A Phase 1/2 interventional study of ALVAC-HIV (vCP2438) and Bivalent Subtype C gp120/MF59 in HIV Infections, sponsored by National Institute of Allergy and Infectious Diseases (NIAID). Completed at 6 sites in 3 countries. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-24.
Sponsored by National Institute of Allergy and Infectious Diseases (NIAID) · Phase 1/2, Interventional, and Prevention
The purpose of this study is to evaluate the safety and immune response to an HIV clade C vaccine and to an MF59- or alum-adjuvanted clade C Env protein in healthy, HIV-uninfected adults.
This study will evaluate the safety, tolerability, and immunogenicity to vCP2438 (an HIV clade C vaccine) and to an unadjuvanted or MF59- or alum-adjuvanted bivalent clade C gp120 in healthy, HIV-uninfected adults.
The study will enroll healthy, HIV-uninfected participants aged 18 to 40 years. Participants will be randomly assigned to one of 4 groups. [describe further]
Study visits will include a physical examination, an interview and/or questionnaire, HIV testing and HIV risk-reduction counseling, and urine and blood collection. A subset of participants will provide rectal fluid, cervical fluid, semen, or stool samples.
General and Demographic Criteria
Good general health as shown by medical history, physical exam, and screening laboratory tests
HIV-Related Criteria:
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)
Platelets = 125,000 to 550,000/mm\^3
Chemistry
Chemistry panel: ALT, AST, and ALP \< 1.25 times the institutional upper limit of normal; creatinine ≤ institutional upper limit of normal.
Virology
Normal urine:
Reproductive Status
Reproductive status: A volunteer who was born female must:
Volunteers who were born female must also agree not to seek pregnancy through alternative methods, such as artificial insemination or in vitro fertilization until after the last required protocol clinic visit
Other
Exclusion Criteria:
General
Pregnant or breastfeeding
Vaccines and other Injections
Allergy treatment with antigen injections within 30 days before first vaccination or that are scheduled within 14 days after first vaccination
Immune System
Immunodeficiency
Clinically significant medical conditions
Clinically significant medical condition, physical examination findings, clinically significant abnormal laboratory results, or past medical history with clinically significant implications for current health. A clinically significant condition or process includes but is not limited to:
Asthma other than mild, well-controlled asthma. (Symptoms of asthma severity as defined in the most recent National Asthma Education and Prevention Program (NAEPP) Expert Panel report).
Exclude a volunteer who:
In the past year has either of the following:
Hypertension:
Participants will receive the ALVAC-HIV (vCP2438) vaccine in the left deltoid at months 0, 1, 3, 6, and 12, and Bivalent Subtype C gp120/MF59 in the right deltoid at months 3, 6, and 12. All injections are via needle and syringe.
Biological: ALVAC-HIV (vCP2438) · Biological: Bivalent Subtype C gp120/MF59
Participants will receive the ALVAC-HIV (vCP2438) vaccine in the left deltoid at months 0, 1, 3, 6, and 12, and Bivalent Subtype C gp120 admixed with Al(OH)3 Suspension in the right deltoid at months 3, 6, and 12. All injections are via needle and syringe.
Biological: ALVAC-HIV (vCP2438) · Biological: Bivalent Subtype C gp120 admixed with Al(OH)3 Suspension
Participants will receive the ALVAC-HIV (vCP2438) vaccine in the left deltoid and Bivalent Subtype C gp120/MF59 in the right deltoid at months 0, 1, 6, and 12. All injections are via needle and syringe.
Biological: ALVAC-HIV (vCP2438) · Biological: Bivalent Subtype C gp120/MF59
Participants will receive the ALVAC-HIV (vCP2438) vaccine in the left deltoid at months 0, 1, 3, 6, and 12, and Bivalent Subtype C gp120 in the right deltoid at months 3, 6, and 12. All injections are via needle and syringe.
Biological: ALVAC-HIV (vCP2438) · Biological: Bivalent Subtype C gp120
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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.
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.
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.
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.
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
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
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.
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.
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.
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.
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
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
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.
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.
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.
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.
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.
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.
| Milestone | 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) |
|---|---|---|---|---|
| Started | 36 | 36 | 36 | 24 |
| Month 6.5 immunogenicity timepoint | 31 | 31 | 31 | 18 |
| Month 12 immunogenicity timepoint | 30 | 31 | 31 | 17 |
| Month 12.5 immunogenicity timepoint | 0 | 0 | 0 | 0 |
| Month 18 immunogenicity timepoint | 0 | 0 | 0 | 0 |
| Completed | 30 | 31 | 32 | 16 |
| Not completed | 6 | 5 | 4 | 8 |
| Withdrew: Withdrawal by subject | 1 | 0 | 1 | 6 |
| Withdrew: Lost to follow-up | 3 | 3 | 1 | 0 |
| Withdrew: Physician decision | 1 | 0 | 0 | 0 |
| Withdrew: Participant unable to adhere to visit schedule | 1 | 0 | 0 | 1 |
| Withdrew: Hiv infection | 0 | 2 | 2 | 1 |
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.
| Participants | 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) |
|---|---|---|
| 1086C_D7gp120.avi/293F | 29 | 26 |
| 96ZM651.D11gp120.avi | 27 | 27 |
| TV1c8_D11gp120.avi/293F | 29 | 27 |
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).
| relative fluorescence units | 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) |
|---|---|---|
| 1086C_D7gp120.avi/293F | 22000 (22000 to 22000) | 22000 (22000 to 22000) |
| 96ZM651.D11gp120.avi | 22000 (22000 to 22000) | 22000 (22000 to 22000) |
| TV1c8_D11gp120.avi/293F | 22000 (22000 to 22000) | 22000 (22000 to 22000) |
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.
| Participants | Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) |
|---|---|---|
| 1086C_D7gp120.avi/293F | 22 | 27 |
| 96ZM651.D11gp120.avi | 12 | 22 |
| TV1c8_D11gp120.avi/293F | 18 | 27 |
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).
| relative fluorescence units | Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) |
|---|---|---|
| 1086C_D7gp120.avi/293F | 22000 (17472 to 22000) | 22000 (22000 to 22000) |
| 96ZM651.D11gp120.avi | 8047.1 (6816.6 to 13252.6) | 7595.5 (5318.3 to 13822.1) |
| TV1c8_D11gp120.avi/293F | 8312.8 (3759.4 to 19844.6) | 12210.8 (6345.9 to 22000) |
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.
| Participants | 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) |
|---|---|---|---|---|
| Pain — None | 21 | 20 | 22 | 17 |
| Pain — Mild | 14 | 13 | 13 | 7 |
| Pain — Moderate | 1 | 3 | 1 | 0 |
| Pain — Severe | 0 | 0 | 0 | 0 |
| Pain — Potentially Life-threatening | 0 | 0 | 0 | 0 |
| Tenderness — None | 20 | 20 | 25 | 16 |
| Tenderness — Mild | 16 | 15 | 11 | 8 |
| Tenderness — Moderate | 0 | 1 | 0 | 0 |
| Tenderness — Severe | 0 | 0 | 0 | 0 |
| Tenderness — Potentially Life-threatening | 0 | 0 | 0 | 0 |
| Pain and/or Tenderness — None | 18 | 15 | 21 | 14 |
| Pain and/or Tenderness — Mild | 17 | 18 | 14 | 10 |
| Pain and/or Tenderness — Moderate | 1 | 3 | 1 | 0 |
| Pain and/or Tenderness — Severe | 0 | 0 | 0 | 0 |
| Pain and/or Tenderness — Potentially Life-threatening | 0 | 0 | 0 | 0 |
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.
| Participants | 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) |
|---|---|---|---|---|
| Erythema — None | 30 | 31 | 33 | 22 |
| Erythema — Not gradable | 4 | 5 | 2 | 1 |
| Erythema — Mild | 1 | 0 | 1 | 1 |
| Erythema — Moderate | 1 | 0 | 0 | 0 |
| Erythema — Severe | 0 | 0 | 0 | 0 |
| Erythema — Potentially Life-threatening | 0 | 0 | 0 | 0 |
| Induration — None | 29 | 28 | 34 | 19 |
| Induration — Not gradable | 2 | 7 | 2 | 2 |
| Induration — Mild | 1 | 0 | 0 | 2 |
| Induration — Moderate | 4 | 1 | 0 | 1 |
| Induration — Severe | 0 | 0 | 0 | 0 |
| Induration — Potentially Life-threatening | 0 | 0 | 0 | 0 |
| Erythema and/or Induration — None | 28 | 27 | 32 | 18 |
| Erythema and/or Induration — Not gradable | 3 | 8 | 3 | 2 |
| Erythema and/or Induration — Mild | 1 | 0 | 1 | 3 |
| Erythema and/or Induration — Moderate | 4 | 1 | 0 | 1 |
| Erythema and/or Induration — Severe | 0 | 0 | 0 | 0 |
| Erythema and/or Induration — Potentially Life-threatening | 0 | 0 | 0 | 0 |
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.
| Participants | 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) |
|---|---|---|---|---|
| Malaise and/or fatigue — None | 32 | 28 | 30 | 21 |
| Malaise and/or fatigue — Mild | 4 | 7 | 6 | 3 |
| Malaise and/or fatigue — Moderate | 0 | 1 | 0 | 0 |
| Malaise and/or fatigue — Severe | 0 | 0 | 0 | 0 |
| Malaise and/or fatigue — Potentially Life-threatening | 0 | 0 | 0 | 0 |
| Myalgia — None | 36 | 35 | 35 | 22 |
| Myalgia — Mild | 0 | 1 | 1 | 2 |
| Myalgia — Moderate | 0 | 0 | 0 | 0 |
| Myalgia — Severe | 0 | 0 | 0 | 0 |
| Myalgia — Potentially Life-threatening | 0 | 0 | 0 | 0 |
| Headache — None | 28 | 28 | 29 | 19 |
| Headache — Mild | 8 | 6 | 7 | 5 |
| Headache — Moderate | 0 | 2 | 0 | 0 |
| Headache — Severe | 0 | 0 | 0 | 0 |
| Headache — Potentially Life-threatening | 0 | 0 | 0 | 0 |
| Nausea — None | 30 | 34 | 32 | 23 |
| Nausea — Mild | 6 | 2 | 4 | 1 |
| Nausea — Moderate | 0 | 0 | 0 | 0 |
| Nausea — Severe | 0 | 0 | 0 | 0 |
| Nausea — Potentially Life-threatening | 0 | 0 | 0 | 0 |
| Vomiting — None | 36 | 35 | 36 | 24 |
| Vomiting — Mild | 0 | 1 | 0 | 0 |
| Vomiting — Moderate | 0 | 0 | 0 | 0 |
| Vomiting — Severe | 0 | 0 | 0 | 0 |
| Vomiting — Potentially Life-threatening | 0 | 0 | 0 | 0 |
| Chills — None | 36 | 34 | 33 | 23 |
| Chills — Mild | 0 | 2 | 3 | 1 |
| Chills — Moderate | 0 | 0 | 0 | 0 |
| Chills — Severe | 0 | 0 | 0 | 0 |
| Chills — Potentially Life-threatening | 0 | 0 | 0 | 0 |
| Arthralgia — None | 34 | 34 | 34 | 24 |
| Arthralgia — Mild | 2 | 2 | 2 | 0 |
| Arthralgia — Moderate | 0 | 0 | 0 | 0 |
| Arthralgia — Severe | 0 | 0 | 0 | 0 |
| Arthralgia — Potentially Life-threatening | 0 | 0 | 0 | 0 |
| Max. Systemic Symptoms — None | 23 | 23 | 25 | 17 |
| Max. Systemic Symptoms — Mild | 13 | 11 | 11 | 7 |
| Max. Systemic Symptoms — Moderate | 0 | 2 | 0 | 0 |
| Max. Systemic Symptoms — Severe | 0 | 0 | 0 | 0 |
| Max. Systemic Symptoms — Potentially Life-threatening | 0 | 0 | 0 | 0 |
| Temperature — None | 36 | 31 | 35 | 24 |
| Temperature — Mild | 0 | 3 | 1 | 0 |
| Temperature — Moderate | 0 | 1 | 0 | 0 |
| Temperature — Severe | 0 | 0 | 0 | 0 |
| Temperature — Potentially Life-threatening | 0 | 1 | 0 | 0 |
For participants reporting multiple AEs over the time frame, the maximum relationship is counted.
| Participants | 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) |
|---|---|---|---|---|
| Related | 1 | 2 | 0 | 0 |
| Not Related | 27 | 26 | 26 | 15 |
| No AE Reported | 8 | 8 | 10 | 9 |
For participants reporting multiple AEs over the time frame, the maximum severity grade is counted.
| Participants | 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) |
|---|---|---|---|---|
| Mild | 5 | 7 | 12 | 2 |
| Moderate | 18 | 16 | 12 | 12 |
| Severe | 3 | 4 | 1 | 1 |
| Potentially Life-Threatening | 2 | 1 | 1 | 0 |
| Death | 0 | 0 | 0 | 0 |
| No AE Reported | 8 | 8 | 10 | 9 |
Measured as outlined in Version 2.0 (January 2010) of the Manual for Expedited Reporting of Adverse Events to DAIDS (DAIDS EAE Manual).
| Participants | 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) |
|---|---|---|---|---|
| Yes | 1 | 0 | 0 | 1 |
| No | 27 | 28 | 26 | 14 |
| No AE Reported | 8 | 8 | 10 | 9 |
There were no adverse events of special interest reported by any participant.
| Participants | 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) |
|---|---|---|---|---|
| Number of Participants Reporting Adverse Events of Special Interest (AESIs) | 0 | 0 | 0 | 0 |
New chronic conditions are adverse events that require medical intervention for \>= 30 days.
| Participants | 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) |
|---|---|---|---|---|
| Yes | 0 | 1 | 0 | 2 |
| No | 28 | 27 | 26 | 13 |
| No AE Reported | 8 | 8 | 10 | 9 |
For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population.
| U/L | 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) |
|---|---|---|---|---|
| Alkaline Phosphatase (U/L)- Screening | 72 (59 to 87) | 70 (62 to 89) | 76 (63.5 to 90.5) | 79.5 (65.5 to 94) |
| Alkaline Phosphatase (U/L)- Day7 | 66.5 (58 to 83) | 68 (57 to 85) | 70 (62 to 82) | 75.5 (58 to 84) |
| Alkaline Phosphatase (U/L)- Day42 | 70 (57 to 84) | 71.5 (60 to 83) | 70.5 (62 to 90) | 78 (64 to 89) |
| Alkaline Phosphatase (U/L)- Day98 | 67.5 (60 to 79) | 64 (54 to 84) | — | 77 (62 to 87) |
| Alkaline Phosphatase (U/L)- Day182 | 70 (58 to 85) | 64 (56 to 78) | 70 (58 to 88) | 77.5 (61 to 84) |
| Alkaline Phosphatase (U/L)- Day378 | 70 (58.5 to 82.5) | 65 (54 to 83) | 73 (68 to 89) | 77.5 (55 to 95) |
| Alkaline Phosphatase (U/L)- Day455 | 71.5 (59 to 82) | 65 (54 to 81) | 71.5 (64 to 89.5) | 76.5 (66 to 89) |
| AST (U/L)- Screening | 19 (16.5 to 22) | 20 (17.5 to 24) | 21.5 (19 to 24.5) | 17 (16.5 to 23) |
| AST (U/L)- Day7 | 18 (16.5 to 23) | 20 (17 to 22) | 21 (18 to 23) | 19 (16 to 20) |
| AST (U/L)- Day42 | 19 (15 to 25) | 21 (17 to 26) | 21 (18 to 24) | 21 (17 to 25) |
| AST (U/L)- Day98 | 21 (16 to 23.5) | 20 (17 to 27) | — | 20 (18 to 27) |
| AST (U/L)- Day182 | 20 (18 to 24) | 21 (18 to 25) | 21 (19 to 26) | 18.5 (16 to 26) |
| AST (U/L)- Day378 | 20 (16.5 to 27) | 19 (18 to 23) | 22 (19 to 29) | 21.5 (18 to 25) |
| AST (U/L)- Day455 | 22.5 (17 to 26) | 20 (17 to 24) | 21 (18.5 to 26) | 19 (16 to 27) |
| ALT (SGPT) (U/L)- Screening | 15 (13 to 19) | 15 (11 to 20.5) | 16.5 (13.5 to 21.5) | 14.5 (12 to 20) |
| ALT (SGPT) (U/L)- Day7 | 15.5 (12 to 19.5) | 16 (12 to 19) | 15 (11 to 19) | 15.5 (11 to 20) |
| ALT (SGPT) (U/L)- Day42 | 16 (12 to 19) | 18.5 (11 to 25) | 15 (12 to 18) | 17.5 (12 to 22) |
| ALT (SGPT) (U/L)- Day98 | 16 (13 to 20) | 15 (11 to 23) | — | 17 (12 to 19) |
| ALT (SGPT) (U/L)- Day182 | 18 (13 to 20) | 16.5 (13 to 23) | 15 (12 to 23) | 15 (11 to 22) |
| ALT (SGPT) (U/L)- Day378 | 16 (13 to 19.5) | 16 (11 to 24) | 15 (12 to 24) | 19 (12 to 24) |
| ALT (SGPT) (U/L)- Day455 | 16 (14 to 20) | 16 (13 to 22) | 16 (11 to 21) | 15 (12 to 22) |
For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population.
| g/dL | 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) |
|---|---|---|---|---|
| Creatinine (g/dL)- Screening | 0.00071 (0.0006 to 0.00082) | 0.0007 (0.000605 to 0.000805) | 0.000705 (0.00061 to 0.00084) | 0.0007 (0.0006 to 0.0008) |
| Creatinine (g/dL)- Day7 | 0.00071 (0.000675 to 0.000845) | 0.0007 (0.0006 to 0.0008) | 0.0007 (0.00063 to 0.0008) | 0.00075 (0.0006 to 0.0008) |
| Creatinine (g/dL)- Day42 | 0.00071 (0.00064 to 0.0008) | 0.0007 (0.00068 to 0.0008) | 0.0007 (0.00063 to 0.0008) | 0.00071 (0.0007 to 0.0008) |
| Creatinine (g/dL)- Day98 | 0.000705 (0.000615 to 0.00088) | 0.0008 (0.0007 to 0.00085) | — | 0.00072 (0.0007 to 0.0008) |
| Creatinine (g/dL)- Day182 | 0.00073 (0.00064 to 0.0009) | 0.000715 (0.00068 to 0.0009) | 0.00078 (0.00067 to 0.00088) | 0.00077 (0.0007 to 0.0009) |
| Creatinine (g/dL)- Day378 | 0.00079 (0.0007 to 0.00088) | 0.00076 (0.0007 to 0.00084) | 0.0007 (0.000645 to 0.000835) | 0.0007 (0.00063 to 0.0008) |
| Creatinine (g/dL)- Day455 | 0.000795 (0.00067 to 0.0009) | 0.00074 (0.0007 to 0.0009) | 0.00071 (0.000605 to 0.000835) | 0.0007 (0.00063 to 0.0009) |
For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population.
| g/dL | 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) |
|---|---|---|---|---|
| Hemoglobin (g/dL)- Screening | 13.75 (13.15 to 14.9) | 13.95 (12.9 to 15.2) | 13.85 (13.3 to 15.5) | 14.05 (13.25 to 14.9) |
| Hemoglobin (g/dL)- Day7 | 13.5 (12.3 to 14.4) | 13.5 (12 to 14.3) | 13.4 (12.4 to 14.7) | 13.5 (12.4 to 14.5) |
| Hemoglobin (g/dL)- Day42 | 13.7 (12.8 to 14.4) | 13.55 (12.8 to 14.5) | 13.65 (12.5 to 15) | 13.65 (12.9 to 14.7) |
| Hemoglobin (g/dL)- Day98 | 13.35 (12.25 to 14.3) | 13.6 (12 to 14.3) | — | 13.2 (12.5 to 13.7) |
| Hemoglobin (g/dL)- Day182 | 13.4 (12.4 to 14.1) | 13.5 (12.6 to 14.5) | 13.75 (12.2 to 14.9) | 13.25 (12.6 to 14.8) |
| Hemoglobin (g/dL)- Day378 | 13.3 (12.45 to 14.05) | 13.5 (12 to 14) | 13.2 (11.8 to 14.4) | 13.3 (12.7 to 14) |
| Hemoglobin (g/dL)- Day455 | 13.6 (12.6 to 14.3) | 13.8 (12.9 to 14.4) | 12.75 (12 to 14.6) | 13.6 (12.7 to 14.5) |
For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population.
| thousand cells/cubic mm | 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) |
|---|---|---|---|---|
| Lymphocytes (1000/cubic mm)- Screening | 2.1395 (1.7555 to 2.5785) | 2.095 (1.777 to 2.396) | 2.01 (1.6825 to 2.461) | 2.341 (2.0555 to 2.634) |
| Lymphocytes (1000/cubic mm)- Day0 | — | — | 2.0755 (1.66 to 2.283) | — |
| Lymphocytes (1000/cubic mm)- Day1 | — | — | 1.982 (1.73 to 2.078) | — |
| Lymphocytes (1000/cubic mm)- Day3 | — | — | 1.96 (1.547 to 2.166) | — |
| Lymphocytes (1000/cubic mm)- Day7 | 1.883 (1.6385 to 2.3735) | 1.93 (1.752 to 2.22) | 1.976 (1.622 to 2.445) | 2.2185 (1.738 to 2.571) |
| Lymphocytes (1000/cubic mm)- Day42 | 1.76 (1.594 to 2.13) | 1.8915 (1.627 to 2.204) | 1.9915 (1.54 to 2.373) | 2.1375 (1.735 to 2.55) |
| Lymphocytes (1000/cubic mm)- Day84 | 1.891 (1.726 to 2.179) | 1.919 (1.624 to 2.29) | 1.99 (1.42 to 2.042) | 2.035 (1.75 to 2.298) |
| Lymphocytes (1000/cubic mm)- Day85 | 1.646 (1.327 to 2.119) | 1.7245 (1.4675 to 2.003) | — | 2.024 (1.763 to 2.589) |
| Lymphocytes (1000/cubic mm)- Day87 | 1.8725 (1.418 to 2.648) | 1.83 (1.659 to 2.157) | — | 2.076 (1.471 to 2.21) |
| Lymphocytes (1000/cubic mm)- Day91 | 1.8455 (1.522 to 2.302) | 2.02 (1.6795 to 2.36) | — | 2.036 (1.668 to 2.253) |
| Lymphocytes (1000/cubic mm)- Day98 | 1.7605 (1.58 to 2.291) | 1.89 (1.601 to 2.247) | — | 2.085 (1.642 to 2.323) |
| Lymphocytes (1000/cubic mm)- Day182 | 1.969 (1.627 to 2.32) | 1.9905 (1.578 to 2.437) | 1.797 (1.481 to 2.17) | 1.9615 (1.751 to 2.263) |
| Lymphocytes (1000/cubic mm)- Day378 | 1.7105 (1.487 to 2.102) | 1.859 (1.643 to 2.202) | 1.871 (1.543 to 2.211) | 2.0975 (1.608 to 2.321) |
| Lymphocytes (1000/cubic mm)- Day455 | 1.753 (1.537 to 2.162) | 1.77 (1.51 to 2.087) | 1.9 (1.4515 to 2.1575) | 1.977 (1.548 to 2.22) |
| Neutrophils (1000/cubic mm)- Screening | 2.9315 (2.29 to 5.254) | 2.9575 (2.154 to 4.3915) | 2.986 (1.88 to 3.7035) | 3.2245 (2.311 to 4.0635) |
| Neutrophils (1000/cubic mm)- Day0 | — | — | 3.1935 (2.207 to 3.928) | — |
| Neutrophils (1000/cubic mm)- Day1 | — | — | 4.482 (3.854 to 5.877) | — |
| Neutrophils (1000/cubic mm)- Day3 | — | — | 2.82 (2.218 to 4.488) | — |
| Neutrophils (1000/cubic mm)- Day7 | 2.903 (2.196 to 4.0295) | 2.84 (2.46 to 4.201) | 2.567 (1.9935 to 3.268) | 2.5425 (2.292 to 3.45) |
| Neutrophils (1000/cubic mm)- Day42 | 2.687 (1.863 to 3.2) | 2.9545 (2.246 to 3.605) | 2.6145 (1.761 to 3.142) | 2.679 (2.02 to 3.412) |
| Neutrophils (1000/cubic mm)- Day84 | 3.065 (1.953 to 5.112) | 3.82 (2.521 to 4.914) | 1.739 (1.56 to 1.806) | 3.114 (2.024 to 3.748) |
| Neutrophils (1000/cubic mm)- Day85 | 4.224 (3.41 to 5.2045) | 5.1475 (3.9985 to 6.6755) | — | 3.355 (2.415 to 3.872) |
| Neutrophils (1000/cubic mm)- Day87 | 2.798 (1.794 to 4.522) | 3.214 (2.66 to 4.71) | — | 2.352 (1.868 to 3.389) |
| Neutrophils (1000/cubic mm)- Day91 | 3.34 (2.42 to 4.598) | 3.65 (3.096 to 4.8395) | — | 3.407 (2.084 to 3.667) |
| Neutrophils (1000/cubic mm)- Day98 | 2.4375 (1.6465 to 3.898) | 2.814 (1.841 to 3.51) | — | 2.94 (2.157 to 3.657) |
| Neutrophils (1000/cubic mm)- Day182 | 2.734 (1.83 to 3.304) | 2.4915 (1.811 to 3.812) | 2.3075 (1.78 to 2.844) | 2.6895 (2.324 to 3.412) |
| Neutrophils (1000/cubic mm)- Day378 | 2.6995 (2.0775 to 3.781) | 2.535 (1.92 to 3.34) | 2.292 (1.913 to 3.248) | 2.811 (2.13 to 3.41) |
| Neutrophils (1000/cubic mm)- Day455 | 2.5 (1.837 to 3.342) | 2.282 (1.748 to 3.921) | 2.2415 (1.77 to 3.1005) | 2.2905 (1.769 to 3.08) |
For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population.
| thousand cells/cubic mm | 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) |
|---|---|---|---|---|
| WBC (1000/cubic mm)- Screening | 5.805 (5.015 to 8.18) | 5.5 (4.83 to 6.97) | 5.575 (4.23 to 6.57) | 6.415 (5.525 to 7.3) |
| WBC (1000/cubic mm)- Day0 | — | — | 5.67 (4.53 to 7.23) | — |
| WBC (1000/cubic mm)- Day1 | — | — | 7.18 (6.49 to 8.53) | — |
| WBC (1000/cubic mm)- Day3 | — | — | 5.74 (4.51 to 7.04) | — |
| WBC (1000/cubic mm)- Day7 | 5.5 (4.49 to 7.07) | 5.56 (4.88 to 6.69) | 5.275 (4.24 to 6.005) | 5.36 (4.43 to 6.64) |
| WBC (1000/cubic mm)- Day42 | 4.89 (4.02 to 6.64) | 5.3 (4.63 to 6.09) | 5.05 (4.38 to 6.12) | 5.31 (4.09 to 6.17) |
| WBC (1000/cubic mm)- Day84 | 5.66 (4.19 to 7.33) | 5.95 (5.13 to 7.73) | 4.21 (3.86 to 4.48) | 5.42 (4.79 to 6.53) |
| WBC (1000/cubic mm)- Day85 | 6.965 (5.62 to 7.535) | 7.685 (6.38 to 9.15) | — | 5.8 (4.97 to 7.17) |
| WBC (1000/cubic mm)- Day87 | 5.55 (3.58 to 7.92) | 5.84 (5.31 to 7.38) | — | 4.88 (4.2 to 6.53) |
| WBC (1000/cubic mm)- Day91 | 6.39 (4.35 to 8.8) | 6.585 (5.275 to 7.03) | — | 5.305 (4.57 to 6.85) |
| WBC (1000/cubic mm)- Day98 | 4.935 (3.945 to 6.65) | 5.22 (4.54 to 6.18) | — | 5.5 (4.52 to 6.29) |
| WBC (1000/cubic mm)- Day182 | 5.17 (4.22 to 6.61) | 5 (4.4 to 6.06) | 4.895 (4.19 to 5.98) | 5.405 (4.64 to 6.66) |
| WBC (1000/cubic mm)- Day378 | 5.37 (4.265 to 5.895) | 5.05 (4.07 to 5.75) | 5.06 (4.08 to 6.03) | 5.67 (4.62 to 6.06) |
| WBC (1000/cubic mm)- Day455 | 4.795 (3.55 to 6.61) | 4.62 (3.78 to 6.33) | 4.565 (4.035 to 5.675) | 4.745 (3.96 to 5.93) |
| Platelets (1000/cubic mm)- Screening | 269.5 (232.5 to 321.5) | 269.5 (226.5 to 301.5) | 255.5 (224.5 to 298.5) | 260.5 (236 to 307) |
| Platelets (1000/cubic mm)- Day0 | — | — | 269 (234 to 307) | — |
| Platelets (1000/cubic mm)- Day1 | — | — | 252 (232 to 292) | — |
| Platelets (1000/cubic mm)- Day3 | — | — | 242 (224 to 282) | — |
| Platelets (1000/cubic mm)- Day7 | 269.5 (234.5 to 309) | 286 (232 to 305) | 256 (220 to 292) | 286 (239 to 306) |
| Platelets (1000/cubic mm)- Day42 | 267 (226 to 318) | 277 (238 to 307) | 256 (230 to 321) | 257.5 (244 to 302) |
| Platelets (1000/cubic mm)- Day84 | 277 (251 to 311) | 261 (218 to 320) | 189 (126 to 250) | 271 (228 to 334) |
| Platelets (1000/cubic mm)- Day85 | 272.5 (244 to 323.5) | 281 (237.5 to 318.5) | — | 272 (215 to 309) |
| Platelets (1000/cubic mm)- Day87 | 283 (241 to 320) | 273 (237 to 319) | — | 265 (235 to 299) |
| Platelets (1000/cubic mm)- Day91 | 286 (241 to 339) | 279.5 (256.5 to 309.5) | — | 289.5 (245 to 315) |
| Platelets (1000/cubic mm)- Day98 | 260 (235.5 to 317) | 256 (232 to 326) | — | 276 (231 to 321) |
| Platelets (1000/cubic mm)- Day182 | 282 (239 to 306) | 272 (234 to 322) | 245.5 (222 to 287) | 256 (238 to 308) |
| Platelets (1000/cubic mm)- Day378 | 274 (243.5 to 316.5) | 282 (245 to 318) | 262 (241 to 314) | 275.5 (237 to 323) |
| Platelets (1000/cubic mm)- Day455 | 265.5 (220 to 308) | 275 (233 to 292) | 262 (219 to 292.5) | 259 (223 to 273) |
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.
| Participants | 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) |
|---|---|---|---|---|
| AST (U/L)- Day7 | 0 | 0 | 0 | 1 |
| AST (U/L)- Day42 | 1 | 1 | 0 | 2 |
| AST (U/L)- Day98 | 1 | 1 | — | 0 |
| AST (U/L)- Day182 | 0 | 0 | 2 | 0 |
| AST (U/L)- Day378 | 0 | 0 | 2 | 1 |
| ALT (SGPT) (U/L)- Day7 | 0 | 1 | 0 | 0 |
| ALT (SGPT) (U/L)- Day42 | 2 | 1 | 1 | 1 |
| ALT (SGPT) (U/L)- Day84 | — | — | 1 | — |
| ALT (SGPT) (U/L)- Day98 | 1 | 1 | — | 0 |
| ALT (SGPT) (U/L)- Day182 | 0 | 0 | 1 | 0 |
| ALT (SGPT) (U/L)- Day378 | 0 | 0 | 1 | 0 |
| Hemoglobin (g/dL)- Day7 | 0 | 1 | 0 | 0 |
| Hemoglobin (g/dL)- Day42 | 1 | 0 | 0 | 0 |
| Hemoglobin (g/dL)- Day84 | 0 | 0 | 0 | 2 |
| Hemoglobin (g/dL)- Day85 | 0 | 1 | — | 0 |
| Hemoglobin (g/dL)- Day87 | 0 | 1 | — | 0 |
| Hemoglobin (g/dL)- Day91 | 0 | 1 | — | 1 |
| Hemoglobin (g/dL)- Day98 | 0 | 1 | — | 1 |
| Hemoglobin (g/dL)- Day182 | 0 | 2 | 1 | 0 |
| Hemoglobin (g/dL)- Day378 | 2 | 2 | 0 | 0 |
| Hemoglobin (g/dL)- Day455 | 0 | 1 | 0 | 0 |
| Creatinine (g/dL)- Day7 | 4 | 1 | 1 | 2 |
| Creatinine (g/dL)- Day42 | 3 | 1 | 0 | 0 |
| Creatinine (g/dL)- Day84 | 1 | — | — | — |
| Creatinine (g/dL)- Day98 | 4 | 4 | — | 0 |
| Creatinine (g/dL)- Day182 | 3 | 2 | 3 | 0 |
| Creatinine (g/dL)- Day378 | 4 | 1 | 1 | 0 |
| Creatinine (g/dL)- Day455 | 1 | 0 | 0 | 0 |
| Platelets (1000/cubic mm)- Day7 | 0 | 0 | 1 | 0 |
| Platelets (1000/cubic mm)- Day42 | 0 | 0 | 1 | 0 |
| Platelets (1000/cubic mm)- Day182 | 0 | 0 | 1 | 0 |
| Neutrophils (1000/cubic mm)- Day91 | 1 | 0 | — | 0 |
| Neutrophils (1000/cubic mm)- Day98 | 1 | 0 | — | 0 |
| Neutrophils (1000/cubic mm)- Day182 | 1 | 1 | 0 | 0 |
| Neutrophils (1000/cubic mm)- Day378 | 1 | 1 | 1 | 0 |
There were no early study terminations associated with an AE or reactogenicity reported by any participant.
| Participants | Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) gp120/MF59 mo(3,6,12) | Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) gp120+Alum mo(3,6,12) | Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12)p120/MF59 mo(0,1,6,12) | Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) gp120 mo(3,6,12) |
|---|---|---|---|---|
| Number of Participants With Early Study Termination Associated With an AE or Reactogenicity | 0 | 0 | 0 | 0 |
From the study product discontinuation form, study product discontinuation reasons are tabulated by treatment arm.
| Participants | 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) |
|---|---|---|---|---|
| Clinical event other than reactogenicity | 1 | 1 | 0 | 0 |
| Reactogenicity | 0 | 0 | 0 | 0 |
| Other reason | 4 | 3 | 4 | 6 |
| No discontinuation | 31 | 32 | 32 | 18 |
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.
| Participants | 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) |
|---|---|---|---|---|
| 1086C_D7gp120.avi/293F (Month 6.5) | 29 | 26 | 32 | 17 |
| 96ZM651.D11gp120.avi (Month 6.5) | 27 | 27 | 30 | 17 |
| TV1c8_D11gp120.avi/293F (Month 6.5) | 29 | 27 | 32 | 17 |
| 1086C_D7gp120.avi/293F (Month 12) | 29 | 26 | 29 | 17 |
| 96ZM651.D11gp120.avi (Month 12) | 7 | 5 | 25 | 1 |
| TV1c8_D11gp120.avi/293F (Month 12) | 25 | 22 | 29 | 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).
| relative fluorescence units | 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) |
|---|---|---|---|---|
| 1086C_D7gp120.avi/293F (Month 6.5) | 22000 (22000 to 22000) | 22000 (22000 to 22000) | 22000 (22000 to 22000) | 22000 (22000 to 22000) |
| 96ZM651.D11gp120.avi (Month 6.5) | 22000 (22000 to 22000) | 22000 (22000 to 22000) | 22000 (22000 to 22000) | 22000 (13363 to 22000) |
| TV1c8_D11gp120.avi/293F (Month 6.5) | 22000 (22000 to 22000) | 22000 (22000 to 22000) | 22000 (22000 to 22000) | 22000 (22000 to 22000) |
| 1086C_D7gp120.avi/293F (Month 12) | 6759.8 (3662.2 to 15765.5) | 11657.1 (3131.1 to 18042.6) | 22000 (13782 to 22000) | 4265.8 (2385 to 8666.5) |
| 96ZM651.D11gp120.avi (Month 12) | 3182.8 (1705.4 to 4285.9) | 2167.8 (1767.5 to 2524.8) | 3000 (1871.5 to 6561) | 1676 (1676 to 1676) |
| TV1c8_D11gp120.avi/293F (Month 12) | 1252.5 (686 to 3761.2) | 1660 (892.6 to 2898.4) | 10750 (5326.5 to 22000) | 1086 (442.6 to 2429.1) |
| 1086C_D7gp120.avi/293F (Month 12.5) | 22000 (22000 to 22000) | 22000 (22000 to 22000) | 22000 (22000 to 22000) | 22000 (22000 to 22000) |
| 96ZM651.D11gp120.avi (Month 12.5) | 22000 (22000 to 22000) | 22000 (22000 to 22000) | 22000 (22000 to 22000) | 22000 (22000 to 22000) |
| TV1c8_D11gp120.avi/293F (Month 12.5) | 22000 (22000 to 22000) | 22000 (22000 to 22000) | 22000 (22000 to 22000) | 22000 (22000 to 22000) |
| 1086C_D7gp120.avi/293F (Month 18) | 22000 (13447.4 to 22000) | 22000 (17031.4 to 22000) | 22000 (16465.8 to 22000) | 16187 (8260.8 to 22000) |
| 96ZM651.D11gp120.avi (Month 18) | 6135.8 (4058.2 to 10887) | 5439 (2617.8 to 8736.1) | 5372.6 (3140.4 to 12123.9) | 2794 (2226 to 4364.1) |
| TV1c8_D11gp120.avi/293F (Month 18) | 8367.6 (2745.8 to 21097.6) | 8893.4 (3450.6 to 20507.7) | 20549 (8176.7 to 22000) | 6794.5 (2788.2 to 9961.5) |
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.
| Participants | 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) |
|---|---|---|---|---|
| 00MSA 4076 gp140 (Month 6.5) | 27 | 27 | 30 | 15 |
| A1.con.env03 140 CF (Month 6.5) | 27 | 27 | 31 | 17 |
| AE.A244 V1V2 Tags/293F (Month 6.5) | 22 | 23 | 28 | 11 |
| C.1086C_V1_V2 Tags (Month 6.5) | 14 | 13 | 16 | 2 |
| Con 6 gp120/B (Month 6.5) | 26 | 26 | 29 | 17 |
| Con S gp140 CFI (Month 6.5) | 29 | 27 | 32 | 17 |
| gp41 (Month 6.5) | 0 | 1 | 0 | 0 |
| gp70-96ZM651.02 V1v2 (Month 6.5) | 8 | 13 | 19 | 4 |
| gp70-TV1.GSKvacV1V2/293F (Month 6.5) | 17 | 15 | 26 | 4 |
| gp70_B.CaseA2 V1/V2/169K (Month 6.5) | 10 | 14 | 24 | 4 |
| gp70_B.CaseA_V1_V2 (Month 6.5) | 9 | 13 | 25 | 3 |
| 00MSA 4076 gp140 (Month 12) | 4 | 1 | 12 | 1 |
| A1.con.env03 140 CF (Month 12) | 15 | 14 | 25 | 5 |
| AE.A244 V1V2 Tags/293F (Month 12) | 4 | 6 | 6 | 1 |
| C.1086C_V1_V2 Tags (Month 12) | 0 | 0 | 0 | 1 |
| Con 6 gp120/B (Month 12) | 3 | 1 | 14 | 1 |
| Con S gp140 CFI (Month 12) | 22 | 25 | 30 | 13 |
| gp41 (Month 12) | 0 | 0 | 0 | 1 |
| gp70-96ZM651.02 V1v2 (Month 12) | 0 | 1 | 2 | 0 |
| gp70-TV1.GSKvacV1V2/293F (Month 12) | 1 | 2 | 6 | 1 |
| gp70_B.CaseA2 V1/V2/169K (Month 12) | 1 | 2 | 3 | 0 |
| gp70_B.CaseA_V1_V2 (Month 12) | 1 | 1 | 4 | 0 |
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).
| relative fluorescence units | 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) |
|---|---|---|---|---|
| 00MSA 4076 gp140 (Month 6.5) | 18852.2 (10385.8 to 22000) | 11851.2 (4795.8 to 20954.4) | 22000 (19705.7 to 22000) | 9648.8 (4793.4 to 18959) |
| A1.con.env03 140 CF (Month 6.5) | 21481.5 (10941 to 22000) | 15307.5 (7928.9 to 22000) | 22000 (19518.4 to 22000) | 12791.2 (6158.2 to 21474) |
| AE.A244 V1V2 Tags/293F (Month 6.5) | 7008.2 (1079.8 to 9841.2) | 4347.5 (2171.8 to 7081.4) | 3203 (1343.1 to 10818.8) | 489 (409.5 to 2427.8) |
| C.1086C_V1_V2 Tags (Month 6.5) | 1284.5 (1139.7 to 1831.6) | 954.5 (866.2 to 3260) | 1830.8 (1104.4 to 2254.2) | 865.6 (796.6 to 934.7) |
| Con 6 gp120/B (Month 6.5) | 21899.6 (11363.6 to 22000) | 14046.6 (9418.1 to 22000) | 22000 (22000 to 22000) | 9978 (5492 to 20428.5) |
| Con S gp140 CFI (Month 6.5) | 22000 (22000 to 22000) | 22000 (22000 to 22000) | 22000 (22000 to 22000) | 22000 (22000 to 22000) |
| gp41 (Month 6.5) | — | 4472.8 (4472.8 to 4472.8) | — | — |
| gp70-96ZM651.02 V1v2 (Month 6.5) | 968 (745.2 to 1412.3) | 1963 (1040.5 to 4739.8) | 2631.8 (1444 to 6033.8) | 1219.4 (695.3 to 1835.2) |
| gp70-TV1.GSKvacV1V2/293F (Month 6.5) | 714.8 (386.5 to 1925) | 1367.5 (916.9 to 4679.8) | 6205.1 (1550.6 to 13995.4) | 727.1 (430.1 to 1152.1) |
| gp70_B.CaseA2 V1/V2/169K (Month 6.5) | 1476 (587.5 to 3383) | 1888.8 (1204.9 to 4129) | 6450.5 (1593.2 to 8631.6) | 406.9 (355.6 to 725.1) |
| gp70_B.CaseA_V1_V2 (Month 6.5) | 1368.8 (727 to 3992.5) | 1292.5 (819.5 to 5713.8) | 4521.2 (1193.5 to 10484) | 651.8 (520.8 to 1328.8) |
| 00MSA 4076 gp140 (Month 12) | 1557.1 (919.9 to 2207.1) | 1390.2 (1390.2 to 1390.2) | 1425.8 (1151.9 to 2257.9) | 952 (952 to 952) |
| A1.con.env03 140 CF (Month 12) | 286.5 (199.6 to 483.8) | 318.1 (206.5 to 527.6) | 834.8 (360 to 1718) | 339.2 (169.8 to 709.2) |
| AE.A244 V1V2 Tags/293F (Month 12) | 290.4 (226 to 497.6) | 237.5 (196.7 to 270.4) | 279.2 (245.8 to 309.8) | 124.2 (124.2 to 124.2) |
| C.1086C_V1_V2 Tags (Month 12) | — | — | — | 1296.8 (1296.8 to 1296.8) |
| Con 6 gp120/B (Month 12) | 2429.8 (1981.9 to 3020.2) | 1139.8 (1139.8 to 1139.8) | 1908.5 (1479.8 to 2280.8) | 2036.8 (2036.8 to 2036.8) |
| Con S gp140 CFI (Month 12) | 954 (556.6 to 2888.4) | 1599 (916.2 to 2333.5) | 6908.8 (2639.8 to 14532.9) | 680.2 (397 to 1169) |
| gp41 (Month 12) | — | — | — | 9264 (9264 to 9264) |
| gp70-96ZM651.02 V1v2 (Month 12) | — | 1264.8 (1264.8 to 1264.8) | 819.9 (561.7 to 1078.1) | — |
| gp70-TV1.GSKvacV1V2/293F (Month 12) | 495.2 (495.2 to 495.2) | 502.4 (421.6 to 583.2) | 722.4 (218.6 to 1481.9) | 2504.8 (2504.8 to 2504.8) |
| gp70_B.CaseA2 V1/V2/169K (Month 12) | 693.8 (693.8 to 693.8) | 559.9 (490.7 to 629.1) | 427 (378.2 to 1999.4) | — |
| gp70_B.CaseA_V1_V2 (Month 12) | 949 (949 to 949) | 442.5 (442.5 to 442.5) | 487.2 (283.1 to 1070) | — |
| 00MSA 4076 gp140 (Month 12.5) | 22000 (18877.6 to 22000) | 22000 (13449.4 to 22000) | 22000 (17787.8 to 22000) | 22000 (11267.2 to 22000) |
| A1.con.env03 140 CF (Month 12.5) | 22000 (20752 to 22000) | 22000 (17453.4 to 22000) | 22000 (22000 to 22000) | 22000 (16264.4 to 22000) |
| AE.A244 V1V2 Tags/293F (Month 12.5) | 4553.5 (2286.2 to 9393.8) | 3313.8 (1245.9 to 10641.6) | 5728.8 (2011.8 to 10929.1) | 1034.2 (482.6 to 5401.9) |
| C.1086C_V1_V2 Tags (Month 12.5) | 2021.2 (1142.2 to 3862.8) | 3476 (906 to 6288.5) | 3484.6 (994 to 8674.6) | 1380.2 (601 to 3883) |
| Con 6 gp120/B (Month 12.5) | 22000 (22000 to 22000) | 22000 (20433.4 to 22000) | 22000 (22000 to 22000) | 22000 (15222.2 to 22000) |
| Con S gp140 CFI (Month 12.5) | 22000 (22000 to 22000) | 22000 (22000 to 22000) | 22000 (22000 to 22000) | 22000 (22000 to 22000) |
| gp41 (Month 12.5) | — | — | 4644.8 (3651.8 to 13322.4) | 8348.5 (5951.1 to 10745.9) |
| gp70-96ZM651.02 V1v2 (Month 12.5) | 1427.2 (891.8 to 9947.6) | 3770.8 (1125 to 10077.4) | 8793.6 (1318.6 to 21615.9) | 1639.8 (1290.2 to 6055.9) |
| gp70-TV1.GSKvacV1V2/293F (Month 12.5) | 1407.4 (993.3 to 3027.4) | 2057.8 (714.5 to 6260.2) | 12436.5 (1806.4 to 22000) | 2031.8 (1158.8 to 4055.5) |
| gp70_B.CaseA2 V1/V2/169K (Month 12.5) | 1213.2 (734.6 to 3588.6) | 2332.9 (732.9 to 5249.1) | 8987.2 (2613.6 to 22000) | 1324.4 (941.3 to 3481.6) |
| gp70_B.CaseA_V1_V2 (Month 12.5) | 763.5 (670.1 to 3615.2) | 2246.5 (999.1 to 5417.9) | 8372.5 (1587.8 to 21441.9) | 2869.5 (1171.8 to 4368.3) |
| 00MSA 4076 gp140 (Month 18) | 1954 (1242.2 to 3022) | 2546.9 (1072.2 to 7260.1) | 1571 (1131.2 to 3575.8) | 1351.9 (1189.6 to 1367.8) |
| A1.con.env03 140 CF (Month 18) | 1106 (444.2 to 2628) | 1552.5 (607 to 3231.8) | 1853.2 (929.5 to 4194.5) | 961.5 (695.8 to 1429.6) |
| AE.A244 V1V2 Tags/293F (Month 18) | 137 (110.2 to 484) | 462 (371.2 to 512.5) | 362.2 (194.8 to 1003.6) | 445.9 (429.3 to 462.4) |
| C.1086C_V1_V2 Tags (Month 18) | 1204.5 (1204.5 to 1204.5) | 1523.2 (1067.4 to 5288.9) | 821.8 (714.1 to 2419.4) | 909 (909 to 909) |
| Con 6 gp120/B (Month 18) | 2373.2 (1574 to 4438.2) | 2805 (1459.5 to 4348.8) | 2405.5 (1517.5 to 4459.5) | 1185.2 (993.6 to 1463.2) |
| Con S gp140 CFI (Month 18) | 8793.8 (3178.8 to 16947.8) | 9031.1 (3772.2 to 22000) | 13261.8 (7458.2 to 22000) | 5032.5 (3082 to 9318.4) |
| gp41 (Month 18) | — | 2549.2 (2549.2 to 2549.2) | 7284.8 (5785.5 to 14642.4) | 19096.5 (19096.5 to 19096.5) |
| gp70-96ZM651.02 V1v2 (Month 18) | 370.8 (370.8 to 370.8) | 584 (541.4 to 872.1) | 987.8 (590.4 to 1672.9) | 2221.8 (2221.8 to 2221.8) |
| gp70-TV1.GSKvacV1V2/293F (Month 18) | 163.1 (125.2 to 272.5) | 180.2 (130.4 to 208.4) | 1319.2 (605.5 to 1729.8) | 1114.2 (1114.2 to 1114.2) |
| gp70_B.CaseA2 V1/V2/169K (Month 18) | 244.5 (244.5 to 244.5) | 1593.8 (914.8 to 1638.4) | 1332 (425 to 1556) | 1227.5 (1227.5 to 1227.5) |
| gp70_B.CaseA_V1_V2 (Month 18) | 314.2 (314.2 to 314.2) | 1717.6 (1210.9 to 2224.3) | 623.8 (383.3 to 886.9) | 593.2 (593.2 to 593.2) |
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.
| Participants | 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) |
|---|---|---|---|---|
| 1086 gp120 (Month 6.5) | 15 | 19 | 16 | 6 |
| Any Env (Month 6.5) | 16 | 20 | 21 | 8 |
| Any HIV (Month 6.5) | 17 | 20 | 21 | 8 |
| Env ZM96 (Month 6.5) | 12 | 14 | 8 | 5 |
| Env-1-ZM96 (Month 6.5) | 12 | 15 | 7 | 5 |
| Env-2-ZM96 (Month 6.5) | 3 | 5 | 6 | 1 |
| LAI Gag (Month 6.5) | 1 | 0 | 1 | 2 |
| TV1 gp120 (Month 6.5) | 15 | 20 | 20 | 6 |
| 1086 gp120 (Month 12) | 6 | 13 | 10 | 0 |
| Any Env (Month 12) | 9 | 16 | 13 | 5 |
| Any HIV (Month 12) | 10 | 16 | 14 | 5 |
| Env ZM96 (Month 12) | 6 | 9 | 4 | 4 |
| Env-1-ZM96 (Month 12) | 6 | 9 | 4 | 5 |
| Env-2-ZM96 (Month 12) | 1 | 4 | 2 | 0 |
| LAI Gag (Month 12) | 1 | 2 | 1 | 1 |
| TV1 gp120 (Month 12) | 8 | 17 | 13 | 2 |
| 1086 gp120 (Month 12.5) | 15 | 21 | 12 | 5 |
| Any Env (Month 12.5) | 25 | 24 | 18 | 9 |
| Any HIV (Month 12.5) | 25 | 24 | 19 | 9 |
| Env ZM96 (Month 12.5) | 15 | 20 | 6 | 8 |
| Env-1-ZM96 (Month 12.5) | 15 | 20 | 5 | 9 |
| Env-2-ZM96 (Month 12.5) | 1 | 8 | 4 | 0 |
| LAI Gag (Month 12.5) | 1 | 2 | 1 | 1 |
| TV1 gp120 (Month 12.5) | 20 | 24 | 16 | 8 |
| 1086 gp120 (Month 18) | 9 | 21 | 10 | 5 |
| Any Env (Month 18) | 16 | 23 | 13 | 9 |
| Any HIV (Month 18) | 17 | 23 | 14 | 9 |
| Env ZM96 (Month 18) | 14 | 18 | 4 | 6 |
| Env-1-ZM96 (Month 18) | 14 | 20 | 3 | 6 |
| Env-2-ZM96 (Month 18) | 0 | 4 | 2 | 0 |
| LAI Gag (Month 18) | 1 | 2 | 1 | 0 |
| TV1 gp120 (Month 18) | 11 | 23 | 11 | 7 |
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.
| % CD4+ T-cells | 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) |
|---|---|---|---|---|
| 1086 gp120 (Month 6.5) | 0.209 (0.115 to 0.259) | 0.181 (0.123 to 0.277) | 0.222 (0.08 to 0.294) | 0.124 (0.108 to 0.161) |
| Any Env (Month 6.5) | 0.216 (0.136 to 0.339) | 0.182 (0.145 to 0.407) | 0.149 (0.121 to 0.332) | 0.142 (0.115 to 0.209) |
| Any HIV (Month 6.5) | 0.221 (0.136 to 0.358) | 0.221 (0.158 to 0.43) | 0.202 (0.118 to 0.319) | 0.148 (0.135 to 0.291) |
| Env ZM96 (Month 6.5) | 0.224 (0.104 to 0.339) | 0.162 (0.142 to 0.276) | 0.237 (0.194 to 0.255) | 0.137 (0.133 to 0.262) |
| Env-1-ZM96 (Month 6.5) | 0.186 (0.078 to 0.269) | 0.151 (0.098 to 0.233) | 0.16 (0.136 to 0.162) | 0.13 (0.117 to 0.189) |
| Env-2-ZM96 (Month 6.5) | 0.107 (0.1 to 0.147) | 0.067 (0.059 to 0.102) | 0.097 (0.084 to 0.111) | 0.072 (0.072 to 0.072) |
| LAI Gag (Month 6.5) | 0.108 (0.108 to 0.108) | — | 0.09 (0.09 to 0.09) | 0.092 (0.082 to 0.102) |
| TV1 gp120 (Month 6.5) | 0.193 (0.114 to 0.258) | 0.175 (0.135 to 0.326) | 0.152 (0.11 to 0.275) | 0.132 (0.104 to 0.184) |
| 1086 gp120 (Month 12) | 0.173 (0.156 to 0.199) | 0.157 (0.117 to 0.322) | 0.153 (0.127 to 0.177) | — |
| Any Env (Month 12) | 0.15 (0.119 to 0.286) | 0.185 (0.116 to 0.298) | 0.156 (0.095 to 0.255) | 0.124 (0.089 to 0.176) |
| Any HIV (Month 12) | 0.149 (0.104 to 0.281) | 0.206 (0.134 to 0.317) | 0.161 (0.11 to 0.264) | 0.167 (0.124 to 0.172) |
| Env ZM96 (Month 12) | 0.238 (0.131 to 0.307) | 0.146 (0.13 to 0.365) | 0.157 (0.133 to 0.197) | 0.133 (0.083 to 0.178) |
| Env-1-ZM96 (Month 12) | 0.215 (0.134 to 0.225) | 0.125 (0.092 to 0.196) | 0.085 (0.077 to 0.128) | 0.107 (0.089 to 0.17) |
| Env-2-ZM96 (Month 12) | 0.101 (0.101 to 0.101) | 0.113 (0.056 to 0.172) | 0.072 (0.066 to 0.077) | — |
| LAI Gag (Month 12) | 0.065 (0.065 to 0.065) | 0.053 (0.05 to 0.056) | 0.159 (0.159 to 0.159) | 0.056 (0.056 to 0.056) |
| TV1 gp120 (Month 12) | 0.124 (0.095 to 0.286) | 0.172 (0.109 to 0.237) | 0.118 (0.089 to 0.219) | 0.087 (0.078 to 0.097) |
| 1086 gp120 (Month 12.5) | 0.118 (0.097 to 0.189) | 0.158 (0.13 to 0.298) | 0.142 (0.104 to 0.259) | 0.161 (0.105 to 0.18) |
| Any Env (Month 12.5) | 0.172 (0.105 to 0.215) | 0.277 (0.148 to 0.472) | 0.138 (0.103 to 0.236) | 0.18 (0.096 to 0.207) |
| Any HIV (Month 12.5) | 0.172 (0.127 to 0.209) | 0.314 (0.165 to 0.526) | 0.148 (0.112 to 0.263) | 0.188 (0.125 to 0.252) |
| Env ZM96 (Month 12.5) | 0.149 (0.077 to 0.248) | 0.172 (0.124 to 0.288) | 0.202 (0.146 to 0.242) | 0.126 (0.099 to 0.201) |
| Env-1-ZM96 (Month 12.5) | 0.14 (0.092 to 0.257) | 0.135 (0.099 to 0.183) | 0.157 (0.098 to 0.173) | 0.106 (0.096 to 0.206) |
| Env-2-ZM96 (Month 12.5) | 0.128 (0.128 to 0.128) | 0.163 (0.087 to 0.258) | 0.084 (0.075 to 0.094) | — |
| LAI Gag (Month 12.5) | 0.11 (0.11 to 0.11) | 0.085 (0.071 to 0.099) | 0.136 (0.136 to 0.136) | 0.081 (0.081 to 0.081) |
| TV1 gp120 (Month 12.5) | 0.133 (0.103 to 0.228) | 0.275 (0.138 to 0.379) | 0.138 (0.112 to 0.233) | 0.147 (0.1 to 0.236) |
| 1086 gp120 (Month 18) | 0.106 (0.095 to 0.126) | 0.121 (0.093 to 0.237) | 0.121 (0.099 to 0.133) | 0.107 (0.089 to 0.116) |
| Any Env (Month 18) | 0.117 (0.082 to 0.19) | 0.169 (0.096 to 0.272) | 0.122 (0.121 to 0.157) | 0.123 (0.085 to 0.164) |
| Any HIV (Month 18) | 0.105 (0.079 to 0.186) | 0.156 (0.115 to 0.329) | 0.129 (0.102 to 0.178) | 0.123 (0.115 to 0.187) |
| Env ZM96 (Month 18) | 0.085 (0.062 to 0.132) | 0.133 (0.087 to 0.155) | 0.117 (0.114 to 0.121) | 0.133 (0.093 to 0.165) |
| Env-1-ZM96 (Month 18) | 0.09 (0.07 to 0.131) | 0.111 (0.078 to 0.131) | 0.077 (0.072 to 0.083) | 0.124 (0.081 to 0.14) |
| Env-2-ZM96 (Month 18) | — | 0.132 (0.118 to 0.175) | 0.064 (0.055 to 0.072) | — |
| LAI Gag (Month 18) | 0.076 (0.076 to 0.076) | 0.059 (0.051 to 0.067) | 0.07 (0.07 to 0.07) | — |
| TV1 gp120 (Month 18) | 0.109 (0.084 to 0.217) | 0.158 (0.105 to 0.258) | 0.122 (0.11 to 0.168) | 0.085 (0.076 to 0.113) |
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.
| Participants | 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) |
|---|---|---|---|---|
| 1086C_D7gp120.avi/293F (Month 6.5) | 28 | 27 | 30 | 18 |
| 96ZM651.D11gp120.avi (Month 6.5) | 27 | 24 | 26 | 16 |
| AE.A244 V1V2 Tags/293F (Month 6.5) | 9 | 13 | 14 | 3 |
| C.1086C_V1_V2 Tags (Month 6.5) | 9 | 12 | 13 | 2 |
| Con 6 gp120/B (Month 6.5) | 19 | 22 | 18 | 15 |
| Con S gp140 CFI (Month 6.5) | 28 | 27 | 25 | 17 |
| TV1c8_D11gp120.avi/293F (Month 6.5) | 27 | 26 | 29 | 17 |
| gp41 (Month 6.5) | 0 | 0 | 0 | 0 |
| gp70-96ZM651.02 V1v2 (Month 6.5) | 2 | 3 | 7 | 0 |
| gp70-TV1.GSKvacV1V2/293F (Month 6.5) | 3 | 3 | 10 | 0 |
| gp70_B.CaseA2 V1/V2/169K (Month 6.5) | 3 | 3 | 7 | 0 |
| gp70_B.CaseA_V1_V2 (Month 6.5) | 2 | 2 | 7 | 0 |
| 1086C_D7gp120.avi/293F (Month 12) | 11 | 16 | 17 | 8 |
| 96ZM651.D11gp120.avi (Month 12) | 0 | 2 | 0 | 0 |
| AE.A244 V1V2 Tags/293F (Month 12) | 1 | 0 | 2 | 0 |
| C.1086C_V1_V2 Tags (Month 12) | 0 | 0 | 0 | 0 |
| Con 6 gp120/B (Month 12) | 0 | 0 | 0 | 0 |
| Con S gp140 CFI (Month 12) | 1 | 2 | 1 | 0 |
| TV1c8_D11gp120.avi/293F (Month 12) | 3 | 3 | 5 | 2 |
| gp41 (Month 12) | 0 | 0 | 0 | 0 |
| gp70-96ZM651.02 V1v2 (Month 12) | 1 | 0 | 1 | 0 |
| gp70-TV1.GSKvacV1V2/293F (Month 12) | 1 | 0 | 1 | 0 |
| gp70_B.CaseA2 V1/V2/169K (Month 12) | 1 | 1 | 0 | 0 |
| gp70_B.CaseA_V1_V2 (Month 12) | 1 | 0 | 0 | 0 |
| 1086C_D7gp120.avi/293F (Month 12.5) | 28 | 28 | 29 | 15 |
| 96ZM651.D11gp120.avi (Month 12.5) | 14 | 17 | 14 | 8 |
| AE.A244 V1V2 Tags/293F (Month 12.5) | 6 | 9 | 13 | 4 |
| C.1086C_V1_V2 Tags (Month 12.5) | 4 | 7 | 10 | 1 |
| Con 6 gp120/B (Month 12.5) | 6 | 10 | 5 | 4 |
| Con S gp140 CFI (Month 12.5) | 18 | 21 | 19 | 10 |
| TV1c8_D11gp120.avi/293F (Month 12.5) | 25 | 25 | 28 | 13 |
| gp41 (Month 12.5) | 0 | 0 | 0 | 1 |
| gp70-96ZM651.02 V1v2 (Month 12.5) | 3 | 3 | 5 | 1 |
| gp70-TV1.GSKvacV1V2/293F (Month 12.5) | 2 | 2 | 8 | 0 |
| gp70_B.CaseA2 V1/V2/169K (Month 12.5) | 1 | 2 | 7 | 0 |
| gp70_B.CaseA_V1_V2 (Month 12.5) | 1 | 2 | 4 | 0 |
| 1086C_D7gp120.avi/293F (Month 18) | 11 | 16 | 15 | 4 |
| 96ZM651.D11gp120.avi (Month 18) | 0 | 0 | 0 | 0 |
| AE.A244 V1V2 Tags/293F (Month 18) | 1 | 0 | 5 | 0 |
| C.1086C_V1_V2 Tags (Month 18) | 0 | 0 | 0 | 0 |
| Con 6 gp120/B (Month 18) | 0 | 0 | 1 | 0 |
| Con S gp140 CFI (Month 18) | 4 | 4 | 0 | 0 |
| TV1c8_D11gp120.avi/293F (Month 18) | 6 | 6 | 4 | 2 |
| gp41 (Month 18) | 0 | 0 | 0 | 2 |
| gp70-96ZM651.02 V1v2 (Month 18) | 1 | 0 | 2 | 0 |
| gp70-TV1.GSKvacV1V2/293F (Month 18) | 1 | 0 | 1 | 0 |
| gp70_B.CaseA2 V1/V2/169K (Month 18) | 1 | 0 | 1 | 0 |
| gp70_B.CaseA_V1_V2 (Month 18) | 1 | 0 | 0 | 0 |
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).
| relative fluorescence units | 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) |
|---|---|---|---|---|
| 1086C_D7gp120.avi/293F (Month 6.5) | 3002.2 (1394.2 to 5955.3) | 3236 (2115.9 to 8234.4) | 2824 (1284.9 to 4232.1) | 2728.9 (1994.4 to 5368.3) |
| 96ZM651.D11gp120.avi (Month 6.5) | 810.5 (364.6 to 2145.9) | 594.5 (318.3 to 1383.3) | 448.1 (315.6 to 1256.3) | 613.2 (299.9 to 965.6) |
| AE.A244 V1V2 Tags/293F (Month 6.5) | 596.8 (267.8 to 1343.5) | 265 (162.2 to 547.5) | 527.2 (338.8 to 1143.7) | 135.2 (128.5 to 350.6) |
| C.1086C_V1_V2 Tags (Month 6.5) | 372.2 (154.5 to 885) | 218.4 (135.9 to 409.5) | 418.8 (274.8 to 1135.8) | 222.1 (173.3 to 270.9) |
| Con 6 gp120/B (Month 6.5) | 384.2 (256.2 to 619.1) | 299.2 (222.2 to 645.2) | 260.6 (168.3 to 431.9) | 197.2 (147.8 to 232.1) |
| Con S gp140 CFI (Month 6.5) | 653.1 (413.8 to 1959.5) | 936.8 (534.8 to 2301.9) | 497.8 (320 to 1017) | 435.2 (346.5 to 885) |
| TV1c8_D11gp120.avi/293F (Month 6.5) | 2134.8 (494 to 4958.9) | 1517.2 (618.8 to 2555.9) | 1306.2 (665 to 3785.2) | 2277 (1024.2 to 3621) |
| gp70-96ZM651.02 V1v2 (Month 6.5) | 3929.5 (2035.8 to 5823.2) | 790 (536 to 898.8) | 1142 (760.2 to 1352.5) | — |
| gp70-TV1.GSKvacV1V2/293F (Month 6.5) | 3242.8 (1691.4 to 5474.6) | 230.2 (223.8 to 407.2) | 512.6 (177.4 to 1562.3) | — |
| gp70_B.CaseA2 V1/V2/169K (Month 6.5) | 501.8 (339 to 6053.9) | 257.5 (250.9 to 440.6) | 1197 (473.6 to 1605) | — |
| gp70_B.CaseA_V1_V2 (Month 6.5) | 4118.6 (2113.9 to 6123.3) | 742 (498.8 to 985.2) | 858.5 (134.6 to 2379.6) | — |
| 1086C_D7gp120.avi/293F (Month 12) | 327 (195.5 to 453.1) | 288.8 (203.6 to 805.1) | 164.5 (121.8 to 301.2) | 220.4 (150.2 to 365.7) |
| 96ZM651.D11gp120.avi (Month 12) | — | 131.5 (129.2 to 133.8) | — | — |
| AE.A244 V1V2 Tags/293F (Month 12) | 148.2 (148.2 to 148.2) | — | 605.9 (363.3 to 848.4) | — |
| Con S gp140 CFI (Month 12) | 297.8 (297.8 to 297.8) | 100.4 (100.2 to 100.6) | 125.8 (125.8 to 125.8) | — |
| TV1c8_D11gp120.avi/293F (Month 12) | 128.8 (118.9 to 2735.2) | 148.8 (129.4 to 168) | 281.5 (236 to 1467.5) | 9282.5 (5013.1 to 13551.9) |
| gp70-96ZM651.02 V1v2 (Month 12) | 502.8 (502.8 to 502.8) | — | 268.8 (268.8 to 268.8) | — |
| gp70-TV1.GSKvacV1V2/293F (Month 12) | 874.8 (874.8 to 874.8) | — | 121.8 (121.8 to 121.8) | — |
| gp70_B.CaseA2 V1/V2/169K (Month 12) | 1348.5 (1348.5 to 1348.5) | 225 (225 to 225) | — | — |
| gp70_B.CaseA_V1_V2 (Month 12) | 798.2 (798.2 to 798.2) | — | — | — |
| 1086C_D7gp120.avi/293F (Month 12.5) | 1049.2 (390 to 2565.1) | 1184.2 (711.1 to 3716.6) | 1086.2 (606.8 to 2699.8) | 1739 (593.4 to 5582.2) |
| 96ZM651.D11gp120.avi (Month 12.5) | 300.9 (161.9 to 838.8) | 314.5 (149 to 681.5) | 314.9 (189.6 to 439.3) | 264.5 (203.9 to 391) |
| AE.A244 V1V2 Tags/293F (Month 12.5) | 283.9 (178.3 to 762) | 271 (193.5 to 666.2) | 480 (289.2 to 697) | 479.1 (308.5 to 5950.9) |
| C.1086C_V1_V2 Tags (Month 12.5) | 470 (320.7 to 1060.8) | 197.8 (152.6 to 332.5) | 379.2 (218.2 to 473) | 22000 (22000 to 22000) |
| Con 6 gp120/B (Month 12.5) | 284 (197.3 to 345.2) | 329.5 (174.1 to 376) | 540 (278.5 to 672.5) | 203 (131 to 510.4) |
| Con S gp140 CFI (Month 12.5) | 264.1 (179 to 623.1) | 322.8 (202.2 to 1225.2) | 208.2 (160.5 to 382.6) | 476.8 (118.7 to 581.4) |
| TV1c8_D11gp120.avi/293F (Month 12.5) | 586.8 (385.5 to 2959.5) | 673.8 (415 to 2072.2) | 439.4 (199.9 to 1111.1) | 1017.2 (708 to 3056.2) |
| gp41 (Month 12.5) | — | — | — | 3020.8 (3020.8 to 3020.8) |
| gp70-96ZM651.02 V1v2 (Month 12.5) | 157.8 (130.9 to 992.2) | 354 (287.8 to 431.9) | 2402.8 (1323.5 to 3308.5) | 4707.5 (4707.5 to 4707.5) |
| gp70-TV1.GSKvacV1V2/293F (Month 12.5) | 853.5 (564.1 to 1142.9) | 231.6 (181.9 to 281.3) | 487.8 (167.2 to 1114.6) | — |
| gp70_B.CaseA2 V1/V2/169K (Month 12.5) | 2010.8 (2010.8 to 2010.8) | 255.4 (191.4 to 319.3) | 551 (175 to 850.4) | — |
| gp70_B.CaseA_V1_V2 (Month 12.5) | 1262.5 (1262.5 to 1262.5) | 233.5 (205.1 to 261.9) | 1457.8 (642 to 2307.9) | — |
| 1086C_D7gp120.avi/293F (Month 18) | 204 (146.2 to 522.4) | 266.4 (172.9 to 555.9) | 167.5 (158.5 to 217.5) | 133 (109.4 to 236.1) |
| AE.A244 V1V2 Tags/293F (Month 18) | 187.8 (187.8 to 187.8) | — | 245.2 (197.2 to 479.5) | — |
| Con 6 gp120/B (Month 18) | — | — | 368.8 (368.8 to 368.8) | — |
| Con S gp140 CFI (Month 18) | 126.6 (100 to 155.2) | 136.6 (126.4 to 156.8) | — | — |
| TV1c8_D11gp120.avi/293F (Month 18) | 451.2 (202.6 to 915.9) | 198.9 (125.4 to 362) | 725.9 (239.6 to 1298.6) | 6535.8 (3329.8 to 9741.8) |
| gp41 (Month 18) | — | — | — | 9170.6 (6114.3 to 12226.9) |
| gp70-96ZM651.02 V1v2 (Month 18) | 434.8 (434.8 to 434.8) | — | 196.6 (151.1 to 242.2) | — |
| gp70-TV1.GSKvacV1V2/293F (Month 18) | 534.8 (534.8 to 534.8) | — | 170.5 (170.5 to 170.5) | — |
| gp70_B.CaseA2 V1/V2/169K (Month 18) | 887.5 (887.5 to 887.5) | — | 177.5 (177.5 to 177.5) | — |
| gp70_B.CaseA_V1_V2 (Month 18) | 474 (474 to 474) | — | — | — |
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.
| Participants | 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) |
|---|---|---|---|---|
| 00MSA 4076 gp140 (Month 6.5) | 10 | 11 | 17 | 5 |
| 1086C_D7gp120.avi/293F (Month 6.5) | 22 | 19 | 27 | 14 |
| 96ZM651.D11gp120.avi (Month 6.5) | 12 | 8 | 22 | 4 |
| A1.con.env03 140 CF (Month 6.5) | 11 | 8 | 18 | 6 |
| AE.A244 V1V2 Tags/293F (Month 6.5) | 1 | 0 | 1 | 1 |
| C.1086C_V1_V2 Tags (Month 6.5) | 1 | 1 | 1 | 1 |
| Con 6 gp120/B (Month 6.5) | 10 | 9 | 15 | 4 |
| Con S gp140 CFI (Month 6.5) | 17 | 16 | 24 | 7 |
| TV1c8_D11gp120.avi/293F (Month 6.5) | 18 | 19 | 27 | 11 |
| gp41 (Month 6.5) | 0 | 1 | 0 | 0 |
| gp70-96ZM651.02 V1v2 (Month 6.5) | 0 | 0 | 0 | 0 |
| gp70-TV1.GSKvacV1V2/293F (Month 6.5) | 1 | 0 | 0 | 0 |
| gp70_B.CaseA2 V1/V2/169K (Month 6.5) | 1 | 0 | 0 | 0 |
| gp70_B.CaseA_V1_V2 (Month 6.5) | 0 | 0 | 0 | 0 |
| 00MSA 4076 gp140 (Month 12) | 3 | 3 | 4 | 1 |
| 1086C_D7gp120.avi/293F (Month 12) | 20 | 17 | 24 | 11 |
| 96ZM651.D11gp120.avi (Month 12) | 2 | 4 | 4 | 1 |
| A1.con.env03 140 CF (Month 12) | 3 | 3 | 5 | 1 |
| AE.A244 V1V2 Tags/293F (Month 12) | 1 | 0 | 0 | 0 |
| C.1086C_V1_V2 Tags (Month 12) | 1 | 0 | 0 | 0 |
| Con 6 gp120/B (Month 12) | 3 | 2 | 3 | 1 |
| Con S gp140 CFI (Month 12) | 4 | 4 | 7 | 2 |
| TV1c8_D11gp120.avi/293F (Month 12) | 7 | 10 | 22 | 5 |
| gp41 (Month 12) | 0 | 0 | 0 | 0 |
| gp70-96ZM651.02 V1v2 (Month 12) | 0 | 0 | 0 | 0 |
| gp70-TV1.GSKvacV1V2/293F (Month 12) | 1 | 1 | 0 | 0 |
| gp70_B.CaseA2 V1/V2/169K (Month 12) | 1 | 0 | 0 | 0 |
| gp70_B.CaseA_V1_V2 (Month 12) | 0 | 1 | 0 | 0 |
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).
| relative fluorescence units | 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) |
|---|---|---|---|---|
| 00MSA 4076 gp140 (Month 6.5) | 1845.2 (488.2 to 8688.9) | 661 (255.5 to 1376.9) | 1434.2 (526.8 to 8249.5) | 2502 (1231.5 to 2833.8) |
| 1086C_D7gp120.avi/293F (Month 6.5) | 22000 (17472 to 22000) | 22000 (13255.1 to 22000) | 22000 (22000 to 22000) | 20863 (11859 to 22000) |
| 96ZM651.D11gp120.avi (Month 6.5) | 8047.1 (6816.6 to 13252.6) | 8849.6 (6323.8 to 10004.8) | 7595.5 (5318.3 to 13822.1) | 11444 (7878.1 to 15391.1) |
| A1.con.env03 140 CF (Month 6.5) | 2823.8 (535.9 to 8015.5) | 1407.1 (612.2 to 1760.2) | 1909.9 (648.1 to 6867.4) | 2191.9 (1343.3 to 5852.8) |
| AE.A244 V1V2 Tags/293F (Month 6.5) | 6260.8 (6260.8 to 6260.8) | — | 1998 (1998 to 1998) | 4791.2 (4791.2 to 4791.2) |
| C.1086C_V1_V2 Tags (Month 6.5) | 9201.2 (9201.2 to 9201.2) | 882.5 (882.5 to 882.5) | 1978.5 (1978.5 to 1978.5) | 4818.8 (4818.8 to 4818.8) |
| Con 6 gp120/B (Month 6.5) | 9493.6 (3152.8 to 11729.6) | 3719.8 (3271.2 to 4214) | 4863.5 (3355.6 to 7182) | 6432.1 (3135 to 9692.9) |
| Con S gp140 CFI (Month 6.5) | 5888.5 (3208.2 to 17024.2) | 4698.9 (3204.9 to 6151.9) | 6925.8 (3836.3 to 22000) | 5943.2 (4851.8 to 13324) |
| TV1c8_D11gp120.avi/293F (Month 6.5) | 8312.8 (3759.4 to 19844.6) | 5613.2 (1829.4 to 7662.5) | 12210.8 (6345.9 to 22000) | 4144.5 (3052.5 to 13847.4) |
| gp41 (Month 6.5) | — | 3047.2 (3047.2 to 3047.2) | — | — |
| gp70-TV1.GSKvacV1V2/293F (Month 6.5) | 813.8 (813.8 to 813.8) | — | — | — |
| gp70_B.CaseA2 V1/V2/169K (Month 6.5) | 22000 (22000 to 22000) | — | — | — |
| 00MSA 4076 gp140 (Month 12) | 2229 (1760 to 5844.8) | 1486.5 (813.4 to 2417) | 1501.5 (421.4 to 3012.2) | 727.5 (727.5 to 727.5) |
| 1086C_D7gp120.avi/293F (Month 12) | 7533.6 (4651.4 to 16946) | 4962.8 (2254.8 to 7956.5) | 9267.8 (5751.8 to 15500.5) | 3780.8 (2303.6 to 9670.9) |
| 96ZM651.D11gp120.avi (Month 12) | 5390.6 (4675.2 to 6106.1) | 10692 (8753.4 to 13069.9) | 6160 (5252.9 to 7161.4) | 10678.8 (10678.8 to 10678.8) |
| A1.con.env03 140 CF (Month 12) | 6053.5 (3152.1 to 6928.8) | 2047.2 (1493.4 to 2679.6) | 1051.8 (580.2 to 7617) | 1290 (1290 to 1290) |
| AE.A244 V1V2 Tags/293F (Month 12) | 3551 (3551 to 3551) | — | — | — |
| C.1086C_V1_V2 Tags (Month 12) | 6647 (6647 to 6647) | — | — | — |
| Con 6 gp120/B (Month 12) | 3134.5 (2691.1 to 3441.2) | 5267.4 (4380.6 to 6154.2) | 2058 (2014 to 3017.9) | 3144 (3144 to 3144) |
| Con S gp140 CFI (Month 12) | 5268 (2966.7 to 10882.8) | 7882.6 (2290.9 to 15009.9) | 5614.8 (3224.8 to 12063.2) | 5104.8 (4650.4 to 5559.1) |
| TV1c8_D11gp120.avi/293F (Month 12) | 3505.5 (1538.2 to 4408.2) | 1366.6 (875.6 to 2180.6) | 2812 (1200.9 to 6530.2) | 4003 (2953.5 to 14074.2) |
| gp70-TV1.GSKvacV1V2/293F (Month 12) | 137.5 (137.5 to 137.5) | 993 (993 to 993) | — | — |
| gp70_B.CaseA2 V1/V2/169K (Month 12) | 22000 (22000 to 22000) | — | — | — |
| gp70_B.CaseA_V1_V2 (Month 12) | — | 1540 (1540 to 1540) | — | — |
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.
| Functionality Score | 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) |
|---|---|---|---|---|
| 1086 gp120 (Month 6.5) | 0.169 (0.108 to 0.204) | 0.171 (0.147 to 0.217) | 0.158 (0.136 to 0.2) | 0.15 (0.13 to 0.18) |
| 1086 gp120 (Month 12) | 0.108 (0.069 to 0.148) | 0.129 (0.111 to 0.161) | 0.129 (0.084 to 0.16) | 0.101 (0.076 to 0.12) |
| 1086 gp120 (Month 12.5) | 0.17 (0.148 to 0.206) | 0.188 (0.149 to 0.229) | 0.131 (0.087 to 0.173) | 0.138 (0.097 to 0.191) |
| 1086 gp120 (Month 18) | 0.143 (0.118 to 0.185) | 0.156 (0.126 to 0.179) | 0.111 (0.079 to 0.165) | 0.114 (0.091 to 0.139) |
| Any Env ZM96 (Month 6.5) | 0.157 (0.109 to 0.21) | 0.175 (0.116 to 0.203) | 0.126 (0.094 to 0.155) | 0.123 (0.078 to 0.193) |
| Any Env ZM96 (Month 12) | 0.126 (0.085 to 0.166) | 0.129 (0.115 to 0.159) | 0.106 (0.068 to 0.13) | 0.111 (0.093 to 0.15) |
| Any Env ZM96 (Month 12.5) | 0.187 (0.12 to 0.225) | 0.197 (0.142 to 0.224) | 0.117 (0.087 to 0.144) | 0.158 (0.12 to 0.183) |
| Any Env ZM96 (Month 18) | 0.159 (0.089 to 0.179) | 0.163 (0.112 to 0.181) | 0.11 (0.083 to 0.128) | 0.131 (0.054 to 0.157) |
| Env-1-ZM96 (Month 6.5) | 0.157 (0.109 to 0.21) | 0.177 (0.119 to 0.203) | 0.126 (0.094 to 0.155) | 0.123 (0.078 to 0.193) |
| Env-1-ZM96 (Month 12) | 0.126 (0.085 to 0.166) | 0.129 (0.115 to 0.159) | 0.106 (0.068 to 0.124) | 0.111 (0.093 to 0.15) |
| Env-1-ZM96 (Month 12.5) | 0.187 (0.12 to 0.225) | 0.197 (0.142 to 0.224) | 0.117 (0.087 to 0.144) | 0.158 (0.12 to 0.183) |
| Env-1-ZM96 (Month 18) | 0.159 (0.089 to 0.179) | 0.163 (0.112 to 0.181) | 0.11 (0.082 to 0.128) | 0.131 (0.054 to 0.157) |
| Env-2-ZM96 (Month 6.5) | 0.032 (0.015 to 0.072) | 0.027 (0.017 to 0.076) | 0.04 (0.028 to 0.068) | 0.046 (0.023 to 0.062) |
| Env-2-ZM96 (Month 12) | 0.015 (0.003 to 0.024) | 0.044 (0.015 to 0.074) | 0.032 (0.011 to 0.072) | 0.033 (0.018 to 0.047) |
| Env-2-ZM96 (Month 12.5) | 0.024 (0.013 to 0.061) | 0.065 (0.022 to 0.098) | 0.023 (0.018 to 0.038) | 0.033 (0.013 to 0.071) |
| Env-2-ZM96 (Month 18) | 0.016 (0.007 to 0.026) | 0.039 (0.019 to 0.082) | 0.021 (0.011 to 0.062) | 0.028 (0.011 to 0.039) |
| LAI-Gag (Month 6.5) | 0.04 (0.021 to 0.069) | 0.057 (0.027 to 0.071) | 0.03 (0.012 to 0.039) | 0.036 (0.029 to 0.069) |
| LAI-Gag (Month 12) | 0.04 (0.014 to 0.053) | 0.04 (0.015 to 0.066) | 0.025 (0.009 to 0.042) | 0.026 (0.016 to 0.05) |
| LAI-Gag (Month 12.5) | 0.03 (0.016 to 0.07) | 0.041 (0.02 to 0.069) | 0.037 (0.023 to 0.055) | 0.038 (0.012 to 0.068) |
| LAI-Gag (Month 18) | 0.024 (0.016 to 0.041) | 0.031 (0.018 to 0.065) | 0.02 (0.011 to 0.038) | 0.037 (0.017 to 0.061) |
| TV1 gp120 (Month 6.5) | 0.165 (0.122 to 0.227) | 0.186 (0.143 to 0.214) | 0.177 (0.137 to 0.218) | 0.156 (0.121 to 0.187) |
| TV1 gp120 (Month 12) | 0.125 (0.105 to 0.179) | 0.165 (0.107 to 0.192) | 0.153 (0.112 to 0.178) | 0.124 (0.065 to 0.145) |
| TV1 gp120 (Month 12.5) | 0.217 (0.173 to 0.232) | 0.231 (0.161 to 0.252) | 0.172 (0.125 to 0.207) | 0.15 (0.113 to 0.205) |
| TV1 gp120 (Month 18) | 0.161 (0.136 to 0.21) | 0.172 (0.16 to 0.199) | 0.143 (0.119 to 0.177) | 0.099 (0.055 to 0.17) |
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.
| Polyfunctionality Score | 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) |
|---|---|---|---|---|
| 1086 gp120 (Month 6.5) | 0.11 (0.051 to 0.135) | 0.12 (0.095 to 0.141) | 0.098 (0.065 to 0.122) | 0.106 (0.09 to 0.116) |
| 1086 gp120 (Month 12) | 0.067 (0.05 to 0.105) | 0.087 (0.064 to 0.113) | 0.062 (0.049 to 0.098) | 0.07 (0.038 to 0.081) |
| 1086 gp120 (Month 12.5) | 0.108 (0.076 to 0.135) | 0.129 (0.082 to 0.148) | 0.067 (0.048 to 0.098) | 0.091 (0.053 to 0.109) |
| 1086 gp120 (Month 18) | 0.1 (0.072 to 0.121) | 0.108 (0.08 to 0.126) | 0.062 (0.044 to 0.099) | 0.064 (0.056 to 0.09) |
| Any Env ZM96 (Month 6.5) | 0.111 (0.084 to 0.134) | 0.124 (0.091 to 0.136) | 0.083 (0.051 to 0.105) | 0.092 (0.058 to 0.124) |
| Any Env ZM96 (Month 12) | 0.082 (0.063 to 0.119) | 0.099 (0.062 to 0.107) | 0.06 (0.042 to 0.086) | 0.09 (0.049 to 0.101) |
| Any Env ZM96 (Month 12.5) | 0.127 (0.087 to 0.146) | 0.132 (0.088 to 0.144) | 0.069 (0.046 to 0.09) | 0.111 (0.088 to 0.12) |
| Any Env ZM96 (Month 18) | 0.114 (0.064 to 0.127) | 0.115 (0.083 to 0.126) | 0.066 (0.042 to 0.095) | 0.085 (0.046 to 0.111) |
| Env-1-ZM96 (Month 6.5) | 0.111 (0.084 to 0.134) | 0.124 (0.094 to 0.136) | 0.083 (0.051 to 0.105) | 0.092 (0.058 to 0.124) |
| Env-1-ZM96 (Month 12) | 0.082 (0.063 to 0.119) | 0.099 (0.062 to 0.107) | 0.057 (0.042 to 0.073) | 0.09 (0.049 to 0.101) |
| Env-1-ZM96 (Month 12.5) | 0.127 (0.087 to 0.146) | 0.132 (0.088 to 0.144) | 0.069 (0.044 to 0.09) | 0.111 (0.088 to 0.12) |
| Env-1-ZM96 (Month 18) | 0.114 (0.064 to 0.127) | 0.115 (0.083 to 0.126) | 0.066 (0.039 to 0.095) | 0.085 (0.046 to 0.111) |
| Env-2-ZM96 (Month 6.5) | 0.019 (0.011 to 0.05) | 0.026 (0.013 to 0.066) | 0.029 (0.014 to 0.037) | 0.023 (0.018 to 0.036) |
| Env-2-ZM96 (Month 12) | 0.01 (0.001 to 0.015) | 0.026 (0.012 to 0.044) | 0.028 (0.009 to 0.042) | 0.02 (0.014 to 0.029) |
| Env-2-ZM96 (Month 12.5) | 0.015 (0.006 to 0.045) | 0.039 (0.014 to 0.07) | 0.017 (0.009 to 0.034) | 0.02 (0.006 to 0.045) |
| Env-2-ZM96 (Month 18) | 0.013 (0.005 to 0.019) | 0.025 (0.013 to 0.051) | 0.012 (0.008 to 0.04) | 0.022 (0.011 to 0.029) |
| LAI-Gag (Month 6.5) | 0.051 (0.017 to 0.064) | 0.055 (0.024 to 0.072) | 0.025 (0.008 to 0.051) | 0.038 (0.031 to 0.072) |
| LAI-Gag (Month 12) | 0.036 (0.008 to 0.055) | 0.027 (0.006 to 0.05) | 0.019 (0.007 to 0.036) | 0.027 (0.012 to 0.059) |
| LAI-Gag (Month 12.5) | 0.031 (0.014 to 0.061) | 0.035 (0.019 to 0.058) | 0.038 (0.021 to 0.054) | 0.035 (0.009 to 0.067) |
| LAI-Gag (Month 18) | 0.02 (0.015 to 0.039) | 0.027 (0.019 to 0.062) | 0.017 (0.006 to 0.033) | 0.035 (0.017 to 0.059) |
| TV1 gp120 (Month 6.5) | 0.111 (0.076 to 0.146) | 0.13 (0.095 to 0.142) | 0.108 (0.075 to 0.136) | 0.091 (0.06 to 0.122) |
| TV1 gp120 (Month 12) | 0.079 (0.056 to 0.109) | 0.111 (0.071 to 0.12) | 0.084 (0.056 to 0.115) | 0.078 (0.031 to 0.095) |
| TV1 gp120 (Month 12.5) | 0.137 (0.094 to 0.147) | 0.146 (0.113 to 0.157) | 0.095 (0.062 to 0.129) | 0.1 (0.071 to 0.133) |
| TV1 gp120 (Month 18) | 0.109 (0.073 to 0.14) | 0.118 (0.112 to 0.135) | 0.084 (0.061 to 0.11) | 0.069 (0.035 to 0.106) |
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.
| Participants | 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) |
|---|---|---|---|---|
| 1086C_D7gp120.avi/293F (Month 12.5) | 30 | 27 | 31 | 16 |
| 96ZM651.D11gp120.avi (Month 12.5) | 26 | 28 | 30 | 15 |
| TV1c8_D11gp120.avi/293F (Month 12.5) | 28 | 28 | 29 | 15 |
| 1086C_D7gp120.avi/293F (Month 18) | 27 | 27 | 32 | 16 |
| 96ZM651.D11gp120.avi (Month 18) | 17 | 22 | 28 | 7 |
| TV1c8_D11gp120.avi/293F (Month 18) | 26 | 28 | 30 | 15 |
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).
| relative fluorescence units | 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) |
|---|---|---|---|---|
| 1086C_D7gp120.avi/293F (Month 12.5) | 22000 (22000 to 22000) | 22000 (22000 to 22000) | 22000 (22000 to 22000) | 22000 (22000 to 22000) |
| 96ZM651.D11gp120.avi (Month 12.5) | 22000 (22000 to 22000) | 22000 (22000 to 22000) | 22000 (22000 to 22000) | 22000 (22000 to 22000) |
| TV1c8_D11gp120.avi/293F (Month 12.5) | 22000 (22000 to 22000) | 22000 (22000 to 22000) | 22000 (22000 to 22000) | 22000 (22000 to 22000) |
| 1086C_D7gp120.avi/293F (Month 18) | 22000 (13447.4 to 22000) | 22000 (17031.4 to 22000) | 22000 (16465.8 to 22000) | 16187 (8260.8 to 22000) |
| 96ZM651.D11gp120.avi (Month 18) | 6135.8 (4058.2 to 10887) | 5439 (2617.8 to 8736.1) | 5372.6 (3140.4 to 12123.9) | 2794 (2226 to 4364.1) |
| TV1c8_D11gp120.avi/293F (Month 18) | 8367.6 (2745.8 to 21097.6) | 8893.4 (3450.6 to 20507.7) | 20549 (8176.7 to 22000) | 6794.5 (2788.2 to 9961.5) |
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.
| Participants | 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) |
|---|---|---|---|---|
| 00MSA 4076 gp140 (Month 12.5) | 26 | 28 | 29 | 15 |
| A1.con.env03 140 CF (Month 12.5) | 27 | 28 | 29 | 15 |
| AE.A244 V1V2 Tags/293F (Month 12.5) | 21 | 27 | 27 | 14 |
| C.1086C_V1_V2 Tags (Month 12.5) | 19 | 21 | 22 | 9 |
| Con 6 gp120/B (Month 12.5) | 26 | 28 | 29 | 15 |
| Con S gp140 CFI (Month 12.5) | 28 | 28 | 30 | 15 |
| gp41 (Month 12.5) | 0 | 0 | 3 | 2 |
| gp70-96ZM651.02 V1v2 (Month 12.5) | 10 | 18 | 18 | 7 |
| gp70-TV1.GSKvacV1V2/293F (Month 12.5) | 16 | 25 | 24 | 9 |
| gp70_B.CaseA2 V1/V2/169K (Month 12.5) | 12 | 22 | 23 | 8 |
| gp70_B.CaseA_V1_V2 (Month 12.5) | 11 | 20 | 22 | 6 |
| 00MSA 4076 gp140 (Month 18) | 11 | 12 | 18 | 4 |
| A1.con.env03 140 CF (Month 18) | 23 | 26 | 29 | 11 |
| AE.A244 V1V2 Tags/293F (Month 18) | 5 | 9 | 12 | 2 |
| C.1086C_V1_V2 Tags (Month 18) | 1 | 3 | 3 | 1 |
| Con 6 gp120/B (Month 18) | 13 | 17 | 25 | 6 |
| Con S gp140 CFI (Month 18) | 25 | 28 | 31 | 15 |
| gp41 (Month 18) | 0 | 1 | 3 | 1 |
| gp70-96ZM651.02 V1v2 (Month 18) | 1 | 3 | 4 | 1 |
| gp70-TV1.GSKvacV1V2/293F (Month 18) | 4 | 10 | 11 | 1 |
| gp70_B.CaseA2 V1/V2/169K (Month 18) | 1 | 3 | 7 | 1 |
| gp70_B.CaseA_V1_V2 (Month 18) | 1 | 2 | 6 | 1 |
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).
| relative fluorescence units | 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) |
|---|---|---|---|---|
| 00MSA 4076 gp140 (Month 12.5) | 22000 (18877.6 to 22000) | 22000 (13449.4 to 22000) | 22000 (17787.8 to 22000) | 22000 (11267.2 to 22000) |
| A1.con.env03 140 CF (Month 12.5) | 22000 (20752 to 22000) | 22000 (17453.4 to 22000) | 22000 (22000 to 22000) | 22000 (16264.4 to 22000) |
| AE.A244 V1V2 Tags/293F (Month 12.5) | 4553.5 (2286.2 to 9393.8) | 3313.8 (1245.9 to 10641.6) | 5728.8 (2011.8 to 10929.1) | 1034.2 (482.6 to 5401.9) |
| C.1086C_V1_V2 Tags (Month 12.5) | 2021.2 (1142.2 to 3862.8) | 3476 (906 to 6288.5) | 3484.6 (994 to 8674.6) | 1380.2 (601 to 3883) |
| Con 6 gp120/B (Month 12.5) | 22000 (22000 to 22000) | 22000 (20433.4 to 22000) | 22000 (22000 to 22000) | 22000 (15222.2 to 22000) |
| Con S gp140 CFI (Month 12.5) | 22000 (22000 to 22000) | 22000 (22000 to 22000) | 22000 (22000 to 22000) | 22000 (22000 to 22000) |
| gp41 (Month 12.5) | — | — | 4644.8 (3651.8 to 13322.4) | 8348.5 (5951.1 to 10745.9) |
| gp70-96ZM651.02 V1v2 (Month 12.5) | 1427.2 (891.8 to 9947.6) | 3770.8 (1125 to 10077.4) | 8793.6 (1318.6 to 21615.9) | 1639.8 (1290.2 to 6055.9) |
| gp70-TV1.GSKvacV1V2/293F (Month 12.5) | 1407.4 (993.3 to 3027.4) | 2057.8 (714.5 to 6260.2) | 12436.5 (1806.4 to 22000) | 2031.8 (1158.8 to 4055.5) |
| gp70_B.CaseA2 V1/V2/169K (Month 12.5) | 1213.2 (734.6 to 3588.6) | 2332.9 (732.9 to 5249.1) | 8987.2 (2613.6 to 22000) | 1324.4 (941.3 to 3481.6) |
| gp70_B.CaseA_V1_V2 (Month 12.5) | 763.5 (670.1 to 3615.2) | 2246.5 (999.1 to 5417.9) | 8372.5 (1587.8 to 21441.9) | 2869.5 (1171.8 to 4368.3) |
| 00MSA 4076 gp140 (Month 18) | 1954 (1242.2 to 3022) | 2546.9 (1072.2 to 7260.1) | 1571 (1131.2 to 3575.8) | 1351.9 (1189.6 to 1367.8) |
| A1.con.env03 140 CF (Month 18) | 1106 (444.2 to 2628) | 1552.5 (607 to 3231.8) | 1853.2 (929.5 to 4194.5) | 961.5 (695.8 to 1429.6) |
| AE.A244 V1V2 Tags/293F (Month 18) | 137 (110.2 to 484) | 462 (371.2 to 512.5) | 362.2 (194.8 to 1003.6) | 445.9 (429.3 to 462.4) |
| C.1086C_V1_V2 Tags (Month 18) | 1204.5 (1204.5 to 1204.5) | 1523.2 (1067.4 to 5288.9) | 821.8 (714.1 to 2419.4) | 909 (909 to 909) |
| Con 6 gp120/B (Month 18) | 2373.2 (1574 to 4438.2) | 2805 (1459.5 to 4348.8) | 2405.5 (1517.5 to 4459.5) | 1185.2 (993.6 to 1463.2) |
| Con S gp140 CFI (Month 18) | 8793.8 (3178.8 to 16947.8) | 9031.1 (3772.2 to 22000) | 13261.8 (7458.2 to 22000) | 5032.5 (3082 to 9318.4) |
| gp41 (Month 18) | — | 2549.2 (2549.2 to 2549.2) | 7284.8 (5785.5 to 14642.4) | 19096.5 (19096.5 to 19096.5) |
| gp70-96ZM651.02 V1v2 (Month 18) | 370.8 (370.8 to 370.8) | 584 (541.4 to 872.1) | 987.8 (590.4 to 1672.9) | 2221.8 (2221.8 to 2221.8) |
| gp70-TV1.GSKvacV1V2/293F (Month 18) | 163.1 (125.2 to 272.5) | 180.2 (130.4 to 208.4) | 1319.2 (605.5 to 1729.8) | 1114.2 (1114.2 to 1114.2) |
| gp70_B.CaseA2 V1/V2/169K (Month 18) | 244.5 (244.5 to 244.5) | 1593.8 (914.8 to 1638.4) | 1332 (425 to 1556) | 1227.5 (1227.5 to 1227.5) |
| gp70_B.CaseA_V1_V2 (Month 18) | 314.2 (314.2 to 314.2) | 1717.6 (1210.9 to 2224.3) | 623.8 (383.3 to 886.9) | 593.2 (593.2 to 593.2) |
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.
| Participants | 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) |
|---|---|---|---|---|
| 1086C_D7gp120.avi/293F (Month 12.5) | 28 | 28 | 29 | 15 |
| 96ZM651.D11gp120.avi (Month 12.5) | 14 | 17 | 14 | 8 |
| AE.A244 V1V2 Tags/293F (Month 12.5) | 6 | 9 | 13 | 4 |
| C.1086C_V1_V2 Tags (Month 12.5) | 4 | 7 | 10 | 1 |
| Con 6 gp120/B (Month 12.5) | 6 | 10 | 5 | 4 |
| Con S gp140 CFI (Month 12.5) | 18 | 21 | 19 | 10 |
| TV1c8_D11gp120.avi/293F (Month 12.5) | 25 | 25 | 28 | 13 |
| gp41 (Month 12.5) | 0 | 0 | 0 | 1 |
| gp70-96ZM651.02 V1v2 (Month 12.5) | 3 | 3 | 5 | 1 |
| gp70-TV1.GSKvacV1V2/293F (Month 12.5) | 2 | 2 | 8 | 0 |
| gp70_B.CaseA2 V1/V2/169K (Month 12.5) | 1 | 2 | 7 | 0 |
| gp70_B.CaseA_V1_V2 (Month 12.5) | 1 | 2 | 4 | 0 |
| 1086C_D7gp120.avi/293F (Month 18) | 11 | 16 | 15 | 4 |
| 96ZM651.D11gp120.avi (Month 18) | 0 | 0 | 0 | 0 |
| AE.A244 V1V2 Tags/293F (Month 18) | 1 | 0 | 5 | 0 |
| C.1086C_V1_V2 Tags (Month 18) | 0 | 0 | 0 | 0 |
| Con 6 gp120/B (Month 18) | 0 | 0 | 1 | 0 |
| Con S gp140 CFI (Month 18) | 4 | 4 | 0 | 0 |
| TV1c8_D11gp120.avi/293F (Month 18) | 6 | 6 | 4 | 2 |
| gp41 (Month 18) | 0 | 0 | 0 | 2 |
| gp70-96ZM651.02 V1v2 (Month 18) | 1 | 0 | 2 | 0 |
| gp70-TV1.GSKvacV1V2/293F (Month 18) | 1 | 0 | 1 | 0 |
| gp70_B.CaseA2 V1/V2/169K (Month 18) | 1 | 0 | 1 | 0 |
| gp70_B.CaseA_V1_V2 (Month 18) | 1 | 0 | 0 | 0 |
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).
| relative fluorescence units | 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) |
|---|---|---|---|---|
| 1086C_D7gp120.avi/293F (Month 12.5) | 1049.2 (390 to 2565.1) | 1184.2 (711.1 to 3716.6) | 1086.2 (606.8 to 2699.8) | 1739 (593.4 to 5582.2) |
| 96ZM651.D11gp120.avi (Month 12.5) | 300.9 (161.9 to 838.8) | 314.5 (149 to 681.5) | 314.9 (189.6 to 439.3) | 264.5 (203.9 to 391) |
| AE.A244 V1V2 Tags/293F (Month 12.5) | 283.9 (178.3 to 762) | 271 (193.5 to 666.2) | 480 (289.2 to 697) | 479.1 (308.5 to 5950.9) |
| C.1086C_V1_V2 Tags (Month 12.5) | 470 (320.7 to 1060.8) | 197.8 (152.6 to 332.5) | 379.2 (218.2 to 473) | 22000 (22000 to 22000) |
| Con 6 gp120/B (Month 12.5) | 284 (197.3 to 345.2) | 329.5 (174.1 to 376) | 540 (278.5 to 672.5) | 203 (131 to 510.4) |
| Con S gp140 CFI (Month 12.5) | 264.1 (179 to 623.1) | 322.8 (202.2 to 1225.2) | 208.2 (160.5 to 382.6) | 476.8 (118.7 to 581.4) |
| TV1c8_D11gp120.avi/293F (Month 12.5) | 586.8 (385.5 to 2959.5) | 673.8 (415 to 2072.2) | 439.4 (199.9 to 1111.1) | 1017.2 (708 to 3056.2) |
| gp41 (Month 12.5) | — | — | — | 3020.8 (3020.8 to 3020.8) |
| gp70-96ZM651.02 V1v2 (Month 12.5) | 157.8 (130.9 to 992.2) | 354 (287.8 to 431.9) | 2402.8 (1323.5 to 3308.5) | 4707.5 (4707.5 to 4707.5) |
| gp70-TV1.GSKvacV1V2/293F (Month 12.5) | 853.5 (564.1 to 1142.9) | 231.6 (181.9 to 281.3) | 487.8 (167.2 to 1114.6) | — |
| gp70_B.CaseA2 V1/V2/169K (Month 12.5) | 2010.8 (2010.8 to 2010.8) | 255.4 (191.4 to 319.3) | 551 (175 to 850.4) | — |
| gp70_B.CaseA_V1_V2 (Month 12.5) | 1262.5 (1262.5 to 1262.5) | 233.5 (205.1 to 261.9) | 1457.8 (642 to 2307.9) | — |
| 1086C_D7gp120.avi/293F (Month 18) | 204 (146.2 to 522.4) | 266.4 (172.9 to 555.9) | 167.5 (158.5 to 217.5) | 133 (109.4 to 236.1) |
| AE.A244 V1V2 Tags/293F (Month 18) | 187.8 (187.8 to 187.8) | — | 245.2 (197.2 to 479.5) | — |
| Con 6 gp120/B (Month 18) | — | — | 368.8 (368.8 to 368.8) | — |
| Con S gp140 CFI (Month 18) | 126.6 (100 to 155.2) | 136.6 (126.4 to 156.8) | — | — |
| TV1c8_D11gp120.avi/293F (Month 18) | 451.2 (202.6 to 915.9) | 198.9 (125.4 to 362) | 725.9 (239.6 to 1298.6) | 6535.8 (3329.8 to 9741.8) |
| gp41 (Month 18) | — | — | — | 9170.6 (6114.3 to 12226.9) |
| gp70-96ZM651.02 V1v2 (Month 18) | 434.8 (434.8 to 434.8) | — | 196.6 (151.1 to 242.2) | — |
| gp70-TV1.GSKvacV1V2/293F (Month 18) | 534.8 (534.8 to 534.8) | — | 170.5 (170.5 to 170.5) | — |
| gp70_B.CaseA2 V1/V2/169K (Month 18) | 887.5 (887.5 to 887.5) | — | 177.5 (177.5 to 177.5) | — |
| gp70_B.CaseA_V1_V2 (Month 18) | 474 (474 to 474) | — | — | — |
Collected over Serious adverse events, adverse events of special interest, and new chronic conditions requiring medical intervention of more than 30 days were collected through month 18. All other AEs were collected through 30 days after each vaccination (vaccinations were given at months 0, 1, 3, and 6 for Groups 1, 2, and 4 and at months 0, 1, and 6 for Group 3).. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12) | 0/36 (0%) | 1/36 (2.8%) | 28/36 (77.8%) |
| Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12) | 0/36 (0%) | 0/36 (0%) | 28/36 (77.8%) |
| Group 3: ALVAC mo(0,1,6,12) + Bivalent Subtype C gp120/MF59 mo(0,1,6,12) | 0/36 (0%) | 0/36 (0%) | 26/36 (72.2%) |
| Group 4: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120 mo(3,6,12) | 0/24 (0%) | 1/24 (4.2%) | 15/24 (62.5%) |
| Event | 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) |
|---|---|---|---|---|
| Any Event in SOCInjury, poisoning and procedural complications | 1/36 | 0/36 | 0/36 | 1/24 |
| Skin lacerationInjury, poisoning and procedural complications | 0/36 | 0/36 | 0/36 | 1/24 |
| Traumatic haemothoraxInjury, poisoning and procedural complications | 1/36 | 0/36 | 0/36 | 0/24 |
| Event | 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) |
|---|---|---|---|---|
| Any Event in SOCInvestigations | 20/36 | 14/36 | 10/36 | 6/24 |
| Any Event in SOCInfections and infestations | 15/36 | 14/36 | 10/36 | 11/24 |
| Blood creatinine increasedInvestigations | 10/36 | 6/36 | 4/36 | 2/24 |
| Any Event in SOCNervous system disorders | 2/36 | 6/36 | 2/36 | 0/24 |
| Genitourinary chlamydia infectionInfections and infestations | 4/36 | 5/36 | 2/36 | 0/24 |
| Haemoglobin decreasedInvestigations | 2/36 | 5/36 | 0/36 | 1/24 |
| Any Event in SOCMusculoskeletal and connective tissue disorders | 0/36 | 5/36 | 0/36 | 2/24 |
| Any Event in SOCInjury, poisoning and procedural complications | 2/36 | 2/36 | 4/36 | 3/24 |
| Any Event in SOCRenal and urinary disorders | 2/36 | 2/36 | 1/36 | 3/24 |
| Any Event in SOCGastrointestinal disorders | 4/36 | 4/36 | 2/36 | 1/24 |
| Age, Continuous(years) | 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) | Total |
|---|---|---|---|---|---|
| Median | 24 (18 to 39) | 25 (18 to 37) | 25 (19 to 39) | 25 (18 to 33) | 25 (18 to 39) |
| Age, Customized(Participants) | 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) | Total |
|---|---|---|---|---|---|
| Less than 18 years | 0 | 0 | 0 | 0 | 0 |
| 18 - 20 years | 7 | 4 | 4 | 6 | 21 |
| 21 - 30 years | 24 | 28 | 29 | 16 | 97 |
| 31 - 40 years | 5 | 4 | 3 | 2 | 14 |
| 41 - 50 years | 0 | 0 | 0 | 0 | 0 |
| Above 50 years | 0 | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | 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) | Total |
|---|---|---|---|---|---|
| Female | 23 | 21 | 20 | 15 | 79 |
| Male | 13 | 15 | 16 | 9 | 53 |
| Ethnicity (NIH/OMB)(Participants) | 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) | Total |
|---|---|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 | 0 | 0 |
| Not Hispanic or Latino | 36 | 36 | 36 | 24 | 132 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 |
| Race/Ethnicity, Customized(Participants) | 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) | Total |
|---|---|---|---|---|---|
| Black | 36 | 36 | 36 | 24 | 132 |
| Region of Enrollment(Participants) | 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) | Total |
|---|---|---|---|---|---|
| Mozambique | 7 | 7 | 7 | 3 | 24 |
| South Africa | 21 | 21 | 21 | 17 | 80 |
| Zimbabwe | 8 | 8 | 8 | 4 | 28 |
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