA-SE adjuvanted protein: Sodium Chloride for Injection, 0.9%. |
|
|
AdC7-HIVgp140 5 x 10^10 vp at Month 0 and AdC6-HIVgp140 5 x 10^10 vp at Month 3 and CH505TF/GLA-SE 400mg at Month 6 |
| OG002 | Part B, Group 6: Placebo | Placebo+Placebo+Placebo Control for AdC6-HIVgp140 or AdC7-HIVgp140, Sodium Chloride for Injection, 0.9%. Control for CH505TF gp120/GLA-SE adjuvanted protein: Sodium Chloride for Injection, 0.9%. |
|
|
|
|
| OG002 |
| Part B, Group 6: Placebo |
Placebo+Placebo+Placebo Control for AdC6-HIVgp140 or AdC7-HIVgp140, Sodium Chloride for Injection, 0.9%. Control for CH505TF gp120/GLA-SE adjuvanted protein: Sodium Chloride for Injection, 0.9%. |
|
|
| Part B, Group 5: Vaccine |
AdC7-HIVgp140 5 x 10^10 vp at Month 0 and AdC6-HIVgp140 5 x 10^10 vp at Month 3 and CH505TF/GLA-SE 400mg at Month 6 |
| OG002 | Part B, Group 6: Placebo | Placebo+Placebo+Placebo Control for AdC6-HIVgp140 or AdC7-HIVgp140, Sodium Chloride for Injection, 0.9%. Control for CH505TF gp120/GLA-SE adjuvanted protein: Sodium Chloride for Injection, 0.9%. |
|
|
Placebo+Placebo+Placebo
Control for AdC6-HIVgp140 or AdC7-HIVgp140, Sodium Chloride for Injection, 0.9%. Control for CH505TF gp120/GLA-SE adjuvanted protein: Sodium Chloride for Injection, 0.9%.
|
|
AdC7-HIVgp140 5 x 10^10 vp at Month 0 and AdC6-HIVgp140 5 x 10^10 vp at Month 3 and CH505TF/GLA-SE 400mg at Month 6
| OG002 | Part B, Group 6: Placebo | Placebo+Placebo+Placebo Control for AdC6-HIVgp140 or AdC7-HIVgp140, Sodium Chloride for Injection, 0.9%. Control for CH505TF gp120/GLA-SE adjuvanted protein: Sodium Chloride for Injection, 0.9%. |
|
|
AdC7-HIVgp140 5 x 10^10 vp at Month 0 and AdC6-HIVgp140 5 x 10^10 vp at Month 3 and CH505TF/GLA-SE 400mg at Month 6 |
| OG002 | Part B, Group 6: Placebo | Placebo+Placebo+Placebo Control for AdC6-HIVgp140 or AdC7-HIVgp140, Sodium Chloride for Injection, 0.9%. Control for CH505TF gp120/GLA-SE adjuvanted protein: Sodium Chloride for Injection, 0.9%. |
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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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