HIV Infections
Conditions
Keywords
HIV
Brief summary
The purpose of this study is to evaluate the safety and immune response to an HIV clade C vaccine and to an MF59- or alum-adjuvanted clade C Env protein in healthy, HIV-uninfected adults.
Detailed description
This study will evaluate the safety, tolerability, and immunogenicity to vCP2438 (an HIV clade C vaccine) and to an unadjuvanted or MF59- or alum-adjuvanted bivalent clade C gp120 in healthy, HIV-uninfected adults. The study will enroll healthy, HIV-uninfected participants aged 18 to 40 years. Participants will be randomly assigned to one of 4 groups. \[describe further\] Study visits will include a physical examination, an interview and/or questionnaire, HIV testing and HIV risk-reduction counseling, and urine and blood collection. A subset of participants will provide rectal fluid, cervical fluid, semen, or stool samples.
Interventions
BIOLOGICALALVAC-HIV (vCP2438)
Expresses the gene products ZM96 gp120 (clade C strain) linked to the sequences encoding the HIV-1 transmembrane (TM) anchor sequence of gp41 (28 amino acids clade B LAI strain) and gag and pro (clade B LAI strain); formulated as a lyophilized vaccine for injection at a viral titer ≥ 1 × 10\^6 cell culture infectious dose (CCID)50 and \< 1 × 10\^8 CCID50 (nominal dose of 10\^7 CCID50) and reconstituted with 1mL of sterile sodium chloride solution (NaCl 0.4%) for intramuscular (IM) injection as a single dose
BIOLOGICALBivalent Subtype C gp120/MF59
Consists of 2 subtype C recombinant monomeric proteins, TV1.C gp120 Env and 1086.C gp120 Env, each at a dose of 100 mcg, mixed with MF59 adjuvant (an oil-in-water emulsion); delivered as a 0.5 mL IM injection
BIOLOGICALBivalent Subtype C gp120 admixed with Al(OH)3 Suspension
Consists of 2 subtype C recombinant monomeric proteins, TV1.C gp120 Env and 1086.C gp120 Env, each at a dose of 100 mcg, admixed with Aluminum Hydroxide Suspension (\~625 mcg aluminum content); delivered as a 0.5 mL IM injection
BIOLOGICALBivalent Subtype C gp120
Consists of 2 subtype C recombinant monomeric proteins, TV1.C gp120 Env and 1086.C gp120 Env, each at a dose of 100 mcg, mixed with sodium chloride for injection, 0.9%; delivered as a 0.5 mL IM injection
Sponsors
National Institute of Allergy and Infectious Diseases (NIAID)
HIV Vaccine Trials Network
Sanofi Pasteur, a Sanofi Company
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
General and Demographic Criteria 1. Age of 18 to 40 years 2. Access to a participating HVTN CRS and willingness to be followed for the planned duration of the study 3. Ability and willingness to provide informed consent 4. Assessment of understanding: volunteer demonstrates understanding of this study; completes a questionnaire prior to first vaccination with verbal demonstration of understanding of all questionnaire items answered incorrectly 5. Agrees not to enroll in another study of an investigational research agent 6. Good general health as shown by medical history, physical exam, and screening laboratory tests HIV-Related Criteria: 7. Willingness to receive HIV test results 8. Willingness to discuss HIV infection risks and amenable to HIV risk reduction counseling. 9. Assessed by the clinic staff as being at "low risk" for HIV infection and committed to maintaining behavior consistent with low risk of HIV exposure through the last required protocol clinic visit. Laboratory Inclusion Values Hemogram/Complete blood count (CBC) 10. Hemoglobin ≥ 11.0 g/dL for volunteers who were born female, ≥ 13.0 g/dL for volunteers who were born male 11. White blood cell count = 3,300 to 12,000 cells/mm\^3 12. Total lymphocyte count ≥ 800 cells/mm\^3 13. Remaining differential either within institutional normal range or with site physician approval 14. Platelets = 125,000 to 550,000/mm\^3 Chemistry 15. Chemistry panel: ALT, AST, and ALP \< 1.25 times the institutional upper limit of normal; creatinine ≤ institutional upper limit of normal. Virology 16. Negative HIV-1 and -2 blood test: Sites may use locally available assays that have been approved by HVTN Laboratory Operations. 17. Negative Hepatitis B surface antigen (HBsAg) 18. Negative anti-Hepatitis C virus antibodies (anti-HCV), or negative HCV polymerase chain reaction (PCR) if the anti-HCV is positive Urine 19. Normal urine: * Negative urine glucose, and * Negative or trace urine protein, and * Negative or trace urine hemoglobin (if trace hemoglobin is present on dipstick, a microscopic urinalysis with red blood cells levels within institutional normal range). Reproductive Status 20. Volunteers who were born female: negative serum or urine beta human chorionic gonadotropin (β-HCG) pregnancy test performed prior to vaccination on the day of initial vaccination. Persons who are NOT of reproductive potential due to having undergone total hysterectomy or bilateral oophorectomy (verified by medical records), are not required to undergo pregnancy testing. 21. Reproductive status: A volunteer who was born female must: * Agree to consistently use effective contraception for sexual activity that could lead to pregnancy from at least 21 days prior to enrollment through the last required protocol clinic visit. Effective contraception is defined as using condoms (male or female), or diaphragm or cervical cap, PLUS 1 of the following methods: Intrauterine device (IUD), Hormonal contraception (in accordance with Republic of South Africa: National Contraception Clinical Guidelines), successful vasectomy in the male partner (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 any other contraceptive method approved by the HVTN 107 Protocol Safety Review Team * Or not be of reproductive potential, such as having reached menopause (no menses for 1 year) or having undergone hysterectomy, bilateral oophorectomy, or tubal ligation; * Or be sexually abstinent. 22. Volunteers who were born female must also agree not to seek pregnancy through alternative methods, such as artificial insemination or in vitro fertilization until after the last required protocol clinic visit Other 23. Volunteers who were born female consenting to provide cervical samples: pap smear within the 3 years prior to enrollment, with the latest result reported as normal or ASCUS (atypical squamous cells of undetermined significance); for those 21 years and older that have not had a pap smear within the last 3 years prior to enrollment, must be willing to undergo a pap smear with the result reported as normal or ASCUS prior to sample collection.
Exclusion criteria
General 1. Blood products received within 120 days before first vaccination 2. Investigational research agents received within 30 days before first vaccination 3. Body mass index (BMI) ≥ 40; or BMI ≥ 35 with 2 or more of the following: systolic blood pressure \> 140 mm Hg, diastolic blood pressure \> 90 mm Hg, current smoker, known hyperlipidemia 4. Intent to participate in another study of an investigational research agent or any other study that requires non-HVTN HIV antibody testing during the planned duration of the HVTN 107 study 5. Pregnant or breastfeeding Vaccines and other Injections 6. HIV vaccine(s) received in a prior HIV vaccine trial. For volunteers who have received control/placebo in an HIV vaccine trial, the HVTN 107 PSRT will determine eligibility on a case-by-case basis. 7. Non-HIV experimental vaccine(s) received within the last 5 years in a prior vaccine trial. Exceptions may be made for vaccines that have subsequently undergone licensure in a volunteer's country of residence. For volunteers who have received control/placebo in an experimental vaccine trial, the HVTN 107 PSRT will determine eligibility on a case-by-case basis. For volunteers who have received an experimental vaccine(s) greater than 5 years ago, eligibility for enrollment will be determined by the HVTN 107 PSRT on a case-by-case basis. 8. Live attenuated vaccines other than influenza vaccine received within 30 days before first vaccination or scheduled within 14 days after injection (eg, measles, mumps, and rubella \[MMR\]; oral polio vaccine \[OPV\]; varicella; yellow fever) 9. Influenza vaccine or any vaccines that are not live attenuated vaccines and were received within 14 days prior to first vaccination (eg, tetanus, pneumococcal, Hepatitis A or B) 10. Allergy treatment with antigen injections within 30 days before first vaccination or that are scheduled within 14 days after first vaccination Immune System 11. Immunosuppressive medications received within 168 days before first vaccination. (Not exclusionary: \[1\] corticosteroid nasal spray; \[2\] inhaled corticosteroids; \[3\] topical corticosteroids for mild, uncomplicated dermatitis; or \[4\] a single course of oral/parenteral corticosteroids at doses \< 2 mg/kg/day and length of therapy \< 11 days with completion at least 30 days prior to enrollment.) 12. Serious adverse reactions to vaccines or to vaccine components such as eggs, egg products, or neomycin, including history of anaphylaxis and related symptoms such as hives, respiratory difficulty, angioedema, and/or abdominal pain. (Not excluded from participation: a volunteer who had a nonanaphylactic adverse reaction to pertussis vaccine as a child.) 13. Immunoglobulin received within 60 days before first vaccination 14. Autoimmune disease 15. Immunodeficiency Clinically significant medical conditions 16. Untreated or incompletely treated syphilis infection 17. 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 |
|---|---|---|
| Occurrence of Vaccine-induced Systemic IgG Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C) in Group 1 and Group 2 | Measured at Month 6.5 | Serum IgG responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay, run at 1:50 dilution. The readout is background-subtracted mean fluorescent intensity (MFI), with background adjustment for an antigen-specific plate level control. For each sample, response magnitude is net MFI, defined as experimental antigen MFI minus reference antigen MFI. Net MFI \< 1 is set to 1, and net MFI \> 22,000 is set to 22,000. Data are excluded if blood draw date was outside the allowable window, a participant was HIV-infected, reference antigen \> 5,000 MFI, or baseline net MFI \> 6,500. Samples from post-enrollment visits have positive responses if they meet three criteria: (1) net MFI greater than or equal to an antigen-specific response threshold (defined as the maximum of 100 and the 95th percentile of baseline net MFI), (2) net MFI values are greater than 3 times baseline net MFI, and (3) experimental antigen MFI values are greater than 3 times baseline MFI. |
| Level of Vaccine-induced Systemic IgG Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C) in Group 1 and Group 2 | Measured at Month 6.5 | Serum IgG responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay, run at 1:50 dilution. The readout is background-subtracted mean fluorescent intensity (MFI), with background adjustment for an antigen-specific plate level control. For each sample, response magnitude is net MFI, defined as experimental antigen MFI minus reference antigen MFI. Net MFI \< 1 is set to 1, and net MFI \> 22,000 is set to 22,000. Data are excluded if blood draw date was outside the allowable window, a participant was HIV-infected, reference antigen \> 5,000 MFI, or baseline net MFI \> 6,500. Comparisons were performed among positive responders only (positivity criteria are described in Outcome 1). |
| Occurrence of Vaccine-induced Serum IgA Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C) in Group 1 and Group 3 | Measured at Month 6.5 | Serum IgA responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay, run at 1:10 dilution. The readout is background-subtracted mean fluorescent intensity (MFI), with background adjustment for an antigen-specific plate level control. For each sample, response magnitude is net MFI, defined as experimental antigen MFI minus reference antigen MFI. Net MFI \< 1 is set to 1, and net MFI \> 22,000 is set to 22,000. Data are excluded if blood draw date was outside the allowable window, a participant was HIV-infected, reference antigen \> 5,000 MFI, or baseline net MFI \> 6,500. Samples from post-enrollment visits have positive responses if they meet three criteria: (1) net MFI greater than or equal to an antigen-specific response threshold (defined as the maximum of 100 and the 95th percentile of baseline net MFI), (2) net MFI values are greater than 3 times baseline net MFI, and (3) experimental antigen MFI values are greater than 3 times baseline MFI. |
| Level of Vaccine-induced Serum IgA Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C) in Group 1 and Group 3 | Measured at Month 6.5 | Serum IgA responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay, run at 1:10 dilution. The readout is background-subtracted mean fluorescent intensity (MFI), with background adjustment for an antigen-specific plate level control. For each sample, response magnitude is net MFI, defined as experimental antigen MFI minus reference antigen MFI. Net MFI \< 1 is set to 1, and net MFI \> 22,000 is set to 22,000. Data are excluded if blood draw date was outside the allowable window, a participant was HIV-infected, reference antigen \> 5,000 MFI, or baseline net MFI \> 6,500. Comparisons were performed among positive responders only (positivity criteria are described in Outcome 1). |
| Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Measured through Month Measured through 3 days after each vaccine dose at Months 0, 1, 3, 6, and 12 | 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 Month Measured through 3 days after each vaccine dose at Months 0, 1, 3, 6, and 12 | 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 Month Measured through 3 days after each vaccine dose at Months 0, 1, 3, 6, and 12 | Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 \[July 2017\]. The following symptoms are considered as systemic reactogenicity if the onset date was within the periods of assessment specified in the protocol: malaise and/or fatigue, myalgia, headache, nausea, vomiting, chills, arthralgia, and body temperature. The item Max. Systemic Symptoms is the maximum of the individual systemic reactogenicities excluding body temperature for a participant. |
| Number of Participants Reporting Adverse Events (AEs), by Relationship to Study Product | Measured through 30 days after each vaccine dose at Months 0, 1, 3, 6, and 12 | For participants reporting multiple AEs over the time frame, the maximum relationship is counted. |
| Number of Participants Reporting Adverse Events (AEs), by Severity Grade | Measured through 30 days after each vaccine dose at Months 0, 1, 3, 6, and 12 | For participants reporting multiple AEs over the time frame, the maximum severity grade is counted. |
| Number of Participants Reporting Serious Adverse Events (SAEs) | Measured through Month 18 | Measured as outlined in Version 2.0 (January 2010) of the Manual for Expedited Reporting of Adverse Events to DAIDS (DAIDS EAE Manual). |
| Number of Participants Reporting Adverse Events of Special Interest (AESIs) | Measured through Month 18 | There were no adverse events of special interest reported by any participant. |
| Number of Participants Reporting New Chronic Conditions (Requiring Medical Intervention for >= 30 Days) | Measured through Month 18 | New chronic conditions are adverse events that require medical intervention for \>= 30 days. |
| Chemistry and Hematology Laboratory Measures - ALT (SGPT), AST, Alkaline Phosphatase | Measured during screening, Days 7, 42, 98, 182, 378, and 455 | For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population. |
| Chemistry and Hematology Laboratory Measures - Creatinine | Measured during screening, Days 7, 42, 98, 182, 378, and 455 | For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population. |
| Chemistry and Hematology Laboratory Measures - Hemoglobin | Measured during screening, Days 7, 42, 98, 182, 378, and 455 | For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population. |
| Chemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils | Measured during screening, Days 0, 1, 3, 7, 42, 84, 85, 87, 91, 98, 182, 378, and 455 | For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population. |
| Chemistry and Hematology Laboratory Measures - Platelets, WBC | Measured during screening, Days 0, 1, 3, 7, 42, 84, 85, 87, 91, 98, 182, 378, and 455 | For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population. |
| Numbers of Participants With Grade 1 or Higher Local Laboratory Results | Measured during screening, Days 0, 1, 3, 7, 42, 84, 85, 87, 91, 98, 182, 378, and 455 | The number (percentage) of participants with local laboratory values recorded as meeting Grade 1 AE criteria or above as specified in the DAIDS AE Grading Table were tabulated by treatment arm for each post-vaccination time point. |
| Number of Participants With Early Study Termination Associated With an AE or Reactogenicity | Measured through Month 18 | There were no early study terminations associated with an AE or reactogenicity reported by any participant. |
| Number of Participants With Study Product Discontinuation Associated With an AE or Reactogenicity | Measured through Month 18 | From the study product discontinuation form, study product discontinuation reasons are tabulated by treatment arm. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of Vaccine-induced Serum IgG Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C) | Measured at Months 6.5 and 12. | Serum IgG responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay, run at 1:50 dilution. The readout is background-subtracted mean fluorescent intensity (MFI), with background adjustment for an antigen-specific plate level control. For each sample, response magnitude is net MFI, defined as experimental antigen MFI minus reference antigen MFI. Net MFI \< 1 is set to 1, and net MFI \> 22,000 is set to 22,000. Data are excluded if blood draw date was outside the allowable window, a participant was HIV-infected, reference antigen \> 5,000 MFI, or baseline net MFI \> 6,500. Samples from post-enrollment visits have positive responses if they meet three criteria: (1) net MFI greater than or equal to an antigen-specific response threshold (defined as the maximum of 100 and the 95th percentile of baseline net MFI), (2) net MFI values are greater than 3 times baseline net MFI, and (3) experimental antigen MFI values are greater than 3 times baseline MFI. |
| Level of Vaccine-induced Serum IgG Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C) | Measured at Months 6.5 and 12. | Serum IgG responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay, run at 1:50 dilution. The readout is background-subtracted mean fluorescent intensity (MFI), with background adjustment for an antigen-specific plate level control. For each sample, response magnitude is net MFI, defined as experimental antigen MFI minus reference antigen MFI. Net MFI \< 1 is set to 1, and net MFI \> 22,000 is set to 22,000. Data are excluded if blood draw date was outside the allowable window, a participant was HIV-infected, reference antigen \> 5,000 MFI, or baseline net MFI \> 6,500. Summary was calculated among positive responders only (positivity criteria are described in Outcome 1). |
| Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | Measured at Months 6.5 and 12. | Serum IgG responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay, run at 1:50 dilution. The readout is background-subtracted mean fluorescent intensity (MFI), with background adjustment for an antigen-specific plate level control. For each sample, response magnitude is net MFI, defined as experimental antigen MFI minus reference antigen MFI. Net MFI \< 1 is set to 1, and net MFI \> 22,000 is set to 22,000. Data are excluded if blood draw date was outside the allowable window, a participant was HIV-infected, reference antigen \> 5,000 MFI, or baseline net MFI \> 6,500. Samples from post-enrollment visits have positive responses if they meet three criteria: (1) net MFI greater than or equal to an antigen-specific response threshold (defined as the maximum of 100 and the 95th percentile of baseline net MFI), (2) net MFI values are greater than 3 times baseline net MFI, and (3) experimental antigen MFI values are greater than 3 times baseline MFI. |
| Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | Measured at Months 6.5 and 12. | Serum IgG responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay, run at 1:50 dilution. The readout is background-subtracted mean fluorescent intensity (MFI), with background adjustment for an antigen-specific plate level control. For each sample, response magnitude is net MFI, defined as experimental antigen MFI minus reference antigen MFI. Net MFI \< 1 is set to 1, and net MFI \> 22,000 is set to 22,000. Data are excluded if blood draw date was outside the allowable window, a participant was HIV-infected, reference antigen \> 5,000 MFI, or baseline net MFI \> 6,500. Summary was calculated among positive responders only (positivity criteria are described in Outcome 1). |
| Vaccine-induced Occurrence of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | Measured at Months 6.5, 12, 12.5, and 18 | PBMC samples are stimulated with synthetic peptide pools or left unstimulated as a negative control. For each sample, T-cell subset, and peptide pool, response magnitude is % cells expressing markers (IFNg and/or IL-2) after peptide stimulation minus % cells expressing markers after no stimulation. A contingency table is constructed to assess response: stimulation (peptide/none) vs. marker expression (yes/no). A one-sided Fisher's exact test is applied, testing if the number of cells positive for the marker is equal in the stimulated vs. unstimulated cells. A discrete Bonferroni adjustment is made over the peptide pools. Response is positive if adjusted p-value \<=0.00001. Any Env magnitude is the maximum of 1086 gp120, TV1 gp120, and Env ZM96 magnitudes. Any HIV magnitude is the sum of Any Env and LAI Gag magnitudes. Data are excluded if blood draw date was outside the visit window, participant was HIV-infected, PBMC viability or T-cell count were low, or negative control was high. |
| Vaccine-induced Percentage of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | Measured at Months 6.5, 12, 12.5, and 18 | PBMC samples are stimulated with synthetic peptide pools or left unstimulated as a negative control. For each sample, T-cell subset, and peptide pool, response magnitude is % cells expressing markers (IFNg and/or IL-2) after peptide stimulation minus % cells expressing markers after no stimulation. A contingency table is constructed to assess response: stimulation (peptide/none) vs. marker expression (yes/no). A one-sided Fisher's exact test is applied, testing if the number of cells positive for the marker is equal in the stimulated vs. unstimulated cells. A discrete Bonferroni adjustment is made over the peptide pools. Response is positive if adjusted p-value \<=0.00001. Any Env magnitude is the maximum of 1086 gp120, TV1 gp120, and Env ZM96 magnitudes. Any HIV magnitude is the sum of Any Env and LAI Gag magnitudes. Data are excluded if blood draw date was outside the visit window, participant was HIV-infected, PBMC viability or T-cell count were low, or negative control was high. |
| Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | Measured at Months 6.5 and 12. | Serum IgG3 responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay, run at 1:40 dilution. The readout is background-subtracted mean fluorescent intensity (MFI), with background adjustment for an antigen-specific plate level control. For each sample, response magnitude is net MFI, defined as experimental antigen MFI minus reference antigen MFI. Net MFI \< 1 is set to 1, and net MFI \> 22,000 is set to 22,000. Data are excluded if blood draw date was outside the allowable window, a participant was HIV-infected, reference antigen \> 5,000 MFI, or baseline net MFI \> 6,500. Samples from post-enrollment visits have positive responses if they meet three criteria: (1) net MFI greater than or equal to an antigen-specific response threshold (defined as the maximum of 100 and the 95th percentile of baseline net MFI), (2) net MFI values are greater than 3 times baseline net MFI, and (3) experimental antigen MFI values are greater than 3 times baseline MFI. |
| Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | Measured at Months 6.5 and 12. | Serum IgG3 responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay, run at 1:40 dilution. The readout is background-subtracted mean fluorescent intensity (MFI), with background adjustment for an antigen-specific plate level control. For each sample, response magnitude is net MFI, defined as experimental antigen MFI minus reference antigen MFI. Net MFI \< 1 is set to 1, and net MFI \> 22,000 is set to 22,000. Data are excluded if blood draw date was outside the allowable window, a participant was HIV-infected, reference antigen \> 5,000 MFI, or baseline net MFI \> 6,500. Summary was calculated among positive responders only (positivity criteria are described in Outcome 1). |
| Occurrence of Vaccine-induced Serum IgA Ab Binding to Env Proteins | Measured at Months 6.5 and 12. | Serum IgA responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay, run at 1:10 dilution. The readout is background-subtracted mean fluorescent intensity (MFI), with background adjustment for an antigen-specific plate level control. For each sample, response magnitude is net MFI, defined as experimental antigen MFI minus reference antigen MFI. Net MFI \< 1 is set to 1, and net MFI \> 22,000 is set to 22,000. Data are excluded if blood draw date was outside the allowable window, a participant was HIV-infected, reference antigen \> 5,000 MFI, or baseline net MFI \> 6,500. Samples from post-enrollment visits have positive responses if they meet three criteria: (1) net MFI greater than or equal to an antigen-specific response threshold (defined as the maximum of 100 and the 95th percentile of baseline net MFI), (2) net MFI values are greater than 3 times baseline net MFI, and (3) experimental antigen MFI values are greater than 3 times baseline MFI. |
| Level of Vaccine-induced Serum IgA Ab Binding to Env Proteins | Measured at Months 6.5 and 12. | Serum IgA responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay, run at 1:10 dilution. The readout is background-subtracted mean fluorescent intensity (MFI), with background adjustment for an antigen-specific plate level control. For each sample, response magnitude is net MFI, defined as experimental antigen MFI minus reference antigen MFI. Net MFI \< 1 is set to 1, and net MFI \> 22,000 is set to 22,000. Data are excluded if blood draw date was outside the allowable window, a participant was HIV-infected, reference antigen \> 5,000 MFI, or baseline net MFI \> 6,500. Summary was calculated among positive responders only (positivity criteria are described in Outcome 1). |
| HIV-specific CD4+ T Cell Polyfunctionality by ICS - Functionality Scores | Measured at Months 6.5, 12, 12.5, and 18 | COMPASS uses a Bayesian hierarchical framework to model all observed functional cell subsets and select those most likely to exhibit antigen-specific responses. Cell-subset responses are quantified by posterior probabilities. The functionality score (FS) summarizes, as a single number for each participant, the proportion of antigen-specific cell subsets among all measured subsets, irrespective of degree of functionality. FS ranges from zero to one. FS will assign a higher score to participants that exhibit antigen specificity in more cell subsets irrespective of their degree of functionality. |
| HIV-specific CD4+ T Cell Polyfunctionality by ICS - Polyfunctionality Scores | Measured at Months 6.5, 12, 12.5, and 18 | COMPASS uses a Bayesian hierarchical framework to model all observed functional cell subsets and select those most likely to exhibit antigen-specific responses. Cell-subset responses are quantified by posterior probabilities. The polyfunctionality score (PFS) summarizes, as a single number for each participant, the proportion of antigen-specific cell subsets among all measured subsets, weighted by the degree of functionality of the corresponding subset. PFS ranges from zero to one. PFS will assign a higher score to participants with antigen-specific cell subsets of higher degree. |
Countries
Mozambique, South Africa, Zimbabwe
Contacts
STUDY_CHAIRPaul Goepfert
University of Alabama at Birmingham
STUDY_CHAIRKathy Mngadi
Centre for the AIDS Programme of Research in South Africa
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, and 12 AND Bivalent Subtype C gp120/MF59 (an admixture of 100 mcg of TV1.C gp120, 100 mcg of 1086.C gp120, and MF59C.1) to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, and 12 | 36 |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, and 12 AND Bivalent Subtype C gp120 (an admixture of 100 mcg of TV1.C gp120 and 100 mcg of 1806.C gp120) admixed with Aluminum Hydroxide Suspension to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, and 12 | 36 |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 6, and 12 AND Bivalent Subtype C gp120/MF59 (an admixture of 100 mcg of TV1.C gp120, 100 mcg of 1086.C gp120, and MF59C.1) to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 0, 1, 6, and 12 | 36 |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) ALVAC-HIV (vCP2438) to be administered as 1 mL IM in LEFT deltoid (unless medically contraindicated) at months 0, 1, 3, 6, and 12 AND Bivalent Subtype C gp120 (an admixture of 100 mcg of TV1.C gp120 and 100 mcg of 1806.C gp120) admixed with Sodium Chloride for Injection, 0.9% to be administered as 0.5mL IM in RIGHT deltoid (unless medically contraindicated) at Months 3, 6, and 12 | 24 |
| Total | 132 |
Baseline characteristics
| Characteristic | Total | Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) |
|---|---|---|---|---|---|
| Age, Continuous | 25 years | 24 years | 25 years | 25 years | 25 years |
| Age, Customized 18 - 20 years | 21 Participants | 7 Participants | 4 Participants | 4 Participants | 6 Participants |
| Age, Customized 21 - 30 years | 97 Participants | 24 Participants | 28 Participants | 29 Participants | 16 Participants |
| Age, Customized 31 - 40 years | 14 Participants | 5 Participants | 4 Participants | 3 Participants | 2 Participants |
| Age, Customized 41 - 50 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Customized Above 50 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Customized Less than 18 years | 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 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 132 Participants | 36 Participants | 36 Participants | 36 Participants | 24 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Black | 132 Participants | 36 Participants | 36 Participants | 36 Participants | 24 Participants |
| Region of Enrollment Mozambique | 24 Participants | 7 Participants | 7 Participants | 7 Participants | 3 Participants |
| Region of Enrollment South Africa | 80 Participants | 21 Participants | 21 Participants | 21 Participants | 17 Participants |
| Region of Enrollment Zimbabwe | 28 Participants | 8 Participants | 8 Participants | 8 Participants | 4 Participants |
| Sex: Female, Male Female | 79 Participants | 23 Participants | 21 Participants | 20 Participants | 15 Participants |
| Sex: Female, Male Male | 53 Participants | 13 Participants | 15 Participants | 16 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 36 | 0 / 36 | 0 / 36 | 0 / 24 |
| other Total, other adverse events | 28 / 36 | 28 / 36 | 26 / 36 | 15 / 24 |
| serious Total, serious adverse events | 1 / 36 | 0 / 36 | 0 / 36 | 1 / 24 |
Outcome results
Primary
Chemistry and Hematology Laboratory Measures - ALT (SGPT), AST, Alkaline Phosphatase
For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population.
Time frame: Measured during screening, Days 7, 42, 98, 182, 378, and 455
Population: Overall Number of Participants Analyzed represents participants enrolled and eligible for laboratory assessment. Participants do not have laboratory assessments if they attended the visit but laboratory specimens were not collected, missed the scheduled visit, or terminated participation in the study prior to the scheduled visit.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Chemistry and Hematology Laboratory Measures - ALT (SGPT), AST, Alkaline Phosphatase | Alkaline Phosphatase (U/L)- Day455 | 71.5 U/L |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Chemistry and Hematology Laboratory Measures - ALT (SGPT), AST, Alkaline Phosphatase | Alkaline Phosphatase (U/L)- Day378 | 70 U/L |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Chemistry and Hematology Laboratory Measures - ALT (SGPT), AST, Alkaline Phosphatase | ALT (SGPT) (U/L)- Day98 | 16 U/L |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Chemistry and Hematology Laboratory Measures - ALT (SGPT), AST, Alkaline Phosphatase | ALT (SGPT) (U/L)- Screening | 15 U/L |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Chemistry and Hematology Laboratory Measures - ALT (SGPT), AST, Alkaline Phosphatase | AST (U/L)- Day98 | 21 U/L |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Chemistry and Hematology Laboratory Measures - ALT (SGPT), AST, Alkaline Phosphatase | Alkaline Phosphatase (U/L)- Day182 | 70 U/L |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Chemistry and Hematology Laboratory Measures - ALT (SGPT), AST, Alkaline Phosphatase | Alkaline Phosphatase (U/L)- Day98 | 67.5 U/L |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Chemistry and Hematology Laboratory Measures - ALT (SGPT), AST, Alkaline Phosphatase | ALT (SGPT) (U/L)- Day7 | 15.5 U/L |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Chemistry and Hematology Laboratory Measures - ALT (SGPT), AST, Alkaline Phosphatase | AST (U/L)- Day42 | 19 U/L |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Chemistry and Hematology Laboratory Measures - ALT (SGPT), AST, Alkaline Phosphatase | Alkaline Phosphatase (U/L)- Screening | 72 U/L |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Chemistry and Hematology Laboratory Measures - ALT (SGPT), AST, Alkaline Phosphatase | ALT (SGPT) (U/L)- Day182 | 18 U/L |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Chemistry and Hematology Laboratory Measures - ALT (SGPT), AST, Alkaline Phosphatase | ALT (SGPT) (U/L)- Day42 | 16 U/L |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Chemistry and Hematology Laboratory Measures - ALT (SGPT), AST, Alkaline Phosphatase | AST (U/L)- Screening | 19 U/L |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Chemistry and Hematology Laboratory Measures - ALT (SGPT), AST, Alkaline Phosphatase | Alkaline Phosphatase (U/L)- Day7 | 66.5 U/L |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Chemistry and Hematology Laboratory Measures - ALT (SGPT), AST, Alkaline Phosphatase | AST (U/L)- Day182 | 20 U/L |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Chemistry and Hematology Laboratory Measures - ALT (SGPT), AST, Alkaline Phosphatase | ALT (SGPT) (U/L)- Day378 | 16 U/L |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Chemistry and Hematology Laboratory Measures - ALT (SGPT), AST, Alkaline Phosphatase | AST (U/L)- Day455 | 22.5 U/L |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Chemistry and Hematology Laboratory Measures - ALT (SGPT), AST, Alkaline Phosphatase | AST (U/L)- Day7 | 18 U/L |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Chemistry and Hematology Laboratory Measures - ALT (SGPT), AST, Alkaline Phosphatase | AST (U/L)- Day378 | 20 U/L |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Chemistry and Hematology Laboratory Measures - ALT (SGPT), AST, Alkaline Phosphatase | ALT (SGPT) (U/L)- Day455 | 16 U/L |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Chemistry and Hematology Laboratory Measures - ALT (SGPT), AST, Alkaline Phosphatase | Alkaline Phosphatase (U/L)- Day42 | 70 U/L |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Chemistry and Hematology Laboratory Measures - ALT (SGPT), AST, Alkaline Phosphatase | Alkaline Phosphatase (U/L)- Day378 | 65 U/L |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Chemistry and Hematology Laboratory Measures - ALT (SGPT), AST, Alkaline Phosphatase | AST (U/L)- Day378 | 19 U/L |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Chemistry and Hematology Laboratory Measures - ALT (SGPT), AST, Alkaline Phosphatase | AST (U/L)- Day455 | 20 U/L |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Chemistry and Hematology Laboratory Measures - ALT (SGPT), AST, Alkaline Phosphatase | ALT (SGPT) (U/L)- Day98 | 15 U/L |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Chemistry and Hematology Laboratory Measures - ALT (SGPT), AST, Alkaline Phosphatase | ALT (SGPT) (U/L)- Day182 | 16.5 U/L |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Chemistry and Hematology Laboratory Measures - ALT (SGPT), AST, Alkaline Phosphatase | ALT (SGPT) (U/L)- Day378 | 16 U/L |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Chemistry and Hematology Laboratory Measures - ALT (SGPT), AST, Alkaline Phosphatase | AST (U/L)- Day182 | 21 U/L |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Chemistry and Hematology Laboratory Measures - ALT (SGPT), AST, Alkaline Phosphatase | ALT (SGPT) (U/L)- Day455 | 16 U/L |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Chemistry and Hematology Laboratory Measures - ALT (SGPT), AST, Alkaline Phosphatase | Alkaline Phosphatase (U/L)- Day7 | 68 U/L |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Chemistry and Hematology Laboratory Measures - ALT (SGPT), AST, Alkaline Phosphatase | ALT (SGPT) (U/L)- Screening | 15 U/L |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Chemistry and Hematology Laboratory Measures - ALT (SGPT), AST, Alkaline Phosphatase | ALT (SGPT) (U/L)- Day7 | 16 U/L |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Chemistry and Hematology Laboratory Measures - ALT (SGPT), AST, Alkaline Phosphatase | Alkaline Phosphatase (U/L)- Day98 | 64 U/L |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Chemistry and Hematology Laboratory Measures - ALT (SGPT), AST, Alkaline Phosphatase | ALT (SGPT) (U/L)- Day42 | 18.5 U/L |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Chemistry and Hematology Laboratory Measures - ALT (SGPT), AST, Alkaline Phosphatase | Alkaline Phosphatase (U/L)- Screening | 70 U/L |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Chemistry and Hematology Laboratory Measures - ALT (SGPT), AST, Alkaline Phosphatase | Alkaline Phosphatase (U/L)- Day42 | 71.5 U/L |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Chemistry and Hematology Laboratory Measures - ALT (SGPT), AST, Alkaline Phosphatase | Alkaline Phosphatase (U/L)- Day182 | 64 U/L |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Chemistry and Hematology Laboratory Measures - ALT (SGPT), AST, Alkaline Phosphatase | AST (U/L)- Screening | 20 U/L |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Chemistry and Hematology Laboratory Measures - ALT (SGPT), AST, Alkaline Phosphatase | Alkaline Phosphatase (U/L)- Day455 | 65 U/L |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Chemistry and Hematology Laboratory Measures - ALT (SGPT), AST, Alkaline Phosphatase | AST (U/L)- Day7 | 20 U/L |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Chemistry and Hematology Laboratory Measures - ALT (SGPT), AST, Alkaline Phosphatase | AST (U/L)- Day42 | 21 U/L |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Chemistry and Hematology Laboratory Measures - ALT (SGPT), AST, Alkaline Phosphatase | AST (U/L)- Day98 | 20 U/L |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Chemistry and Hematology Laboratory Measures - ALT (SGPT), AST, Alkaline Phosphatase | Alkaline Phosphatase (U/L)- Day182 | 70 U/L |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Chemistry and Hematology Laboratory Measures - ALT (SGPT), AST, Alkaline Phosphatase | ALT (SGPT) (U/L)- Screening | 16.5 U/L |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Chemistry and Hematology Laboratory Measures - ALT (SGPT), AST, Alkaline Phosphatase | AST (U/L)- Day455 | 21 U/L |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Chemistry and Hematology Laboratory Measures - ALT (SGPT), AST, Alkaline Phosphatase | AST (U/L)- Day378 | 22 U/L |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Chemistry and Hematology Laboratory Measures - ALT (SGPT), AST, Alkaline Phosphatase | Alkaline Phosphatase (U/L)- Day378 | 73 U/L |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Chemistry and Hematology Laboratory Measures - ALT (SGPT), AST, Alkaline Phosphatase | Alkaline Phosphatase (U/L)- Day455 | 71.5 U/L |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Chemistry and Hematology Laboratory Measures - ALT (SGPT), AST, Alkaline Phosphatase | AST (U/L)- Day182 | 21 U/L |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Chemistry and Hematology Laboratory Measures - ALT (SGPT), AST, Alkaline Phosphatase | AST (U/L)- Day42 | 21 U/L |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Chemistry and Hematology Laboratory Measures - ALT (SGPT), AST, Alkaline Phosphatase | ALT (SGPT) (U/L)- Day378 | 15 U/L |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Chemistry and Hematology Laboratory Measures - ALT (SGPT), AST, Alkaline Phosphatase | AST (U/L)- Screening | 21.5 U/L |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Chemistry and Hematology Laboratory Measures - ALT (SGPT), AST, Alkaline Phosphatase | ALT (SGPT) (U/L)- Day42 | 15 U/L |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Chemistry and Hematology Laboratory Measures - ALT (SGPT), AST, Alkaline Phosphatase | ALT (SGPT) (U/L)- Day455 | 16 U/L |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Chemistry and Hematology Laboratory Measures - ALT (SGPT), AST, Alkaline Phosphatase | Alkaline Phosphatase (U/L)- Day7 | 70 U/L |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Chemistry and Hematology Laboratory Measures - ALT (SGPT), AST, Alkaline Phosphatase | ALT (SGPT) (U/L)- Day7 | 15 U/L |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Chemistry and Hematology Laboratory Measures - ALT (SGPT), AST, Alkaline Phosphatase | AST (U/L)- Day7 | 21 U/L |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Chemistry and Hematology Laboratory Measures - ALT (SGPT), AST, Alkaline Phosphatase | Alkaline Phosphatase (U/L)- Screening | 76 U/L |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Chemistry and Hematology Laboratory Measures - ALT (SGPT), AST, Alkaline Phosphatase | ALT (SGPT) (U/L)- Day182 | 15 U/L |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Chemistry and Hematology Laboratory Measures - ALT (SGPT), AST, Alkaline Phosphatase | Alkaline Phosphatase (U/L)- Day42 | 70.5 U/L |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Chemistry and Hematology Laboratory Measures - ALT (SGPT), AST, Alkaline Phosphatase | ALT (SGPT) (U/L)- Day98 | 17 U/L |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Chemistry and Hematology Laboratory Measures - ALT (SGPT), AST, Alkaline Phosphatase | Alkaline Phosphatase (U/L)- Day7 | 75.5 U/L |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Chemistry and Hematology Laboratory Measures - ALT (SGPT), AST, Alkaline Phosphatase | Alkaline Phosphatase (U/L)- Day42 | 78 U/L |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Chemistry and Hematology Laboratory Measures - ALT (SGPT), AST, Alkaline Phosphatase | Alkaline Phosphatase (U/L)- Day98 | 77 U/L |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Chemistry and Hematology Laboratory Measures - ALT (SGPT), AST, Alkaline Phosphatase | Alkaline Phosphatase (U/L)- Day455 | 76.5 U/L |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Chemistry and Hematology Laboratory Measures - ALT (SGPT), AST, Alkaline Phosphatase | AST (U/L)- Screening | 17 U/L |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Chemistry and Hematology Laboratory Measures - ALT (SGPT), AST, Alkaline Phosphatase | AST (U/L)- Day98 | 20 U/L |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Chemistry and Hematology Laboratory Measures - ALT (SGPT), AST, Alkaline Phosphatase | AST (U/L)- Day455 | 19 U/L |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Chemistry and Hematology Laboratory Measures - ALT (SGPT), AST, Alkaline Phosphatase | ALT (SGPT) (U/L)- Screening | 14.5 U/L |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Chemistry and Hematology Laboratory Measures - ALT (SGPT), AST, Alkaline Phosphatase | ALT (SGPT) (U/L)- Day7 | 15.5 U/L |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Chemistry and Hematology Laboratory Measures - ALT (SGPT), AST, Alkaline Phosphatase | ALT (SGPT) (U/L)- Day455 | 15 U/L |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Chemistry and Hematology Laboratory Measures - ALT (SGPT), AST, Alkaline Phosphatase | Alkaline Phosphatase (U/L)- Day182 | 77.5 U/L |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Chemistry and Hematology Laboratory Measures - ALT (SGPT), AST, Alkaline Phosphatase | Alkaline Phosphatase (U/L)- Day378 | 77.5 U/L |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Chemistry and Hematology Laboratory Measures - ALT (SGPT), AST, Alkaline Phosphatase | AST (U/L)- Day7 | 19 U/L |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Chemistry and Hematology Laboratory Measures - ALT (SGPT), AST, Alkaline Phosphatase | AST (U/L)- Day42 | 21 U/L |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Chemistry and Hematology Laboratory Measures - ALT (SGPT), AST, Alkaline Phosphatase | AST (U/L)- Day182 | 18.5 U/L |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Chemistry and Hematology Laboratory Measures - ALT (SGPT), AST, Alkaline Phosphatase | AST (U/L)- Day378 | 21.5 U/L |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Chemistry and Hematology Laboratory Measures - ALT (SGPT), AST, Alkaline Phosphatase | ALT (SGPT) (U/L)- Day42 | 17.5 U/L |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Chemistry and Hematology Laboratory Measures - ALT (SGPT), AST, Alkaline Phosphatase | Alkaline Phosphatase (U/L)- Screening | 79.5 U/L |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Chemistry and Hematology Laboratory Measures - ALT (SGPT), AST, Alkaline Phosphatase | ALT (SGPT) (U/L)- Day182 | 15 U/L |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Chemistry and Hematology Laboratory Measures - ALT (SGPT), AST, Alkaline Phosphatase | ALT (SGPT) (U/L)- Day378 | 19 U/L |
Primary
Chemistry and Hematology Laboratory Measures - Creatinine
For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population.
Time frame: Measured during screening, Days 7, 42, 98, 182, 378, and 455
Population: Overall Number of Participants Analyzed represents participants enrolled and eligible for laboratory assessment. Participants do not have laboratory assessments if they attended the visit but laboratory specimens were not collected, missed the scheduled visit, or terminated participation in the study prior to the scheduled visit.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Chemistry and Hematology Laboratory Measures - Creatinine | Creatinine (g/dL)- Day455 | 0.000795 g/dL |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Chemistry and Hematology Laboratory Measures - Creatinine | Creatinine (g/dL)- Day42 | 0.00071 g/dL |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Chemistry and Hematology Laboratory Measures - Creatinine | Creatinine (g/dL)- Day182 | 0.00073 g/dL |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Chemistry and Hematology Laboratory Measures - Creatinine | Creatinine (g/dL)- Day378 | 0.00079 g/dL |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Chemistry and Hematology Laboratory Measures - Creatinine | Creatinine (g/dL)- Day7 | 0.00071 g/dL |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Chemistry and Hematology Laboratory Measures - Creatinine | Creatinine (g/dL)- Screening | 0.00071 g/dL |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Chemistry and Hematology Laboratory Measures - Creatinine | Creatinine (g/dL)- Day98 | 0.000705 g/dL |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Chemistry and Hematology Laboratory Measures - Creatinine | Creatinine (g/dL)- Day182 | 0.000715 g/dL |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Chemistry and Hematology Laboratory Measures - Creatinine | Creatinine (g/dL)- Screening | 0.0007 g/dL |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Chemistry and Hematology Laboratory Measures - Creatinine | Creatinine (g/dL)- Day7 | 0.0007 g/dL |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Chemistry and Hematology Laboratory Measures - Creatinine | Creatinine (g/dL)- Day42 | 0.0007 g/dL |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Chemistry and Hematology Laboratory Measures - Creatinine | Creatinine (g/dL)- Day378 | 0.00076 g/dL |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Chemistry and Hematology Laboratory Measures - Creatinine | Creatinine (g/dL)- Day455 | 0.00074 g/dL |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Chemistry and Hematology Laboratory Measures - Creatinine | Creatinine (g/dL)- Day98 | 0.0008 g/dL |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Chemistry and Hematology Laboratory Measures - Creatinine | Creatinine (g/dL)- Day378 | 0.0007 g/dL |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Chemistry and Hematology Laboratory Measures - Creatinine | Creatinine (g/dL)- Day455 | 0.00071 g/dL |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Chemistry and Hematology Laboratory Measures - Creatinine | Creatinine (g/dL)- Day42 | 0.0007 g/dL |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Chemistry and Hematology Laboratory Measures - Creatinine | Creatinine (g/dL)- Day7 | 0.0007 g/dL |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Chemistry and Hematology Laboratory Measures - Creatinine | Creatinine (g/dL)- Screening | 0.000705 g/dL |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Chemistry and Hematology Laboratory Measures - Creatinine | Creatinine (g/dL)- Day182 | 0.00078 g/dL |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Chemistry and Hematology Laboratory Measures - Creatinine | Creatinine (g/dL)- Day98 | 0.00072 g/dL |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Chemistry and Hematology Laboratory Measures - Creatinine | Creatinine (g/dL)- Day42 | 0.00071 g/dL |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Chemistry and Hematology Laboratory Measures - Creatinine | Creatinine (g/dL)- Day378 | 0.0007 g/dL |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Chemistry and Hematology Laboratory Measures - Creatinine | Creatinine (g/dL)- Day7 | 0.00075 g/dL |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Chemistry and Hematology Laboratory Measures - Creatinine | Creatinine (g/dL)- Screening | 0.0007 g/dL |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Chemistry and Hematology Laboratory Measures - Creatinine | Creatinine (g/dL)- Day182 | 0.00077 g/dL |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Chemistry and Hematology Laboratory Measures - Creatinine | Creatinine (g/dL)- Day455 | 0.0007 g/dL |
Primary
Chemistry and Hematology Laboratory Measures - Hemoglobin
For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population.
Time frame: Measured during screening, Days 7, 42, 98, 182, 378, and 455
Population: Overall Number of Participants Analyzed represents participants enrolled and eligible for laboratory assessment. Participants do not have laboratory assessments if they attended the visit but laboratory specimens were not collected, missed the scheduled visit, or terminated participation in the study prior to the scheduled visit.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Chemistry and Hematology Laboratory Measures - Hemoglobin | Hemoglobin (g/dL)- Screening | 13.75 g/dL |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Chemistry and Hematology Laboratory Measures - Hemoglobin | Hemoglobin (g/dL)- Day182 | 13.4 g/dL |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Chemistry and Hematology Laboratory Measures - Hemoglobin | Hemoglobin (g/dL)- Day7 | 13.5 g/dL |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Chemistry and Hematology Laboratory Measures - Hemoglobin | Hemoglobin (g/dL)- Day455 | 13.6 g/dL |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Chemistry and Hematology Laboratory Measures - Hemoglobin | Hemoglobin (g/dL)- Day42 | 13.7 g/dL |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Chemistry and Hematology Laboratory Measures - Hemoglobin | Hemoglobin (g/dL)- Day98 | 13.35 g/dL |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Chemistry and Hematology Laboratory Measures - Hemoglobin | Hemoglobin (g/dL)- Day378 | 13.3 g/dL |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Chemistry and Hematology Laboratory Measures - Hemoglobin | Hemoglobin (g/dL)- Day42 | 13.55 g/dL |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Chemistry and Hematology Laboratory Measures - Hemoglobin | Hemoglobin (g/dL)- Day7 | 13.5 g/dL |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Chemistry and Hematology Laboratory Measures - Hemoglobin | Hemoglobin (g/dL)- Day98 | 13.6 g/dL |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Chemistry and Hematology Laboratory Measures - Hemoglobin | Hemoglobin (g/dL)- Day182 | 13.5 g/dL |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Chemistry and Hematology Laboratory Measures - Hemoglobin | Hemoglobin (g/dL)- Screening | 13.95 g/dL |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Chemistry and Hematology Laboratory Measures - Hemoglobin | Hemoglobin (g/dL)- Day378 | 13.5 g/dL |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Chemistry and Hematology Laboratory Measures - Hemoglobin | Hemoglobin (g/dL)- Day455 | 13.8 g/dL |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Chemistry and Hematology Laboratory Measures - Hemoglobin | Hemoglobin (g/dL)- Day42 | 13.65 g/dL |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Chemistry and Hematology Laboratory Measures - Hemoglobin | Hemoglobin (g/dL)- Day7 | 13.4 g/dL |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Chemistry and Hematology Laboratory Measures - Hemoglobin | Hemoglobin (g/dL)- Day182 | 13.75 g/dL |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Chemistry and Hematology Laboratory Measures - Hemoglobin | Hemoglobin (g/dL)- Day455 | 12.75 g/dL |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Chemistry and Hematology Laboratory Measures - Hemoglobin | Hemoglobin (g/dL)- Day378 | 13.2 g/dL |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Chemistry and Hematology Laboratory Measures - Hemoglobin | Hemoglobin (g/dL)- Screening | 13.85 g/dL |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Chemistry and Hematology Laboratory Measures - Hemoglobin | Hemoglobin (g/dL)- Day455 | 13.6 g/dL |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Chemistry and Hematology Laboratory Measures - Hemoglobin | Hemoglobin (g/dL)- Day7 | 13.5 g/dL |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Chemistry and Hematology Laboratory Measures - Hemoglobin | Hemoglobin (g/dL)- Day42 | 13.65 g/dL |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Chemistry and Hematology Laboratory Measures - Hemoglobin | Hemoglobin (g/dL)- Day378 | 13.3 g/dL |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Chemistry and Hematology Laboratory Measures - Hemoglobin | Hemoglobin (g/dL)- Day98 | 13.2 g/dL |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Chemistry and Hematology Laboratory Measures - Hemoglobin | Hemoglobin (g/dL)- Day182 | 13.25 g/dL |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Chemistry and Hematology Laboratory Measures - Hemoglobin | Hemoglobin (g/dL)- Screening | 14.05 g/dL |
Primary
Chemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils
For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population.
Time frame: Measured during screening, Days 0, 1, 3, 7, 42, 84, 85, 87, 91, 98, 182, 378, and 455
Population: Overall Number of Participants Analyzed represents participants enrolled and eligible for laboratory assessment. Participants do not have laboratory assessments if they attended the visit but laboratory specimens were not collected, missed the scheduled visit, or terminated participation in the study prior to the scheduled visit.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Chemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils | Lymphocytes (1000/cubic mm)- Day182 | 1.969 thousand cells/cubic mm |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Chemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils | Lymphocytes (1000/cubic mm)- Day91 | 1.8455 thousand cells/cubic mm |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Chemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils | Neutrophils (1000/cubic mm)- Screening | 2.9315 thousand cells/cubic mm |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Chemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils | Lymphocytes (1000/cubic mm)- Day98 | 1.7605 thousand cells/cubic mm |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Chemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils | Lymphocytes (1000/cubic mm)- Day84 | 1.891 thousand cells/cubic mm |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Chemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils | Neutrophils (1000/cubic mm)- Day91 | 3.34 thousand cells/cubic mm |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Chemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils | Lymphocytes (1000/cubic mm)- Day455 | 1.753 thousand cells/cubic mm |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Chemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils | Neutrophils (1000/cubic mm)- Day84 | 3.065 thousand cells/cubic mm |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Chemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils | Neutrophils (1000/cubic mm)- Day87 | 2.798 thousand cells/cubic mm |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Chemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils | Neutrophils (1000/cubic mm)- Day182 | 2.734 thousand cells/cubic mm |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Chemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils | Neutrophils (1000/cubic mm)- Day98 | 2.4375 thousand cells/cubic mm |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Chemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils | Neutrophils (1000/cubic mm)- Day378 | 2.6995 thousand cells/cubic mm |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Chemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils | Lymphocytes (1000/cubic mm)- Day87 | 1.8725 thousand cells/cubic mm |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Chemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils | Neutrophils (1000/cubic mm)- Day85 | 4.224 thousand cells/cubic mm |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Chemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils | Neutrophils (1000/cubic mm)- Day455 | 2.5 thousand cells/cubic mm |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Chemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils | Lymphocytes (1000/cubic mm)- Screening | 2.1395 thousand cells/cubic mm |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Chemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils | Neutrophils (1000/cubic mm)- Day42 | 2.687 thousand cells/cubic mm |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Chemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils | Lymphocytes (1000/cubic mm)- Day85 | 1.646 thousand cells/cubic mm |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Chemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils | Lymphocytes (1000/cubic mm)- Day7 | 1.883 thousand cells/cubic mm |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Chemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils | Lymphocytes (1000/cubic mm)- Day378 | 1.7105 thousand cells/cubic mm |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Chemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils | Lymphocytes (1000/cubic mm)- Day42 | 1.76 thousand cells/cubic mm |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Chemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils | Neutrophils (1000/cubic mm)- Day7 | 2.903 thousand cells/cubic mm |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Chemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils | Neutrophils (1000/cubic mm)- Day85 | 5.1475 thousand cells/cubic mm |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Chemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils | Lymphocytes (1000/cubic mm)- Day84 | 1.919 thousand cells/cubic mm |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Chemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils | Lymphocytes (1000/cubic mm)- Day85 | 1.7245 thousand cells/cubic mm |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Chemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils | Lymphocytes (1000/cubic mm)- Day87 | 1.83 thousand cells/cubic mm |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Chemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils | Neutrophils (1000/cubic mm)- Screening | 2.9575 thousand cells/cubic mm |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Chemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils | Lymphocytes (1000/cubic mm)- Day42 | 1.8915 thousand cells/cubic mm |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Chemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils | Lymphocytes (1000/cubic mm)- Day91 | 2.02 thousand cells/cubic mm |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Chemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils | Neutrophils (1000/cubic mm)- Day378 | 2.535 thousand cells/cubic mm |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Chemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils | Neutrophils (1000/cubic mm)- Day7 | 2.84 thousand cells/cubic mm |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Chemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils | Lymphocytes (1000/cubic mm)- Day98 | 1.89 thousand cells/cubic mm |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Chemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils | Neutrophils (1000/cubic mm)- Day91 | 3.65 thousand cells/cubic mm |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Chemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils | Lymphocytes (1000/cubic mm)- Day378 | 1.859 thousand cells/cubic mm |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Chemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils | Neutrophils (1000/cubic mm)- Day455 | 2.282 thousand cells/cubic mm |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Chemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils | Lymphocytes (1000/cubic mm)- Day455 | 1.77 thousand cells/cubic mm |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Chemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils | Neutrophils (1000/cubic mm)- Day87 | 3.214 thousand cells/cubic mm |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Chemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils | Lymphocytes (1000/cubic mm)- Day7 | 1.93 thousand cells/cubic mm |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Chemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils | Neutrophils (1000/cubic mm)- Day84 | 3.82 thousand cells/cubic mm |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Chemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils | Neutrophils (1000/cubic mm)- Day98 | 2.814 thousand cells/cubic mm |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Chemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils | Lymphocytes (1000/cubic mm)- Screening | 2.095 thousand cells/cubic mm |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Chemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils | Lymphocytes (1000/cubic mm)- Day182 | 1.9905 thousand cells/cubic mm |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Chemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils | Neutrophils (1000/cubic mm)- Day182 | 2.4915 thousand cells/cubic mm |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Chemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils | Neutrophils (1000/cubic mm)- Day42 | 2.9545 thousand cells/cubic mm |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Chemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils | Lymphocytes (1000/cubic mm)- Day0 | 2.0755 thousand cells/cubic mm |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Chemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils | Lymphocytes (1000/cubic mm)- Day182 | 1.797 thousand cells/cubic mm |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Chemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils | Lymphocytes (1000/cubic mm)- Day378 | 1.871 thousand cells/cubic mm |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Chemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils | Neutrophils (1000/cubic mm)- Day182 | 2.3075 thousand cells/cubic mm |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Chemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils | Neutrophils (1000/cubic mm)- Day378 | 2.292 thousand cells/cubic mm |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Chemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils | Lymphocytes (1000/cubic mm)- Screening | 2.01 thousand cells/cubic mm |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Chemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils | Lymphocytes (1000/cubic mm)- Day1 | 1.982 thousand cells/cubic mm |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Chemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils | Lymphocytes (1000/cubic mm)- Day3 | 1.96 thousand cells/cubic mm |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Chemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils | Lymphocytes (1000/cubic mm)- Day7 | 1.976 thousand cells/cubic mm |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Chemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils | Lymphocytes (1000/cubic mm)- Day42 | 1.9915 thousand cells/cubic mm |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Chemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils | Lymphocytes (1000/cubic mm)- Day84 | 1.99 thousand cells/cubic mm |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Chemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils | Lymphocytes (1000/cubic mm)- Day455 | 1.9 thousand cells/cubic mm |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Chemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils | Neutrophils (1000/cubic mm)- Screening | 2.986 thousand cells/cubic mm |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Chemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils | Neutrophils (1000/cubic mm)- Day0 | 3.1935 thousand cells/cubic mm |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Chemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils | Neutrophils (1000/cubic mm)- Day1 | 4.482 thousand cells/cubic mm |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Chemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils | Neutrophils (1000/cubic mm)- Day3 | 2.82 thousand cells/cubic mm |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Chemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils | Neutrophils (1000/cubic mm)- Day7 | 2.567 thousand cells/cubic mm |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Chemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils | Neutrophils (1000/cubic mm)- Day42 | 2.6145 thousand cells/cubic mm |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Chemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils | Neutrophils (1000/cubic mm)- Day84 | 1.739 thousand cells/cubic mm |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Chemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils | Neutrophils (1000/cubic mm)- Day455 | 2.2415 thousand cells/cubic mm |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Chemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils | Lymphocytes (1000/cubic mm)- Day182 | 1.9615 thousand cells/cubic mm |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Chemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils | Lymphocytes (1000/cubic mm)- Day42 | 2.1375 thousand cells/cubic mm |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Chemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils | Lymphocytes (1000/cubic mm)- Day7 | 2.2185 thousand cells/cubic mm |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Chemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils | Neutrophils (1000/cubic mm)- Day91 | 3.407 thousand cells/cubic mm |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Chemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils | Neutrophils (1000/cubic mm)- Day7 | 2.5425 thousand cells/cubic mm |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Chemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils | Lymphocytes (1000/cubic mm)- Day84 | 2.035 thousand cells/cubic mm |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Chemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils | Lymphocytes (1000/cubic mm)- Screening | 2.341 thousand cells/cubic mm |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Chemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils | Lymphocytes (1000/cubic mm)- Day85 | 2.024 thousand cells/cubic mm |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Chemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils | Neutrophils (1000/cubic mm)- Day455 | 2.2905 thousand cells/cubic mm |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Chemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils | Neutrophils (1000/cubic mm)- Day84 | 3.114 thousand cells/cubic mm |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Chemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils | Neutrophils (1000/cubic mm)- Day378 | 2.811 thousand cells/cubic mm |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Chemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils | Neutrophils (1000/cubic mm)- Day182 | 2.6895 thousand cells/cubic mm |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Chemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils | Neutrophils (1000/cubic mm)- Day85 | 3.355 thousand cells/cubic mm |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Chemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils | Lymphocytes (1000/cubic mm)- Day98 | 2.085 thousand cells/cubic mm |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Chemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils | Neutrophils (1000/cubic mm)- Day98 | 2.94 thousand cells/cubic mm |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Chemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils | Lymphocytes (1000/cubic mm)- Day455 | 1.977 thousand cells/cubic mm |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Chemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils | Lymphocytes (1000/cubic mm)- Day91 | 2.036 thousand cells/cubic mm |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Chemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils | Lymphocytes (1000/cubic mm)- Day87 | 2.076 thousand cells/cubic mm |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Chemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils | Neutrophils (1000/cubic mm)- Day42 | 2.679 thousand cells/cubic mm |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Chemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils | Neutrophils (1000/cubic mm)- Screening | 3.2245 thousand cells/cubic mm |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Chemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils | Neutrophils (1000/cubic mm)- Day87 | 2.352 thousand cells/cubic mm |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Chemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils | Lymphocytes (1000/cubic mm)- Day378 | 2.0975 thousand cells/cubic mm |
Primary
Chemistry and Hematology Laboratory Measures - Platelets, WBC
For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population.
Time frame: Measured during screening, Days 0, 1, 3, 7, 42, 84, 85, 87, 91, 98, 182, 378, and 455
Population: Overall Number of Participants Analyzed represents participants enrolled and eligible for laboratory assessment. Participants do not have laboratory assessments if they attended the visit but laboratory specimens were not collected, missed the scheduled visit, or terminated participation in the study prior to the scheduled visit.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Chemistry and Hematology Laboratory Measures - Platelets, WBC | WBC (1000/cubic mm)- Day84 | 5.66 thousand cells/cubic mm |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Chemistry and Hematology Laboratory Measures - Platelets, WBC | Platelets (1000/cubic mm)- Screening | 269.5 thousand cells/cubic mm |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Chemistry and Hematology Laboratory Measures - Platelets, WBC | WBC (1000/cubic mm)- Day85 | 6.965 thousand cells/cubic mm |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Chemistry and Hematology Laboratory Measures - Platelets, WBC | WBC (1000/cubic mm)- Day182 | 5.17 thousand cells/cubic mm |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Chemistry and Hematology Laboratory Measures - Platelets, WBC | Platelets (1000/cubic mm)- Day98 | 260 thousand cells/cubic mm |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Chemistry and Hematology Laboratory Measures - Platelets, WBC | WBC (1000/cubic mm)- Day455 | 4.795 thousand cells/cubic mm |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Chemistry and Hematology Laboratory Measures - Platelets, WBC | WBC (1000/cubic mm)- Day378 | 5.37 thousand cells/cubic mm |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Chemistry and Hematology Laboratory Measures - Platelets, WBC | Platelets (1000/cubic mm)- Day42 | 267 thousand cells/cubic mm |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Chemistry and Hematology Laboratory Measures - Platelets, WBC | Platelets (1000/cubic mm)- Day87 | 283 thousand cells/cubic mm |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Chemistry and Hematology Laboratory Measures - Platelets, WBC | Platelets (1000/cubic mm)- Day91 | 286 thousand cells/cubic mm |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Chemistry and Hematology Laboratory Measures - Platelets, WBC | Platelets (1000/cubic mm)- Day85 | 272.5 thousand cells/cubic mm |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Chemistry and Hematology Laboratory Measures - Platelets, WBC | Platelets (1000/cubic mm)- Day378 | 274 thousand cells/cubic mm |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Chemistry and Hematology Laboratory Measures - Platelets, WBC | WBC (1000/cubic mm)- Day91 | 6.39 thousand cells/cubic mm |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Chemistry and Hematology Laboratory Measures - Platelets, WBC | WBC (1000/cubic mm)- Day87 | 5.55 thousand cells/cubic mm |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Chemistry and Hematology Laboratory Measures - Platelets, WBC | Platelets (1000/cubic mm)- Day455 | 265.5 thousand cells/cubic mm |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Chemistry and Hematology Laboratory Measures - Platelets, WBC | WBC (1000/cubic mm)- Screening | 5.805 thousand cells/cubic mm |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Chemistry and Hematology Laboratory Measures - Platelets, WBC | Platelets (1000/cubic mm)- Day182 | 282 thousand cells/cubic mm |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Chemistry and Hematology Laboratory Measures - Platelets, WBC | Platelets (1000/cubic mm)- Day84 | 277 thousand cells/cubic mm |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Chemistry and Hematology Laboratory Measures - Platelets, WBC | WBC (1000/cubic mm)- Day98 | 4.935 thousand cells/cubic mm |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Chemistry and Hematology Laboratory Measures - Platelets, WBC | WBC (1000/cubic mm)- Day7 | 5.5 thousand cells/cubic mm |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Chemistry and Hematology Laboratory Measures - Platelets, WBC | Platelets (1000/cubic mm)- Day7 | 269.5 thousand cells/cubic mm |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Chemistry and Hematology Laboratory Measures - Platelets, WBC | WBC (1000/cubic mm)- Day42 | 4.89 thousand cells/cubic mm |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Chemistry and Hematology Laboratory Measures - Platelets, WBC | Platelets (1000/cubic mm)- Day378 | 282 thousand cells/cubic mm |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Chemistry and Hematology Laboratory Measures - Platelets, WBC | WBC (1000/cubic mm)- Day84 | 5.95 thousand cells/cubic mm |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Chemistry and Hematology Laboratory Measures - Platelets, WBC | WBC (1000/cubic mm)- Day87 | 5.84 thousand cells/cubic mm |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Chemistry and Hematology Laboratory Measures - Platelets, WBC | WBC (1000/cubic mm)- Day98 | 5.22 thousand cells/cubic mm |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Chemistry and Hematology Laboratory Measures - Platelets, WBC | Platelets (1000/cubic mm)- Day98 | 256 thousand cells/cubic mm |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Chemistry and Hematology Laboratory Measures - Platelets, WBC | WBC (1000/cubic mm)- Day85 | 7.685 thousand cells/cubic mm |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Chemistry and Hematology Laboratory Measures - Platelets, WBC | WBC (1000/cubic mm)- Day455 | 4.62 thousand cells/cubic mm |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Chemistry and Hematology Laboratory Measures - Platelets, WBC | WBC (1000/cubic mm)- Day42 | 5.3 thousand cells/cubic mm |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Chemistry and Hematology Laboratory Measures - Platelets, WBC | WBC (1000/cubic mm)- Day182 | 5 thousand cells/cubic mm |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Chemistry and Hematology Laboratory Measures - Platelets, WBC | Platelets (1000/cubic mm)- Day455 | 275 thousand cells/cubic mm |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Chemistry and Hematology Laboratory Measures - Platelets, WBC | WBC (1000/cubic mm)- Day91 | 6.585 thousand cells/cubic mm |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Chemistry and Hematology Laboratory Measures - Platelets, WBC | Platelets (1000/cubic mm)- Day84 | 261 thousand cells/cubic mm |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Chemistry and Hematology Laboratory Measures - Platelets, WBC | WBC (1000/cubic mm)- Day378 | 5.05 thousand cells/cubic mm |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Chemistry and Hematology Laboratory Measures - Platelets, WBC | WBC (1000/cubic mm)- Day7 | 5.56 thousand cells/cubic mm |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Chemistry and Hematology Laboratory Measures - Platelets, WBC | Platelets (1000/cubic mm)- Day87 | 273 thousand cells/cubic mm |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Chemistry and Hematology Laboratory Measures - Platelets, WBC | WBC (1000/cubic mm)- Screening | 5.5 thousand cells/cubic mm |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Chemistry and Hematology Laboratory Measures - Platelets, WBC | Platelets (1000/cubic mm)- Day7 | 286 thousand cells/cubic mm |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Chemistry and Hematology Laboratory Measures - Platelets, WBC | Platelets (1000/cubic mm)- Day91 | 279.5 thousand cells/cubic mm |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Chemistry and Hematology Laboratory Measures - Platelets, WBC | Platelets (1000/cubic mm)- Day85 | 281 thousand cells/cubic mm |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Chemistry and Hematology Laboratory Measures - Platelets, WBC | Platelets (1000/cubic mm)- Day182 | 272 thousand cells/cubic mm |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Chemistry and Hematology Laboratory Measures - Platelets, WBC | Platelets (1000/cubic mm)- Day42 | 277 thousand cells/cubic mm |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Chemistry and Hematology Laboratory Measures - Platelets, WBC | Platelets (1000/cubic mm)- Screening | 269.5 thousand cells/cubic mm |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Chemistry and Hematology Laboratory Measures - Platelets, WBC | Platelets (1000/cubic mm)- Day84 | 189 thousand cells/cubic mm |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Chemistry and Hematology Laboratory Measures - Platelets, WBC | Platelets (1000/cubic mm)- Day7 | 256 thousand cells/cubic mm |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Chemistry and Hematology Laboratory Measures - Platelets, WBC | Platelets (1000/cubic mm)- Day182 | 245.5 thousand cells/cubic mm |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Chemistry and Hematology Laboratory Measures - Platelets, WBC | Platelets (1000/cubic mm)- Day378 | 262 thousand cells/cubic mm |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Chemistry and Hematology Laboratory Measures - Platelets, WBC | Platelets (1000/cubic mm)- Day455 | 262 thousand cells/cubic mm |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Chemistry and Hematology Laboratory Measures - Platelets, WBC | WBC (1000/cubic mm)- Screening | 5.575 thousand cells/cubic mm |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Chemistry and Hematology Laboratory Measures - Platelets, WBC | WBC (1000/cubic mm)- Day0 | 5.67 thousand cells/cubic mm |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Chemistry and Hematology Laboratory Measures - Platelets, WBC | WBC (1000/cubic mm)- Day1 | 7.18 thousand cells/cubic mm |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Chemistry and Hematology Laboratory Measures - Platelets, WBC | WBC (1000/cubic mm)- Day3 | 5.74 thousand cells/cubic mm |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Chemistry and Hematology Laboratory Measures - Platelets, WBC | WBC (1000/cubic mm)- Day7 | 5.275 thousand cells/cubic mm |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Chemistry and Hematology Laboratory Measures - Platelets, WBC | WBC (1000/cubic mm)- Day42 | 5.05 thousand cells/cubic mm |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Chemistry and Hematology Laboratory Measures - Platelets, WBC | WBC (1000/cubic mm)- Day84 | 4.21 thousand cells/cubic mm |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Chemistry and Hematology Laboratory Measures - Platelets, WBC | WBC (1000/cubic mm)- Day182 | 4.895 thousand cells/cubic mm |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Chemistry and Hematology Laboratory Measures - Platelets, WBC | WBC (1000/cubic mm)- Day378 | 5.06 thousand cells/cubic mm |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Chemistry and Hematology Laboratory Measures - Platelets, WBC | WBC (1000/cubic mm)- Day455 | 4.565 thousand cells/cubic mm |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Chemistry and Hematology Laboratory Measures - Platelets, WBC | Platelets (1000/cubic mm)- Screening | 255.5 thousand cells/cubic mm |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Chemistry and Hematology Laboratory Measures - Platelets, WBC | Platelets (1000/cubic mm)- Day0 | 269 thousand cells/cubic mm |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Chemistry and Hematology Laboratory Measures - Platelets, WBC | Platelets (1000/cubic mm)- Day1 | 252 thousand cells/cubic mm |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Chemistry and Hematology Laboratory Measures - Platelets, WBC | Platelets (1000/cubic mm)- Day3 | 242 thousand cells/cubic mm |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Chemistry and Hematology Laboratory Measures - Platelets, WBC | Platelets (1000/cubic mm)- Day42 | 256 thousand cells/cubic mm |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Chemistry and Hematology Laboratory Measures - Platelets, WBC | WBC (1000/cubic mm)- Day42 | 5.31 thousand cells/cubic mm |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Chemistry and Hematology Laboratory Measures - Platelets, WBC | Platelets (1000/cubic mm)- Day7 | 286 thousand cells/cubic mm |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Chemistry and Hematology Laboratory Measures - Platelets, WBC | Platelets (1000/cubic mm)- Screening | 260.5 thousand cells/cubic mm |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Chemistry and Hematology Laboratory Measures - Platelets, WBC | WBC (1000/cubic mm)- Day98 | 5.5 thousand cells/cubic mm |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Chemistry and Hematology Laboratory Measures - Platelets, WBC | Platelets (1000/cubic mm)- Day98 | 276 thousand cells/cubic mm |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Chemistry and Hematology Laboratory Measures - Platelets, WBC | WBC (1000/cubic mm)- Day91 | 5.305 thousand cells/cubic mm |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Chemistry and Hematology Laboratory Measures - Platelets, WBC | WBC (1000/cubic mm)- Day7 | 5.36 thousand cells/cubic mm |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Chemistry and Hematology Laboratory Measures - Platelets, WBC | WBC (1000/cubic mm)- Day87 | 4.88 thousand cells/cubic mm |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Chemistry and Hematology Laboratory Measures - Platelets, WBC | Platelets (1000/cubic mm)- Day42 | 257.5 thousand cells/cubic mm |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Chemistry and Hematology Laboratory Measures - Platelets, WBC | WBC (1000/cubic mm)- Screening | 6.415 thousand cells/cubic mm |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Chemistry and Hematology Laboratory Measures - Platelets, WBC | Platelets (1000/cubic mm)- Day455 | 259 thousand cells/cubic mm |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Chemistry and Hematology Laboratory Measures - Platelets, WBC | Platelets (1000/cubic mm)- Day378 | 275.5 thousand cells/cubic mm |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Chemistry and Hematology Laboratory Measures - Platelets, WBC | Platelets (1000/cubic mm)- Day84 | 271 thousand cells/cubic mm |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Chemistry and Hematology Laboratory Measures - Platelets, WBC | Platelets (1000/cubic mm)- Day182 | 256 thousand cells/cubic mm |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Chemistry and Hematology Laboratory Measures - Platelets, WBC | Platelets (1000/cubic mm)- Day91 | 289.5 thousand cells/cubic mm |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Chemistry and Hematology Laboratory Measures - Platelets, WBC | Platelets (1000/cubic mm)- Day85 | 272 thousand cells/cubic mm |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Chemistry and Hematology Laboratory Measures - Platelets, WBC | WBC (1000/cubic mm)- Day378 | 5.67 thousand cells/cubic mm |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Chemistry and Hematology Laboratory Measures - Platelets, WBC | WBC (1000/cubic mm)- Day182 | 5.405 thousand cells/cubic mm |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Chemistry and Hematology Laboratory Measures - Platelets, WBC | WBC (1000/cubic mm)- Day85 | 5.8 thousand cells/cubic mm |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Chemistry and Hematology Laboratory Measures - Platelets, WBC | Platelets (1000/cubic mm)- Day87 | 265 thousand cells/cubic mm |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Chemistry and Hematology Laboratory Measures - Platelets, WBC | WBC (1000/cubic mm)- Day455 | 4.745 thousand cells/cubic mm |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Chemistry and Hematology Laboratory Measures - Platelets, WBC | WBC (1000/cubic mm)- Day84 | 5.42 thousand cells/cubic mm |
Primary
Level of Vaccine-induced Serum IgA Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C) in Group 1 and Group 3
Serum IgA responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay, run at 1:10 dilution. The readout is background-subtracted mean fluorescent intensity (MFI), with background adjustment for an antigen-specific plate level control. For each sample, response magnitude is net MFI, defined as experimental antigen MFI minus reference antigen MFI. Net MFI \< 1 is set to 1, and net MFI \> 22,000 is set to 22,000. Data are excluded if blood draw date was outside the allowable window, a participant was HIV-infected, reference antigen \> 5,000 MFI, or baseline net MFI \> 6,500. Comparisons were performed among positive responders only (positivity criteria are described in Outcome 1).
Time frame: Measured at Month 6.5
Population: Overall Number of Participants Analyzed represents the HIV uninfected participants with specimens at Month 6.5. Number Analyzed shows the number of participants with available BAMA data after filtering for assay specific quality control criteria at each timepoint.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Level of Vaccine-induced Serum IgA Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C) in Group 1 and Group 3 | 1086C_D7gp120.avi/293F | 22000 relative fluorescence units |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Level of Vaccine-induced Serum IgA Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C) in Group 1 and Group 3 | 96ZM651.D11gp120.avi | 8047.1 relative fluorescence units |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Level of Vaccine-induced Serum IgA Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C) in Group 1 and Group 3 | TV1c8_D11gp120.avi/293F | 8312.8 relative fluorescence units |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Level of Vaccine-induced Serum IgA Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C) in Group 1 and Group 3 | 1086C_D7gp120.avi/293F | 22000 relative fluorescence units |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Level of Vaccine-induced Serum IgA Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C) in Group 1 and Group 3 | 96ZM651.D11gp120.avi | 7595.5 relative fluorescence units |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Level of Vaccine-induced Serum IgA Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C) in Group 1 and Group 3 | TV1c8_D11gp120.avi/293F | 12210.8 relative fluorescence units |
Comparison: IgAAb binding to 1086C\_D7gp120.avi/293F in Group 1 versus Group 3p-value: 0.215Wilcoxon (Mann-Whitney)
Comparison: IgAAb binding to 96ZM651.D11gp120.avi in Group 1 versus Group 3p-value: 0.683Wilcoxon (Mann-Whitney)
Comparison: IgAAb binding to TV1c8\_D11gp120.avi/293F in Group 1 versus Group 3p-value: 0.322Wilcoxon (Mann-Whitney)
Primary
Level of Vaccine-induced Systemic IgG Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C) in Group 1 and Group 2
Serum IgG responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay, run at 1:50 dilution. The readout is background-subtracted mean fluorescent intensity (MFI), with background adjustment for an antigen-specific plate level control. For each sample, response magnitude is net MFI, defined as experimental antigen MFI minus reference antigen MFI. Net MFI \< 1 is set to 1, and net MFI \> 22,000 is set to 22,000. Data are excluded if blood draw date was outside the allowable window, a participant was HIV-infected, reference antigen \> 5,000 MFI, or baseline net MFI \> 6,500. Comparisons were performed among positive responders only (positivity criteria are described in Outcome 1).
Time frame: Measured at Month 6.5
Population: Overall Number of Participants Analyzed represents the HIV uninfected participants with specimens at Month 6.5. Number Analyzed shows the number of participants with available BAMA data after filtering for assay specific quality control criteria at each timepoint.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Level of Vaccine-induced Systemic IgG Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C) in Group 1 and Group 2 | 1086C_D7gp120.avi/293F | 22000 relative fluorescence units |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Level of Vaccine-induced Systemic IgG Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C) in Group 1 and Group 2 | TV1c8_D11gp120.avi/293F | 22000 relative fluorescence units |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Level of Vaccine-induced Systemic IgG Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C) in Group 1 and Group 2 | 96ZM651.D11gp120.avi | 22000 relative fluorescence units |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Level of Vaccine-induced Systemic IgG Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C) in Group 1 and Group 2 | 1086C_D7gp120.avi/293F | 22000 relative fluorescence units |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Level of Vaccine-induced Systemic IgG Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C) in Group 1 and Group 2 | 96ZM651.D11gp120.avi | 22000 relative fluorescence units |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Level of Vaccine-induced Systemic IgG Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C) in Group 1 and Group 2 | TV1c8_D11gp120.avi/293F | 22000 relative fluorescence units |
Comparison: IgGAb binding to 1086C\_D7gp120.avi/293F in Group 1 versus Group 2p-value: 0.238Wilcoxon (Mann-Whitney)
Comparison: IgGAb binding to 96ZM651.D11gp120.avi in Group 1 versus Group 2p-value: 0.893Wilcoxon (Mann-Whitney)
Comparison: IgGAb binding to TV1c8\_D11gp120.avi/293F in Group 1 versus Group 2p-value: 0.411Wilcoxon (Mann-Whitney)
Primary
Number of Participants Reporting Adverse Events (AEs), by Relationship to Study Product
For participants reporting multiple AEs over the time frame, the maximum relationship is counted.
Time frame: Measured through 30 days after each vaccine dose at Months 0, 1, 3, 6, and 12
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Number of Participants Reporting Adverse Events (AEs), by Relationship to Study Product | Related | 1 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Number of Participants Reporting Adverse Events (AEs), by Relationship to Study Product | No AE Reported | 8 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Number of Participants Reporting Adverse Events (AEs), by Relationship to Study Product | Not Related | 27 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Number of Participants Reporting Adverse Events (AEs), by Relationship to Study Product | Related | 2 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Number of Participants Reporting Adverse Events (AEs), by Relationship to Study Product | No AE Reported | 8 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Number of Participants Reporting Adverse Events (AEs), by Relationship to Study Product | Not Related | 26 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Number of Participants Reporting Adverse Events (AEs), by Relationship to Study Product | Not Related | 26 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Number of Participants Reporting Adverse Events (AEs), by Relationship to Study Product | Related | 0 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Number of Participants Reporting Adverse Events (AEs), by Relationship to Study Product | No AE Reported | 10 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Number of Participants Reporting Adverse Events (AEs), by Relationship to Study Product | Related | 0 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Number of Participants Reporting Adverse Events (AEs), by Relationship to Study Product | No AE Reported | 9 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Number of Participants Reporting Adverse Events (AEs), by Relationship to Study Product | Not Related | 15 Participants |
Primary
Number of Participants Reporting Adverse Events (AEs), by Severity Grade
For participants reporting multiple AEs over the time frame, the maximum severity grade is counted.
Time frame: Measured through 30 days after each vaccine dose at Months 0, 1, 3, 6, and 12
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Number of Participants Reporting Adverse Events (AEs), by Severity Grade | Severe | 3 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Number of Participants Reporting Adverse Events (AEs), by Severity Grade | Potentially Life-Threatening | 2 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Number of Participants Reporting Adverse Events (AEs), by Severity Grade | Mild | 5 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Number of Participants Reporting Adverse Events (AEs), by Severity Grade | Moderate | 18 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Number of Participants Reporting Adverse Events (AEs), by Severity Grade | Death | 0 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Number of Participants Reporting Adverse Events (AEs), by Severity Grade | No AE Reported | 8 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Number of Participants Reporting Adverse Events (AEs), by Severity Grade | Mild | 7 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Number of Participants Reporting Adverse Events (AEs), by Severity Grade | No AE Reported | 8 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Number of Participants Reporting Adverse Events (AEs), by Severity Grade | Moderate | 16 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Number of Participants Reporting Adverse Events (AEs), by Severity Grade | Potentially Life-Threatening | 1 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Number of Participants Reporting Adverse Events (AEs), by Severity Grade | Severe | 4 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Number of Participants Reporting Adverse Events (AEs), by Severity Grade | Death | 0 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Number of Participants Reporting Adverse Events (AEs), by Severity Grade | Death | 0 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Number of Participants Reporting Adverse Events (AEs), by Severity Grade | No AE Reported | 10 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Number of Participants Reporting Adverse Events (AEs), by Severity Grade | Mild | 12 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Number of Participants Reporting Adverse Events (AEs), by Severity Grade | Potentially Life-Threatening | 1 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Number of Participants Reporting Adverse Events (AEs), by Severity Grade | Moderate | 12 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Number of Participants Reporting Adverse Events (AEs), by Severity Grade | Severe | 1 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Number of Participants Reporting Adverse Events (AEs), by Severity Grade | Moderate | 12 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Number of Participants Reporting Adverse Events (AEs), by Severity Grade | No AE Reported | 9 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Number of Participants Reporting Adverse Events (AEs), by Severity Grade | Potentially Life-Threatening | 0 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Number of Participants Reporting Adverse Events (AEs), by Severity Grade | Severe | 1 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Number of Participants Reporting Adverse Events (AEs), by Severity Grade | Mild | 2 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Number of Participants Reporting Adverse Events (AEs), by Severity Grade | Death | 0 Participants |
Primary
Number of Participants Reporting Adverse Events of Special Interest (AESIs)
There were no adverse events of special interest reported by any participant.
Time frame: Measured through Month 18
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Number of Participants Reporting Adverse Events of Special Interest (AESIs) | 0 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Number of Participants Reporting Adverse Events of Special Interest (AESIs) | 0 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Number of Participants Reporting Adverse Events of Special Interest (AESIs) | 0 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Number of Participants Reporting Adverse Events of Special Interest (AESIs) | 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 Month Measured through 3 days after each vaccine dose at Months 0, 1, 3, 6, and 12
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration | Moderate | 4 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration | Mild | 1 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema | Potentially Life-threatening | 0 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Potentially Life-threatening | 0 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration | Not gradable | 2 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration | None | 29 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Moderate | 4 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Mild | 1 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema | Mild | 1 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema | None | 30 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Not gradable | 3 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | None | 28 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema | Moderate | 1 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Severe | 0 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration | Potentially Life-threatening | 0 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration | Severe | 0 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema | Severe | 0 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema | Not gradable | 4 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema | Mild | 0 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema | None | 31 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema | Not gradable | 5 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema | Moderate | 0 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema | Severe | 0 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema | Potentially Life-threatening | 0 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration | None | 28 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration | Not gradable | 7 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration | Mild | 0 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration | Moderate | 1 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration | Severe | 0 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration | Potentially Life-threatening | 0 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | None | 27 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Not gradable | 8 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Mild | 0 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Moderate | 1 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Severe | 0 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Potentially Life-threatening | 0 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema | Severe | 0 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration | Moderate | 0 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration | Severe | 0 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema | Moderate | 0 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Potentially Life-threatening | 0 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration | Potentially Life-threatening | 0 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Severe | 0 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | None | 32 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema | Mild | 1 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Not gradable | 3 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema | None | 33 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Mild | 1 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema | Not gradable | 2 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration | None | 34 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema | Potentially Life-threatening | 0 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration | Not gradable | 2 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Moderate | 0 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration | Mild | 0 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration | None | 19 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Moderate | 1 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Not gradable | 2 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration | Moderate | 1 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema | Moderate | 0 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema | None | 22 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema | Not gradable | 1 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration | Severe | 0 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema | Severe | 0 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Potentially Life-threatening | 0 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Mild | 3 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration | Potentially Life-threatening | 0 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema | Mild | 1 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema | Potentially Life-threatening | 0 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration | Mild | 2 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | None | 18 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration | Not gradable | 2 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Severe | 0 Participants |
Primary
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness
Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 \[July 2017\]. The maximum grade observed for each symptom over the time frame is presented.
Time frame: Measured through Month Measured through 3 days after each vaccine dose at Months 0, 1, 3, 6, and 12
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Pain | None | 21 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Tenderness | Severe | 0 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Pain | Moderate | 1 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Pain and/or Tenderness | Severe | 0 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Tenderness | Potentially Life-threatening | 0 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Pain and/or Tenderness | Moderate | 1 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Pain | Severe | 0 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Pain | Mild | 14 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Pain and/or Tenderness | None | 18 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Pain | Potentially Life-threatening | 0 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Tenderness | None | 20 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Tenderness | Mild | 16 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Pain and/or Tenderness | Mild | 17 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Pain and/or Tenderness | Potentially Life-threatening | 0 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Tenderness | Moderate | 0 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Pain and/or Tenderness | Potentially Life-threatening | 0 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Pain and/or Tenderness | Severe | 0 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Tenderness | Moderate | 1 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Tenderness | Severe | 0 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Pain | Potentially Life-threatening | 0 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Pain | Mild | 13 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Tenderness | Potentially Life-threatening | 0 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Tenderness | Mild | 15 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Pain and/or Tenderness | Moderate | 3 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Pain | Moderate | 3 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Pain and/or Tenderness | Mild | 18 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Pain and/or Tenderness | None | 15 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Tenderness | None | 20 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Pain | Severe | 0 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Pain | None | 20 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Tenderness | Moderate | 0 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Pain | None | 22 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Pain | Mild | 13 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Pain | Moderate | 1 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Pain | Severe | 0 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Pain | Potentially Life-threatening | 0 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Tenderness | None | 25 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Tenderness | Mild | 11 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Tenderness | Severe | 0 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Pain and/or Tenderness | Moderate | 1 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Pain and/or Tenderness | Severe | 0 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Pain and/or Tenderness | Potentially Life-threatening | 0 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Tenderness | Potentially Life-threatening | 0 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Pain and/or Tenderness | None | 21 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Pain and/or Tenderness | Mild | 14 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Tenderness | Mild | 8 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Tenderness | None | 16 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Pain | Mild | 7 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Pain and/or Tenderness | Potentially Life-threatening | 0 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Pain | Potentially Life-threatening | 0 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Pain | None | 17 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Tenderness | Potentially Life-threatening | 0 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Pain | Severe | 0 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Pain | Moderate | 0 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Pain and/or Tenderness | Mild | 10 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Pain and/or Tenderness | Moderate | 0 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Tenderness | Severe | 0 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Tenderness | Moderate | 0 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Pain and/or Tenderness | None | 14 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Pain and/or Tenderness | Severe | 0 Participants |
Primary
Number of Participants Reporting New Chronic Conditions (Requiring Medical Intervention for >= 30 Days)
New chronic conditions are adverse events that require medical intervention for \>= 30 days.
Time frame: Measured through Month 18
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Number of Participants Reporting New Chronic Conditions (Requiring Medical Intervention for >= 30 Days) | No | 28 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Number of Participants Reporting New Chronic Conditions (Requiring Medical Intervention for >= 30 Days) | Yes | 0 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Number of Participants Reporting New Chronic Conditions (Requiring Medical Intervention for >= 30 Days) | No AE Reported | 8 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Number of Participants Reporting New Chronic Conditions (Requiring Medical Intervention for >= 30 Days) | Yes | 1 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Number of Participants Reporting New Chronic Conditions (Requiring Medical Intervention for >= 30 Days) | No | 27 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Number of Participants Reporting New Chronic Conditions (Requiring Medical Intervention for >= 30 Days) | No AE Reported | 8 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Number of Participants Reporting New Chronic Conditions (Requiring Medical Intervention for >= 30 Days) | Yes | 0 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Number of Participants Reporting New Chronic Conditions (Requiring Medical Intervention for >= 30 Days) | No AE Reported | 10 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Number of Participants Reporting New Chronic Conditions (Requiring Medical Intervention for >= 30 Days) | No | 26 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Number of Participants Reporting New Chronic Conditions (Requiring Medical Intervention for >= 30 Days) | No | 13 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Number of Participants Reporting New Chronic Conditions (Requiring Medical Intervention for >= 30 Days) | Yes | 2 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Number of Participants Reporting New Chronic Conditions (Requiring Medical Intervention for >= 30 Days) | No AE Reported | 9 Participants |
Primary
Number of Participants Reporting Serious Adverse Events (SAEs)
Measured as outlined in Version 2.0 (January 2010) of the Manual for Expedited Reporting of Adverse Events to DAIDS (DAIDS EAE Manual).
Time frame: Measured through Month 18
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Number of Participants Reporting Serious Adverse Events (SAEs) | Yes | 1 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Number of Participants Reporting Serious Adverse Events (SAEs) | No AE Reported | 8 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Number of Participants Reporting Serious Adverse Events (SAEs) | No | 27 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Number of Participants Reporting Serious Adverse Events (SAEs) | Yes | 0 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Number of Participants Reporting Serious Adverse Events (SAEs) | No AE Reported | 8 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Number of Participants Reporting Serious Adverse Events (SAEs) | No | 28 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Number of Participants Reporting Serious Adverse Events (SAEs) | No | 26 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Number of Participants Reporting Serious Adverse Events (SAEs) | Yes | 0 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Number of Participants Reporting Serious Adverse Events (SAEs) | No AE Reported | 10 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Number of Participants Reporting Serious Adverse Events (SAEs) | Yes | 1 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Number of Participants Reporting Serious Adverse Events (SAEs) | No AE Reported | 9 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Number of Participants Reporting Serious Adverse Events (SAEs) | No | 14 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 following symptoms are considered as systemic reactogenicity if the onset date was within the periods of assessment specified in the protocol: malaise and/or fatigue, myalgia, headache, nausea, vomiting, chills, arthralgia, and body temperature. The item Max. Systemic Symptoms is the maximum of the individual systemic reactogenicities excluding body temperature for a participant.
Time frame: Measured through Month Measured through 3 days after each vaccine dose at Months 0, 1, 3, 6, and 12
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Vomiting | Severe | 0 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Vomiting | Potentially Life-threatening | 0 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Moderate | 0 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Moderate | 0 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Mild | 0 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Mild | 0 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Severe | 0 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | None | 36 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | None | 34 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Potentially Life-threatening | 0 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Mild | 2 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | None | 28 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | None | 23 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Moderate | 0 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Severe | 0 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Mild | 0 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Potentially Life-threatening | 0 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | None | 36 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Severe | 0 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Moderate | 0 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Potentially Life-threatening | 0 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Potentially Life-threatening | 0 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Mild | 8 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Moderate | 0 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Moderate | 0 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Severe | 0 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Severe | 0 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Mild | 13 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | None | 32 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | None | 30 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Severe | 0 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Potentially Life-threatening | 0 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Mild | 6 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Potentially Life-threatening | 0 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Moderate | 0 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Severe | 0 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Severe | 0 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Potentially Life-threatening | 0 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Moderate | 0 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Vomiting | None | 36 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | None | 36 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Vomiting | Mild | 0 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Potentially Life-threatening | 0 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Vomiting | Moderate | 0 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Mild | 4 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Severe | 0 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Vomiting | Severe | 0 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Moderate | 0 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Potentially Life-threatening | 0 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Vomiting | Potentially Life-threatening | 0 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Vomiting | Moderate | 0 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Moderate | 2 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Potentially Life-threatening | 0 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Mild | 2 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Mild | 11 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Mild | 1 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | None | 34 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Severe | 0 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Mild | 7 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Severe | 0 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Severe | 0 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | None | 34 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Potentially Life-threatening | 1 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Potentially Life-threatening | 0 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Mild | 2 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | None | 31 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Moderate | 0 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Potentially Life-threatening | 0 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | None | 23 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Severe | 0 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Moderate | 0 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Mild | 3 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | None | 34 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Potentially Life-threatening | 0 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Potentially Life-threatening | 0 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Moderate | 1 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Vomiting | Mild | 1 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Mild | 2 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Severe | 0 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | None | 35 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Severe | 0 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Vomiting | None | 35 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Potentially Life-threatening | 0 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Moderate | 1 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Severe | 0 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | None | 28 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | None | 28 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Moderate | 2 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Moderate | 0 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Mild | 6 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Potentially Life-threatening | 0 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | None | 30 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Moderate | 0 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Severe | 0 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Potentially Life-threatening | 0 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | None | 35 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Mild | 1 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Moderate | 0 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Severe | 0 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Potentially Life-threatening | 0 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | None | 29 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Mild | 7 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Moderate | 0 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Severe | 0 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Potentially Life-threatening | 0 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | None | 32 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Mild | 4 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Moderate | 0 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Severe | 0 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Potentially Life-threatening | 0 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Vomiting | None | 36 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Vomiting | Mild | 0 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Vomiting | Moderate | 0 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Vomiting | Potentially Life-threatening | 0 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | None | 33 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Moderate | 0 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Potentially Life-threatening | 0 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Severe | 0 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | None | 25 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Moderate | 0 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Mild | 1 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Vomiting | Severe | 0 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Mild | 3 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Severe | 0 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | None | 34 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Mild | 2 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Moderate | 0 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Potentially Life-threatening | 0 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Mild | 11 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Severe | 0 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Potentially Life-threatening | 0 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | None | 35 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Moderate | 0 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Severe | 0 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Mild | 6 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Severe | 0 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Vomiting | Mild | 0 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Vomiting | None | 24 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | None | 22 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Potentially Life-threatening | 0 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Mild | 0 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Potentially Life-threatening | 0 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Severe | 0 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Mild | 3 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Moderate | 0 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Moderate | 0 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Mild | 1 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Severe | 0 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | None | 23 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Potentially Life-threatening | 0 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Moderate | 0 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | None | 17 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Severe | 0 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Moderate | 0 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Severe | 0 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Mild | 7 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Mild | 5 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | None | 19 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Potentially Life-threatening | 0 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Moderate | 0 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Severe | 0 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Severe | 0 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | None | 21 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Potentially Life-threatening | 0 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Moderate | 0 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Moderate | 0 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Mild | 2 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Potentially Life-threatening | 0 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Potentially Life-threatening | 0 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | None | 24 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Severe | 0 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Potentially Life-threatening | 0 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Moderate | 0 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | None | 23 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | None | 24 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Mild | 1 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Vomiting | Potentially Life-threatening | 0 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Vomiting | Severe | 0 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Vomiting | Moderate | 0 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Mild | 0 Participants |
Primary
Number of Participants With Early Study Termination Associated With an AE or Reactogenicity
There were no early study terminations associated with an AE or reactogenicity reported by any participant.
Time frame: Measured through Month 18
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Number of Participants With Early Study Termination Associated With an AE or Reactogenicity | 0 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Number of Participants With Early Study Termination Associated With an AE or Reactogenicity | 0 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Number of Participants With Early Study Termination Associated With an AE or Reactogenicity | 0 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Number of Participants With Early Study Termination Associated With an AE or Reactogenicity | 0 Participants |
Primary
Number of Participants With Study Product Discontinuation Associated With an AE or Reactogenicity
From the study product discontinuation form, study product discontinuation reasons are tabulated by treatment arm.
Time frame: Measured through Month 18
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Number of Participants With Study Product Discontinuation Associated With an AE or Reactogenicity | Reactogenicity | 0 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Number of Participants With Study Product Discontinuation Associated With an AE or Reactogenicity | No discontinuation | 31 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Number of Participants With Study Product Discontinuation Associated With an AE or Reactogenicity | Clinical event other than reactogenicity | 1 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Number of Participants With Study Product Discontinuation Associated With an AE or Reactogenicity | Other reason | 4 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Number of Participants With Study Product Discontinuation Associated With an AE or Reactogenicity | Other reason | 3 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Number of Participants With Study Product Discontinuation Associated With an AE or Reactogenicity | Clinical event other than reactogenicity | 1 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Number of Participants With Study Product Discontinuation Associated With an AE or Reactogenicity | No discontinuation | 32 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Number of Participants With Study Product Discontinuation Associated With an AE or Reactogenicity | Reactogenicity | 0 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Number of Participants With Study Product Discontinuation Associated With an AE or Reactogenicity | No discontinuation | 32 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Number of Participants With Study Product Discontinuation Associated With an AE or Reactogenicity | Clinical event other than reactogenicity | 0 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Number of Participants With Study Product Discontinuation Associated With an AE or Reactogenicity | Reactogenicity | 0 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Number of Participants With Study Product Discontinuation Associated With an AE or Reactogenicity | Other reason | 4 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Number of Participants With Study Product Discontinuation Associated With an AE or Reactogenicity | No discontinuation | 18 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Number of Participants With Study Product Discontinuation Associated With an AE or Reactogenicity | Clinical event other than reactogenicity | 0 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Number of Participants With Study Product Discontinuation Associated With an AE or Reactogenicity | Other reason | 6 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Number of Participants With Study Product Discontinuation Associated With an AE or Reactogenicity | Reactogenicity | 0 Participants |
Primary
Numbers of Participants With Grade 1 or Higher Local Laboratory Results
The number (percentage) of participants with local laboratory values recorded as meeting Grade 1 AE criteria or above as specified in the DAIDS AE Grading Table were tabulated by treatment arm for each post-vaccination time point.
Time frame: Measured during screening, Days 0, 1, 3, 7, 42, 84, 85, 87, 91, 98, 182, 378, and 455
Population: Overall Number of Participants Analyzed represents participants enrolled and eligible for laboratory assessment. Participants do not have laboratory assessments if they attended the visit but laboratory specimens were not collected, missed the scheduled visit, or terminated participation in the study prior to the scheduled visit.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Numbers of Participants With Grade 1 or Higher Local Laboratory Results | AST (U/L)- Day7 | 0 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Numbers of Participants With Grade 1 or Higher Local Laboratory Results | AST (U/L)- Day42 | 1 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Numbers of Participants With Grade 1 or Higher Local Laboratory Results | AST (U/L)- Day98 | 1 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Numbers of Participants With Grade 1 or Higher Local Laboratory Results | ALT (SGPT) (U/L)- Day42 | 2 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Numbers of Participants With Grade 1 or Higher Local Laboratory Results | ALT (SGPT) (U/L)- Day378 | 0 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Numbers of Participants With Grade 1 or Higher Local Laboratory Results | Hemoglobin (g/dL)- Day7 | 0 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Numbers of Participants With Grade 1 or Higher Local Laboratory Results | Creatinine (g/dL)- Day7 | 4 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Numbers of Participants With Grade 1 or Higher Local Laboratory Results | Creatinine (g/dL)- Day42 | 3 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Numbers of Participants With Grade 1 or Higher Local Laboratory Results | Creatinine (g/dL)- Day84 | 1 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Numbers of Participants With Grade 1 or Higher Local Laboratory Results | Creatinine (g/dL)- Day98 | 4 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Numbers of Participants With Grade 1 or Higher Local Laboratory Results | Creatinine (g/dL)- Day182 | 3 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Numbers of Participants With Grade 1 or Higher Local Laboratory Results | Platelets (1000/cubic mm)- Day42 | 0 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Numbers of Participants With Grade 1 or Higher Local Laboratory Results | Neutrophils (1000/cubic mm)- Day378 | 1 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Numbers of Participants With Grade 1 or Higher Local Laboratory Results | AST (U/L)- Day182 | 0 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Numbers of Participants With Grade 1 or Higher Local Laboratory Results | AST (U/L)- Day378 | 0 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Numbers of Participants With Grade 1 or Higher Local Laboratory Results | ALT (SGPT) (U/L)- Day7 | 0 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Numbers of Participants With Grade 1 or Higher Local Laboratory Results | ALT (SGPT) (U/L)- Day98 | 1 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Numbers of Participants With Grade 1 or Higher Local Laboratory Results | ALT (SGPT) (U/L)- Day182 | 0 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Numbers of Participants With Grade 1 or Higher Local Laboratory Results | Hemoglobin (g/dL)- Day42 | 1 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Numbers of Participants With Grade 1 or Higher Local Laboratory Results | Hemoglobin (g/dL)- Day84 | 0 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Numbers of Participants With Grade 1 or Higher Local Laboratory Results | Hemoglobin (g/dL)- Day85 | 0 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Numbers of Participants With Grade 1 or Higher Local Laboratory Results | Hemoglobin (g/dL)- Day87 | 0 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Numbers of Participants With Grade 1 or Higher Local Laboratory Results | Hemoglobin (g/dL)- Day91 | 0 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Numbers of Participants With Grade 1 or Higher Local Laboratory Results | Hemoglobin (g/dL)- Day98 | 0 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Numbers of Participants With Grade 1 or Higher Local Laboratory Results | Hemoglobin (g/dL)- Day182 | 0 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Numbers of Participants With Grade 1 or Higher Local Laboratory Results | Hemoglobin (g/dL)- Day378 | 2 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Numbers of Participants With Grade 1 or Higher Local Laboratory Results | Hemoglobin (g/dL)- Day455 | 0 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Numbers of Participants With Grade 1 or Higher Local Laboratory Results | Creatinine (g/dL)- Day378 | 4 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Numbers of Participants With Grade 1 or Higher Local Laboratory Results | Creatinine (g/dL)- Day455 | 1 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Numbers of Participants With Grade 1 or Higher Local Laboratory Results | Platelets (1000/cubic mm)- Day7 | 0 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Numbers of Participants With Grade 1 or Higher Local Laboratory Results | Platelets (1000/cubic mm)- Day182 | 0 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Numbers of Participants With Grade 1 or Higher Local Laboratory Results | Neutrophils (1000/cubic mm)- Day91 | 1 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Numbers of Participants With Grade 1 or Higher Local Laboratory Results | Neutrophils (1000/cubic mm)- Day98 | 1 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Numbers of Participants With Grade 1 or Higher Local Laboratory Results | Neutrophils (1000/cubic mm)- Day182 | 1 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Numbers of Participants With Grade 1 or Higher Local Laboratory Results | Hemoglobin (g/dL)- Day84 | 0 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Numbers of Participants With Grade 1 or Higher Local Laboratory Results | ALT (SGPT) (U/L)- Day378 | 0 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Numbers of Participants With Grade 1 or Higher Local Laboratory Results | ALT (SGPT) (U/L)- Day7 | 1 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Numbers of Participants With Grade 1 or Higher Local Laboratory Results | Hemoglobin (g/dL)- Day378 | 2 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Numbers of Participants With Grade 1 or Higher Local Laboratory Results | Hemoglobin (g/dL)- Day42 | 0 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Numbers of Participants With Grade 1 or Higher Local Laboratory Results | Hemoglobin (g/dL)- Day98 | 1 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Numbers of Participants With Grade 1 or Higher Local Laboratory Results | Creatinine (g/dL)- Day7 | 1 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Numbers of Participants With Grade 1 or Higher Local Laboratory Results | Creatinine (g/dL)- Day42 | 1 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Numbers of Participants With Grade 1 or Higher Local Laboratory Results | ALT (SGPT) (U/L)- Day98 | 1 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Numbers of Participants With Grade 1 or Higher Local Laboratory Results | Hemoglobin (g/dL)- Day455 | 1 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Numbers of Participants With Grade 1 or Higher Local Laboratory Results | Creatinine (g/dL)- Day98 | 4 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Numbers of Participants With Grade 1 or Higher Local Laboratory Results | ALT (SGPT) (U/L)- Day182 | 0 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Numbers of Participants With Grade 1 or Higher Local Laboratory Results | Hemoglobin (g/dL)- Day7 | 1 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Numbers of Participants With Grade 1 or Higher Local Laboratory Results | Neutrophils (1000/cubic mm)- Day378 | 1 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Numbers of Participants With Grade 1 or Higher Local Laboratory Results | Neutrophils (1000/cubic mm)- Day91 | 0 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Numbers of Participants With Grade 1 or Higher Local Laboratory Results | Creatinine (g/dL)- Day455 | 0 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Numbers of Participants With Grade 1 or Higher Local Laboratory Results | AST (U/L)- Day7 | 0 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Numbers of Participants With Grade 1 or Higher Local Laboratory Results | Platelets (1000/cubic mm)- Day7 | 0 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Numbers of Participants With Grade 1 or Higher Local Laboratory Results | Hemoglobin (g/dL)- Day85 | 1 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Numbers of Participants With Grade 1 or Higher Local Laboratory Results | Creatinine (g/dL)- Day182 | 2 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Numbers of Participants With Grade 1 or Higher Local Laboratory Results | AST (U/L)- Day98 | 1 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Numbers of Participants With Grade 1 or Higher Local Laboratory Results | Hemoglobin (g/dL)- Day87 | 1 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Numbers of Participants With Grade 1 or Higher Local Laboratory Results | Platelets (1000/cubic mm)- Day42 | 0 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Numbers of Participants With Grade 1 or Higher Local Laboratory Results | Platelets (1000/cubic mm)- Day182 | 0 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Numbers of Participants With Grade 1 or Higher Local Laboratory Results | Hemoglobin (g/dL)- Day91 | 1 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Numbers of Participants With Grade 1 or Higher Local Laboratory Results | AST (U/L)- Day182 | 0 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Numbers of Participants With Grade 1 or Higher Local Laboratory Results | Neutrophils (1000/cubic mm)- Day98 | 0 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Numbers of Participants With Grade 1 or Higher Local Laboratory Results | Hemoglobin (g/dL)- Day182 | 2 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Numbers of Participants With Grade 1 or Higher Local Laboratory Results | AST (U/L)- Day42 | 1 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Numbers of Participants With Grade 1 or Higher Local Laboratory Results | AST (U/L)- Day378 | 0 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Numbers of Participants With Grade 1 or Higher Local Laboratory Results | ALT (SGPT) (U/L)- Day42 | 1 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Numbers of Participants With Grade 1 or Higher Local Laboratory Results | Neutrophils (1000/cubic mm)- Day182 | 1 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Numbers of Participants With Grade 1 or Higher Local Laboratory Results | Creatinine (g/dL)- Day378 | 1 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Numbers of Participants With Grade 1 or Higher Local Laboratory Results | AST (U/L)- Day7 | 0 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Numbers of Participants With Grade 1 or Higher Local Laboratory Results | Creatinine (g/dL)- Day455 | 0 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Numbers of Participants With Grade 1 or Higher Local Laboratory Results | Creatinine (g/dL)- Day42 | 0 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Numbers of Participants With Grade 1 or Higher Local Laboratory Results | Creatinine (g/dL)- Day378 | 1 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Numbers of Participants With Grade 1 or Higher Local Laboratory Results | AST (U/L)- Day42 | 0 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Numbers of Participants With Grade 1 or Higher Local Laboratory Results | Hemoglobin (g/dL)- Day182 | 1 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Numbers of Participants With Grade 1 or Higher Local Laboratory Results | Hemoglobin (g/dL)- Day42 | 0 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Numbers of Participants With Grade 1 or Higher Local Laboratory Results | Neutrophils (1000/cubic mm)- Day378 | 1 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Numbers of Participants With Grade 1 or Higher Local Laboratory Results | ALT (SGPT) (U/L)- Day42 | 1 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Numbers of Participants With Grade 1 or Higher Local Laboratory Results | AST (U/L)- Day378 | 2 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Numbers of Participants With Grade 1 or Higher Local Laboratory Results | ALT (SGPT) (U/L)- Day182 | 1 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Numbers of Participants With Grade 1 or Higher Local Laboratory Results | AST (U/L)- Day182 | 2 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Numbers of Participants With Grade 1 or Higher Local Laboratory Results | Hemoglobin (g/dL)- Day455 | 0 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Numbers of Participants With Grade 1 or Higher Local Laboratory Results | Platelets (1000/cubic mm)- Day7 | 1 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Numbers of Participants With Grade 1 or Higher Local Laboratory Results | ALT (SGPT) (U/L)- Day378 | 1 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Numbers of Participants With Grade 1 or Higher Local Laboratory Results | Creatinine (g/dL)- Day182 | 3 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Numbers of Participants With Grade 1 or Higher Local Laboratory Results | Platelets (1000/cubic mm)- Day182 | 1 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Numbers of Participants With Grade 1 or Higher Local Laboratory Results | Hemoglobin (g/dL)- Day84 | 0 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Numbers of Participants With Grade 1 or Higher Local Laboratory Results | Hemoglobin (g/dL)- Day7 | 0 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Numbers of Participants With Grade 1 or Higher Local Laboratory Results | ALT (SGPT) (U/L)- Day7 | 0 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Numbers of Participants With Grade 1 or Higher Local Laboratory Results | Hemoglobin (g/dL)- Day378 | 0 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Numbers of Participants With Grade 1 or Higher Local Laboratory Results | Platelets (1000/cubic mm)- Day42 | 1 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Numbers of Participants With Grade 1 or Higher Local Laboratory Results | Creatinine (g/dL)- Day7 | 1 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Numbers of Participants With Grade 1 or Higher Local Laboratory Results | Neutrophils (1000/cubic mm)- Day182 | 0 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Numbers of Participants With Grade 1 or Higher Local Laboratory Results | ALT (SGPT) (U/L)- Day84 | 1 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Numbers of Participants With Grade 1 or Higher Local Laboratory Results | Creatinine (g/dL)- Day98 | 0 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Numbers of Participants With Grade 1 or Higher Local Laboratory Results | Platelets (1000/cubic mm)- Day7 | 0 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Numbers of Participants With Grade 1 or Higher Local Laboratory Results | Neutrophils (1000/cubic mm)- Day182 | 0 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Numbers of Participants With Grade 1 or Higher Local Laboratory Results | Neutrophils (1000/cubic mm)- Day378 | 0 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Numbers of Participants With Grade 1 or Higher Local Laboratory Results | AST (U/L)- Day42 | 2 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Numbers of Participants With Grade 1 or Higher Local Laboratory Results | AST (U/L)- Day98 | 0 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Numbers of Participants With Grade 1 or Higher Local Laboratory Results | Creatinine (g/dL)- Day182 | 0 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Numbers of Participants With Grade 1 or Higher Local Laboratory Results | AST (U/L)- Day182 | 0 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Numbers of Participants With Grade 1 or Higher Local Laboratory Results | AST (U/L)- Day378 | 1 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Numbers of Participants With Grade 1 or Higher Local Laboratory Results | ALT (SGPT) (U/L)- Day7 | 0 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Numbers of Participants With Grade 1 or Higher Local Laboratory Results | ALT (SGPT) (U/L)- Day98 | 0 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Numbers of Participants With Grade 1 or Higher Local Laboratory Results | Creatinine (g/dL)- Day378 | 0 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Numbers of Participants With Grade 1 or Higher Local Laboratory Results | Hemoglobin (g/dL)- Day7 | 0 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Numbers of Participants With Grade 1 or Higher Local Laboratory Results | Hemoglobin (g/dL)- Day42 | 0 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Numbers of Participants With Grade 1 or Higher Local Laboratory Results | Hemoglobin (g/dL)- Day84 | 2 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Numbers of Participants With Grade 1 or Higher Local Laboratory Results | Hemoglobin (g/dL)- Day85 | 0 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Numbers of Participants With Grade 1 or Higher Local Laboratory Results | Creatinine (g/dL)- Day455 | 0 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Numbers of Participants With Grade 1 or Higher Local Laboratory Results | Hemoglobin (g/dL)- Day87 | 0 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Numbers of Participants With Grade 1 or Higher Local Laboratory Results | Neutrophils (1000/cubic mm)- Day91 | 0 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Numbers of Participants With Grade 1 or Higher Local Laboratory Results | Hemoglobin (g/dL)- Day91 | 1 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Numbers of Participants With Grade 1 or Higher Local Laboratory Results | Hemoglobin (g/dL)- Day98 | 1 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Numbers of Participants With Grade 1 or Higher Local Laboratory Results | Platelets (1000/cubic mm)- Day42 | 0 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Numbers of Participants With Grade 1 or Higher Local Laboratory Results | AST (U/L)- Day7 | 1 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Numbers of Participants With Grade 1 or Higher Local Laboratory Results | Hemoglobin (g/dL)- Day182 | 0 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Numbers of Participants With Grade 1 or Higher Local Laboratory Results | ALT (SGPT) (U/L)- Day42 | 1 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Numbers of Participants With Grade 1 or Higher Local Laboratory Results | ALT (SGPT) (U/L)- Day182 | 0 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Numbers of Participants With Grade 1 or Higher Local Laboratory Results | Neutrophils (1000/cubic mm)- Day98 | 0 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Numbers of Participants With Grade 1 or Higher Local Laboratory Results | ALT (SGPT) (U/L)- Day378 | 0 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Numbers of Participants With Grade 1 or Higher Local Laboratory Results | Hemoglobin (g/dL)- Day455 | 0 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Numbers of Participants With Grade 1 or Higher Local Laboratory Results | Creatinine (g/dL)- Day7 | 2 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Numbers of Participants With Grade 1 or Higher Local Laboratory Results | Hemoglobin (g/dL)- Day378 | 0 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Numbers of Participants With Grade 1 or Higher Local Laboratory Results | Creatinine (g/dL)- Day42 | 0 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Numbers of Participants With Grade 1 or Higher Local Laboratory Results | Platelets (1000/cubic mm)- Day182 | 0 Participants |
Primary
Occurrence of Vaccine-induced Serum IgA Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C) in Group 1 and Group 3
Serum IgA responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay, run at 1:10 dilution. The readout is background-subtracted mean fluorescent intensity (MFI), with background adjustment for an antigen-specific plate level control. For each sample, response magnitude is net MFI, defined as experimental antigen MFI minus reference antigen MFI. Net MFI \< 1 is set to 1, and net MFI \> 22,000 is set to 22,000. Data are excluded if blood draw date was outside the allowable window, a participant was HIV-infected, reference antigen \> 5,000 MFI, or baseline net MFI \> 6,500. Samples from post-enrollment visits have positive responses if they meet three criteria: (1) net MFI greater than or equal to an antigen-specific response threshold (defined as the maximum of 100 and the 95th percentile of baseline net MFI), (2) net MFI values are greater than 3 times baseline net MFI, and (3) experimental antigen MFI values are greater than 3 times baseline MFI.
Time frame: Measured at Month 6.5
Population: Overall Number of Participants Analyzed represents the HIV uninfected participants with specimens at Month 6.5. Number Analyzed shows the number of participants with available BAMA data after filtering for assay specific quality control criteria at each timepoint.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgA Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C) in Group 1 and Group 3 | 1086C_D7gp120.avi/293F | 22 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgA Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C) in Group 1 and Group 3 | 96ZM651.D11gp120.avi | 12 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgA Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C) in Group 1 and Group 3 | TV1c8_D11gp120.avi/293F | 18 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Occurrence of Vaccine-induced Serum IgA Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C) in Group 1 and Group 3 | 1086C_D7gp120.avi/293F | 27 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Occurrence of Vaccine-induced Serum IgA Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C) in Group 1 and Group 3 | 96ZM651.D11gp120.avi | 22 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Occurrence of Vaccine-induced Serum IgA Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C) in Group 1 and Group 3 | TV1c8_D11gp120.avi/293F | 27 Participants |
Comparison: IgAAb binding to 1086C\_D7gp120.avi/293F in Group 1 versus Group 3p-value: 1Barnard's test
Comparison: IgAAb binding to 96ZM651.D11gp120.avi in Group 1 versus Group 3p-value: 0.044Barnard's test
Comparison: IgAAb binding to TV1c8\_D11gp120.avi/293F in Group 1 versus Group 3p-value: 0.045Barnard's test
Primary
Occurrence of Vaccine-induced Systemic IgG Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C) in Group 1 and Group 2
Serum IgG responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay, run at 1:50 dilution. The readout is background-subtracted mean fluorescent intensity (MFI), with background adjustment for an antigen-specific plate level control. For each sample, response magnitude is net MFI, defined as experimental antigen MFI minus reference antigen MFI. Net MFI \< 1 is set to 1, and net MFI \> 22,000 is set to 22,000. Data are excluded if blood draw date was outside the allowable window, a participant was HIV-infected, reference antigen \> 5,000 MFI, or baseline net MFI \> 6,500. Samples from post-enrollment visits have positive responses if they meet three criteria: (1) net MFI greater than or equal to an antigen-specific response threshold (defined as the maximum of 100 and the 95th percentile of baseline net MFI), (2) net MFI values are greater than 3 times baseline net MFI, and (3) experimental antigen MFI values are greater than 3 times baseline MFI.
Time frame: Measured at Month 6.5
Population: Overall Number of Participants Analyzed represents the HIV uninfected participants with specimens at Month 6.5. Number Analyzed shows the number of participants with available BAMA data after filtering for assay specific quality control criteria at each timepoint.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Occurrence of Vaccine-induced Systemic IgG Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C) in Group 1 and Group 2 | 1086C_D7gp120.avi/293F | 29 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Occurrence of Vaccine-induced Systemic IgG Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C) in Group 1 and Group 2 | 96ZM651.D11gp120.avi | 27 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Occurrence of Vaccine-induced Systemic IgG Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C) in Group 1 and Group 2 | TV1c8_D11gp120.avi/293F | 29 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Occurrence of Vaccine-induced Systemic IgG Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C) in Group 1 and Group 2 | 1086C_D7gp120.avi/293F | 26 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Occurrence of Vaccine-induced Systemic IgG Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C) in Group 1 and Group 2 | 96ZM651.D11gp120.avi | 27 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Occurrence of Vaccine-induced Systemic IgG Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C) in Group 1 and Group 2 | TV1c8_D11gp120.avi/293F | 27 Participants |
Comparison: IgGAb binding to 1086C\_D7gp120.avi/293F in Group 1 versus Group 2p-value: 0.358Barnard's test
Comparison: IgGAb binding to 96ZM651.D11gp120.avi in Group 1 versus Group 2p-value: 1Barnard's test
Comparison: IgGAb binding to TV1c8\_D11gp120.avi/293F in Group 1 versus Group 2p-value: 0.361Barnard's test
Secondary
HIV-specific CD4+ T Cell Polyfunctionality by ICS - Functionality Scores
COMPASS uses a Bayesian hierarchical framework to model all observed functional cell subsets and select those most likely to exhibit antigen-specific responses. Cell-subset responses are quantified by posterior probabilities. The functionality score (FS) summarizes, as a single number for each participant, the proportion of antigen-specific cell subsets among all measured subsets, irrespective of degree of functionality. FS ranges from zero to one. FS will assign a higher score to participants that exhibit antigen specificity in more cell subsets irrespective of their degree of functionality.
Time frame: Measured at Months 6.5, 12, 12.5, and 18
Population: Overall Number of Participants Analyzed represents the number of participants in the per-protocol population. Number Analyzed shows the number of HIV uninfected participants with available COMPASS data after filtering for assay specific quality control criteria at each timepoint.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | HIV-specific CD4+ T Cell Polyfunctionality by ICS - Functionality Scores | Env-1-ZM96 (Month 6.5) | 0.157 Functionality Score |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | HIV-specific CD4+ T Cell Polyfunctionality by ICS - Functionality Scores | Any Env ZM96 (Month 18) | 0.159 Functionality Score |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | HIV-specific CD4+ T Cell Polyfunctionality by ICS - Functionality Scores | 1086 gp120 (Month 6.5) | 0.169 Functionality Score |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | HIV-specific CD4+ T Cell Polyfunctionality by ICS - Functionality Scores | TV1 gp120 (Month 12.5) | 0.217 Functionality Score |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | HIV-specific CD4+ T Cell Polyfunctionality by ICS - Functionality Scores | Any Env ZM96 (Month 12.5) | 0.187 Functionality Score |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | HIV-specific CD4+ T Cell Polyfunctionality by ICS - Functionality Scores | Any Env ZM96 (Month 12) | 0.126 Functionality Score |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | HIV-specific CD4+ T Cell Polyfunctionality by ICS - Functionality Scores | 1086 gp120 (Month 12) | 0.108 Functionality Score |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | HIV-specific CD4+ T Cell Polyfunctionality by ICS - Functionality Scores | LAI-Gag (Month 6.5) | 0.04 Functionality Score |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | HIV-specific CD4+ T Cell Polyfunctionality by ICS - Functionality Scores | Any Env ZM96 (Month 6.5) | 0.157 Functionality Score |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | HIV-specific CD4+ T Cell Polyfunctionality by ICS - Functionality Scores | 1086 gp120 (Month 18) | 0.143 Functionality Score |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | HIV-specific CD4+ T Cell Polyfunctionality by ICS - Functionality Scores | 1086 gp120 (Month 12.5) | 0.17 Functionality Score |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | HIV-specific CD4+ T Cell Polyfunctionality by ICS - Functionality Scores | Env-2-ZM96 (Month 12.5) | 0.024 Functionality Score |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | HIV-specific CD4+ T Cell Polyfunctionality by ICS - Functionality Scores | TV1 gp120 (Month 6.5) | 0.165 Functionality Score |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | HIV-specific CD4+ T Cell Polyfunctionality by ICS - Functionality Scores | Env-2-ZM96 (Month 18) | 0.016 Functionality Score |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | HIV-specific CD4+ T Cell Polyfunctionality by ICS - Functionality Scores | Env-2-ZM96 (Month 12) | 0.015 Functionality Score |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | HIV-specific CD4+ T Cell Polyfunctionality by ICS - Functionality Scores | Env-2-ZM96 (Month 6.5) | 0.032 Functionality Score |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | HIV-specific CD4+ T Cell Polyfunctionality by ICS - Functionality Scores | TV1 gp120 (Month 12) | 0.125 Functionality Score |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | HIV-specific CD4+ T Cell Polyfunctionality by ICS - Functionality Scores | LAI-Gag (Month 12.5) | 0.03 Functionality Score |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | HIV-specific CD4+ T Cell Polyfunctionality by ICS - Functionality Scores | Env-1-ZM96 (Month 18) | 0.159 Functionality Score |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | HIV-specific CD4+ T Cell Polyfunctionality by ICS - Functionality Scores | LAI-Gag (Month 12) | 0.04 Functionality Score |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | HIV-specific CD4+ T Cell Polyfunctionality by ICS - Functionality Scores | Env-1-ZM96 (Month 12.5) | 0.187 Functionality Score |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | HIV-specific CD4+ T Cell Polyfunctionality by ICS - Functionality Scores | Env-1-ZM96 (Month 12) | 0.126 Functionality Score |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | HIV-specific CD4+ T Cell Polyfunctionality by ICS - Functionality Scores | TV1 gp120 (Month 18) | 0.161 Functionality Score |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | HIV-specific CD4+ T Cell Polyfunctionality by ICS - Functionality Scores | LAI-Gag (Month 18) | 0.024 Functionality Score |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | HIV-specific CD4+ T Cell Polyfunctionality by ICS - Functionality Scores | Any Env ZM96 (Month 12.5) | 0.197 Functionality Score |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | HIV-specific CD4+ T Cell Polyfunctionality by ICS - Functionality Scores | Any Env ZM96 (Month 18) | 0.163 Functionality Score |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | HIV-specific CD4+ T Cell Polyfunctionality by ICS - Functionality Scores | Env-1-ZM96 (Month 12.5) | 0.197 Functionality Score |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | HIV-specific CD4+ T Cell Polyfunctionality by ICS - Functionality Scores | Env-2-ZM96 (Month 18) | 0.039 Functionality Score |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | HIV-specific CD4+ T Cell Polyfunctionality by ICS - Functionality Scores | LAI-Gag (Month 18) | 0.031 Functionality Score |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | HIV-specific CD4+ T Cell Polyfunctionality by ICS - Functionality Scores | TV1 gp120 (Month 6.5) | 0.186 Functionality Score |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | HIV-specific CD4+ T Cell Polyfunctionality by ICS - Functionality Scores | TV1 gp120 (Month 12) | 0.165 Functionality Score |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | HIV-specific CD4+ T Cell Polyfunctionality by ICS - Functionality Scores | TV1 gp120 (Month 12.5) | 0.231 Functionality Score |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | HIV-specific CD4+ T Cell Polyfunctionality by ICS - Functionality Scores | TV1 gp120 (Month 18) | 0.172 Functionality Score |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | HIV-specific CD4+ T Cell Polyfunctionality by ICS - Functionality Scores | 1086 gp120 (Month 6.5) | 0.171 Functionality Score |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | HIV-specific CD4+ T Cell Polyfunctionality by ICS - Functionality Scores | 1086 gp120 (Month 12) | 0.129 Functionality Score |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | HIV-specific CD4+ T Cell Polyfunctionality by ICS - Functionality Scores | 1086 gp120 (Month 12.5) | 0.188 Functionality Score |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | HIV-specific CD4+ T Cell Polyfunctionality by ICS - Functionality Scores | 1086 gp120 (Month 18) | 0.156 Functionality Score |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | HIV-specific CD4+ T Cell Polyfunctionality by ICS - Functionality Scores | Any Env ZM96 (Month 6.5) | 0.175 Functionality Score |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | HIV-specific CD4+ T Cell Polyfunctionality by ICS - Functionality Scores | Any Env ZM96 (Month 12) | 0.129 Functionality Score |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | HIV-specific CD4+ T Cell Polyfunctionality by ICS - Functionality Scores | Env-1-ZM96 (Month 6.5) | 0.177 Functionality Score |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | HIV-specific CD4+ T Cell Polyfunctionality by ICS - Functionality Scores | Env-1-ZM96 (Month 12) | 0.129 Functionality Score |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | HIV-specific CD4+ T Cell Polyfunctionality by ICS - Functionality Scores | Env-1-ZM96 (Month 18) | 0.163 Functionality Score |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | HIV-specific CD4+ T Cell Polyfunctionality by ICS - Functionality Scores | Env-2-ZM96 (Month 6.5) | 0.027 Functionality Score |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | HIV-specific CD4+ T Cell Polyfunctionality by ICS - Functionality Scores | Env-2-ZM96 (Month 12) | 0.044 Functionality Score |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | HIV-specific CD4+ T Cell Polyfunctionality by ICS - Functionality Scores | Env-2-ZM96 (Month 12.5) | 0.065 Functionality Score |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | HIV-specific CD4+ T Cell Polyfunctionality by ICS - Functionality Scores | LAI-Gag (Month 6.5) | 0.057 Functionality Score |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | HIV-specific CD4+ T Cell Polyfunctionality by ICS - Functionality Scores | LAI-Gag (Month 12) | 0.04 Functionality Score |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | HIV-specific CD4+ T Cell Polyfunctionality by ICS - Functionality Scores | LAI-Gag (Month 12.5) | 0.041 Functionality Score |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | HIV-specific CD4+ T Cell Polyfunctionality by ICS - Functionality Scores | Any Env ZM96 (Month 18) | 0.11 Functionality Score |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | HIV-specific CD4+ T Cell Polyfunctionality by ICS - Functionality Scores | TV1 gp120 (Month 6.5) | 0.177 Functionality Score |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | HIV-specific CD4+ T Cell Polyfunctionality by ICS - Functionality Scores | Any Env ZM96 (Month 12.5) | 0.117 Functionality Score |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | HIV-specific CD4+ T Cell Polyfunctionality by ICS - Functionality Scores | Env-2-ZM96 (Month 12) | 0.032 Functionality Score |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | HIV-specific CD4+ T Cell Polyfunctionality by ICS - Functionality Scores | TV1 gp120 (Month 12.5) | 0.172 Functionality Score |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | HIV-specific CD4+ T Cell Polyfunctionality by ICS - Functionality Scores | Env-1-ZM96 (Month 12.5) | 0.117 Functionality Score |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | HIV-specific CD4+ T Cell Polyfunctionality by ICS - Functionality Scores | LAI-Gag (Month 12.5) | 0.037 Functionality Score |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | HIV-specific CD4+ T Cell Polyfunctionality by ICS - Functionality Scores | Env-2-ZM96 (Month 12.5) | 0.023 Functionality Score |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | HIV-specific CD4+ T Cell Polyfunctionality by ICS - Functionality Scores | Env-1-ZM96 (Month 6.5) | 0.126 Functionality Score |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | HIV-specific CD4+ T Cell Polyfunctionality by ICS - Functionality Scores | Env-2-ZM96 (Month 18) | 0.021 Functionality Score |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | HIV-specific CD4+ T Cell Polyfunctionality by ICS - Functionality Scores | TV1 gp120 (Month 12) | 0.153 Functionality Score |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | HIV-specific CD4+ T Cell Polyfunctionality by ICS - Functionality Scores | LAI-Gag (Month 18) | 0.02 Functionality Score |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | HIV-specific CD4+ T Cell Polyfunctionality by ICS - Functionality Scores | 1086 gp120 (Month 12.5) | 0.131 Functionality Score |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | HIV-specific CD4+ T Cell Polyfunctionality by ICS - Functionality Scores | 1086 gp120 (Month 6.5) | 0.158 Functionality Score |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | HIV-specific CD4+ T Cell Polyfunctionality by ICS - Functionality Scores | Env-1-ZM96 (Month 18) | 0.11 Functionality Score |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | HIV-specific CD4+ T Cell Polyfunctionality by ICS - Functionality Scores | TV1 gp120 (Month 18) | 0.143 Functionality Score |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | HIV-specific CD4+ T Cell Polyfunctionality by ICS - Functionality Scores | 1086 gp120 (Month 18) | 0.111 Functionality Score |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | HIV-specific CD4+ T Cell Polyfunctionality by ICS - Functionality Scores | LAI-Gag (Month 12) | 0.025 Functionality Score |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | HIV-specific CD4+ T Cell Polyfunctionality by ICS - Functionality Scores | 1086 gp120 (Month 12) | 0.129 Functionality Score |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | HIV-specific CD4+ T Cell Polyfunctionality by ICS - Functionality Scores | LAI-Gag (Month 6.5) | 0.03 Functionality Score |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | HIV-specific CD4+ T Cell Polyfunctionality by ICS - Functionality Scores | Any Env ZM96 (Month 6.5) | 0.126 Functionality Score |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | HIV-specific CD4+ T Cell Polyfunctionality by ICS - Functionality Scores | Env-1-ZM96 (Month 12) | 0.106 Functionality Score |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | HIV-specific CD4+ T Cell Polyfunctionality by ICS - Functionality Scores | Env-2-ZM96 (Month 6.5) | 0.04 Functionality Score |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | HIV-specific CD4+ T Cell Polyfunctionality by ICS - Functionality Scores | Any Env ZM96 (Month 12) | 0.106 Functionality Score |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | HIV-specific CD4+ T Cell Polyfunctionality by ICS - Functionality Scores | LAI-Gag (Month 6.5) | 0.036 Functionality Score |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | HIV-specific CD4+ T Cell Polyfunctionality by ICS - Functionality Scores | Any Env ZM96 (Month 12) | 0.111 Functionality Score |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | HIV-specific CD4+ T Cell Polyfunctionality by ICS - Functionality Scores | Any Env ZM96 (Month 12.5) | 0.158 Functionality Score |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | HIV-specific CD4+ T Cell Polyfunctionality by ICS - Functionality Scores | TV1 gp120 (Month 18) | 0.099 Functionality Score |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | HIV-specific CD4+ T Cell Polyfunctionality by ICS - Functionality Scores | Any Env ZM96 (Month 18) | 0.131 Functionality Score |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | HIV-specific CD4+ T Cell Polyfunctionality by ICS - Functionality Scores | TV1 gp120 (Month 12) | 0.124 Functionality Score |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | HIV-specific CD4+ T Cell Polyfunctionality by ICS - Functionality Scores | Env-1-ZM96 (Month 6.5) | 0.123 Functionality Score |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | HIV-specific CD4+ T Cell Polyfunctionality by ICS - Functionality Scores | TV1 gp120 (Month 12.5) | 0.15 Functionality Score |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | HIV-specific CD4+ T Cell Polyfunctionality by ICS - Functionality Scores | Env-1-ZM96 (Month 12) | 0.111 Functionality Score |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | HIV-specific CD4+ T Cell Polyfunctionality by ICS - Functionality Scores | Env-1-ZM96 (Month 12.5) | 0.158 Functionality Score |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | HIV-specific CD4+ T Cell Polyfunctionality by ICS - Functionality Scores | LAI-Gag (Month 12) | 0.026 Functionality Score |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | HIV-specific CD4+ T Cell Polyfunctionality by ICS - Functionality Scores | Env-1-ZM96 (Month 18) | 0.131 Functionality Score |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | HIV-specific CD4+ T Cell Polyfunctionality by ICS - Functionality Scores | TV1 gp120 (Month 6.5) | 0.156 Functionality Score |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | HIV-specific CD4+ T Cell Polyfunctionality by ICS - Functionality Scores | Env-2-ZM96 (Month 6.5) | 0.046 Functionality Score |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | HIV-specific CD4+ T Cell Polyfunctionality by ICS - Functionality Scores | Env-2-ZM96 (Month 12) | 0.033 Functionality Score |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | HIV-specific CD4+ T Cell Polyfunctionality by ICS - Functionality Scores | LAI-Gag (Month 18) | 0.037 Functionality Score |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | HIV-specific CD4+ T Cell Polyfunctionality by ICS - Functionality Scores | Env-2-ZM96 (Month 12.5) | 0.033 Functionality Score |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | HIV-specific CD4+ T Cell Polyfunctionality by ICS - Functionality Scores | Env-2-ZM96 (Month 18) | 0.028 Functionality Score |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | HIV-specific CD4+ T Cell Polyfunctionality by ICS - Functionality Scores | 1086 gp120 (Month 12.5) | 0.138 Functionality Score |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | HIV-specific CD4+ T Cell Polyfunctionality by ICS - Functionality Scores | 1086 gp120 (Month 12) | 0.101 Functionality Score |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | HIV-specific CD4+ T Cell Polyfunctionality by ICS - Functionality Scores | LAI-Gag (Month 12.5) | 0.038 Functionality Score |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | HIV-specific CD4+ T Cell Polyfunctionality by ICS - Functionality Scores | 1086 gp120 (Month 18) | 0.114 Functionality Score |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | HIV-specific CD4+ T Cell Polyfunctionality by ICS - Functionality Scores | Any Env ZM96 (Month 6.5) | 0.123 Functionality Score |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | HIV-specific CD4+ T Cell Polyfunctionality by ICS - Functionality Scores | 1086 gp120 (Month 6.5) | 0.15 Functionality Score |
Secondary
HIV-specific CD4+ T Cell Polyfunctionality by ICS - Polyfunctionality Scores
COMPASS uses a Bayesian hierarchical framework to model all observed functional cell subsets and select those most likely to exhibit antigen-specific responses. Cell-subset responses are quantified by posterior probabilities. The polyfunctionality score (PFS) summarizes, as a single number for each participant, the proportion of antigen-specific cell subsets among all measured subsets, weighted by the degree of functionality of the corresponding subset. PFS ranges from zero to one. PFS will assign a higher score to participants with antigen-specific cell subsets of higher degree.
Time frame: Measured at Months 6.5, 12, 12.5, and 18
Population: Overall Number of Participants Analyzed represents the number of participants in the per-protocol population. Number Analyzed shows the number of HIV uninfected participants with available COMPASS data after filtering for assay specific quality control criteria at each timepoint.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | HIV-specific CD4+ T Cell Polyfunctionality by ICS - Polyfunctionality Scores | Any Env ZM96 (Month 12.5) | 0.127 Polyfunctionality Score |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | HIV-specific CD4+ T Cell Polyfunctionality by ICS - Polyfunctionality Scores | TV1 gp120 (Month 6.5) | 0.111 Polyfunctionality Score |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | HIV-specific CD4+ T Cell Polyfunctionality by ICS - Polyfunctionality Scores | Env-2-ZM96 (Month 6.5) | 0.019 Polyfunctionality Score |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | HIV-specific CD4+ T Cell Polyfunctionality by ICS - Polyfunctionality Scores | Env-1-ZM96 (Month 18) | 0.114 Polyfunctionality Score |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | HIV-specific CD4+ T Cell Polyfunctionality by ICS - Polyfunctionality Scores | Any Env ZM96 (Month 18) | 0.114 Polyfunctionality Score |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | HIV-specific CD4+ T Cell Polyfunctionality by ICS - Polyfunctionality Scores | 1086 gp120 (Month 12.5) | 0.108 Polyfunctionality Score |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | HIV-specific CD4+ T Cell Polyfunctionality by ICS - Polyfunctionality Scores | Env-1-ZM96 (Month 12.5) | 0.127 Polyfunctionality Score |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | HIV-specific CD4+ T Cell Polyfunctionality by ICS - Polyfunctionality Scores | Env-1-ZM96 (Month 12) | 0.082 Polyfunctionality Score |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | HIV-specific CD4+ T Cell Polyfunctionality by ICS - Polyfunctionality Scores | Env-1-ZM96 (Month 6.5) | 0.111 Polyfunctionality Score |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | HIV-specific CD4+ T Cell Polyfunctionality by ICS - Polyfunctionality Scores | TV1 gp120 (Month 12.5) | 0.137 Polyfunctionality Score |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | HIV-specific CD4+ T Cell Polyfunctionality by ICS - Polyfunctionality Scores | LAI-Gag (Month 12.5) | 0.031 Polyfunctionality Score |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | HIV-specific CD4+ T Cell Polyfunctionality by ICS - Polyfunctionality Scores | LAI-Gag (Month 18) | 0.02 Polyfunctionality Score |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | HIV-specific CD4+ T Cell Polyfunctionality by ICS - Polyfunctionality Scores | 1086 gp120 (Month 18) | 0.1 Polyfunctionality Score |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | HIV-specific CD4+ T Cell Polyfunctionality by ICS - Polyfunctionality Scores | 1086 gp120 (Month 12) | 0.067 Polyfunctionality Score |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | HIV-specific CD4+ T Cell Polyfunctionality by ICS - Polyfunctionality Scores | LAI-Gag (Month 12) | 0.036 Polyfunctionality Score |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | HIV-specific CD4+ T Cell Polyfunctionality by ICS - Polyfunctionality Scores | LAI-Gag (Month 6.5) | 0.051 Polyfunctionality Score |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | HIV-specific CD4+ T Cell Polyfunctionality by ICS - Polyfunctionality Scores | Any Env ZM96 (Month 6.5) | 0.111 Polyfunctionality Score |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | HIV-specific CD4+ T Cell Polyfunctionality by ICS - Polyfunctionality Scores | TV1 gp120 (Month 18) | 0.109 Polyfunctionality Score |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | HIV-specific CD4+ T Cell Polyfunctionality by ICS - Polyfunctionality Scores | 1086 gp120 (Month 6.5) | 0.11 Polyfunctionality Score |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | HIV-specific CD4+ T Cell Polyfunctionality by ICS - Polyfunctionality Scores | Env-2-ZM96 (Month 18) | 0.013 Polyfunctionality Score |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | HIV-specific CD4+ T Cell Polyfunctionality by ICS - Polyfunctionality Scores | Any Env ZM96 (Month 12) | 0.082 Polyfunctionality Score |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | HIV-specific CD4+ T Cell Polyfunctionality by ICS - Polyfunctionality Scores | TV1 gp120 (Month 12) | 0.079 Polyfunctionality Score |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | HIV-specific CD4+ T Cell Polyfunctionality by ICS - Polyfunctionality Scores | Env-2-ZM96 (Month 12.5) | 0.015 Polyfunctionality Score |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | HIV-specific CD4+ T Cell Polyfunctionality by ICS - Polyfunctionality Scores | Env-2-ZM96 (Month 12) | 0.01 Polyfunctionality Score |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | HIV-specific CD4+ T Cell Polyfunctionality by ICS - Polyfunctionality Scores | Env-2-ZM96 (Month 18) | 0.025 Polyfunctionality Score |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | HIV-specific CD4+ T Cell Polyfunctionality by ICS - Polyfunctionality Scores | 1086 gp120 (Month 6.5) | 0.12 Polyfunctionality Score |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | HIV-specific CD4+ T Cell Polyfunctionality by ICS - Polyfunctionality Scores | 1086 gp120 (Month 12) | 0.087 Polyfunctionality Score |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | HIV-specific CD4+ T Cell Polyfunctionality by ICS - Polyfunctionality Scores | 1086 gp120 (Month 12.5) | 0.129 Polyfunctionality Score |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | HIV-specific CD4+ T Cell Polyfunctionality by ICS - Polyfunctionality Scores | 1086 gp120 (Month 18) | 0.108 Polyfunctionality Score |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | HIV-specific CD4+ T Cell Polyfunctionality by ICS - Polyfunctionality Scores | Any Env ZM96 (Month 6.5) | 0.124 Polyfunctionality Score |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | HIV-specific CD4+ T Cell Polyfunctionality by ICS - Polyfunctionality Scores | Any Env ZM96 (Month 12) | 0.099 Polyfunctionality Score |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | HIV-specific CD4+ T Cell Polyfunctionality by ICS - Polyfunctionality Scores | Any Env ZM96 (Month 12.5) | 0.132 Polyfunctionality Score |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | HIV-specific CD4+ T Cell Polyfunctionality by ICS - Polyfunctionality Scores | Any Env ZM96 (Month 18) | 0.115 Polyfunctionality Score |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | HIV-specific CD4+ T Cell Polyfunctionality by ICS - Polyfunctionality Scores | Env-1-ZM96 (Month 6.5) | 0.124 Polyfunctionality Score |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | HIV-specific CD4+ T Cell Polyfunctionality by ICS - Polyfunctionality Scores | Env-1-ZM96 (Month 12) | 0.099 Polyfunctionality Score |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | HIV-specific CD4+ T Cell Polyfunctionality by ICS - Polyfunctionality Scores | Env-1-ZM96 (Month 12.5) | 0.132 Polyfunctionality Score |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | HIV-specific CD4+ T Cell Polyfunctionality by ICS - Polyfunctionality Scores | Env-1-ZM96 (Month 18) | 0.115 Polyfunctionality Score |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | HIV-specific CD4+ T Cell Polyfunctionality by ICS - Polyfunctionality Scores | Env-2-ZM96 (Month 6.5) | 0.026 Polyfunctionality Score |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | HIV-specific CD4+ T Cell Polyfunctionality by ICS - Polyfunctionality Scores | Env-2-ZM96 (Month 12) | 0.026 Polyfunctionality Score |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | HIV-specific CD4+ T Cell Polyfunctionality by ICS - Polyfunctionality Scores | Env-2-ZM96 (Month 12.5) | 0.039 Polyfunctionality Score |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | HIV-specific CD4+ T Cell Polyfunctionality by ICS - Polyfunctionality Scores | LAI-Gag (Month 6.5) | 0.055 Polyfunctionality Score |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | HIV-specific CD4+ T Cell Polyfunctionality by ICS - Polyfunctionality Scores | LAI-Gag (Month 12) | 0.027 Polyfunctionality Score |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | HIV-specific CD4+ T Cell Polyfunctionality by ICS - Polyfunctionality Scores | LAI-Gag (Month 12.5) | 0.035 Polyfunctionality Score |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | HIV-specific CD4+ T Cell Polyfunctionality by ICS - Polyfunctionality Scores | LAI-Gag (Month 18) | 0.027 Polyfunctionality Score |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | HIV-specific CD4+ T Cell Polyfunctionality by ICS - Polyfunctionality Scores | TV1 gp120 (Month 6.5) | 0.13 Polyfunctionality Score |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | HIV-specific CD4+ T Cell Polyfunctionality by ICS - Polyfunctionality Scores | TV1 gp120 (Month 12) | 0.111 Polyfunctionality Score |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | HIV-specific CD4+ T Cell Polyfunctionality by ICS - Polyfunctionality Scores | TV1 gp120 (Month 12.5) | 0.146 Polyfunctionality Score |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | HIV-specific CD4+ T Cell Polyfunctionality by ICS - Polyfunctionality Scores | TV1 gp120 (Month 18) | 0.118 Polyfunctionality Score |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | HIV-specific CD4+ T Cell Polyfunctionality by ICS - Polyfunctionality Scores | 1086 gp120 (Month 12) | 0.062 Polyfunctionality Score |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | HIV-specific CD4+ T Cell Polyfunctionality by ICS - Polyfunctionality Scores | Env-2-ZM96 (Month 6.5) | 0.029 Polyfunctionality Score |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | HIV-specific CD4+ T Cell Polyfunctionality by ICS - Polyfunctionality Scores | Env-2-ZM96 (Month 12) | 0.028 Polyfunctionality Score |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | HIV-specific CD4+ T Cell Polyfunctionality by ICS - Polyfunctionality Scores | Any Env ZM96 (Month 12) | 0.06 Polyfunctionality Score |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | HIV-specific CD4+ T Cell Polyfunctionality by ICS - Polyfunctionality Scores | TV1 gp120 (Month 12) | 0.084 Polyfunctionality Score |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | HIV-specific CD4+ T Cell Polyfunctionality by ICS - Polyfunctionality Scores | Env-2-ZM96 (Month 12.5) | 0.017 Polyfunctionality Score |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | HIV-specific CD4+ T Cell Polyfunctionality by ICS - Polyfunctionality Scores | Any Env ZM96 (Month 6.5) | 0.083 Polyfunctionality Score |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | HIV-specific CD4+ T Cell Polyfunctionality by ICS - Polyfunctionality Scores | Env-2-ZM96 (Month 18) | 0.012 Polyfunctionality Score |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | HIV-specific CD4+ T Cell Polyfunctionality by ICS - Polyfunctionality Scores | LAI-Gag (Month 6.5) | 0.025 Polyfunctionality Score |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | HIV-specific CD4+ T Cell Polyfunctionality by ICS - Polyfunctionality Scores | 1086 gp120 (Month 18) | 0.062 Polyfunctionality Score |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | HIV-specific CD4+ T Cell Polyfunctionality by ICS - Polyfunctionality Scores | TV1 gp120 (Month 6.5) | 0.108 Polyfunctionality Score |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | HIV-specific CD4+ T Cell Polyfunctionality by ICS - Polyfunctionality Scores | LAI-Gag (Month 12) | 0.019 Polyfunctionality Score |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | HIV-specific CD4+ T Cell Polyfunctionality by ICS - Polyfunctionality Scores | 1086 gp120 (Month 12.5) | 0.067 Polyfunctionality Score |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | HIV-specific CD4+ T Cell Polyfunctionality by ICS - Polyfunctionality Scores | TV1 gp120 (Month 18) | 0.084 Polyfunctionality Score |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | HIV-specific CD4+ T Cell Polyfunctionality by ICS - Polyfunctionality Scores | LAI-Gag (Month 12.5) | 0.038 Polyfunctionality Score |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | HIV-specific CD4+ T Cell Polyfunctionality by ICS - Polyfunctionality Scores | TV1 gp120 (Month 12.5) | 0.095 Polyfunctionality Score |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | HIV-specific CD4+ T Cell Polyfunctionality by ICS - Polyfunctionality Scores | LAI-Gag (Month 18) | 0.017 Polyfunctionality Score |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | HIV-specific CD4+ T Cell Polyfunctionality by ICS - Polyfunctionality Scores | Env-1-ZM96 (Month 6.5) | 0.083 Polyfunctionality Score |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | HIV-specific CD4+ T Cell Polyfunctionality by ICS - Polyfunctionality Scores | Env-1-ZM96 (Month 12) | 0.057 Polyfunctionality Score |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | HIV-specific CD4+ T Cell Polyfunctionality by ICS - Polyfunctionality Scores | Any Env ZM96 (Month 18) | 0.066 Polyfunctionality Score |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | HIV-specific CD4+ T Cell Polyfunctionality by ICS - Polyfunctionality Scores | Env-1-ZM96 (Month 12.5) | 0.069 Polyfunctionality Score |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | HIV-specific CD4+ T Cell Polyfunctionality by ICS - Polyfunctionality Scores | 1086 gp120 (Month 6.5) | 0.098 Polyfunctionality Score |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | HIV-specific CD4+ T Cell Polyfunctionality by ICS - Polyfunctionality Scores | Env-1-ZM96 (Month 18) | 0.066 Polyfunctionality Score |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | HIV-specific CD4+ T Cell Polyfunctionality by ICS - Polyfunctionality Scores | Any Env ZM96 (Month 12.5) | 0.069 Polyfunctionality Score |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | HIV-specific CD4+ T Cell Polyfunctionality by ICS - Polyfunctionality Scores | TV1 gp120 (Month 12.5) | 0.1 Polyfunctionality Score |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | HIV-specific CD4+ T Cell Polyfunctionality by ICS - Polyfunctionality Scores | Env-1-ZM96 (Month 6.5) | 0.092 Polyfunctionality Score |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | HIV-specific CD4+ T Cell Polyfunctionality by ICS - Polyfunctionality Scores | Env-2-ZM96 (Month 6.5) | 0.023 Polyfunctionality Score |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | HIV-specific CD4+ T Cell Polyfunctionality by ICS - Polyfunctionality Scores | Any Env ZM96 (Month 12) | 0.09 Polyfunctionality Score |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | HIV-specific CD4+ T Cell Polyfunctionality by ICS - Polyfunctionality Scores | TV1 gp120 (Month 18) | 0.069 Polyfunctionality Score |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | HIV-specific CD4+ T Cell Polyfunctionality by ICS - Polyfunctionality Scores | 1086 gp120 (Month 6.5) | 0.106 Polyfunctionality Score |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | HIV-specific CD4+ T Cell Polyfunctionality by ICS - Polyfunctionality Scores | Env-2-ZM96 (Month 12) | 0.02 Polyfunctionality Score |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | HIV-specific CD4+ T Cell Polyfunctionality by ICS - Polyfunctionality Scores | Any Env ZM96 (Month 18) | 0.085 Polyfunctionality Score |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | HIV-specific CD4+ T Cell Polyfunctionality by ICS - Polyfunctionality Scores | LAI-Gag (Month 12) | 0.027 Polyfunctionality Score |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | HIV-specific CD4+ T Cell Polyfunctionality by ICS - Polyfunctionality Scores | LAI-Gag (Month 18) | 0.035 Polyfunctionality Score |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | HIV-specific CD4+ T Cell Polyfunctionality by ICS - Polyfunctionality Scores | Env-2-ZM96 (Month 12.5) | 0.02 Polyfunctionality Score |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | HIV-specific CD4+ T Cell Polyfunctionality by ICS - Polyfunctionality Scores | Any Env ZM96 (Month 6.5) | 0.092 Polyfunctionality Score |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | HIV-specific CD4+ T Cell Polyfunctionality by ICS - Polyfunctionality Scores | Env-1-ZM96 (Month 12.5) | 0.111 Polyfunctionality Score |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | HIV-specific CD4+ T Cell Polyfunctionality by ICS - Polyfunctionality Scores | Env-1-ZM96 (Month 12) | 0.09 Polyfunctionality Score |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | HIV-specific CD4+ T Cell Polyfunctionality by ICS - Polyfunctionality Scores | Env-2-ZM96 (Month 18) | 0.022 Polyfunctionality Score |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | HIV-specific CD4+ T Cell Polyfunctionality by ICS - Polyfunctionality Scores | 1086 gp120 (Month 18) | 0.064 Polyfunctionality Score |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | HIV-specific CD4+ T Cell Polyfunctionality by ICS - Polyfunctionality Scores | TV1 gp120 (Month 12) | 0.078 Polyfunctionality Score |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | HIV-specific CD4+ T Cell Polyfunctionality by ICS - Polyfunctionality Scores | Any Env ZM96 (Month 12.5) | 0.111 Polyfunctionality Score |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | HIV-specific CD4+ T Cell Polyfunctionality by ICS - Polyfunctionality Scores | LAI-Gag (Month 6.5) | 0.038 Polyfunctionality Score |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | HIV-specific CD4+ T Cell Polyfunctionality by ICS - Polyfunctionality Scores | 1086 gp120 (Month 12) | 0.07 Polyfunctionality Score |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | HIV-specific CD4+ T Cell Polyfunctionality by ICS - Polyfunctionality Scores | LAI-Gag (Month 12.5) | 0.035 Polyfunctionality Score |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | HIV-specific CD4+ T Cell Polyfunctionality by ICS - Polyfunctionality Scores | 1086 gp120 (Month 12.5) | 0.091 Polyfunctionality Score |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | HIV-specific CD4+ T Cell Polyfunctionality by ICS - Polyfunctionality Scores | Env-1-ZM96 (Month 18) | 0.085 Polyfunctionality Score |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | HIV-specific CD4+ T Cell Polyfunctionality by ICS - Polyfunctionality Scores | TV1 gp120 (Month 6.5) | 0.091 Polyfunctionality Score |
Secondary
Level of Vaccine-induced Serum IgA Ab Binding to Env Proteins
Serum IgA responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay, run at 1:10 dilution. The readout is background-subtracted mean fluorescent intensity (MFI), with background adjustment for an antigen-specific plate level control. For each sample, response magnitude is net MFI, defined as experimental antigen MFI minus reference antigen MFI. Net MFI \< 1 is set to 1, and net MFI \> 22,000 is set to 22,000. Data are excluded if blood draw date was outside the allowable window, a participant was HIV-infected, reference antigen \> 5,000 MFI, or baseline net MFI \> 6,500. Summary was calculated among positive responders only (positivity criteria are described in Outcome 1).
Time frame: Measured at Months 6.5 and 12.
Population: Overall Number of Participants Analyzed represents the number of enrolled participants with available specimens. Number Analyzed shows the number of HIV uninfected participants with available BAMA data after filtering for assay specific quality control criteria at each timepoint.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Level of Vaccine-induced Serum IgA Ab Binding to Env Proteins | 00MSA 4076 gp140 (Month 12) | 2229 relative fluorescence units |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Level of Vaccine-induced Serum IgA Ab Binding to Env Proteins | 96ZM651.D11gp120.avi (Month 12) | 5390.6 relative fluorescence units |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Level of Vaccine-induced Serum IgA Ab Binding to Env Proteins | C.1086C_V1_V2 Tags (Month 12) | 6647 relative fluorescence units |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Level of Vaccine-induced Serum IgA Ab Binding to Env Proteins | A1.con.env03 140 CF (Month 12) | 6053.5 relative fluorescence units |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Level of Vaccine-induced Serum IgA Ab Binding to Env Proteins | A1.con.env03 140 CF (Month 6.5) | 2823.8 relative fluorescence units |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Level of Vaccine-induced Serum IgA Ab Binding to Env Proteins | AE.A244 V1V2 Tags/293F (Month 12) | 3551 relative fluorescence units |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Level of Vaccine-induced Serum IgA Ab Binding to Env Proteins | AE.A244 V1V2 Tags/293F (Month 6.5) | 6260.8 relative fluorescence units |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Level of Vaccine-induced Serum IgA Ab Binding to Env Proteins | gp70-TV1.GSKvacV1V2/293F (Month 12) | 137.5 relative fluorescence units |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Level of Vaccine-induced Serum IgA Ab Binding to Env Proteins | TV1c8_D11gp120.avi/293F (Month 6.5) | 8312.8 relative fluorescence units |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Level of Vaccine-induced Serum IgA Ab Binding to Env Proteins | TV1c8_D11gp120.avi/293F (Month 12) | 3505.5 relative fluorescence units |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Level of Vaccine-induced Serum IgA Ab Binding to Env Proteins | C.1086C_V1_V2 Tags (Month 6.5) | 9201.2 relative fluorescence units |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Level of Vaccine-induced Serum IgA Ab Binding to Env Proteins | gp70_B.CaseA2 V1/V2/169K (Month 12) | 22000 relative fluorescence units |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Level of Vaccine-induced Serum IgA Ab Binding to Env Proteins | Con 6 gp120/B (Month 6.5) | 9493.6 relative fluorescence units |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Level of Vaccine-induced Serum IgA Ab Binding to Env Proteins | 00MSA 4076 gp140 (Month 6.5) | 1845.2 relative fluorescence units |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Level of Vaccine-induced Serum IgA Ab Binding to Env Proteins | Con S gp140 CFI (Month 6.5) | 5888.5 relative fluorescence units |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Level of Vaccine-induced Serum IgA Ab Binding to Env Proteins | Con S gp140 CFI (Month 12) | 5268 relative fluorescence units |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Level of Vaccine-induced Serum IgA Ab Binding to Env Proteins | 96ZM651.D11gp120.avi (Month 6.5) | 8047.1 relative fluorescence units |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Level of Vaccine-induced Serum IgA Ab Binding to Env Proteins | gp70-TV1.GSKvacV1V2/293F (Month 6.5) | 813.8 relative fluorescence units |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Level of Vaccine-induced Serum IgA Ab Binding to Env Proteins | gp70_B.CaseA2 V1/V2/169K (Month 6.5) | 22000 relative fluorescence units |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Level of Vaccine-induced Serum IgA Ab Binding to Env Proteins | Con 6 gp120/B (Month 12) | 3134.5 relative fluorescence units |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Level of Vaccine-induced Serum IgA Ab Binding to Env Proteins | 1086C_D7gp120.avi/293F (Month 12) | 7533.6 relative fluorescence units |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Level of Vaccine-induced Serum IgA Ab Binding to Env Proteins | 1086C_D7gp120.avi/293F (Month 6.5) | 22000 relative fluorescence units |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Level of Vaccine-induced Serum IgA Ab Binding to Env Proteins | gp70-TV1.GSKvacV1V2/293F (Month 12) | 993 relative fluorescence units |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Level of Vaccine-induced Serum IgA Ab Binding to Env Proteins | TV1c8_D11gp120.avi/293F (Month 12) | 1366.6 relative fluorescence units |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Level of Vaccine-induced Serum IgA Ab Binding to Env Proteins | Con S gp140 CFI (Month 12) | 7882.6 relative fluorescence units |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Level of Vaccine-induced Serum IgA Ab Binding to Env Proteins | 96ZM651.D11gp120.avi (Month 12) | 10692 relative fluorescence units |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Level of Vaccine-induced Serum IgA Ab Binding to Env Proteins | 1086C_D7gp120.avi/293F (Month 12) | 4962.8 relative fluorescence units |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Level of Vaccine-induced Serum IgA Ab Binding to Env Proteins | Con 6 gp120/B (Month 12) | 5267.4 relative fluorescence units |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Level of Vaccine-induced Serum IgA Ab Binding to Env Proteins | Con S gp140 CFI (Month 6.5) | 4698.9 relative fluorescence units |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Level of Vaccine-induced Serum IgA Ab Binding to Env Proteins | 1086C_D7gp120.avi/293F (Month 6.5) | 22000 relative fluorescence units |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Level of Vaccine-induced Serum IgA Ab Binding to Env Proteins | C.1086C_V1_V2 Tags (Month 6.5) | 882.5 relative fluorescence units |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Level of Vaccine-induced Serum IgA Ab Binding to Env Proteins | gp41 (Month 6.5) | 3047.2 relative fluorescence units |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Level of Vaccine-induced Serum IgA Ab Binding to Env Proteins | A1.con.env03 140 CF (Month 12) | 2047.2 relative fluorescence units |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Level of Vaccine-induced Serum IgA Ab Binding to Env Proteins | 00MSA 4076 gp140 (Month 6.5) | 661 relative fluorescence units |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Level of Vaccine-induced Serum IgA Ab Binding to Env Proteins | TV1c8_D11gp120.avi/293F (Month 6.5) | 5613.2 relative fluorescence units |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Level of Vaccine-induced Serum IgA Ab Binding to Env Proteins | 96ZM651.D11gp120.avi (Month 6.5) | 8849.6 relative fluorescence units |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Level of Vaccine-induced Serum IgA Ab Binding to Env Proteins | Con 6 gp120/B (Month 6.5) | 3719.8 relative fluorescence units |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Level of Vaccine-induced Serum IgA Ab Binding to Env Proteins | 00MSA 4076 gp140 (Month 12) | 1486.5 relative fluorescence units |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Level of Vaccine-induced Serum IgA Ab Binding to Env Proteins | A1.con.env03 140 CF (Month 6.5) | 1407.1 relative fluorescence units |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Level of Vaccine-induced Serum IgA Ab Binding to Env Proteins | gp70_B.CaseA_V1_V2 (Month 12) | 1540 relative fluorescence units |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Level of Vaccine-induced Serum IgA Ab Binding to Env Proteins | Con S gp140 CFI (Month 12) | 5614.8 relative fluorescence units |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Level of Vaccine-induced Serum IgA Ab Binding to Env Proteins | Con S gp140 CFI (Month 6.5) | 6925.8 relative fluorescence units |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Level of Vaccine-induced Serum IgA Ab Binding to Env Proteins | 00MSA 4076 gp140 (Month 6.5) | 1434.2 relative fluorescence units |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Level of Vaccine-induced Serum IgA Ab Binding to Env Proteins | 1086C_D7gp120.avi/293F (Month 6.5) | 22000 relative fluorescence units |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Level of Vaccine-induced Serum IgA Ab Binding to Env Proteins | 96ZM651.D11gp120.avi (Month 6.5) | 7595.5 relative fluorescence units |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Level of Vaccine-induced Serum IgA Ab Binding to Env Proteins | A1.con.env03 140 CF (Month 6.5) | 1909.9 relative fluorescence units |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Level of Vaccine-induced Serum IgA Ab Binding to Env Proteins | AE.A244 V1V2 Tags/293F (Month 6.5) | 1998 relative fluorescence units |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Level of Vaccine-induced Serum IgA Ab Binding to Env Proteins | C.1086C_V1_V2 Tags (Month 6.5) | 1978.5 relative fluorescence units |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Level of Vaccine-induced Serum IgA Ab Binding to Env Proteins | Con 6 gp120/B (Month 6.5) | 4863.5 relative fluorescence units |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Level of Vaccine-induced Serum IgA Ab Binding to Env Proteins | TV1c8_D11gp120.avi/293F (Month 6.5) | 12210.8 relative fluorescence units |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Level of Vaccine-induced Serum IgA Ab Binding to Env Proteins | 00MSA 4076 gp140 (Month 12) | 1501.5 relative fluorescence units |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Level of Vaccine-induced Serum IgA Ab Binding to Env Proteins | 1086C_D7gp120.avi/293F (Month 12) | 9267.8 relative fluorescence units |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Level of Vaccine-induced Serum IgA Ab Binding to Env Proteins | 96ZM651.D11gp120.avi (Month 12) | 6160 relative fluorescence units |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Level of Vaccine-induced Serum IgA Ab Binding to Env Proteins | A1.con.env03 140 CF (Month 12) | 1051.8 relative fluorescence units |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Level of Vaccine-induced Serum IgA Ab Binding to Env Proteins | Con 6 gp120/B (Month 12) | 2058 relative fluorescence units |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Level of Vaccine-induced Serum IgA Ab Binding to Env Proteins | TV1c8_D11gp120.avi/293F (Month 12) | 2812 relative fluorescence units |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Level of Vaccine-induced Serum IgA Ab Binding to Env Proteins | 00MSA 4076 gp140 (Month 12) | 727.5 relative fluorescence units |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Level of Vaccine-induced Serum IgA Ab Binding to Env Proteins | TV1c8_D11gp120.avi/293F (Month 6.5) | 4144.5 relative fluorescence units |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Level of Vaccine-induced Serum IgA Ab Binding to Env Proteins | 1086C_D7gp120.avi/293F (Month 12) | 3780.8 relative fluorescence units |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Level of Vaccine-induced Serum IgA Ab Binding to Env Proteins | Con 6 gp120/B (Month 12) | 3144 relative fluorescence units |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Level of Vaccine-induced Serum IgA Ab Binding to Env Proteins | Con S gp140 CFI (Month 6.5) | 5943.2 relative fluorescence units |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Level of Vaccine-induced Serum IgA Ab Binding to Env Proteins | Con 6 gp120/B (Month 6.5) | 6432.1 relative fluorescence units |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Level of Vaccine-induced Serum IgA Ab Binding to Env Proteins | C.1086C_V1_V2 Tags (Month 6.5) | 4818.8 relative fluorescence units |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Level of Vaccine-induced Serum IgA Ab Binding to Env Proteins | Con S gp140 CFI (Month 12) | 5104.8 relative fluorescence units |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Level of Vaccine-induced Serum IgA Ab Binding to Env Proteins | AE.A244 V1V2 Tags/293F (Month 6.5) | 4791.2 relative fluorescence units |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Level of Vaccine-induced Serum IgA Ab Binding to Env Proteins | A1.con.env03 140 CF (Month 6.5) | 2191.9 relative fluorescence units |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Level of Vaccine-induced Serum IgA Ab Binding to Env Proteins | 1086C_D7gp120.avi/293F (Month 6.5) | 20863 relative fluorescence units |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Level of Vaccine-induced Serum IgA Ab Binding to Env Proteins | TV1c8_D11gp120.avi/293F (Month 12) | 4003 relative fluorescence units |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Level of Vaccine-induced Serum IgA Ab Binding to Env Proteins | 96ZM651.D11gp120.avi (Month 6.5) | 11444 relative fluorescence units |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Level of Vaccine-induced Serum IgA Ab Binding to Env Proteins | 00MSA 4076 gp140 (Month 6.5) | 2502 relative fluorescence units |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Level of Vaccine-induced Serum IgA Ab Binding to Env Proteins | A1.con.env03 140 CF (Month 12) | 1290 relative fluorescence units |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Level of Vaccine-induced Serum IgA Ab Binding to Env Proteins | 96ZM651.D11gp120.avi (Month 12) | 10678.8 relative fluorescence units |
Secondary
Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins
Serum IgG3 responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay, run at 1:40 dilution. The readout is background-subtracted mean fluorescent intensity (MFI), with background adjustment for an antigen-specific plate level control. For each sample, response magnitude is net MFI, defined as experimental antigen MFI minus reference antigen MFI. Net MFI \< 1 is set to 1, and net MFI \> 22,000 is set to 22,000. Data are excluded if blood draw date was outside the allowable window, a participant was HIV-infected, reference antigen \> 5,000 MFI, or baseline net MFI \> 6,500. Summary was calculated among positive responders only (positivity criteria are described in Outcome 1).
Time frame: Measured at Months 12.5 and 18.
Population: Overall Number of Participants Analyzed represents the number of enrolled participants with available specimens. Number Analyzed shows the number of HIV uninfected participants with available BAMA data after filtering for assay specific quality control criteria at each timepoint.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | 1086C_D7gp120.avi/293F (Month 12.5) | 1049.2 relative fluorescence units |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | 1086C_D7gp120.avi/293F (Month 18) | 204 relative fluorescence units |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | C.1086C_V1_V2 Tags (Month 12.5) | 470 relative fluorescence units |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | AE.A244 V1V2 Tags/293F (Month 18) | 187.8 relative fluorescence units |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | 96ZM651.D11gp120.avi (Month 12.5) | 300.9 relative fluorescence units |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | gp70-96ZM651.02 V1v2 (Month 18) | 434.8 relative fluorescence units |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | Con 6 gp120/B (Month 12.5) | 284 relative fluorescence units |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | Con S gp140 CFI (Month 12.5) | 264.1 relative fluorescence units |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | TV1c8_D11gp120.avi/293F (Month 18) | 451.2 relative fluorescence units |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | TV1c8_D11gp120.avi/293F (Month 12.5) | 586.8 relative fluorescence units |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | gp70_B.CaseA2 V1/V2/169K (Month 18) | 887.5 relative fluorescence units |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | Con S gp140 CFI (Month 18) | 126.6 relative fluorescence units |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | gp70-96ZM651.02 V1v2 (Month 12.5) | 157.8 relative fluorescence units |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | AE.A244 V1V2 Tags/293F (Month 12.5) | 283.9 relative fluorescence units |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | gp70-TV1.GSKvacV1V2/293F (Month 12.5) | 853.5 relative fluorescence units |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | gp70_B.CaseA2 V1/V2/169K (Month 12.5) | 2010.8 relative fluorescence units |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | gp70_B.CaseA_V1_V2 (Month 18) | 474 relative fluorescence units |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | gp70_B.CaseA_V1_V2 (Month 12.5) | 1262.5 relative fluorescence units |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | gp70-TV1.GSKvacV1V2/293F (Month 18) | 534.8 relative fluorescence units |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | gp70-TV1.GSKvacV1V2/293F (Month 12.5) | 231.6 relative fluorescence units |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | AE.A244 V1V2 Tags/293F (Month 12.5) | 271 relative fluorescence units |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | gp70-96ZM651.02 V1v2 (Month 12.5) | 354 relative fluorescence units |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | gp70_B.CaseA2 V1/V2/169K (Month 12.5) | 255.4 relative fluorescence units |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | Con S gp140 CFI (Month 18) | 136.6 relative fluorescence units |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | Con 6 gp120/B (Month 12.5) | 329.5 relative fluorescence units |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | gp70_B.CaseA_V1_V2 (Month 12.5) | 233.5 relative fluorescence units |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | 96ZM651.D11gp120.avi (Month 12.5) | 314.5 relative fluorescence units |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | TV1c8_D11gp120.avi/293F (Month 18) | 198.9 relative fluorescence units |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | 1086C_D7gp120.avi/293F (Month 18) | 266.4 relative fluorescence units |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | TV1c8_D11gp120.avi/293F (Month 12.5) | 673.8 relative fluorescence units |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | Con S gp140 CFI (Month 12.5) | 322.8 relative fluorescence units |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | C.1086C_V1_V2 Tags (Month 12.5) | 197.8 relative fluorescence units |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | 1086C_D7gp120.avi/293F (Month 12.5) | 1184.2 relative fluorescence units |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | Con 6 gp120/B (Month 18) | 368.8 relative fluorescence units |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | 1086C_D7gp120.avi/293F (Month 12.5) | 1086.2 relative fluorescence units |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | 96ZM651.D11gp120.avi (Month 12.5) | 314.9 relative fluorescence units |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | AE.A244 V1V2 Tags/293F (Month 12.5) | 480 relative fluorescence units |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | C.1086C_V1_V2 Tags (Month 12.5) | 379.2 relative fluorescence units |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | Con 6 gp120/B (Month 12.5) | 540 relative fluorescence units |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | Con S gp140 CFI (Month 12.5) | 208.2 relative fluorescence units |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | TV1c8_D11gp120.avi/293F (Month 12.5) | 439.4 relative fluorescence units |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | gp70-96ZM651.02 V1v2 (Month 12.5) | 2402.8 relative fluorescence units |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | gp70-TV1.GSKvacV1V2/293F (Month 12.5) | 487.8 relative fluorescence units |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | gp70_B.CaseA2 V1/V2/169K (Month 12.5) | 551 relative fluorescence units |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | gp70_B.CaseA_V1_V2 (Month 12.5) | 1457.8 relative fluorescence units |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | 1086C_D7gp120.avi/293F (Month 18) | 167.5 relative fluorescence units |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | AE.A244 V1V2 Tags/293F (Month 18) | 245.2 relative fluorescence units |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | TV1c8_D11gp120.avi/293F (Month 18) | 725.9 relative fluorescence units |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | gp70-96ZM651.02 V1v2 (Month 18) | 196.6 relative fluorescence units |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | gp70-TV1.GSKvacV1V2/293F (Month 18) | 170.5 relative fluorescence units |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | gp70_B.CaseA2 V1/V2/169K (Month 18) | 177.5 relative fluorescence units |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | Con S gp140 CFI (Month 12.5) | 476.8 relative fluorescence units |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | Con 6 gp120/B (Month 12.5) | 203 relative fluorescence units |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | 1086C_D7gp120.avi/293F (Month 12.5) | 1739 relative fluorescence units |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | TV1c8_D11gp120.avi/293F (Month 18) | 6535.8 relative fluorescence units |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | gp41 (Month 18) | 9170.6 relative fluorescence units |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | C.1086C_V1_V2 Tags (Month 12.5) | 22000 relative fluorescence units |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | 96ZM651.D11gp120.avi (Month 12.5) | 264.5 relative fluorescence units |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | 1086C_D7gp120.avi/293F (Month 18) | 133 relative fluorescence units |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | AE.A244 V1V2 Tags/293F (Month 12.5) | 479.1 relative fluorescence units |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | gp70-96ZM651.02 V1v2 (Month 12.5) | 4707.5 relative fluorescence units |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | gp41 (Month 12.5) | 3020.8 relative fluorescence units |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | TV1c8_D11gp120.avi/293F (Month 12.5) | 1017.2 relative fluorescence units |
Secondary
Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins
Serum IgG3 responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay, run at 1:40 dilution. The readout is background-subtracted mean fluorescent intensity (MFI), with background adjustment for an antigen-specific plate level control. For each sample, response magnitude is net MFI, defined as experimental antigen MFI minus reference antigen MFI. Net MFI \< 1 is set to 1, and net MFI \> 22,000 is set to 22,000. Data are excluded if blood draw date was outside the allowable window, a participant was HIV-infected, reference antigen \> 5,000 MFI, or baseline net MFI \> 6,500. Summary was calculated among positive responders only (positivity criteria are described in Outcome 1).
Time frame: Measured at Months 6.5 and 12.
Population: Overall Number of Participants Analyzed represents the number of enrolled participants with available specimens. Number Analyzed shows the number of HIV uninfected participants with available BAMA data after filtering for assay specific quality control criteria at each timepoint.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | gp70_B.CaseA2 V1/V2/169K (Month 6.5) | 501.8 relative fluorescence units |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | gp70-TV1.GSKvacV1V2/293F (Month 6.5) | 3242.8 relative fluorescence units |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | AE.A244 V1V2 Tags/293F (Month 6.5) | 596.8 relative fluorescence units |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | 1086C_D7gp120.avi/293F (Month 6.5) | 3002.2 relative fluorescence units |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | gp70-96ZM651.02 V1v2 (Month 6.5) | 3929.5 relative fluorescence units |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | TV1c8_D11gp120.avi/293F (Month 6.5) | 2134.8 relative fluorescence units |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | C.1086C_V1_V2 Tags (Month 6.5) | 372.2 relative fluorescence units |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | TV1c8_D11gp120.avi/293F (Month 12) | 128.8 relative fluorescence units |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | Con S gp140 CFI (Month 6.5) | 653.1 relative fluorescence units |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | Con 6 gp120/B (Month 6.5) | 384.2 relative fluorescence units |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | gp70-96ZM651.02 V1v2 (Month 12.5) | 157.8 relative fluorescence units |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | gp70_B.CaseA_V1_V2 (Month 12.5) | 1262.5 relative fluorescence units |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | TV1c8_D11gp120.avi/293F (Month 12.5) | 586.8 relative fluorescence units |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | Con S gp140 CFI (Month 12.5) | 264.1 relative fluorescence units |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | Con 6 gp120/B (Month 12.5) | 284 relative fluorescence units |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | 1086C_D7gp120.avi/293F (Month 18) | 204 relative fluorescence units |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | gp70-96ZM651.02 V1v2 (Month 12) | 502.8 relative fluorescence units |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | C.1086C_V1_V2 Tags (Month 12.5) | 470 relative fluorescence units |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | 96ZM651.D11gp120.avi (Month 12.5) | 300.9 relative fluorescence units |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | AE.A244 V1V2 Tags/293F (Month 18) | 187.8 relative fluorescence units |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | 1086C_D7gp120.avi/293F (Month 12.5) | 1049.2 relative fluorescence units |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | gp70_B.CaseA_V1_V2 (Month 12) | 798.2 relative fluorescence units |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | Con S gp140 CFI (Month 18) | 126.6 relative fluorescence units |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | AE.A244 V1V2 Tags/293F (Month 12.5) | 283.9 relative fluorescence units |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | TV1c8_D11gp120.avi/293F (Month 18) | 451.2 relative fluorescence units |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | gp70_B.CaseA2 V1/V2/169K (Month 12) | 1348.5 relative fluorescence units |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | gp70-TV1.GSKvacV1V2/293F (Month 12) | 874.8 relative fluorescence units |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | gp70-96ZM651.02 V1v2 (Month 18) | 434.8 relative fluorescence units |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | Con S gp140 CFI (Month 12) | 297.8 relative fluorescence units |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | gp70-TV1.GSKvacV1V2/293F (Month 18) | 534.8 relative fluorescence units |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | gp70_B.CaseA2 V1/V2/169K (Month 18) | 887.5 relative fluorescence units |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | AE.A244 V1V2 Tags/293F (Month 12) | 148.2 relative fluorescence units |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | gp70_B.CaseA_V1_V2 (Month 18) | 474 relative fluorescence units |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | gp70_B.CaseA2 V1/V2/169K (Month 12.5) | 2010.8 relative fluorescence units |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | 1086C_D7gp120.avi/293F (Month 12) | 327 relative fluorescence units |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | gp70_B.CaseA_V1_V2 (Month 6.5) | 4118.6 relative fluorescence units |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | 96ZM651.D11gp120.avi (Month 6.5) | 810.5 relative fluorescence units |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | gp70-TV1.GSKvacV1V2/293F (Month 12.5) | 853.5 relative fluorescence units |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | gp70_B.CaseA_V1_V2 (Month 12.5) | 233.5 relative fluorescence units |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | C.1086C_V1_V2 Tags (Month 12.5) | 197.8 relative fluorescence units |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | Con 6 gp120/B (Month 12.5) | 329.5 relative fluorescence units |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | TV1c8_D11gp120.avi/293F (Month 18) | 198.9 relative fluorescence units |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | 1086C_D7gp120.avi/293F (Month 18) | 266.4 relative fluorescence units |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | Con S gp140 CFI (Month 18) | 136.6 relative fluorescence units |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | 1086C_D7gp120.avi/293F (Month 6.5) | 3236 relative fluorescence units |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | 96ZM651.D11gp120.avi (Month 6.5) | 594.5 relative fluorescence units |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | AE.A244 V1V2 Tags/293F (Month 6.5) | 265 relative fluorescence units |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | C.1086C_V1_V2 Tags (Month 6.5) | 218.4 relative fluorescence units |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | Con 6 gp120/B (Month 6.5) | 299.2 relative fluorescence units |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | Con S gp140 CFI (Month 6.5) | 936.8 relative fluorescence units |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | TV1c8_D11gp120.avi/293F (Month 6.5) | 1517.2 relative fluorescence units |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | gp70-96ZM651.02 V1v2 (Month 6.5) | 790 relative fluorescence units |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | gp70-TV1.GSKvacV1V2/293F (Month 6.5) | 230.2 relative fluorescence units |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | gp70_B.CaseA2 V1/V2/169K (Month 6.5) | 257.5 relative fluorescence units |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | gp70_B.CaseA_V1_V2 (Month 6.5) | 742 relative fluorescence units |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | 1086C_D7gp120.avi/293F (Month 12) | 288.8 relative fluorescence units |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | 96ZM651.D11gp120.avi (Month 12) | 131.5 relative fluorescence units |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | Con S gp140 CFI (Month 12) | 100.4 relative fluorescence units |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | TV1c8_D11gp120.avi/293F (Month 12) | 148.8 relative fluorescence units |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | gp70_B.CaseA2 V1/V2/169K (Month 12) | 225 relative fluorescence units |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | 1086C_D7gp120.avi/293F (Month 12.5) | 1184.2 relative fluorescence units |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | 96ZM651.D11gp120.avi (Month 12.5) | 314.5 relative fluorescence units |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | AE.A244 V1V2 Tags/293F (Month 12.5) | 271 relative fluorescence units |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | Con S gp140 CFI (Month 12.5) | 322.8 relative fluorescence units |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | TV1c8_D11gp120.avi/293F (Month 12.5) | 673.8 relative fluorescence units |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | gp70-96ZM651.02 V1v2 (Month 12.5) | 354 relative fluorescence units |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | gp70-TV1.GSKvacV1V2/293F (Month 12.5) | 231.6 relative fluorescence units |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | gp70_B.CaseA2 V1/V2/169K (Month 12.5) | 255.4 relative fluorescence units |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | TV1c8_D11gp120.avi/293F (Month 12.5) | 439.4 relative fluorescence units |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | 1086C_D7gp120.avi/293F (Month 12.5) | 1086.2 relative fluorescence units |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | TV1c8_D11gp120.avi/293F (Month 12) | 281.5 relative fluorescence units |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | 96ZM651.D11gp120.avi (Month 12.5) | 314.9 relative fluorescence units |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | gp70-TV1.GSKvacV1V2/293F (Month 12.5) | 487.8 relative fluorescence units |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | 1086C_D7gp120.avi/293F (Month 18) | 167.5 relative fluorescence units |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | C.1086C_V1_V2 Tags (Month 12.5) | 379.2 relative fluorescence units |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | gp70_B.CaseA_V1_V2 (Month 12.5) | 1457.8 relative fluorescence units |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | Con 6 gp120/B (Month 12.5) | 540 relative fluorescence units |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | gp70-TV1.GSKvacV1V2/293F (Month 18) | 170.5 relative fluorescence units |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | AE.A244 V1V2 Tags/293F (Month 12.5) | 480 relative fluorescence units |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | Con 6 gp120/B (Month 6.5) | 260.6 relative fluorescence units |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | C.1086C_V1_V2 Tags (Month 6.5) | 418.8 relative fluorescence units |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | Con S gp140 CFI (Month 12.5) | 208.2 relative fluorescence units |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | Con S gp140 CFI (Month 6.5) | 497.8 relative fluorescence units |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | TV1c8_D11gp120.avi/293F (Month 6.5) | 1306.2 relative fluorescence units |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | AE.A244 V1V2 Tags/293F (Month 6.5) | 527.2 relative fluorescence units |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | gp70-96ZM651.02 V1v2 (Month 6.5) | 1142 relative fluorescence units |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | AE.A244 V1V2 Tags/293F (Month 12) | 605.9 relative fluorescence units |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | gp70-TV1.GSKvacV1V2/293F (Month 6.5) | 512.6 relative fluorescence units |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | 96ZM651.D11gp120.avi (Month 6.5) | 448.1 relative fluorescence units |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | gp70_B.CaseA2 V1/V2/169K (Month 6.5) | 1197 relative fluorescence units |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | gp70_B.CaseA_V1_V2 (Month 6.5) | 858.5 relative fluorescence units |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | 1086C_D7gp120.avi/293F (Month 6.5) | 2824 relative fluorescence units |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | 1086C_D7gp120.avi/293F (Month 12) | 164.5 relative fluorescence units |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | gp70_B.CaseA2 V1/V2/169K (Month 18) | 177.5 relative fluorescence units |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | gp70-96ZM651.02 V1v2 (Month 18) | 196.6 relative fluorescence units |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | gp70_B.CaseA2 V1/V2/169K (Month 12.5) | 551 relative fluorescence units |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | Con S gp140 CFI (Month 12) | 125.8 relative fluorescence units |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | gp70-96ZM651.02 V1v2 (Month 12.5) | 2402.8 relative fluorescence units |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | gp70-96ZM651.02 V1v2 (Month 12) | 268.8 relative fluorescence units |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | gp70-TV1.GSKvacV1V2/293F (Month 12) | 121.8 relative fluorescence units |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | TV1c8_D11gp120.avi/293F (Month 18) | 725.9 relative fluorescence units |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | Con 6 gp120/B (Month 18) | 368.8 relative fluorescence units |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | AE.A244 V1V2 Tags/293F (Month 18) | 245.2 relative fluorescence units |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | 1086C_D7gp120.avi/293F (Month 6.5) | 2728.9 relative fluorescence units |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | TV1c8_D11gp120.avi/293F (Month 12.5) | 1017.2 relative fluorescence units |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | AE.A244 V1V2 Tags/293F (Month 12.5) | 479.1 relative fluorescence units |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | Con S gp140 CFI (Month 6.5) | 435.2 relative fluorescence units |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | gp41 (Month 12.5) | 3020.8 relative fluorescence units |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | 1086C_D7gp120.avi/293F (Month 12.5) | 1739 relative fluorescence units |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | 1086C_D7gp120.avi/293F (Month 12) | 220.4 relative fluorescence units |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | Con 6 gp120/B (Month 12.5) | 203 relative fluorescence units |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | 1086C_D7gp120.avi/293F (Month 18) | 133 relative fluorescence units |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | C.1086C_V1_V2 Tags (Month 6.5) | 222.1 relative fluorescence units |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | AE.A244 V1V2 Tags/293F (Month 6.5) | 135.2 relative fluorescence units |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | 96ZM651.D11gp120.avi (Month 12.5) | 264.5 relative fluorescence units |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | Con S gp140 CFI (Month 12.5) | 476.8 relative fluorescence units |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | TV1c8_D11gp120.avi/293F (Month 12) | 9282.5 relative fluorescence units |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | Con 6 gp120/B (Month 6.5) | 197.2 relative fluorescence units |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | TV1c8_D11gp120.avi/293F (Month 18) | 6535.8 relative fluorescence units |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | gp41 (Month 18) | 9170.6 relative fluorescence units |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | C.1086C_V1_V2 Tags (Month 12.5) | 22000 relative fluorescence units |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | gp70-96ZM651.02 V1v2 (Month 12.5) | 4707.5 relative fluorescence units |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | TV1c8_D11gp120.avi/293F (Month 6.5) | 2277 relative fluorescence units |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Level of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | 96ZM651.D11gp120.avi (Month 6.5) | 613.2 relative fluorescence units |
Secondary
Level of Vaccine-induced Serum IgG Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C)
Serum IgG responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay, run at 1:50 dilution. The readout is background-subtracted mean fluorescent intensity (MFI), with background adjustment for an antigen-specific plate level control. For each sample, response magnitude is net MFI, defined as experimental antigen MFI minus reference antigen MFI. Net MFI \< 1 is set to 1, and net MFI \> 22,000 is set to 22,000. Data are excluded if blood draw date was outside the allowable window, a participant was HIV-infected, reference antigen \> 5,000 MFI, or baseline net MFI \> 6,500. Summary was calculated among positive responders only (positivity criteria are described in Outcome 1).
Time frame: Measured at Months 12.5 and 18.
Population: Overall Number of Participants Analyzed represents the number of enrolled participants with available specimens. Number Analyzed shows the number of HIV uninfected participants with available BAMA data after filtering for assay specific quality control criteria at each timepoint.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C) | 96ZM651.D11gp120.avi (Month 18) | 6135.8 relative fluorescence units |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C) | TV1c8_D11gp120.avi/293F (Month 18) | 8367.6 relative fluorescence units |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C) | 96ZM651.D11gp120.avi (Month 12.5) | 22000 relative fluorescence units |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C) | 1086C_D7gp120.avi/293F (Month 18) | 22000 relative fluorescence units |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C) | TV1c8_D11gp120.avi/293F (Month 12.5) | 22000 relative fluorescence units |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C) | 1086C_D7gp120.avi/293F (Month 12.5) | 22000 relative fluorescence units |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C) | TV1c8_D11gp120.avi/293F (Month 12.5) | 22000 relative fluorescence units |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C) | 96ZM651.D11gp120.avi (Month 18) | 5439 relative fluorescence units |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C) | 1086C_D7gp120.avi/293F (Month 18) | 22000 relative fluorescence units |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C) | 96ZM651.D11gp120.avi (Month 12.5) | 22000 relative fluorescence units |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C) | 1086C_D7gp120.avi/293F (Month 12.5) | 22000 relative fluorescence units |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C) | TV1c8_D11gp120.avi/293F (Month 18) | 8893.4 relative fluorescence units |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C) | TV1c8_D11gp120.avi/293F (Month 12.5) | 22000 relative fluorescence units |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C) | 1086C_D7gp120.avi/293F (Month 18) | 22000 relative fluorescence units |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C) | TV1c8_D11gp120.avi/293F (Month 18) | 20549 relative fluorescence units |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C) | 1086C_D7gp120.avi/293F (Month 12.5) | 22000 relative fluorescence units |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C) | 96ZM651.D11gp120.avi (Month 12.5) | 22000 relative fluorescence units |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C) | 96ZM651.D11gp120.avi (Month 18) | 5372.6 relative fluorescence units |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C) | TV1c8_D11gp120.avi/293F (Month 12.5) | 22000 relative fluorescence units |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C) | TV1c8_D11gp120.avi/293F (Month 18) | 6794.5 relative fluorescence units |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C) | 96ZM651.D11gp120.avi (Month 18) | 2794 relative fluorescence units |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C) | 96ZM651.D11gp120.avi (Month 12.5) | 22000 relative fluorescence units |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C) | 1086C_D7gp120.avi/293F (Month 12.5) | 22000 relative fluorescence units |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C) | 1086C_D7gp120.avi/293F (Month 18) | 16187 relative fluorescence units |
Secondary
Level of Vaccine-induced Serum IgG Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C)
Serum IgG responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay, run at 1:50 dilution. The readout is background-subtracted mean fluorescent intensity (MFI), with background adjustment for an antigen-specific plate level control. For each sample, response magnitude is net MFI, defined as experimental antigen MFI minus reference antigen MFI. Net MFI \< 1 is set to 1, and net MFI \> 22,000 is set to 22,000. Data are excluded if blood draw date was outside the allowable window, a participant was HIV-infected, reference antigen \> 5,000 MFI, or baseline net MFI \> 6,500. Summary was calculated among positive responders only (positivity criteria are described in Outcome 1).
Time frame: Measured at Months 6.5 and 12.
Population: Overall Number of Participants Analyzed represents the number of enrolled participants with available specimens. Number Analyzed shows the number of HIV uninfected participants with available BAMA data after filtering for assay specific quality control criteria at each timepoint.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C) | 1086C_D7gp120.avi/293F (Month 6.5) | 22000 relative fluorescence units |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C) | TV1c8_D11gp120.avi/293F (Month 12.5) | 22000 relative fluorescence units |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C) | 1086C_D7gp120.avi/293F (Month 18) | 22000 relative fluorescence units |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C) | TV1c8_D11gp120.avi/293F (Month 18) | 8367.6 relative fluorescence units |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C) | TV1c8_D11gp120.avi/293F (Month 12) | 1252.5 relative fluorescence units |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C) | 96ZM651.D11gp120.avi (Month 6.5) | 22000 relative fluorescence units |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C) | 96ZM651.D11gp120.avi (Month 12.5) | 22000 relative fluorescence units |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C) | 96ZM651.D11gp120.avi (Month 18) | 6135.8 relative fluorescence units |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C) | TV1c8_D11gp120.avi/293F (Month 6.5) | 22000 relative fluorescence units |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C) | 1086C_D7gp120.avi/293F (Month 12.5) | 22000 relative fluorescence units |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C) | 1086C_D7gp120.avi/293F (Month 12) | 6759.8 relative fluorescence units |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C) | 96ZM651.D11gp120.avi (Month 12) | 3182.8 relative fluorescence units |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C) | 1086C_D7gp120.avi/293F (Month 12) | 11657.1 relative fluorescence units |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C) | 96ZM651.D11gp120.avi (Month 12) | 2167.8 relative fluorescence units |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C) | 96ZM651.D11gp120.avi (Month 18) | 5439 relative fluorescence units |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C) | 1086C_D7gp120.avi/293F (Month 12.5) | 22000 relative fluorescence units |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C) | TV1c8_D11gp120.avi/293F (Month 12) | 1660 relative fluorescence units |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C) | 96ZM651.D11gp120.avi (Month 12.5) | 22000 relative fluorescence units |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C) | 1086C_D7gp120.avi/293F (Month 18) | 22000 relative fluorescence units |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C) | TV1c8_D11gp120.avi/293F (Month 12.5) | 22000 relative fluorescence units |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C) | 1086C_D7gp120.avi/293F (Month 6.5) | 22000 relative fluorescence units |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C) | 96ZM651.D11gp120.avi (Month 6.5) | 22000 relative fluorescence units |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C) | TV1c8_D11gp120.avi/293F (Month 18) | 8893.4 relative fluorescence units |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C) | TV1c8_D11gp120.avi/293F (Month 6.5) | 22000 relative fluorescence units |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C) | TV1c8_D11gp120.avi/293F (Month 12.5) | 22000 relative fluorescence units |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C) | 96ZM651.D11gp120.avi (Month 6.5) | 22000 relative fluorescence units |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C) | 1086C_D7gp120.avi/293F (Month 6.5) | 22000 relative fluorescence units |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C) | TV1c8_D11gp120.avi/293F (Month 6.5) | 22000 relative fluorescence units |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C) | 1086C_D7gp120.avi/293F (Month 12) | 22000 relative fluorescence units |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C) | 96ZM651.D11gp120.avi (Month 12) | 3000 relative fluorescence units |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C) | TV1c8_D11gp120.avi/293F (Month 12) | 10750 relative fluorescence units |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C) | 1086C_D7gp120.avi/293F (Month 12.5) | 22000 relative fluorescence units |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C) | 96ZM651.D11gp120.avi (Month 12.5) | 22000 relative fluorescence units |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C) | 1086C_D7gp120.avi/293F (Month 18) | 22000 relative fluorescence units |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C) | 96ZM651.D11gp120.avi (Month 18) | 5372.6 relative fluorescence units |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C) | TV1c8_D11gp120.avi/293F (Month 18) | 20549 relative fluorescence units |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C) | 96ZM651.D11gp120.avi (Month 18) | 2794 relative fluorescence units |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C) | TV1c8_D11gp120.avi/293F (Month 12.5) | 22000 relative fluorescence units |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C) | 96ZM651.D11gp120.avi (Month 12.5) | 22000 relative fluorescence units |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C) | 96ZM651.D11gp120.avi (Month 6.5) | 22000 relative fluorescence units |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C) | 1086C_D7gp120.avi/293F (Month 18) | 16187 relative fluorescence units |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C) | 1086C_D7gp120.avi/293F (Month 12) | 4265.8 relative fluorescence units |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C) | TV1c8_D11gp120.avi/293F (Month 6.5) | 22000 relative fluorescence units |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C) | TV1c8_D11gp120.avi/293F (Month 12) | 1086 relative fluorescence units |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C) | 96ZM651.D11gp120.avi (Month 12) | 1676 relative fluorescence units |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C) | TV1c8_D11gp120.avi/293F (Month 18) | 6794.5 relative fluorescence units |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C) | 1086C_D7gp120.avi/293F (Month 12.5) | 22000 relative fluorescence units |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C) | 1086C_D7gp120.avi/293F (Month 6.5) | 22000 relative fluorescence units |
Secondary
Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins
Serum IgG responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay, run at 1:50 dilution. The readout is background-subtracted mean fluorescent intensity (MFI), with background adjustment for an antigen-specific plate level control. For each sample, response magnitude is net MFI, defined as experimental antigen MFI minus reference antigen MFI. Net MFI \< 1 is set to 1, and net MFI \> 22,000 is set to 22,000. Data are excluded if blood draw date was outside the allowable window, a participant was HIV-infected, reference antigen \> 5,000 MFI, or baseline net MFI \> 6,500. Summary was calculated among positive responders only (positivity criteria are described in Outcome 1).
Time frame: Measured at Months 12.5 and 18.
Population: Overall Number of Participants Analyzed represents the number of enrolled participants with available specimens. Number Analyzed shows the number of HIV uninfected participants with available BAMA data after filtering for assay specific quality control criteria at each timepoint.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | C.1086C_V1_V2 Tags (Month 18) | 1204.5 relative fluorescence units |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | gp70_B.CaseA_V1_V2 (Month 12.5) | 763.5 relative fluorescence units |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | Con S gp140 CFI (Month 18) | 8793.8 relative fluorescence units |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | AE.A244 V1V2 Tags/293F (Month 18) | 137 relative fluorescence units |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | A1.con.env03 140 CF (Month 18) | 1106 relative fluorescence units |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | Con S gp140 CFI (Month 12.5) | 22000 relative fluorescence units |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | gp70_B.CaseA_V1_V2 (Month 18) | 314.2 relative fluorescence units |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | Con 6 gp120/B (Month 18) | 2373.2 relative fluorescence units |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | 00MSA 4076 gp140 (Month 18) | 1954 relative fluorescence units |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | gp70-96ZM651.02 V1v2 (Month 12.5) | 1427.2 relative fluorescence units |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | A1.con.env03 140 CF (Month 12.5) | 22000 relative fluorescence units |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | C.1086C_V1_V2 Tags (Month 12.5) | 2021.2 relative fluorescence units |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | AE.A244 V1V2 Tags/293F (Month 12.5) | 4553.5 relative fluorescence units |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | gp70-TV1.GSKvacV1V2/293F (Month 12.5) | 1407.4 relative fluorescence units |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | Con 6 gp120/B (Month 12.5) | 22000 relative fluorescence units |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | 00MSA 4076 gp140 (Month 12.5) | 22000 relative fluorescence units |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | gp70-TV1.GSKvacV1V2/293F (Month 18) | 163.1 relative fluorescence units |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | gp70_B.CaseA2 V1/V2/169K (Month 12.5) | 1213.2 relative fluorescence units |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | gp70_B.CaseA2 V1/V2/169K (Month 18) | 244.5 relative fluorescence units |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | gp70-96ZM651.02 V1v2 (Month 18) | 370.8 relative fluorescence units |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | gp70-96ZM651.02 V1v2 (Month 12.5) | 3770.8 relative fluorescence units |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | Con S gp140 CFI (Month 12.5) | 22000 relative fluorescence units |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | gp70-TV1.GSKvacV1V2/293F (Month 12.5) | 2057.8 relative fluorescence units |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | gp70_B.CaseA2 V1/V2/169K (Month 12.5) | 2332.9 relative fluorescence units |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | gp70_B.CaseA_V1_V2 (Month 12.5) | 2246.5 relative fluorescence units |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | 00MSA 4076 gp140 (Month 18) | 2546.9 relative fluorescence units |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | A1.con.env03 140 CF (Month 18) | 1552.5 relative fluorescence units |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | AE.A244 V1V2 Tags/293F (Month 18) | 462 relative fluorescence units |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | gp41 (Month 18) | 2549.2 relative fluorescence units |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | gp70-96ZM651.02 V1v2 (Month 18) | 584 relative fluorescence units |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | gp70-TV1.GSKvacV1V2/293F (Month 18) | 180.2 relative fluorescence units |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | 00MSA 4076 gp140 (Month 12.5) | 22000 relative fluorescence units |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | A1.con.env03 140 CF (Month 12.5) | 22000 relative fluorescence units |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | AE.A244 V1V2 Tags/293F (Month 12.5) | 3313.8 relative fluorescence units |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | C.1086C_V1_V2 Tags (Month 12.5) | 3476 relative fluorescence units |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | Con 6 gp120/B (Month 12.5) | 22000 relative fluorescence units |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | C.1086C_V1_V2 Tags (Month 18) | 1523.2 relative fluorescence units |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | Con 6 gp120/B (Month 18) | 2805 relative fluorescence units |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | Con S gp140 CFI (Month 18) | 9031.1 relative fluorescence units |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | gp70_B.CaseA2 V1/V2/169K (Month 18) | 1593.8 relative fluorescence units |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | gp70_B.CaseA_V1_V2 (Month 18) | 1717.6 relative fluorescence units |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | Con S gp140 CFI (Month 18) | 13261.8 relative fluorescence units |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | gp41 (Month 12.5) | 4644.8 relative fluorescence units |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | A1.con.env03 140 CF (Month 12.5) | 22000 relative fluorescence units |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | 00MSA 4076 gp140 (Month 18) | 1571 relative fluorescence units |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | Con 6 gp120/B (Month 12.5) | 22000 relative fluorescence units |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | C.1086C_V1_V2 Tags (Month 18) | 821.8 relative fluorescence units |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | gp70-TV1.GSKvacV1V2/293F (Month 12.5) | 12436.5 relative fluorescence units |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | gp41 (Month 18) | 7284.8 relative fluorescence units |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | AE.A244 V1V2 Tags/293F (Month 12.5) | 5728.8 relative fluorescence units |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | Con S gp140 CFI (Month 12.5) | 22000 relative fluorescence units |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | A1.con.env03 140 CF (Month 18) | 1853.2 relative fluorescence units |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | gp70_B.CaseA2 V1/V2/169K (Month 18) | 1332 relative fluorescence units |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | gp70_B.CaseA_V1_V2 (Month 12.5) | 8372.5 relative fluorescence units |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | gp70-96ZM651.02 V1v2 (Month 12.5) | 8793.6 relative fluorescence units |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | AE.A244 V1V2 Tags/293F (Month 18) | 362.2 relative fluorescence units |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | gp70-TV1.GSKvacV1V2/293F (Month 18) | 1319.2 relative fluorescence units |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | C.1086C_V1_V2 Tags (Month 12.5) | 3484.6 relative fluorescence units |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | 00MSA 4076 gp140 (Month 12.5) | 22000 relative fluorescence units |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | Con 6 gp120/B (Month 18) | 2405.5 relative fluorescence units |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | gp70_B.CaseA_V1_V2 (Month 18) | 623.8 relative fluorescence units |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | gp70_B.CaseA2 V1/V2/169K (Month 12.5) | 8987.2 relative fluorescence units |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | gp70-96ZM651.02 V1v2 (Month 18) | 987.8 relative fluorescence units |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | Con 6 gp120/B (Month 18) | 1185.2 relative fluorescence units |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | gp70-96ZM651.02 V1v2 (Month 18) | 2221.8 relative fluorescence units |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | gp70-TV1.GSKvacV1V2/293F (Month 12.5) | 2031.8 relative fluorescence units |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | Con 6 gp120/B (Month 12.5) | 22000 relative fluorescence units |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | gp70_B.CaseA2 V1/V2/169K (Month 18) | 1227.5 relative fluorescence units |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | A1.con.env03 140 CF (Month 12.5) | 22000 relative fluorescence units |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | 00MSA 4076 gp140 (Month 12.5) | 22000 relative fluorescence units |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | gp70-96ZM651.02 V1v2 (Month 12.5) | 1639.8 relative fluorescence units |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | AE.A244 V1V2 Tags/293F (Month 12.5) | 1034.2 relative fluorescence units |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | C.1086C_V1_V2 Tags (Month 12.5) | 1380.2 relative fluorescence units |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | gp70-TV1.GSKvacV1V2/293F (Month 18) | 1114.2 relative fluorescence units |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | Con S gp140 CFI (Month 12.5) | 22000 relative fluorescence units |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | gp41 (Month 12.5) | 8348.5 relative fluorescence units |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | C.1086C_V1_V2 Tags (Month 18) | 909 relative fluorescence units |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | 00MSA 4076 gp140 (Month 18) | 1351.9 relative fluorescence units |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | gp70_B.CaseA_V1_V2 (Month 12.5) | 2869.5 relative fluorescence units |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | A1.con.env03 140 CF (Month 18) | 961.5 relative fluorescence units |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | gp70_B.CaseA_V1_V2 (Month 18) | 593.2 relative fluorescence units |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | AE.A244 V1V2 Tags/293F (Month 18) | 445.9 relative fluorescence units |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | gp70_B.CaseA2 V1/V2/169K (Month 12.5) | 1324.4 relative fluorescence units |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | Con S gp140 CFI (Month 18) | 5032.5 relative fluorescence units |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | gp41 (Month 18) | 19096.5 relative fluorescence units |
Secondary
Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins
Serum IgG responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay, run at 1:50 dilution. The readout is background-subtracted mean fluorescent intensity (MFI), with background adjustment for an antigen-specific plate level control. For each sample, response magnitude is net MFI, defined as experimental antigen MFI minus reference antigen MFI. Net MFI \< 1 is set to 1, and net MFI \> 22,000 is set to 22,000. Data are excluded if blood draw date was outside the allowable window, a participant was HIV-infected, reference antigen \> 5,000 MFI, or baseline net MFI \> 6,500. Summary was calculated among positive responders only (positivity criteria are described in Outcome 1).
Time frame: Measured at Months 6.5 and 12.
Population: Overall Number of Participants Analyzed represents the number of enrolled participants with available specimens. Number Analyzed shows the number of HIV uninfected participants with available BAMA data after filtering for assay specific quality control criteria at each timepoint.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | Con 6 gp120/B (Month 12.5) | 22000 relative fluorescence units |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | AE.A244 V1V2 Tags/293F (Month 6.5) | 7008.2 relative fluorescence units |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | gp70-TV1.GSKvacV1V2/293F (Month 12) | 495.2 relative fluorescence units |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | C.1086C_V1_V2 Tags (Month 6.5) | 1284.5 relative fluorescence units |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | A1.con.env03 140 CF (Month 12.5) | 22000 relative fluorescence units |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | Con 6 gp120/B (Month 6.5) | 21899.6 relative fluorescence units |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | C.1086C_V1_V2 Tags (Month 12.5) | 2021.2 relative fluorescence units |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | C.1086C_V1_V2 Tags (Month 18) | 1204.5 relative fluorescence units |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | Con S gp140 CFI (Month 6.5) | 22000 relative fluorescence units |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | gp70_B.CaseA_V1_V2 (Month 18) | 314.2 relative fluorescence units |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | gp70_B.CaseA2 V1/V2/169K (Month 12.5) | 1213.2 relative fluorescence units |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | gp70-96ZM651.02 V1v2 (Month 12.5) | 1427.2 relative fluorescence units |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | gp70-96ZM651.02 V1v2 (Month 6.5) | 968 relative fluorescence units |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | AE.A244 V1V2 Tags/293F (Month 18) | 137 relative fluorescence units |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | gp70-TV1.GSKvacV1V2/293F (Month 6.5) | 714.8 relative fluorescence units |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | AE.A244 V1V2 Tags/293F (Month 12.5) | 4553.5 relative fluorescence units |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | A1.con.env03 140 CF (Month 12) | 286.5 relative fluorescence units |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | gp70-96ZM651.02 V1v2 (Month 18) | 370.8 relative fluorescence units |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | gp70_B.CaseA2 V1/V2/169K (Month 12) | 693.8 relative fluorescence units |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | Con S gp140 CFI (Month 12.5) | 22000 relative fluorescence units |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | gp70-TV1.GSKvacV1V2/293F (Month 12.5) | 1407.4 relative fluorescence units |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | A1.con.env03 140 CF (Month 18) | 1106 relative fluorescence units |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | 00MSA 4076 gp140 (Month 12) | 1557.1 relative fluorescence units |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | gp70_B.CaseA_V1_V2 (Month 12) | 949 relative fluorescence units |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | gp70_B.CaseA_V1_V2 (Month 6.5) | 1368.8 relative fluorescence units |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | Con S gp140 CFI (Month 18) | 8793.8 relative fluorescence units |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | 00MSA 4076 gp140 (Month 18) | 1954 relative fluorescence units |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | AE.A244 V1V2 Tags/293F (Month 12) | 290.4 relative fluorescence units |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | 00MSA 4076 gp140 (Month 6.5) | 18852.2 relative fluorescence units |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | gp70_B.CaseA2 V1/V2/169K (Month 18) | 244.5 relative fluorescence units |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | Con 6 gp120/B (Month 12) | 2429.8 relative fluorescence units |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | gp70-TV1.GSKvacV1V2/293F (Month 18) | 163.1 relative fluorescence units |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | Con S gp140 CFI (Month 12) | 954 relative fluorescence units |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | Con 6 gp120/B (Month 18) | 2373.2 relative fluorescence units |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | A1.con.env03 140 CF (Month 6.5) | 21481.5 relative fluorescence units |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | 00MSA 4076 gp140 (Month 12.5) | 22000 relative fluorescence units |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | gp70_B.CaseA_V1_V2 (Month 12.5) | 763.5 relative fluorescence units |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | gp70_B.CaseA2 V1/V2/169K (Month 6.5) | 1476 relative fluorescence units |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | Con 6 gp120/B (Month 12) | 1139.8 relative fluorescence units |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | gp70_B.CaseA_V1_V2 (Month 12.5) | 2246.5 relative fluorescence units |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | gp70-96ZM651.02 V1v2 (Month 18) | 584 relative fluorescence units |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | gp70-96ZM651.02 V1v2 (Month 12) | 1264.8 relative fluorescence units |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | gp70-TV1.GSKvacV1V2/293F (Month 12) | 502.4 relative fluorescence units |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | 00MSA 4076 gp140 (Month 6.5) | 11851.2 relative fluorescence units |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | gp70_B.CaseA2 V1/V2/169K (Month 12) | 559.9 relative fluorescence units |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | gp70_B.CaseA_V1_V2 (Month 12) | 442.5 relative fluorescence units |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | Con S gp140 CFI (Month 6.5) | 22000 relative fluorescence units |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | 00MSA 4076 gp140 (Month 12.5) | 22000 relative fluorescence units |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | gp70_B.CaseA2 V1/V2/169K (Month 12.5) | 2332.9 relative fluorescence units |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | A1.con.env03 140 CF (Month 12.5) | 22000 relative fluorescence units |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | AE.A244 V1V2 Tags/293F (Month 12.5) | 3313.8 relative fluorescence units |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | C.1086C_V1_V2 Tags (Month 12.5) | 3476 relative fluorescence units |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | gp70-TV1.GSKvacV1V2/293F (Month 12.5) | 2057.8 relative fluorescence units |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | Con 6 gp120/B (Month 12.5) | 22000 relative fluorescence units |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | gp70-96ZM651.02 V1v2 (Month 6.5) | 1963 relative fluorescence units |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | gp70-96ZM651.02 V1v2 (Month 12.5) | 3770.8 relative fluorescence units |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | Con S gp140 CFI (Month 12.5) | 22000 relative fluorescence units |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | C.1086C_V1_V2 Tags (Month 6.5) | 954.5 relative fluorescence units |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | Con 6 gp120/B (Month 18) | 2805 relative fluorescence units |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | Con S gp140 CFI (Month 18) | 9031.1 relative fluorescence units |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | gp41 (Month 18) | 2549.2 relative fluorescence units |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | gp70-TV1.GSKvacV1V2/293F (Month 18) | 180.2 relative fluorescence units |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | A1.con.env03 140 CF (Month 6.5) | 15307.5 relative fluorescence units |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | C.1086C_V1_V2 Tags (Month 18) | 1523.2 relative fluorescence units |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | AE.A244 V1V2 Tags/293F (Month 6.5) | 4347.5 relative fluorescence units |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | gp70_B.CaseA2 V1/V2/169K (Month 18) | 1593.8 relative fluorescence units |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | Con 6 gp120/B (Month 6.5) | 14046.6 relative fluorescence units |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | AE.A244 V1V2 Tags/293F (Month 18) | 462 relative fluorescence units |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | gp41 (Month 6.5) | 4472.8 relative fluorescence units |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | gp70-TV1.GSKvacV1V2/293F (Month 6.5) | 1367.5 relative fluorescence units |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | A1.con.env03 140 CF (Month 18) | 1552.5 relative fluorescence units |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | gp70_B.CaseA2 V1/V2/169K (Month 6.5) | 1888.8 relative fluorescence units |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | A1.con.env03 140 CF (Month 12) | 318.1 relative fluorescence units |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | gp70_B.CaseA_V1_V2 (Month 6.5) | 1292.5 relative fluorescence units |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | 00MSA 4076 gp140 (Month 12) | 1390.2 relative fluorescence units |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | gp70_B.CaseA_V1_V2 (Month 18) | 1717.6 relative fluorescence units |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | 00MSA 4076 gp140 (Month 18) | 2546.9 relative fluorescence units |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | AE.A244 V1V2 Tags/293F (Month 12) | 237.5 relative fluorescence units |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | Con S gp140 CFI (Month 12) | 1599 relative fluorescence units |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | gp70_B.CaseA2 V1/V2/169K (Month 12.5) | 8987.2 relative fluorescence units |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | 00MSA 4076 gp140 (Month 6.5) | 22000 relative fluorescence units |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | AE.A244 V1V2 Tags/293F (Month 6.5) | 3203 relative fluorescence units |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | Con 6 gp120/B (Month 6.5) | 22000 relative fluorescence units |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | gp70-96ZM651.02 V1v2 (Month 6.5) | 2631.8 relative fluorescence units |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | gp70_B.CaseA_V1_V2 (Month 6.5) | 4521.2 relative fluorescence units |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | A1.con.env03 140 CF (Month 12) | 834.8 relative fluorescence units |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | 00MSA 4076 gp140 (Month 12.5) | 22000 relative fluorescence units |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | Con S gp140 CFI (Month 12.5) | 22000 relative fluorescence units |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | AE.A244 V1V2 Tags/293F (Month 18) | 362.2 relative fluorescence units |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | gp70_B.CaseA2 V1/V2/169K (Month 18) | 1332 relative fluorescence units |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | A1.con.env03 140 CF (Month 6.5) | 22000 relative fluorescence units |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | C.1086C_V1_V2 Tags (Month 6.5) | 1830.8 relative fluorescence units |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | Con S gp140 CFI (Month 6.5) | 22000 relative fluorescence units |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | gp70-TV1.GSKvacV1V2/293F (Month 6.5) | 6205.1 relative fluorescence units |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | gp70_B.CaseA2 V1/V2/169K (Month 6.5) | 6450.5 relative fluorescence units |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | 00MSA 4076 gp140 (Month 12) | 1425.8 relative fluorescence units |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | AE.A244 V1V2 Tags/293F (Month 12) | 279.2 relative fluorescence units |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | Con 6 gp120/B (Month 12) | 1908.5 relative fluorescence units |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | Con S gp140 CFI (Month 12) | 6908.8 relative fluorescence units |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | gp70-96ZM651.02 V1v2 (Month 12) | 819.9 relative fluorescence units |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | gp70-TV1.GSKvacV1V2/293F (Month 12) | 722.4 relative fluorescence units |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | gp70_B.CaseA2 V1/V2/169K (Month 12) | 427 relative fluorescence units |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | gp70_B.CaseA_V1_V2 (Month 12) | 487.2 relative fluorescence units |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | A1.con.env03 140 CF (Month 12.5) | 22000 relative fluorescence units |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | C.1086C_V1_V2 Tags (Month 12.5) | 3484.6 relative fluorescence units |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | AE.A244 V1V2 Tags/293F (Month 12.5) | 5728.8 relative fluorescence units |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | Con 6 gp120/B (Month 12.5) | 22000 relative fluorescence units |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | gp41 (Month 12.5) | 4644.8 relative fluorescence units |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | gp70-96ZM651.02 V1v2 (Month 12.5) | 8793.6 relative fluorescence units |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | gp70-TV1.GSKvacV1V2/293F (Month 12.5) | 12436.5 relative fluorescence units |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | gp70_B.CaseA_V1_V2 (Month 12.5) | 8372.5 relative fluorescence units |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | 00MSA 4076 gp140 (Month 18) | 1571 relative fluorescence units |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | A1.con.env03 140 CF (Month 18) | 1853.2 relative fluorescence units |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | C.1086C_V1_V2 Tags (Month 18) | 821.8 relative fluorescence units |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | Con 6 gp120/B (Month 18) | 2405.5 relative fluorescence units |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | Con S gp140 CFI (Month 18) | 13261.8 relative fluorescence units |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | gp41 (Month 18) | 7284.8 relative fluorescence units |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | gp70-96ZM651.02 V1v2 (Month 18) | 987.8 relative fluorescence units |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | gp70-TV1.GSKvacV1V2/293F (Month 18) | 1319.2 relative fluorescence units |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | gp70_B.CaseA_V1_V2 (Month 18) | 623.8 relative fluorescence units |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | gp70_B.CaseA2 V1/V2/169K (Month 12.5) | 1324.4 relative fluorescence units |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | gp41 (Month 12) | 9264 relative fluorescence units |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | Con S gp140 CFI (Month 12) | 680.2 relative fluorescence units |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | AE.A244 V1V2 Tags/293F (Month 6.5) | 489 relative fluorescence units |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | gp70_B.CaseA_V1_V2 (Month 12.5) | 2869.5 relative fluorescence units |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | A1.con.env03 140 CF (Month 12) | 339.2 relative fluorescence units |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | 00MSA 4076 gp140 (Month 12) | 952 relative fluorescence units |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | C.1086C_V1_V2 Tags (Month 12) | 1296.8 relative fluorescence units |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | 00MSA 4076 gp140 (Month 18) | 1351.9 relative fluorescence units |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | gp70_B.CaseA_V1_V2 (Month 6.5) | 651.8 relative fluorescence units |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | gp70-TV1.GSKvacV1V2/293F (Month 6.5) | 727.1 relative fluorescence units |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | gp70_B.CaseA_V1_V2 (Month 18) | 593.2 relative fluorescence units |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | A1.con.env03 140 CF (Month 18) | 961.5 relative fluorescence units |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | gp70-96ZM651.02 V1v2 (Month 6.5) | 1219.4 relative fluorescence units |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | Con S gp140 CFI (Month 6.5) | 22000 relative fluorescence units |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | AE.A244 V1V2 Tags/293F (Month 18) | 445.9 relative fluorescence units |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | Con 6 gp120/B (Month 6.5) | 9978 relative fluorescence units |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | A1.con.env03 140 CF (Month 6.5) | 12791.2 relative fluorescence units |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | gp70-TV1.GSKvacV1V2/293F (Month 18) | 1114.2 relative fluorescence units |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | 00MSA 4076 gp140 (Month 6.5) | 9648.8 relative fluorescence units |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | AE.A244 V1V2 Tags/293F (Month 12) | 124.2 relative fluorescence units |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | Con 6 gp120/B (Month 18) | 1185.2 relative fluorescence units |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | gp70_B.CaseA2 V1/V2/169K (Month 18) | 1227.5 relative fluorescence units |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | gp70_B.CaseA2 V1/V2/169K (Month 6.5) | 406.9 relative fluorescence units |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | Con S gp140 CFI (Month 18) | 5032.5 relative fluorescence units |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | gp70-96ZM651.02 V1v2 (Month 18) | 2221.8 relative fluorescence units |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | C.1086C_V1_V2 Tags (Month 6.5) | 865.6 relative fluorescence units |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | gp41 (Month 18) | 19096.5 relative fluorescence units |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | gp41 (Month 12.5) | 8348.5 relative fluorescence units |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | Con S gp140 CFI (Month 12.5) | 22000 relative fluorescence units |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | Con 6 gp120/B (Month 12.5) | 22000 relative fluorescence units |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | C.1086C_V1_V2 Tags (Month 18) | 909 relative fluorescence units |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | gp70-96ZM651.02 V1v2 (Month 12.5) | 1639.8 relative fluorescence units |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | C.1086C_V1_V2 Tags (Month 12.5) | 1380.2 relative fluorescence units |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | AE.A244 V1V2 Tags/293F (Month 12.5) | 1034.2 relative fluorescence units |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | Con 6 gp120/B (Month 12) | 2036.8 relative fluorescence units |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | gp70-TV1.GSKvacV1V2/293F (Month 12.5) | 2031.8 relative fluorescence units |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | A1.con.env03 140 CF (Month 12.5) | 22000 relative fluorescence units |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | 00MSA 4076 gp140 (Month 12.5) | 22000 relative fluorescence units |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Level of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | gp70-TV1.GSKvacV1V2/293F (Month 12) | 2504.8 relative fluorescence units |
Secondary
Occurrence of Vaccine-induced Serum IgA Ab Binding to Env Proteins
Serum IgA responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay, run at 1:10 dilution. The readout is background-subtracted mean fluorescent intensity (MFI), with background adjustment for an antigen-specific plate level control. For each sample, response magnitude is net MFI, defined as experimental antigen MFI minus reference antigen MFI. Net MFI \< 1 is set to 1, and net MFI \> 22,000 is set to 22,000. Data are excluded if blood draw date was outside the allowable window, a participant was HIV-infected, reference antigen \> 5,000 MFI, or baseline net MFI \> 6,500. Samples from post-enrollment visits have positive responses if they meet three criteria: (1) net MFI greater than or equal to an antigen-specific response threshold (defined as the maximum of 100 and the 95th percentile of baseline net MFI), (2) net MFI values are greater than 3 times baseline net MFI, and (3) experimental antigen MFI values are greater than 3 times baseline MFI.
Time frame: Measured at Months 6.5 and 12.
Population: Overall Number of Participants Analyzed represents the number of enrolled participants with available specimens. Number Analyzed shows the number of HIV uninfected participants with available BAMA data after filtering for assay specific quality control criteria at each timepoint.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgA Ab Binding to Env Proteins | A1.con.env03 140 CF (Month 12) | 3 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgA Ab Binding to Env Proteins | 00MSA 4076 gp140 (Month 12) | 3 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgA Ab Binding to Env Proteins | gp70-TV1.GSKvacV1V2/293F (Month 12) | 1 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgA Ab Binding to Env Proteins | Con S gp140 CFI (Month 6.5) | 17 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgA Ab Binding to Env Proteins | AE.A244 V1V2 Tags/293F (Month 12) | 1 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgA Ab Binding to Env Proteins | 1086C_D7gp120.avi/293F (Month 6.5) | 22 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgA Ab Binding to Env Proteins | gp41 (Month 12) | 0 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgA Ab Binding to Env Proteins | TV1c8_D11gp120.avi/293F (Month 6.5) | 18 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgA Ab Binding to Env Proteins | AE.A244 V1V2 Tags/293F (Month 6.5) | 1 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgA Ab Binding to Env Proteins | C.1086C_V1_V2 Tags (Month 12) | 1 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgA Ab Binding to Env Proteins | 96ZM651.D11gp120.avi (Month 12) | 2 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgA Ab Binding to Env Proteins | gp41 (Month 6.5) | 0 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgA Ab Binding to Env Proteins | gp70-96ZM651.02 V1v2 (Month 12) | 0 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgA Ab Binding to Env Proteins | gp70_B.CaseA_V1_V2 (Month 12) | 0 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgA Ab Binding to Env Proteins | TV1c8_D11gp120.avi/293F (Month 12) | 7 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgA Ab Binding to Env Proteins | gp70-96ZM651.02 V1v2 (Month 6.5) | 0 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgA Ab Binding to Env Proteins | C.1086C_V1_V2 Tags (Month 6.5) | 1 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgA Ab Binding to Env Proteins | gp70_B.CaseA2 V1/V2/169K (Month 12) | 1 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgA Ab Binding to Env Proteins | A1.con.env03 140 CF (Month 6.5) | 11 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgA Ab Binding to Env Proteins | gp70-TV1.GSKvacV1V2/293F (Month 6.5) | 1 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgA Ab Binding to Env Proteins | Con 6 gp120/B (Month 12) | 3 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgA Ab Binding to Env Proteins | 96ZM651.D11gp120.avi (Month 6.5) | 12 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgA Ab Binding to Env Proteins | Con S gp140 CFI (Month 12) | 4 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgA Ab Binding to Env Proteins | gp70_B.CaseA2 V1/V2/169K (Month 6.5) | 1 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgA Ab Binding to Env Proteins | 1086C_D7gp120.avi/293F (Month 12) | 20 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgA Ab Binding to Env Proteins | 00MSA 4076 gp140 (Month 6.5) | 10 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgA Ab Binding to Env Proteins | Con 6 gp120/B (Month 6.5) | 10 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgA Ab Binding to Env Proteins | gp70_B.CaseA_V1_V2 (Month 6.5) | 0 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Occurrence of Vaccine-induced Serum IgA Ab Binding to Env Proteins | Con 6 gp120/B (Month 6.5) | 9 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Occurrence of Vaccine-induced Serum IgA Ab Binding to Env Proteins | 00MSA 4076 gp140 (Month 12) | 3 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Occurrence of Vaccine-induced Serum IgA Ab Binding to Env Proteins | C.1086C_V1_V2 Tags (Month 12) | 0 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Occurrence of Vaccine-induced Serum IgA Ab Binding to Env Proteins | 1086C_D7gp120.avi/293F (Month 12) | 17 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Occurrence of Vaccine-induced Serum IgA Ab Binding to Env Proteins | A1.con.env03 140 CF (Month 6.5) | 8 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Occurrence of Vaccine-induced Serum IgA Ab Binding to Env Proteins | 96ZM651.D11gp120.avi (Month 12) | 4 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Occurrence of Vaccine-induced Serum IgA Ab Binding to Env Proteins | 00MSA 4076 gp140 (Month 6.5) | 11 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Occurrence of Vaccine-induced Serum IgA Ab Binding to Env Proteins | AE.A244 V1V2 Tags/293F (Month 12) | 0 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Occurrence of Vaccine-induced Serum IgA Ab Binding to Env Proteins | A1.con.env03 140 CF (Month 12) | 3 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Occurrence of Vaccine-induced Serum IgA Ab Binding to Env Proteins | gp70-96ZM651.02 V1v2 (Month 12) | 0 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Occurrence of Vaccine-induced Serum IgA Ab Binding to Env Proteins | AE.A244 V1V2 Tags/293F (Month 6.5) | 0 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Occurrence of Vaccine-induced Serum IgA Ab Binding to Env Proteins | gp70_B.CaseA_V1_V2 (Month 12) | 1 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Occurrence of Vaccine-induced Serum IgA Ab Binding to Env Proteins | C.1086C_V1_V2 Tags (Month 6.5) | 1 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Occurrence of Vaccine-induced Serum IgA Ab Binding to Env Proteins | 96ZM651.D11gp120.avi (Month 6.5) | 8 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Occurrence of Vaccine-induced Serum IgA Ab Binding to Env Proteins | gp70-TV1.GSKvacV1V2/293F (Month 12) | 1 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Occurrence of Vaccine-induced Serum IgA Ab Binding to Env Proteins | gp70_B.CaseA_V1_V2 (Month 6.5) | 0 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Occurrence of Vaccine-induced Serum IgA Ab Binding to Env Proteins | gp70_B.CaseA2 V1/V2/169K (Month 12) | 0 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Occurrence of Vaccine-induced Serum IgA Ab Binding to Env Proteins | gp41 (Month 12) | 0 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Occurrence of Vaccine-induced Serum IgA Ab Binding to Env Proteins | Con S gp140 CFI (Month 6.5) | 16 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Occurrence of Vaccine-induced Serum IgA Ab Binding to Env Proteins | TV1c8_D11gp120.avi/293F (Month 6.5) | 19 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Occurrence of Vaccine-induced Serum IgA Ab Binding to Env Proteins | 1086C_D7gp120.avi/293F (Month 6.5) | 19 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Occurrence of Vaccine-induced Serum IgA Ab Binding to Env Proteins | TV1c8_D11gp120.avi/293F (Month 12) | 10 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Occurrence of Vaccine-induced Serum IgA Ab Binding to Env Proteins | gp41 (Month 6.5) | 1 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Occurrence of Vaccine-induced Serum IgA Ab Binding to Env Proteins | gp70-96ZM651.02 V1v2 (Month 6.5) | 0 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Occurrence of Vaccine-induced Serum IgA Ab Binding to Env Proteins | Con S gp140 CFI (Month 12) | 4 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Occurrence of Vaccine-induced Serum IgA Ab Binding to Env Proteins | gp70-TV1.GSKvacV1V2/293F (Month 6.5) | 0 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Occurrence of Vaccine-induced Serum IgA Ab Binding to Env Proteins | gp70_B.CaseA2 V1/V2/169K (Month 6.5) | 0 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Occurrence of Vaccine-induced Serum IgA Ab Binding to Env Proteins | Con 6 gp120/B (Month 12) | 2 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Occurrence of Vaccine-induced Serum IgA Ab Binding to Env Proteins | gp41 (Month 12) | 0 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Occurrence of Vaccine-induced Serum IgA Ab Binding to Env Proteins | 00MSA 4076 gp140 (Month 6.5) | 17 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Occurrence of Vaccine-induced Serum IgA Ab Binding to Env Proteins | 1086C_D7gp120.avi/293F (Month 6.5) | 27 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Occurrence of Vaccine-induced Serum IgA Ab Binding to Env Proteins | 96ZM651.D11gp120.avi (Month 6.5) | 22 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Occurrence of Vaccine-induced Serum IgA Ab Binding to Env Proteins | A1.con.env03 140 CF (Month 6.5) | 18 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Occurrence of Vaccine-induced Serum IgA Ab Binding to Env Proteins | AE.A244 V1V2 Tags/293F (Month 6.5) | 1 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Occurrence of Vaccine-induced Serum IgA Ab Binding to Env Proteins | C.1086C_V1_V2 Tags (Month 6.5) | 1 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Occurrence of Vaccine-induced Serum IgA Ab Binding to Env Proteins | Con 6 gp120/B (Month 6.5) | 15 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Occurrence of Vaccine-induced Serum IgA Ab Binding to Env Proteins | Con S gp140 CFI (Month 6.5) | 24 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Occurrence of Vaccine-induced Serum IgA Ab Binding to Env Proteins | TV1c8_D11gp120.avi/293F (Month 6.5) | 27 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Occurrence of Vaccine-induced Serum IgA Ab Binding to Env Proteins | gp41 (Month 6.5) | 0 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Occurrence of Vaccine-induced Serum IgA Ab Binding to Env Proteins | gp70-96ZM651.02 V1v2 (Month 6.5) | 0 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Occurrence of Vaccine-induced Serum IgA Ab Binding to Env Proteins | gp70-TV1.GSKvacV1V2/293F (Month 6.5) | 0 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Occurrence of Vaccine-induced Serum IgA Ab Binding to Env Proteins | gp70_B.CaseA2 V1/V2/169K (Month 6.5) | 0 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Occurrence of Vaccine-induced Serum IgA Ab Binding to Env Proteins | gp70_B.CaseA_V1_V2 (Month 6.5) | 0 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Occurrence of Vaccine-induced Serum IgA Ab Binding to Env Proteins | 00MSA 4076 gp140 (Month 12) | 4 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Occurrence of Vaccine-induced Serum IgA Ab Binding to Env Proteins | 1086C_D7gp120.avi/293F (Month 12) | 24 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Occurrence of Vaccine-induced Serum IgA Ab Binding to Env Proteins | 96ZM651.D11gp120.avi (Month 12) | 4 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Occurrence of Vaccine-induced Serum IgA Ab Binding to Env Proteins | A1.con.env03 140 CF (Month 12) | 5 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Occurrence of Vaccine-induced Serum IgA Ab Binding to Env Proteins | AE.A244 V1V2 Tags/293F (Month 12) | 0 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Occurrence of Vaccine-induced Serum IgA Ab Binding to Env Proteins | C.1086C_V1_V2 Tags (Month 12) | 0 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Occurrence of Vaccine-induced Serum IgA Ab Binding to Env Proteins | Con 6 gp120/B (Month 12) | 3 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Occurrence of Vaccine-induced Serum IgA Ab Binding to Env Proteins | Con S gp140 CFI (Month 12) | 7 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Occurrence of Vaccine-induced Serum IgA Ab Binding to Env Proteins | TV1c8_D11gp120.avi/293F (Month 12) | 22 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Occurrence of Vaccine-induced Serum IgA Ab Binding to Env Proteins | gp70-96ZM651.02 V1v2 (Month 12) | 0 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Occurrence of Vaccine-induced Serum IgA Ab Binding to Env Proteins | gp70-TV1.GSKvacV1V2/293F (Month 12) | 0 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Occurrence of Vaccine-induced Serum IgA Ab Binding to Env Proteins | gp70_B.CaseA2 V1/V2/169K (Month 12) | 0 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Occurrence of Vaccine-induced Serum IgA Ab Binding to Env Proteins | gp70_B.CaseA_V1_V2 (Month 12) | 0 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgA Ab Binding to Env Proteins | gp70_B.CaseA2 V1/V2/169K (Month 6.5) | 0 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgA Ab Binding to Env Proteins | 1086C_D7gp120.avi/293F (Month 6.5) | 14 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgA Ab Binding to Env Proteins | Con 6 gp120/B (Month 12) | 1 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgA Ab Binding to Env Proteins | gp70-TV1.GSKvacV1V2/293F (Month 6.5) | 0 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgA Ab Binding to Env Proteins | gp70-96ZM651.02 V1v2 (Month 6.5) | 0 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgA Ab Binding to Env Proteins | 00MSA 4076 gp140 (Month 6.5) | 5 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgA Ab Binding to Env Proteins | Con S gp140 CFI (Month 12) | 2 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgA Ab Binding to Env Proteins | gp41 (Month 6.5) | 0 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgA Ab Binding to Env Proteins | TV1c8_D11gp120.avi/293F (Month 6.5) | 11 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgA Ab Binding to Env Proteins | gp70_B.CaseA_V1_V2 (Month 12) | 0 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgA Ab Binding to Env Proteins | TV1c8_D11gp120.avi/293F (Month 12) | 5 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgA Ab Binding to Env Proteins | Con S gp140 CFI (Month 6.5) | 7 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgA Ab Binding to Env Proteins | Con 6 gp120/B (Month 6.5) | 4 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgA Ab Binding to Env Proteins | C.1086C_V1_V2 Tags (Month 6.5) | 1 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgA Ab Binding to Env Proteins | gp41 (Month 12) | 0 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgA Ab Binding to Env Proteins | AE.A244 V1V2 Tags/293F (Month 6.5) | 1 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgA Ab Binding to Env Proteins | A1.con.env03 140 CF (Month 6.5) | 6 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgA Ab Binding to Env Proteins | gp70_B.CaseA2 V1/V2/169K (Month 12) | 0 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgA Ab Binding to Env Proteins | gp70-96ZM651.02 V1v2 (Month 12) | 0 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgA Ab Binding to Env Proteins | A1.con.env03 140 CF (Month 12) | 1 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgA Ab Binding to Env Proteins | 96ZM651.D11gp120.avi (Month 12) | 1 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgA Ab Binding to Env Proteins | 96ZM651.D11gp120.avi (Month 6.5) | 4 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgA Ab Binding to Env Proteins | AE.A244 V1V2 Tags/293F (Month 12) | 0 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgA Ab Binding to Env Proteins | 1086C_D7gp120.avi/293F (Month 12) | 11 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgA Ab Binding to Env Proteins | 00MSA 4076 gp140 (Month 12) | 1 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgA Ab Binding to Env Proteins | gp70-TV1.GSKvacV1V2/293F (Month 12) | 0 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgA Ab Binding to Env Proteins | C.1086C_V1_V2 Tags (Month 12) | 0 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgA Ab Binding to Env Proteins | gp70_B.CaseA_V1_V2 (Month 6.5) | 0 Participants |
Secondary
Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins
Serum IgG3 responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay, run at 1:40 dilution. The readout is background-subtracted mean fluorescent intensity (MFI), with background adjustment for an antigen-specific plate level control. For each sample, response magnitude is net MFI, defined as experimental antigen MFI minus reference antigen MFI. Net MFI \< 1 is set to 1, and net MFI \> 22,000 is set to 22,000. Data are excluded if blood draw date was outside the allowable window, a participant was HIV-infected, reference antigen \> 5,000 MFI, or baseline net MFI \> 6,500. Samples from post-enrollment visits have positive responses if they meet three criteria: (1) net MFI greater than or equal to an antigen-specific response threshold (defined as the maximum of 100 and the 95th percentile of baseline net MFI), (2) net MFI values are greater than 3 times baseline net MFI, and (3) experimental antigen MFI values are greater than 3 times baseline MFI.
Time frame: Measured at Months 12.5 and 18.
Population: Overall Number of Participants Analyzed represents the number of enrolled participants with available specimens. Number Analyzed shows the number of HIV uninfected participants with available BAMA data after filtering for assay specific quality control criteria at each timepoint.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | gp70_B.CaseA2 V1/V2/169K (Month 12.5) | 1 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | Con S gp140 CFI (Month 12.5) | 18 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | TV1c8_D11gp120.avi/293F (Month 12.5) | 25 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | gp41 (Month 12.5) | 0 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | gp70-96ZM651.02 V1v2 (Month 12.5) | 3 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | gp70-TV1.GSKvacV1V2/293F (Month 12.5) | 2 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | gp70_B.CaseA_V1_V2 (Month 12.5) | 1 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | 1086C_D7gp120.avi/293F (Month 18) | 11 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | 96ZM651.D11gp120.avi (Month 18) | 0 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | AE.A244 V1V2 Tags/293F (Month 18) | 1 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | C.1086C_V1_V2 Tags (Month 18) | 0 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | Con 6 gp120/B (Month 18) | 0 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | Con S gp140 CFI (Month 18) | 4 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | TV1c8_D11gp120.avi/293F (Month 18) | 6 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | gp41 (Month 18) | 0 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | gp70-96ZM651.02 V1v2 (Month 18) | 1 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | gp70-TV1.GSKvacV1V2/293F (Month 18) | 1 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | gp70_B.CaseA2 V1/V2/169K (Month 18) | 1 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | gp70_B.CaseA_V1_V2 (Month 18) | 1 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | 96ZM651.D11gp120.avi (Month 12.5) | 14 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | 1086C_D7gp120.avi/293F (Month 12.5) | 28 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | AE.A244 V1V2 Tags/293F (Month 12.5) | 6 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | C.1086C_V1_V2 Tags (Month 12.5) | 4 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | Con 6 gp120/B (Month 12.5) | 6 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | 1086C_D7gp120.avi/293F (Month 12.5) | 28 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | gp70_B.CaseA2 V1/V2/169K (Month 12.5) | 2 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | gp70_B.CaseA_V1_V2 (Month 12.5) | 2 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | 1086C_D7gp120.avi/293F (Month 18) | 16 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | 96ZM651.D11gp120.avi (Month 18) | 0 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | AE.A244 V1V2 Tags/293F (Month 18) | 0 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | 96ZM651.D11gp120.avi (Month 12.5) | 17 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | C.1086C_V1_V2 Tags (Month 18) | 0 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | Con 6 gp120/B (Month 18) | 0 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | Con S gp140 CFI (Month 18) | 4 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | TV1c8_D11gp120.avi/293F (Month 18) | 6 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | AE.A244 V1V2 Tags/293F (Month 12.5) | 9 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | gp41 (Month 18) | 0 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | gp70-96ZM651.02 V1v2 (Month 18) | 0 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | gp70-TV1.GSKvacV1V2/293F (Month 18) | 0 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | Con 6 gp120/B (Month 12.5) | 10 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | gp70_B.CaseA2 V1/V2/169K (Month 18) | 0 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | Con S gp140 CFI (Month 12.5) | 21 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | TV1c8_D11gp120.avi/293F (Month 12.5) | 25 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | gp41 (Month 12.5) | 0 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | C.1086C_V1_V2 Tags (Month 12.5) | 7 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | gp70-96ZM651.02 V1v2 (Month 12.5) | 3 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | gp70_B.CaseA_V1_V2 (Month 18) | 0 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | gp70-TV1.GSKvacV1V2/293F (Month 12.5) | 2 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | 96ZM651.D11gp120.avi (Month 12.5) | 14 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | gp70_B.CaseA2 V1/V2/169K (Month 18) | 1 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | Con 6 gp120/B (Month 18) | 1 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | gp70-96ZM651.02 V1v2 (Month 12.5) | 5 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | Con S gp140 CFI (Month 18) | 0 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | Con 6 gp120/B (Month 12.5) | 5 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | TV1c8_D11gp120.avi/293F (Month 12.5) | 28 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | TV1c8_D11gp120.avi/293F (Month 18) | 4 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | gp41 (Month 18) | 0 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | AE.A244 V1V2 Tags/293F (Month 12.5) | 13 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | gp70-96ZM651.02 V1v2 (Month 18) | 2 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | gp41 (Month 12.5) | 0 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | gp70-TV1.GSKvacV1V2/293F (Month 18) | 1 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | 1086C_D7gp120.avi/293F (Month 12.5) | 29 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | gp70_B.CaseA2 V1/V2/169K (Month 12.5) | 7 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | gp70_B.CaseA_V1_V2 (Month 18) | 0 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | gp70_B.CaseA_V1_V2 (Month 12.5) | 4 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | 1086C_D7gp120.avi/293F (Month 18) | 15 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | C.1086C_V1_V2 Tags (Month 12.5) | 10 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | gp70-TV1.GSKvacV1V2/293F (Month 12.5) | 8 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | 96ZM651.D11gp120.avi (Month 18) | 0 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | AE.A244 V1V2 Tags/293F (Month 18) | 5 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | Con S gp140 CFI (Month 12.5) | 19 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | C.1086C_V1_V2 Tags (Month 18) | 0 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | gp41 (Month 12.5) | 1 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | AE.A244 V1V2 Tags/293F (Month 18) | 0 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | C.1086C_V1_V2 Tags (Month 18) | 0 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | Con 6 gp120/B (Month 18) | 0 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | 96ZM651.D11gp120.avi (Month 12.5) | 8 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | gp70_B.CaseA2 V1/V2/169K (Month 12.5) | 0 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | 96ZM651.D11gp120.avi (Month 18) | 0 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | Con S gp140 CFI (Month 18) | 0 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | 1086C_D7gp120.avi/293F (Month 12.5) | 15 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | C.1086C_V1_V2 Tags (Month 12.5) | 1 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | gp70_B.CaseA_V1_V2 (Month 12.5) | 0 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | TV1c8_D11gp120.avi/293F (Month 18) | 2 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | TV1c8_D11gp120.avi/293F (Month 12.5) | 13 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | gp70_B.CaseA2 V1/V2/169K (Month 18) | 0 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | gp70_B.CaseA_V1_V2 (Month 18) | 0 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | gp41 (Month 18) | 2 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | Con 6 gp120/B (Month 12.5) | 4 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | gp70-96ZM651.02 V1v2 (Month 12.5) | 1 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | gp70-TV1.GSKvacV1V2/293F (Month 12.5) | 0 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | gp70-96ZM651.02 V1v2 (Month 18) | 0 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | AE.A244 V1V2 Tags/293F (Month 12.5) | 4 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | 1086C_D7gp120.avi/293F (Month 18) | 4 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | Con S gp140 CFI (Month 12.5) | 10 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | gp70-TV1.GSKvacV1V2/293F (Month 18) | 0 Participants |
Secondary
Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins
Serum IgG3 responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay, run at 1:40 dilution. The readout is background-subtracted mean fluorescent intensity (MFI), with background adjustment for an antigen-specific plate level control. For each sample, response magnitude is net MFI, defined as experimental antigen MFI minus reference antigen MFI. Net MFI \< 1 is set to 1, and net MFI \> 22,000 is set to 22,000. Data are excluded if blood draw date was outside the allowable window, a participant was HIV-infected, reference antigen \> 5,000 MFI, or baseline net MFI \> 6,500. Samples from post-enrollment visits have positive responses if they meet three criteria: (1) net MFI greater than or equal to an antigen-specific response threshold (defined as the maximum of 100 and the 95th percentile of baseline net MFI), (2) net MFI values are greater than 3 times baseline net MFI, and (3) experimental antigen MFI values are greater than 3 times baseline MFI.
Time frame: Measured at Months 6.5 and 12.
Population: Overall Number of Participants Analyzed represents the number of enrolled participants with available specimens. Number Analyzed shows the number of HIV uninfected participants with available BAMA data after filtering for assay specific quality control criteria at each timepoint.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | gp70-96ZM651.02 V1v2 (Month 18) | 1 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | gp70_B.CaseA_V1_V2 (Month 12) | 1 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | 1086C_D7gp120.avi/293F (Month 12.5) | 28 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | Con 6 gp120/B (Month 6.5) | 19 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | 96ZM651.D11gp120.avi (Month 12.5) | 14 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | gp70_B.CaseA_V1_V2 (Month 12.5) | 1 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | AE.A244 V1V2 Tags/293F (Month 12.5) | 6 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | C.1086C_V1_V2 Tags (Month 12.5) | 4 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | gp70_B.CaseA2 V1/V2/169K (Month 12.5) | 1 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | Con 6 gp120/B (Month 12.5) | 6 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | Con S gp140 CFI (Month 12.5) | 18 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | Con S gp140 CFI (Month 6.5) | 28 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | gp70-TV1.GSKvacV1V2/293F (Month 12.5) | 2 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | TV1c8_D11gp120.avi/293F (Month 12.5) | 25 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | gp41 (Month 12.5) | 0 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | gp70_B.CaseA2 V1/V2/169K (Month 18) | 1 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | gp70-96ZM651.02 V1v2 (Month 12.5) | 3 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | gp41 (Month 18) | 0 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | TV1c8_D11gp120.avi/293F (Month 6.5) | 27 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | gp41 (Month 6.5) | 0 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | TV1c8_D11gp120.avi/293F (Month 18) | 6 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | gp70-96ZM651.02 V1v2 (Month 6.5) | 2 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | 1086C_D7gp120.avi/293F (Month 6.5) | 28 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | gp70-TV1.GSKvacV1V2/293F (Month 6.5) | 3 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | gp70_B.CaseA2 V1/V2/169K (Month 6.5) | 3 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | Con S gp140 CFI (Month 18) | 4 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | gp70_B.CaseA_V1_V2 (Month 6.5) | 2 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | 1086C_D7gp120.avi/293F (Month 12) | 11 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | 96ZM651.D11gp120.avi (Month 6.5) | 27 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | Con 6 gp120/B (Month 18) | 0 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | 96ZM651.D11gp120.avi (Month 12) | 0 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | AE.A244 V1V2 Tags/293F (Month 12) | 1 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | gp70-96ZM651.02 V1v2 (Month 12) | 1 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | C.1086C_V1_V2 Tags (Month 18) | 0 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | C.1086C_V1_V2 Tags (Month 12) | 0 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | gp70-TV1.GSKvacV1V2/293F (Month 18) | 1 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | Con 6 gp120/B (Month 12) | 0 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | AE.A244 V1V2 Tags/293F (Month 18) | 1 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | Con S gp140 CFI (Month 12) | 1 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | gp70_B.CaseA_V1_V2 (Month 18) | 1 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | TV1c8_D11gp120.avi/293F (Month 12) | 3 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | 96ZM651.D11gp120.avi (Month 18) | 0 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | gp41 (Month 12) | 0 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | C.1086C_V1_V2 Tags (Month 6.5) | 9 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | 1086C_D7gp120.avi/293F (Month 18) | 11 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | gp70-TV1.GSKvacV1V2/293F (Month 12) | 1 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | AE.A244 V1V2 Tags/293F (Month 6.5) | 9 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | gp70_B.CaseA2 V1/V2/169K (Month 12) | 1 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | gp70_B.CaseA2 V1/V2/169K (Month 12) | 1 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | gp70_B.CaseA2 V1/V2/169K (Month 6.5) | 3 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | gp41 (Month 12) | 0 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | 1086C_D7gp120.avi/293F (Month 12.5) | 28 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | Con 6 gp120/B (Month 12) | 0 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | gp70_B.CaseA_V1_V2 (Month 12.5) | 2 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | AE.A244 V1V2 Tags/293F (Month 6.5) | 13 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | 96ZM651.D11gp120.avi (Month 12.5) | 17 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | Con 6 gp120/B (Month 6.5) | 22 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | gp70_B.CaseA_V1_V2 (Month 6.5) | 2 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | gp70-TV1.GSKvacV1V2/293F (Month 18) | 0 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | AE.A244 V1V2 Tags/293F (Month 12.5) | 9 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | gp70_B.CaseA2 V1/V2/169K (Month 12.5) | 2 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | Con 6 gp120/B (Month 18) | 0 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | C.1086C_V1_V2 Tags (Month 12.5) | 7 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | gp70-96ZM651.02 V1v2 (Month 6.5) | 3 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | gp70-TV1.GSKvacV1V2/293F (Month 12) | 0 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | 1086C_D7gp120.avi/293F (Month 12) | 16 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | Con 6 gp120/B (Month 12.5) | 10 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | gp41 (Month 18) | 0 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | gp70-TV1.GSKvacV1V2/293F (Month 12.5) | 2 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | 1086C_D7gp120.avi/293F (Month 18) | 16 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | Con S gp140 CFI (Month 12.5) | 21 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | Con S gp140 CFI (Month 12) | 2 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | gp70-96ZM651.02 V1v2 (Month 12) | 0 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | 96ZM651.D11gp120.avi (Month 12) | 2 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | TV1c8_D11gp120.avi/293F (Month 12.5) | 25 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | Con S gp140 CFI (Month 6.5) | 27 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | gp70-96ZM651.02 V1v2 (Month 12.5) | 3 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | 96ZM651.D11gp120.avi (Month 6.5) | 24 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | gp41 (Month 12.5) | 0 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | C.1086C_V1_V2 Tags (Month 18) | 0 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | 96ZM651.D11gp120.avi (Month 18) | 0 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | AE.A244 V1V2 Tags/293F (Month 12) | 0 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | C.1086C_V1_V2 Tags (Month 6.5) | 12 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | TV1c8_D11gp120.avi/293F (Month 6.5) | 26 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | gp70_B.CaseA_V1_V2 (Month 18) | 0 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | TV1c8_D11gp120.avi/293F (Month 18) | 6 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | TV1c8_D11gp120.avi/293F (Month 12) | 3 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | gp41 (Month 6.5) | 0 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | gp70_B.CaseA2 V1/V2/169K (Month 18) | 0 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | gp70-96ZM651.02 V1v2 (Month 18) | 0 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | C.1086C_V1_V2 Tags (Month 12) | 0 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | gp70_B.CaseA_V1_V2 (Month 12) | 0 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | AE.A244 V1V2 Tags/293F (Month 18) | 0 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | gp70-TV1.GSKvacV1V2/293F (Month 6.5) | 3 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | 1086C_D7gp120.avi/293F (Month 6.5) | 27 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | Con S gp140 CFI (Month 18) | 4 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | gp70_B.CaseA_V1_V2 (Month 12.5) | 4 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | gp70_B.CaseA_V1_V2 (Month 12) | 0 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | AE.A244 V1V2 Tags/293F (Month 12.5) | 13 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | 1086C_D7gp120.avi/293F (Month 6.5) | 30 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | 96ZM651.D11gp120.avi (Month 6.5) | 26 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | AE.A244 V1V2 Tags/293F (Month 6.5) | 14 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | C.1086C_V1_V2 Tags (Month 6.5) | 13 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | Con 6 gp120/B (Month 6.5) | 18 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | Con S gp140 CFI (Month 6.5) | 25 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | TV1c8_D11gp120.avi/293F (Month 6.5) | 29 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | gp41 (Month 6.5) | 0 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | gp70-96ZM651.02 V1v2 (Month 6.5) | 7 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | gp70-TV1.GSKvacV1V2/293F (Month 6.5) | 10 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | gp70_B.CaseA2 V1/V2/169K (Month 6.5) | 7 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | gp70_B.CaseA_V1_V2 (Month 6.5) | 7 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | 1086C_D7gp120.avi/293F (Month 12) | 17 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | 96ZM651.D11gp120.avi (Month 12) | 0 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | AE.A244 V1V2 Tags/293F (Month 12) | 2 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | C.1086C_V1_V2 Tags (Month 12) | 0 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | Con 6 gp120/B (Month 12) | 0 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | Con S gp140 CFI (Month 12) | 1 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | TV1c8_D11gp120.avi/293F (Month 12) | 5 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | gp41 (Month 12) | 0 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | gp70-96ZM651.02 V1v2 (Month 12) | 1 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | gp70-TV1.GSKvacV1V2/293F (Month 12) | 1 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | gp70_B.CaseA2 V1/V2/169K (Month 12) | 0 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | 1086C_D7gp120.avi/293F (Month 12.5) | 29 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | 96ZM651.D11gp120.avi (Month 12.5) | 14 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | C.1086C_V1_V2 Tags (Month 12.5) | 10 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | Con 6 gp120/B (Month 12.5) | 5 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | Con S gp140 CFI (Month 12.5) | 19 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | TV1c8_D11gp120.avi/293F (Month 12.5) | 28 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | gp41 (Month 12.5) | 0 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | gp70-96ZM651.02 V1v2 (Month 12.5) | 5 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | gp70-TV1.GSKvacV1V2/293F (Month 12.5) | 8 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | gp70_B.CaseA2 V1/V2/169K (Month 12.5) | 7 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | 1086C_D7gp120.avi/293F (Month 18) | 15 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | 96ZM651.D11gp120.avi (Month 18) | 0 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | AE.A244 V1V2 Tags/293F (Month 18) | 5 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | C.1086C_V1_V2 Tags (Month 18) | 0 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | Con 6 gp120/B (Month 18) | 1 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | Con S gp140 CFI (Month 18) | 0 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | TV1c8_D11gp120.avi/293F (Month 18) | 4 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | gp41 (Month 18) | 0 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | gp70-96ZM651.02 V1v2 (Month 18) | 2 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | gp70-TV1.GSKvacV1V2/293F (Month 18) | 1 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | gp70_B.CaseA2 V1/V2/169K (Month 18) | 1 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | gp70_B.CaseA_V1_V2 (Month 18) | 0 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | gp70_B.CaseA_V1_V2 (Month 12.5) | 0 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | gp70-96ZM651.02 V1v2 (Month 12) | 0 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | gp41 (Month 12) | 0 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | gp70-96ZM651.02 V1v2 (Month 18) | 0 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | 1086C_D7gp120.avi/293F (Month 18) | 4 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | TV1c8_D11gp120.avi/293F (Month 12) | 2 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | Con S gp140 CFI (Month 12) | 0 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | 96ZM651.D11gp120.avi (Month 6.5) | 16 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | 96ZM651.D11gp120.avi (Month 18) | 0 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | Con 6 gp120/B (Month 12) | 0 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | C.1086C_V1_V2 Tags (Month 12) | 0 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | 1086C_D7gp120.avi/293F (Month 6.5) | 18 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | AE.A244 V1V2 Tags/293F (Month 18) | 0 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | AE.A244 V1V2 Tags/293F (Month 12) | 0 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | 96ZM651.D11gp120.avi (Month 12) | 0 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | gp70-96ZM651.02 V1v2 (Month 6.5) | 0 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | C.1086C_V1_V2 Tags (Month 18) | 0 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | 1086C_D7gp120.avi/293F (Month 12) | 8 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | gp70_B.CaseA_V1_V2 (Month 6.5) | 0 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | gp70-TV1.GSKvacV1V2/293F (Month 18) | 0 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | Con 6 gp120/B (Month 18) | 0 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | gp70_B.CaseA2 V1/V2/169K (Month 6.5) | 0 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | gp70-TV1.GSKvacV1V2/293F (Month 6.5) | 0 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | gp70_B.CaseA_V1_V2 (Month 12) | 0 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | Con S gp140 CFI (Month 18) | 0 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | gp41 (Month 6.5) | 0 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | TV1c8_D11gp120.avi/293F (Month 6.5) | 17 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | gp70_B.CaseA_V1_V2 (Month 18) | 0 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | TV1c8_D11gp120.avi/293F (Month 18) | 2 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | Con S gp140 CFI (Month 6.5) | 17 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | Con 6 gp120/B (Month 6.5) | 15 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | gp70_B.CaseA2 V1/V2/169K (Month 18) | 0 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | gp41 (Month 18) | 2 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | gp41 (Month 12.5) | 1 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | TV1c8_D11gp120.avi/293F (Month 12.5) | 13 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | C.1086C_V1_V2 Tags (Month 6.5) | 2 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | gp70-96ZM651.02 V1v2 (Month 12.5) | 1 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | Con S gp140 CFI (Month 12.5) | 10 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | Con 6 gp120/B (Month 12.5) | 4 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | AE.A244 V1V2 Tags/293F (Month 6.5) | 3 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | gp70-TV1.GSKvacV1V2/293F (Month 12.5) | 0 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | C.1086C_V1_V2 Tags (Month 12.5) | 1 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | AE.A244 V1V2 Tags/293F (Month 12.5) | 4 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | gp70_B.CaseA2 V1/V2/169K (Month 12) | 0 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | gp70_B.CaseA2 V1/V2/169K (Month 12.5) | 0 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | 96ZM651.D11gp120.avi (Month 12.5) | 8 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | 1086C_D7gp120.avi/293F (Month 12.5) | 15 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG3 Ab Binding to Env Proteins | gp70-TV1.GSKvacV1V2/293F (Month 12) | 0 Participants |
Secondary
Occurrence of Vaccine-induced Serum IgG Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C)
Serum IgG responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay, run at 1:50 dilution. The readout is background-subtracted mean fluorescent intensity (MFI), with background adjustment for an antigen-specific plate level control. For each sample, response magnitude is net MFI, defined as experimental antigen MFI minus reference antigen MFI. Net MFI \< 1 is set to 1, and net MFI \> 22,000 is set to 22,000. Data are excluded if blood draw date was outside the allowable window, a participant was HIV-infected, reference antigen \> 5,000 MFI, or baseline net MFI \> 6,500. Samples from post-enrollment visits have positive responses if they meet three criteria: (1) net MFI greater than or equal to an antigen-specific response threshold (defined as the maximum of 100 and the 95th percentile of baseline net MFI), (2) net MFI values are greater than 3 times baseline net MFI, and (3) experimental antigen MFI values are greater than 3 times baseline MFI.
Time frame: Measured at Months 12.5 and 18.
Population: Overall Number of Participants Analyzed represents the number of enrolled participants with available specimens. Number Analyzed shows the number of HIV uninfected participants with available BAMA data after filtering for assay specific quality control criteria at each timepoint.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C) | 96ZM651.D11gp120.avi (Month 18) | 17 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C) | TV1c8_D11gp120.avi/293F (Month 18) | 26 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C) | 1086C_D7gp120.avi/293F (Month 12.5) | 30 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C) | TV1c8_D11gp120.avi/293F (Month 12.5) | 28 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C) | 96ZM651.D11gp120.avi (Month 12.5) | 26 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C) | 1086C_D7gp120.avi/293F (Month 18) | 27 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C) | 1086C_D7gp120.avi/293F (Month 12.5) | 27 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C) | 1086C_D7gp120.avi/293F (Month 18) | 27 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C) | 96ZM651.D11gp120.avi (Month 12.5) | 28 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C) | 96ZM651.D11gp120.avi (Month 18) | 22 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C) | TV1c8_D11gp120.avi/293F (Month 12.5) | 28 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C) | TV1c8_D11gp120.avi/293F (Month 18) | 28 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C) | TV1c8_D11gp120.avi/293F (Month 12.5) | 29 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C) | 1086C_D7gp120.avi/293F (Month 18) | 32 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C) | 1086C_D7gp120.avi/293F (Month 12.5) | 31 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C) | 96ZM651.D11gp120.avi (Month 18) | 28 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C) | TV1c8_D11gp120.avi/293F (Month 18) | 30 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C) | 96ZM651.D11gp120.avi (Month 12.5) | 30 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C) | TV1c8_D11gp120.avi/293F (Month 18) | 15 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C) | 1086C_D7gp120.avi/293F (Month 12.5) | 16 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C) | 1086C_D7gp120.avi/293F (Month 18) | 16 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C) | 96ZM651.D11gp120.avi (Month 18) | 7 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C) | 96ZM651.D11gp120.avi (Month 12.5) | 15 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C) | TV1c8_D11gp120.avi/293F (Month 12.5) | 15 Participants |
Secondary
Occurrence of Vaccine-induced Serum IgG Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C)
Serum IgG responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay, run at 1:50 dilution. The readout is background-subtracted mean fluorescent intensity (MFI), with background adjustment for an antigen-specific plate level control. For each sample, response magnitude is net MFI, defined as experimental antigen MFI minus reference antigen MFI. Net MFI \< 1 is set to 1, and net MFI \> 22,000 is set to 22,000. Data are excluded if blood draw date was outside the allowable window, a participant was HIV-infected, reference antigen \> 5,000 MFI, or baseline net MFI \> 6,500. Samples from post-enrollment visits have positive responses if they meet three criteria: (1) net MFI greater than or equal to an antigen-specific response threshold (defined as the maximum of 100 and the 95th percentile of baseline net MFI), (2) net MFI values are greater than 3 times baseline net MFI, and (3) experimental antigen MFI values are greater than 3 times baseline MFI.
Time frame: Measured at Months 6.5 and 12.
Population: Overall Number of Participants Analyzed represents the number of enrolled participants with available specimens. Number Analyzed shows the number of HIV uninfected participants with available BAMA data after filtering for assay specific quality control criteria at each timepoint.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C) | 1086C_D7gp120.avi/293F (Month 6.5) | 29 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C) | 1086C_D7gp120.avi/293F (Month 12) | 29 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C) | TV1c8_D11gp120.avi/293F (Month 12) | 25 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C) | 96ZM651.D11gp120.avi (Month 12) | 7 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C) | 96ZM651.D11gp120.avi (Month 6.5) | 27 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C) | TV1c8_D11gp120.avi/293F (Month 6.5) | 29 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C) | 96ZM651.D11gp120.avi (Month 6.5) | 27 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C) | TV1c8_D11gp120.avi/293F (Month 6.5) | 27 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C) | TV1c8_D11gp120.avi/293F (Month 12) | 22 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C) | 96ZM651.D11gp120.avi (Month 12) | 5 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C) | 1086C_D7gp120.avi/293F (Month 6.5) | 26 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C) | 1086C_D7gp120.avi/293F (Month 12) | 26 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C) | TV1c8_D11gp120.avi/293F (Month 12) | 29 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C) | 96ZM651.D11gp120.avi (Month 6.5) | 30 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C) | 96ZM651.D11gp120.avi (Month 12) | 25 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C) | 1086C_D7gp120.avi/293F (Month 6.5) | 32 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C) | TV1c8_D11gp120.avi/293F (Month 6.5) | 32 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C) | 1086C_D7gp120.avi/293F (Month 12) | 29 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C) | TV1c8_D11gp120.avi/293F (Month 6.5) | 17 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C) | 1086C_D7gp120.avi/293F (Month 6.5) | 17 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C) | TV1c8_D11gp120.avi/293F (Month 12) | 12 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C) | 96ZM651.D11gp120.avi (Month 12) | 1 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C) | 1086C_D7gp120.avi/293F (Month 12) | 17 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C) | 96ZM651.D11gp120.avi (Month 6.5) | 17 Participants |
Secondary
Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins
Serum IgG responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay, run at 1:50 dilution. The readout is background-subtracted mean fluorescent intensity (MFI), with background adjustment for an antigen-specific plate level control. For each sample, response magnitude is net MFI, defined as experimental antigen MFI minus reference antigen MFI. Net MFI \< 1 is set to 1, and net MFI \> 22,000 is set to 22,000. Data are excluded if blood draw date was outside the allowable window, a participant was HIV-infected, reference antigen \> 5,000 MFI, or baseline net MFI \> 6,500. Samples from post-enrollment visits have positive responses if they meet three criteria: (1) net MFI greater than or equal to an antigen-specific response threshold (defined as the maximum of 100 and the 95th percentile of baseline net MFI), (2) net MFI values are greater than 3 times baseline net MFI, and (3) experimental antigen MFI values are greater than 3 times baseline MFI.
Time frame: Measured at Months 6.5 and 12.
Population: Overall Number of Participants Analyzed represents the number of enrolled participants with available specimens. Number Analyzed shows the number of HIV uninfected participants with available BAMA data after filtering for assay specific quality control criteria at each timepoint.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | gp70_B.CaseA_V1_V2 (Month 12) | 1 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | Con S gp140 CFI (Month 6.5) | 29 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | 00MSA 4076 gp140 (Month 6.5) | 27 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | A1.con.env03 140 CF (Month 6.5) | 27 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | C.1086C_V1_V2 Tags (Month 12) | 0 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | Con 6 gp120/B (Month 6.5) | 26 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | C.1086C_V1_V2 Tags (Month 6.5) | 14 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | AE.A244 V1V2 Tags/293F (Month 6.5) | 22 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | AE.A244 V1V2 Tags/293F (Month 12) | 4 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | 00MSA 4076 gp140 (Month 12) | 4 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | gp70_B.CaseA_V1_V2 (Month 6.5) | 9 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | A1.con.env03 140 CF (Month 12) | 15 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | gp70_B.CaseA2 V1/V2/169K (Month 6.5) | 10 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | gp70_B.CaseA2 V1/V2/169K (Month 12) | 1 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | gp70-TV1.GSKvacV1V2/293F (Month 12) | 1 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | gp41 (Month 12) | 0 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | Con S gp140 CFI (Month 12) | 22 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | gp70-96ZM651.02 V1v2 (Month 12) | 0 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | gp70-TV1.GSKvacV1V2/293F (Month 6.5) | 17 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | Con 6 gp120/B (Month 12) | 3 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | gp70-96ZM651.02 V1v2 (Month 6.5) | 8 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | gp41 (Month 6.5) | 0 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | gp70_B.CaseA_V1_V2 (Month 12) | 1 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | gp70_B.CaseA2 V1/V2/169K (Month 6.5) | 14 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | Con 6 gp120/B (Month 12) | 1 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | Con S gp140 CFI (Month 12) | 25 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | gp41 (Month 12) | 0 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | gp70-TV1.GSKvacV1V2/293F (Month 12) | 2 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | 00MSA 4076 gp140 (Month 6.5) | 27 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | A1.con.env03 140 CF (Month 6.5) | 27 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | AE.A244 V1V2 Tags/293F (Month 6.5) | 23 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | C.1086C_V1_V2 Tags (Month 6.5) | 13 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | Con 6 gp120/B (Month 6.5) | 26 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | Con S gp140 CFI (Month 6.5) | 27 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | gp41 (Month 6.5) | 1 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | gp70-96ZM651.02 V1v2 (Month 6.5) | 13 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | gp70-TV1.GSKvacV1V2/293F (Month 6.5) | 15 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | gp70_B.CaseA_V1_V2 (Month 6.5) | 13 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | 00MSA 4076 gp140 (Month 12) | 1 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | A1.con.env03 140 CF (Month 12) | 14 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | AE.A244 V1V2 Tags/293F (Month 12) | 6 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | C.1086C_V1_V2 Tags (Month 12) | 0 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | gp70-96ZM651.02 V1v2 (Month 12) | 1 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | gp70_B.CaseA2 V1/V2/169K (Month 12) | 2 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | AE.A244 V1V2 Tags/293F (Month 12) | 6 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | gp70-96ZM651.02 V1v2 (Month 12) | 2 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | gp70_B.CaseA2 V1/V2/169K (Month 6.5) | 24 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | gp41 (Month 6.5) | 0 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | C.1086C_V1_V2 Tags (Month 12) | 0 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | gp70_B.CaseA_V1_V2 (Month 6.5) | 25 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | Con 6 gp120/B (Month 12) | 14 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | 00MSA 4076 gp140 (Month 12) | 12 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | Con 6 gp120/B (Month 6.5) | 29 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | AE.A244 V1V2 Tags/293F (Month 6.5) | 28 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | gp70-TV1.GSKvacV1V2/293F (Month 12) | 6 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | gp70-TV1.GSKvacV1V2/293F (Month 6.5) | 26 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | Con S gp140 CFI (Month 12) | 30 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | C.1086C_V1_V2 Tags (Month 6.5) | 16 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | A1.con.env03 140 CF (Month 6.5) | 31 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | A1.con.env03 140 CF (Month 12) | 25 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | gp70_B.CaseA2 V1/V2/169K (Month 12) | 3 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | gp70_B.CaseA_V1_V2 (Month 12) | 4 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | gp41 (Month 12) | 0 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | Con S gp140 CFI (Month 6.5) | 32 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | 00MSA 4076 gp140 (Month 6.5) | 30 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | gp70-96ZM651.02 V1v2 (Month 6.5) | 19 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | gp70_B.CaseA2 V1/V2/169K (Month 12) | 0 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | gp41 (Month 6.5) | 0 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | gp70-96ZM651.02 V1v2 (Month 12) | 0 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | gp70-TV1.GSKvacV1V2/293F (Month 6.5) | 4 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | C.1086C_V1_V2 Tags (Month 12) | 1 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | gp70_B.CaseA2 V1/V2/169K (Month 6.5) | 4 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | 00MSA 4076 gp140 (Month 12) | 1 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | C.1086C_V1_V2 Tags (Month 6.5) | 2 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | gp70-TV1.GSKvacV1V2/293F (Month 12) | 1 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | A1.con.env03 140 CF (Month 12) | 5 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | gp70_B.CaseA_V1_V2 (Month 6.5) | 3 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | 00MSA 4076 gp140 (Month 6.5) | 15 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | AE.A244 V1V2 Tags/293F (Month 12) | 1 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | gp70_B.CaseA_V1_V2 (Month 12) | 0 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | gp70-96ZM651.02 V1v2 (Month 6.5) | 4 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | Con 6 gp120/B (Month 12) | 1 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | AE.A244 V1V2 Tags/293F (Month 6.5) | 11 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | A1.con.env03 140 CF (Month 6.5) | 17 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | Con S gp140 CFI (Month 12) | 13 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | Con 6 gp120/B (Month 6.5) | 17 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | Con S gp140 CFI (Month 6.5) | 17 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | gp41 (Month 12) | 1 Participants |
Secondary
Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins
Serum IgG responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay, run at 1:50 dilution. The readout is background-subtracted mean fluorescent intensity (MFI), with background adjustment for an antigen-specific plate level control. For each sample, response magnitude is net MFI, defined as experimental antigen MFI minus reference antigen MFI. Net MFI \< 1 is set to 1, and net MFI \> 22,000 is set to 22,000. Data are excluded if blood draw date was outside the allowable window, a participant was HIV-infected, reference antigen \> 5,000 MFI, or baseline net MFI \> 6,500. Samples from post-enrollment visits have positive responses if they meet three criteria: (1) net MFI greater than or equal to an antigen-specific response threshold (defined as the maximum of 100 and the 95th percentile of baseline net MFI), (2) net MFI values are greater than 3 times baseline net MFI, and (3) experimental antigen MFI values are greater than 3 times baseline MFI.
Time frame: Measured at Months 12.5 and 18.
Population: Overall Number of Participants Analyzed represents the number of enrolled participants with available specimens. Number Analyzed shows the number of HIV uninfected participants with available BAMA data after filtering for assay specific quality control criteria at each timepoint.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | C.1086C_V1_V2 Tags (Month 12.5) | 19 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | 00MSA 4076 gp140 (Month 12.5) | 26 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | A1.con.env03 140 CF (Month 12.5) | 27 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | AE.A244 V1V2 Tags/293F (Month 12.5) | 21 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | Con 6 gp120/B (Month 12.5) | 26 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | Con S gp140 CFI (Month 12.5) | 28 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | gp41 (Month 12.5) | 0 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | gp70-96ZM651.02 V1v2 (Month 12.5) | 10 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | gp70-TV1.GSKvacV1V2/293F (Month 12.5) | 16 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | gp70_B.CaseA2 V1/V2/169K (Month 12.5) | 12 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | gp70_B.CaseA_V1_V2 (Month 12.5) | 11 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | 00MSA 4076 gp140 (Month 18) | 11 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | A1.con.env03 140 CF (Month 18) | 23 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | AE.A244 V1V2 Tags/293F (Month 18) | 5 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | C.1086C_V1_V2 Tags (Month 18) | 1 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | Con 6 gp120/B (Month 18) | 13 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | Con S gp140 CFI (Month 18) | 25 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | gp41 (Month 18) | 0 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | gp70-96ZM651.02 V1v2 (Month 18) | 1 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | gp70-TV1.GSKvacV1V2/293F (Month 18) | 4 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | gp70_B.CaseA2 V1/V2/169K (Month 18) | 1 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | gp70_B.CaseA_V1_V2 (Month 18) | 1 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | gp41 (Month 18) | 1 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | gp70_B.CaseA2 V1/V2/169K (Month 12.5) | 22 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | Con S gp140 CFI (Month 18) | 28 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | A1.con.env03 140 CF (Month 18) | 26 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | Con S gp140 CFI (Month 12.5) | 28 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | gp70_B.CaseA_V1_V2 (Month 12.5) | 20 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | C.1086C_V1_V2 Tags (Month 18) | 3 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | AE.A244 V1V2 Tags/293F (Month 18) | 9 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | 00MSA 4076 gp140 (Month 18) | 12 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | A1.con.env03 140 CF (Month 12.5) | 28 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | AE.A244 V1V2 Tags/293F (Month 12.5) | 27 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | gp41 (Month 12.5) | 0 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | gp70_B.CaseA_V1_V2 (Month 18) | 2 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | 00MSA 4076 gp140 (Month 12.5) | 28 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | Con 6 gp120/B (Month 18) | 17 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | gp70-96ZM651.02 V1v2 (Month 12.5) | 18 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | Con 6 gp120/B (Month 12.5) | 28 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | gp70-TV1.GSKvacV1V2/293F (Month 18) | 10 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | gp70_B.CaseA2 V1/V2/169K (Month 18) | 3 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | gp70-TV1.GSKvacV1V2/293F (Month 12.5) | 25 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | C.1086C_V1_V2 Tags (Month 12.5) | 21 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | gp70-96ZM651.02 V1v2 (Month 18) | 3 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | AE.A244 V1V2 Tags/293F (Month 12.5) | 27 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | C.1086C_V1_V2 Tags (Month 12.5) | 22 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | Con 6 gp120/B (Month 12.5) | 29 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | Con S gp140 CFI (Month 18) | 31 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | gp41 (Month 12.5) | 3 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | gp70-96ZM651.02 V1v2 (Month 12.5) | 18 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | gp70-TV1.GSKvacV1V2/293F (Month 12.5) | 24 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | gp70_B.CaseA2 V1/V2/169K (Month 12.5) | 23 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | gp41 (Month 18) | 3 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | 00MSA 4076 gp140 (Month 18) | 18 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | gp70_B.CaseA2 V1/V2/169K (Month 18) | 7 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | A1.con.env03 140 CF (Month 18) | 29 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | gp70_B.CaseA_V1_V2 (Month 18) | 6 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | AE.A244 V1V2 Tags/293F (Month 18) | 12 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | gp70-TV1.GSKvacV1V2/293F (Month 18) | 11 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | C.1086C_V1_V2 Tags (Month 18) | 3 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | Con S gp140 CFI (Month 12.5) | 30 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | gp70_B.CaseA_V1_V2 (Month 12.5) | 22 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | gp70-96ZM651.02 V1v2 (Month 18) | 4 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | 00MSA 4076 gp140 (Month 12.5) | 29 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | Con 6 gp120/B (Month 18) | 25 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | A1.con.env03 140 CF (Month 12.5) | 29 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | gp70-TV1.GSKvacV1V2/293F (Month 18) | 1 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | AE.A244 V1V2 Tags/293F (Month 12.5) | 14 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | Con S gp140 CFI (Month 12.5) | 15 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | A1.con.env03 140 CF (Month 12.5) | 15 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | gp70_B.CaseA2 V1/V2/169K (Month 12.5) | 8 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | gp70-TV1.GSKvacV1V2/293F (Month 12.5) | 9 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | Con 6 gp120/B (Month 18) | 6 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | gp70-96ZM651.02 V1v2 (Month 18) | 1 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | gp70-96ZM651.02 V1v2 (Month 12.5) | 7 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | gp70_B.CaseA2 V1/V2/169K (Month 18) | 1 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | 00MSA 4076 gp140 (Month 18) | 4 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | gp70_B.CaseA_V1_V2 (Month 18) | 1 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | Con S gp140 CFI (Month 18) | 15 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | A1.con.env03 140 CF (Month 18) | 11 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | gp41 (Month 12.5) | 2 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | gp41 (Month 18) | 1 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | Con 6 gp120/B (Month 12.5) | 15 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | AE.A244 V1V2 Tags/293F (Month 18) | 2 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | 00MSA 4076 gp140 (Month 12.5) | 15 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | gp70_B.CaseA_V1_V2 (Month 12.5) | 6 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | C.1086C_V1_V2 Tags (Month 12.5) | 9 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Occurrence of Vaccine-induced Serum IgG Ab Binding to V2 Env Proteins | C.1086C_V1_V2 Tags (Month 18) | 1 Participants |
Secondary
Vaccine-induced Occurrence of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine
PBMC samples are stimulated with synthetic peptide pools or left unstimulated as a negative control. For each sample, T-cell subset, and peptide pool, response magnitude is % cells expressing markers (IFNg and/or IL-2) after peptide stimulation minus % cells expressing markers after no stimulation. A contingency table is constructed to assess response: stimulation (peptide/none) vs. marker expression (yes/no). A one-sided Fisher's exact test is applied, testing if the number of cells positive for the marker is equal in the stimulated vs. unstimulated cells. A discrete Bonferroni adjustment is made over the peptide pools. Response is positive if adjusted p-value \<=0.00001. Any Env magnitude is the maximum of 1086 gp120, TV1 gp120, and Env ZM96 magnitudes. Any HIV magnitude is the sum of Any Env and LAI Gag magnitudes. Data are excluded if blood draw date was outside the visit window, participant was HIV-infected, PBMC viability or T-cell count were low, or negative control was high.
Time frame: Measured at Months 6.5, 12, 12.5, and 18
Population: Overall Number of Participants Analyzed represents the number of enrolled participants with available specimens. Number Analyzed shows the number of HIV uninfected participants with available ICS data after filtering for assay specific quality control criteria at each timepoint.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Vaccine-induced Occurrence of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | Env-1-ZM96 (Month 12.5) | 15 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Vaccine-induced Occurrence of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | LAI Gag (Month 6.5) | 1 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Vaccine-induced Occurrence of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | Any HIV (Month 12.5) | 25 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Vaccine-induced Occurrence of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | 1086 gp120 (Month 18) | 9 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Vaccine-induced Occurrence of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | Any Env (Month 12.5) | 25 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Vaccine-induced Occurrence of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | TV1 gp120 (Month 6.5) | 15 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Vaccine-induced Occurrence of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | TV1 gp120 (Month 12.5) | 20 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Vaccine-induced Occurrence of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | Env ZM96 (Month 12.5) | 15 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Vaccine-induced Occurrence of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | LAI Gag (Month 12.5) | 1 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Vaccine-induced Occurrence of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | 1086 gp120 (Month 12) | 6 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Vaccine-induced Occurrence of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | Env-2-ZM96 (Month 12.5) | 1 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Vaccine-induced Occurrence of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | TV1 gp120 (Month 18) | 11 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Vaccine-induced Occurrence of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | LAI Gag (Month 18) | 1 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Vaccine-induced Occurrence of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | Any Env (Month 12) | 9 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Vaccine-induced Occurrence of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | Any HIV (Month 12) | 10 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Vaccine-induced Occurrence of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | Env-1-ZM96 (Month 12) | 6 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Vaccine-induced Occurrence of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | Env ZM96 (Month 12) | 6 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Vaccine-induced Occurrence of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | Env-2-ZM96 (Month 18) | 0 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Vaccine-induced Occurrence of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | Env-2-ZM96 (Month 12) | 1 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Vaccine-induced Occurrence of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | Env-1-ZM96 (Month 18) | 14 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Vaccine-induced Occurrence of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | LAI Gag (Month 12) | 1 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Vaccine-induced Occurrence of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | Env ZM96 (Month 18) | 14 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Vaccine-induced Occurrence of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | 1086 gp120 (Month 12.5) | 15 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Vaccine-induced Occurrence of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | Any Env (Month 6.5) | 16 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Vaccine-induced Occurrence of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | TV1 gp120 (Month 12) | 8 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Vaccine-induced Occurrence of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | 1086 gp120 (Month 6.5) | 15 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Vaccine-induced Occurrence of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | Any HIV (Month 6.5) | 17 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Vaccine-induced Occurrence of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | Any HIV (Month 18) | 17 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Vaccine-induced Occurrence of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | Env ZM96 (Month 6.5) | 12 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Vaccine-induced Occurrence of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | Env-1-ZM96 (Month 6.5) | 12 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Vaccine-induced Occurrence of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | Any Env (Month 18) | 16 Participants |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Vaccine-induced Occurrence of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | Env-2-ZM96 (Month 6.5) | 3 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Vaccine-induced Occurrence of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | Any HIV (Month 18) | 23 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Vaccine-induced Occurrence of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | Env-1-ZM96 (Month 12) | 9 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Vaccine-induced Occurrence of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | LAI Gag (Month 6.5) | 0 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Vaccine-induced Occurrence of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | Env-1-ZM96 (Month 18) | 20 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Vaccine-induced Occurrence of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | Env-1-ZM96 (Month 6.5) | 15 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Vaccine-induced Occurrence of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | TV1 gp120 (Month 12.5) | 24 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Vaccine-induced Occurrence of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | Env-2-ZM96 (Month 12) | 4 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Vaccine-induced Occurrence of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | Any HIV (Month 6.5) | 20 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Vaccine-induced Occurrence of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | TV1 gp120 (Month 6.5) | 20 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Vaccine-induced Occurrence of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | Any HIV (Month 12.5) | 24 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Vaccine-induced Occurrence of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | Any Env (Month 12) | 16 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Vaccine-induced Occurrence of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | LAI Gag (Month 12.5) | 2 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Vaccine-induced Occurrence of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | LAI Gag (Month 12) | 2 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Vaccine-induced Occurrence of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | Env ZM96 (Month 12.5) | 20 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Vaccine-induced Occurrence of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | LAI Gag (Month 18) | 2 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Vaccine-induced Occurrence of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | 1086 gp120 (Month 6.5) | 19 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Vaccine-induced Occurrence of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | 1086 gp120 (Month 18) | 21 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Vaccine-induced Occurrence of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | Env-1-ZM96 (Month 12.5) | 20 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Vaccine-induced Occurrence of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | Env ZM96 (Month 18) | 18 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Vaccine-induced Occurrence of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | Env-2-ZM96 (Month 12.5) | 8 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Vaccine-induced Occurrence of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | Env-2-ZM96 (Month 6.5) | 5 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Vaccine-induced Occurrence of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | 1086 gp120 (Month 12) | 13 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Vaccine-induced Occurrence of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | Env ZM96 (Month 6.5) | 14 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Vaccine-induced Occurrence of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | 1086 gp120 (Month 12.5) | 21 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Vaccine-induced Occurrence of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | TV1 gp120 (Month 12) | 17 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Vaccine-induced Occurrence of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | Env ZM96 (Month 12) | 9 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Vaccine-induced Occurrence of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | Env-2-ZM96 (Month 18) | 4 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Vaccine-induced Occurrence of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | Any Env (Month 18) | 23 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Vaccine-induced Occurrence of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | Any HIV (Month 12) | 16 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Vaccine-induced Occurrence of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | Any Env (Month 6.5) | 20 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Vaccine-induced Occurrence of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | Any Env (Month 12.5) | 24 Participants |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Vaccine-induced Occurrence of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | TV1 gp120 (Month 18) | 23 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Vaccine-induced Occurrence of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | Any Env (Month 6.5) | 21 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Vaccine-induced Occurrence of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | 1086 gp120 (Month 6.5) | 16 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Vaccine-induced Occurrence of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | Any HIV (Month 6.5) | 21 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Vaccine-induced Occurrence of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | Env-1-ZM96 (Month 12) | 4 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Vaccine-induced Occurrence of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | Env-2-ZM96 (Month 12) | 2 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Vaccine-induced Occurrence of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | TV1 gp120 (Month 12) | 13 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Vaccine-induced Occurrence of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | TV1 gp120 (Month 6.5) | 20 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Vaccine-induced Occurrence of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | 1086 gp120 (Month 12) | 10 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Vaccine-induced Occurrence of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | Any Env (Month 12) | 13 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Vaccine-induced Occurrence of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | Any HIV (Month 12) | 14 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Vaccine-induced Occurrence of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | Env ZM96 (Month 12) | 4 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Vaccine-induced Occurrence of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | LAI Gag (Month 12) | 1 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Vaccine-induced Occurrence of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | 1086 gp120 (Month 12.5) | 12 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Vaccine-induced Occurrence of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | Env ZM96 (Month 6.5) | 8 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Vaccine-induced Occurrence of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | Env-1-ZM96 (Month 6.5) | 7 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Vaccine-induced Occurrence of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | Env-2-ZM96 (Month 6.5) | 6 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Vaccine-induced Occurrence of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | LAI Gag (Month 6.5) | 1 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Vaccine-induced Occurrence of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | Any Env (Month 12.5) | 18 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Vaccine-induced Occurrence of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | Any HIV (Month 12.5) | 19 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Vaccine-induced Occurrence of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | Env ZM96 (Month 12.5) | 6 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Vaccine-induced Occurrence of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | Env-1-ZM96 (Month 12.5) | 5 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Vaccine-induced Occurrence of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | Env-2-ZM96 (Month 12.5) | 4 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Vaccine-induced Occurrence of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | LAI Gag (Month 12.5) | 1 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Vaccine-induced Occurrence of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | TV1 gp120 (Month 12.5) | 16 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Vaccine-induced Occurrence of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | 1086 gp120 (Month 18) | 10 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Vaccine-induced Occurrence of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | Any Env (Month 18) | 13 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Vaccine-induced Occurrence of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | Any HIV (Month 18) | 14 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Vaccine-induced Occurrence of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | Env ZM96 (Month 18) | 4 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Vaccine-induced Occurrence of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | Env-1-ZM96 (Month 18) | 3 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Vaccine-induced Occurrence of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | Env-2-ZM96 (Month 18) | 2 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Vaccine-induced Occurrence of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | LAI Gag (Month 18) | 1 Participants |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Vaccine-induced Occurrence of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | TV1 gp120 (Month 18) | 11 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Vaccine-induced Occurrence of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | LAI Gag (Month 6.5) | 2 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Vaccine-induced Occurrence of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | Env-2-ZM96 (Month 6.5) | 1 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Vaccine-induced Occurrence of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | 1086 gp120 (Month 12) | 0 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Vaccine-induced Occurrence of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | 1086 gp120 (Month 18) | 5 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Vaccine-induced Occurrence of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | Env-1-ZM96 (Month 6.5) | 5 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Vaccine-induced Occurrence of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | Env ZM96 (Month 6.5) | 5 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Vaccine-induced Occurrence of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | TV1 gp120 (Month 6.5) | 6 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Vaccine-induced Occurrence of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | Any Env (Month 18) | 9 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Vaccine-induced Occurrence of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | Any HIV (Month 6.5) | 8 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Vaccine-induced Occurrence of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | Any Env (Month 6.5) | 8 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Vaccine-induced Occurrence of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | TV1 gp120 (Month 18) | 7 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Vaccine-induced Occurrence of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | Any HIV (Month 18) | 9 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Vaccine-induced Occurrence of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | TV1 gp120 (Month 12) | 2 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Vaccine-induced Occurrence of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | LAI Gag (Month 12) | 1 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Vaccine-induced Occurrence of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | LAI Gag (Month 18) | 0 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Vaccine-induced Occurrence of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | Env ZM96 (Month 18) | 6 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Vaccine-induced Occurrence of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | Env-2-ZM96 (Month 12) | 0 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Vaccine-induced Occurrence of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | Env-1-ZM96 (Month 12) | 5 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Vaccine-induced Occurrence of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | Any HIV (Month 12) | 5 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Vaccine-induced Occurrence of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | Env-1-ZM96 (Month 18) | 6 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Vaccine-induced Occurrence of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | Env ZM96 (Month 12) | 4 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Vaccine-induced Occurrence of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | Env-1-ZM96 (Month 12.5) | 9 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Vaccine-induced Occurrence of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | Any Env (Month 12) | 5 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Vaccine-induced Occurrence of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | Env-2-ZM96 (Month 12.5) | 0 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Vaccine-induced Occurrence of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | Env ZM96 (Month 12.5) | 8 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Vaccine-induced Occurrence of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | Any HIV (Month 12.5) | 9 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Vaccine-induced Occurrence of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | 1086 gp120 (Month 6.5) | 6 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Vaccine-induced Occurrence of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | LAI Gag (Month 12.5) | 1 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Vaccine-induced Occurrence of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | Any Env (Month 12.5) | 9 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Vaccine-induced Occurrence of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | 1086 gp120 (Month 12.5) | 5 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Vaccine-induced Occurrence of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | Env-2-ZM96 (Month 18) | 0 Participants |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Vaccine-induced Occurrence of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | TV1 gp120 (Month 12.5) | 8 Participants |
Secondary
Vaccine-induced Percentage of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine
PBMC samples are stimulated with synthetic peptide pools or left unstimulated as a negative control. For each sample, T-cell subset, and peptide pool, response magnitude is % cells expressing markers (IFNg and/or IL-2) after peptide stimulation minus % cells expressing markers after no stimulation. A contingency table is constructed to assess response: stimulation (peptide/none) vs. marker expression (yes/no). A one-sided Fisher's exact test is applied, testing if the number of cells positive for the marker is equal in the stimulated vs. unstimulated cells. A discrete Bonferroni adjustment is made over the peptide pools. Response is positive if adjusted p-value \<=0.00001. Any Env magnitude is the maximum of 1086 gp120, TV1 gp120, and Env ZM96 magnitudes. Any HIV magnitude is the sum of Any Env and LAI Gag magnitudes. Data are excluded if blood draw date was outside the visit window, participant was HIV-infected, PBMC viability or T-cell count were low, or negative control was high.
Time frame: Measured at Months 6.5, 12, 12.5, and 18
Population: Overall Number of Participants Analyzed represents the number of enrolled participants with available specimens. Number Analyzed shows the number of HIV uninfected participants with available ICS data after filtering for assay specific quality control criteria at each timepoint.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Vaccine-induced Percentage of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | Any Env (Month 6.5) | 0.216 % CD4+ T-cells |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Vaccine-induced Percentage of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | LAI Gag (Month 12) | 0.065 % CD4+ T-cells |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Vaccine-induced Percentage of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | Env-2-ZM96 (Month 12) | 0.101 % CD4+ T-cells |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Vaccine-induced Percentage of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | 1086 gp120 (Month 12) | 0.173 % CD4+ T-cells |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Vaccine-induced Percentage of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | LAI Gag (Month 18) | 0.076 % CD4+ T-cells |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Vaccine-induced Percentage of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | Env-1-ZM96 (Month 12) | 0.215 % CD4+ T-cells |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Vaccine-induced Percentage of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | Any Env (Month 12) | 0.15 % CD4+ T-cells |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Vaccine-induced Percentage of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | Any HIV (Month 18) | 0.105 % CD4+ T-cells |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Vaccine-induced Percentage of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | Env ZM96 (Month 12) | 0.238 % CD4+ T-cells |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Vaccine-induced Percentage of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | Any HIV (Month 12) | 0.149 % CD4+ T-cells |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Vaccine-induced Percentage of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | Any Env (Month 18) | 0.117 % CD4+ T-cells |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Vaccine-induced Percentage of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | Any HIV (Month 6.5) | 0.221 % CD4+ T-cells |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Vaccine-induced Percentage of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | 1086 gp120 (Month 6.5) | 0.209 % CD4+ T-cells |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Vaccine-induced Percentage of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | 1086 gp120 (Month 18) | 0.106 % CD4+ T-cells |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Vaccine-induced Percentage of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | TV1 gp120 (Month 12.5) | 0.133 % CD4+ T-cells |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Vaccine-induced Percentage of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | Env ZM96 (Month 6.5) | 0.224 % CD4+ T-cells |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Vaccine-induced Percentage of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | TV1 gp120 (Month 18) | 0.109 % CD4+ T-cells |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Vaccine-induced Percentage of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | LAI Gag (Month 12.5) | 0.11 % CD4+ T-cells |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Vaccine-induced Percentage of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | Env-2-ZM96 (Month 12.5) | 0.128 % CD4+ T-cells |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Vaccine-induced Percentage of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | Env-1-ZM96 (Month 6.5) | 0.186 % CD4+ T-cells |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Vaccine-induced Percentage of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | Env-1-ZM96 (Month 18) | 0.09 % CD4+ T-cells |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Vaccine-induced Percentage of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | Env-1-ZM96 (Month 12.5) | 0.14 % CD4+ T-cells |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Vaccine-induced Percentage of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | Env ZM96 (Month 12.5) | 0.149 % CD4+ T-cells |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Vaccine-induced Percentage of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | Env-2-ZM96 (Month 6.5) | 0.107 % CD4+ T-cells |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Vaccine-induced Percentage of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | Env ZM96 (Month 18) | 0.085 % CD4+ T-cells |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Vaccine-induced Percentage of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | Any HIV (Month 12.5) | 0.172 % CD4+ T-cells |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Vaccine-induced Percentage of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | Any Env (Month 12.5) | 0.172 % CD4+ T-cells |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Vaccine-induced Percentage of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | LAI Gag (Month 6.5) | 0.108 % CD4+ T-cells |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Vaccine-induced Percentage of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | 1086 gp120 (Month 12.5) | 0.118 % CD4+ T-cells |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Vaccine-induced Percentage of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | TV1 gp120 (Month 12) | 0.124 % CD4+ T-cells |
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Vaccine-induced Percentage of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | TV1 gp120 (Month 6.5) | 0.193 % CD4+ T-cells |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Vaccine-induced Percentage of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | TV1 gp120 (Month 12.5) | 0.275 % CD4+ T-cells |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Vaccine-induced Percentage of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | 1086 gp120 (Month 6.5) | 0.181 % CD4+ T-cells |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Vaccine-induced Percentage of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | Any Env (Month 6.5) | 0.182 % CD4+ T-cells |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Vaccine-induced Percentage of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | Any HIV (Month 6.5) | 0.221 % CD4+ T-cells |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Vaccine-induced Percentage of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | Env ZM96 (Month 6.5) | 0.162 % CD4+ T-cells |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Vaccine-induced Percentage of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | Env-1-ZM96 (Month 6.5) | 0.151 % CD4+ T-cells |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Vaccine-induced Percentage of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | Env-2-ZM96 (Month 6.5) | 0.067 % CD4+ T-cells |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Vaccine-induced Percentage of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | TV1 gp120 (Month 6.5) | 0.175 % CD4+ T-cells |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Vaccine-induced Percentage of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | 1086 gp120 (Month 12) | 0.157 % CD4+ T-cells |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Vaccine-induced Percentage of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | Any Env (Month 12) | 0.185 % CD4+ T-cells |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Vaccine-induced Percentage of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | Any HIV (Month 12) | 0.206 % CD4+ T-cells |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Vaccine-induced Percentage of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | Env ZM96 (Month 12) | 0.146 % CD4+ T-cells |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Vaccine-induced Percentage of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | Env-1-ZM96 (Month 12) | 0.125 % CD4+ T-cells |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Vaccine-induced Percentage of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | Env-2-ZM96 (Month 12) | 0.113 % CD4+ T-cells |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Vaccine-induced Percentage of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | LAI Gag (Month 12) | 0.053 % CD4+ T-cells |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Vaccine-induced Percentage of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | TV1 gp120 (Month 12) | 0.172 % CD4+ T-cells |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Vaccine-induced Percentage of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | 1086 gp120 (Month 12.5) | 0.158 % CD4+ T-cells |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Vaccine-induced Percentage of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | Any Env (Month 12.5) | 0.277 % CD4+ T-cells |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Vaccine-induced Percentage of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | Any HIV (Month 12.5) | 0.314 % CD4+ T-cells |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Vaccine-induced Percentage of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | Env ZM96 (Month 12.5) | 0.172 % CD4+ T-cells |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Vaccine-induced Percentage of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | Env-1-ZM96 (Month 12.5) | 0.135 % CD4+ T-cells |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Vaccine-induced Percentage of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | Env-2-ZM96 (Month 12.5) | 0.163 % CD4+ T-cells |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Vaccine-induced Percentage of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | LAI Gag (Month 12.5) | 0.085 % CD4+ T-cells |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Vaccine-induced Percentage of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | 1086 gp120 (Month 18) | 0.121 % CD4+ T-cells |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Vaccine-induced Percentage of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | Any Env (Month 18) | 0.169 % CD4+ T-cells |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Vaccine-induced Percentage of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | Any HIV (Month 18) | 0.156 % CD4+ T-cells |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Vaccine-induced Percentage of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | Env ZM96 (Month 18) | 0.133 % CD4+ T-cells |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Vaccine-induced Percentage of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | Env-1-ZM96 (Month 18) | 0.111 % CD4+ T-cells |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Vaccine-induced Percentage of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | Env-2-ZM96 (Month 18) | 0.132 % CD4+ T-cells |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Vaccine-induced Percentage of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | LAI Gag (Month 18) | 0.059 % CD4+ T-cells |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | Vaccine-induced Percentage of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | TV1 gp120 (Month 18) | 0.158 % CD4+ T-cells |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Vaccine-induced Percentage of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | TV1 gp120 (Month 12) | 0.118 % CD4+ T-cells |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Vaccine-induced Percentage of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | LAI Gag (Month 6.5) | 0.09 % CD4+ T-cells |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Vaccine-induced Percentage of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | Env ZM96 (Month 18) | 0.117 % CD4+ T-cells |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Vaccine-induced Percentage of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | 1086 gp120 (Month 12.5) | 0.142 % CD4+ T-cells |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Vaccine-induced Percentage of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | 1086 gp120 (Month 6.5) | 0.222 % CD4+ T-cells |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Vaccine-induced Percentage of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | Any HIV (Month 12.5) | 0.148 % CD4+ T-cells |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Vaccine-induced Percentage of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | Any Env (Month 12.5) | 0.138 % CD4+ T-cells |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Vaccine-induced Percentage of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | Env ZM96 (Month 12.5) | 0.202 % CD4+ T-cells |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Vaccine-induced Percentage of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | Env-1-ZM96 (Month 6.5) | 0.16 % CD4+ T-cells |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Vaccine-induced Percentage of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | Env-1-ZM96 (Month 18) | 0.077 % CD4+ T-cells |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Vaccine-induced Percentage of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | Env-1-ZM96 (Month 12.5) | 0.157 % CD4+ T-cells |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Vaccine-induced Percentage of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | Env-2-ZM96 (Month 12.5) | 0.084 % CD4+ T-cells |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Vaccine-induced Percentage of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | Env ZM96 (Month 6.5) | 0.237 % CD4+ T-cells |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Vaccine-induced Percentage of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | LAI Gag (Month 12.5) | 0.136 % CD4+ T-cells |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Vaccine-induced Percentage of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | TV1 gp120 (Month 12.5) | 0.138 % CD4+ T-cells |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Vaccine-induced Percentage of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | Any HIV (Month 6.5) | 0.202 % CD4+ T-cells |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Vaccine-induced Percentage of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | Env-2-ZM96 (Month 18) | 0.064 % CD4+ T-cells |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Vaccine-induced Percentage of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | 1086 gp120 (Month 18) | 0.121 % CD4+ T-cells |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Vaccine-induced Percentage of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | Any Env (Month 18) | 0.122 % CD4+ T-cells |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Vaccine-induced Percentage of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | Any HIV (Month 12) | 0.161 % CD4+ T-cells |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Vaccine-induced Percentage of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | Any Env (Month 12) | 0.156 % CD4+ T-cells |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Vaccine-induced Percentage of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | Any Env (Month 6.5) | 0.149 % CD4+ T-cells |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Vaccine-induced Percentage of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | Env ZM96 (Month 12) | 0.157 % CD4+ T-cells |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Vaccine-induced Percentage of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | 1086 gp120 (Month 12) | 0.153 % CD4+ T-cells |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Vaccine-induced Percentage of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | TV1 gp120 (Month 18) | 0.122 % CD4+ T-cells |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Vaccine-induced Percentage of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | Env-1-ZM96 (Month 12) | 0.085 % CD4+ T-cells |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Vaccine-induced Percentage of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | Any HIV (Month 18) | 0.129 % CD4+ T-cells |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Vaccine-induced Percentage of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | Env-2-ZM96 (Month 12) | 0.072 % CD4+ T-cells |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Vaccine-induced Percentage of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | TV1 gp120 (Month 6.5) | 0.152 % CD4+ T-cells |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Vaccine-induced Percentage of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | LAI Gag (Month 12) | 0.159 % CD4+ T-cells |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Vaccine-induced Percentage of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | LAI Gag (Month 18) | 0.07 % CD4+ T-cells |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | Vaccine-induced Percentage of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | Env-2-ZM96 (Month 6.5) | 0.097 % CD4+ T-cells |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Vaccine-induced Percentage of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | 1086 gp120 (Month 12.5) | 0.161 % CD4+ T-cells |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Vaccine-induced Percentage of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | Env-2-ZM96 (Month 6.5) | 0.072 % CD4+ T-cells |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Vaccine-induced Percentage of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | Env ZM96 (Month 18) | 0.133 % CD4+ T-cells |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Vaccine-induced Percentage of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | Any Env (Month 12.5) | 0.18 % CD4+ T-cells |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Vaccine-induced Percentage of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | Env-1-ZM96 (Month 12) | 0.107 % CD4+ T-cells |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Vaccine-induced Percentage of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | TV1 gp120 (Month 6.5) | 0.132 % CD4+ T-cells |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Vaccine-induced Percentage of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | Env ZM96 (Month 12) | 0.133 % CD4+ T-cells |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Vaccine-induced Percentage of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | Any HIV (Month 12.5) | 0.188 % CD4+ T-cells |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Vaccine-induced Percentage of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | Env-1-ZM96 (Month 6.5) | 0.13 % CD4+ T-cells |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Vaccine-induced Percentage of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | 1086 gp120 (Month 18) | 0.107 % CD4+ T-cells |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Vaccine-induced Percentage of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | Any Env (Month 6.5) | 0.142 % CD4+ T-cells |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Vaccine-induced Percentage of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | Env ZM96 (Month 12.5) | 0.126 % CD4+ T-cells |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Vaccine-induced Percentage of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | Any HIV (Month 18) | 0.123 % CD4+ T-cells |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Vaccine-induced Percentage of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | 1086 gp120 (Month 6.5) | 0.124 % CD4+ T-cells |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Vaccine-induced Percentage of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | Any Env (Month 12) | 0.124 % CD4+ T-cells |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Vaccine-induced Percentage of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | Env-1-ZM96 (Month 12.5) | 0.106 % CD4+ T-cells |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Vaccine-induced Percentage of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | Env ZM96 (Month 6.5) | 0.137 % CD4+ T-cells |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Vaccine-induced Percentage of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | Env-1-ZM96 (Month 18) | 0.124 % CD4+ T-cells |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Vaccine-induced Percentage of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | Any Env (Month 18) | 0.123 % CD4+ T-cells |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Vaccine-induced Percentage of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | TV1 gp120 (Month 12) | 0.087 % CD4+ T-cells |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Vaccine-induced Percentage of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | TV1 gp120 (Month 18) | 0.085 % CD4+ T-cells |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Vaccine-induced Percentage of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | Any HIV (Month 12) | 0.167 % CD4+ T-cells |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Vaccine-induced Percentage of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | LAI Gag (Month 12.5) | 0.081 % CD4+ T-cells |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Vaccine-induced Percentage of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | Any HIV (Month 6.5) | 0.148 % CD4+ T-cells |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Vaccine-induced Percentage of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | LAI Gag (Month 12) | 0.056 % CD4+ T-cells |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Vaccine-induced Percentage of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | LAI Gag (Month 6.5) | 0.092 % CD4+ T-cells |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | Vaccine-induced Percentage of CD4+ T-cells Expressing Markers in Response to HIV Proteins Included in the Vaccine | TV1 gp120 (Month 12.5) | 0.147 % CD4+ T-cells |