HIV Infections
Conditions
Keywords
HIV
Brief summary
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.
Detailed description
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.
Interventions
BIOLOGICALAdC6-HIVgp140
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).
BIOLOGICALAdC7-HIVgp140
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.
BIOLOGICALCH505TF gp120
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.
BIOLOGICALGLA-SE (glucopyranosyl lipid A - stable emulsion; [labeled as AP 10-201])
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.
BIOLOGICALPlacebo
Placebo will be Sodium Chloride for Injection, 0.9%, will be used as the placebo. It must be stored as recommended by the manufacturer.
Sponsors
National Institute of Allergy and Infectious Diseases (NIAID)
National Institutes of Health (NIH)
Department of Health and Human Services
HIV Vaccine Trials Network
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
General and Demographic Criteria * Age of 18 through 50 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 and that in a previous trial with an adenovirus type 5 (Ad5) vector there was an association of increased HIV acquisition with receipt of that study product; completes a questionnaire prior to first vaccination with verbal demonstration of understanding of all questionnaire items answered incorrectly. * Willing to be contacted annually after completion of scheduled clinic visits for a total of 3 years following initial study injection. * Agrees not to enroll in another study of an investigational research agent until the last scheduled clinic visit. * 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 as low risk for HIV acquisition per low risk guidelines (see Appendix M), agrees to discuss HIV infection risks, agrees to risk reduction counseling, and agrees to avoid behavior associated with high risk of HIV exposure through the final study visit. Low risk may include persons stably taking PrEP as prescribed for 6 months or longer. Laboratory Inclusion Values Hemogram/Complete blood count (CBC) * Hemoglobin * 11.0 g/dL for volunteers who were assigned female sex at birth * 13.0 g/dL for volunteers who were assigned male sex at birth and transgender male who have been on hormone therapy for more than 6 consecutive months * 12.0 g/dL for transgender female who have been on hormone therapy for more than 6 consecutive months 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 * White blood cell count = 2,500 to 12,000 cells/mm3 with normal differential, or differential approved by Investigator of Record (IoR) or designee as not clinically significant * Total lymphocyte count ≥ 650 cells/mm3 with normal differential, or differential approved by Investigator of Record (IoR) or designee as not clinically significant * Remaining differential either within institutional normal range or with site physician approval. * Platelets = 125,000 to 550,000 cells/mm3. Chemistry * Alanine aminotransferase (ALT) \< 1.25 times the institutional upper limit of normal; * Creatinine \<1.1 times the institutional upper limit of normal Virology * Negative HIV-1 and -2 blood test: US volunteers must have a negative FDA-approved enzyme immunoassay (EIA) or chemiluminescent microparticle immunoassay (CMIA). * Negative Hepatitis B surface antigen (HBsAg). * Negative anti-Hepatitis C virus antibodies (anti-HCV), or negative HCV nucleic acid test if the anti-HCV is positive Urine * Normal urine: * Negative or trace urine protein, and * Negative, trace, or 1+ blood/hemoglobin on urine dipstick. If 1+ hemoglobin is present on dipstick, a microscopic urinalysis with red blood cells levels within institutional normal range is required. 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. * Condoms (male or female) with or without a spermicide, * Diaphragm or cervical cap with spermicide, * Intrauterine device (IUD), * Hormonal contraception, * Tubal ligation, or * Any other contraceptive method approved by the HVTN 139 PSRT * Successful vasectomy in any partner assigned male sex at birth (considered successful if a volunteer reports that a male partner has \[1\] documentation of azoospermia by microscopy, or \[2\] a vasectomy more than 2 years ago with no resultant pregnancy despite sexual activity postvasectomy); * Or not be of reproductive potential, such as having reached menopause (no menses for 1 year) or having undergone hysterectomy, or bilateral oophorectomy; * Or be sexually abstinent. * 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
* 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: age \> 45, systolic blood pressure \> 140 mm Hg, diastolic blood pressure \> 90 mm Hg, current tobacco 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 139 study. * Pregnant or breastfeeding. * Active duty and reserve US military personnel. 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 139 PSRT will determine eligibility on a case-by-case basis. * Previous receipt of monoclonal antibodies (mAbs), whether licensed or investigational. Exceptions may be made by the HVTN 139 PSRT on a case-by-case basis. * Non-HIV experimental vaccine(s) received within the last 1 year in a prior vaccine trial. Exceptions may be made by the HVTN 139 PSRT for vaccines that have subsequently undergone licensure by the FDA. For volunteers who have received control/placebo in an experimental vaccine trial, the HVTN 139 PSRT will determine eligibility on a case-by-case basis. For volunteers who have received an experimental vaccine(s) greater than 1 years ago, eligibility for enrollment will be determined by the HVTN 139 PSRT on a case-by-case basis. * Live attenuated vaccines received within 30 days before first vaccination or scheduled within 28 days after injection (eg, measles, mumps, and rubella \[MMR\]; oral polio vaccine \[OPV\]; varicella; yellow fever; live attenuated influenza vaccine). * 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 dermatologic condition; or \[4\] a single course of oral/parenteral prednisone or equivalent at doses \< 60 mg/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 glycerol, sodium chloride, tris (hydroxymethyl)aminomethane 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 90 days before first vaccination (for mAb see criterion 8 above). * Autoimmune disease, current or history. (Not exclusionary: well-controlled psoriasis that does not require systemic therapy) * AESIs 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) * Immunodeficiency. 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: * A process that would affect the immune response, * A process that would require medication that affects the immune response, * Any contraindication to repeated injections or blood draws, * A condition that requires active medical intervention or monitoring to avert grave danger to the volunteer's health or well-being during the study period, * A condition or process for which signs or symptoms could be confused with reactions to vaccine, or * Any condition specifically listed among the
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Reporting Local Reactogenicity Events Signs and Symptoms: Pain and/or Tenderness | 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). | 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. |
| Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | 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). | 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. |
| Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | 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). | 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. |
| Numbers of Participant With Early Study Termination Associated With Reactogenicity, AE, or Death During Main Study and AESI Visits. | 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). | 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. |
| Number of Participants Reporting Serious Adverse Events (SAEs) | 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). | From adverse event (AE) forms, counts are tabulated by treatment arm. AE forms were collected during main study clinical visits and AESI contact visits |
| Number of Participants Reporting Medically Attended Adverse Events (MAAEs) | 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). | From adverse event (AE) forms, counts are tabulated by treatment arm. AE forms were collected during main study clinical visits and AESI contact visits |
| Number of Participants Reporting Adverse Event of Special Interests (AESIs) | 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). | From adverse event (AE) forms, counts are tabulated by treatment arm. AE forms were collected during main study clinical visits and AESI contact visits |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination | Measured at Month 4 for 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. |
| Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination | Measured at Month 4 for 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). |
| Part B: HIV-specific Serum IgG Binding Antibodies Magnitude Breadth of AUC by Panel and Treatment Arm Assessed 4 Weeks After the Second Vaccination | Measured at Month 4 for 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 |
| Part B: Response Rate of HIV-specific CD4+ and CD8+ T-cell Responses Assessed 4 Weeks After the Second Vaccination | Measured at Month 4 for 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. |
| 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 | Measured at Month 4 for 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 |
| 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 | Measured at Month 4 for 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. |
| 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 | Measured at Month 4 for 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). 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). |
| Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | Measured at Month 1 for both Part A and 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. |
| Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination | Measured at Month 6.5 for 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). |
| Part B: HIV-specific Serum IgG Binding Antibodies Magnitude Breadth of AUC by Panel and Treatment Arm Assessed 2 Weeks After the Third Vaccination | Measured at Month 6.5 for 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 |
| Part B: Response Rate of HIV-specific CD4+ and CD8+ T-cell Responses Assessed 2 Weeks After the Third Vaccination | Measured at Month 6.5 for 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. |
| 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 | Measured at Month 6.5 for 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 |
| 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 | Measured at Month 6.5 for 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. |
| 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 | Measured at Month 6.5 for 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). 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). |
| Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination | Measured at Month 6.5 for 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. |
| Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | Measured at Month 1 for both Part A and 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). |
| 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) | Measured at Month 1 for both Part A and 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 |
| 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) | Measured at Month 1 for both Part A and 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. |
| 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) | Measured at Month 1 for both Part A and 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 |
| 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) | Measured at Month 1 for both Part A and 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. |
| 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) | Measured at Month 1 for both Part A and 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). |
Countries
South Africa
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Part A, Group 1: Vaccine AdC6-HIVgp140 1 x 10\^10 vp to be administrated IM at Month 0 | 5 |
| Part A, Group 2: Vaccine AdC7-HIVgp140 1 x 10\^10 vp to be administrated IM at Month 0 | 5 |
| 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%. | 2 |
| 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 | 10 |
| 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 | 10 |
| 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%. | 2 |
| Total | 34 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Overall Study | Death | 0 | 0 | 0 | 0 | 1 | 0 |
| Overall Study | Participant unable to adhere Visit Schedule | 0 | 0 | 0 | 1 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 0 | 0 | 0 | 2 | 0 |
Baseline characteristics
| Characteristic | Total | Part A, Group 1: Vaccine | Part A, Group 2: Vaccine | Part A, Group 3: Placebo | Part B, Group 4: Vaccine | Part B, Group 5: Vaccine | Part B, Group 6: Placebo |
|---|---|---|---|---|---|---|---|
| Age, Continuous | 25.5 years | 23 years | 23 years | 24.5 years | 28 years | 28 years | 21.5 years |
| Age, Customized 18-20 | 7 Participants | 2 Participants | 2 Participants | 0 Participants | 1 Participants | 1 Participants | 1 Participants |
| Age, Customized 21-30 | 18 Participants | 2 Participants | 2 Participants | 2 Participants | 6 Participants | 5 Participants | 1 Participants |
| Age, Customized 31-40 | 9 Participants | 1 Participants | 1 Participants | 0 Participants | 3 Participants | 4 Participants | 0 Participants |
| Age, Customized 41-50 | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Customized Age Category : Above 50 | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Customized Less than 18 | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Customized Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 34 Participants | 5 Participants | 5 Participants | 2 Participants | 10 Participants | 10 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Black | 34 Participants | 5 Participants | 5 Participants | 2 Participants | 10 Participants | 10 Participants | 2 Participants |
| Race/Ethnicity, Customized Colored | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Indian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Other | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized White | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 34 Participants | 5 Participants | 5 Participants | 2 Participants | 10 Participants | 10 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment South Africa | 34 Participants | 5 Participants | 5 Participants | 2 Participants | 10 Participants | 10 Participants | 2 Participants |
| Sex: Female, Male Female | 12 Participants | 2 Participants | 2 Participants | 0 Participants | 3 Participants | 5 Participants | 0 Participants |
| Sex: Female, Male Male | 22 Participants | 3 Participants | 3 Participants | 2 Participants | 7 Participants | 5 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 5 | 0 / 5 | 0 / 2 | 0 / 10 | 1 / 10 | 0 / 2 |
| other Total, other adverse events | 1 / 5 | 1 / 5 | 1 / 2 | 7 / 10 | 3 / 10 | 0 / 2 |
| serious Total, serious adverse events | 0 / 5 | 0 / 5 | 0 / 2 | 0 / 10 | 1 / 10 | 0 / 2 |
Outcome results
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
Time frame: 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).
Population: Safety population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part A, Group 1: Vaccine | Number of Participants Reporting Adverse Event of Special Interests (AESIs) | 0 Participants |
| Part A, Group 2: Vaccine | Number of Participants Reporting Adverse Event of Special Interests (AESIs) | 0 Participants |
| Part A, Group 3: Placebo | Number of Participants Reporting Adverse Event of Special Interests (AESIs) | 0 Participants |
| Part B, Group 4: Vaccine | Number of Participants Reporting Adverse Event of Special Interests (AESIs) | 0 Participants |
| Part B, Group 5: Vaccine | Number of Participants Reporting Adverse Event of Special Interests (AESIs) | 0 Participants |
| Part B, Group 6: Placebo | Number of Participants Reporting Adverse Event of Special Interests (AESIs) | 0 Participants |
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.
Time frame: 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).
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A, Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Events Signs and Symptoms: Pain and/or Tenderness | None | 5 Participants |
| Part A, Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Events Signs and Symptoms: Pain and/or Tenderness | Moderate | 0 Participants |
| Part A, Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Events Signs and Symptoms: Pain and/or Tenderness | Mild | 0 Participants |
| Part A, Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Events Signs and Symptoms: Pain and/or Tenderness | Potentially Life-threatening | 0 Participants |
| Part A, Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Events Signs and Symptoms: Pain and/or Tenderness | Severe | 0 Participants |
| Part A, Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Events Signs and Symptoms: Pain and/or Tenderness | Severe | 0 Participants |
| Part A, Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Events Signs and Symptoms: Pain and/or Tenderness | None | 4 Participants |
| Part A, Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Events Signs and Symptoms: Pain and/or Tenderness | Moderate | 0 Participants |
| Part A, Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Events Signs and Symptoms: Pain and/or Tenderness | Potentially Life-threatening | 0 Participants |
| Part A, Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Events Signs and Symptoms: Pain and/or Tenderness | Mild | 1 Participants |
| Part A, Group 3: Placebo | Number of Participants Reporting Local Reactogenicity Events Signs and Symptoms: Pain and/or Tenderness | Moderate | 0 Participants |
| Part A, Group 3: Placebo | Number of Participants Reporting Local Reactogenicity Events Signs and Symptoms: Pain and/or Tenderness | Potentially Life-threatening | 0 Participants |
| Part A, Group 3: Placebo | Number of Participants Reporting Local Reactogenicity Events Signs and Symptoms: Pain and/or Tenderness | Mild | 1 Participants |
| Part A, Group 3: Placebo | Number of Participants Reporting Local Reactogenicity Events Signs and Symptoms: Pain and/or Tenderness | Severe | 0 Participants |
| Part A, Group 3: Placebo | Number of Participants Reporting Local Reactogenicity Events Signs and Symptoms: Pain and/or Tenderness | None | 1 Participants |
| Part B, Group 4: Vaccine | Number of Participants Reporting Local Reactogenicity Events Signs and Symptoms: Pain and/or Tenderness | Moderate | 0 Participants |
| Part B, Group 4: Vaccine | Number of Participants Reporting Local Reactogenicity Events Signs and Symptoms: Pain and/or Tenderness | None | 6 Participants |
| Part B, Group 4: Vaccine | Number of Participants Reporting Local Reactogenicity Events Signs and Symptoms: Pain and/or Tenderness | Mild | 4 Participants |
| Part B, Group 4: Vaccine | Number of Participants Reporting Local Reactogenicity Events Signs and Symptoms: Pain and/or Tenderness | Severe | 0 Participants |
| Part B, Group 4: Vaccine | Number of Participants Reporting Local Reactogenicity Events Signs and Symptoms: Pain and/or Tenderness | Potentially Life-threatening | 0 Participants |
| Part B, Group 5: Vaccine | Number of Participants Reporting Local Reactogenicity Events Signs and Symptoms: Pain and/or Tenderness | Severe | 0 Participants |
| Part B, Group 5: Vaccine | Number of Participants Reporting Local Reactogenicity Events Signs and Symptoms: Pain and/or Tenderness | None | 5 Participants |
| Part B, Group 5: Vaccine | Number of Participants Reporting Local Reactogenicity Events Signs and Symptoms: Pain and/or Tenderness | Potentially Life-threatening | 0 Participants |
| Part B, Group 5: Vaccine | Number of Participants Reporting Local Reactogenicity Events Signs and Symptoms: Pain and/or Tenderness | Mild | 2 Participants |
| Part B, Group 5: Vaccine | Number of Participants Reporting Local Reactogenicity Events Signs and Symptoms: Pain and/or Tenderness | Moderate | 3 Participants |
| Part B, Group 6: Placebo | Number of Participants Reporting Local Reactogenicity Events Signs and Symptoms: Pain and/or Tenderness | None | 2 Participants |
| Part B, Group 6: Placebo | Number of Participants Reporting Local Reactogenicity Events Signs and Symptoms: Pain and/or Tenderness | Severe | 0 Participants |
| Part B, Group 6: Placebo | Number of Participants Reporting Local Reactogenicity Events Signs and Symptoms: Pain and/or Tenderness | Mild | 0 Participants |
| Part B, Group 6: Placebo | Number of Participants Reporting Local Reactogenicity Events Signs and Symptoms: Pain and/or Tenderness | Potentially Life-threatening | 0 Participants |
| Part B, Group 6: Placebo | Number of Participants Reporting Local Reactogenicity Events Signs and Symptoms: Pain and/or Tenderness | Moderate | 0 Participants |
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.
Time frame: 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).
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Part A, Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Severe | 0 Participants |
| Part A, Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Moderate | 0 Participants |
| Part A, Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Potentially Life-threatening | 0 Participants |
| Part A, Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Severe | 0 Participants |
| Part A, Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Moderate | 0 Participants |
| Part A, Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Mild | 0 Participants |
| Part A, Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Mild | 0 Participants |
| Part A, Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | None | 5 Participants |
| Part A, Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | None | 5 Participants |
| Part A, Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Potentially Life-threatening | 0 Participants |
| Part A, Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Mild | 0 Participants |
| Part A, Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | None | 5 Participants |
| Part A, Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Moderate | 0 Participants |
| Part A, Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Severe | 0 Participants |
| Part A, Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Potentially Life-threatening | 0 Participants |
| Part A, Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | None | 5 Participants |
| Part A, Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Mild | 0 Participants |
| Part A, Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Moderate | 0 Participants |
| Part A, Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Severe | 0 Participants |
| Part A, Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Potentially Life-threatening | 0 Participants |
| Part A, Group 3: Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Severe | 0 Participants |
| Part A, Group 3: Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Moderate | 0 Participants |
| Part A, Group 3: Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | None | 2 Participants |
| Part A, Group 3: Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Potentially Life-threatening | 0 Participants |
| Part A, Group 3: Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Moderate | 0 Participants |
| Part A, Group 3: Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Mild | 0 Participants |
| Part A, Group 3: Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | None | 2 Participants |
| Part A, Group 3: Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Severe | 0 Participants |
| Part A, Group 3: Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Potentially Life-threatening | 0 Participants |
| Part A, Group 3: Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Mild | 0 Participants |
| Part B, Group 4: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Mild | 0 Participants |
| Part B, Group 4: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Moderate | 0 Participants |
| Part B, Group 4: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Mild | 0 Participants |
| Part B, Group 4: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Potentially Life-threatening | 0 Participants |
| Part B, Group 4: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Severe | 0 Participants |
| Part B, Group 4: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | None | 10 Participants |
| Part B, Group 4: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | None | 10 Participants |
| Part B, Group 4: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Potentially Life-threatening | 0 Participants |
| Part B, Group 4: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Severe | 0 Participants |
| Part B, Group 4: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Moderate | 0 Participants |
| Part B, Group 5: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Mild | 0 Participants |
| Part B, Group 5: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Severe | 0 Participants |
| Part B, Group 5: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Potentially Life-threatening | 0 Participants |
| Part B, Group 5: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | None | 10 Participants |
| Part B, Group 5: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | None | 8 Participants |
| Part B, Group 5: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Moderate | 0 Participants |
| Part B, Group 5: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Potentially Life-threatening | 0 Participants |
| Part B, Group 5: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Severe | 0 Participants |
| Part B, Group 5: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Moderate | 0 Participants |
| Part B, Group 5: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Mild | 2 Participants |
| Part B, Group 6: Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | None | 2 Participants |
| Part B, Group 6: Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Potentially Life-threatening | 0 Participants |
| Part B, Group 6: Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Mild | 0 Participants |
| Part B, Group 6: Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Moderate | 0 Participants |
| Part B, Group 6: Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Potentially Life-threatening | 0 Participants |
| Part B, Group 6: Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Mild | 0 Participants |
| Part B, Group 6: Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Severe | 0 Participants |
| Part B, Group 6: Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Moderate | 0 Participants |
| Part B, Group 6: Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | None | 2 Participants |
| Part B, Group 6: Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Severe | 0 Participants |
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
Time frame: 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).
Population: Safety population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part A, Group 1: Vaccine | Number of Participants Reporting Medically Attended Adverse Events (MAAEs) | 0 Participants |
| Part A, Group 2: Vaccine | Number of Participants Reporting Medically Attended Adverse Events (MAAEs) | 1 Participants |
| Part A, Group 3: Placebo | Number of Participants Reporting Medically Attended Adverse Events (MAAEs) | 0 Participants |
| Part B, Group 4: Vaccine | Number of Participants Reporting Medically Attended Adverse Events (MAAEs) | 1 Participants |
| Part B, Group 5: Vaccine | Number of Participants Reporting Medically Attended Adverse Events (MAAEs) | 0 Participants |
| Part B, Group 6: Placebo | Number of Participants Reporting Medically Attended Adverse Events (MAAEs) | 0 Participants |
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
Time frame: 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).
Population: Safety population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part A, Group 1: Vaccine | Number of Participants Reporting Serious Adverse Events (SAEs) | 0 Participants |
| Part A, Group 2: Vaccine | Number of Participants Reporting Serious Adverse Events (SAEs) | 0 Participants |
| Part A, Group 3: Placebo | Number of Participants Reporting Serious Adverse Events (SAEs) | 0 Participants |
| Part B, Group 4: Vaccine | Number of Participants Reporting Serious Adverse Events (SAEs) | 0 Participants |
| Part B, Group 5: Vaccine | Number of Participants Reporting Serious Adverse Events (SAEs) | 1 Participants |
| Part B, Group 6: Placebo | Number of Participants Reporting Serious Adverse Events (SAEs) | 0 Participants |
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.
Time frame: 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).
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Part A, Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Severe | 0 Participants |
| Part A, Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Potentially Life-threatening | 0 Participants |
| Part A, Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Potentially Life-threatening | 0 Participants |
| Part A, Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Potentially Life-threatening | 0 Participants |
| Part A, Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | None | 5 Participants |
| Part A, Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Mild | 0 Participants |
| Part A, Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Moderate | 0 Participants |
| Part A, Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Severe | 0 Participants |
| Part A, Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | None | 5 Participants |
| Part A, Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Mild | 0 Participants |
| Part A, Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Moderate | 0 Participants |
| Part A, Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Severe | 0 Participants |
| Part A, Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | None | 5 Participants |
| Part A, Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Mild | 0 Participants |
| Part A, Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Moderate | 0 Participants |
| Part A, Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Severe | 0 Participants |
| Part A, Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Potentially Life-threatening | 0 Participants |
| Part A, Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Mild | 0 Participants |
| Part A, Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Moderate | 0 Participants |
| Part A, Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Severe | 0 Participants |
| Part A, Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Potentially Life-threatening | 0 Participants |
| Part A, Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | None | 5 Participants |
| Part A, Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Mild | 0 Participants |
| Part A, Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Moderate | 0 Participants |
| Part A, Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Severe | 0 Participants |
| Part A, Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Potentially Life-threatening | 0 Participants |
| Part A, Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | None | 5 Participants |
| Part A, Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Mild | 0 Participants |
| Part A, Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Moderate | 0 Participants |
| Part A, Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Severe | 0 Participants |
| Part A, Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Potentially Life-threatening | 0 Participants |
| Part A, Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | None | 5 Participants |
| Part A, Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Mild | 0 Participants |
| Part A, Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Moderate | 0 Participants |
| Part A, Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Severe | 0 Participants |
| Part A, Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Potentially Life-threatening | 0 Participants |
| Part A, Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | None | 5 Participants |
| Part A, Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Mild | 0 Participants |
| Part A, Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Moderate | 0 Participants |
| Part A, Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | None | 5 Participants |
| Part A, Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Mild | 1 Participants |
| Part A, Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Moderate | 0 Participants |
| Part A, Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Severe | 0 Participants |
| Part A, Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | None | 5 Participants |
| Part A, Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Moderate | 0 Participants |
| Part A, Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Mild | 0 Participants |
| Part A, Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Severe | 0 Participants |
| Part A, Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Moderate | 0 Participants |
| Part A, Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Severe | 0 Participants |
| Part A, Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | None | 3 Participants |
| Part A, Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Mild | 2 Participants |
| Part A, Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Moderate | 0 Participants |
| Part A, Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Severe | 0 Participants |
| Part A, Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Potentially Life-threatening | 0 Participants |
| Part A, Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Potentially Life-threatening | 0 Participants |
| Part A, Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Mild | 0 Participants |
| Part A, Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Moderate | 0 Participants |
| Part A, Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Severe | 0 Participants |
| Part A, Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | None | 5 Participants |
| Part A, Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | None | 4 Participants |
| Part A, Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Mild | 0 Participants |
| Part A, Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Moderate | 0 Participants |
| Part A, Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Severe | 0 Participants |
| Part A, Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Potentially Life-threatening | 0 Participants |
| Part A, Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | None | 3 Participants |
| Part A, Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Mild | 1 Participants |
| Part A, Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Moderate | 0 Participants |
| Part A, Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Severe | 0 Participants |
| Part A, Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Potentially Life-threatening | 0 Participants |
| Part A, Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | None | 5 Participants |
| Part A, Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Mild | 0 Participants |
| Part A, Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | None | 5 Participants |
| Part A, Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Potentially Life-threatening | 0 Participants |
| Part A, Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Mild | 2 Participants |
| Part A, Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Potentially Life-threatening | 0 Participants |
| Part A, Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Potentially Life-threatening | 0 Participants |
| Part A, Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Severe | 0 Participants |
| Part A, Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Potentially Life-threatening | 0 Participants |
| Part A, Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Moderate | 0 Participants |
| Part A, Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | None | 4 Participants |
| Part A, Group 3: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | None | 2 Participants |
| Part A, Group 3: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Potentially Life-threatening | 0 Participants |
| Part A, Group 3: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Moderate | 0 Participants |
| Part A, Group 3: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Potentially Life-threatening | 0 Participants |
| Part A, Group 3: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | None | 2 Participants |
| Part A, Group 3: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Mild | 0 Participants |
| Part A, Group 3: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | None | 2 Participants |
| Part A, Group 3: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Mild | 0 Participants |
| Part A, Group 3: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Severe | 0 Participants |
| Part A, Group 3: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Severe | 0 Participants |
| Part A, Group 3: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | None | 2 Participants |
| Part A, Group 3: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Moderate | 0 Participants |
| Part A, Group 3: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Mild | 0 Participants |
| Part A, Group 3: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | None | 2 Participants |
| Part A, Group 3: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Moderate | 0 Participants |
| Part A, Group 3: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Severe | 0 Participants |
| Part A, Group 3: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Potentially Life-threatening | 0 Participants |
| Part A, Group 3: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Potentially Life-threatening | 0 Participants |
| Part A, Group 3: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Moderate | 0 Participants |
| Part A, Group 3: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Moderate | 0 Participants |
| Part A, Group 3: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Severe | 0 Participants |
| Part A, Group 3: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Moderate | 0 Participants |
| Part A, Group 3: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Severe | 0 Participants |
| Part A, Group 3: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Mild | 0 Participants |
| Part A, Group 3: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Potentially Life-threatening | 0 Participants |
| Part A, Group 3: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Mild | 0 Participants |
| Part A, Group 3: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Potentially Life-threatening | 0 Participants |
| Part A, Group 3: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Severe | 0 Participants |
| Part A, Group 3: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Moderate | 0 Participants |
| Part A, Group 3: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Mild | 0 Participants |
| Part A, Group 3: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | None | 2 Participants |
| Part A, Group 3: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Moderate | 0 Participants |
| Part A, Group 3: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | None | 2 Participants |
| Part A, Group 3: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Potentially Life-threatening | 0 Participants |
| Part A, Group 3: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Potentially Life-threatening | 0 Participants |
| Part A, Group 3: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | None | 2 Participants |
| Part A, Group 3: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Mild | 0 Participants |
| Part A, Group 3: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Mild | 0 Participants |
| Part A, Group 3: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Severe | 0 Participants |
| Part A, Group 3: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Severe | 0 Participants |
| Part B, Group 4: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Severe | 0 Participants |
| Part B, Group 4: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Severe | 0 Participants |
| Part B, Group 4: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Moderate | 1 Participants |
| Part B, Group 4: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Severe | 0 Participants |
| Part B, Group 4: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Potentially Life-threatening | 0 Participants |
| Part B, Group 4: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | None | 6 Participants |
| Part B, Group 4: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Mild | 3 Participants |
| Part B, Group 4: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Potentially Life-threatening | 0 Participants |
| Part B, Group 4: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Moderate | 1 Participants |
| Part B, Group 4: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Potentially Life-threatening | 0 Participants |
| Part B, Group 4: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Severe | 0 Participants |
| Part B, Group 4: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Potentially Life-threatening | 0 Participants |
| Part B, Group 4: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Moderate | 1 Participants |
| Part B, Group 4: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | None | 7 Participants |
| Part B, Group 4: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | None | 5 Participants |
| Part B, Group 4: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Mild | 2 Participants |
| Part B, Group 4: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Mild | 4 Participants |
| Part B, Group 4: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | None | 9 Participants |
| Part B, Group 4: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | None | 8 Participants |
| Part B, Group 4: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Severe | 0 Participants |
| Part B, Group 4: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Potentially Life-threatening | 0 Participants |
| Part B, Group 4: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Severe | 0 Participants |
| Part B, Group 4: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | None | 7 Participants |
| Part B, Group 4: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Mild | 3 Participants |
| Part B, Group 4: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Moderate | 0 Participants |
| Part B, Group 4: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Severe | 0 Participants |
| Part B, Group 4: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Mild | 0 Participants |
| Part B, Group 4: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Potentially Life-threatening | 0 Participants |
| Part B, Group 4: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | None | 7 Participants |
| Part B, Group 4: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Potentially Life-threatening | 0 Participants |
| Part B, Group 4: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Mild | 2 Participants |
| Part B, Group 4: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Mild | 1 Participants |
| Part B, Group 4: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Moderate | 1 Participants |
| Part B, Group 4: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Moderate | 1 Participants |
| Part B, Group 4: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Severe | 0 Participants |
| Part B, Group 4: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Potentially Life-threatening | 0 Participants |
| Part B, Group 4: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | None | 10 Participants |
| Part B, Group 4: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Mild | 0 Participants |
| Part B, Group 4: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Moderate | 1 Participants |
| Part B, Group 4: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Moderate | 0 Participants |
| Part B, Group 5: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Severe | 0 Participants |
| Part B, Group 5: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | None | 5 Participants |
| Part B, Group 5: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Severe | 0 Participants |
| Part B, Group 5: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Mild | 0 Participants |
| Part B, Group 5: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | None | 7 Participants |
| Part B, Group 5: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Severe | 0 Participants |
| Part B, Group 5: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Potentially Life-threatening | 0 Participants |
| Part B, Group 5: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Severe | 0 Participants |
| Part B, Group 5: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Severe | 0 Participants |
| Part B, Group 5: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Moderate | 2 Participants |
| Part B, Group 5: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Potentially Life-threatening | 0 Participants |
| Part B, Group 5: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | None | 8 Participants |
| Part B, Group 5: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Potentially Life-threatening | 0 Participants |
| Part B, Group 5: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Moderate | 1 Participants |
| Part B, Group 5: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Potentially Life-threatening | 0 Participants |
| Part B, Group 5: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Moderate | 1 Participants |
| Part B, Group 5: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Severe | 0 Participants |
| Part B, Group 5: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Potentially Life-threatening | 0 Participants |
| Part B, Group 5: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Mild | 3 Participants |
| Part B, Group 5: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Potentially Life-threatening | 0 Participants |
| Part B, Group 5: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Moderate | 0 Participants |
| Part B, Group 5: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | None | 4 Participants |
| Part B, Group 5: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Moderate | 2 Participants |
| Part B, Group 5: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Mild | 3 Participants |
| Part B, Group 5: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Mild | 2 Participants |
| Part B, Group 5: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Moderate | 3 Participants |
| Part B, Group 5: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Moderate | 1 Participants |
| Part B, Group 5: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Potentially Life-threatening | 0 Participants |
| Part B, Group 5: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Moderate | 1 Participants |
| Part B, Group 5: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Potentially Life-threatening | 0 Participants |
| Part B, Group 5: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Mild | 0 Participants |
| Part B, Group 5: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Mild | 2 Participants |
| Part B, Group 5: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | None | 9 Participants |
| Part B, Group 5: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | None | 7 Participants |
| Part B, Group 5: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Severe | 0 Participants |
| Part B, Group 5: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | None | 8 Participants |
| Part B, Group 5: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | None | 6 Participants |
| Part B, Group 5: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Mild | 2 Participants |
| Part B, Group 5: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Mild | 3 Participants |
| Part B, Group 5: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Severe | 0 Participants |
| Part B, Group 6: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Moderate | 0 Participants |
| Part B, Group 6: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Potentially Life-threatening | 0 Participants |
| Part B, Group 6: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | None | 2 Participants |
| Part B, Group 6: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | None | 2 Participants |
| Part B, Group 6: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Potentially Life-threatening | 0 Participants |
| Part B, Group 6: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | None | 2 Participants |
| Part B, Group 6: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Mild | 0 Participants |
| Part B, Group 6: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Severe | 0 Participants |
| Part B, Group 6: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Potentially Life-threatening | 0 Participants |
| Part B, Group 6: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Mild | 0 Participants |
| Part B, Group 6: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Moderate | 0 Participants |
| Part B, Group 6: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Severe | 0 Participants |
| Part B, Group 6: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Moderate | 0 Participants |
| Part B, Group 6: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Severe | 0 Participants |
| Part B, Group 6: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | None | 1 Participants |
| Part B, Group 6: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Moderate | 0 Participants |
| Part B, Group 6: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | None | 2 Participants |
| Part B, Group 6: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Potentially Life-threatening | 0 Participants |
| Part B, Group 6: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | None | 2 Participants |
| Part B, Group 6: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Mild | 0 Participants |
| Part B, Group 6: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Mild | 0 Participants |
| Part B, Group 6: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Severe | 0 Participants |
| Part B, Group 6: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Severe | 0 Participants |
| Part B, Group 6: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Mild | 0 Participants |
| Part B, Group 6: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Potentially Life-threatening | 0 Participants |
| Part B, Group 6: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Mild | 1 Participants |
| Part B, Group 6: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Moderate | 0 Participants |
| Part B, Group 6: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Severe | 0 Participants |
| Part B, Group 6: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Potentially Life-threatening | 0 Participants |
| Part B, Group 6: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Potentially Life-threatening | 0 Participants |
| Part B, Group 6: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | None | 2 Participants |
| Part B, Group 6: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Moderate | 0 Participants |
| Part B, Group 6: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Moderate | 0 Participants |
| Part B, Group 6: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Mild | 0 Participants |
| Part B, Group 6: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Potentially Life-threatening | 0 Participants |
| Part B, Group 6: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Moderate | 0 Participants |
| Part B, Group 6: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Mild | 1 Participants |
| Part B, Group 6: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Severe | 0 Participants |
| Part B, Group 6: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Severe | 0 Participants |
| Part B, Group 6: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | None | 1 Participants |
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.
Time frame: 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).
Population: Safety population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part A, Group 1: Vaccine | Numbers of Participant With Early Study Termination Associated With Reactogenicity, AE, or Death During Main Study and AESI Visits. | 0 Participants |
| Part A, Group 2: Vaccine | Numbers of Participant With Early Study Termination Associated With Reactogenicity, AE, or Death During Main Study and AESI Visits. | 0 Participants |
| Part A, Group 3: Placebo | Numbers of Participant With Early Study Termination Associated With Reactogenicity, AE, or Death During Main Study and AESI Visits. | 0 Participants |
| Part B, Group 4: Vaccine | Numbers of Participant With Early Study Termination Associated With Reactogenicity, AE, or Death During Main Study and AESI Visits. | 0 Participants |
| Part B, Group 5: Vaccine | Numbers of Participant With Early Study Termination Associated With Reactogenicity, AE, or Death During Main Study and AESI Visits. | 1 Participants |
| Part B, Group 6: Placebo | Numbers of Participant With Early Study Termination Associated With Reactogenicity, AE, or Death During Main Study and AESI Visits. | 0 Participants |
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
Time frame: Measured at Month 1 for both Part A and Part B
Population: 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
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Part A, Group 1: Vaccine | 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) | Clade C gp70 V1V2 measured at Month 1 | 2.05 log10(net MFI) |
| Part A, Group 1: Vaccine | 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) | Clade C gp120 measured at Month 1 | 2 log10(net MFI) |
| Part A, Group 2: Vaccine | 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) | Clade C gp70 V1V2 measured at Month 1 | 2 log10(net MFI) |
| Part A, Group 2: Vaccine | 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) | Clade C gp120 measured at Month 1 | 2 log10(net MFI) |
| Part A, Group 3: Placebo | 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) | Clade C gp120 measured at Month 1 | 2 log10(net MFI) |
| Part A, Group 3: Placebo | 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) | Clade C gp70 V1V2 measured at Month 1 | 2 log10(net MFI) |
| Part B, Group 4: Vaccine | 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) | Clade C gp120 measured at Month 1 | 2.19 log10(net MFI) |
| Part B, Group 4: Vaccine | 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) | Clade C gp70 V1V2 measured at Month 1 | 2 log10(net MFI) |
| Part B, Group 5: Vaccine | 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) | Clade C gp120 measured at Month 1 | 2 log10(net MFI) |
| Part B, Group 5: Vaccine | 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) | Clade C gp70 V1V2 measured at Month 1 | 2.12 log10(net MFI) |
| Part B, Group 6: Placebo | 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) | Clade C gp70 V1V2 measured at Month 1 | 2 log10(net MFI) |
| Part B, Group 6: Placebo | 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) | Clade C gp120 measured at Month 1 | 2 log10(net MFI) |
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
Time frame: Measured at Month 1 for both Part A and Part B
Population: 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
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Part A, Group 1: Vaccine | 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) | ENV-2-PTEG-SEQ for CD4+ T Cells, measured at Month 1 | 0.011 Percentage of cells |
| Part A, Group 1: Vaccine | 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) | Any Env for CD8+ T Cells, measured at Month 1 | 0.011 Percentage of cells |
| Part A, Group 1: Vaccine | 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) | Any Env for CD4+ T Cells, measured at Month 1 | 0.019 Percentage of cells |
| Part A, Group 1: Vaccine | 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) | ENV-1-PTEG-SEQ for CD4+ T Cells, measured at Month 1 | 0.008 Percentage of cells |
| Part A, Group 1: Vaccine | 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) | ENV-2-PTEG-SEQ for CD8+ T Cells, measured at Month 1 | 0.001 Percentage of cells |
| Part A, Group 1: Vaccine | 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) | ENV-1-PTEG-SEQ for CD8+ T Cells, measured at Month 1 | 0.011 Percentage of cells |
| Part A, Group 2: Vaccine | 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) | Any Env for CD4+ T Cells, measured at Month 1 | 0.103 Percentage of cells |
| Part A, Group 2: Vaccine | 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) | ENV-2-PTEG-SEQ for CD4+ T Cells, measured at Month 1 | 0.049 Percentage of cells |
| Part A, Group 2: Vaccine | 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) | ENV-2-PTEG-SEQ for CD8+ T Cells, measured at Month 1 | 0.011 Percentage of cells |
| Part A, Group 2: Vaccine | 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) | ENV-1-PTEG-SEQ for CD8+ T Cells, measured at Month 1 | 0.038 Percentage of cells |
| Part A, Group 2: Vaccine | 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) | ENV-1-PTEG-SEQ for CD4+ T Cells, measured at Month 1 | 0.066 Percentage of cells |
| Part A, Group 2: Vaccine | 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) | Any Env for CD8+ T Cells, measured at Month 1 | 0.096 Percentage of cells |
| Part A, Group 3: Placebo | 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) | ENV-1-PTEG-SEQ for CD8+ T Cells, measured at Month 1 | 0.017 Percentage of cells |
| Part A, Group 3: Placebo | 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) | ENV-1-PTEG-SEQ for CD4+ T Cells, measured at Month 1 | 0.001 Percentage of cells |
| Part A, Group 3: Placebo | 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) | ENV-2-PTEG-SEQ for CD4+ T Cells, measured at Month 1 | 0.001 Percentage of cells |
| Part A, Group 3: Placebo | 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) | Any Env for CD8+ T Cells, measured at Month 1 | 0.028 Percentage of cells |
| Part A, Group 3: Placebo | 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) | Any Env for CD4+ T Cells, measured at Month 1 | 0.001 Percentage of cells |
| Part A, Group 3: Placebo | 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) | ENV-2-PTEG-SEQ for CD8+ T Cells, measured at Month 1 | 0.012 Percentage of cells |
| Part B, Group 4: Vaccine | 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) | Any Env for CD4+ T Cells, measured at Month 1 | 0.028 Percentage of cells |
| Part B, Group 4: Vaccine | 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) | Any Env for CD8+ T Cells, measured at Month 1 | 0.044 Percentage of cells |
| Part B, Group 4: Vaccine | 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) | ENV-1-PTEG-SEQ for CD8+ T Cells, measured at Month 1 | 0.028 Percentage of cells |
| Part B, Group 4: Vaccine | 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) | ENV-1-PTEG-SEQ for CD4+ T Cells, measured at Month 1 | 0.008 Percentage of cells |
| Part B, Group 4: Vaccine | 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) | ENV-2-PTEG-SEQ for CD4+ T Cells, measured at Month 1 | 0.019 Percentage of cells |
| Part B, Group 4: Vaccine | 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) | ENV-2-PTEG-SEQ for CD8+ T Cells, measured at Month 1 | 0.014 Percentage of cells |
| Part B, Group 5: Vaccine | 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) | ENV-1-PTEG-SEQ for CD8+ T Cells, measured at Month 1 | 0.033 Percentage of cells |
| Part B, Group 5: Vaccine | 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) | Any Env for CD4+ T Cells, measured at Month 1 | 0.13 Percentage of cells |
| Part B, Group 5: Vaccine | 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) | Any Env for CD8+ T Cells, measured at Month 1 | 0.067 Percentage of cells |
| Part B, Group 5: Vaccine | 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) | ENV-1-PTEG-SEQ for CD4+ T Cells, measured at Month 1 | 0.047 Percentage of cells |
| Part B, Group 5: Vaccine | 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) | ENV-2-PTEG-SEQ for CD4+ T Cells, measured at Month 1 | 0.065 Percentage of cells |
| Part B, Group 5: Vaccine | 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) | ENV-2-PTEG-SEQ for CD8+ T Cells, measured at Month 1 | 0.023 Percentage of cells |
| Part B, Group 6: Placebo | 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) | ENV-1-PTEG-SEQ for CD4+ T Cells, measured at Month 1 | 0.011 Percentage of cells |
| Part B, Group 6: Placebo | 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) | Any Env for CD8+ T Cells, measured at Month 1 | 0.025 Percentage of cells |
| Part B, Group 6: Placebo | 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) | Any Env for CD4+ T Cells, measured at Month 1 | 0.011 Percentage of cells |
| Part B, Group 6: Placebo | 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) | ENV-1-PTEG-SEQ for CD8+ T Cells, measured at Month 1 | 0.016 Percentage of cells |
| Part B, Group 6: Placebo | 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) | ENV-2-PTEG-SEQ for CD8+ T Cells, measured at Month 1 | 0.009 Percentage of cells |
| Part B, Group 6: Placebo | 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) | ENV-2-PTEG-SEQ for CD4+ T Cells, measured at Month 1 | 0.001 Percentage of cells |
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).
Time frame: Measured at Month 1 for both Part A and Part B
Population: 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
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Part A, Group 1: Vaccine | Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp70-CAP210.2.00.E8 V1V2 measured at Month 1 | 1 Net MFI |
| Part A, Group 1: Vaccine | Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | 1428_D11gp120.avi/293F measured at Month 1 | 1 Net MFI |
| Part A, Group 1: Vaccine | Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp70-1394C9G1 V1V2 measured at Month 1 | 1 Net MFI |
| Part A, Group 1: Vaccine | Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | 96ZM651.D11gp120.avi measured at Month 1 | 54.8 Net MFI |
| Part A, Group 1: Vaccine | Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | CAP45_D11gp120.avi/293F measured at Month 1 | 25.4 Net MFI |
| Part A, Group 1: Vaccine | Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | 1086C_D7gp120.avi/293F measured at Month 1 | 691.2 Net MFI |
| Part A, Group 1: Vaccine | Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp70-BF1266_431a_V1V2 measured at Month 1 | 26.8 Net MFI |
| Part A, Group 1: Vaccine | Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | Con 6 gp120/B measured at Month 1 | 38.9 Net MFI |
| Part A, Group 1: Vaccine | Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp70-Ce1086_B2 V1V2 measured at Month 1 | 29.9 Net MFI |
| Part A, Group 1: Vaccine | Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp70-001428.2.42 V1V2 measured at Month 1 | 1 Net MFI |
| Part A, Group 1: Vaccine | Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp70-Ce704010042_2ES V1V2 measured at Month 1 | 1 Net MFI |
| Part A, Group 1: Vaccine | Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp70-1012.11.TC21.3257 V1V2 measured at Month 1 | 1 Net MFI |
| Part A, Group 1: Vaccine | Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp70_CH505TF_V1V2_avi/293F measured at Month 1 | 1 Net MFI |
| Part A, Group 1: Vaccine | Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp70-TV1.21 V1V2 measured at Month 1 | 1800.6 Net MFI |
| Part A, Group 1: Vaccine | Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp41 measured at Month 1 | 5349.6 Net MFI |
| Part A, Group 1: Vaccine | Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp70_CH505TF_V1V2_N156KN160K_avi/293F measured at Month 1 | 425.9 Net MFI |
| Part A, Group 1: Vaccine | Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | CH505TFD8N156KN160K_avi/293i Mon measured at Month 1 | 104.8 Net MFI |
| Part A, Group 1: Vaccine | Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | Du156_D11gp120.avi/293F measured at Month 1 | 61.9 Net MFI |
| Part A, Group 1: Vaccine | Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | TV1c8_D11gp120.avi/293F measured at Month 1 | 101.9 Net MFI |
| Part A, Group 1: Vaccine | Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | 1641A7_D11gp120.avi/293F measured at Month 1 | 1 Net MFI |
| Part A, Group 1: Vaccine | Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | 1394C9_G1.D11gp120.avi measured at Month 1 | 3.5 Net MFI |
| Part A, Group 1: Vaccine | Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp70-CAP45.2.00.G3 V1V2 measured at Month 1 | 1 Net MFI |
| Part A, Group 1: Vaccine | Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp70-Du156.12 V1V2 measured at Month 1 | 1 Net MFI |
| Part A, Group 1: Vaccine | Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp70-Ce1176 V1V2 measured at Month 1 | 1 Net MFI |
| Part A, Group 1: Vaccine | Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | CH0505_CON D7gp120_avi/293F/Mon measured at Month 1 | 71.6 Net MFI |
| Part A, Group 1: Vaccine | Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp70-1051.12.C22 V1V2 measured at Month 1 | 1 Net MFI |
| Part A, Group 1: Vaccine | Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | CAP210_D11gp120.avi/293F measured at Month 1 | 68.6 Net MFI |
| Part A, Group 1: Vaccine | Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | Con S gp140 CFI measured at Month 1 | 436.5 Net MFI |
| Part A, Group 1: Vaccine | Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | Ce0042_D11gp120.avi/293F measured at Month 1 | 103.2 Net MFI |
| Part A, Group 1: Vaccine | Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp70-96ZM651.02 V1v2 measured at Month 1 | 443.5 Net MFI |
| Part A, Group 1: Vaccine | Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | CH505TF D7gp120d371_avi/293F/Mon measured at Month 1 | 63.2 Net MFI |
| Part A, Group 1: Vaccine | Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp70-7060101641 V1V2 measured at Month 1 | 1 Net MFI |
| Part A, Group 1: Vaccine | Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp70-ConC V1V2 measured at Month 1 | 1 Net MFI |
| Part A, Group 2: Vaccine | Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp70-1394C9G1 V1V2 measured at Month 1 | 1 Net MFI |
| Part A, Group 2: Vaccine | Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp70-Ce1176 V1V2 measured at Month 1 | 70.2 Net MFI |
| Part A, Group 2: Vaccine | Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp70-7060101641 V1V2 measured at Month 1 | 1 Net MFI |
| Part A, Group 2: Vaccine | Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | CAP45_D11gp120.avi/293F measured at Month 1 | 7.1 Net MFI |
| Part A, Group 2: Vaccine | Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp70-96ZM651.02 V1v2 measured at Month 1 | 2.5 Net MFI |
| Part A, Group 2: Vaccine | Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp70-Ce1086_B2 V1V2 measured at Month 1 | 1 Net MFI |
| Part A, Group 2: Vaccine | Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp70-BF1266_431a_V1V2 measured at Month 1 | 1.6 Net MFI |
| Part A, Group 2: Vaccine | Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp70-CAP45.2.00.G3 V1V2 measured at Month 1 | 1 Net MFI |
| Part A, Group 2: Vaccine | Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | 1428_D11gp120.avi/293F measured at Month 1 | 57.4 Net MFI |
| Part A, Group 2: Vaccine | Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | CH0505_CON D7gp120_avi/293F/Mon measured at Month 1 | 336.5 Net MFI |
| Part A, Group 2: Vaccine | Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | 1394C9_G1.D11gp120.avi measured at Month 1 | 1.2 Net MFI |
| Part A, Group 2: Vaccine | Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | CH505TF D7gp120d371_avi/293F/Mon measured at Month 1 | 347 Net MFI |
| Part A, Group 2: Vaccine | Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | CH505TFD8N156KN160K_avi/293i Mon measured at Month 1 | 292.6 Net MFI |
| Part A, Group 2: Vaccine | Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | 1086C_D7gp120.avi/293F measured at Month 1 | 65.8 Net MFI |
| Part A, Group 2: Vaccine | Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | Ce0042_D11gp120.avi/293F measured at Month 1 | 103 Net MFI |
| Part A, Group 2: Vaccine | Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | Con 6 gp120/B measured at Month 1 | 36.1 Net MFI |
| Part A, Group 2: Vaccine | Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | 96ZM651.D11gp120.avi measured at Month 1 | 186.9 Net MFI |
| Part A, Group 2: Vaccine | Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp70_CH505TF_V1V2_avi/293F measured at Month 1 | 1 Net MFI |
| Part A, Group 2: Vaccine | Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp70_CH505TF_V1V2_N156KN160K_avi/293F measured at Month 1 | 59.6 Net MFI |
| Part A, Group 2: Vaccine | Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp41 measured at Month 1 | 3582.8 Net MFI |
| Part A, Group 2: Vaccine | Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp70-TV1.21 V1V2 measured at Month 1 | 183.6 Net MFI |
| Part A, Group 2: Vaccine | Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp70-001428.2.42 V1V2 measured at Month 1 | 1 Net MFI |
| Part A, Group 2: Vaccine | Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp70-CAP210.2.00.E8 V1V2 measured at Month 1 | 65.2 Net MFI |
| Part A, Group 2: Vaccine | Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | Con S gp140 CFI measured at Month 1 | 272.1 Net MFI |
| Part A, Group 2: Vaccine | Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp70-Du156.12 V1V2 measured at Month 1 | 1 Net MFI |
| Part A, Group 2: Vaccine | Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | Du156_D11gp120.avi/293F measured at Month 1 | 7.9 Net MFI |
| Part A, Group 2: Vaccine | Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | TV1c8_D11gp120.avi/293F measured at Month 1 | 1 Net MFI |
| Part A, Group 2: Vaccine | Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | CAP210_D11gp120.avi/293F measured at Month 1 | 81.9 Net MFI |
| Part A, Group 2: Vaccine | Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp70-ConC V1V2 measured at Month 1 | 1 Net MFI |
| Part A, Group 2: Vaccine | Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp70-1012.11.TC21.3257 V1V2 measured at Month 1 | 1 Net MFI |
| Part A, Group 2: Vaccine | Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp70-1051.12.C22 V1V2 measured at Month 1 | 1 Net MFI |
| Part A, Group 2: Vaccine | Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | 1641A7_D11gp120.avi/293F measured at Month 1 | 25.1 Net MFI |
| Part A, Group 2: Vaccine | Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp70-Ce704010042_2ES V1V2 measured at Month 1 | 1 Net MFI |
| Part A, Group 3: Placebo | Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | 1086C_D7gp120.avi/293F measured at Month 1 | 1 Net MFI |
| Part A, Group 3: Placebo | Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | CAP45_D11gp120.avi/293F measured at Month 1 | 1 Net MFI |
| Part A, Group 3: Placebo | Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp70-CAP210.2.00.E8 V1V2 measured at Month 1 | 1 Net MFI |
| Part A, Group 3: Placebo | Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp70-Du156.12 V1V2 measured at Month 1 | 1 Net MFI |
| Part A, Group 3: Placebo | Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | CH505TFD8N156KN160K_avi/293i Mon measured at Month 1 | 1 Net MFI |
| Part A, Group 3: Placebo | Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | 1641A7_D11gp120.avi/293F measured at Month 1 | 1 Net MFI |
| Part A, Group 3: Placebo | Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | 1394C9_G1.D11gp120.avi measured at Month 1 | 1 Net MFI |
| Part A, Group 3: Placebo | Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | CH505TF D7gp120d371_avi/293F/Mon measured at Month 1 | 1 Net MFI |
| Part A, Group 3: Placebo | Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp70-96ZM651.02 V1v2 measured at Month 1 | 1 Net MFI |
| Part A, Group 3: Placebo | Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | CH0505_CON D7gp120_avi/293F/Mon measured at Month 1 | 1 Net MFI |
| Part A, Group 3: Placebo | Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp70-Ce704010042_2ES V1V2 measured at Month 1 | 1 Net MFI |
| Part A, Group 3: Placebo | Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | 1428_D11gp120.avi/293F measured at Month 1 | 1 Net MFI |
| Part A, Group 3: Placebo | Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp70-CAP45.2.00.G3 V1V2 measured at Month 1 | 1 Net MFI |
| Part A, Group 3: Placebo | Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp70-Ce1086_B2 V1V2 measured at Month 1 | 1 Net MFI |
| Part A, Group 3: Placebo | Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp70-7060101641 V1V2 measured at Month 1 | 1 Net MFI |
| Part A, Group 3: Placebo | Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp70-1051.12.C22 V1V2 measured at Month 1 | 1 Net MFI |
| Part A, Group 3: Placebo | Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp70-001428.2.42 V1V2 measured at Month 1 | 1 Net MFI |
| Part A, Group 3: Placebo | Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | CAP210_D11gp120.avi/293F measured at Month 1 | 1 Net MFI |
| Part A, Group 3: Placebo | Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp70-ConC V1V2 measured at Month 1 | 1 Net MFI |
| Part A, Group 3: Placebo | Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | TV1c8_D11gp120.avi/293F measured at Month 1 | 1 Net MFI |
| Part A, Group 3: Placebo | Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp70_CH505TF_V1V2_N156KN160K_avi/293F measured at Month 1 | 1 Net MFI |
| Part A, Group 3: Placebo | Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | 96ZM651.D11gp120.avi measured at Month 1 | 1 Net MFI |
| Part A, Group 3: Placebo | Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp70-TV1.21 V1V2 measured at Month 1 | 1 Net MFI |
| Part A, Group 3: Placebo | Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | Du156_D11gp120.avi/293F measured at Month 1 | 1 Net MFI |
| Part A, Group 3: Placebo | Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp70-Ce1176 V1V2 measured at Month 1 | 1 Net MFI |
| Part A, Group 3: Placebo | Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp41 measured at Month 1 | 2214.9 Net MFI |
| Part A, Group 3: Placebo | Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp70-BF1266_431a_V1V2 measured at Month 1 | 1 Net MFI |
| Part A, Group 3: Placebo | Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | Con S gp140 CFI measured at Month 1 | 8.6 Net MFI |
| Part A, Group 3: Placebo | Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | Con 6 gp120/B measured at Month 1 | 1 Net MFI |
| Part A, Group 3: Placebo | Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp70-1394C9G1 V1V2 measured at Month 1 | 22.9 Net MFI |
| Part A, Group 3: Placebo | Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp70-1012.11.TC21.3257 V1V2 measured at Month 1 | 1 Net MFI |
| Part A, Group 3: Placebo | Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp70_CH505TF_V1V2_avi/293F measured at Month 1 | 1 Net MFI |
| Part A, Group 3: Placebo | Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | Ce0042_D11gp120.avi/293F measured at Month 1 | 23.9 Net MFI |
| Part B, Group 4: Vaccine | Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp70-ConC V1V2 measured at Month 1 | 1 Net MFI |
| Part B, Group 4: Vaccine | Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | 1394C9_G1.D11gp120.avi measured at Month 1 | 22.2 Net MFI |
| Part B, Group 4: Vaccine | Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | 1641A7_D11gp120.avi/293F measured at Month 1 | 238.6 Net MFI |
| Part B, Group 4: Vaccine | Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | 96ZM651.D11gp120.avi measured at Month 1 | 497.1 Net MFI |
| Part B, Group 4: Vaccine | Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | CAP210_D11gp120.avi/293F measured at Month 1 | 291.5 Net MFI |
| Part B, Group 4: Vaccine | Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | CAP45_D11gp120.avi/293F measured at Month 1 | 89.6 Net MFI |
| Part B, Group 4: Vaccine | Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | CH0505_CON D7gp120_avi/293F/Mon measured at Month 1 | 137 Net MFI |
| Part B, Group 4: Vaccine | Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | Ce0042_D11gp120.avi/293F measured at Month 1 | 167.2 Net MFI |
| Part B, Group 4: Vaccine | Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | Con 6 gp120/B measured at Month 1 | 36.5 Net MFI |
| Part B, Group 4: Vaccine | Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | Du156_D11gp120.avi/293F measured at Month 1 | 615.2 Net MFI |
| Part B, Group 4: Vaccine | Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | TV1c8_D11gp120.avi/293F measured at Month 1 | 1227.5 Net MFI |
| Part B, Group 4: Vaccine | Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp70-BF1266_431a_V1V2 measured at Month 1 | 1 Net MFI |
| Part B, Group 4: Vaccine | Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | CH505TFD8N156KN160K_avi/293i Mon measured at Month 1 | 124.5 Net MFI |
| Part B, Group 4: Vaccine | Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | Con S gp140 CFI measured at Month 1 | 3530.2 Net MFI |
| Part B, Group 4: Vaccine | Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp41 measured at Month 1 | 22000 Net MFI |
| Part B, Group 4: Vaccine | Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp70-001428.2.42 V1V2 measured at Month 1 | 1 Net MFI |
| Part B, Group 4: Vaccine | Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp70-1012.11.TC21.3257 V1V2 measured at Month 1 | 1 Net MFI |
| Part B, Group 4: Vaccine | Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp70-1051.12.C22 V1V2 measured at Month 1 | 1 Net MFI |
| Part B, Group 4: Vaccine | Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp70-1394C9G1 V1V2 measured at Month 1 | 1 Net MFI |
| Part B, Group 4: Vaccine | Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp70-7060101641 V1V2 measured at Month 1 | 1 Net MFI |
| Part B, Group 4: Vaccine | Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp70-96ZM651.02 V1v2 measured at Month 1 | 679.8 Net MFI |
| Part B, Group 4: Vaccine | Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp70-CAP210.2.00.E8 V1V2 measured at Month 1 | 1 Net MFI |
| Part B, Group 4: Vaccine | Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp70-CAP45.2.00.G3 V1V2 measured at Month 1 | 1 Net MFI |
| Part B, Group 4: Vaccine | Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp70-Ce1086_B2 V1V2 measured at Month 1 | 6.5 Net MFI |
| Part B, Group 4: Vaccine | Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp70-Ce1176 V1V2 measured at Month 1 | 1 Net MFI |
| Part B, Group 4: Vaccine | Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp70-Ce704010042_2ES V1V2 measured at Month 1 | 1 Net MFI |
| Part B, Group 4: Vaccine | Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp70-Du156.12 V1V2 measured at Month 1 | 1 Net MFI |
| Part B, Group 4: Vaccine | Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp70-TV1.21 V1V2 measured at Month 1 | 1 Net MFI |
| Part B, Group 4: Vaccine | Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp70_CH505TF_V1V2_N156KN160K_avi/293F measured at Month 1 | 1 Net MFI |
| Part B, Group 4: Vaccine | Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp70_CH505TF_V1V2_avi/293F measured at Month 1 | 1 Net MFI |
| Part B, Group 4: Vaccine | Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | 1086C_D7gp120.avi/293F measured at Month 1 | 371.8 Net MFI |
| Part B, Group 4: Vaccine | Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | 1428_D11gp120.avi/293F measured at Month 1 | 178.6 Net MFI |
| Part B, Group 4: Vaccine | Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | CH505TF D7gp120d371_avi/293F/Mon measured at Month 1 | 136.1 Net MFI |
| Part B, Group 5: Vaccine | Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp70-1051.12.C22 V1V2 measured at Month 1 | 41.6 Net MFI |
| Part B, Group 5: Vaccine | Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | Du156_D11gp120.avi/293F measured at Month 1 | 14 Net MFI |
| Part B, Group 5: Vaccine | Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | 1641A7_D11gp120.avi/293F measured at Month 1 | 23 Net MFI |
| Part B, Group 5: Vaccine | Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp70-ConC V1V2 measured at Month 1 | 1 Net MFI |
| Part B, Group 5: Vaccine | Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | CAP210_D11gp120.avi/293F measured at Month 1 | 1 Net MFI |
| Part B, Group 5: Vaccine | Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | Con 6 gp120/B measured at Month 1 | 1 Net MFI |
| Part B, Group 5: Vaccine | Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp70-Ce1176 V1V2 measured at Month 1 | 232.2 Net MFI |
| Part B, Group 5: Vaccine | Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | 1394C9_G1.D11gp120.avi measured at Month 1 | 40.9 Net MFI |
| Part B, Group 5: Vaccine | Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp70_CH505TF_V1V2_avi/293F measured at Month 1 | 929.6 Net MFI |
| Part B, Group 5: Vaccine | Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | Con S gp140 CFI measured at Month 1 | 650.2 Net MFI |
| Part B, Group 5: Vaccine | Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | Ce0042_D11gp120.avi/293F measured at Month 1 | 109.2 Net MFI |
| Part B, Group 5: Vaccine | Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp70_CH505TF_V1V2_N156KN160K_avi/293F measured at Month 1 | 62.2 Net MFI |
| Part B, Group 5: Vaccine | Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | CH505TFD8N156KN160K_avi/293i Mon measured at Month 1 | 1 Net MFI |
| Part B, Group 5: Vaccine | Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | CH505TF D7gp120d371_avi/293F/Mon measured at Month 1 | 1 Net MFI |
| Part B, Group 5: Vaccine | Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | 1086C_D7gp120.avi/293F measured at Month 1 | 164.5 Net MFI |
| Part B, Group 5: Vaccine | Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | 96ZM651.D11gp120.avi measured at Month 1 | 27 Net MFI |
| Part B, Group 5: Vaccine | Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | CH0505_CON D7gp120_avi/293F/Mon measured at Month 1 | 1 Net MFI |
| Part B, Group 5: Vaccine | Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp70-Du156.12 V1V2 measured at Month 1 | 1 Net MFI |
| Part B, Group 5: Vaccine | Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp70-Ce704010042_2ES V1V2 measured at Month 1 | 1 Net MFI |
| Part B, Group 5: Vaccine | Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | CAP45_D11gp120.avi/293F measured at Month 1 | 41.8 Net MFI |
| Part B, Group 5: Vaccine | Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp70-7060101641 V1V2 measured at Month 1 | 1 Net MFI |
| Part B, Group 5: Vaccine | Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | 1428_D11gp120.avi/293F measured at Month 1 | 3 Net MFI |
| Part B, Group 5: Vaccine | Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp41 measured at Month 1 | 13128 Net MFI |
| Part B, Group 5: Vaccine | Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp70-CAP210.2.00.E8 V1V2 measured at Month 1 | 263.5 Net MFI |
| Part B, Group 5: Vaccine | Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp70-1012.11.TC21.3257 V1V2 measured at Month 1 | 79 Net MFI |
| Part B, Group 5: Vaccine | Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp70-BF1266_431a_V1V2 measured at Month 1 | 166.5 Net MFI |
| Part B, Group 5: Vaccine | Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp70-1394C9G1 V1V2 measured at Month 1 | 1 Net MFI |
| Part B, Group 5: Vaccine | Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp70-CAP45.2.00.G3 V1V2 measured at Month 1 | 1 Net MFI |
| Part B, Group 5: Vaccine | Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp70-TV1.21 V1V2 measured at Month 1 | 1173 Net MFI |
| Part B, Group 5: Vaccine | Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp70-001428.2.42 V1V2 measured at Month 1 | 1 Net MFI |
| Part B, Group 5: Vaccine | Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp70-96ZM651.02 V1v2 measured at Month 1 | 365.2 Net MFI |
| Part B, Group 5: Vaccine | Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | TV1c8_D11gp120.avi/293F measured at Month 1 | 20.6 Net MFI |
| Part B, Group 5: Vaccine | Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp70-Ce1086_B2 V1V2 measured at Month 1 | 1 Net MFI |
| Part B, Group 6: Placebo | Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | CAP210_D11gp120.avi/293F measured at Month 1 | 2725.2 Net MFI |
| Part B, Group 6: Placebo | Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp70-Ce1086_B2 V1V2 measured at Month 1 | 1 Net MFI |
| Part B, Group 6: Placebo | Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp70-1394C9G1 V1V2 measured at Month 1 | 1 Net MFI |
| Part B, Group 6: Placebo | Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp70-Ce1176 V1V2 measured at Month 1 | 1 Net MFI |
| Part B, Group 6: Placebo | Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp70-1051.12.C22 V1V2 measured at Month 1 | 1 Net MFI |
| Part B, Group 6: Placebo | Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp70-1012.11.TC21.3257 V1V2 measured at Month 1 | 1 Net MFI |
| Part B, Group 6: Placebo | Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | 96ZM651.D11gp120.avi measured at Month 1 | 1 Net MFI |
| Part B, Group 6: Placebo | Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp70-Ce704010042_2ES V1V2 measured at Month 1 | 1 Net MFI |
| Part B, Group 6: Placebo | Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp70-001428.2.42 V1V2 measured at Month 1 | 1 Net MFI |
| Part B, Group 6: Placebo | Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | 1086C_D7gp120.avi/293F measured at Month 1 | 8.1 Net MFI |
| Part B, Group 6: Placebo | Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp70-ConC V1V2 measured at Month 1 | 1 Net MFI |
| Part B, Group 6: Placebo | Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | Con S gp140 CFI measured at Month 1 | 575 Net MFI |
| Part B, Group 6: Placebo | Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp70-Du156.12 V1V2 measured at Month 1 | 1 Net MFI |
| Part B, Group 6: Placebo | Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp41 measured at Month 1 | 1268.5 Net MFI |
| Part B, Group 6: Placebo | Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | TV1c8_D11gp120.avi/293F measured at Month 1 | 152 Net MFI |
| Part B, Group 6: Placebo | Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | 1641A7_D11gp120.avi/293F measured at Month 1 | 92.5 Net MFI |
| Part B, Group 6: Placebo | Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp70-TV1.21 V1V2 measured at Month 1 | 15.8 Net MFI |
| Part B, Group 6: Placebo | Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | Du156_D11gp120.avi/293F measured at Month 1 | 62 Net MFI |
| Part B, Group 6: Placebo | Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp70_CH505TF_V1V2_N156KN160K_avi/293F measured at Month 1 | 79.2 Net MFI |
| Part B, Group 6: Placebo | Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | Con 6 gp120/B measured at Month 1 | 12 Net MFI |
| Part B, Group 6: Placebo | Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | Ce0042_D11gp120.avi/293F measured at Month 1 | 365.6 Net MFI |
| Part B, Group 6: Placebo | Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp70_CH505TF_V1V2_avi/293F measured at Month 1 | 283.2 Net MFI |
| Part B, Group 6: Placebo | Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | CH505TFD8N156KN160K_avi/293i Mon measured at Month 1 | 1 Net MFI |
| Part B, Group 6: Placebo | Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | CH0505_CON D7gp120_avi/293F/Mon measured at Month 1 | 3306.9 Net MFI |
| Part B, Group 6: Placebo | Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | 1394C9_G1.D11gp120.avi measured at Month 1 | 1 Net MFI |
| Part B, Group 6: Placebo | Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | CAP45_D11gp120.avi/293F measured at Month 1 | 345.8 Net MFI |
| Part B, Group 6: Placebo | Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | CH505TF D7gp120d371_avi/293F/Mon measured at Month 1 | 3192 Net MFI |
| Part B, Group 6: Placebo | Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp70-CAP210.2.00.E8 V1V2 measured at Month 1 | 1 Net MFI |
| Part B, Group 6: Placebo | Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp70-BF1266_431a_V1V2 measured at Month 1 | 1 Net MFI |
| Part B, Group 6: Placebo | Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | 1428_D11gp120.avi/293F measured at Month 1 | 1874 Net MFI |
| Part B, Group 6: Placebo | Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp70-CAP45.2.00.G3 V1V2 measured at Month 1 | 1 Net MFI |
| Part B, Group 6: Placebo | Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp70-96ZM651.02 V1v2 measured at Month 1 | 1 Net MFI |
| Part B, Group 6: Placebo | Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp70-7060101641 V1V2 measured at Month 1 | 1 Net MFI |
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).
Time frame: Measured at Month 1 for both Part A and Part B
Population: 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
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Part A, Group 1: Vaccine | 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) | DU172.17 at dilution 50, measured at Month 1 | 5 titer |
| Part A, Group 1: Vaccine | 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) | CH505TF at dilution 80, measured at Month 1 | 5 titer |
| Part A, Group 1: Vaccine | 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) | CH505TF at dilution 50, measured at Month 1 | 5 titer |
| Part A, Group 1: Vaccine | 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) | DU172.17 at dilution 80, measured at Month 1 | 5 titer |
| Part A, Group 1: Vaccine | 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) | Du422.1 at dilution 50, measured at Month 1 | 5 titer |
| Part A, Group 1: Vaccine | 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) | Du422.1 at dilution 80, measured at Month 1 | 5 titer |
| Part A, Group 1: Vaccine | 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) | MW965.26 at dilution 50, measured at Month 1 | 5 titer |
| Part A, Group 1: Vaccine | 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) | MW965.26 at dilution 80, measured at Month 1 | 5 titer |
| Part A, Group 2: Vaccine | 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) | DU172.17 at dilution 80, measured at Month 1 | 5 titer |
| Part A, Group 2: Vaccine | 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) | MW965.26 at dilution 80, measured at Month 1 | 5 titer |
| Part A, Group 2: Vaccine | 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) | CH505TF at dilution 50, measured at Month 1 | 5 titer |
| Part A, Group 2: Vaccine | 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) | MW965.26 at dilution 50, measured at Month 1 | 5 titer |
| Part A, Group 2: Vaccine | 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) | Du422.1 at dilution 80, measured at Month 1 | 5 titer |
| Part A, Group 2: Vaccine | 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) | DU172.17 at dilution 50, measured at Month 1 | 5 titer |
| Part A, Group 2: Vaccine | 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) | CH505TF at dilution 80, measured at Month 1 | 5 titer |
| Part A, Group 2: Vaccine | 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) | Du422.1 at dilution 50, measured at Month 1 | 5 titer |
| Part A, Group 3: Placebo | 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) | CH505TF at dilution 80, measured at Month 1 | 5 titer |
| Part A, Group 3: Placebo | 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) | DU172.17 at dilution 50, measured at Month 1 | 5 titer |
| Part A, Group 3: Placebo | 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) | DU172.17 at dilution 80, measured at Month 1 | 5 titer |
| Part A, Group 3: Placebo | 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) | MW965.26 at dilution 80, measured at Month 1 | 5 titer |
| Part A, Group 3: Placebo | 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) | Du422.1 at dilution 50, measured at Month 1 | 5 titer |
| Part A, Group 3: Placebo | 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) | Du422.1 at dilution 80, measured at Month 1 | 5 titer |
| Part A, Group 3: Placebo | 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) | MW965.26 at dilution 50, measured at Month 1 | 5 titer |
| Part A, Group 3: Placebo | 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) | CH505TF at dilution 50, measured at Month 1 | 5 titer |
| Part B, Group 4: Vaccine | 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) | MW965.26 at dilution 50, measured at Month 1 | 5 titer |
| Part B, Group 4: Vaccine | 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) | Du422.1 at dilution 80, measured at Month 1 | 5 titer |
| Part B, Group 4: Vaccine | 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) | Du422.1 at dilution 50, measured at Month 1 | 5 titer |
| Part B, Group 4: Vaccine | 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) | CH505TF at dilution 50, measured at Month 1 | 5 titer |
| Part B, Group 4: Vaccine | 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) | DU172.17 at dilution 50, measured at Month 1 | 5 titer |
| Part B, Group 4: Vaccine | 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) | DU172.17 at dilution 80, measured at Month 1 | 5 titer |
| Part B, Group 4: Vaccine | 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) | MW965.26 at dilution 80, measured at Month 1 | 5 titer |
| Part B, Group 4: Vaccine | 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) | CH505TF at dilution 80, measured at Month 1 | 5 titer |
| Part B, Group 5: Vaccine | 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) | MW965.26 at dilution 80, measured at Month 1 | 5 titer |
| Part B, Group 5: Vaccine | 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) | CH505TF at dilution 50, measured at Month 1 | 5 titer |
| Part B, Group 5: Vaccine | 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) | Du422.1 at dilution 50, measured at Month 1 | 5 titer |
| Part B, Group 5: Vaccine | 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) | Du422.1 at dilution 80, measured at Month 1 | 5 titer |
| Part B, Group 5: Vaccine | 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) | MW965.26 at dilution 50, measured at Month 1 | 5 titer |
| Part B, Group 5: Vaccine | 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) | CH505TF at dilution 80, measured at Month 1 | 5 titer |
| Part B, Group 5: Vaccine | 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) | DU172.17 at dilution 50, measured at Month 1 | 5 titer |
| Part B, Group 5: Vaccine | 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) | DU172.17 at dilution 80, measured at Month 1 | 5 titer |
| Part B, Group 6: Placebo | 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) | MW965.26 at dilution 80, measured at Month 1 | 5 titer |
| Part B, Group 6: Placebo | 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) | Du422.1 at dilution 50, measured at Month 1 | 5 titer |
| Part B, Group 6: Placebo | 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) | DU172.17 at dilution 50, measured at Month 1 | 5 titer |
| Part B, Group 6: Placebo | 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) | DU172.17 at dilution 80, measured at Month 1 | 5 titer |
| Part B, Group 6: Placebo | 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) | Du422.1 at dilution 80, measured at Month 1 | 5 titer |
| Part B, Group 6: Placebo | 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) | CH505TF at dilution 80, measured at Month 1 | 5 titer |
| Part B, Group 6: Placebo | 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) | MW965.26 at dilution 50, measured at Month 1 | 5 titer |
| Part B, Group 6: Placebo | 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) | CH505TF at dilution 50, measured at Month 1 | 5 titer |
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
Time frame: Measured at Month 6.5 for Part B
Population: 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
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Part A, Group 1: Vaccine | Part B: HIV-specific Serum IgG Binding Antibodies Magnitude Breadth of AUC by Panel and Treatment Arm Assessed 2 Weeks After the Third Vaccination | Clade C gp70 V1V2 measured at Month 6.5 | 2.33 log10(net MFI) |
| Part A, Group 1: Vaccine | Part B: HIV-specific Serum IgG Binding Antibodies Magnitude Breadth of AUC by Panel and Treatment Arm Assessed 2 Weeks After the Third Vaccination | Clade C gp120 measured at Month 6.5 | 4.34 log10(net MFI) |
| Part A, Group 2: Vaccine | Part B: HIV-specific Serum IgG Binding Antibodies Magnitude Breadth of AUC by Panel and Treatment Arm Assessed 2 Weeks After the Third Vaccination | Clade C gp120 measured at Month 6.5 | 4.22 log10(net MFI) |
| Part A, Group 2: Vaccine | Part B: HIV-specific Serum IgG Binding Antibodies Magnitude Breadth of AUC by Panel and Treatment Arm Assessed 2 Weeks After the Third Vaccination | Clade C gp70 V1V2 measured at Month 6.5 | 2.22 log10(net MFI) |
| Part A, Group 3: Placebo | Part B: HIV-specific Serum IgG Binding Antibodies Magnitude Breadth of AUC by Panel and Treatment Arm Assessed 2 Weeks After the Third Vaccination | Clade C gp120 measured at Month 6.5 | 2 log10(net MFI) |
| Part A, Group 3: Placebo | Part B: HIV-specific Serum IgG Binding Antibodies Magnitude Breadth of AUC by Panel and Treatment Arm Assessed 2 Weeks After the Third Vaccination | Clade C gp70 V1V2 measured at Month 6.5 | 2 log10(net MFI) |
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
Time frame: Measured at Month 4 for Part B
Population: 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
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Part A, Group 1: Vaccine | Part B: HIV-specific Serum IgG Binding Antibodies Magnitude Breadth of AUC by Panel and Treatment Arm Assessed 4 Weeks After the Second Vaccination | Clade C gp120 measured at Month 4 | 2.94 log10(net MFI) |
| Part A, Group 1: Vaccine | Part B: HIV-specific Serum IgG Binding Antibodies Magnitude Breadth of AUC by Panel and Treatment Arm Assessed 4 Weeks After the Second Vaccination | Clade C gp70 V1V2 measured at Month 4 | 2 log10(net MFI) |
| Part A, Group 2: Vaccine | Part B: HIV-specific Serum IgG Binding Antibodies Magnitude Breadth of AUC by Panel and Treatment Arm Assessed 4 Weeks After the Second Vaccination | Clade C gp120 measured at Month 4 | 2.64 log10(net MFI) |
| Part A, Group 2: Vaccine | Part B: HIV-specific Serum IgG Binding Antibodies Magnitude Breadth of AUC by Panel and Treatment Arm Assessed 4 Weeks After the Second Vaccination | Clade C gp70 V1V2 measured at Month 4 | 2.05 log10(net MFI) |
| Part A, Group 3: Placebo | Part B: HIV-specific Serum IgG Binding Antibodies Magnitude Breadth of AUC by Panel and Treatment Arm Assessed 4 Weeks After the Second Vaccination | Clade C gp120 measured at Month 4 | 2 log10(net MFI) |
| Part A, Group 3: Placebo | Part B: HIV-specific Serum IgG Binding Antibodies Magnitude Breadth of AUC by Panel and Treatment Arm Assessed 4 Weeks After the Second Vaccination | Clade C gp70 V1V2 measured at Month 4 | 2 log10(net MFI) |
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
Time frame: Measured at Month 6.5 for Part B
Population: 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
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Part A, Group 1: Vaccine | 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 | ENV-2-PTEG-SEQ for CD8+ T Cells, measured at Month 6.5 | 0.012 Percentage of cells |
| Part A, Group 1: Vaccine | 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 | ENV-1-PTEG-SEQ for CD4+ T Cells, measured at Month 6.5 | 0.1 Percentage of cells |
| Part A, Group 1: Vaccine | 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 | Any Env for CD4+ T Cells, measured at Month 6.5 | 0.172 Percentage of cells |
| Part A, Group 1: Vaccine | 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 | Any Env for CD8+ T Cells, measured at Month 6.5 | 0.067 Percentage of cells |
| Part A, Group 1: Vaccine | 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 | ENV-1-PTEG-SEQ for CD8+ T Cells, measured at Month 6.5 | 0.059 Percentage of cells |
| Part A, Group 1: Vaccine | 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 | ENV-2-PTEG-SEQ for CD4+ T Cells, measured at Month 6.5 | 0.072 Percentage of cells |
| Part A, Group 2: Vaccine | 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 | ENV-2-PTEG-SEQ for CD4+ T Cells, measured at Month 6.5 | 0.071 Percentage of cells |
| Part A, Group 2: Vaccine | 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 | Any Env for CD8+ T Cells, measured at Month 6.5 | 0.094 Percentage of cells |
| Part A, Group 2: Vaccine | 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 | ENV-1-PTEG-SEQ for CD8+ T Cells, measured at Month 6.5 | 0.065 Percentage of cells |
| Part A, Group 2: Vaccine | 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 | ENV-1-PTEG-SEQ for CD4+ T Cells, measured at Month 6.5 | 0.158 Percentage of cells |
| Part A, Group 2: Vaccine | 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 | ENV-2-PTEG-SEQ for CD8+ T Cells, measured at Month 6.5 | 0.03 Percentage of cells |
| Part A, Group 2: Vaccine | 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 | Any Env for CD4+ T Cells, measured at Month 6.5 | 0.257 Percentage of cells |
| Part A, Group 3: Placebo | 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 | ENV-2-PTEG-SEQ for CD8+ T Cells, measured at Month 6.5 | 0.001 Percentage of cells |
| Part A, Group 3: Placebo | 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 | Any Env for CD4+ T Cells, measured at Month 6.5 | 0.007 Percentage of cells |
| Part A, Group 3: Placebo | 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 | ENV-1-PTEG-SEQ for CD4+ T Cells, measured at Month 6.5 | 0.007 Percentage of cells |
| Part A, Group 3: Placebo | 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 | Any Env for CD8+ T Cells, measured at Month 6.5 | 0.002 Percentage of cells |
| Part A, Group 3: Placebo | 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 | ENV-2-PTEG-SEQ for CD4+ T Cells, measured at Month 6.5 | 0.001 Percentage of cells |
| Part A, Group 3: Placebo | 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 | ENV-1-PTEG-SEQ for CD8+ T Cells, measured at Month 6.5 | 0.002 Percentage of cells |
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
Time frame: Measured at Month 4 for Part B
Population: 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
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Part A, Group 1: Vaccine | 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 | Any Env for CD4+ T Cells, measured at Month 4 | 0.049 Percentage of cells |
| Part A, Group 1: Vaccine | 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 | Any Env for CD8+ T Cells, measured at Month 4 | 0.091 Percentage of cells |
| Part A, Group 1: Vaccine | 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 | ENV-1-PTEG-SEQ for CD4+ T Cells, measured at Month 4 | 0.031 Percentage of cells |
| Part A, Group 1: Vaccine | 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 | ENV-1-PTEG-SEQ for CD8+ T Cells, measured at Month 4 | 0.043 Percentage of cells |
| Part A, Group 1: Vaccine | 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 | ENV-2-PTEG-SEQ for CD4+ T Cells, measured at Month 4 | 0.024 Percentage of cells |
| Part A, Group 1: Vaccine | 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 | ENV-2-PTEG-SEQ for CD8+ T Cells, measured at Month 4 | 0.011 Percentage of cells |
| Part A, Group 2: Vaccine | 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 | ENV-2-PTEG-SEQ for CD8+ T Cells, measured at Month 4 | 0.03 Percentage of cells |
| Part A, Group 2: Vaccine | 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 | Any Env for CD4+ T Cells, measured at Month 4 | 0.09 Percentage of cells |
| Part A, Group 2: Vaccine | 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 | ENV-1-PTEG-SEQ for CD8+ T Cells, measured at Month 4 | 0.074 Percentage of cells |
| Part A, Group 2: Vaccine | 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 | ENV-2-PTEG-SEQ for CD4+ T Cells, measured at Month 4 | 0.04 Percentage of cells |
| Part A, Group 2: Vaccine | 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 | Any Env for CD8+ T Cells, measured at Month 4 | 0.11 Percentage of cells |
| Part A, Group 2: Vaccine | 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 | ENV-1-PTEG-SEQ for CD4+ T Cells, measured at Month 4 | 0.046 Percentage of cells |
| Part A, Group 3: Placebo | 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 | Any Env for CD8+ T Cells, measured at Month 4 | 0.011 Percentage of cells |
| Part A, Group 3: Placebo | 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 | ENV-1-PTEG-SEQ for CD4+ T Cells, measured at Month 4 | 0.004 Percentage of cells |
| Part A, Group 3: Placebo | 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 | ENV-2-PTEG-SEQ for CD8+ T Cells, measured at Month 4 | 0.006 Percentage of cells |
| Part A, Group 3: Placebo | 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 | ENV-1-PTEG-SEQ for CD8+ T Cells, measured at Month 4 | 0.005 Percentage of cells |
| Part A, Group 3: Placebo | 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 | Any Env for CD4+ T Cells, measured at Month 4 | 0.009 Percentage of cells |
| Part A, Group 3: Placebo | 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 | ENV-2-PTEG-SEQ for CD4+ T Cells, measured at Month 4 | 0.005 Percentage of cells |
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).
Time frame: Measured at Month 6.5 for Part B
Population: 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
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Part A, Group 1: Vaccine | Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination | CH505TFD8N156KN160K_avi/293i Mon measured at Month 6.5 | 22000 Net MFI |
| Part A, Group 1: Vaccine | Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination | 1394C9_G1.D11gp120.avi measured at Month 6.5 | 20251.9 Net MFI |
| Part A, Group 1: Vaccine | Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination | gp70-BF1266_431a_V1V2 measured at Month 6.5 | 1508.5 Net MFI |
| Part A, Group 1: Vaccine | Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination | Ce0042_D11gp120.avi/293F measured at Month 6.5 | 22000 Net MFI |
| Part A, Group 1: Vaccine | Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination | gp70-TV1.21 V1V2 measured at Month 6.5 | 863 Net MFI |
| Part A, Group 1: Vaccine | Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination | gp70-1394C9G1 V1V2 measured at Month 6.5 | 1375.8 Net MFI |
| Part A, Group 1: Vaccine | Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination | Con 6 gp120/B measured at Month 6.5 | 22000 Net MFI |
| Part A, Group 1: Vaccine | Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination | 1428_D11gp120.avi/293F measured at Month 6.5 | 22000 Net MFI |
| Part A, Group 1: Vaccine | Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination | gp70-1051.12.C22 V1V2 measured at Month 6.5 | 283.2 Net MFI |
| Part A, Group 1: Vaccine | Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination | Con S gp140 CFI measured at Month 6.5 | 22000 Net MFI |
| Part A, Group 1: Vaccine | Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination | TV1c8_D11gp120.avi/293F measured at Month 6.5 | 22000 Net MFI |
| Part A, Group 1: Vaccine | Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination | gp70-1012.11.TC21.3257 V1V2 measured at Month 6.5 | 344 Net MFI |
| Part A, Group 1: Vaccine | Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination | Du156_D11gp120.avi/293F measured at Month 6.5 | 22000 Net MFI |
| Part A, Group 1: Vaccine | Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination | gp70-Du156.12 V1V2 measured at Month 6.5 | 1 Net MFI |
| Part A, Group 1: Vaccine | Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination | gp41 measured at Month 6.5 | 11919.2 Net MFI |
| Part A, Group 1: Vaccine | Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination | 1641A7_D11gp120.avi/293F measured at Month 6.5 | 22000 Net MFI |
| Part A, Group 1: Vaccine | Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination | gp70_CH505TF_V1V2_avi/293F measured at Month 6.5 | 1721.8 Net MFI |
| Part A, Group 1: Vaccine | Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination | gp70-ConC V1V2 measured at Month 6.5 | 66.8 Net MFI |
| Part A, Group 1: Vaccine | Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination | 96ZM651.D11gp120.avi measured at Month 6.5 | 22000 Net MFI |
| Part A, Group 1: Vaccine | Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination | gp70-7060101641 V1V2 measured at Month 6.5 | 126.5 Net MFI |
| Part A, Group 1: Vaccine | Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination | gp70-Ce704010042_2ES V1V2 measured at Month 6.5 | 1 Net MFI |
| Part A, Group 1: Vaccine | Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination | CAP210_D11gp120.avi/293F measured at Month 6.5 | 22000 Net MFI |
| Part A, Group 1: Vaccine | Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination | gp70-96ZM651.02 V1v2 measured at Month 6.5 | 614.8 Net MFI |
| Part A, Group 1: Vaccine | Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination | gp70-Ce1176 V1V2 measured at Month 6.5 | 1 Net MFI |
| Part A, Group 1: Vaccine | Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination | CAP45_D11gp120.avi/293F measured at Month 6.5 | 22000 Net MFI |
| Part A, Group 1: Vaccine | Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination | 1086C_D7gp120.avi/293F measured at Month 6.5 | 22000 Net MFI |
| Part A, Group 1: Vaccine | Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination | gp70-Ce1086_B2 V1V2 measured at Month 6.5 | 262.5 Net MFI |
| Part A, Group 1: Vaccine | Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination | CH0505_CON D7gp120_avi/293F/Mon measured at Month 6.5 | 22000 Net MFI |
| Part A, Group 1: Vaccine | Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination | gp70-001428.2.42 V1V2 measured at Month 6.5 | 81.8 Net MFI |
| Part A, Group 1: Vaccine | Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination | gp70-CAP45.2.00.G3 V1V2 measured at Month 6.5 | 1 Net MFI |
| Part A, Group 1: Vaccine | Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination | CH505TF D7gp120d371_avi/293F/Mon measured at Month 6.5 | 22000 Net MFI |
| Part A, Group 1: Vaccine | Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination | gp70_CH505TF_V1V2_N156KN160K_avi/293F measured at Month 6.5 | 623.8 Net MFI |
| Part A, Group 1: Vaccine | Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination | gp70-CAP210.2.00.E8 V1V2 measured at Month 6.5 | 1 Net MFI |
| Part A, Group 2: Vaccine | Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination | Ce0042_D11gp120.avi/293F measured at Month 6.5 | 11018.1 Net MFI |
| Part A, Group 2: Vaccine | Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination | gp70-001428.2.42 V1V2 measured at Month 6.5 | 496 Net MFI |
| Part A, Group 2: Vaccine | Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination | 1086C_D7gp120.avi/293F measured at Month 6.5 | 22000 Net MFI |
| Part A, Group 2: Vaccine | Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination | 1428_D11gp120.avi/293F measured at Month 6.5 | 22000 Net MFI |
| Part A, Group 2: Vaccine | Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination | 1641A7_D11gp120.avi/293F measured at Month 6.5 | 22000 Net MFI |
| Part A, Group 2: Vaccine | Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination | 96ZM651.D11gp120.avi measured at Month 6.5 | 22000 Net MFI |
| Part A, Group 2: Vaccine | Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination | CAP210_D11gp120.avi/293F measured at Month 6.5 | 22000 Net MFI |
| Part A, Group 2: Vaccine | Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination | CAP45_D11gp120.avi/293F measured at Month 6.5 | 13516.5 Net MFI |
| Part A, Group 2: Vaccine | Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination | CH0505_CON D7gp120_avi/293F/Mon measured at Month 6.5 | 22000 Net MFI |
| Part A, Group 2: Vaccine | Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination | CH505TF D7gp120d371_avi/293F/Mon measured at Month 6.5 | 22000 Net MFI |
| Part A, Group 2: Vaccine | Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination | CH505TFD8N156KN160K_avi/293i Mon measured at Month 6.5 | 22000 Net MFI |
| Part A, Group 2: Vaccine | Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination | 1394C9_G1.D11gp120.avi measured at Month 6.5 | 5330.2 Net MFI |
| Part A, Group 2: Vaccine | Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination | Con 6 gp120/B measured at Month 6.5 | 21599.8 Net MFI |
| Part A, Group 2: Vaccine | Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination | Con S gp140 CFI measured at Month 6.5 | 22000 Net MFI |
| Part A, Group 2: Vaccine | Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination | Du156_D11gp120.avi/293F measured at Month 6.5 | 22000 Net MFI |
| Part A, Group 2: Vaccine | Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination | TV1c8_D11gp120.avi/293F measured at Month 6.5 | 22000 Net MFI |
| Part A, Group 2: Vaccine | Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination | gp41 measured at Month 6.5 | 22000 Net MFI |
| Part A, Group 2: Vaccine | Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination | gp70-1012.11.TC21.3257 V1V2 measured at Month 6.5 | 601.8 Net MFI |
| Part A, Group 2: Vaccine | Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination | gp70-1051.12.C22 V1V2 measured at Month 6.5 | 399.8 Net MFI |
| Part A, Group 2: Vaccine | Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination | gp70-1394C9G1 V1V2 measured at Month 6.5 | 1141.5 Net MFI |
| Part A, Group 2: Vaccine | Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination | gp70-7060101641 V1V2 measured at Month 6.5 | 196.6 Net MFI |
| Part A, Group 2: Vaccine | Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination | gp70-96ZM651.02 V1v2 measured at Month 6.5 | 1780.1 Net MFI |
| Part A, Group 2: Vaccine | Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination | gp70-BF1266_431a_V1V2 measured at Month 6.5 | 491.2 Net MFI |
| Part A, Group 2: Vaccine | Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination | gp70-CAP210.2.00.E8 V1V2 measured at Month 6.5 | 1032.4 Net MFI |
| Part A, Group 2: Vaccine | Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination | gp70-CAP45.2.00.G3 V1V2 measured at Month 6.5 | 89.9 Net MFI |
| Part A, Group 2: Vaccine | Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination | gp70-Ce1086_B2 V1V2 measured at Month 6.5 | 864.4 Net MFI |
| Part A, Group 2: Vaccine | Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination | gp70-Ce1176 V1V2 measured at Month 6.5 | 572.9 Net MFI |
| Part A, Group 2: Vaccine | Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination | gp70-Ce704010042_2ES V1V2 measured at Month 6.5 | 1 Net MFI |
| Part A, Group 2: Vaccine | Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination | gp70-ConC V1V2 measured at Month 6.5 | 161.8 Net MFI |
| Part A, Group 2: Vaccine | Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination | gp70-Du156.12 V1V2 measured at Month 6.5 | 1 Net MFI |
| Part A, Group 2: Vaccine | Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination | gp70-TV1.21 V1V2 measured at Month 6.5 | 694 Net MFI |
| Part A, Group 2: Vaccine | Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination | gp70_CH505TF_V1V2_N156KN160K_avi/293F measured at Month 6.5 | 445.8 Net MFI |
| Part A, Group 2: Vaccine | Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination | gp70_CH505TF_V1V2_avi/293F measured at Month 6.5 | 2548 Net MFI |
| Part A, Group 3: Placebo | Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination | CH505TFD8N156KN160K_avi/293i Mon measured at Month 6.5 | 1 Net MFI |
| Part A, Group 3: Placebo | Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination | gp70_CH505TF_V1V2_N156KN160K_avi/293F measured at Month 6.5 | 71 Net MFI |
| Part A, Group 3: Placebo | Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination | gp70-BF1266_431a_V1V2 measured at Month 6.5 | 1 Net MFI |
| Part A, Group 3: Placebo | Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination | CH505TF D7gp120d371_avi/293F/Mon measured at Month 6.5 | 2626.6 Net MFI |
| Part A, Group 3: Placebo | Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination | gp70-Du156.12 V1V2 measured at Month 6.5 | 7.2 Net MFI |
| Part A, Group 3: Placebo | Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination | gp70-CAP210.2.00.E8 V1V2 measured at Month 6.5 | 1 Net MFI |
| Part A, Group 3: Placebo | Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination | CH0505_CON D7gp120_avi/293F/Mon measured at Month 6.5 | 2943.4 Net MFI |
| Part A, Group 3: Placebo | Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination | 1394C9_G1.D11gp120.avi measured at Month 6.5 | 6 Net MFI |
| Part A, Group 3: Placebo | Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination | gp70-CAP45.2.00.G3 V1V2 measured at Month 6.5 | 1 Net MFI |
| Part A, Group 3: Placebo | Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination | CAP45_D11gp120.avi/293F measured at Month 6.5 | 234.4 Net MFI |
| Part A, Group 3: Placebo | Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination | gp70-1394C9G1 V1V2 measured at Month 6.5 | 1 Net MFI |
| Part A, Group 3: Placebo | Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination | gp70-Ce1086_B2 V1V2 measured at Month 6.5 | 1 Net MFI |
| Part A, Group 3: Placebo | Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination | CAP210_D11gp120.avi/293F measured at Month 6.5 | 2226.2 Net MFI |
| Part A, Group 3: Placebo | Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination | gp70-TV1.21 V1V2 measured at Month 6.5 | 1 Net MFI |
| Part A, Group 3: Placebo | Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination | gp70-Ce1176 V1V2 measured at Month 6.5 | 1 Net MFI |
| Part A, Group 3: Placebo | Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination | 96ZM651.D11gp120.avi measured at Month 6.5 | 1 Net MFI |
| Part A, Group 3: Placebo | Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination | TV1c8_D11gp120.avi/293F measured at Month 6.5 | 113.9 Net MFI |
| Part A, Group 3: Placebo | Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination | Du156_D11gp120.avi/293F measured at Month 6.5 | 55.6 Net MFI |
| Part A, Group 3: Placebo | Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination | 1086C_D7gp120.avi/293F measured at Month 6.5 | 13.5 Net MFI |
| Part A, Group 3: Placebo | Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination | gp41 measured at Month 6.5 | 1415.2 Net MFI |
| Part A, Group 3: Placebo | Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination | gp70-001428.2.42 V1V2 measured at Month 6.5 | 1 Net MFI |
| Part A, Group 3: Placebo | Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination | Con S gp140 CFI measured at Month 6.5 | 417.6 Net MFI |
| Part A, Group 3: Placebo | Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination | gp70-Ce704010042_2ES V1V2 measured at Month 6.5 | 1 Net MFI |
| Part A, Group 3: Placebo | Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination | gp70-1012.11.TC21.3257 V1V2 measured at Month 6.5 | 1 Net MFI |
| Part A, Group 3: Placebo | Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination | Con 6 gp120/B measured at Month 6.5 | 6.9 Net MFI |
| Part A, Group 3: Placebo | Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination | 1641A7_D11gp120.avi/293F measured at Month 6.5 | 70.5 Net MFI |
| Part A, Group 3: Placebo | Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination | gp70-1051.12.C22 V1V2 measured at Month 6.5 | 1 Net MFI |
| Part A, Group 3: Placebo | Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination | Ce0042_D11gp120.avi/293F measured at Month 6.5 | 314.5 Net MFI |
| Part A, Group 3: Placebo | Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination | gp70_CH505TF_V1V2_avi/293F measured at Month 6.5 | 286.5 Net MFI |
| Part A, Group 3: Placebo | Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination | gp70-ConC V1V2 measured at Month 6.5 | 1 Net MFI |
| Part A, Group 3: Placebo | Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination | gp70-7060101641 V1V2 measured at Month 6.5 | 1.9 Net MFI |
| Part A, Group 3: Placebo | Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination | 1428_D11gp120.avi/293F measured at Month 6.5 | 1499.4 Net MFI |
| Part A, Group 3: Placebo | Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination | gp70-96ZM651.02 V1v2 measured at Month 6.5 | 1 Net MFI |
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).
Time frame: Measured at Month 4 for Part B
Population: 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
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Part A, Group 1: Vaccine | Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination | 1394C9_G1.D11gp120.avi measured at Month 4 | 287.2 Net MFI |
| Part A, Group 1: Vaccine | Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination | gp70-BF1266_431a_V1V2 measured at Month 4 | 1 Net MFI |
| Part A, Group 1: Vaccine | Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination | gp70-Du156.12 V1V2 measured at Month 4 | 1 Net MFI |
| Part A, Group 1: Vaccine | Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination | gp70-96ZM651.02 V1v2 measured at Month 4 | 447 Net MFI |
| Part A, Group 1: Vaccine | Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination | Con 6 gp120/B measured at Month 4 | 889 Net MFI |
| Part A, Group 1: Vaccine | Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination | 1428_D11gp120.avi/293F measured at Month 4 | 1886 Net MFI |
| Part A, Group 1: Vaccine | Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination | gp70-7060101641 V1V2 measured at Month 4 | 1 Net MFI |
| Part A, Group 1: Vaccine | Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination | Con S gp140 CFI measured at Month 4 | 22000 Net MFI |
| Part A, Group 1: Vaccine | Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination | Ce0042_D11gp120.avi/293F measured at Month 4 | 561.2 Net MFI |
| Part A, Group 1: Vaccine | Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination | gp70-1394C9G1 V1V2 measured at Month 4 | 7.5 Net MFI |
| Part A, Group 1: Vaccine | Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination | Du156_D11gp120.avi/293F measured at Month 4 | 3444.8 Net MFI |
| Part A, Group 1: Vaccine | Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination | gp70-ConC V1V2 measured at Month 4 | 1 Net MFI |
| Part A, Group 1: Vaccine | Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination | gp70-1051.12.C22 V1V2 measured at Month 4 | 1 Net MFI |
| Part A, Group 1: Vaccine | Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination | TV1c8_D11gp120.avi/293F measured at Month 4 | 5688.5 Net MFI |
| Part A, Group 1: Vaccine | Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination | 1641A7_D11gp120.avi/293F measured at Month 4 | 2174.2 Net MFI |
| Part A, Group 1: Vaccine | Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination | gp70-1012.11.TC21.3257 V1V2 measured at Month 4 | 31.5 Net MFI |
| Part A, Group 1: Vaccine | Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination | gp41 measured at Month 4 | 22000 Net MFI |
| Part A, Group 1: Vaccine | Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination | gp70_CH505TF_V1V2_N156KN160K_avi/293F measured at Month 4 | 1 Net MFI |
| Part A, Group 1: Vaccine | Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination | gp70-001428.2.42 V1V2 measured at Month 4 | 1 Net MFI |
| Part A, Group 1: Vaccine | Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination | gp70-Ce704010042_2ES V1V2 measured at Month 4 | 1 Net MFI |
| Part A, Group 1: Vaccine | Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination | CAP210_D11gp120.avi/293F measured at Month 4 | 1553 Net MFI |
| Part A, Group 1: Vaccine | Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination | gp70_CH505TF_V1V2_avi/293F measured at Month 4 | 1 Net MFI |
| Part A, Group 1: Vaccine | Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination | gp70-Ce1176 V1V2 measured at Month 4 | 1 Net MFI |
| Part A, Group 1: Vaccine | Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination | CAP45_D11gp120.avi/293F measured at Month 4 | 595.5 Net MFI |
| Part A, Group 1: Vaccine | Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination | gp70-TV1.21 V1V2 measured at Month 4 | 42.1 Net MFI |
| Part A, Group 1: Vaccine | Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination | gp70-Ce1086_B2 V1V2 measured at Month 4 | 157.9 Net MFI |
| Part A, Group 1: Vaccine | Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination | CH0505_CON D7gp120_avi/293F/Mon measured at Month 4 | 1790.2 Net MFI |
| Part A, Group 1: Vaccine | Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination | 96ZM651.D11gp120.avi measured at Month 4 | 3297.8 Net MFI |
| Part A, Group 1: Vaccine | Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination | gp70-CAP45.2.00.G3 V1V2 measured at Month 4 | 1 Net MFI |
| Part A, Group 1: Vaccine | Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination | CH505TF D7gp120d371_avi/293F/Mon measured at Month 4 | 1589.8 Net MFI |
| Part A, Group 1: Vaccine | Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination | 1086C_D7gp120.avi/293F measured at Month 4 | 7160.2 Net MFI |
| Part A, Group 1: Vaccine | Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination | gp70-CAP210.2.00.E8 V1V2 measured at Month 4 | 1 Net MFI |
| Part A, Group 1: Vaccine | Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination | CH505TFD8N156KN160K_avi/293i Mon measured at Month 4 | 1826.2 Net MFI |
| Part A, Group 2: Vaccine | Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination | gp70-CAP45.2.00.G3 V1V2 measured at Month 4 | 84.5 Net MFI |
| Part A, Group 2: Vaccine | Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination | 1394C9_G1.D11gp120.avi measured at Month 4 | 168.6 Net MFI |
| Part A, Group 2: Vaccine | Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination | 96ZM651.D11gp120.avi measured at Month 4 | 844.8 Net MFI |
| Part A, Group 2: Vaccine | Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination | gp70-7060101641 V1V2 measured at Month 4 | 1 Net MFI |
| Part A, Group 2: Vaccine | Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination | gp70-TV1.21 V1V2 measured at Month 4 | 331.6 Net MFI |
| Part A, Group 2: Vaccine | Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination | 1086C_D7gp120.avi/293F measured at Month 4 | 5318.9 Net MFI |
| Part A, Group 2: Vaccine | Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination | 1428_D11gp120.avi/293F measured at Month 4 | 1826.8 Net MFI |
| Part A, Group 2: Vaccine | Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination | 1641A7_D11gp120.avi/293F measured at Month 4 | 2312.1 Net MFI |
| Part A, Group 2: Vaccine | Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination | CAP210_D11gp120.avi/293F measured at Month 4 | 437.5 Net MFI |
| Part A, Group 2: Vaccine | Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination | CAP45_D11gp120.avi/293F measured at Month 4 | 653.6 Net MFI |
| Part A, Group 2: Vaccine | Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination | CH0505_CON D7gp120_avi/293F/Mon measured at Month 4 | 355 Net MFI |
| Part A, Group 2: Vaccine | Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination | CH505TF D7gp120d371_avi/293F/Mon measured at Month 4 | 340.2 Net MFI |
| Part A, Group 2: Vaccine | Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination | CH505TFD8N156KN160K_avi/293i Mon measured at Month 4 | 364 Net MFI |
| Part A, Group 2: Vaccine | Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination | Ce0042_D11gp120.avi/293F measured at Month 4 | 207 Net MFI |
| Part A, Group 2: Vaccine | Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination | Con 6 gp120/B measured at Month 4 | 979.9 Net MFI |
| Part A, Group 2: Vaccine | Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination | Con S gp140 CFI measured at Month 4 | 22000 Net MFI |
| Part A, Group 2: Vaccine | Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination | Du156_D11gp120.avi/293F measured at Month 4 | 5790.4 Net MFI |
| Part A, Group 2: Vaccine | Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination | TV1c8_D11gp120.avi/293F measured at Month 4 | 9944.1 Net MFI |
| Part A, Group 2: Vaccine | Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination | gp41 measured at Month 4 | 22000 Net MFI |
| Part A, Group 2: Vaccine | Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination | gp70-001428.2.42 V1V2 measured at Month 4 | 83.2 Net MFI |
| Part A, Group 2: Vaccine | Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination | gp70-1012.11.TC21.3257 V1V2 measured at Month 4 | 194.2 Net MFI |
| Part A, Group 2: Vaccine | Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination | gp70-1051.12.C22 V1V2 measured at Month 4 | 295.5 Net MFI |
| Part A, Group 2: Vaccine | Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination | gp70-1394C9G1 V1V2 measured at Month 4 | 188.5 Net MFI |
| Part A, Group 2: Vaccine | Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination | gp70-96ZM651.02 V1v2 measured at Month 4 | 609.8 Net MFI |
| Part A, Group 2: Vaccine | Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination | gp70-BF1266_431a_V1V2 measured at Month 4 | 107.8 Net MFI |
| Part A, Group 2: Vaccine | Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination | gp70-CAP210.2.00.E8 V1V2 measured at Month 4 | 167.8 Net MFI |
| Part A, Group 2: Vaccine | Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination | gp70-Ce1086_B2 V1V2 measured at Month 4 | 219.8 Net MFI |
| Part A, Group 2: Vaccine | Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination | gp70-Ce1176 V1V2 measured at Month 4 | 114.8 Net MFI |
| Part A, Group 2: Vaccine | Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination | gp70-Ce704010042_2ES V1V2 measured at Month 4 | 1 Net MFI |
| Part A, Group 2: Vaccine | Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination | gp70-ConC V1V2 measured at Month 4 | 3 Net MFI |
| Part A, Group 2: Vaccine | Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination | gp70-Du156.12 V1V2 measured at Month 4 | 1 Net MFI |
| Part A, Group 2: Vaccine | Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination | gp70_CH505TF_V1V2_N156KN160K_avi/293F measured at Month 4 | 244 Net MFI |
| Part A, Group 2: Vaccine | Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination | gp70_CH505TF_V1V2_avi/293F measured at Month 4 | 1463 Net MFI |
| Part A, Group 3: Placebo | Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination | gp70-96ZM651.02 V1v2 measured at Month 4 | 1 Net MFI |
| Part A, Group 3: Placebo | Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination | CH505TFD8N156KN160K_avi/293i Mon measured at Month 4 | 1 Net MFI |
| Part A, Group 3: Placebo | Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination | gp70-Du156.12 V1V2 measured at Month 4 | 1 Net MFI |
| Part A, Group 3: Placebo | Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination | gp70-BF1266_431a_V1V2 measured at Month 4 | 1 Net MFI |
| Part A, Group 3: Placebo | Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination | CH505TF D7gp120d371_avi/293F/Mon measured at Month 4 | 3744.6 Net MFI |
| Part A, Group 3: Placebo | Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination | gp70-7060101641 V1V2 measured at Month 4 | 1 Net MFI |
| Part A, Group 3: Placebo | Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination | gp70-CAP210.2.00.E8 V1V2 measured at Month 4 | 1 Net MFI |
| Part A, Group 3: Placebo | Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination | CH0505_CON D7gp120_avi/293F/Mon measured at Month 4 | 3982.1 Net MFI |
| Part A, Group 3: Placebo | Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination | 1086C_D7gp120.avi/293F measured at Month 4 | 15.2 Net MFI |
| Part A, Group 3: Placebo | Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination | gp70-CAP45.2.00.G3 V1V2 measured at Month 4 | 1 Net MFI |
| Part A, Group 3: Placebo | Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination | CAP45_D11gp120.avi/293F measured at Month 4 | 388.6 Net MFI |
| Part A, Group 3: Placebo | Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination | gp70-TV1.21 V1V2 measured at Month 4 | 14.2 Net MFI |
| Part A, Group 3: Placebo | Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination | gp70-Ce1086_B2 V1V2 measured at Month 4 | 1 Net MFI |
| Part A, Group 3: Placebo | Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination | CAP210_D11gp120.avi/293F measured at Month 4 | 3179.5 Net MFI |
| Part A, Group 3: Placebo | Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination | gp70-1012.11.TC21.3257 V1V2 measured at Month 4 | 13.8 Net MFI |
| Part A, Group 3: Placebo | Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination | gp70-Ce1176 V1V2 measured at Month 4 | 1 Net MFI |
| Part A, Group 3: Placebo | Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination | 96ZM651.D11gp120.avi measured at Month 4 | 1 Net MFI |
| Part A, Group 3: Placebo | Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination | gp70_CH505TF_V1V2_avi/293F measured at Month 4 | 307.8 Net MFI |
| Part A, Group 3: Placebo | Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination | gp70-Ce704010042_2ES V1V2 measured at Month 4 | 1 Net MFI |
| Part A, Group 3: Placebo | Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination | gp41 measured at Month 4 | 1532.9 Net MFI |
| Part A, Group 3: Placebo | Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination | 1428_D11gp120.avi/293F measured at Month 4 | 2131.1 Net MFI |
| Part A, Group 3: Placebo | Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination | gp70-001428.2.42 V1V2 measured at Month 4 | 1 Net MFI |
| Part A, Group 3: Placebo | Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination | TV1c8_D11gp120.avi/293F measured at Month 4 | 197.8 Net MFI |
| Part A, Group 3: Placebo | Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination | gp70_CH505TF_V1V2_N156KN160K_avi/293F measured at Month 4 | 93.8 Net MFI |
| Part A, Group 3: Placebo | Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination | Du156_D11gp120.avi/293F measured at Month 4 | 84.4 Net MFI |
| Part A, Group 3: Placebo | Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination | gp70-ConC V1V2 measured at Month 4 | 1 Net MFI |
| Part A, Group 3: Placebo | Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination | gp70-1051.12.C22 V1V2 measured at Month 4 | 1 Net MFI |
| Part A, Group 3: Placebo | Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination | Con S gp140 CFI measured at Month 4 | 654.1 Net MFI |
| Part A, Group 3: Placebo | Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination | 1394C9_G1.D11gp120.avi measured at Month 4 | 1 Net MFI |
| Part A, Group 3: Placebo | Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination | gp70-1394C9G1 V1V2 measured at Month 4 | 1 Net MFI |
| Part A, Group 3: Placebo | Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination | Con 6 gp120/B measured at Month 4 | 27.5 Net MFI |
| Part A, Group 3: Placebo | Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination | Ce0042_D11gp120.avi/293F measured at Month 4 | 457 Net MFI |
| Part A, Group 3: Placebo | Part B: Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination | 1641A7_D11gp120.avi/293F measured at Month 4 | 104.5 Net MFI |
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).
Time frame: Measured at Month 6.5 for Part B
Population: 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
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Part A, Group 1: Vaccine | 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 | DU172.17 at dilution 80, measured at Month 6.5 | 5 titer |
| Part A, Group 1: Vaccine | 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 | Du422.1 at dilution 50, measured at Month 6.5 | 5 titer |
| Part A, Group 1: Vaccine | 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 | MW965.26 at dilution 50, measured at Month 6.5 | 2298.1 titer |
| Part A, Group 1: Vaccine | 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 | MW965.26 at dilution 80, measured at Month 6.5 | 757.6 titer |
| Part A, Group 1: Vaccine | 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 | CH505TF at dilution 50, measured at Month 6.5 | 5 titer |
| Part A, Group 1: Vaccine | 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 | DU172.17 at dilution 50, measured at Month 6.5 | 5 titer |
| Part A, Group 1: Vaccine | 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 | CH505TF at dilution 80, measured at Month 6.5 | 5 titer |
| Part A, Group 1: Vaccine | 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 | Du422.1 at dilution 80, measured at Month 6.5 | 5 titer |
| Part A, Group 2: Vaccine | 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 | CH505TF at dilution 80, measured at Month 6.5 | 5 titer |
| Part A, Group 2: Vaccine | 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 | DU172.17 at dilution 50, measured at Month 6.5 | 5 titer |
| Part A, Group 2: Vaccine | 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 | Du422.1 at dilution 50, measured at Month 6.5 | 5 titer |
| Part A, Group 2: Vaccine | 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 | Du422.1 at dilution 80, measured at Month 6.5 | 5 titer |
| Part A, Group 2: Vaccine | 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 | MW965.26 at dilution 50, measured at Month 6.5 | 418.7 titer |
| Part A, Group 2: Vaccine | 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 | MW965.26 at dilution 80, measured at Month 6.5 | 104.5 titer |
| Part A, Group 2: Vaccine | 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 | CH505TF at dilution 50, measured at Month 6.5 | 5 titer |
| Part A, Group 2: Vaccine | 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 | DU172.17 at dilution 80, measured at Month 6.5 | 5 titer |
| Part A, Group 3: Placebo | 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 | MW965.26 at dilution 50, measured at Month 6.5 | 5 titer |
| Part A, Group 3: Placebo | 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 | CH505TF at dilution 50, measured at Month 6.5 | 5 titer |
| Part A, Group 3: Placebo | 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 | MW965.26 at dilution 80, measured at Month 6.5 | 5 titer |
| Part A, Group 3: Placebo | 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 | Du422.1 at dilution 50, measured at Month 6.5 | 5 titer |
| Part A, Group 3: Placebo | 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 | DU172.17 at dilution 50, measured at Month 6.5 | 5 titer |
| Part A, Group 3: Placebo | 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 | CH505TF at dilution 80, measured at Month 6.5 | 5 titer |
| Part A, Group 3: Placebo | 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 | Du422.1 at dilution 80, measured at Month 6.5 | 5 titer |
| Part A, Group 3: Placebo | 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 | DU172.17 at dilution 80, measured at Month 6.5 | 5 titer |
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).
Time frame: Measured at Month 4 for Part B
Population: 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
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Part A, Group 1: Vaccine | 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 | CH505TF at dilution 50, measured at Month 4 | 5 titer |
| Part A, Group 1: Vaccine | 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 | Du422.1 at dilution 80, measured at Month 4 | 5 titer |
| Part A, Group 1: Vaccine | 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 | MW965.26 at dilution 80, measured at Month 4 | 14.6 titer |
| Part A, Group 1: Vaccine | 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 | CH505TF at dilution 80, measured at Month 4 | 5 titer |
| Part A, Group 1: Vaccine | 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 | DU172.17 at dilution 50, measured at Month 4 | 5 titer |
| Part A, Group 1: Vaccine | 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 | DU172.17 at dilution 80, measured at Month 4 | 5 titer |
| Part A, Group 1: Vaccine | 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 | Du422.1 at dilution 50, measured at Month 4 | 5 titer |
| Part A, Group 1: Vaccine | 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 | MW965.26 at dilution 50, measured at Month 4 | 79.2 titer |
| Part A, Group 2: Vaccine | 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 | CH505TF at dilution 80, measured at Month 4 | 5 titer |
| Part A, Group 2: Vaccine | 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 | DU172.17 at dilution 80, measured at Month 4 | 5 titer |
| Part A, Group 2: Vaccine | 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 | Du422.1 at dilution 50, measured at Month 4 | 5 titer |
| Part A, Group 2: Vaccine | 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 | MW965.26 at dilution 80, measured at Month 4 | 14.7 titer |
| Part A, Group 2: Vaccine | 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 | DU172.17 at dilution 50, measured at Month 4 | 5 titer |
| Part A, Group 2: Vaccine | 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 | Du422.1 at dilution 80, measured at Month 4 | 5 titer |
| Part A, Group 2: Vaccine | 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 | MW965.26 at dilution 50, measured at Month 4 | 71 titer |
| Part A, Group 2: Vaccine | 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 | CH505TF at dilution 50, measured at Month 4 | 5 titer |
| Part A, Group 3: Placebo | 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 | DU172.17 at dilution 80, measured at Month 4 | 5 titer |
| Part A, Group 3: Placebo | 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 | CH505TF at dilution 80, measured at Month 4 | 5 titer |
| Part A, Group 3: Placebo | 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 | MW965.26 at dilution 80, measured at Month 4 | 5 titer |
| Part A, Group 3: Placebo | 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 | DU172.17 at dilution 50, measured at Month 4 | 7.8 titer |
| Part A, Group 3: Placebo | 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 | CH505TF at dilution 50, measured at Month 4 | 9.5 titer |
| Part A, Group 3: Placebo | 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 | Du422.1 at dilution 80, measured at Month 4 | 5 titer |
| Part A, Group 3: Placebo | 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 | MW965.26 at dilution 50, measured at Month 4 | 5 titer |
| Part A, Group 3: Placebo | 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 | Du422.1 at dilution 50, measured at Month 4 | 9.9 titer |
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.
Time frame: Measured at Month 6.5 for Part B
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A, Group 1: Vaccine | Part B: Response Rate of HIV-specific CD4+ and CD8+ T-cell Responses Assessed 2 Weeks After the Third Vaccination | Any Env for CD4+ T Cells, measured at Month 6.5 | 7 Participants |
| Part A, Group 1: Vaccine | Part B: Response Rate of HIV-specific CD4+ and CD8+ T-cell Responses Assessed 2 Weeks After the Third Vaccination | Any Env for CD8+ T Cells, measured at Month 6.5 | 6 Participants |
| Part A, Group 1: Vaccine | Part B: Response Rate of HIV-specific CD4+ and CD8+ T-cell Responses Assessed 2 Weeks After the Third Vaccination | ENV-1-PTEG-SEQ for CD4+ T Cells, measured at Month 6.5 | 7 Participants |
| Part A, Group 1: Vaccine | Part B: Response Rate of HIV-specific CD4+ and CD8+ T-cell Responses Assessed 2 Weeks After the Third Vaccination | ENV-1-PTEG-SEQ for CD8+ T Cells, measured at Month 6.5 | 6 Participants |
| Part A, Group 1: Vaccine | Part B: Response Rate of HIV-specific CD4+ and CD8+ T-cell Responses Assessed 2 Weeks After the Third Vaccination | ENV-2-PTEG-SEQ for CD4+ T Cells, measured at Month 6.5 | 5 Participants |
| Part A, Group 1: Vaccine | Part B: Response Rate of HIV-specific CD4+ and CD8+ T-cell Responses Assessed 2 Weeks After the Third Vaccination | ENV-2-PTEG-SEQ for CD8+ T Cells, measured at Month 6.5 | 3 Participants |
| Part A, Group 2: Vaccine | Part B: Response Rate of HIV-specific CD4+ and CD8+ T-cell Responses Assessed 2 Weeks After the Third Vaccination | ENV-2-PTEG-SEQ for CD8+ T Cells, measured at Month 6.5 | 3 Participants |
| Part A, Group 2: Vaccine | Part B: Response Rate of HIV-specific CD4+ and CD8+ T-cell Responses Assessed 2 Weeks After the Third Vaccination | Any Env for CD4+ T Cells, measured at Month 6.5 | 6 Participants |
| Part A, Group 2: Vaccine | Part B: Response Rate of HIV-specific CD4+ and CD8+ T-cell Responses Assessed 2 Weeks After the Third Vaccination | ENV-1-PTEG-SEQ for CD8+ T Cells, measured at Month 6.5 | 5 Participants |
| Part A, Group 2: Vaccine | Part B: Response Rate of HIV-specific CD4+ and CD8+ T-cell Responses Assessed 2 Weeks After the Third Vaccination | ENV-2-PTEG-SEQ for CD4+ T Cells, measured at Month 6.5 | 6 Participants |
| Part A, Group 2: Vaccine | Part B: Response Rate of HIV-specific CD4+ and CD8+ T-cell Responses Assessed 2 Weeks After the Third Vaccination | Any Env for CD8+ T Cells, measured at Month 6.5 | 5 Participants |
| Part A, Group 2: Vaccine | Part B: Response Rate of HIV-specific CD4+ and CD8+ T-cell Responses Assessed 2 Weeks After the Third Vaccination | ENV-1-PTEG-SEQ for CD4+ T Cells, measured at Month 6.5 | 6 Participants |
| Part A, Group 3: Placebo | Part B: Response Rate of HIV-specific CD4+ and CD8+ T-cell Responses Assessed 2 Weeks After the Third Vaccination | Any Env for CD8+ T Cells, measured at Month 6.5 | 0 Participants |
| Part A, Group 3: Placebo | Part B: Response Rate of HIV-specific CD4+ and CD8+ T-cell Responses Assessed 2 Weeks After the Third Vaccination | ENV-1-PTEG-SEQ for CD4+ T Cells, measured at Month 6.5 | 0 Participants |
| Part A, Group 3: Placebo | Part B: Response Rate of HIV-specific CD4+ and CD8+ T-cell Responses Assessed 2 Weeks After the Third Vaccination | ENV-2-PTEG-SEQ for CD8+ T Cells, measured at Month 6.5 | 0 Participants |
| Part A, Group 3: Placebo | Part B: Response Rate of HIV-specific CD4+ and CD8+ T-cell Responses Assessed 2 Weeks After the Third Vaccination | ENV-1-PTEG-SEQ for CD8+ T Cells, measured at Month 6.5 | 0 Participants |
| Part A, Group 3: Placebo | Part B: Response Rate of HIV-specific CD4+ and CD8+ T-cell Responses Assessed 2 Weeks After the Third Vaccination | Any Env for CD4+ T Cells, measured at Month 6.5 | 0 Participants |
| Part A, Group 3: Placebo | Part B: Response Rate of HIV-specific CD4+ and CD8+ T-cell Responses Assessed 2 Weeks After the Third Vaccination | ENV-2-PTEG-SEQ for CD4+ T Cells, measured at Month 6.5 | 0 Participants |
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.
Time frame: Measured at Month 4 for Part B
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A, Group 1: Vaccine | Part B: Response Rate of HIV-specific CD4+ and CD8+ T-cell Responses Assessed 4 Weeks After the Second Vaccination | Any Env for CD4+ T Cells, measured at Month 4 | 3 Participants |
| Part A, Group 1: Vaccine | Part B: Response Rate of HIV-specific CD4+ and CD8+ T-cell Responses Assessed 4 Weeks After the Second Vaccination | Any Env for CD8+ T Cells, measured at Month 4 | 5 Participants |
| Part A, Group 1: Vaccine | Part B: Response Rate of HIV-specific CD4+ and CD8+ T-cell Responses Assessed 4 Weeks After the Second Vaccination | ENV-1-PTEG-SEQ for CD4+ T Cells, measured at Month 4 | 3 Participants |
| Part A, Group 1: Vaccine | Part B: Response Rate of HIV-specific CD4+ and CD8+ T-cell Responses Assessed 4 Weeks After the Second Vaccination | ENV-1-PTEG-SEQ for CD8+ T Cells, measured at Month 4 | 5 Participants |
| Part A, Group 1: Vaccine | Part B: Response Rate of HIV-specific CD4+ and CD8+ T-cell Responses Assessed 4 Weeks After the Second Vaccination | ENV-2-PTEG-SEQ for CD4+ T Cells, measured at Month 4 | 3 Participants |
| Part A, Group 1: Vaccine | Part B: Response Rate of HIV-specific CD4+ and CD8+ T-cell Responses Assessed 4 Weeks After the Second Vaccination | ENV-2-PTEG-SEQ for CD8+ T Cells, measured at Month 4 | 4 Participants |
| Part A, Group 2: Vaccine | Part B: Response Rate of HIV-specific CD4+ and CD8+ T-cell Responses Assessed 4 Weeks After the Second Vaccination | ENV-2-PTEG-SEQ for CD8+ T Cells, measured at Month 4 | 5 Participants |
| Part A, Group 2: Vaccine | Part B: Response Rate of HIV-specific CD4+ and CD8+ T-cell Responses Assessed 4 Weeks After the Second Vaccination | Any Env for CD4+ T Cells, measured at Month 4 | 6 Participants |
| Part A, Group 2: Vaccine | Part B: Response Rate of HIV-specific CD4+ and CD8+ T-cell Responses Assessed 4 Weeks After the Second Vaccination | ENV-1-PTEG-SEQ for CD8+ T Cells, measured at Month 4 | 5 Participants |
| Part A, Group 2: Vaccine | Part B: Response Rate of HIV-specific CD4+ and CD8+ T-cell Responses Assessed 4 Weeks After the Second Vaccination | ENV-2-PTEG-SEQ for CD4+ T Cells, measured at Month 4 | 4 Participants |
| Part A, Group 2: Vaccine | Part B: Response Rate of HIV-specific CD4+ and CD8+ T-cell Responses Assessed 4 Weeks After the Second Vaccination | Any Env for CD8+ T Cells, measured at Month 4 | 5 Participants |
| Part A, Group 2: Vaccine | Part B: Response Rate of HIV-specific CD4+ and CD8+ T-cell Responses Assessed 4 Weeks After the Second Vaccination | ENV-1-PTEG-SEQ for CD4+ T Cells, measured at Month 4 | 6 Participants |
| Part A, Group 3: Placebo | Part B: Response Rate of HIV-specific CD4+ and CD8+ T-cell Responses Assessed 4 Weeks After the Second Vaccination | Any Env for CD8+ T Cells, measured at Month 4 | 0 Participants |
| Part A, Group 3: Placebo | Part B: Response Rate of HIV-specific CD4+ and CD8+ T-cell Responses Assessed 4 Weeks After the Second Vaccination | ENV-1-PTEG-SEQ for CD4+ T Cells, measured at Month 4 | 0 Participants |
| Part A, Group 3: Placebo | Part B: Response Rate of HIV-specific CD4+ and CD8+ T-cell Responses Assessed 4 Weeks After the Second Vaccination | ENV-2-PTEG-SEQ for CD8+ T Cells, measured at Month 4 | 0 Participants |
| Part A, Group 3: Placebo | Part B: Response Rate of HIV-specific CD4+ and CD8+ T-cell Responses Assessed 4 Weeks After the Second Vaccination | ENV-1-PTEG-SEQ for CD8+ T Cells, measured at Month 4 | 0 Participants |
| Part A, Group 3: Placebo | Part B: Response Rate of HIV-specific CD4+ and CD8+ T-cell Responses Assessed 4 Weeks After the Second Vaccination | Any Env for CD4+ T Cells, measured at Month 4 | 0 Participants |
| Part A, Group 3: Placebo | Part B: Response Rate of HIV-specific CD4+ and CD8+ T-cell Responses Assessed 4 Weeks After the Second Vaccination | ENV-2-PTEG-SEQ for CD4+ T Cells, measured at Month 4 | 0 Participants |
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.
Time frame: Measured at Month 6.5 for Part B
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A, Group 1: Vaccine | Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination | Con 6 gp120/B measured at Month 6.5 | 8 Participants |
| Part A, Group 1: Vaccine | Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination | gp70-7060101641 V1V2 measured at Month 6.5 | 3 Participants |
| Part A, Group 1: Vaccine | Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination | CH0505_CON D7gp120_avi/293F/Mon measured at Month 6.5 | 8 Participants |
| Part A, Group 1: Vaccine | Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination | gp70-Ce1176 V1V2 measured at Month 6.5 | 1 Participants |
| Part A, Group 1: Vaccine | Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination | CH505TF D7gp120d371_avi/293F/Mon measured at Month 6.5 | 8 Participants |
| Part A, Group 1: Vaccine | Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination | 1086C_D7gp120.avi/293F measured at Month 6.5 | 8 Participants |
| Part A, Group 1: Vaccine | Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination | gp70-1394C9G1 V1V2 measured at Month 6.5 | 4 Participants |
| Part A, Group 1: Vaccine | Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination | CH505TFD8N156KN160K_avi/293i Mon measured at Month 6.5 | 8 Participants |
| Part A, Group 1: Vaccine | Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination | gp70-TV1.21 V1V2 measured at Month 6.5 | 1 Participants |
| Part A, Group 1: Vaccine | Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination | gp70-1051.12.C22 V1V2 measured at Month 6.5 | 3 Participants |
| Part A, Group 1: Vaccine | Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination | Ce0042_D11gp120.avi/293F measured at Month 6.5 | 8 Participants |
| Part A, Group 1: Vaccine | Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination | gp70-Ce1086_B2 V1V2 measured at Month 6.5 | 3 Participants |
| Part A, Group 1: Vaccine | Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination | gp70-1012.11.TC21.3257 V1V2 measured at Month 6.5 | 4 Participants |
| Part A, Group 1: Vaccine | Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination | 1394C9_G1.D11gp120.avi measured at Month 6.5 | 8 Participants |
| Part A, Group 1: Vaccine | Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination | gp70-001428.2.42 V1V2 measured at Month 6.5 | 3 Participants |
| Part A, Group 1: Vaccine | Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination | Con S gp140 CFI measured at Month 6.5 | 8 Participants |
| Part A, Group 1: Vaccine | Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination | gp70_CH505TF_V1V2_avi/293F measured at Month 6.5 | 3 Participants |
| Part A, Group 1: Vaccine | Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination | gp41 measured at Month 6.5 | 7 Participants |
| Part A, Group 1: Vaccine | Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination | Du156_D11gp120.avi/293F measured at Month 6.5 | 8 Participants |
| Part A, Group 1: Vaccine | Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination | TV1c8_D11gp120.avi/293F measured at Month 6.5 | 8 Participants |
| Part A, Group 1: Vaccine | Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination | 1428_D11gp120.avi/293F measured at Month 6.5 | 8 Participants |
| Part A, Group 1: Vaccine | Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination | gp70-Du156.12 V1V2 measured at Month 6.5 | 0 Participants |
| Part A, Group 1: Vaccine | Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination | gp70-CAP45.2.00.G3 V1V2 measured at Month 6.5 | 3 Participants |
| Part A, Group 1: Vaccine | Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination | 1641A7_D11gp120.avi/293F measured at Month 6.5 | 8 Participants |
| Part A, Group 1: Vaccine | Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination | gp70-ConC V1V2 measured at Month 6.5 | 2 Participants |
| Part A, Group 1: Vaccine | Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination | gp70-CAP210.2.00.E8 V1V2 measured at Month 6.5 | 2 Participants |
| Part A, Group 1: Vaccine | Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination | 96ZM651.D11gp120.avi measured at Month 6.5 | 8 Participants |
| Part A, Group 1: Vaccine | Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination | gp70-Ce704010042_2ES V1V2 measured at Month 6.5 | 1 Participants |
| Part A, Group 1: Vaccine | Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination | gp70-BF1266_431a_V1V2 measured at Month 6.5 | 3 Participants |
| Part A, Group 1: Vaccine | Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination | CAP210_D11gp120.avi/293F measured at Month 6.5 | 8 Participants |
| Part A, Group 1: Vaccine | Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination | gp70_CH505TF_V1V2_N156KN160K_avi/293F measured at Month 6.5 | 2 Participants |
| Part A, Group 1: Vaccine | Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination | gp70-96ZM651.02 V1v2 measured at Month 6.5 | 2 Participants |
| Part A, Group 1: Vaccine | Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination | CAP45_D11gp120.avi/293F measured at Month 6.5 | 8 Participants |
| Part A, Group 2: Vaccine | Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination | gp70_CH505TF_V1V2_avi/293F measured at Month 6.5 | 2 Participants |
| Part A, Group 2: Vaccine | Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination | Du156_D11gp120.avi/293F measured at Month 6.5 | 7 Participants |
| Part A, Group 2: Vaccine | Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination | gp70-1012.11.TC21.3257 V1V2 measured at Month 6.5 | 3 Participants |
| Part A, Group 2: Vaccine | Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination | gp70-1394C9G1 V1V2 measured at Month 6.5 | 4 Participants |
| Part A, Group 2: Vaccine | Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination | gp70-7060101641 V1V2 measured at Month 6.5 | 2 Participants |
| Part A, Group 2: Vaccine | Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination | gp70-Ce1086_B2 V1V2 measured at Month 6.5 | 3 Participants |
| Part A, Group 2: Vaccine | Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination | gp70_CH505TF_V1V2_N156KN160K_avi/293F measured at Month 6.5 | 2 Participants |
| Part A, Group 2: Vaccine | Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination | 1086C_D7gp120.avi/293F measured at Month 6.5 | 7 Participants |
| Part A, Group 2: Vaccine | Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination | 1394C9_G1.D11gp120.avi measured at Month 6.5 | 7 Participants |
| Part A, Group 2: Vaccine | Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination | 1428_D11gp120.avi/293F measured at Month 6.5 | 6 Participants |
| Part A, Group 2: Vaccine | Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination | 1641A7_D11gp120.avi/293F measured at Month 6.5 | 7 Participants |
| Part A, Group 2: Vaccine | Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination | 96ZM651.D11gp120.avi measured at Month 6.5 | 6 Participants |
| Part A, Group 2: Vaccine | Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination | CAP210_D11gp120.avi/293F measured at Month 6.5 | 6 Participants |
| Part A, Group 2: Vaccine | Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination | CAP45_D11gp120.avi/293F measured at Month 6.5 | 7 Participants |
| Part A, Group 2: Vaccine | Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination | CH0505_CON D7gp120_avi/293F/Mon measured at Month 6.5 | 6 Participants |
| Part A, Group 2: Vaccine | Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination | CH505TF D7gp120d371_avi/293F/Mon measured at Month 6.5 | 6 Participants |
| Part A, Group 2: Vaccine | Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination | CH505TFD8N156KN160K_avi/293i Mon measured at Month 6.5 | 6 Participants |
| Part A, Group 2: Vaccine | Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination | Ce0042_D11gp120.avi/293F measured at Month 6.5 | 6 Participants |
| Part A, Group 2: Vaccine | Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination | Con 6 gp120/B measured at Month 6.5 | 7 Participants |
| Part A, Group 2: Vaccine | Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination | Con S gp140 CFI measured at Month 6.5 | 7 Participants |
| Part A, Group 2: Vaccine | Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination | TV1c8_D11gp120.avi/293F measured at Month 6.5 | 7 Participants |
| Part A, Group 2: Vaccine | Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination | gp41 measured at Month 6.5 | 4 Participants |
| Part A, Group 2: Vaccine | Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination | gp70-001428.2.42 V1V2 measured at Month 6.5 | 3 Participants |
| Part A, Group 2: Vaccine | Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination | gp70-1051.12.C22 V1V2 measured at Month 6.5 | 4 Participants |
| Part A, Group 2: Vaccine | Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination | gp70-96ZM651.02 V1v2 measured at Month 6.5 | 2 Participants |
| Part A, Group 2: Vaccine | Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination | gp70-BF1266_431a_V1V2 measured at Month 6.5 | 3 Participants |
| Part A, Group 2: Vaccine | Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination | gp70-CAP210.2.00.E8 V1V2 measured at Month 6.5 | 4 Participants |
| Part A, Group 2: Vaccine | Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination | gp70-CAP45.2.00.G3 V1V2 measured at Month 6.5 | 2 Participants |
| Part A, Group 2: Vaccine | Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination | gp70-Ce1176 V1V2 measured at Month 6.5 | 2 Participants |
| Part A, Group 2: Vaccine | Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination | gp70-Ce704010042_2ES V1V2 measured at Month 6.5 | 1 Participants |
| Part A, Group 2: Vaccine | Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination | gp70-ConC V1V2 measured at Month 6.5 | 1 Participants |
| Part A, Group 2: Vaccine | Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination | gp70-Du156.12 V1V2 measured at Month 6.5 | 1 Participants |
| Part A, Group 2: Vaccine | Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination | gp70-TV1.21 V1V2 measured at Month 6.5 | 2 Participants |
| Part A, Group 3: Placebo | Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination | gp70-1051.12.C22 V1V2 measured at Month 6.5 | 0 Participants |
| Part A, Group 3: Placebo | Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination | CH505TF D7gp120d371_avi/293F/Mon measured at Month 6.5 | 0 Participants |
| Part A, Group 3: Placebo | Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination | gp70-1394C9G1 V1V2 measured at Month 6.5 | 0 Participants |
| Part A, Group 3: Placebo | Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination | CAP45_D11gp120.avi/293F measured at Month 6.5 | 0 Participants |
| Part A, Group 3: Placebo | Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination | gp70-7060101641 V1V2 measured at Month 6.5 | 0 Participants |
| Part A, Group 3: Placebo | Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination | CAP210_D11gp120.avi/293F measured at Month 6.5 | 0 Participants |
| Part A, Group 3: Placebo | Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination | gp70_CH505TF_V1V2_N156KN160K_avi/293F measured at Month 6.5 | 0 Participants |
| Part A, Group 3: Placebo | Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination | gp70-96ZM651.02 V1v2 measured at Month 6.5 | 0 Participants |
| Part A, Group 3: Placebo | Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination | 96ZM651.D11gp120.avi measured at Month 6.5 | 0 Participants |
| Part A, Group 3: Placebo | Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination | gp70-ConC V1V2 measured at Month 6.5 | 0 Participants |
| Part A, Group 3: Placebo | Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination | 1641A7_D11gp120.avi/293F measured at Month 6.5 | 0 Participants |
| Part A, Group 3: Placebo | Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination | gp70-Ce704010042_2ES V1V2 measured at Month 6.5 | 0 Participants |
| Part A, Group 3: Placebo | Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination | gp70-CAP210.2.00.E8 V1V2 measured at Month 6.5 | 0 Participants |
| Part A, Group 3: Placebo | Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination | 1428_D11gp120.avi/293F measured at Month 6.5 | 0 Participants |
| Part A, Group 3: Placebo | Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination | CH0505_CON D7gp120_avi/293F/Mon measured at Month 6.5 | 0 Participants |
| Part A, Group 3: Placebo | Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination | gp70-CAP45.2.00.G3 V1V2 measured at Month 6.5 | 0 Participants |
| Part A, Group 3: Placebo | Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination | 1086C_D7gp120.avi/293F measured at Month 6.5 | 0 Participants |
| Part A, Group 3: Placebo | Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination | gp70-Ce1086_B2 V1V2 measured at Month 6.5 | 0 Participants |
| Part A, Group 3: Placebo | Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination | gp70_CH505TF_V1V2_avi/293F measured at Month 6.5 | 0 Participants |
| Part A, Group 3: Placebo | Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination | gp70-BF1266_431a_V1V2 measured at Month 6.5 | 0 Participants |
| Part A, Group 3: Placebo | Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination | Du156_D11gp120.avi/293F measured at Month 6.5 | 0 Participants |
| Part A, Group 3: Placebo | Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination | gp70-Ce1176 V1V2 measured at Month 6.5 | 0 Participants |
| Part A, Group 3: Placebo | Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination | TV1c8_D11gp120.avi/293F measured at Month 6.5 | 0 Participants |
| Part A, Group 3: Placebo | Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination | Con S gp140 CFI measured at Month 6.5 | 0 Participants |
| Part A, Group 3: Placebo | Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination | gp70-TV1.21 V1V2 measured at Month 6.5 | 0 Participants |
| Part A, Group 3: Placebo | Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination | gp41 measured at Month 6.5 | 0 Participants |
| Part A, Group 3: Placebo | Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination | Con 6 gp120/B measured at Month 6.5 | 0 Participants |
| Part A, Group 3: Placebo | Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination | 1394C9_G1.D11gp120.avi measured at Month 6.5 | 0 Participants |
| Part A, Group 3: Placebo | Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination | gp70-001428.2.42 V1V2 measured at Month 6.5 | 0 Participants |
| Part A, Group 3: Placebo | Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination | Ce0042_D11gp120.avi/293F measured at Month 6.5 | 0 Participants |
| Part A, Group 3: Placebo | Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination | gp70-1012.11.TC21.3257 V1V2 measured at Month 6.5 | 0 Participants |
| Part A, Group 3: Placebo | Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination | CH505TFD8N156KN160K_avi/293i Mon measured at Month 6.5 | 0 Participants |
| Part A, Group 3: Placebo | Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 2 Weeks After the Third Vaccination | gp70-Du156.12 V1V2 measured at Month 6.5 | 0 Participants |
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.
Time frame: Measured at Month 4 for Part B
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A, Group 1: Vaccine | Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination | CH0505_CON D7gp120_avi/293F/Mon measured at Month 4 | 5 Participants |
| Part A, Group 1: Vaccine | Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination | gp70-BF1266_431a_V1V2 measured at Month 4 | 0 Participants |
| Part A, Group 1: Vaccine | Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination | gp70-CAP210.2.00.E8 V1V2 measured at Month 4 | 0 Participants |
| Part A, Group 1: Vaccine | Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination | gp70-CAP45.2.00.G3 V1V2 measured at Month 4 | 0 Participants |
| Part A, Group 1: Vaccine | Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination | CH505TF D7gp120d371_avi/293F/Mon measured at Month 4 | 6 Participants |
| Part A, Group 1: Vaccine | Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination | gp70-Ce1086_B2 V1V2 measured at Month 4 | 0 Participants |
| Part A, Group 1: Vaccine | Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination | gp70-Ce1176 V1V2 measured at Month 4 | 0 Participants |
| Part A, Group 1: Vaccine | Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination | 1086C_D7gp120.avi/293F measured at Month 4 | 9 Participants |
| Part A, Group 1: Vaccine | Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination | gp70-Ce704010042_2ES V1V2 measured at Month 4 | 0 Participants |
| Part A, Group 1: Vaccine | Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination | gp70-ConC V1V2 measured at Month 4 | 0 Participants |
| Part A, Group 1: Vaccine | Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination | CH505TFD8N156KN160K_avi/293i Mon measured at Month 4 | 6 Participants |
| Part A, Group 1: Vaccine | Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination | gp70-Du156.12 V1V2 measured at Month 4 | 0 Participants |
| Part A, Group 1: Vaccine | Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination | gp70-TV1.21 V1V2 measured at Month 4 | 0 Participants |
| Part A, Group 1: Vaccine | Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination | 1641A7_D11gp120.avi/293F measured at Month 4 | 8 Participants |
| Part A, Group 1: Vaccine | Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination | gp70_CH505TF_V1V2_N156KN160K_avi/293F measured at Month 4 | 0 Participants |
| Part A, Group 1: Vaccine | Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination | Ce0042_D11gp120.avi/293F measured at Month 4 | 3 Participants |
| Part A, Group 1: Vaccine | Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination | gp70_CH505TF_V1V2_avi/293F measured at Month 4 | 0 Participants |
| Part A, Group 1: Vaccine | Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination | Con 6 gp120/B measured at Month 4 | 8 Participants |
| Part A, Group 1: Vaccine | Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination | 1394C9_G1.D11gp120.avi measured at Month 4 | 4 Participants |
| Part A, Group 1: Vaccine | Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination | Con S gp140 CFI measured at Month 4 | 9 Participants |
| Part A, Group 1: Vaccine | Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination | 96ZM651.D11gp120.avi measured at Month 4 | 6 Participants |
| Part A, Group 1: Vaccine | Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination | Du156_D11gp120.avi/293F measured at Month 4 | 9 Participants |
| Part A, Group 1: Vaccine | Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination | TV1c8_D11gp120.avi/293F measured at Month 4 | 9 Participants |
| Part A, Group 1: Vaccine | Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination | gp41 measured at Month 4 | 8 Participants |
| Part A, Group 1: Vaccine | Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination | CAP210_D11gp120.avi/293F measured at Month 4 | 5 Participants |
| Part A, Group 1: Vaccine | Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination | gp70-001428.2.42 V1V2 measured at Month 4 | 0 Participants |
| Part A, Group 1: Vaccine | Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination | gp70-1012.11.TC21.3257 V1V2 measured at Month 4 | 2 Participants |
| Part A, Group 1: Vaccine | Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination | gp70-1051.12.C22 V1V2 measured at Month 4 | 1 Participants |
| Part A, Group 1: Vaccine | Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination | CAP45_D11gp120.avi/293F measured at Month 4 | 6 Participants |
| Part A, Group 1: Vaccine | Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination | gp70-1394C9G1 V1V2 measured at Month 4 | 0 Participants |
| Part A, Group 1: Vaccine | Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination | gp70-7060101641 V1V2 measured at Month 4 | 0 Participants |
| Part A, Group 1: Vaccine | Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination | 1428_D11gp120.avi/293F measured at Month 4 | 7 Participants |
| Part A, Group 1: Vaccine | Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination | gp70-96ZM651.02 V1v2 measured at Month 4 | 2 Participants |
| Part A, Group 2: Vaccine | Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination | 1641A7_D11gp120.avi/293F measured at Month 4 | 6 Participants |
| Part A, Group 2: Vaccine | Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination | gp70-001428.2.42 V1V2 measured at Month 4 | 1 Participants |
| Part A, Group 2: Vaccine | Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination | gp70-BF1266_431a_V1V2 measured at Month 4 | 2 Participants |
| Part A, Group 2: Vaccine | Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination | CH0505_CON D7gp120_avi/293F/Mon measured at Month 4 | 2 Participants |
| Part A, Group 2: Vaccine | Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination | Con 6 gp120/B measured at Month 4 | 6 Participants |
| Part A, Group 2: Vaccine | Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination | gp70-CAP210.2.00.E8 V1V2 measured at Month 4 | 3 Participants |
| Part A, Group 2: Vaccine | Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination | 1428_D11gp120.avi/293F measured at Month 4 | 4 Participants |
| Part A, Group 2: Vaccine | Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination | CAP210_D11gp120.avi/293F measured at Month 4 | 3 Participants |
| Part A, Group 2: Vaccine | Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination | gp70-CAP45.2.00.G3 V1V2 measured at Month 4 | 1 Participants |
| Part A, Group 2: Vaccine | Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination | gp70-1394C9G1 V1V2 measured at Month 4 | 3 Participants |
| Part A, Group 2: Vaccine | Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination | Con S gp140 CFI measured at Month 4 | 7 Participants |
| Part A, Group 2: Vaccine | Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination | gp70-Ce1086_B2 V1V2 measured at Month 4 | 1 Participants |
| Part A, Group 2: Vaccine | Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination | CH505TF D7gp120d371_avi/293F/Mon measured at Month 4 | 2 Participants |
| Part A, Group 2: Vaccine | Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination | gp70-1012.11.TC21.3257 V1V2 measured at Month 4 | 3 Participants |
| Part A, Group 2: Vaccine | Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination | gp70-Ce1176 V1V2 measured at Month 4 | 2 Participants |
| Part A, Group 2: Vaccine | Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination | 1086C_D7gp120.avi/293F measured at Month 4 | 7 Participants |
| Part A, Group 2: Vaccine | Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination | Du156_D11gp120.avi/293F measured at Month 4 | 6 Participants |
| Part A, Group 2: Vaccine | Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination | gp70-Ce704010042_2ES V1V2 measured at Month 4 | 1 Participants |
| Part A, Group 2: Vaccine | Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination | 96ZM651.D11gp120.avi measured at Month 4 | 3 Participants |
| Part A, Group 2: Vaccine | Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination | gp70-ConC V1V2 measured at Month 4 | 1 Participants |
| Part A, Group 2: Vaccine | Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination | CAP45_D11gp120.avi/293F measured at Month 4 | 3 Participants |
| Part A, Group 2: Vaccine | Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination | TV1c8_D11gp120.avi/293F measured at Month 4 | 7 Participants |
| Part A, Group 2: Vaccine | Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination | gp70-Du156.12 V1V2 measured at Month 4 | 1 Participants |
| Part A, Group 2: Vaccine | Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination | CH505TFD8N156KN160K_avi/293i Mon measured at Month 4 | 3 Participants |
| Part A, Group 2: Vaccine | Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination | 1394C9_G1.D11gp120.avi measured at Month 4 | 2 Participants |
| Part A, Group 2: Vaccine | Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination | gp70-TV1.21 V1V2 measured at Month 4 | 2 Participants |
| Part A, Group 2: Vaccine | Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination | gp70-1051.12.C22 V1V2 measured at Month 4 | 4 Participants |
| Part A, Group 2: Vaccine | Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination | gp41 measured at Month 4 | 5 Participants |
| Part A, Group 2: Vaccine | Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination | gp70_CH505TF_V1V2_N156KN160K_avi/293F measured at Month 4 | 1 Participants |
| Part A, Group 2: Vaccine | Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination | gp70-96ZM651.02 V1v2 measured at Month 4 | 2 Participants |
| Part A, Group 2: Vaccine | Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination | gp70-7060101641 V1V2 measured at Month 4 | 1 Participants |
| Part A, Group 2: Vaccine | Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination | gp70_CH505TF_V1V2_avi/293F measured at Month 4 | 1 Participants |
| Part A, Group 2: Vaccine | Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination | Ce0042_D11gp120.avi/293F measured at Month 4 | 2 Participants |
| Part A, Group 3: Placebo | Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination | gp70_CH505TF_V1V2_avi/293F measured at Month 4 | 0 Participants |
| Part A, Group 3: Placebo | Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination | 1086C_D7gp120.avi/293F measured at Month 4 | 0 Participants |
| Part A, Group 3: Placebo | Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination | 1394C9_G1.D11gp120.avi measured at Month 4 | 0 Participants |
| Part A, Group 3: Placebo | Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination | 1428_D11gp120.avi/293F measured at Month 4 | 0 Participants |
| Part A, Group 3: Placebo | Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination | 1641A7_D11gp120.avi/293F measured at Month 4 | 0 Participants |
| Part A, Group 3: Placebo | Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination | 96ZM651.D11gp120.avi measured at Month 4 | 0 Participants |
| Part A, Group 3: Placebo | Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination | CAP210_D11gp120.avi/293F measured at Month 4 | 0 Participants |
| Part A, Group 3: Placebo | Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination | CAP45_D11gp120.avi/293F measured at Month 4 | 0 Participants |
| Part A, Group 3: Placebo | Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination | CH0505_CON D7gp120_avi/293F/Mon measured at Month 4 | 0 Participants |
| Part A, Group 3: Placebo | Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination | CH505TF D7gp120d371_avi/293F/Mon measured at Month 4 | 0 Participants |
| Part A, Group 3: Placebo | Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination | CH505TFD8N156KN160K_avi/293i Mon measured at Month 4 | 0 Participants |
| Part A, Group 3: Placebo | Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination | Ce0042_D11gp120.avi/293F measured at Month 4 | 0 Participants |
| Part A, Group 3: Placebo | Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination | Con 6 gp120/B measured at Month 4 | 0 Participants |
| Part A, Group 3: Placebo | Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination | Con S gp140 CFI measured at Month 4 | 0 Participants |
| Part A, Group 3: Placebo | Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination | Du156_D11gp120.avi/293F measured at Month 4 | 0 Participants |
| Part A, Group 3: Placebo | Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination | TV1c8_D11gp120.avi/293F measured at Month 4 | 0 Participants |
| Part A, Group 3: Placebo | Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination | gp41 measured at Month 4 | 0 Participants |
| Part A, Group 3: Placebo | Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination | gp70-001428.2.42 V1V2 measured at Month 4 | 0 Participants |
| Part A, Group 3: Placebo | Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination | gp70-1012.11.TC21.3257 V1V2 measured at Month 4 | 0 Participants |
| Part A, Group 3: Placebo | Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination | gp70-1051.12.C22 V1V2 measured at Month 4 | 0 Participants |
| Part A, Group 3: Placebo | Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination | gp70-1394C9G1 V1V2 measured at Month 4 | 0 Participants |
| Part A, Group 3: Placebo | Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination | gp70-7060101641 V1V2 measured at Month 4 | 0 Participants |
| Part A, Group 3: Placebo | Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination | gp70-96ZM651.02 V1v2 measured at Month 4 | 0 Participants |
| Part A, Group 3: Placebo | Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination | gp70-BF1266_431a_V1V2 measured at Month 4 | 0 Participants |
| Part A, Group 3: Placebo | Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination | gp70-CAP210.2.00.E8 V1V2 measured at Month 4 | 0 Participants |
| Part A, Group 3: Placebo | Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination | gp70-CAP45.2.00.G3 V1V2 measured at Month 4 | 0 Participants |
| Part A, Group 3: Placebo | Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination | gp70-Ce1086_B2 V1V2 measured at Month 4 | 0 Participants |
| Part A, Group 3: Placebo | Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination | gp70-Ce1176 V1V2 measured at Month 4 | 0 Participants |
| Part A, Group 3: Placebo | Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination | gp70-ConC V1V2 measured at Month 4 | 0 Participants |
| Part A, Group 3: Placebo | Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination | gp70-Du156.12 V1V2 measured at Month 4 | 0 Participants |
| Part A, Group 3: Placebo | Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination | gp70-TV1.21 V1V2 measured at Month 4 | 0 Participants |
| Part A, Group 3: Placebo | Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination | gp70_CH505TF_V1V2_N156KN160K_avi/293F measured at Month 4 | 0 Participants |
| Part A, Group 3: Placebo | Part B: Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After the Second Vaccination | gp70-Ce704010042_2ES V1V2 measured at Month 4 | 0 Participants |
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.
Time frame: Measured at Month 6.5 for Part B
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A, Group 1: Vaccine | 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 | MW965.26 at dilution 50, measured at Month 6.5 | 8 Participants |
| Part A, Group 1: Vaccine | 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 | DU172.17 at dilution 50, measured at Month 6.5 | 2 Participants |
| Part A, Group 1: Vaccine | 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 | MW965.26 at dilution 80, measured at Month 6.5 | 8 Participants |
| Part A, Group 1: Vaccine | 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 | Du422.1 at dilution 80, measured at Month 6.5 | 0 Participants |
| Part A, Group 1: Vaccine | 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 | DU172.17 at dilution 80, measured at Month 6.5 | 0 Participants |
| Part A, Group 1: Vaccine | 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 | Du422.1 at dilution 50, measured at Month 6.5 | 1 Participants |
| Part A, Group 1: Vaccine | 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 | CH505TF at dilution 80, measured at Month 6.5 | 1 Participants |
| Part A, Group 1: Vaccine | 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 | CH505TF at dilution 50, measured at Month 6.5 | 1 Participants |
| Part A, Group 2: Vaccine | 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 | DU172.17 at dilution 80, measured at Month 6.5 | 0 Participants |
| Part A, Group 2: Vaccine | 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 | Du422.1 at dilution 80, measured at Month 6.5 | 0 Participants |
| Part A, Group 2: Vaccine | 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 | MW965.26 at dilution 50, measured at Month 6.5 | 7 Participants |
| Part A, Group 2: Vaccine | 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 | CH505TF at dilution 50, measured at Month 6.5 | 2 Participants |
| Part A, Group 2: Vaccine | 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 | CH505TF at dilution 80, measured at Month 6.5 | 0 Participants |
| Part A, Group 2: Vaccine | 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 | DU172.17 at dilution 50, measured at Month 6.5 | 0 Participants |
| Part A, Group 2: Vaccine | 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 | Du422.1 at dilution 50, measured at Month 6.5 | 1 Participants |
| Part A, Group 2: Vaccine | 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 | MW965.26 at dilution 80, measured at Month 6.5 | 7 Participants |
| Part A, Group 3: Placebo | 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 | Du422.1 at dilution 50, measured at Month 6.5 | 0 Participants |
| Part A, Group 3: Placebo | 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 | DU172.17 at dilution 50, measured at Month 6.5 | 0 Participants |
| Part A, Group 3: Placebo | 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 | Du422.1 at dilution 80, measured at Month 6.5 | 0 Participants |
| Part A, Group 3: Placebo | 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 | CH505TF at dilution 80, measured at Month 6.5 | 0 Participants |
| Part A, Group 3: Placebo | 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 | MW965.26 at dilution 50, measured at Month 6.5 | 0 Participants |
| Part A, Group 3: Placebo | 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 | CH505TF at dilution 50, measured at Month 6.5 | 0 Participants |
| Part A, Group 3: Placebo | 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 | DU172.17 at dilution 80, measured at Month 6.5 | 0 Participants |
| Part A, Group 3: Placebo | 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 | MW965.26 at dilution 80, measured at Month 6.5 | 0 Participants |
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.
Time frame: Measured at Month 4 for Part B
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A, Group 1: Vaccine | 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 | DU172.17 at dilution 50, measured at Month 4 | 0 Participants |
| Part A, Group 1: Vaccine | 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 | CH505TF at dilution 50, measured at Month 4 | 0 Participants |
| Part A, Group 1: Vaccine | 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 | DU172.17 at dilution 80, measured at Month 4 | 0 Participants |
| Part A, Group 1: Vaccine | 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 | MW965.26 at dilution 80, measured at Month 4 | 5 Participants |
| Part A, Group 1: Vaccine | 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 | MW965.26 at dilution 50, measured at Month 4 | 8 Participants |
| Part A, Group 1: Vaccine | 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 | Du422.1 at dilution 50, measured at Month 4 | 0 Participants |
| Part A, Group 1: Vaccine | 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 | CH505TF at dilution 80, measured at Month 4 | 0 Participants |
| Part A, Group 1: Vaccine | 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 | Du422.1 at dilution 80, measured at Month 4 | 0 Participants |
| Part A, Group 2: Vaccine | 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 | Du422.1 at dilution 80, measured at Month 4 | 0 Participants |
| Part A, Group 2: Vaccine | 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 | CH505TF at dilution 80, measured at Month 4 | 0 Participants |
| Part A, Group 2: Vaccine | 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 | MW965.26 at dilution 50, measured at Month 4 | 6 Participants |
| Part A, Group 2: Vaccine | 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 | MW965.26 at dilution 80, measured at Month 4 | 5 Participants |
| Part A, Group 2: Vaccine | 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 | DU172.17 at dilution 50, measured at Month 4 | 0 Participants |
| Part A, Group 2: Vaccine | 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 | DU172.17 at dilution 80, measured at Month 4 | 0 Participants |
| Part A, Group 2: Vaccine | 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 | CH505TF at dilution 50, measured at Month 4 | 0 Participants |
| Part A, Group 2: Vaccine | 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 | Du422.1 at dilution 50, measured at Month 4 | 0 Participants |
| Part A, Group 3: Placebo | 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 | MW965.26 at dilution 80, measured at Month 4 | 0 Participants |
| Part A, Group 3: Placebo | 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 | CH505TF at dilution 80, measured at Month 4 | 0 Participants |
| Part A, Group 3: Placebo | 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 | CH505TF at dilution 50, measured at Month 4 | 1 Participants |
| Part A, Group 3: Placebo | 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 | DU172.17 at dilution 50, measured at Month 4 | 1 Participants |
| Part A, Group 3: Placebo | 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 | DU172.17 at dilution 80, measured at Month 4 | 0 Participants |
| Part A, Group 3: Placebo | 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 | Du422.1 at dilution 50, measured at Month 4 | 1 Participants |
| Part A, Group 3: Placebo | 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 | Du422.1 at dilution 80, measured at Month 4 | 0 Participants |
| Part A, Group 3: Placebo | 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 | MW965.26 at dilution 50, measured at Month 4 | 0 Participants |
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.
Time frame: Measured at Month 1 for both Part A and Part B
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A, Group 1: Vaccine | 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) | ENV-2-PTEG-SEQ for CD8+ T Cells, measured at Month 1 | 0 Participants |
| Part A, Group 1: Vaccine | 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) | ENV-2-PTEG-SEQ for CD4+ T Cells, measured at Month 1 | 1 Participants |
| Part A, Group 1: Vaccine | 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) | Any Env for CD8+ T Cells, measured at Month 1 | 1 Participants |
| Part A, Group 1: Vaccine | 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) | ENV-1-PTEG-SEQ for CD8+ T Cells, measured at Month 1 | 1 Participants |
| Part A, Group 1: Vaccine | 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) | ENV-1-PTEG-SEQ for CD4+ T Cells, measured at Month 1 | 0 Participants |
| Part A, Group 1: Vaccine | 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) | Any Env for CD4+ T Cells, measured at Month 1 | 1 Participants |
| Part A, Group 2: Vaccine | 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) | ENV-1-PTEG-SEQ for CD8+ T Cells, measured at Month 1 | 2 Participants |
| Part A, Group 2: Vaccine | 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) | Any Env for CD8+ T Cells, measured at Month 1 | 2 Participants |
| Part A, Group 2: Vaccine | 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) | Any Env for CD4+ T Cells, measured at Month 1 | 3 Participants |
| Part A, Group 2: Vaccine | 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) | ENV-1-PTEG-SEQ for CD4+ T Cells, measured at Month 1 | 3 Participants |
| Part A, Group 2: Vaccine | 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) | ENV-2-PTEG-SEQ for CD4+ T Cells, measured at Month 1 | 2 Participants |
| Part A, Group 2: Vaccine | 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) | ENV-2-PTEG-SEQ for CD8+ T Cells, measured at Month 1 | 1 Participants |
| Part A, Group 3: Placebo | 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) | Any Env for CD4+ T Cells, measured at Month 1 | 0 Participants |
| Part A, Group 3: Placebo | 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) | Any Env for CD8+ T Cells, measured at Month 1 | 1 Participants |
| Part A, Group 3: Placebo | 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) | ENV-1-PTEG-SEQ for CD8+ T Cells, measured at Month 1 | 1 Participants |
| Part A, Group 3: Placebo | 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) | ENV-2-PTEG-SEQ for CD8+ T Cells, measured at Month 1 | 0 Participants |
| Part A, Group 3: Placebo | 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) | ENV-1-PTEG-SEQ for CD4+ T Cells, measured at Month 1 | 0 Participants |
| Part A, Group 3: Placebo | 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) | ENV-2-PTEG-SEQ for CD4+ T Cells, measured at Month 1 | 0 Participants |
| Part B, Group 4: Vaccine | 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) | ENV-1-PTEG-SEQ for CD8+ T Cells, measured at Month 1 | 4 Participants |
| Part B, Group 4: Vaccine | 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) | Any Env for CD8+ T Cells, measured at Month 1 | 5 Participants |
| Part B, Group 4: Vaccine | 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) | ENV-2-PTEG-SEQ for CD8+ T Cells, measured at Month 1 | 1 Participants |
| Part B, Group 4: Vaccine | 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) | Any Env for CD4+ T Cells, measured at Month 1 | 3 Participants |
| Part B, Group 4: Vaccine | 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) | ENV-2-PTEG-SEQ for CD4+ T Cells, measured at Month 1 | 3 Participants |
| Part B, Group 4: Vaccine | 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) | ENV-1-PTEG-SEQ for CD4+ T Cells, measured at Month 1 | 0 Participants |
| Part B, Group 5: Vaccine | 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) | Any Env for CD4+ T Cells, measured at Month 1 | 7 Participants |
| Part B, Group 5: Vaccine | 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) | ENV-2-PTEG-SEQ for CD8+ T Cells, measured at Month 1 | 4 Participants |
| Part B, Group 5: Vaccine | 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) | Any Env for CD8+ T Cells, measured at Month 1 | 5 Participants |
| Part B, Group 5: Vaccine | 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) | ENV-1-PTEG-SEQ for CD4+ T Cells, measured at Month 1 | 6 Participants |
| Part B, Group 5: Vaccine | 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) | ENV-1-PTEG-SEQ for CD8+ T Cells, measured at Month 1 | 4 Participants |
| Part B, Group 5: Vaccine | 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) | ENV-2-PTEG-SEQ for CD4+ T Cells, measured at Month 1 | 6 Participants |
| Part B, Group 6: Placebo | 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) | ENV-2-PTEG-SEQ for CD4+ T Cells, measured at Month 1 | 0 Participants |
| Part B, Group 6: Placebo | 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) | ENV-1-PTEG-SEQ for CD8+ T Cells, measured at Month 1 | 0 Participants |
| Part B, Group 6: Placebo | 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) | ENV-1-PTEG-SEQ for CD4+ T Cells, measured at Month 1 | 0 Participants |
| Part B, Group 6: Placebo | 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) | Any Env for CD8+ T Cells, measured at Month 1 | 0 Participants |
| Part B, Group 6: Placebo | 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) | Any Env for CD4+ T Cells, measured at Month 1 | 0 Participants |
| Part B, Group 6: Placebo | 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) | ENV-2-PTEG-SEQ for CD8+ T Cells, measured at Month 1 | 0 Participants |
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.
Time frame: Measured at Month 1 for both Part A and Part B
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A, Group 1: Vaccine | Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp70-CAP210.2.00.E8 V1V2 measured at Month 1 | 0 Participants |
| Part A, Group 1: Vaccine | Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | TV1c8_D11gp120.avi/293F measured at Month 1 | 1 Participants |
| Part A, Group 1: Vaccine | Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp70-TV1.21 V1V2 measured at Month 1 | 1 Participants |
| Part A, Group 1: Vaccine | Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp70-Du156.12 V1V2 measured at Month 1 | 0 Participants |
| Part A, Group 1: Vaccine | Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp70-ConC V1V2 measured at Month 1 | 0 Participants |
| Part A, Group 1: Vaccine | Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | Du156_D11gp120.avi/293F measured at Month 1 | 1 Participants |
| Part A, Group 1: Vaccine | Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp70-CAP45.2.00.G3 V1V2 measured at Month 1 | 0 Participants |
| Part A, Group 1: Vaccine | Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | CH0505_CON D7gp120_avi/293F/Mon measured at Month 1 | 0 Participants |
| Part A, Group 1: Vaccine | Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp70_CH505TF_V1V2_N156KN160K_avi/293F measured at Month 1 | 0 Participants |
| Part A, Group 1: Vaccine | Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp70-Ce1086_B2 V1V2 measured at Month 1 | 0 Participants |
| Part A, Group 1: Vaccine | Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp70-Ce704010042_2ES V1V2 measured at Month 1 | 0 Participants |
| Part A, Group 1: Vaccine | Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | CAP45_D11gp120.avi/293F measured at Month 1 | 0 Participants |
| Part A, Group 1: Vaccine | Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp70-Ce1176 V1V2 measured at Month 1 | 0 Participants |
| Part A, Group 1: Vaccine | Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp70-96ZM651.02 V1v2 measured at Month 1 | 1 Participants |
| Part A, Group 1: Vaccine | Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp41 measured at Month 1 | 2 Participants |
| Part A, Group 1: Vaccine | Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | Con S gp140 CFI measured at Month 1 | 1 Participants |
| Part A, Group 1: Vaccine | Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | CAP210_D11gp120.avi/293F measured at Month 1 | 0 Participants |
| Part A, Group 1: Vaccine | Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | 96ZM651.D11gp120.avi measured at Month 1 | 0 Participants |
| Part A, Group 1: Vaccine | Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | 1641A7_D11gp120.avi/293F measured at Month 1 | 0 Participants |
| Part A, Group 1: Vaccine | Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp70-7060101641 V1V2 measured at Month 1 | 0 Participants |
| Part A, Group 1: Vaccine | Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp70-001428.2.42 V1V2 measured at Month 1 | 0 Participants |
| Part A, Group 1: Vaccine | Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | Con 6 gp120/B measured at Month 1 | 0 Participants |
| Part A, Group 1: Vaccine | Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | 1428_D11gp120.avi/293F measured at Month 1 | 0 Participants |
| Part A, Group 1: Vaccine | Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | 1394C9_G1.D11gp120.avi measured at Month 1 | 0 Participants |
| Part A, Group 1: Vaccine | Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp70-1394C9G1 V1V2 measured at Month 1 | 0 Participants |
| Part A, Group 1: Vaccine | Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | Ce0042_D11gp120.avi/293F measured at Month 1 | 0 Participants |
| Part A, Group 1: Vaccine | Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp70-1051.12.C22 V1V2 measured at Month 1 | 0 Participants |
| Part A, Group 1: Vaccine | Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | CH505TFD8N156KN160K_avi/293i Mon measured at Month 1 | 0 Participants |
| Part A, Group 1: Vaccine | Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | 1086C_D7gp120.avi/293F measured at Month 1 | 4 Participants |
| Part A, Group 1: Vaccine | Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp70_CH505TF_V1V2_avi/293F measured at Month 1 | 0 Participants |
| Part A, Group 1: Vaccine | Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp70-BF1266_431a_V1V2 measured at Month 1 | 0 Participants |
| Part A, Group 1: Vaccine | Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | CH505TF D7gp120d371_avi/293F/Mon measured at Month 1 | 0 Participants |
| Part A, Group 1: Vaccine | Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp70-1012.11.TC21.3257 V1V2 measured at Month 1 | 0 Participants |
| Part A, Group 2: Vaccine | Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp70-96ZM651.02 V1v2 measured at Month 1 | 0 Participants |
| Part A, Group 2: Vaccine | Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | Du156_D11gp120.avi/293F measured at Month 1 | 0 Participants |
| Part A, Group 2: Vaccine | Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | TV1c8_D11gp120.avi/293F measured at Month 1 | 0 Participants |
| Part A, Group 2: Vaccine | Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp41 measured at Month 1 | 0 Participants |
| Part A, Group 2: Vaccine | Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp70-001428.2.42 V1V2 measured at Month 1 | 0 Participants |
| Part A, Group 2: Vaccine | Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp70-1012.11.TC21.3257 V1V2 measured at Month 1 | 0 Participants |
| Part A, Group 2: Vaccine | Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp70-1051.12.C22 V1V2 measured at Month 1 | 0 Participants |
| Part A, Group 2: Vaccine | Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp70-BF1266_431a_V1V2 measured at Month 1 | 0 Participants |
| Part A, Group 2: Vaccine | Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp70-CAP210.2.00.E8 V1V2 measured at Month 1 | 1 Participants |
| Part A, Group 2: Vaccine | Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp70_CH505TF_V1V2_N156KN160K_avi/293F measured at Month 1 | 0 Participants |
| Part A, Group 2: Vaccine | Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp70-CAP45.2.00.G3 V1V2 measured at Month 1 | 0 Participants |
| Part A, Group 2: Vaccine | Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp70-Ce1176 V1V2 measured at Month 1 | 1 Participants |
| Part A, Group 2: Vaccine | Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp70_CH505TF_V1V2_avi/293F measured at Month 1 | 0 Participants |
| Part A, Group 2: Vaccine | Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp70-ConC V1V2 measured at Month 1 | 0 Participants |
| Part A, Group 2: Vaccine | Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp70-Du156.12 V1V2 measured at Month 1 | 0 Participants |
| Part A, Group 2: Vaccine | Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp70-TV1.21 V1V2 measured at Month 1 | 1 Participants |
| Part A, Group 2: Vaccine | Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | 1086C_D7gp120.avi/293F measured at Month 1 | 2 Participants |
| Part A, Group 2: Vaccine | Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | 1394C9_G1.D11gp120.avi measured at Month 1 | 0 Participants |
| Part A, Group 2: Vaccine | Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp70-1394C9G1 V1V2 measured at Month 1 | 0 Participants |
| Part A, Group 2: Vaccine | Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | 1428_D11gp120.avi/293F measured at Month 1 | 0 Participants |
| Part A, Group 2: Vaccine | Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp70-Ce704010042_2ES V1V2 measured at Month 1 | 0 Participants |
| Part A, Group 2: Vaccine | Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | 96ZM651.D11gp120.avi measured at Month 1 | 0 Participants |
| Part A, Group 2: Vaccine | Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | CAP210_D11gp120.avi/293F measured at Month 1 | 0 Participants |
| Part A, Group 2: Vaccine | Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | CAP45_D11gp120.avi/293F measured at Month 1 | 0 Participants |
| Part A, Group 2: Vaccine | Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp70-7060101641 V1V2 measured at Month 1 | 0 Participants |
| Part A, Group 2: Vaccine | Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | CH0505_CON D7gp120_avi/293F/Mon measured at Month 1 | 0 Participants |
| Part A, Group 2: Vaccine | Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | CH505TF D7gp120d371_avi/293F/Mon measured at Month 1 | 0 Participants |
| Part A, Group 2: Vaccine | Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp70-Ce1086_B2 V1V2 measured at Month 1 | 0 Participants |
| Part A, Group 2: Vaccine | Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | CH505TFD8N156KN160K_avi/293i Mon measured at Month 1 | 0 Participants |
| Part A, Group 2: Vaccine | Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | 1641A7_D11gp120.avi/293F measured at Month 1 | 0 Participants |
| Part A, Group 2: Vaccine | Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | Ce0042_D11gp120.avi/293F measured at Month 1 | 0 Participants |
| Part A, Group 2: Vaccine | Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | Con 6 gp120/B measured at Month 1 | 1 Participants |
| Part A, Group 2: Vaccine | Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | Con S gp140 CFI measured at Month 1 | 1 Participants |
| Part A, Group 3: Placebo | Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | 1086C_D7gp120.avi/293F measured at Month 1 | 0 Participants |
| Part A, Group 3: Placebo | Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | TV1c8_D11gp120.avi/293F measured at Month 1 | 0 Participants |
| Part A, Group 3: Placebo | Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | Con 6 gp120/B measured at Month 1 | 0 Participants |
| Part A, Group 3: Placebo | Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | CH0505_CON D7gp120_avi/293F/Mon measured at Month 1 | 0 Participants |
| Part A, Group 3: Placebo | Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | 96ZM651.D11gp120.avi measured at Month 1 | 0 Participants |
| Part A, Group 3: Placebo | Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp70-7060101641 V1V2 measured at Month 1 | 0 Participants |
| Part A, Group 3: Placebo | Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp70-Ce1086_B2 V1V2 measured at Month 1 | 0 Participants |
| Part A, Group 3: Placebo | Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp70-BF1266_431a_V1V2 measured at Month 1 | 0 Participants |
| Part A, Group 3: Placebo | Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp70-Ce704010042_2ES V1V2 measured at Month 1 | 0 Participants |
| Part A, Group 3: Placebo | Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | CH505TF D7gp120d371_avi/293F/Mon measured at Month 1 | 0 Participants |
| Part A, Group 3: Placebo | Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp70-1394C9G1 V1V2 measured at Month 1 | 0 Participants |
| Part A, Group 3: Placebo | Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp70-Ce1176 V1V2 measured at Month 1 | 0 Participants |
| Part A, Group 3: Placebo | Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp41 measured at Month 1 | 0 Participants |
| Part A, Group 3: Placebo | Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | Ce0042_D11gp120.avi/293F measured at Month 1 | 0 Participants |
| Part A, Group 3: Placebo | Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | CAP210_D11gp120.avi/293F measured at Month 1 | 0 Participants |
| Part A, Group 3: Placebo | Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp70_CH505TF_V1V2_avi/293F measured at Month 1 | 0 Participants |
| Part A, Group 3: Placebo | Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | 1641A7_D11gp120.avi/293F measured at Month 1 | 0 Participants |
| Part A, Group 3: Placebo | Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp70-1012.11.TC21.3257 V1V2 measured at Month 1 | 0 Participants |
| Part A, Group 3: Placebo | Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp70-96ZM651.02 V1v2 measured at Month 1 | 0 Participants |
| Part A, Group 3: Placebo | Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp70-ConC V1V2 measured at Month 1 | 0 Participants |
| Part A, Group 3: Placebo | Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp70-001428.2.42 V1V2 measured at Month 1 | 0 Participants |
| Part A, Group 3: Placebo | Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp70-Du156.12 V1V2 measured at Month 1 | 0 Participants |
| Part A, Group 3: Placebo | Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp70-CAP45.2.00.G3 V1V2 measured at Month 1 | 0 Participants |
| Part A, Group 3: Placebo | Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | 1394C9_G1.D11gp120.avi measured at Month 1 | 0 Participants |
| Part A, Group 3: Placebo | Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | CH505TFD8N156KN160K_avi/293i Mon measured at Month 1 | 0 Participants |
| Part A, Group 3: Placebo | Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp70-CAP210.2.00.E8 V1V2 measured at Month 1 | 0 Participants |
| Part A, Group 3: Placebo | Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp70-TV1.21 V1V2 measured at Month 1 | 0 Participants |
| Part A, Group 3: Placebo | Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | Du156_D11gp120.avi/293F measured at Month 1 | 0 Participants |
| Part A, Group 3: Placebo | Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | CAP45_D11gp120.avi/293F measured at Month 1 | 0 Participants |
| Part A, Group 3: Placebo | Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | 1428_D11gp120.avi/293F measured at Month 1 | 0 Participants |
| Part A, Group 3: Placebo | Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp70-1051.12.C22 V1V2 measured at Month 1 | 0 Participants |
| Part A, Group 3: Placebo | Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | Con S gp140 CFI measured at Month 1 | 0 Participants |
| Part A, Group 3: Placebo | Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp70_CH505TF_V1V2_N156KN160K_avi/293F measured at Month 1 | 0 Participants |
| Part B, Group 4: Vaccine | Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | 1086C_D7gp120.avi/293F measured at Month 1 | 6 Participants |
| Part B, Group 4: Vaccine | Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp70-001428.2.42 V1V2 measured at Month 1 | 0 Participants |
| Part B, Group 4: Vaccine | Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp70-BF1266_431a_V1V2 measured at Month 1 | 0 Participants |
| Part B, Group 4: Vaccine | Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | 1394C9_G1.D11gp120.avi measured at Month 1 | 0 Participants |
| Part B, Group 4: Vaccine | Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | Du156_D11gp120.avi/293F measured at Month 1 | 7 Participants |
| Part B, Group 4: Vaccine | Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | Con S gp140 CFI measured at Month 1 | 9 Participants |
| Part B, Group 4: Vaccine | Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | 1428_D11gp120.avi/293F measured at Month 1 | 1 Participants |
| Part B, Group 4: Vaccine | Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp70-Ce1176 V1V2 measured at Month 1 | 0 Participants |
| Part B, Group 4: Vaccine | Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp41 measured at Month 1 | 8 Participants |
| Part B, Group 4: Vaccine | Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | Ce0042_D11gp120.avi/293F measured at Month 1 | 0 Participants |
| Part B, Group 4: Vaccine | Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | 96ZM651.D11gp120.avi measured at Month 1 | 0 Participants |
| Part B, Group 4: Vaccine | Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp70-1394C9G1 V1V2 measured at Month 1 | 0 Participants |
| Part B, Group 4: Vaccine | Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp70-CAP45.2.00.G3 V1V2 measured at Month 1 | 0 Participants |
| Part B, Group 4: Vaccine | Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | CAP210_D11gp120.avi/293F measured at Month 1 | 1 Participants |
| Part B, Group 4: Vaccine | Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp70_CH505TF_V1V2_avi/293F measured at Month 1 | 0 Participants |
| Part B, Group 4: Vaccine | Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp70-96ZM651.02 V1v2 measured at Month 1 | 4 Participants |
| Part B, Group 4: Vaccine | Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | TV1c8_D11gp120.avi/293F measured at Month 1 | 8 Participants |
| Part B, Group 4: Vaccine | Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | CAP45_D11gp120.avi/293F measured at Month 1 | 1 Participants |
| Part B, Group 4: Vaccine | Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | CH0505_CON D7gp120_avi/293F/Mon measured at Month 1 | 0 Participants |
| Part B, Group 4: Vaccine | Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | Con 6 gp120/B measured at Month 1 | 1 Participants |
| Part B, Group 4: Vaccine | Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | CH505TF D7gp120d371_avi/293F/Mon measured at Month 1 | 0 Participants |
| Part B, Group 4: Vaccine | Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp70-7060101641 V1V2 measured at Month 1 | 0 Participants |
| Part B, Group 4: Vaccine | Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | 1641A7_D11gp120.avi/293F measured at Month 1 | 3 Participants |
| Part B, Group 4: Vaccine | Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp70-Ce1086_B2 V1V2 measured at Month 1 | 1 Participants |
| Part B, Group 4: Vaccine | Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp70-Ce704010042_2ES V1V2 measured at Month 1 | 0 Participants |
| Part B, Group 4: Vaccine | Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp70_CH505TF_V1V2_N156KN160K_avi/293F measured at Month 1 | 0 Participants |
| Part B, Group 4: Vaccine | Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp70-1012.11.TC21.3257 V1V2 measured at Month 1 | 0 Participants |
| Part B, Group 4: Vaccine | Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp70-ConC V1V2 measured at Month 1 | 0 Participants |
| Part B, Group 4: Vaccine | Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp70-CAP210.2.00.E8 V1V2 measured at Month 1 | 0 Participants |
| Part B, Group 4: Vaccine | Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp70-TV1.21 V1V2 measured at Month 1 | 0 Participants |
| Part B, Group 4: Vaccine | Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp70-1051.12.C22 V1V2 measured at Month 1 | 0 Participants |
| Part B, Group 4: Vaccine | Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp70-Du156.12 V1V2 measured at Month 1 | 0 Participants |
| Part B, Group 4: Vaccine | Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | CH505TFD8N156KN160K_avi/293i Mon measured at Month 1 | 1 Participants |
| Part B, Group 5: Vaccine | Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp70-Ce1086_B2 V1V2 measured at Month 1 | 1 Participants |
| Part B, Group 5: Vaccine | Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | 1641A7_D11gp120.avi/293F measured at Month 1 | 1 Participants |
| Part B, Group 5: Vaccine | Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | Ce0042_D11gp120.avi/293F measured at Month 1 | 0 Participants |
| Part B, Group 5: Vaccine | Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp70-1012.11.TC21.3257 V1V2 measured at Month 1 | 2 Participants |
| Part B, Group 5: Vaccine | Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp70-1051.12.C22 V1V2 measured at Month 1 | 2 Participants |
| Part B, Group 5: Vaccine | Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp70-1394C9G1 V1V2 measured at Month 1 | 2 Participants |
| Part B, Group 5: Vaccine | Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp70-7060101641 V1V2 measured at Month 1 | 0 Participants |
| Part B, Group 5: Vaccine | Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp70-96ZM651.02 V1v2 measured at Month 1 | 1 Participants |
| Part B, Group 5: Vaccine | Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp70-BF1266_431a_V1V2 measured at Month 1 | 2 Participants |
| Part B, Group 5: Vaccine | Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp70-CAP210.2.00.E8 V1V2 measured at Month 1 | 3 Participants |
| Part B, Group 5: Vaccine | Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp70-CAP45.2.00.G3 V1V2 measured at Month 1 | 1 Participants |
| Part B, Group 5: Vaccine | Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp70-Ce1176 V1V2 measured at Month 1 | 2 Participants |
| Part B, Group 5: Vaccine | Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp70-Ce704010042_2ES V1V2 measured at Month 1 | 0 Participants |
| Part B, Group 5: Vaccine | Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp70-Du156.12 V1V2 measured at Month 1 | 0 Participants |
| Part B, Group 5: Vaccine | Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp70-TV1.21 V1V2 measured at Month 1 | 2 Participants |
| Part B, Group 5: Vaccine | Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | 1086C_D7gp120.avi/293F measured at Month 1 | 5 Participants |
| Part B, Group 5: Vaccine | Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | 1394C9_G1.D11gp120.avi measured at Month 1 | 0 Participants |
| Part B, Group 5: Vaccine | Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | 1428_D11gp120.avi/293F measured at Month 1 | 0 Participants |
| Part B, Group 5: Vaccine | Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | 96ZM651.D11gp120.avi measured at Month 1 | 0 Participants |
| Part B, Group 5: Vaccine | Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | CAP210_D11gp120.avi/293F measured at Month 1 | 0 Participants |
| Part B, Group 5: Vaccine | Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | CAP45_D11gp120.avi/293F measured at Month 1 | 0 Participants |
| Part B, Group 5: Vaccine | Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | CH0505_CON D7gp120_avi/293F/Mon measured at Month 1 | 0 Participants |
| Part B, Group 5: Vaccine | Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | CH505TF D7gp120d371_avi/293F/Mon measured at Month 1 | 0 Participants |
| Part B, Group 5: Vaccine | Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | CH505TFD8N156KN160K_avi/293i Mon measured at Month 1 | 0 Participants |
| Part B, Group 5: Vaccine | Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | Con 6 gp120/B measured at Month 1 | 2 Participants |
| Part B, Group 5: Vaccine | Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | Con S gp140 CFI measured at Month 1 | 3 Participants |
| Part B, Group 5: Vaccine | Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | Du156_D11gp120.avi/293F measured at Month 1 | 2 Participants |
| Part B, Group 5: Vaccine | Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | TV1c8_D11gp120.avi/293F measured at Month 1 | 2 Participants |
| Part B, Group 5: Vaccine | Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp41 measured at Month 1 | 3 Participants |
| Part B, Group 5: Vaccine | Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp70-001428.2.42 V1V2 measured at Month 1 | 2 Participants |
| Part B, Group 5: Vaccine | Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp70-ConC V1V2 measured at Month 1 | 1 Participants |
| Part B, Group 5: Vaccine | Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp70_CH505TF_V1V2_N156KN160K_avi/293F measured at Month 1 | 0 Participants |
| Part B, Group 5: Vaccine | Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp70_CH505TF_V1V2_avi/293F measured at Month 1 | 1 Participants |
| Part B, Group 6: Placebo | Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | Du156_D11gp120.avi/293F measured at Month 1 | 0 Participants |
| Part B, Group 6: Placebo | Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | Con S gp140 CFI measured at Month 1 | 0 Participants |
| Part B, Group 6: Placebo | Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp70-BF1266_431a_V1V2 measured at Month 1 | 0 Participants |
| Part B, Group 6: Placebo | Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | Con 6 gp120/B measured at Month 1 | 0 Participants |
| Part B, Group 6: Placebo | Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | Ce0042_D11gp120.avi/293F measured at Month 1 | 0 Participants |
| Part B, Group 6: Placebo | Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp70-CAP45.2.00.G3 V1V2 measured at Month 1 | 0 Participants |
| Part B, Group 6: Placebo | Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | CH505TF D7gp120d371_avi/293F/Mon measured at Month 1 | 0 Participants |
| Part B, Group 6: Placebo | Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | CH0505_CON D7gp120_avi/293F/Mon measured at Month 1 | 0 Participants |
| Part B, Group 6: Placebo | Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | CAP45_D11gp120.avi/293F measured at Month 1 | 0 Participants |
| Part B, Group 6: Placebo | Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp70-Ce1086_B2 V1V2 measured at Month 1 | 0 Participants |
| Part B, Group 6: Placebo | Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | CAP210_D11gp120.avi/293F measured at Month 1 | 0 Participants |
| Part B, Group 6: Placebo | Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | 96ZM651.D11gp120.avi measured at Month 1 | 0 Participants |
| Part B, Group 6: Placebo | Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | 1641A7_D11gp120.avi/293F measured at Month 1 | 0 Participants |
| Part B, Group 6: Placebo | Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp70-Ce1176 V1V2 measured at Month 1 | 0 Participants |
| Part B, Group 6: Placebo | Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | 1428_D11gp120.avi/293F measured at Month 1 | 0 Participants |
| Part B, Group 6: Placebo | Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | 1394C9_G1.D11gp120.avi measured at Month 1 | 0 Participants |
| Part B, Group 6: Placebo | Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | CH505TFD8N156KN160K_avi/293i Mon measured at Month 1 | 0 Participants |
| Part B, Group 6: Placebo | Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp70-ConC V1V2 measured at Month 1 | 0 Participants |
| Part B, Group 6: Placebo | Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | 1086C_D7gp120.avi/293F measured at Month 1 | 0 Participants |
| Part B, Group 6: Placebo | Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp70-TV1.21 V1V2 measured at Month 1 | 0 Participants |
| Part B, Group 6: Placebo | Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp70-Du156.12 V1V2 measured at Month 1 | 0 Participants |
| Part B, Group 6: Placebo | Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp70-Ce704010042_2ES V1V2 measured at Month 1 | 0 Participants |
| Part B, Group 6: Placebo | Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp70-CAP210.2.00.E8 V1V2 measured at Month 1 | 0 Participants |
| Part B, Group 6: Placebo | Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp70-96ZM651.02 V1v2 measured at Month 1 | 0 Participants |
| Part B, Group 6: Placebo | Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp70-7060101641 V1V2 measured at Month 1 | 0 Participants |
| Part B, Group 6: Placebo | Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp70_CH505TF_V1V2_avi/293F measured at Month 1 | 0 Participants |
| Part B, Group 6: Placebo | Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp70_CH505TF_V1V2_N156KN160K_avi/293F measured at Month 1 | 0 Participants |
| Part B, Group 6: Placebo | Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp70-1051.12.C22 V1V2 measured at Month 1 | 0 Participants |
| Part B, Group 6: Placebo | Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp70-1012.11.TC21.3257 V1V2 measured at Month 1 | 0 Participants |
| Part B, Group 6: Placebo | Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp70-001428.2.42 V1V2 measured at Month 1 | 0 Participants |
| Part B, Group 6: Placebo | Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp70-1394C9G1 V1V2 measured at Month 1 | 0 Participants |
| Part B, Group 6: Placebo | Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | gp41 measured at Month 1 | 0 Participants |
| Part B, Group 6: Placebo | Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B) | TV1c8_D11gp120.avi/293F measured at Month 1 | 0 Participants |
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.
Time frame: Measured at Month 1 for both Part A and Part B
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A, Group 1: Vaccine | 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) | CH505TF at dilution 80, measured at Month 1 | 0 Participants |
| Part A, Group 1: Vaccine | 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) | Du422.1 at dilution 80, measured at Month 1 | 0 Participants |
| Part A, Group 1: Vaccine | 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) | CH505TF at dilution 50, measured at Month 1 | 0 Participants |
| Part A, Group 1: Vaccine | 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) | MW965.26 at dilution 80, measured at Month 1 | 0 Participants |
| Part A, Group 1: Vaccine | 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) | MW965.26 at dilution 50, measured at Month 1 | 0 Participants |
| Part A, Group 1: Vaccine | 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) | DU172.17 at dilution 50, measured at Month 1 | 0 Participants |
| Part A, Group 1: Vaccine | 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) | DU172.17 at dilution 80, measured at Month 1 | 0 Participants |
| Part A, Group 1: Vaccine | 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) | Du422.1 at dilution 50, measured at Month 1 | 0 Participants |
| Part A, Group 2: Vaccine | 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) | CH505TF at dilution 50, measured at Month 1 | 1 Participants |
| Part A, Group 2: Vaccine | 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) | DU172.17 at dilution 80, measured at Month 1 | 0 Participants |
| Part A, Group 2: Vaccine | 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) | MW965.26 at dilution 50, measured at Month 1 | 0 Participants |
| Part A, Group 2: Vaccine | 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) | DU172.17 at dilution 50, measured at Month 1 | 0 Participants |
| Part A, Group 2: Vaccine | 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) | MW965.26 at dilution 80, measured at Month 1 | 0 Participants |
| Part A, Group 2: Vaccine | 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) | Du422.1 at dilution 50, measured at Month 1 | 0 Participants |
| Part A, Group 2: Vaccine | 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) | Du422.1 at dilution 80, measured at Month 1 | 0 Participants |
| Part A, Group 2: Vaccine | 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) | CH505TF at dilution 80, measured at Month 1 | 0 Participants |
| Part A, Group 3: Placebo | 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) | Du422.1 at dilution 80, measured at Month 1 | 0 Participants |
| Part A, Group 3: Placebo | 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) | CH505TF at dilution 80, measured at Month 1 | 0 Participants |
| Part A, Group 3: Placebo | 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) | CH505TF at dilution 50, measured at Month 1 | 0 Participants |
| Part A, Group 3: Placebo | 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) | Du422.1 at dilution 50, measured at Month 1 | 0 Participants |
| Part A, Group 3: Placebo | 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) | DU172.17 at dilution 80, measured at Month 1 | 0 Participants |
| Part A, Group 3: Placebo | 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) | MW965.26 at dilution 80, measured at Month 1 | 0 Participants |
| Part A, Group 3: Placebo | 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) | MW965.26 at dilution 50, measured at Month 1 | 0 Participants |
| Part A, Group 3: Placebo | 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) | DU172.17 at dilution 50, measured at Month 1 | 0 Participants |
| Part B, Group 4: Vaccine | 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) | MW965.26 at dilution 50, measured at Month 1 | 1 Participants |
| Part B, Group 4: Vaccine | 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) | MW965.26 at dilution 80, measured at Month 1 | 0 Participants |
| Part B, Group 4: Vaccine | 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) | CH505TF at dilution 80, measured at Month 1 | 0 Participants |
| Part B, Group 4: Vaccine | 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) | DU172.17 at dilution 50, measured at Month 1 | 2 Participants |
| Part B, Group 4: Vaccine | 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) | DU172.17 at dilution 80, measured at Month 1 | 0 Participants |
| Part B, Group 4: Vaccine | 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) | CH505TF at dilution 50, measured at Month 1 | 1 Participants |
| Part B, Group 4: Vaccine | 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) | Du422.1 at dilution 50, measured at Month 1 | 1 Participants |
| Part B, Group 4: Vaccine | 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) | Du422.1 at dilution 80, measured at Month 1 | 0 Participants |
| Part B, Group 5: Vaccine | 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) | Du422.1 at dilution 50, measured at Month 1 | 0 Participants |
| Part B, Group 5: Vaccine | 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) | MW965.26 at dilution 50, measured at Month 1 | 0 Participants |
| Part B, Group 5: Vaccine | 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) | Du422.1 at dilution 80, measured at Month 1 | 0 Participants |
| Part B, Group 5: Vaccine | 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) | DU172.17 at dilution 80, measured at Month 1 | 0 Participants |
| Part B, Group 5: Vaccine | 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) | DU172.17 at dilution 50, measured at Month 1 | 0 Participants |
| Part B, Group 5: Vaccine | 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) | CH505TF at dilution 80, measured at Month 1 | 0 Participants |
| Part B, Group 5: Vaccine | 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) | MW965.26 at dilution 80, measured at Month 1 | 0 Participants |
| Part B, Group 5: Vaccine | 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) | CH505TF at dilution 50, measured at Month 1 | 0 Participants |
| Part B, Group 6: Placebo | 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) | MW965.26 at dilution 80, measured at Month 1 | 0 Participants |
| Part B, Group 6: Placebo | 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) | CH505TF at dilution 50, measured at Month 1 | 0 Participants |
| Part B, Group 6: Placebo | 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) | CH505TF at dilution 80, measured at Month 1 | 0 Participants |
| Part B, Group 6: Placebo | 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) | DU172.17 at dilution 50, measured at Month 1 | 0 Participants |
| Part B, Group 6: Placebo | 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) | DU172.17 at dilution 80, measured at Month 1 | 0 Participants |
| Part B, Group 6: Placebo | 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) | Du422.1 at dilution 50, measured at Month 1 | 0 Participants |
| Part B, Group 6: Placebo | 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) | Du422.1 at dilution 80, measured at Month 1 | 0 Participants |
| Part B, Group 6: Placebo | 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) | MW965.26 at dilution 50, measured at Month 1 | 0 Participants |