HIV Infections
Conditions
Keywords
HIV
Brief summary
This study will evaluate the preventive vaccine efficacy, safety, and tolerability of ALVAC-HIV (vCP2438) + Bivalent Subtype C gp120/MF59 in HIV-seronegative South African adults over 24 months and potentially up to 36 months from enrollment.
Detailed description
This study will evaluate the preventive vaccine efficacy, safety, and tolerability of the ALVAC-HIV vaccine + Bivalent Subtype C gp120 protein adjuvanted with MF59 in HIV-seronegative South African adults over 24 months from enrollment. Participants will be randomized to receive ALVAC-HIV (vCP2438), or placebo, by intramuscular injection at weeks 0 and 4; they will receive ALVAC-HIV (vCP2438) + Bivalent Subtype C gp120/MF59, or placebo, by IM injection at weeks 12, 24, and 52. In addition to the vaccination visits, participants will attend study visits at weeks 26, 39, 54, 65, 78, 91, 104, 117, 130, 142, and 156. All study visits, including vaccination visits, will include HIV risk reduction counseling, a physical exam, and an interview/questionnaire. and pregnancy testing for participants capable of becoming pregnant. Select study visits will include a medical history review, physical exam, blood collection, urine collection, HIV testing, and pregnancy testing for participants capable of becoming pregnant. As of February 3, 2020, vaccinations for this study were suspended. Participants have been asked to continue attending follow-up visits for 12 months after the last vaccination they received. Participants who become HIV infected will be followed for 6 months after diagnosis.
Interventions
BIOLOGICALALVAC-HIV (vCP2438)
Expresses the gene products ZM96 gp120 (clade C strain) linked to the sequences encoding the HIV-1 transmembrane anchor (TM) sequence of gp41 (28 amino acids clade B LAI strain) and gag and pro (clade B LAI strain). It is formulated as a lyophilized vaccine for injection at a dose \> 10\^6 cell culture infectious dose 50% (CCIDv50) and \< 1 × 10\^8 CCIDv50 (nominal dose of 10\^7 CCIDv50) and is reconstituted with 1 mL of sterile sodium chloride solution (NaCl 0.4%) delivered IM
BIOLOGICALBivalent Subtype C gp120/MF59
Subtype C TV1.C gp120 Env and 1086.C gp120 Env proteins, each at a dose of 100 mcg, mixed with MF59 adjuvant (an oil-in-water emulsion) and delivered IM
BIOLOGICALPlacebo
Sodium Chloride for injection, 0.9% delivered IM
Sponsors
National Institute of Allergy and Infectious Diseases (NIAID)
Sanofi
GlaxoSmithKline
Bill and Melinda Gates Foundation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 35 Years
Healthy volunteers
Yes
Inclusion criteria
* Age of 18 to 35 years * Sexually active, defined as having had sexual intercourse at least twice in the past 30 days prior to screening, and is considered by the site staff to be at risk for HIV infection. * Access to a participating HVTN CRS and willingness to be followed for the planned duration of the study * Ability and willingness to provide informed consent * Assessment of understanding: volunteer demonstrates understanding of this study prior to first vaccination with verbal demonstration of understanding of all questions. * Agrees not to enroll in another study of an investigational research agent until the participant is unblinded or their study participation ends, whichever occurs last * Good general health as shown by medical history, physical exam, and screening laboratory tests * Willingness to receive HIV test results * Willingness to discuss HIV infection risks and willing to receive HIV risk reduction counseling. * Alanine aminotransferase (ALT) \< 2.5 times the institutional upper limit of normal * Negative HIV-1 and -2 blood test within 30 days prior to enrollment: Sites may use locally available assays that have been approved by HVTN Laboratory Operations. * Volunteers who were born female: negative serum or urine beta human chorionic gonadotropin (β-HCG) pregnancy test performed prior to vaccination on the day of initial vaccination. Persons who are NOT of reproductive potential due to having undergone total hysterectomy or bilateral oophorectomy (verified by medical records), are not required to undergo pregnancy testing. * Reproductive status: A volunteer who was born female must: * Agree to consistently use effective contraception (Appendix B and Appendix C) for sexual activity that could lead to pregnancy from at least 21 days prior to enrollment through 3 months after the last vaccination. Effective contraception is defined as using 2 methods of birth control. These include 1 of the following methods: * Condoms (male or female) * Diaphragm or cervical cap PLUS 1 of the following methods: * Intrauterine device (IUD), * Hormonal contraception (in accordance with applicable national contraception guidelines), or * Successful vasectomy in the male partner (considered successful if a volunteer reports that a male partner has \[1\] documentation of azoospermia by microscopy, or \[2\] a vasectomy more than 2 years ago with no resultant pregnancy despite sexual activity postvasectomy), or * Any other contraceptive method approved by the protocol safety review team; * Or not be of reproductive potential, such as having been diagnosed with premature menopause (with no menses for 1 year) or having undergone hysterectomy, bilateral oophorectomy, or tubal ligation. * Volunteers who were born female must also agree not to seek pregnancy through alternative methods, such as artificial insemination or in vitro fertilization until 3 months after the last vaccination
Exclusion criteria
* Blood products received within 90 days before first vaccination * Investigational research agents received within 30 days before first vaccination * Intent to participate in another study of an investigational research agent or any other study that requires non-HVTN HIV antibody testing during the planned duration of the study * Pregnant or breastfeeding * HIV vaccine(s) received in a prior HIV vaccine trial. For volunteers who have received control/placebo in an HIV vaccine trial, the HVTN 702 PSRT will determine eligibility on a case-by-case basis. * Non-HIV experimental vaccine(s) received within the last 5 years in a prior vaccine trial. Exceptions may be made for vaccines that have subsequently undergone licensure. For volunteers who have received control/placebo in an experimental vaccine trial, the protocol safety review team will determine eligibility on a case-by-case basis. For volunteers who have received an experimental vaccine(s) greater than 5 years ago, eligibility for enrollment will be determined by the protocol safety review team on a case-by-case basis. * Live attenuated vaccines other than influenza vaccine received within 30 days before first vaccination or scheduled within 14 days after injection (eg, measles, mumps, and rubella \[MMR\]; oral polio vaccine \[OPV\]; varicella; yellow fever) * Influenza vaccine or any vaccines that are not live attenuated vaccines and were received within 14 days prior to first vaccination (eg, tetanus, pneumococcal, Hepatitis A or B) * Immunosuppressive medications received within 168 days before first vaccination. (Not exclusionary: \[1\] corticosteroid nasal spray; \[2\] inhaled corticosteroids; \[3\] topical corticosteroids for mild, uncomplicated dermatitis; or \[4\] a single course of oral/parenteral corticosteroids at doses \< 2 mg/kg/day and length of therapy \< 11 days with completion at least 30 days prior to enrollment.) * Serious adverse reactions to vaccines or to vaccine components such as eggs, egg products, or neomycin including history of anaphylaxis and related symptoms such as hives, respiratory difficulty, angioedema, and/or abdominal pain. (Not excluded from participation: a volunteer who had a non-anaphylactic adverse reaction to pertussis vaccine as a child.) * Immunoglobulin received within 60 days before first vaccination * Immunodeficiency * Clinically significant medical condition, physical examination findings, clinically significant abnormal laboratory results, or past medical history with clinically significant implications for current health. A clinically significant condition or process includes but is not limited to: * A process that would affect the immune response, * A process that would require medication that affects the immune response, * Any contraindication to repeated injections or blood draws, * A condition that requires active medical intervention or monitoring to avert grave danger to the volunteer's health or well-being during the study period, * A condition or process for which signs or symptoms could be confused with reactions to vaccine, or * Any condition specifically listed among the
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence Rate of HIV-1 Infection Diagnosed After Enrollment (Concurrent With First Vaccination) Through 24 Months After Enrollment | Measured through 24 months after first vaccination | Vaccine efficacy was calculated as 1 minus the hazard ratio for HIV-1 infection, which was estimated using a sex-stratified Cox proportional-hazards (Cox PH) model and tested using a sex-stratified log-rank test. Vaccine efficacy was also measured using a ratio of cumulative incidences (CIR) of HIV-1 infection in the vaccine group as compared with the placebo group, which was calculated using Nelson-Aalen cumulative hazard estimates and tested using a Wald test. |
| Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Measured through 3 full days following each vaccination | Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 \[July 2017\]. The maximum grade observed for each symptom over the time frame is presented. |
| Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Measured through 3 full days following each vaccination | Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 \[July 2017\]. The maximum grade observed for each symptom over the time frame is presented. |
| Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Measured through 3 full days following each vaccination | Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 \[July 2017\]. The maximum grade observed for each symptom over the time frame is presented. |
| Number of Participants Reporting Adverse Events (AEs), by Relationship to Study Product | Measured through 30 days after each vaccination | For participants reporting multiple AEs over the time frame, the maximum relationship is counted. |
| Number of Participants Reporting Adverse Events (AEs), by Severity Grade | Measured through 30 days after each vaccination | For participants reporting multiple AEs over the time frame, the maximum severity grade is counted. |
| Number of Participants Reporting Serious Adverse Events (SAEs) | Measured through 12 months after last vaccination | Measured as outlined in Version 2.0 (January 2010) of the Manual for Expedited Reporting of Adverse Events to DAIDS (DAIDS EAE Manual). |
| Number of Participants Reporting Adverse Events of Special Interest (AESIs) | Measured through 12 months after last vaccination | Adverse events of special interest (AESI) were described in Appendix J of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases. |
| Number of Participants Reporting New Chronic Medical Conditions | Measured through 12 months after last vaccination | A new chronic medical condition is defined as a new onset or exacerbation of medical condition requiring 2 or more visits to a medical provider during a period of at least 30 days. |
| Number of Participants With Early Study Termination Associated With an AE or Reactogenicity | Measured through study completion (through 6 months after confirmation of HIV-1 diagnosis for participants who acquired HIV and through 12 months after last vaccination for the rest) | From the termination form, early study termination associated with an AE or reactogenicity reasons are tabulated by treatment group. |
| Number of Participants With Study Product Discontinuation Associated With an AE or Reactogenicity | Measured through study completion (through 6 months after confirmation of HIV-1 diagnosis for participants who acquired HIV and through 12 months after last vaccination for the rest) | From the study product discontinuation form, study product discontinuation reasons are tabulated by treatment group. |
| Incidence Rate of HIV-1 Infections Diagnosed Following Enrollment and Throughout All Participant Follow-Up | Measured through 36 months after first vaccination | Per the 23 January 2020 DSMB finding that monitoring boundaries for non-efficacy have been met, Primary outcome 1 has been superseded by this primary outcome. Vaccine efficacy was calculated as 1 minus the hazard ratio for HIV-1 infection, which was estimated using a sex-stratified Cox proportional-hazards (Cox PH) model and tested using a sex-stratified log-rank test. Vaccine efficacy was also measured using a ratio of cumulative incidences (CIR) of HIV-1 infection in the vaccine group as compared with the placebo group, which was calculated using Nelson-Aalen cumulative hazard estimates and tested using a Wald test. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence Rate of HIV-1 Infection Diagnosed After Enrollment Through 36 Months Post Enrollment | Measured through 36 months after first vaccination | This outcome measure is the same as Primary Outcome 12, which was added after pre-established criteria for vaccine non-efficacy had been met. Analysis was not repeated but the outcome is listed for completeness. |
| Incidence Rate of HIV-1 Infection Diagnosed After Month 6.5 Through 24 Months Post Enrollment | Measured after Month 6.5 through 24 months after first vaccination | Vaccine efficacy was calculated as 1 minus the hazard ratio for HIV-1 infection, which was estimated using a sex-stratified Cox proportional-hazards (Cox PH) model and tested using a sex-stratified log-rank test. Vaccine efficacy was also measured using a ratio of cumulative incidences (CIR) of HIV-1 infection in the vaccine group as compared with the placebo group, which was calculated using Nelson-Aalen cumulative hazard estimates and tested using a Wald test. |
| Number of Participants With Occurrence of CD4+ and CD8+ T-Cells Expressing IFN-g and/or IL-2 in Response to HIV Proteins Included in the Vaccine at Month 6.5 | Measured at Month 6.5 | PBMC samples are stimulated with synthetic peptide pools or left unstimulated as negative control. Response magnitude is % cells expressing IFN-g and/or IL-2 after stimulation minus % cells expressing markers after no stimulation. Contingency table is constructed to assess response: stimulation (peptide/none) vs. marker expression (yes/no). One-sided Fisher's exact test is applied, testing if number of cells positive for the marker is equal in stimulated vs. unstimulated cells. Bonferroni-Holm adjustment is made over peptide pools. Response is positive if adjusted p-value le 0.00001. Data are excluded if blood draw date was outside visit window, participant was HIV-infected (post-infection samples), PBMC viability/T-cell count were low or negative control was high. Any Env is the maximum of ZM96 gp120, 1086 gp120, and TV1 gp120. Any HIV is the sum of Any Env and LAI Gag. Negative magnitudes are censored at 0 before calculating sum; if the sum is lt 0.01, it is set to 0.01%. |
| Number of Participants With Occurrence of CD4+ and CD8+ T-Cells Expressing IFN-g and/or IL-2 and/or CD40L in Response to HIV Proteins Included in the Vaccine at Month 6.5 | Measured at Month 6.5 | PBMC samples are stimulated with synthetic peptide pools or left unstimulated as negative control. Response magnitude is % cells expressing IFN-g and/or IL-2 after stimulation minus % cells expressing markers after no stimulation. Contingency table is constructed to assess response: stimulation (peptide/none) vs. marker expression (yes/no). One-sided Fisher's exact test is applied, testing if number of cells positive for the marker is equal in stimulated vs. unstimulated cells. Bonferroni-Holm adjustment is made over peptide pools. Response is positive if adjusted p-value le 0.00001. Data are excluded if blood draw date was outside visit window, participant was HIV-infected (post-infection samples), PBMC viability/T-cell count were low or negative control was high. Any Env is the maximum of ZM96 gp120, 1086 gp120, and TV1 gp120. Any HIV is the sum of Any Env and LAI Gag. Negative magnitudes are censored at 0 before calculating sum; if the sum is lt 0.01, it is set to 0.01%. |
| Level of CD4+ and CD8+ T-Cells Expressing IFN-g and/or IL-2 in Response to HIV Proteins Included in the Vaccine at Month 6.5 | Measured at Month 6.5 | PBMC samples are stimulated with synthetic peptide pools or left unstimulated as negative control. Response magnitude is % cells expressing IFN-g and/or IL-2 after stimulation minus % cells expressing markers after no stimulation. Data are excluded if blood draw date was outside visit window, participant was HIV-infected (post-infection samples), PBMC viability/T-cell count were low or negative control was high. Any Env is the maximum of ZM96 gp120, 1086 gp120, and TV1 gp120. Any HIV is the sum of Any Env and LAI Gag. Negative magnitudes are censored at 0 before calculating sum; if the sum is lt 0.01, it is set to 0.01%. Summary was calculated among positive responders only. |
| Level of CD4+ and CD8+ T-Cells Expressing IFN-g and/or IL-2 and/or CD40L in Response to HIV Proteins Included in the Vaccine at Month 6.5 | Measured at Month 6.5 | PBMC samples are stimulated with synthetic peptide pools or left unstimulated as negative control. Response magnitude is % cells expressing IFN-g and/or IL-2 after stimulation minus % cells expressing markers after no stimulation. Data are excluded if blood draw date was outside visit window, participant was HIV-infected (post-infection samples), PBMC viability/T-cell count were low or negative control was high. Any Env is the maximum of ZM96 gp120, 1086 gp120, and TV1 gp120. Any HIV is the sum of Any Env and LAI Gag. Negative magnitudes are censored at 0 before calculating sum; if the sum is lt 0.01, it is set to 0.01%. Summary was calculated among positive responders only. |
| Number of Participants With Occurrence of Vaccine-induced IgG Binding Antibodies to HIV Proteins at Month 6.5 | Measured at Month 6.5 | Serum IgG responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay, run at 1:50 dilution.The readout is background-subtracted mean fluorescent intensity(MFI),with background adjustment for an antigen-specific plate level control.For each sample,response magnitude is net MFI,defined as experimental antigen MFI minus reference antigen MFI. Net MFI lt 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. |
| Number of Participants With Occurrence of Vaccine-induced IgG3 Binding Antibodies to HIV Proteins at Month 6.5 | Measured at Month 6.5 | 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 lt 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 M |
| Number of Participants With Occurrence of Vaccine-induced IgA Binding Antibodies to HIV Proteins at Month 6.5 | Measured at Month 6.5 | Serum IgA responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay,run at 1:10 dilution.The readout is background-subtracted mean fluorescent intensity (MFI),with background adjustment for an antigen-specific plate level control.For each sample,response magnitude is net MFI,defined as experimental antigen MFI minus reference antigen MFI.Net MFI lt 1 is set to 1, and net MFI \> 22,000 is set to 22,000.Data are excluded if blood draw date was outside the allowable window,a participant was HIV-infected,reference antigen \> 5,000 MFI or baseline net MFI \> 6,500.Samples from post-enrollment visits have positive responses if they meet three criteria:(1) net MFI greater than or equal to an antigen-specific response threshold (defined as the maximum of 100 and the 95th percentile of baseline net MFI),(2) net MFI values are greater than 3 times baseline net MFI, and (3) experimental antigen MFI values are greater than 3 times baseline MFI. |
| Level of Vaccine-induced IgG Binding Antibodies to HIV Proteins at Month 6.5 | Measured at Month 6.5 | Serum IgG responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay, run at 1:50 and 1:100 dilutions. 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 lt 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. The immune response data were also studied for their ability to predict HIV-1 infection through Month 24 (correlates of risk analysis). The comprehensive analysis results are available in Moodie et al 2022 (PubMed ID: 35758878). |
| Level of Vaccine-induced IgG3 Binding Antibodies to HIV Proteins at Month 6.5 | Measured at Month 6.5 | 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 lt 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. The immune response data were also studied for their ability to predict HIV-1 infection through Month 24 (correlates of risk analysis). The comprehensive analysis results are available in Moodie et al 2022 (PubMed ID: 35758878). |
| Level of Vaccine-induced IgA Binding Antibodies to HIV Proteins at Month 6.5 | Measured at Month 6.5 | Serum IgA responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay, run at 1:10 dilution. The readout is background-subtracted mean fluorescent intensity (MFI), with background adjustment for an antigen-specific plate level control. For each sample, response magnitude is net MFI, defined as experimental antigen MFI minus reference antigen MFI. Net MFI lt 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. The immune response data were also studied for their ability to predict HIV-1 infection through Month 24 (correlates of risk analysis). The comprehensive analysis results are available in Moodie et al 2022 (PubMed ID: 35758878). |
| Incidence Rate of HIV-1 Infection Diagnosed After Enrollment Through 24 Months Among Female Participants | Measured through 24 months after first vaccination | Vaccine efficacy was calculated as 1 minus the hazard ratio for HIV-1 infection, which was estimated using a Cox proportional-hazards (Cox PH) model and tested using a log-rank test. |
| Incidence Rate of HIV-1 Infection Diagnosed After Enrollment Through 24 Months Among Male Participants | Measured through 24 months after first vaccination | Vaccine efficacy was calculated as 1 minus the hazard ratio for HIV-1 infection, which was estimated using a Cox proportional-hazards (Cox PH) model and tested using a log-rank test. |
| Incidence Rate of HIV-1 Infection Diagnosed After Enrollment Through 24 Months Among Female Participants Aged 25 or Younger | Measured through 24 months after first vaccination | Vaccine efficacy was calculated as 1 minus the hazard ratio for HIV-1 infection, which was estimated using a Cox proportional-hazards (Cox PH) model and tested using a log-rank test. |
| Incidence Rate of HIV-1 Infection Diagnosed After Enrollment Through 24 Months Among Female Participants Older Than 25 | Measured through 24 months after first vaccination | Vaccine efficacy was calculated as 1 minus the hazard ratio for HIV-1 infection, which was estimated using a Cox proportional-hazards (Cox PH) model and tested using a log-rank test. |
| Incidence Rate of HIV-1 Infection Diagnosed After Enrollment Through Month 24 by Genotypic Characteristics of Viral Sequences From HIV-1 Infected Participants at HIV-1 Diagnosis, Such As Signature Site Mutations | Measured through 24 months after first vaccination | Analysis will only be performed if significant positive evidence of vaccine efficacy from enrollment through 24 months is seen. However, monitoring boundaries for non-efficacy have been met per the 23 January 2020 DSMB finding. |
| Number of Participants With Viral Sequences at HIV-1 Diagnosis | Measured through 24 months after first vaccination | Number of participants in the female mITT cohort with viral sequences were reported. Viral sequencing was conducted on the earliest available plasma specimens with positive HIV-1 RNA PCR tests from study participants who are diagnosed with HIV-1 infection. |
Countries
South Africa
Contacts
STUDY_CHAIRGlenda Gray, MD
Perinatal HIV Research Unit (PHRU), Chris Hani Baragwanath Hospital
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Vaccine ALVAC-HIV at months 0, 1, 3, 6, 12, 18, and bivalent subtype C gp120/MF9 at months 3, 6, 12, 18 | 2,704 |
| Placebo Placebo for ALVAC-HIV at months 0, 1, 3, 6, 12, 18, and placebo for bivalent subtype C gp120/MF9 at months 3, 6, 12, 18 | 2,700 |
| Total | 5,404 |
Baseline characteristics
| Characteristic | Vaccine | Placebo | Total |
|---|---|---|---|
| Age, Continuous Female | 24 Years | 23 Years | 24 Years |
| Age, Continuous Male | 26 Years | 26 Years | 26 Years |
| Age, Customized Female 18 - 20 years | 349 Participants | 392 Participants | 741 Participants |
| Age, Customized Female 21 - 25 years | 917 Participants | 877 Participants | 1794 Participants |
| Age, Customized Female 26 - 30 years | 465 Participants | 461 Participants | 926 Participants |
| Age, Customized Female 31 - 35 years | 162 Participants | 163 Participants | 325 Participants |
| Age, Customized Male 18 - 20 years | 114 Participants | 98 Participants | 212 Participants |
| Age, Customized Male 21 - 25 years | 271 Participants | 276 Participants | 547 Participants |
| Age, Customized Male 26 - 30 years | 244 Participants | 254 Participants | 498 Participants |
| Age, Customized Male 31 - 35 years | 182 Participants | 179 Participants | 361 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 2704 Participants | 2700 Participants | 5404 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Black | 2672 Participants | 2676 Participants | 5348 Participants |
| Race/Ethnicity, Customized Colored/Mixed | 23 Participants | 17 Participants | 40 Participants |
| Race/Ethnicity, Customized Indian | 1 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized More than one race | 5 Participants | 2 Participants | 7 Participants |
| Race/Ethnicity, Customized Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized White | 3 Participants | 3 Participants | 6 Participants |
| Region of Enrollment South Africa | 2704 Participants | 2700 Participants | 5404 Participants |
| Sex: Female, Male Female | 1893 Participants | 1893 Participants | 3786 Participants |
| Sex: Female, Male Male | 811 Participants | 807 Participants | 1618 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 8 / 2,704 | 10 / 2,700 |
| other Total, other adverse events | 1,707 / 2,704 | 1,704 / 2,700 |
| serious Total, serious adverse events | 103 / 2,704 | 95 / 2,700 |
Outcome results
Primary
Incidence Rate of HIV-1 Infection Diagnosed After Enrollment (Concurrent With First Vaccination) Through 24 Months After Enrollment
Vaccine efficacy was calculated as 1 minus the hazard ratio for HIV-1 infection, which was estimated using a sex-stratified Cox proportional-hazards (Cox PH) model and tested using a sex-stratified log-rank test. Vaccine efficacy was also measured using a ratio of cumulative incidences (CIR) of HIV-1 infection in the vaccine group as compared with the placebo group, which was calculated using Nelson-Aalen cumulative hazard estimates and tested using a Wald test.
Time frame: Measured through 24 months after first vaccination
Population: MITT cohort
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vaccine | Incidence Rate of HIV-1 Infection Diagnosed After Enrollment (Concurrent With First Vaccination) Through 24 Months After Enrollment | Cox PH method | 0.034 events per 100 person-years |
| Vaccine | Incidence Rate of HIV-1 Infection Diagnosed After Enrollment (Concurrent With First Vaccination) Through 24 Months After Enrollment | CIR method | 0.034 events per 100 person-years |
| Placebo | Incidence Rate of HIV-1 Infection Diagnosed After Enrollment (Concurrent With First Vaccination) Through 24 Months After Enrollment | Cox PH method | 0.033 events per 100 person-years |
| Placebo | Incidence Rate of HIV-1 Infection Diagnosed After Enrollment (Concurrent With First Vaccination) Through 24 Months After Enrollment | CIR method | 0.033 events per 100 person-years |
p-value: 0.8495% CI: [0.81, 1.3]Log Rank
p-value: 0.8395% CI: [0.81, 1.31]Wald
Primary
Incidence Rate of HIV-1 Infections Diagnosed Following Enrollment and Throughout All Participant Follow-Up
Per the 23 January 2020 DSMB finding that monitoring boundaries for non-efficacy have been met, Primary outcome 1 has been superseded by this primary outcome. Vaccine efficacy was calculated as 1 minus the hazard ratio for HIV-1 infection, which was estimated using a sex-stratified Cox proportional-hazards (Cox PH) model and tested using a sex-stratified log-rank test. Vaccine efficacy was also measured using a ratio of cumulative incidences (CIR) of HIV-1 infection in the vaccine group as compared with the placebo group, which was calculated using Nelson-Aalen cumulative hazard estimates and tested using a Wald test.
Time frame: Measured through 36 months after first vaccination
Population: MITT cohort
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vaccine | Incidence Rate of HIV-1 Infections Diagnosed Following Enrollment and Throughout All Participant Follow-Up | Cox PH method | 0.032 events per 100 person-years |
| Vaccine | Incidence Rate of HIV-1 Infections Diagnosed Following Enrollment and Throughout All Participant Follow-Up | CIR method | 0.038 events per 100 person-years |
| Placebo | Incidence Rate of HIV-1 Infections Diagnosed Following Enrollment and Throughout All Participant Follow-Up | Cox PH method | 0.03 events per 100 person-years |
| Placebo | Incidence Rate of HIV-1 Infections Diagnosed Following Enrollment and Throughout All Participant Follow-Up | CIR method | 0.03 events per 100 person-years |
p-value: 0.6695% CI: [0.85, 1.28]Log Rank
p-value: 0.9895% CI: [0.81, 1.23]Wald
Primary
Number of Participants Reporting Adverse Events (AEs), by Relationship to Study Product
For participants reporting multiple AEs over the time frame, the maximum relationship is counted.
Time frame: Measured through 30 days after each vaccination
Population: Safety cohort
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vaccine | Number of Participants Reporting Adverse Events (AEs), by Relationship to Study Product | Related | 38 Participants |
| Vaccine | Number of Participants Reporting Adverse Events (AEs), by Relationship to Study Product | Not Related | 1689 Participants |
| Vaccine | Number of Participants Reporting Adverse Events (AEs), by Relationship to Study Product | No AE Reported | 977 Participants |
| Placebo | Number of Participants Reporting Adverse Events (AEs), by Relationship to Study Product | Not Related | 1722 Participants |
| Placebo | Number of Participants Reporting Adverse Events (AEs), by Relationship to Study Product | Related | 12 Participants |
| Placebo | Number of Participants Reporting Adverse Events (AEs), by Relationship to Study Product | No AE Reported | 966 Participants |
Primary
Number of Participants Reporting Adverse Events (AEs), by Severity Grade
For participants reporting multiple AEs over the time frame, the maximum severity grade is counted.
Time frame: Measured through 30 days after each vaccination
Population: Safety cohort
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vaccine | Number of Participants Reporting Adverse Events (AEs), by Severity Grade | Mild | 161 Participants |
| Vaccine | Number of Participants Reporting Adverse Events (AEs), by Severity Grade | Moderate | 1443 Participants |
| Vaccine | Number of Participants Reporting Adverse Events (AEs), by Severity Grade | Severe | 98 Participants |
| Vaccine | Number of Participants Reporting Adverse Events (AEs), by Severity Grade | Potentially life-threatening | 17 Participants |
| Vaccine | Number of Participants Reporting Adverse Events (AEs), by Severity Grade | Death | 8 Participants |
| Vaccine | Number of Participants Reporting Adverse Events (AEs), by Severity Grade | No AE Reported | 977 Participants |
| Placebo | Number of Participants Reporting Adverse Events (AEs), by Severity Grade | Death | 10 Participants |
| Placebo | Number of Participants Reporting Adverse Events (AEs), by Severity Grade | Mild | 137 Participants |
| Placebo | Number of Participants Reporting Adverse Events (AEs), by Severity Grade | Potentially life-threatening | 12 Participants |
| Placebo | Number of Participants Reporting Adverse Events (AEs), by Severity Grade | Moderate | 1472 Participants |
| Placebo | Number of Participants Reporting Adverse Events (AEs), by Severity Grade | No AE Reported | 966 Participants |
| Placebo | Number of Participants Reporting Adverse Events (AEs), by Severity Grade | Severe | 103 Participants |
Primary
Number of Participants Reporting Adverse Events of Special Interest (AESIs)
Adverse events of special interest (AESI) were described in Appendix J of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
Time frame: Measured through 12 months after last vaccination
Population: Safety cohort
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vaccine | Number of Participants Reporting Adverse Events of Special Interest (AESIs) | Yes | 4 Participants |
| Vaccine | Number of Participants Reporting Adverse Events of Special Interest (AESIs) | No | 1693 Participants |
| Vaccine | Number of Participants Reporting Adverse Events of Special Interest (AESIs) | No AE Reported | 1007 Participants |
| Placebo | Number of Participants Reporting Adverse Events of Special Interest (AESIs) | Yes | 2 Participants |
| Placebo | Number of Participants Reporting Adverse Events of Special Interest (AESIs) | No | 1700 Participants |
| Placebo | Number of Participants Reporting Adverse Events of Special Interest (AESIs) | No AE Reported | 998 Participants |
Primary
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 \[July 2017\]. The maximum grade observed for each symptom over the time frame is presented.
Time frame: Measured through 3 full days following each vaccination
Population: Safety cohort
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Gr 4: Complications | 0 Participants |
| Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Gr 3: >=10cm / >=100cm^2 / Complications | 32 Participants |
| Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Gr 1: 2.5 - <5cm / 6.25 - <25cm^2 | 108 Participants |
| Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Gr 4: Complications | 0 Participants |
| Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | None / Not Gradable | 2380 Participants |
| Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | None / Not Gradable | 2314 Participants |
| Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Gr 3: >=10cm / >=100cm^2 / Complications | 28 Participants |
| Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Gr 1: 2.5 - <5cm / 6.25 - <25cm^2 | 196 Participants |
| Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Gr 1: 2.5 - <5cm / 6.25 - <25cm^2 | 159 Participants |
| Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Gr 2: 5 - <10cm / 25 - <100cm^2 | 156 Participants |
| Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Gr 2: 5 - <10cm / 25 - <100cm^2 | 74 Participants |
| Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Gr 3: >=10cm / >=100cm^2 / Complications | 38 Participants |
| Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Gr 2: 5 - <10cm / 25 - <100cm^2 | 133 Participants |
| Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Gr 4: Complications | 0 Participants |
| Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | None / Not Gradable | 2494 Participants |
| Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Gr 4: Complications | 0 Participants |
| Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | None / Not Gradable | 2683 Participants |
| Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Gr 1: 2.5 - <5cm / 6.25 - <25cm^2 | 14 Participants |
| Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Gr 2: 5 - <10cm / 25 - <100cm^2 | 3 Participants |
| Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Gr 3: >=10cm / >=100cm^2 / Complications | 0 Participants |
| Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Gr 4: Complications | 0 Participants |
| Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | None / Not Gradable | 2675 Participants |
| Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Gr 1: 2.5 - <5cm / 6.25 - <25cm^2 | 16 Participants |
| Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Gr 2: 5 - <10cm / 25 - <100cm^2 | 7 Participants |
| Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Gr 3: >=10cm / >=100cm^2 / Complications | 2 Participants |
| Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Gr 4: Complications | 0 Participants |
| Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | None / Not Gradable | 2662 Participants |
| Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Gr 1: 2.5 - <5cm / 6.25 - <25cm^2 | 26 Participants |
| Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Gr 2: 5 - <10cm / 25 - <100cm^2 | 10 Participants |
| Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Gr 3: >=10cm / >=100cm^2 / Complications | 2 Participants |
Primary
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness
Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 \[July 2017\]. The maximum grade observed for each symptom over the time frame is presented.
Time frame: Measured through 3 full days following each vaccination
Population: Safety cohort
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Pain | Potentially Life-threatening | 0 Participants |
| Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Tenderness | Severe | 1 Participants |
| Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Pain | Mild | 480 Participants |
| Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Tenderness | Potentially Life-threatening | 0 Participants |
| Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Tenderness | None | 2368 Participants |
| Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Pain and/or Tenderness | None | 2082 Participants |
| Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Pain | Severe | 1 Participants |
| Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Pain and/or Tenderness | Mild | 552 Participants |
| Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Tenderness | Mild | 297 Participants |
| Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Pain and/or Tenderness | Moderate | 69 Participants |
| Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Pain | Moderate | 62 Participants |
| Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Pain and/or Tenderness | Severe | 1 Participants |
| Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Tenderness | Moderate | 38 Participants |
| Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Pain and/or Tenderness | Potentially Life-threatening | 0 Participants |
| Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Pain | None | 2161 Participants |
| Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Pain and/or Tenderness | Potentially Life-threatening | 0 Participants |
| Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Pain | None | 2539 Participants |
| Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Pain | Mild | 149 Participants |
| Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Pain | Moderate | 12 Participants |
| Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Pain | Severe | 0 Participants |
| Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Pain | Potentially Life-threatening | 0 Participants |
| Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Tenderness | None | 2600 Participants |
| Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Tenderness | Mild | 91 Participants |
| Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Tenderness | Moderate | 9 Participants |
| Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Tenderness | Severe | 0 Participants |
| Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Tenderness | Potentially Life-threatening | 0 Participants |
| Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Pain and/or Tenderness | None | 2493 Participants |
| Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Pain and/or Tenderness | Mild | 194 Participants |
| Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Pain and/or Tenderness | Moderate | 13 Participants |
| Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Pain and/or Tenderness | Severe | 0 Participants |
Primary
Number of Participants Reporting New Chronic Medical Conditions
A new chronic medical condition is defined as a new onset or exacerbation of medical condition requiring 2 or more visits to a medical provider during a period of at least 30 days.
Time frame: Measured through 12 months after last vaccination
Population: Safety cohort
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vaccine | Number of Participants Reporting New Chronic Medical Conditions | Yes | 54 Participants |
| Vaccine | Number of Participants Reporting New Chronic Medical Conditions | No | 1673 Participants |
| Vaccine | Number of Participants Reporting New Chronic Medical Conditions | No AE Reported | 977 Participants |
| Placebo | Number of Participants Reporting New Chronic Medical Conditions | Yes | 54 Participants |
| Placebo | Number of Participants Reporting New Chronic Medical Conditions | No | 1680 Participants |
| Placebo | Number of Participants Reporting New Chronic Medical Conditions | No AE Reported | 966 Participants |
Primary
Number of Participants Reporting Serious Adverse Events (SAEs)
Measured as outlined in Version 2.0 (January 2010) of the Manual for Expedited Reporting of Adverse Events to DAIDS (DAIDS EAE Manual).
Time frame: Measured through 12 months after last vaccination
Population: Safety cohort
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vaccine | Number of Participants Reporting Serious Adverse Events (SAEs) | Yes | 103 Participants |
| Vaccine | Number of Participants Reporting Serious Adverse Events (SAEs) | No | 1624 Participants |
| Vaccine | Number of Participants Reporting Serious Adverse Events (SAEs) | No AE Reported | 977 Participants |
| Placebo | Number of Participants Reporting Serious Adverse Events (SAEs) | Yes | 95 Participants |
| Placebo | Number of Participants Reporting Serious Adverse Events (SAEs) | No | 1639 Participants |
| Placebo | Number of Participants Reporting Serious Adverse Events (SAEs) | No AE Reported | 966 Participants |
Primary
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 \[July 2017\]. The maximum grade observed for each symptom over the time frame is presented.
Time frame: Measured through 3 full days following each vaccination
Population: Safety cohort
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Severe | 0 Participants |
| Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | None | 2461 Participants |
| Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Potentially Life-threatening | 0 Participants |
| Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Moderate | 117 Participants |
| Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Missing | 0 Participants |
| Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Potentially Life-threatening | 0 Participants |
| Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | None | 2585 Participants |
| Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Severe | 3 Participants |
| Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Mild | 104 Participants |
| Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Moderate | 3 Participants |
| Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Moderate | 15 Participants |
| Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Potentially Life-threatening | 0 Participants |
| Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Severe | 0 Participants |
| Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Mild | 75 Participants |
| Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Potentially Life-threatening | 0 Participants |
| Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Missing | 0 Participants |
| Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Missing | 0 Participants |
| Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Severe | 0 Participants |
| Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Vomiting | None | 2625 Participants |
| Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Missing | 0 Participants |
| Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Vomiting | Mild | 64 Participants |
| Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Mild | 221 Participants |
| Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Vomiting | Moderate | 15 Participants |
| Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Potentially Life-threatening | 0 Participants |
| Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Vomiting | Severe | 0 Participants |
| Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Moderate | 21 Participants |
| Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Vomiting | Potentially Life-threatening | 0 Participants |
| Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Severe | 0 Participants |
| Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Vomiting | Missing | 0 Participants |
| Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Severe | 1 Participants |
| Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms (excl. Temp.) | None | 2004 Participants |
| Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Missing | 0 Participants |
| Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms (excl. Temp.) | Mild | 545 Participants |
| Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Potentially Life-threatening | 0 Participants |
| Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms (excl. Temp.) | Moderate | 151 Participants |
| Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | None | 2614 Participants |
| Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms (excl. Temp.) | Severe | 4 Participants |
| Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Missing | 0 Participants |
| Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms (excl. Temp.) | Potentially Life-threatening | 0 Participants |
| Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | None | 2267 Participants |
| Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms (excl. Temp.) | Missing | 0 Participants |
| Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | None | 2604 Participants |
| Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | None | 2409 Participants |
| Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Moderate | 7 Participants |
| Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Mild | 168 Participants |
| Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Mild | 85 Participants |
| Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Moderate | 98 Participants |
| Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Mild | 317 Participants |
| Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Severe | 19 Participants |
| Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Moderate | 15 Participants |
| Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Potentially Life-threatening | 1 Participants |
| Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Mild | 87 Participants |
| Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Missing | 9 Participants |
| Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | None | 2622 Participants |
| Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Missing | 14 Participants |
| Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | None | 2649 Participants |
| Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Mild | 40 Participants |
| Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Moderate | 11 Participants |
| Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Severe | 0 Participants |
| Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Potentially Life-threatening | 0 Participants |
| Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Missing | 0 Participants |
| Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | None | 2641 Participants |
| Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Mild | 51 Participants |
| Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Moderate | 8 Participants |
| Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Severe | 0 Participants |
| Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Potentially Life-threatening | 0 Participants |
| Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Missing | 0 Participants |
| Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | None | 2276 Participants |
| Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Mild | 311 Participants |
| Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Moderate | 112 Participants |
| Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Severe | 1 Participants |
| Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Potentially Life-threatening | 0 Participants |
| Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Missing | 0 Participants |
| Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | None | 2497 Participants |
| Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Mild | 177 Participants |
| Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Moderate | 24 Participants |
| Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Severe | 2 Participants |
| Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Potentially Life-threatening | 0 Participants |
| Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Missing | 0 Participants |
| Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | None | 2644 Participants |
| Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Mild | 48 Participants |
| Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Moderate | 8 Participants |
| Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Severe | 0 Participants |
| Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Potentially Life-threatening | 0 Participants |
| Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Missing | 0 Participants |
| Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | None | 2583 Participants |
| Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Mild | 107 Participants |
| Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Moderate | 10 Participants |
| Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Severe | 0 Participants |
| Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Potentially Life-threatening | 0 Participants |
| Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Missing | 0 Participants |
| Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Vomiting | None | 2629 Participants |
| Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Vomiting | Mild | 64 Participants |
| Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Vomiting | Moderate | 7 Participants |
| Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Vomiting | Severe | 0 Participants |
| Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Vomiting | Potentially Life-threatening | 0 Participants |
| Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Vomiting | Missing | 0 Participants |
| Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms (excl. Temp.) | None | 2095 Participants |
| Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms (excl. Temp.) | Mild | 459 Participants |
| Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms (excl. Temp.) | Moderate | 143 Participants |
| Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms (excl. Temp.) | Severe | 3 Participants |
| Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms (excl. Temp.) | Potentially Life-threatening | 0 Participants |
| Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms (excl. Temp.) | Missing | 0 Participants |
| Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | None | 2406 Participants |
| Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Mild | 176 Participants |
| Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Moderate | 84 Participants |
| Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Severe | 15 Participants |
| Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Potentially Life-threatening | 5 Participants |
Primary
Number of Participants With Early Study Termination Associated With an AE or Reactogenicity
From the termination form, early study termination associated with an AE or reactogenicity reasons are tabulated by treatment group.
Time frame: Measured through study completion (through 6 months after confirmation of HIV-1 diagnosis for participants who acquired HIV and through 12 months after last vaccination for the rest)
Population: Safety cohort
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vaccine | Number of Participants With Early Study Termination Associated With an AE or Reactogenicity | Termination associated with adverse event or reactogenicity | 9 Participants |
| Vaccine | Number of Participants With Early Study Termination Associated With an AE or Reactogenicity | Other reason | 140 Participants |
| Vaccine | Number of Participants With Early Study Termination Associated With an AE or Reactogenicity | No discontinuation | 2555 Participants |
| Placebo | Number of Participants With Early Study Termination Associated With an AE or Reactogenicity | Termination associated with adverse event or reactogenicity | 14 Participants |
| Placebo | Number of Participants With Early Study Termination Associated With an AE or Reactogenicity | Other reason | 129 Participants |
| Placebo | Number of Participants With Early Study Termination Associated With an AE or Reactogenicity | No discontinuation | 2557 Participants |
Primary
Number of Participants With Study Product Discontinuation Associated With an AE or Reactogenicity
From the study product discontinuation form, study product discontinuation reasons are tabulated by treatment group.
Time frame: Measured through study completion (through 6 months after confirmation of HIV-1 diagnosis for participants who acquired HIV and through 12 months after last vaccination for the rest)
Population: Safety cohort
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vaccine | Number of Participants With Study Product Discontinuation Associated With an AE or Reactogenicity | Clinical event other than reactogenicity, HIV, infection or death | 8 Participants |
| Vaccine | Number of Participants With Study Product Discontinuation Associated With an AE or Reactogenicity | Reactogenicity symptom | 4 Participants |
| Vaccine | Number of Participants With Study Product Discontinuation Associated With an AE or Reactogenicity | Other reason | 539 Participants |
| Vaccine | Number of Participants With Study Product Discontinuation Associated With an AE or Reactogenicity | No discontinuation | 2153 Participants |
| Placebo | Number of Participants With Study Product Discontinuation Associated With an AE or Reactogenicity | No discontinuation | 2095 Participants |
| Placebo | Number of Participants With Study Product Discontinuation Associated With an AE or Reactogenicity | Clinical event other than reactogenicity, HIV, infection or death | 6 Participants |
| Placebo | Number of Participants With Study Product Discontinuation Associated With an AE or Reactogenicity | Other reason | 598 Participants |
| Placebo | Number of Participants With Study Product Discontinuation Associated With an AE or Reactogenicity | Reactogenicity symptom | 1 Participants |
Secondary
Incidence Rate of HIV-1 Infection Diagnosed After Enrollment Through 24 Months Among Female Participants
Vaccine efficacy was calculated as 1 minus the hazard ratio for HIV-1 infection, which was estimated using a Cox proportional-hazards (Cox PH) model and tested using a log-rank test.
Time frame: Measured through 24 months after first vaccination
Population: Females in MITT cohort
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Vaccine | Incidence Rate of HIV-1 Infection Diagnosed After Enrollment Through 24 Months Among Female Participants | 0.043 events per 100 person-years |
| Placebo | Incidence Rate of HIV-1 Infection Diagnosed After Enrollment Through 24 Months Among Female Participants | 0.042 events per 100 person-years |
p-value: 0.8295% CI: [0.8, 1.33]Log Rank
Secondary
Incidence Rate of HIV-1 Infection Diagnosed After Enrollment Through 24 Months Among Female Participants Aged 25 or Younger
Vaccine efficacy was calculated as 1 minus the hazard ratio for HIV-1 infection, which was estimated using a Cox proportional-hazards (Cox PH) model and tested using a log-rank test.
Time frame: Measured through 24 months after first vaccination
Population: Females in MITT cohort aged 25 or younger
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Vaccine | Incidence Rate of HIV-1 Infection Diagnosed After Enrollment Through 24 Months Among Female Participants Aged 25 or Younger | 0.047 events per 100 person-years |
| Placebo | Incidence Rate of HIV-1 Infection Diagnosed After Enrollment Through 24 Months Among Female Participants Aged 25 or Younger | 0.044 events per 100 person-years |
p-value: 0.695% CI: [0.8, 1.47]Log Rank
Secondary
Incidence Rate of HIV-1 Infection Diagnosed After Enrollment Through 24 Months Among Female Participants Older Than 25
Vaccine efficacy was calculated as 1 minus the hazard ratio for HIV-1 infection, which was estimated using a Cox proportional-hazards (Cox PH) model and tested using a log-rank test.
Time frame: Measured through 24 months after first vaccination
Population: Females in MITT cohort older than 25
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Vaccine | Incidence Rate of HIV-1 Infection Diagnosed After Enrollment Through 24 Months Among Female Participants Older Than 25 | 0.035 events per 100 person-years |
| Placebo | Incidence Rate of HIV-1 Infection Diagnosed After Enrollment Through 24 Months Among Female Participants Older Than 25 | 0.039 events per 100 person-years |
p-value: 0.7195% CI: [0.58, 1.46]Log Rank
Secondary
Incidence Rate of HIV-1 Infection Diagnosed After Enrollment Through 24 Months Among Male Participants
Vaccine efficacy was calculated as 1 minus the hazard ratio for HIV-1 infection, which was estimated using a Cox proportional-hazards (Cox PH) model and tested using a log-rank test.
Time frame: Measured through 24 months after first vaccination
Population: Males in MITT cohort
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Vaccine | Incidence Rate of HIV-1 Infection Diagnosed After Enrollment Through 24 Months Among Male Participants | 0.013 events per 100 person-years |
| Placebo | Incidence Rate of HIV-1 Infection Diagnosed After Enrollment Through 24 Months Among Male Participants | 0.013 events per 100 person-years |
p-value: 0.9895% CI: [0.5, 1.98]Log Rank
Secondary
Incidence Rate of HIV-1 Infection Diagnosed After Enrollment Through 36 Months Post Enrollment
This outcome measure is the same as Primary Outcome 12, which was added after pre-established criteria for vaccine non-efficacy had been met. Analysis was not repeated but the outcome is listed for completeness.
Time frame: Measured through 36 months after first vaccination
Population: This outcome measure is the same as Primary Outcome 12, which was added after pre-established criteria for vaccine non-efficacy had been met. Analysis was not repeated but the outcome is listed for completeness.
Secondary
Incidence Rate of HIV-1 Infection Diagnosed After Enrollment Through Month 24 by Genotypic Characteristics of Viral Sequences From HIV-1 Infected Participants at HIV-1 Diagnosis, Such As Signature Site Mutations
Analysis will only be performed if significant positive evidence of vaccine efficacy from enrollment through 24 months is seen. However, monitoring boundaries for non-efficacy have been met per the 23 January 2020 DSMB finding.
Time frame: Measured through 24 months after first vaccination
Population: Analysis will only be performed if significant positive evidence of vaccine efficacy from enrollment through 24 months is seen. However, monitoring boundaries for non-efficacy have been met per the 23 January 2020 DSMB finding.
Secondary
Incidence Rate of HIV-1 Infection Diagnosed After Month 6.5 Through 24 Months Post Enrollment
Vaccine efficacy was calculated as 1 minus the hazard ratio for HIV-1 infection, which was estimated using a sex-stratified Cox proportional-hazards (Cox PH) model and tested using a sex-stratified log-rank test. Vaccine efficacy was also measured using a ratio of cumulative incidences (CIR) of HIV-1 infection in the vaccine group as compared with the placebo group, which was calculated using Nelson-Aalen cumulative hazard estimates and tested using a Wald test.
Time frame: Measured after Month 6.5 through 24 months after first vaccination
Population: Week 26 at-risk cohort
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vaccine | Incidence Rate of HIV-1 Infection Diagnosed After Month 6.5 Through 24 Months Post Enrollment | Cox PH method | 0.03 events per 100 person-years |
| Vaccine | Incidence Rate of HIV-1 Infection Diagnosed After Month 6.5 Through 24 Months Post Enrollment | CIR method | 0.03 events per 100 person-years |
| Placebo | Incidence Rate of HIV-1 Infection Diagnosed After Month 6.5 Through 24 Months Post Enrollment | Cox PH method | 0.026 events per 100 person-years |
| Placebo | Incidence Rate of HIV-1 Infection Diagnosed After Month 6.5 Through 24 Months Post Enrollment | CIR method | 0.026 events per 100 person-years |
p-value: 0.3995% CI: [0.84, 1.58]Log Rank
p-value: 0.595% CI: [0.81, 1.54]Wald
Secondary
Level of CD4+ and CD8+ T-Cells Expressing IFN-g and/or IL-2 and/or CD40L in Response to HIV Proteins Included in the Vaccine at Month 6.5
PBMC samples are stimulated with synthetic peptide pools or left unstimulated as negative control. Response magnitude is % cells expressing IFN-g and/or IL-2 after stimulation minus % cells expressing markers after no stimulation. Data are excluded if blood draw date was outside visit window, participant was HIV-infected (post-infection samples), PBMC viability/T-cell count were low or negative control was high. Any Env is the maximum of ZM96 gp120, 1086 gp120, and TV1 gp120. Any HIV is the sum of Any Env and LAI Gag. Negative magnitudes are censored at 0 before calculating sum; if the sum is lt 0.01, it is set to 0.01%. Summary was calculated among positive responders only.
Time frame: Measured at Month 6.5
Population: Immunogenicity cohort. Overall Number of Participants Analyzed represents participants in the immunogenicity cohort who have samples collected at Month 6.5 and who were HIV-uninfected. Number Analyzed represents those participants with available data after filtering for assay-specific quality control criteria.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Vaccine | Level of CD4+ and CD8+ T-Cells Expressing IFN-g and/or IL-2 and/or CD40L in Response to HIV Proteins Included in the Vaccine at Month 6.5 | CD4+ : 1086 gp120 | 0.2 % T-Cells |
| Vaccine | Level of CD4+ and CD8+ T-Cells Expressing IFN-g and/or IL-2 and/or CD40L in Response to HIV Proteins Included in the Vaccine at Month 6.5 | CD4+ : ANY ENV | 0.2 % T-Cells |
| Vaccine | Level of CD4+ and CD8+ T-Cells Expressing IFN-g and/or IL-2 and/or CD40L in Response to HIV Proteins Included in the Vaccine at Month 6.5 | CD4+ : ANY HIV | 0.2 % T-Cells |
| Vaccine | Level of CD4+ and CD8+ T-Cells Expressing IFN-g and/or IL-2 and/or CD40L in Response to HIV Proteins Included in the Vaccine at Month 6.5 | CD4+ : LAI Gag | 0.1 % T-Cells |
| Vaccine | Level of CD4+ and CD8+ T-Cells Expressing IFN-g and/or IL-2 and/or CD40L in Response to HIV Proteins Included in the Vaccine at Month 6.5 | CD4+ : TV1 gp120 | 0.2 % T-Cells |
| Vaccine | Level of CD4+ and CD8+ T-Cells Expressing IFN-g and/or IL-2 and/or CD40L in Response to HIV Proteins Included in the Vaccine at Month 6.5 | CD4+ : ZM96 gp120 | 0.2 % T-Cells |
| Vaccine | Level of CD4+ and CD8+ T-Cells Expressing IFN-g and/or IL-2 and/or CD40L in Response to HIV Proteins Included in the Vaccine at Month 6.5 | CD8+ : 1086 gp120 | 0.1 % T-Cells |
| Vaccine | Level of CD4+ and CD8+ T-Cells Expressing IFN-g and/or IL-2 and/or CD40L in Response to HIV Proteins Included in the Vaccine at Month 6.5 | CD8+ : ANY ENV | 0.1 % T-Cells |
| Vaccine | Level of CD4+ and CD8+ T-Cells Expressing IFN-g and/or IL-2 and/or CD40L in Response to HIV Proteins Included in the Vaccine at Month 6.5 | CD8+ : ANY HIV | 0.2 % T-Cells |
| Vaccine | Level of CD4+ and CD8+ T-Cells Expressing IFN-g and/or IL-2 and/or CD40L in Response to HIV Proteins Included in the Vaccine at Month 6.5 | CD8+ : LAI Gag | 0.1 % T-Cells |
| Vaccine | Level of CD4+ and CD8+ T-Cells Expressing IFN-g and/or IL-2 and/or CD40L in Response to HIV Proteins Included in the Vaccine at Month 6.5 | CD8+ : TV1 gp120 | 0.1 % T-Cells |
| Vaccine | Level of CD4+ and CD8+ T-Cells Expressing IFN-g and/or IL-2 and/or CD40L in Response to HIV Proteins Included in the Vaccine at Month 6.5 | CD8+ : ZM96 gp120 | 0.1 % T-Cells |
Secondary
Level of CD4+ and CD8+ T-Cells Expressing IFN-g and/or IL-2 in Response to HIV Proteins Included in the Vaccine at Month 6.5
PBMC samples are stimulated with synthetic peptide pools or left unstimulated as negative control. Response magnitude is % cells expressing IFN-g and/or IL-2 after stimulation minus % cells expressing markers after no stimulation. Data are excluded if blood draw date was outside visit window, participant was HIV-infected (post-infection samples), PBMC viability/T-cell count were low or negative control was high. Any Env is the maximum of ZM96 gp120, 1086 gp120, and TV1 gp120. Any HIV is the sum of Any Env and LAI Gag. Negative magnitudes are censored at 0 before calculating sum; if the sum is lt 0.01, it is set to 0.01%. Summary was calculated among positive responders only.
Time frame: Measured at Month 6.5
Population: Immunogenicity cohort. Overall Number of Participants Analyzed represents participants in the immunogenicity cohort who have samples collected at Month 6.5 and who were HIV-uninfected. Number Analyzed represents those participants with available data after filtering for assay-specific quality control criteria.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Vaccine | Level of CD4+ and CD8+ T-Cells Expressing IFN-g and/or IL-2 in Response to HIV Proteins Included in the Vaccine at Month 6.5 | CD4+ : 1086 gp120 | 0.1 % T-Cells |
| Vaccine | Level of CD4+ and CD8+ T-Cells Expressing IFN-g and/or IL-2 in Response to HIV Proteins Included in the Vaccine at Month 6.5 | CD4+ : ANY ENV | 0.1 % T-Cells |
| Vaccine | Level of CD4+ and CD8+ T-Cells Expressing IFN-g and/or IL-2 in Response to HIV Proteins Included in the Vaccine at Month 6.5 | CD4+ : ANY HIV | 0.2 % T-Cells |
| Vaccine | Level of CD4+ and CD8+ T-Cells Expressing IFN-g and/or IL-2 in Response to HIV Proteins Included in the Vaccine at Month 6.5 | CD4+ : LAI Gag | 0.1 % T-Cells |
| Vaccine | Level of CD4+ and CD8+ T-Cells Expressing IFN-g and/or IL-2 in Response to HIV Proteins Included in the Vaccine at Month 6.5 | CD4+ : TV1 gp120 | 0.1 % T-Cells |
| Vaccine | Level of CD4+ and CD8+ T-Cells Expressing IFN-g and/or IL-2 in Response to HIV Proteins Included in the Vaccine at Month 6.5 | CD4+ : ZM96 gp120 | 0.1 % T-Cells |
| Vaccine | Level of CD4+ and CD8+ T-Cells Expressing IFN-g and/or IL-2 in Response to HIV Proteins Included in the Vaccine at Month 6.5 | CD8+ : 1086 gp120 | 0.1 % T-Cells |
| Vaccine | Level of CD4+ and CD8+ T-Cells Expressing IFN-g and/or IL-2 in Response to HIV Proteins Included in the Vaccine at Month 6.5 | CD8+ : ANY ENV | 0.1 % T-Cells |
| Vaccine | Level of CD4+ and CD8+ T-Cells Expressing IFN-g and/or IL-2 in Response to HIV Proteins Included in the Vaccine at Month 6.5 | CD8+ : ANY HIV | 0.1 % T-Cells |
| Vaccine | Level of CD4+ and CD8+ T-Cells Expressing IFN-g and/or IL-2 in Response to HIV Proteins Included in the Vaccine at Month 6.5 | CD8+ : LAI Gag | 0.1 % T-Cells |
| Vaccine | Level of CD4+ and CD8+ T-Cells Expressing IFN-g and/or IL-2 in Response to HIV Proteins Included in the Vaccine at Month 6.5 | CD8+ : TV1 gp120 | 0.1 % T-Cells |
| Vaccine | Level of CD4+ and CD8+ T-Cells Expressing IFN-g and/or IL-2 in Response to HIV Proteins Included in the Vaccine at Month 6.5 | CD8+ : ZM96 gp120 | 0.1 % T-Cells |
Secondary
Level of Vaccine-induced IgA Binding Antibodies to HIV Proteins at Month 6.5
Serum IgA responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay, run at 1:10 dilution. The readout is background-subtracted mean fluorescent intensity (MFI), with background adjustment for an antigen-specific plate level control. For each sample, response magnitude is net MFI, defined as experimental antigen MFI minus reference antigen MFI. Net MFI lt 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. The immune response data were also studied for their ability to predict HIV-1 infection through Month 24 (correlates of risk analysis). The comprehensive analysis results are available in Moodie et al 2022 (PubMed ID: 35758878).
Time frame: Measured at Month 6.5
Population: Immunogenicity cohort. Overall Number of Participants Analyzed represents participants in the immunogenicity cohort who have samples collected at Month 6.5 and who were HIV-uninfected. Number Analyzed represents those participants with available data after filtering for assay-specific quality control criteria.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Vaccine | Level of Vaccine-induced IgA Binding Antibodies to HIV Proteins at Month 6.5 | RV144 CoR IgA Primary gp120 Score: 00MSA 4076 gp140 | 1521.5 net mean fluorescent intensity (net MFI) |
| Vaccine | Level of Vaccine-induced IgA Binding Antibodies to HIV Proteins at Month 6.5 | RV144 CoR IgA Primary gp120 Score: 92TH023 gp120 gDneg 293F mon | 1024.8 net mean fluorescent intensity (net MFI) |
| Vaccine | Level of Vaccine-induced IgA Binding Antibodies to HIV Proteins at Month 6.5 | RV144 CoR IgA Primary gp120 Score: A1.con.env03 140 CF | 2511.9 net mean fluorescent intensity (net MFI) |
| Vaccine | Level of Vaccine-induced IgA Binding Antibodies to HIV Proteins at Month 6.5 | RV144 CoR IgA Primary gp120 Score: A244 gp 120 gDneg/293F/mon | 801.2 net mean fluorescent intensity (net MFI) |
| Vaccine | Level of Vaccine-induced IgA Binding Antibodies to HIV Proteins at Month 6.5 | RV144 CoR IgA Primary gp120 Score: B.con.env03 140 CF | 3140.2 net mean fluorescent intensity (net MFI) |
| Vaccine | Level of Vaccine-induced IgA Binding Antibodies to HIV Proteins at Month 6.5 | RV144 CoR IgA Primary gp120 Score: C.con.env03 140 CF_avi | 2149.8 net mean fluorescent intensity (net MFI) |
| Vaccine | Level of Vaccine-induced IgA Binding Antibodies to HIV Proteins at Month 6.5 | RV144 CoR IgA Primary gp120 Score: Con 6 gp120/B | 2877.9 net mean fluorescent intensity (net MFI) |
| Vaccine | Level of Vaccine-induced IgA Binding Antibodies to HIV Proteins at Month 6.5 | RV144 CoR IgA Primary gp120 Score: Con S gp140 CFI | 5239.2 net mean fluorescent intensity (net MFI) |
| Vaccine | Level of Vaccine-induced IgA Binding Antibodies to HIV Proteins at Month 6.5 | RV144 CoR IgA Primary gp120 Score: G.con.env03 140 CF | 2845 net mean fluorescent intensity (net MFI) |
| Vaccine | Level of Vaccine-induced IgA Binding Antibodies to HIV Proteins at Month 6.5 | RV144 CoR IgA Primary gp120 Score: HV 13700 AE.con.env03 140 CF | 791 net mean fluorescent intensity (net MFI) |
| Vaccine | Level of Vaccine-induced IgA Binding Antibodies to HIV Proteins at Month 6.5 | RV144 CoR IgA Primary gp120 Score: HV 14000 (DRCBL) gp140 | 1291.5 net mean fluorescent intensity (net MFI) |
| Vaccine | Level of Vaccine-induced IgA Binding Antibodies to HIV Proteins at Month 6.5 | Vaccine Matched Env: 1086C_D7gp120.avi/293F | 22000 net mean fluorescent intensity (net MFI) |
| Vaccine | Level of Vaccine-induced IgA Binding Antibodies to HIV Proteins at Month 6.5 | Vaccine Matched Env: 96ZM651.D11gp120.avi | 6673.8 net mean fluorescent intensity (net MFI) |
| Vaccine | Level of Vaccine-induced IgA Binding Antibodies to HIV Proteins at Month 6.5 | Vaccine Matched Env: TV1c8_D11gp120.avi/293F | 6205 net mean fluorescent intensity (net MFI) |
| Vaccine | Level of Vaccine-induced IgA Binding Antibodies to HIV Proteins at Month 6.5 | gp70-96ZM651.02 V1v2 | 22000 net mean fluorescent intensity (net MFI) |
| Vaccine | Level of Vaccine-induced IgA Binding Antibodies to HIV Proteins at Month 6.5 | gp70-TV1.GSKvacV1V2/293F | 1059.5 net mean fluorescent intensity (net MFI) |
| Vaccine | Level of Vaccine-induced IgA Binding Antibodies to HIV Proteins at Month 6.5 | gp70_C.1086C V1/V2/293F | 5786.5 net mean fluorescent intensity (net MFI) |
Secondary
Level of Vaccine-induced IgG3 Binding Antibodies to HIV Proteins at Month 6.5
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 lt 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. The immune response data were also studied for their ability to predict HIV-1 infection through Month 24 (correlates of risk analysis). The comprehensive analysis results are available in Moodie et al 2022 (PubMed ID: 35758878).
Time frame: Measured at Month 6.5
Population: Immunogenicity cohort. Overall Number of Participants Analyzed represents participants in the immunogenicity cohort who have samples collected at Month 6.5 and who were HIV-uninfected. Number Analyzed represents those participants with available data after filtering for assay-specific quality control criteria.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Vaccine | Level of Vaccine-induced IgG3 Binding Antibodies to HIV Proteins at Month 6.5 | HVTN 505 Env Breadth Panel: A1.con.env03 140 CF | 277.1 net mean fluorescent intensity (net MFI) |
| Vaccine | Level of Vaccine-induced IgG3 Binding Antibodies to HIV Proteins at Month 6.5 | HVTN 505 Env Breadth Panel: B.con.env03 140 CF | 369.5 net mean fluorescent intensity (net MFI) |
| Vaccine | Level of Vaccine-induced IgG3 Binding Antibodies to HIV Proteins at Month 6.5 | HVTN 505 Env Breadth Panel: C.con.env03 140 CF_avi | 302.2 net mean fluorescent intensity (net MFI) |
| Vaccine | Level of Vaccine-induced IgG3 Binding Antibodies to HIV Proteins at Month 6.5 | HVTN 505 Env Breadth Panel: Con 6 gp120/B | 318.5 net mean fluorescent intensity (net MFI) |
| Vaccine | Level of Vaccine-induced IgG3 Binding Antibodies to HIV Proteins at Month 6.5 | HVTN 505 Env Breadth Panel: Con S gp140 CFI | 843 net mean fluorescent intensity (net MFI) |
| Vaccine | Level of Vaccine-induced IgG3 Binding Antibodies to HIV Proteins at Month 6.5 | HVTN 505 Env Breadth Panel: VRC A_avi | 337.8 net mean fluorescent intensity (net MFI) |
| Vaccine | Level of Vaccine-induced IgG3 Binding Antibodies to HIV Proteins at Month 6.5 | HVTN 505 Env Breadth Panel: VRC B gp140 | 208.2 net mean fluorescent intensity (net MFI) |
| Vaccine | Level of Vaccine-induced IgG3 Binding Antibodies to HIV Proteins at Month 6.5 | HVTN 505 Env Breadth Panel: VRC C_avi | 262.9 net mean fluorescent intensity (net MFI) |
| Vaccine | Level of Vaccine-induced IgG3 Binding Antibodies to HIV Proteins at Month 6.5 | RV144 CoR IgG3: C.1086C_V1_V2 Tags | 277.5 net mean fluorescent intensity (net MFI) |
| Vaccine | Level of Vaccine-induced IgG3 Binding Antibodies to HIV Proteins at Month 6.5 | RV144 CoR IgG3: gp70_B.CaseA2 V1/V2/169K | 963.5 net mean fluorescent intensity (net MFI) |
| Vaccine | Level of Vaccine-induced IgG3 Binding Antibodies to HIV Proteins at Month 6.5 | RV144 CoR IgG3: gp70_B.CaseA_V1_V2 | 1598.9 net mean fluorescent intensity (net MFI) |
| Vaccine | Level of Vaccine-induced IgG3 Binding Antibodies to HIV Proteins at Month 6.5 | V1V2 Subtype AW: AE.A244 V1V2 Tags/293F | 350.8 net mean fluorescent intensity (net MFI) |
| Vaccine | Level of Vaccine-induced IgG3 Binding Antibodies to HIV Proteins at Month 6.5 | Vaccine Matched Env: 1086C_D7gp120.avi/293F | 4534.8 net mean fluorescent intensity (net MFI) |
| Vaccine | Level of Vaccine-induced IgG3 Binding Antibodies to HIV Proteins at Month 6.5 | Vaccine Matched Env: 96ZM651.D11gp120.avi | 700.5 net mean fluorescent intensity (net MFI) |
| Vaccine | Level of Vaccine-induced IgG3 Binding Antibodies to HIV Proteins at Month 6.5 | Vaccine Matched Env: TV1c8_D11gp120.avi/293F | 2059.5 net mean fluorescent intensity (net MFI) |
| Vaccine | Level of Vaccine-induced IgG3 Binding Antibodies to HIV Proteins at Month 6.5 | Vaccine Strain Matched V1V2: gp70-96ZM651.02 V1v2 | 1398.2 net mean fluorescent intensity (net MFI) |
| Vaccine | Level of Vaccine-induced IgG3 Binding Antibodies to HIV Proteins at Month 6.5 | Vaccine Strain Matched V1V2: gp70-TV1.GSKvacV1V2/293F | 511.4 net mean fluorescent intensity (net MFI) |
| Vaccine | Level of Vaccine-induced IgG3 Binding Antibodies to HIV Proteins at Month 6.5 | Vaccine Strain Matched V1V2: gp70_C.1086C V1/V2/293F | 572.6 net mean fluorescent intensity (net MFI) |
Secondary
Level of Vaccine-induced IgG Binding Antibodies to HIV Proteins at Month 6.5
Serum IgG responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay, run at 1:50 and 1:100 dilutions. 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 lt 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. The immune response data were also studied for their ability to predict HIV-1 infection through Month 24 (correlates of risk analysis). The comprehensive analysis results are available in Moodie et al 2022 (PubMed ID: 35758878).
Time frame: Measured at Month 6.5
Population: Immunogenicity cohort. Overall Number of Participants Analyzed represents participants in the immunogenicity cohort who have samples collected at Month 6.5 and who were HIV-uninfected. Number Analyzed represents those participants with available data after filtering for assay-specific quality control criteria.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Vaccine | Level of Vaccine-induced IgG Binding Antibodies to HIV Proteins at Month 6.5 | HVTN 505 Env Breadth Panel: VRC A_avi, dilution 1: 50 | 20132 net mean fluorescent intensity (net MFI) |
| Vaccine | Level of Vaccine-induced IgG Binding Antibodies to HIV Proteins at Month 6.5 | HVTN 505 Env Breadth Panel: VRC A_avi, dilution 1:100 | 10290 net mean fluorescent intensity (net MFI) |
| Vaccine | Level of Vaccine-induced IgG Binding Antibodies to HIV Proteins at Month 6.5 | HVTN 505 Env Breadth Panel: VRC B gp140, dilution 1: 50 | 7503.5 net mean fluorescent intensity (net MFI) |
| Vaccine | Level of Vaccine-induced IgG Binding Antibodies to HIV Proteins at Month 6.5 | HVTN 505 Env Breadth Panel: VRC B gp140, dilution 1:100 | 3708.5 net mean fluorescent intensity (net MFI) |
| Vaccine | Level of Vaccine-induced IgG Binding Antibodies to HIV Proteins at Month 6.5 | HVTN 505 Env Breadth Panel: VRC C_avi, dilution 1: 50 | 12765 net mean fluorescent intensity (net MFI) |
| Vaccine | Level of Vaccine-induced IgG Binding Antibodies to HIV Proteins at Month 6.5 | HVTN 505 Env Breadth Panel: VRC C_avi, dilution 1:100 | 6247.2 net mean fluorescent intensity (net MFI) |
| Vaccine | Level of Vaccine-induced IgG Binding Antibodies to HIV Proteins at Month 6.5 | RV144 CoR IgA Primary gp120 Score: 00MSA 4076 gp140, dilution 1: 50 | 17184 net mean fluorescent intensity (net MFI) |
| Vaccine | Level of Vaccine-induced IgG Binding Antibodies to HIV Proteins at Month 6.5 | RV144 CoR IgA Primary gp120 Score: 00MSA 4076 gp140, dilution 1:100 | 8842.2 net mean fluorescent intensity (net MFI) |
| Vaccine | Level of Vaccine-induced IgG Binding Antibodies to HIV Proteins at Month 6.5 | RV144 CoR IgA Primary gp120 Score: A244 gp 120 gDneg/293F/mon, dilution 1: 50 | 18126.8 net mean fluorescent intensity (net MFI) |
| Vaccine | Level of Vaccine-induced IgG Binding Antibodies to HIV Proteins at Month 6.5 | RV144 CoR IgA Primary gp120 Score: A244 gp 120 gDneg/293F/mon, dilution 1:100 | 8697.2 net mean fluorescent intensity (net MFI) |
| Vaccine | Level of Vaccine-induced IgG Binding Antibodies to HIV Proteins at Month 6.5 | RV144 CoR IgA Primary gp120 Score: B.con.env03 140 CF, dilution 1: 50 | 22000 net mean fluorescent intensity (net MFI) |
| Vaccine | Level of Vaccine-induced IgG Binding Antibodies to HIV Proteins at Month 6.5 | RV144 CoR IgA Primary gp120 Score: B.con.env03 140 CF, dilution 1:100 | 21073.2 net mean fluorescent intensity (net MFI) |
| Vaccine | Level of Vaccine-induced IgG Binding Antibodies to HIV Proteins at Month 6.5 | RV144 CoR IgA Primary gp120 Score: C.con.env03 140 CF_avi, dilution 1: 50 | 19326.2 net mean fluorescent intensity (net MFI) |
| Vaccine | Level of Vaccine-induced IgG Binding Antibodies to HIV Proteins at Month 6.5 | RV144 CoR IgA Primary gp120 Score: C.con.env03 140 CF_avi, dilution 1:100 | 11210.5 net mean fluorescent intensity (net MFI) |
| Vaccine | Level of Vaccine-induced IgG Binding Antibodies to HIV Proteins at Month 6.5 | RV144 CoR IgA Primary gp120 Score: Con 6 gp120/B, dilution 1: 50 | 15732 net mean fluorescent intensity (net MFI) |
| Vaccine | Level of Vaccine-induced IgG Binding Antibodies to HIV Proteins at Month 6.5 | RV144 CoR IgA Primary gp120 Score: Con 6 gp120/B, dilution 1:100 | 7617.4 net mean fluorescent intensity (net MFI) |
| Vaccine | Level of Vaccine-induced IgG Binding Antibodies to HIV Proteins at Month 6.5 | RV144 CoR IgA Primary gp120 Score: Con S gp140 CFI, dilution 1: 50 | 22000 net mean fluorescent intensity (net MFI) |
| Vaccine | Level of Vaccine-induced IgG Binding Antibodies to HIV Proteins at Month 6.5 | RV144 CoR IgA Primary gp120 Score: Con S gp140 CFI, dilution 1:100 | 22000 net mean fluorescent intensity (net MFI) |
| Vaccine | Level of Vaccine-induced IgG Binding Antibodies to HIV Proteins at Month 6.5 | RV144 CoR IgA Primary gp120 Score: G.con.env03 140 CF, dilution 1: 50 | 22000 net mean fluorescent intensity (net MFI) |
| Vaccine | Level of Vaccine-induced IgG Binding Antibodies to HIV Proteins at Month 6.5 | RV144 CoR IgA Primary gp120 Score: G.con.env03 140 CF, dilution 1:100 | 22000 net mean fluorescent intensity (net MFI) |
| Vaccine | Level of Vaccine-induced IgG Binding Antibodies to HIV Proteins at Month 6.5 | RV144 CoR IgA Primary gp120 Score: HV 13700 AE.con.env03 140 CF, dilution 1: 50 | 15539.5 net mean fluorescent intensity (net MFI) |
| Vaccine | Level of Vaccine-induced IgG Binding Antibodies to HIV Proteins at Month 6.5 | RV144 CoR IgA Primary gp120 Score: HV 13700 AE.con.env03 140 CF, dilution 1:100 | 6859 net mean fluorescent intensity (net MFI) |
| Vaccine | Level of Vaccine-induced IgG Binding Antibodies to HIV Proteins at Month 6.5 | RV144 CoR IgA Primary gp120 Score: HV 14000 (DRCBL) gp140, dilution 1: 50 | 10932 net mean fluorescent intensity (net MFI) |
| Vaccine | Level of Vaccine-induced IgG Binding Antibodies to HIV Proteins at Month 6.5 | RV144 CoR IgA Primary gp120 Score: HV 14000 (DRCBL) gp140, dilution 1:100 | 5141.5 net mean fluorescent intensity (net MFI) |
| Vaccine | Level of Vaccine-induced IgG Binding Antibodies to HIV Proteins at Month 6.5 | RV144 CoR IgG3: gp70_B.CaseA2 V1/V2/169K, dilution 1: 50 | 1133.8 net mean fluorescent intensity (net MFI) |
| Vaccine | Level of Vaccine-induced IgG Binding Antibodies to HIV Proteins at Month 6.5 | RV144 CoR IgG3: gp70_B.CaseA2 V1/V2/169K, dilution 1:100 | 527.5 net mean fluorescent intensity (net MFI) |
| Vaccine | Level of Vaccine-induced IgG Binding Antibodies to HIV Proteins at Month 6.5 | RV144 CoR IgG: 92TH023 gp120 gDneg 293F mon, dilution 1: 50 | 15096.5 net mean fluorescent intensity (net MFI) |
| Vaccine | Level of Vaccine-induced IgG Binding Antibodies to HIV Proteins at Month 6.5 | RV144 CoR IgG: 92TH023 gp120 gDneg 293F mon, dilution 1:100 | 7544.2 net mean fluorescent intensity (net MFI) |
| Vaccine | Level of Vaccine-induced IgG Binding Antibodies to HIV Proteins at Month 6.5 | RV144 CoR IgG: A1.con.env03 140 CF, dilution 1: 50 | 19319.5 net mean fluorescent intensity (net MFI) |
| Vaccine | Level of Vaccine-induced IgG Binding Antibodies to HIV Proteins at Month 6.5 | RV144 CoR IgG: A1.con.env03 140 CF, dilution 1:100 | 12505.2 net mean fluorescent intensity (net MFI) |
| Vaccine | Level of Vaccine-induced IgG Binding Antibodies to HIV Proteins at Month 6.5 | RV144 CoR IgG: AE.A244 V1V2 Tags/293F, dilution 1: 50 | 2659.8 net mean fluorescent intensity (net MFI) |
| Vaccine | Level of Vaccine-induced IgG Binding Antibodies to HIV Proteins at Month 6.5 | RV144 CoR IgG: AE.A244 V1V2 Tags/293F, dilution 1:100 | 1014.8 net mean fluorescent intensity (net MFI) |
| Vaccine | Level of Vaccine-induced IgG Binding Antibodies to HIV Proteins at Month 6.5 | RV144 CoR IgG: C.1086C_V1_V2 Tags, dilution 1: 50 | 1273 net mean fluorescent intensity (net MFI) |
| Vaccine | Level of Vaccine-induced IgG Binding Antibodies to HIV Proteins at Month 6.5 | RV144 CoR IgG: C.1086C_V1_V2 Tags, dilution 1:100 | 566.5 net mean fluorescent intensity (net MFI) |
| Vaccine | Level of Vaccine-induced IgG Binding Antibodies to HIV Proteins at Month 6.5 | RV144 CoR IgG: gp70-92TH023 V1V2, dilution 1: 50 | 20359.2 net mean fluorescent intensity (net MFI) |
| Vaccine | Level of Vaccine-induced IgG Binding Antibodies to HIV Proteins at Month 6.5 | RV144 CoR IgG: gp70-92TH023 V1V2, dilution 1:100 | 7925.4 net mean fluorescent intensity (net MFI) |
| Vaccine | Level of Vaccine-induced IgG Binding Antibodies to HIV Proteins at Month 6.5 | RV144 CoR IgG: gp70_B.CaseA_V1_V2, dilution 1: 50 | 974.4 net mean fluorescent intensity (net MFI) |
| Vaccine | Level of Vaccine-induced IgG Binding Antibodies to HIV Proteins at Month 6.5 | RV144 CoR IgG: gp70_B.CaseA_V1_V2, dilution 1:100 | 452.8 net mean fluorescent intensity (net MFI) |
| Vaccine | Level of Vaccine-induced IgG Binding Antibodies to HIV Proteins at Month 6.5 | RV144 CoR IgA: Bio-1086C C1_HS, dilution 1: 40 | 657 net mean fluorescent intensity (net MFI) |
| Vaccine | Level of Vaccine-induced IgG Binding Antibodies to HIV Proteins at Month 6.5 | RV144 CoR IgA: Bio-92TH023 C1_HS, dilution 1: 40 | 3345.5 net mean fluorescent intensity (net MFI) |
| Vaccine | Level of Vaccine-induced IgG Binding Antibodies to HIV Proteins at Month 6.5 | RV144 CoR IgA: Bio-96ZM651 C1_HS, dilution 1: 40 | 6250.6 net mean fluorescent intensity (net MFI) |
| Vaccine | Level of Vaccine-induced IgG Binding Antibodies to HIV Proteins at Month 6.5 | RV144 CoR IgA: Bio-TV1 C1_HS, dilution 1: 40 | 318 net mean fluorescent intensity (net MFI) |
| Vaccine | Level of Vaccine-induced IgG Binding Antibodies to HIV Proteins at Month 6.5 | Vaccine Matched Env: 1086C_D7gp120.avi/293F, dilution 1: 50 | 22000 net mean fluorescent intensity (net MFI) |
| Vaccine | Level of Vaccine-induced IgG Binding Antibodies to HIV Proteins at Month 6.5 | Vaccine Matched Env: 1086C_D7gp120.avi/293F, dilution 1:100 | 22000 net mean fluorescent intensity (net MFI) |
| Vaccine | Level of Vaccine-induced IgG Binding Antibodies to HIV Proteins at Month 6.5 | Vaccine Matched Env: 96ZM651.D11gp120.avi, dilution 1: 50 | 22000 net mean fluorescent intensity (net MFI) |
| Vaccine | Level of Vaccine-induced IgG Binding Antibodies to HIV Proteins at Month 6.5 | Vaccine Matched Env: 96ZM651.D11gp120.avi, dilution 1:100 | 19310.5 net mean fluorescent intensity (net MFI) |
| Vaccine | Level of Vaccine-induced IgG Binding Antibodies to HIV Proteins at Month 6.5 | Vaccine Matched Env: TV1c8_D11gp120.avi/293F, dilution 1: 50 | 22000 net mean fluorescent intensity (net MFI) |
| Vaccine | Level of Vaccine-induced IgG Binding Antibodies to HIV Proteins at Month 6.5 | Vaccine Matched Env: TV1c8_D11gp120.avi/293F, dilution 1:100 | 22000 net mean fluorescent intensity (net MFI) |
| Vaccine | Level of Vaccine-induced IgG Binding Antibodies to HIV Proteins at Month 6.5 | Vaccine Strain Matched V1V2: gp70-96ZM651.02 V1v2, dilution 1: 50 | 1319.8 net mean fluorescent intensity (net MFI) |
| Vaccine | Level of Vaccine-induced IgG Binding Antibodies to HIV Proteins at Month 6.5 | Vaccine Strain Matched V1V2: gp70-96ZM651.02 V1v2, dilution 1:100 | 538.5 net mean fluorescent intensity (net MFI) |
| Vaccine | Level of Vaccine-induced IgG Binding Antibodies to HIV Proteins at Month 6.5 | Vaccine Strain Matched V1V2: gp70-TV1.GSKvacV1V2/293F, dilution 1: 50 | 1452.8 net mean fluorescent intensity (net MFI) |
| Vaccine | Level of Vaccine-induced IgG Binding Antibodies to HIV Proteins at Month 6.5 | Vaccine Strain Matched V1V2: gp70-TV1.GSKvacV1V2/293F, dilution 1:100 | 640.2 net mean fluorescent intensity (net MFI) |
| Vaccine | Level of Vaccine-induced IgG Binding Antibodies to HIV Proteins at Month 6.5 | Vaccine Strain Matched V1V2: gp70_C.1086C V1/V2/293F, dilution 1: 50 | 4573.2 net mean fluorescent intensity (net MFI) |
| Vaccine | Level of Vaccine-induced IgG Binding Antibodies to HIV Proteins at Month 6.5 | Vaccine Strain Matched V1V2: gp70_C.1086C V1/V2/293F, dilution 1:100 | 2029.2 net mean fluorescent intensity (net MFI) |
| Vaccine | Level of Vaccine-induced IgG Binding Antibodies to HIV Proteins at Month 6.5 | gp41, dilution 1: 50 | 2125 net mean fluorescent intensity (net MFI) |
| Vaccine | Level of Vaccine-induced IgG Binding Antibodies to HIV Proteins at Month 6.5 | gp41, dilution 1:100 | 780.8 net mean fluorescent intensity (net MFI) |
Secondary
Number of Participants With Occurrence of CD4+ and CD8+ T-Cells Expressing IFN-g and/or IL-2 and/or CD40L in Response to HIV Proteins Included in the Vaccine at Month 6.5
PBMC samples are stimulated with synthetic peptide pools or left unstimulated as negative control. Response magnitude is % cells expressing IFN-g and/or IL-2 after stimulation minus % cells expressing markers after no stimulation. Contingency table is constructed to assess response: stimulation (peptide/none) vs. marker expression (yes/no). One-sided Fisher's exact test is applied, testing if number of cells positive for the marker is equal in stimulated vs. unstimulated cells. Bonferroni-Holm adjustment is made over peptide pools. Response is positive if adjusted p-value le 0.00001. Data are excluded if blood draw date was outside visit window, participant was HIV-infected (post-infection samples), PBMC viability/T-cell count were low or negative control was high. Any Env is the maximum of ZM96 gp120, 1086 gp120, and TV1 gp120. Any HIV is the sum of Any Env and LAI Gag. Negative magnitudes are censored at 0 before calculating sum; if the sum is lt 0.01, it is set to 0.01%.
Time frame: Measured at Month 6.5
Population: Immunogenicity cohort. Overall Number of Participants Analyzed represents participants in the immunogenicity cohort who have samples collected at Month 6.5 and who were HIV-uninfected. Number Analyzed represents those participants with available data after filtering for assay-specific quality control criteria.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vaccine | Number of Participants With Occurrence of CD4+ and CD8+ T-Cells Expressing IFN-g and/or IL-2 and/or CD40L in Response to HIV Proteins Included in the Vaccine at Month 6.5 | CD4+ : 1086 gp120 | 86 Participants |
| Vaccine | Number of Participants With Occurrence of CD4+ and CD8+ T-Cells Expressing IFN-g and/or IL-2 and/or CD40L in Response to HIV Proteins Included in the Vaccine at Month 6.5 | CD4+ : ANY ENV | 103 Participants |
| Vaccine | Number of Participants With Occurrence of CD4+ and CD8+ T-Cells Expressing IFN-g and/or IL-2 and/or CD40L in Response to HIV Proteins Included in the Vaccine at Month 6.5 | CD4+ : ANY HIV | 103 Participants |
| Vaccine | Number of Participants With Occurrence of CD4+ and CD8+ T-Cells Expressing IFN-g and/or IL-2 and/or CD40L in Response to HIV Proteins Included in the Vaccine at Month 6.5 | CD4+ : LAI Gag | 7 Participants |
| Vaccine | Number of Participants With Occurrence of CD4+ and CD8+ T-Cells Expressing IFN-g and/or IL-2 and/or CD40L in Response to HIV Proteins Included in the Vaccine at Month 6.5 | CD4+ : TV1 gp120 | 99 Participants |
| Vaccine | Number of Participants With Occurrence of CD4+ and CD8+ T-Cells Expressing IFN-g and/or IL-2 and/or CD40L in Response to HIV Proteins Included in the Vaccine at Month 6.5 | CD4+ : ZM96 gp120 | 88 Participants |
| Vaccine | Number of Participants With Occurrence of CD4+ and CD8+ T-Cells Expressing IFN-g and/or IL-2 and/or CD40L in Response to HIV Proteins Included in the Vaccine at Month 6.5 | CD8+ : 1086 gp120 | 5 Participants |
| Vaccine | Number of Participants With Occurrence of CD4+ and CD8+ T-Cells Expressing IFN-g and/or IL-2 and/or CD40L in Response to HIV Proteins Included in the Vaccine at Month 6.5 | CD8+ : ANY ENV | 16 Participants |
| Vaccine | Number of Participants With Occurrence of CD4+ and CD8+ T-Cells Expressing IFN-g and/or IL-2 and/or CD40L in Response to HIV Proteins Included in the Vaccine at Month 6.5 | CD8+ : ANY HIV | 17 Participants |
| Vaccine | Number of Participants With Occurrence of CD4+ and CD8+ T-Cells Expressing IFN-g and/or IL-2 and/or CD40L in Response to HIV Proteins Included in the Vaccine at Month 6.5 | CD8+ : LAI Gag | 3 Participants |
| Vaccine | Number of Participants With Occurrence of CD4+ and CD8+ T-Cells Expressing IFN-g and/or IL-2 and/or CD40L in Response to HIV Proteins Included in the Vaccine at Month 6.5 | CD8+ : TV1 gp120 | 6 Participants |
| Vaccine | Number of Participants With Occurrence of CD4+ and CD8+ T-Cells Expressing IFN-g and/or IL-2 and/or CD40L in Response to HIV Proteins Included in the Vaccine at Month 6.5 | CD8+ : ZM96 gp120 | 11 Participants |
| Placebo | Number of Participants With Occurrence of CD4+ and CD8+ T-Cells Expressing IFN-g and/or IL-2 and/or CD40L in Response to HIV Proteins Included in the Vaccine at Month 6.5 | CD8+ : TV1 gp120 | 0 Participants |
| Placebo | Number of Participants With Occurrence of CD4+ and CD8+ T-Cells Expressing IFN-g and/or IL-2 and/or CD40L in Response to HIV Proteins Included in the Vaccine at Month 6.5 | CD4+ : 1086 gp120 | 0 Participants |
| Placebo | Number of Participants With Occurrence of CD4+ and CD8+ T-Cells Expressing IFN-g and/or IL-2 and/or CD40L in Response to HIV Proteins Included in the Vaccine at Month 6.5 | CD8+ : 1086 gp120 | 0 Participants |
| Placebo | Number of Participants With Occurrence of CD4+ and CD8+ T-Cells Expressing IFN-g and/or IL-2 and/or CD40L in Response to HIV Proteins Included in the Vaccine at Month 6.5 | CD4+ : ANY ENV | 0 Participants |
| Placebo | Number of Participants With Occurrence of CD4+ and CD8+ T-Cells Expressing IFN-g and/or IL-2 and/or CD40L in Response to HIV Proteins Included in the Vaccine at Month 6.5 | CD8+ : LAI Gag | 0 Participants |
| Placebo | Number of Participants With Occurrence of CD4+ and CD8+ T-Cells Expressing IFN-g and/or IL-2 and/or CD40L in Response to HIV Proteins Included in the Vaccine at Month 6.5 | CD4+ : ANY HIV | 0 Participants |
| Placebo | Number of Participants With Occurrence of CD4+ and CD8+ T-Cells Expressing IFN-g and/or IL-2 and/or CD40L in Response to HIV Proteins Included in the Vaccine at Month 6.5 | CD8+ : ANY ENV | 0 Participants |
| Placebo | Number of Participants With Occurrence of CD4+ and CD8+ T-Cells Expressing IFN-g and/or IL-2 and/or CD40L in Response to HIV Proteins Included in the Vaccine at Month 6.5 | CD4+ : LAI Gag | 0 Participants |
| Placebo | Number of Participants With Occurrence of CD4+ and CD8+ T-Cells Expressing IFN-g and/or IL-2 and/or CD40L in Response to HIV Proteins Included in the Vaccine at Month 6.5 | CD8+ : ZM96 gp120 | 0 Participants |
| Placebo | Number of Participants With Occurrence of CD4+ and CD8+ T-Cells Expressing IFN-g and/or IL-2 and/or CD40L in Response to HIV Proteins Included in the Vaccine at Month 6.5 | CD4+ : TV1 gp120 | 0 Participants |
| Placebo | Number of Participants With Occurrence of CD4+ and CD8+ T-Cells Expressing IFN-g and/or IL-2 and/or CD40L in Response to HIV Proteins Included in the Vaccine at Month 6.5 | CD8+ : ANY HIV | 0 Participants |
| Placebo | Number of Participants With Occurrence of CD4+ and CD8+ T-Cells Expressing IFN-g and/or IL-2 and/or CD40L in Response to HIV Proteins Included in the Vaccine at Month 6.5 | CD4+ : ZM96 gp120 | 0 Participants |
Secondary
Number of Participants With Occurrence of CD4+ and CD8+ T-Cells Expressing IFN-g and/or IL-2 in Response to HIV Proteins Included in the Vaccine at Month 6.5
PBMC samples are stimulated with synthetic peptide pools or left unstimulated as negative control. Response magnitude is % cells expressing IFN-g and/or IL-2 after stimulation minus % cells expressing markers after no stimulation. Contingency table is constructed to assess response: stimulation (peptide/none) vs. marker expression (yes/no). One-sided Fisher's exact test is applied, testing if number of cells positive for the marker is equal in stimulated vs. unstimulated cells. Bonferroni-Holm adjustment is made over peptide pools. Response is positive if adjusted p-value le 0.00001. Data are excluded if blood draw date was outside visit window, participant was HIV-infected (post-infection samples), PBMC viability/T-cell count were low or negative control was high. Any Env is the maximum of ZM96 gp120, 1086 gp120, and TV1 gp120. Any HIV is the sum of Any Env and LAI Gag. Negative magnitudes are censored at 0 before calculating sum; if the sum is lt 0.01, it is set to 0.01%.
Time frame: Measured at Month 6.5
Population: Immunogenicity cohort. Overall Number of Participants Analyzed represents participants in the immunogenicity cohort who have samples collected at Month 6.5 and who were HIV-uninfected. Number Analyzed represents those participants with available data after filtering for assay-specific quality control criteria.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vaccine | Number of Participants With Occurrence of CD4+ and CD8+ T-Cells Expressing IFN-g and/or IL-2 in Response to HIV Proteins Included in the Vaccine at Month 6.5 | CD4+ : ANY ENV | 88 Participants |
| Vaccine | Number of Participants With Occurrence of CD4+ and CD8+ T-Cells Expressing IFN-g and/or IL-2 in Response to HIV Proteins Included in the Vaccine at Month 6.5 | CD4+ : ANY HIV | 89 Participants |
| Vaccine | Number of Participants With Occurrence of CD4+ and CD8+ T-Cells Expressing IFN-g and/or IL-2 in Response to HIV Proteins Included in the Vaccine at Month 6.5 | CD4+ : LAI Gag | 4 Participants |
| Vaccine | Number of Participants With Occurrence of CD4+ and CD8+ T-Cells Expressing IFN-g and/or IL-2 in Response to HIV Proteins Included in the Vaccine at Month 6.5 | CD4+ : TV1 gp120 | 86 Participants |
| Vaccine | Number of Participants With Occurrence of CD4+ and CD8+ T-Cells Expressing IFN-g and/or IL-2 in Response to HIV Proteins Included in the Vaccine at Month 6.5 | CD4+ : ZM96 gp120 | 78 Participants |
| Vaccine | Number of Participants With Occurrence of CD4+ and CD8+ T-Cells Expressing IFN-g and/or IL-2 in Response to HIV Proteins Included in the Vaccine at Month 6.5 | CD8+ : 1086 gp120 | 2 Participants |
| Vaccine | Number of Participants With Occurrence of CD4+ and CD8+ T-Cells Expressing IFN-g and/or IL-2 in Response to HIV Proteins Included in the Vaccine at Month 6.5 | CD8+ : ANY ENV | 13 Participants |
| Vaccine | Number of Participants With Occurrence of CD4+ and CD8+ T-Cells Expressing IFN-g and/or IL-2 in Response to HIV Proteins Included in the Vaccine at Month 6.5 | CD8+ : ANY HIV | 15 Participants |
| Vaccine | Number of Participants With Occurrence of CD4+ and CD8+ T-Cells Expressing IFN-g and/or IL-2 in Response to HIV Proteins Included in the Vaccine at Month 6.5 | CD8+ : LAI Gag | 4 Participants |
| Vaccine | Number of Participants With Occurrence of CD4+ and CD8+ T-Cells Expressing IFN-g and/or IL-2 in Response to HIV Proteins Included in the Vaccine at Month 6.5 | CD8+ : TV1 gp120 | 4 Participants |
| Vaccine | Number of Participants With Occurrence of CD4+ and CD8+ T-Cells Expressing IFN-g and/or IL-2 in Response to HIV Proteins Included in the Vaccine at Month 6.5 | CD8+ : ZM96 gp120 | 11 Participants |
| Vaccine | Number of Participants With Occurrence of CD4+ and CD8+ T-Cells Expressing IFN-g and/or IL-2 in Response to HIV Proteins Included in the Vaccine at Month 6.5 | CD4+ : 1086 gp120 | 65 Participants |
| Placebo | Number of Participants With Occurrence of CD4+ and CD8+ T-Cells Expressing IFN-g and/or IL-2 in Response to HIV Proteins Included in the Vaccine at Month 6.5 | CD8+ : ZM96 gp120 | 0 Participants |
| Placebo | Number of Participants With Occurrence of CD4+ and CD8+ T-Cells Expressing IFN-g and/or IL-2 in Response to HIV Proteins Included in the Vaccine at Month 6.5 | CD4+ : ANY ENV | 0 Participants |
| Placebo | Number of Participants With Occurrence of CD4+ and CD8+ T-Cells Expressing IFN-g and/or IL-2 in Response to HIV Proteins Included in the Vaccine at Month 6.5 | CD8+ : ANY ENV | 0 Participants |
| Placebo | Number of Participants With Occurrence of CD4+ and CD8+ T-Cells Expressing IFN-g and/or IL-2 in Response to HIV Proteins Included in the Vaccine at Month 6.5 | CD4+ : ANY HIV | 0 Participants |
| Placebo | Number of Participants With Occurrence of CD4+ and CD8+ T-Cells Expressing IFN-g and/or IL-2 in Response to HIV Proteins Included in the Vaccine at Month 6.5 | CD8+ : TV1 gp120 | 0 Participants |
| Placebo | Number of Participants With Occurrence of CD4+ and CD8+ T-Cells Expressing IFN-g and/or IL-2 in Response to HIV Proteins Included in the Vaccine at Month 6.5 | CD4+ : LAI Gag | 0 Participants |
| Placebo | Number of Participants With Occurrence of CD4+ and CD8+ T-Cells Expressing IFN-g and/or IL-2 in Response to HIV Proteins Included in the Vaccine at Month 6.5 | CD8+ : ANY HIV | 0 Participants |
| Placebo | Number of Participants With Occurrence of CD4+ and CD8+ T-Cells Expressing IFN-g and/or IL-2 in Response to HIV Proteins Included in the Vaccine at Month 6.5 | CD4+ : TV1 gp120 | 0 Participants |
| Placebo | Number of Participants With Occurrence of CD4+ and CD8+ T-Cells Expressing IFN-g and/or IL-2 in Response to HIV Proteins Included in the Vaccine at Month 6.5 | CD4+ : 1086 gp120 | 0 Participants |
| Placebo | Number of Participants With Occurrence of CD4+ and CD8+ T-Cells Expressing IFN-g and/or IL-2 in Response to HIV Proteins Included in the Vaccine at Month 6.5 | CD4+ : ZM96 gp120 | 0 Participants |
| Placebo | Number of Participants With Occurrence of CD4+ and CD8+ T-Cells Expressing IFN-g and/or IL-2 in Response to HIV Proteins Included in the Vaccine at Month 6.5 | CD8+ : LAI Gag | 0 Participants |
| Placebo | Number of Participants With Occurrence of CD4+ and CD8+ T-Cells Expressing IFN-g and/or IL-2 in Response to HIV Proteins Included in the Vaccine at Month 6.5 | CD8+ : 1086 gp120 | 0 Participants |
Secondary
Number of Participants With Occurrence of Vaccine-induced IgA Binding Antibodies to HIV Proteins at Month 6.5
Serum IgA responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay,run at 1:10 dilution.The readout is background-subtracted mean fluorescent intensity (MFI),with background adjustment for an antigen-specific plate level control.For each sample,response magnitude is net MFI,defined as experimental antigen MFI minus reference antigen MFI.Net MFI lt 1 is set to 1, and net MFI \> 22,000 is set to 22,000.Data are excluded if blood draw date was outside the allowable window,a participant was HIV-infected,reference antigen \> 5,000 MFI or baseline net MFI \> 6,500.Samples from post-enrollment visits have positive responses if they meet three criteria:(1) net MFI greater than or equal to an antigen-specific response threshold (defined as the maximum of 100 and the 95th percentile of baseline net MFI),(2) net MFI values are greater than 3 times baseline net MFI, and (3) experimental antigen MFI values are greater than 3 times baseline MFI.
Time frame: Measured at Month 6.5
Population: Immunogenicity cohort. Overall Number of Participants Analyzed represents participants in the immunogenicity cohort who have samples collected at Month 6.5 and who were HIV-uninfected. Number Analyzed represents those participants with available data after filtering for assay-specific quality control criteria.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vaccine | Number of Participants With Occurrence of Vaccine-induced IgA Binding Antibodies to HIV Proteins at Month 6.5 | RV144 CoR IgA Primary gp120 Score : G.con.env03 140 CF | 73 Participants |
| Vaccine | Number of Participants With Occurrence of Vaccine-induced IgA Binding Antibodies to HIV Proteins at Month 6.5 | RV144 CoR IgA Primary gp120 Score : A244 gp 120 gDneg/293F/mon | 34 Participants |
| Vaccine | Number of Participants With Occurrence of Vaccine-induced IgA Binding Antibodies to HIV Proteins at Month 6.5 | RV144 CoR IgA Primary gp120 Score : HV 13700 AE.con.env03 140 CF | 41 Participants |
| Vaccine | Number of Participants With Occurrence of Vaccine-induced IgA Binding Antibodies to HIV Proteins at Month 6.5 | Bio-TV1 C1_HS | 0 Participants |
| Vaccine | Number of Participants With Occurrence of Vaccine-induced IgA Binding Antibodies to HIV Proteins at Month 6.5 | RV144 CoR IgA Primary gp120 Score : HV 14000 (DRCBL) gp140 | 65 Participants |
| Vaccine | Number of Participants With Occurrence of Vaccine-induced IgA Binding Antibodies to HIV Proteins at Month 6.5 | RV144 CoR IgA Primary gp120 Score : B.con.env03 140 CF | 83 Participants |
| Vaccine | Number of Participants With Occurrence of Vaccine-induced IgA Binding Antibodies to HIV Proteins at Month 6.5 | RV144 CoR IgA : Bio-92TH023 C1_HS | 0 Participants |
| Vaccine | Number of Participants With Occurrence of Vaccine-induced IgA Binding Antibodies to HIV Proteins at Month 6.5 | RV144 CoR IgA Primary gp120 Score : 92TH023 gp120 gDneg 293F mon | 48 Participants |
| Vaccine | Number of Participants With Occurrence of Vaccine-induced IgA Binding Antibodies to HIV Proteins at Month 6.5 | Vaccine Matched Env : 1086C_D7gp120.avi/293F | 114 Participants |
| Vaccine | Number of Participants With Occurrence of Vaccine-induced IgA Binding Antibodies to HIV Proteins at Month 6.5 | RV144 CoR IgA Primary gp120 Score : C.con.env03 140 CF_avi | 75 Participants |
| Vaccine | Number of Participants With Occurrence of Vaccine-induced IgA Binding Antibodies to HIV Proteins at Month 6.5 | Vaccine Matched Env : 96ZM651.D11gp120.avi | 82 Participants |
| Vaccine | Number of Participants With Occurrence of Vaccine-induced IgA Binding Antibodies to HIV Proteins at Month 6.5 | Bio-96ZM651 C1_HS | 0 Participants |
| Vaccine | Number of Participants With Occurrence of Vaccine-induced IgA Binding Antibodies to HIV Proteins at Month 6.5 | Vaccine Matched Env : TV1c8_D11gp120.avi/293F | 90 Participants |
| Vaccine | Number of Participants With Occurrence of Vaccine-induced IgA Binding Antibodies to HIV Proteins at Month 6.5 | RV144 CoR IgA Primary gp120 Score : Con 6 gp120/B | 68 Participants |
| Vaccine | Number of Participants With Occurrence of Vaccine-induced IgA Binding Antibodies to HIV Proteins at Month 6.5 | gp41 | 0 Participants |
| Vaccine | Number of Participants With Occurrence of Vaccine-induced IgA Binding Antibodies to HIV Proteins at Month 6.5 | RV144 CoR IgA Primary gp120 Score : A1.con.env03 140 CF | 72 Participants |
| Vaccine | Number of Participants With Occurrence of Vaccine-induced IgA Binding Antibodies to HIV Proteins at Month 6.5 | gp70-96ZM651.02 V1v2 | 1 Participants |
| Vaccine | Number of Participants With Occurrence of Vaccine-induced IgA Binding Antibodies to HIV Proteins at Month 6.5 | RV144 CoR IgA Primary gp120 Score : Con S gp140 CFI | 95 Participants |
| Vaccine | Number of Participants With Occurrence of Vaccine-induced IgA Binding Antibodies to HIV Proteins at Month 6.5 | gp70-TV1.GSKvacV1V2/293F | 4 Participants |
| Vaccine | Number of Participants With Occurrence of Vaccine-induced IgA Binding Antibodies to HIV Proteins at Month 6.5 | RV144 CoR IgA Primary gp120 Score : 00MSA 4076 gp140 | 60 Participants |
| Vaccine | Number of Participants With Occurrence of Vaccine-induced IgA Binding Antibodies to HIV Proteins at Month 6.5 | gp70_C.1086C V1/V2/293F | 13 Participants |
| Vaccine | Number of Participants With Occurrence of Vaccine-induced IgA Binding Antibodies to HIV Proteins at Month 6.5 | Bio-1086C C1_HS | 0 Participants |
| Placebo | Number of Participants With Occurrence of Vaccine-induced IgA Binding Antibodies to HIV Proteins at Month 6.5 | gp70_C.1086C V1/V2/293F | 0 Participants |
| Placebo | Number of Participants With Occurrence of Vaccine-induced IgA Binding Antibodies to HIV Proteins at Month 6.5 | Bio-1086C C1_HS | 0 Participants |
| Placebo | Number of Participants With Occurrence of Vaccine-induced IgA Binding Antibodies to HIV Proteins at Month 6.5 | Bio-96ZM651 C1_HS | 0 Participants |
| Placebo | Number of Participants With Occurrence of Vaccine-induced IgA Binding Antibodies to HIV Proteins at Month 6.5 | Bio-TV1 C1_HS | 0 Participants |
| Placebo | Number of Participants With Occurrence of Vaccine-induced IgA Binding Antibodies to HIV Proteins at Month 6.5 | RV144 CoR IgA Primary gp120 Score : 00MSA 4076 gp140 | 0 Participants |
| Placebo | Number of Participants With Occurrence of Vaccine-induced IgA Binding Antibodies to HIV Proteins at Month 6.5 | RV144 CoR IgA Primary gp120 Score : 92TH023 gp120 gDneg 293F mon | 0 Participants |
| Placebo | Number of Participants With Occurrence of Vaccine-induced IgA Binding Antibodies to HIV Proteins at Month 6.5 | RV144 CoR IgA Primary gp120 Score : A1.con.env03 140 CF | 0 Participants |
| Placebo | Number of Participants With Occurrence of Vaccine-induced IgA Binding Antibodies to HIV Proteins at Month 6.5 | RV144 CoR IgA Primary gp120 Score : A244 gp 120 gDneg/293F/mon | 0 Participants |
| Placebo | Number of Participants With Occurrence of Vaccine-induced IgA Binding Antibodies to HIV Proteins at Month 6.5 | RV144 CoR IgA Primary gp120 Score : B.con.env03 140 CF | 0 Participants |
| Placebo | Number of Participants With Occurrence of Vaccine-induced IgA Binding Antibodies to HIV Proteins at Month 6.5 | RV144 CoR IgA Primary gp120 Score : C.con.env03 140 CF_avi | 0 Participants |
| Placebo | Number of Participants With Occurrence of Vaccine-induced IgA Binding Antibodies to HIV Proteins at Month 6.5 | RV144 CoR IgA Primary gp120 Score : Con 6 gp120/B | 0 Participants |
| Placebo | Number of Participants With Occurrence of Vaccine-induced IgA Binding Antibodies to HIV Proteins at Month 6.5 | RV144 CoR IgA Primary gp120 Score : Con S gp140 CFI | 0 Participants |
| Placebo | Number of Participants With Occurrence of Vaccine-induced IgA Binding Antibodies to HIV Proteins at Month 6.5 | RV144 CoR IgA Primary gp120 Score : G.con.env03 140 CF | 0 Participants |
| Placebo | Number of Participants With Occurrence of Vaccine-induced IgA Binding Antibodies to HIV Proteins at Month 6.5 | RV144 CoR IgA Primary gp120 Score : HV 13700 AE.con.env03 140 CF | 0 Participants |
| Placebo | Number of Participants With Occurrence of Vaccine-induced IgA Binding Antibodies to HIV Proteins at Month 6.5 | RV144 CoR IgA Primary gp120 Score : HV 14000 (DRCBL) gp140 | 0 Participants |
| Placebo | Number of Participants With Occurrence of Vaccine-induced IgA Binding Antibodies to HIV Proteins at Month 6.5 | RV144 CoR IgA : Bio-92TH023 C1_HS | 0 Participants |
| Placebo | Number of Participants With Occurrence of Vaccine-induced IgA Binding Antibodies to HIV Proteins at Month 6.5 | Vaccine Matched Env : 1086C_D7gp120.avi/293F | 0 Participants |
| Placebo | Number of Participants With Occurrence of Vaccine-induced IgA Binding Antibodies to HIV Proteins at Month 6.5 | Vaccine Matched Env : 96ZM651.D11gp120.avi | 0 Participants |
| Placebo | Number of Participants With Occurrence of Vaccine-induced IgA Binding Antibodies to HIV Proteins at Month 6.5 | Vaccine Matched Env : TV1c8_D11gp120.avi/293F | 0 Participants |
| Placebo | Number of Participants With Occurrence of Vaccine-induced IgA Binding Antibodies to HIV Proteins at Month 6.5 | gp41 | 0 Participants |
| Placebo | Number of Participants With Occurrence of Vaccine-induced IgA Binding Antibodies to HIV Proteins at Month 6.5 | gp70-96ZM651.02 V1v2 | 0 Participants |
| Placebo | Number of Participants With Occurrence of Vaccine-induced IgA Binding Antibodies to HIV Proteins at Month 6.5 | gp70-TV1.GSKvacV1V2/293F | 0 Participants |
Secondary
Number of Participants With Occurrence of Vaccine-induced IgG3 Binding Antibodies to HIV Proteins at Month 6.5
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 lt 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 M
Time frame: Measured at Month 6.5
Population: Immunogenicity cohort. Overall Number of Participants Analyzed represents participants in the immunogenicity cohort who have samples collected at Month 6.5 and who were HIV-uninfected. Number Analyzed represents those participants with available data after filtering for assay-specific quality control criteria.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vaccine | Number of Participants With Occurrence of Vaccine-induced IgG3 Binding Antibodies to HIV Proteins at Month 6.5 | HVTN 505 Env Breadth Panel : A1.con.env03 140 CF | 74 Participants |
| Vaccine | Number of Participants With Occurrence of Vaccine-induced IgG3 Binding Antibodies to HIV Proteins at Month 6.5 | HVTN 505 Env Breadth Panel : B.con.env03 140 CF | 106 Participants |
| Vaccine | Number of Participants With Occurrence of Vaccine-induced IgG3 Binding Antibodies to HIV Proteins at Month 6.5 | HVTN 505 Env Breadth Panel : C.con.env03 140 CF_avi | 87 Participants |
| Vaccine | Number of Participants With Occurrence of Vaccine-induced IgG3 Binding Antibodies to HIV Proteins at Month 6.5 | HVTN 505 Env Breadth Panel : Con 6 gp120/B | 99 Participants |
| Vaccine | Number of Participants With Occurrence of Vaccine-induced IgG3 Binding Antibodies to HIV Proteins at Month 6.5 | HVTN 505 Env Breadth Panel : Con S gp140 CFI | 115 Participants |
| Vaccine | Number of Participants With Occurrence of Vaccine-induced IgG3 Binding Antibodies to HIV Proteins at Month 6.5 | HVTN 505 Env Breadth Panel : VRC A_avi | 72 Participants |
| Vaccine | Number of Participants With Occurrence of Vaccine-induced IgG3 Binding Antibodies to HIV Proteins at Month 6.5 | HVTN 505 Env Breadth Panel : VRC B gp140 | 42 Participants |
| Vaccine | Number of Participants With Occurrence of Vaccine-induced IgG3 Binding Antibodies to HIV Proteins at Month 6.5 | HVTN 505 Env Breadth Panel : VRC C_avi | 68 Participants |
| Vaccine | Number of Participants With Occurrence of Vaccine-induced IgG3 Binding Antibodies to HIV Proteins at Month 6.5 | RV144 CoR IgG3 : C.1086C_V1_V2 Tags | 32 Participants |
| Vaccine | Number of Participants With Occurrence of Vaccine-induced IgG3 Binding Antibodies to HIV Proteins at Month 6.5 | RV144 CoR IgG3 : gp70_B.CaseA2 V1/V2/169K | 9 Participants |
| Vaccine | Number of Participants With Occurrence of Vaccine-induced IgG3 Binding Antibodies to HIV Proteins at Month 6.5 | RV144 CoR IgG3 : gp70_B.CaseA_V1_V2 | 8 Participants |
| Vaccine | Number of Participants With Occurrence of Vaccine-induced IgG3 Binding Antibodies to HIV Proteins at Month 6.5 | V1V2 Subtype AW : AE.A244 V1V2 Tags/293F | 49 Participants |
| Vaccine | Number of Participants With Occurrence of Vaccine-induced IgG3 Binding Antibodies to HIV Proteins at Month 6.5 | Vaccine Matched Env : 1086C_D7gp120.avi/293F | 120 Participants |
| Vaccine | Number of Participants With Occurrence of Vaccine-induced IgG3 Binding Antibodies to HIV Proteins at Month 6.5 | Vaccine Matched Env : 96ZM651.D11gp120.avi | 110 Participants |
| Vaccine | Number of Participants With Occurrence of Vaccine-induced IgG3 Binding Antibodies to HIV Proteins at Month 6.5 | Vaccine Matched Env : TV1c8_D11gp120.avi/293F | 118 Participants |
| Vaccine | Number of Participants With Occurrence of Vaccine-induced IgG3 Binding Antibodies to HIV Proteins at Month 6.5 | Vaccine Strain Matched V1V2 : gp70-96ZM651.02 V1v2 | 10 Participants |
| Vaccine | Number of Participants With Occurrence of Vaccine-induced IgG3 Binding Antibodies to HIV Proteins at Month 6.5 | Vaccine Strain Matched V1V2 : gp70-TV1.GSKvacV1V2/293F | 12 Participants |
| Vaccine | Number of Participants With Occurrence of Vaccine-induced IgG3 Binding Antibodies to HIV Proteins at Month 6.5 | Vaccine Strain Matched V1V2 : gp70_C.1086C V1/V2/293F | 54 Participants |
| Placebo | Number of Participants With Occurrence of Vaccine-induced IgG3 Binding Antibodies to HIV Proteins at Month 6.5 | Vaccine Matched Env : 96ZM651.D11gp120.avi | 0 Participants |
| Placebo | Number of Participants With Occurrence of Vaccine-induced IgG3 Binding Antibodies to HIV Proteins at Month 6.5 | HVTN 505 Env Breadth Panel : A1.con.env03 140 CF | 0 Participants |
| Placebo | Number of Participants With Occurrence of Vaccine-induced IgG3 Binding Antibodies to HIV Proteins at Month 6.5 | RV144 CoR IgG3 : gp70_B.CaseA2 V1/V2/169K | 0 Participants |
| Placebo | Number of Participants With Occurrence of Vaccine-induced IgG3 Binding Antibodies to HIV Proteins at Month 6.5 | HVTN 505 Env Breadth Panel : B.con.env03 140 CF | 0 Participants |
| Placebo | Number of Participants With Occurrence of Vaccine-induced IgG3 Binding Antibodies to HIV Proteins at Month 6.5 | Vaccine Strain Matched V1V2 : gp70_C.1086C V1/V2/293F | 0 Participants |
| Placebo | Number of Participants With Occurrence of Vaccine-induced IgG3 Binding Antibodies to HIV Proteins at Month 6.5 | HVTN 505 Env Breadth Panel : C.con.env03 140 CF_avi | 0 Participants |
| Placebo | Number of Participants With Occurrence of Vaccine-induced IgG3 Binding Antibodies to HIV Proteins at Month 6.5 | RV144 CoR IgG3 : gp70_B.CaseA_V1_V2 | 0 Participants |
| Placebo | Number of Participants With Occurrence of Vaccine-induced IgG3 Binding Antibodies to HIV Proteins at Month 6.5 | HVTN 505 Env Breadth Panel : Con 6 gp120/B | 0 Participants |
| Placebo | Number of Participants With Occurrence of Vaccine-induced IgG3 Binding Antibodies to HIV Proteins at Month 6.5 | Vaccine Matched Env : TV1c8_D11gp120.avi/293F | 0 Participants |
| Placebo | Number of Participants With Occurrence of Vaccine-induced IgG3 Binding Antibodies to HIV Proteins at Month 6.5 | HVTN 505 Env Breadth Panel : Con S gp140 CFI | 0 Participants |
| Placebo | Number of Participants With Occurrence of Vaccine-induced IgG3 Binding Antibodies to HIV Proteins at Month 6.5 | V1V2 Subtype AW : AE.A244 V1V2 Tags/293F | 0 Participants |
| Placebo | Number of Participants With Occurrence of Vaccine-induced IgG3 Binding Antibodies to HIV Proteins at Month 6.5 | HVTN 505 Env Breadth Panel : VRC A_avi | 0 Participants |
| Placebo | Number of Participants With Occurrence of Vaccine-induced IgG3 Binding Antibodies to HIV Proteins at Month 6.5 | Vaccine Strain Matched V1V2 : gp70-TV1.GSKvacV1V2/293F | 0 Participants |
| Placebo | Number of Participants With Occurrence of Vaccine-induced IgG3 Binding Antibodies to HIV Proteins at Month 6.5 | HVTN 505 Env Breadth Panel : VRC B gp140 | 0 Participants |
| Placebo | Number of Participants With Occurrence of Vaccine-induced IgG3 Binding Antibodies to HIV Proteins at Month 6.5 | Vaccine Matched Env : 1086C_D7gp120.avi/293F | 0 Participants |
| Placebo | Number of Participants With Occurrence of Vaccine-induced IgG3 Binding Antibodies to HIV Proteins at Month 6.5 | HVTN 505 Env Breadth Panel : VRC C_avi | 0 Participants |
| Placebo | Number of Participants With Occurrence of Vaccine-induced IgG3 Binding Antibodies to HIV Proteins at Month 6.5 | Vaccine Strain Matched V1V2 : gp70-96ZM651.02 V1v2 | 0 Participants |
| Placebo | Number of Participants With Occurrence of Vaccine-induced IgG3 Binding Antibodies to HIV Proteins at Month 6.5 | RV144 CoR IgG3 : C.1086C_V1_V2 Tags | 0 Participants |
Secondary
Number of Participants With Occurrence of Vaccine-induced IgG Binding Antibodies to HIV Proteins at Month 6.5
Serum IgG responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay, run at 1:50 dilution.The readout is background-subtracted mean fluorescent intensity(MFI),with background adjustment for an antigen-specific plate level control.For each sample,response magnitude is net MFI,defined as experimental antigen MFI minus reference antigen MFI. Net MFI lt 1 is set to 1,and net MFI \> 22,000 is set to 22,000.Data are excluded if blood draw date was outside the allowable window,a participant was HIV-infected,reference antigen \> 5,000 MFI or baseline net MFI \> 6,500.Samples from post-enrollment visits have positive responses if they meet three criteria:(1) net MFI greater than or equal to an antigen-specific response threshold (defined as the maximum of 100 and the 95th percentile of baseline net MFI),(2) net MFI values are greater than 3 times baseline net MFI, and (3) experimental antigen MFI values are greater than 3 times baseline MFI.
Time frame: Measured at Month 6.5
Population: Immunogenicity cohort. Overall Number of Participants Analyzed represents participants in the immunogenicity cohort who have samples collected at Month 6.5 and who were HIV-uninfected. Number Analyzed represents those participants with available data after filtering for assay-specific quality control criteria.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vaccine | Number of Participants With Occurrence of Vaccine-induced IgG Binding Antibodies to HIV Proteins at Month 6.5 | RV144 CoR IgG : C.1086C_V1_V2 Tags | 86 Participants |
| Vaccine | Number of Participants With Occurrence of Vaccine-induced IgG Binding Antibodies to HIV Proteins at Month 6.5 | RV144 CoR IgA Primary gp120 Score : Con S gp140 CFI | 114 Participants |
| Vaccine | Number of Participants With Occurrence of Vaccine-induced IgG Binding Antibodies to HIV Proteins at Month 6.5 | RV144 CoR IgG : gp70-92TH023 V1V2 | 112 Participants |
| Vaccine | Number of Participants With Occurrence of Vaccine-induced IgG Binding Antibodies to HIV Proteins at Month 6.5 | HVTN 505 Env Breadth Panel : VRC B gp140 | 116 Participants |
| Vaccine | Number of Participants With Occurrence of Vaccine-induced IgG Binding Antibodies to HIV Proteins at Month 6.5 | RV144 CoR IgG : gp70_B.CaseA_V1_V2 | 62 Participants |
| Vaccine | Number of Participants With Occurrence of Vaccine-induced IgG Binding Antibodies to HIV Proteins at Month 6.5 | RV144 CoR IgA Primary gp120 Score : G.con.env03 140 CF | 117 Participants |
| Vaccine | Number of Participants With Occurrence of Vaccine-induced IgG Binding Antibodies to HIV Proteins at Month 6.5 | RV144 CoR IgG3 : gp70_B.CaseA2 V1/V2/169K | 63 Participants |
| Vaccine | Number of Participants With Occurrence of Vaccine-induced IgG Binding Antibodies to HIV Proteins at Month 6.5 | RV144 CoR IgA Primary gp120 Score : B.con.env03 140 CF | 117 Participants |
| Vaccine | Number of Participants With Occurrence of Vaccine-induced IgG Binding Antibodies to HIV Proteins at Month 6.5 | RV144 CoR IgA : Bio-1086C C1_HS | 59 Participants |
| Vaccine | Number of Participants With Occurrence of Vaccine-induced IgG Binding Antibodies to HIV Proteins at Month 6.5 | RV144 CoR IgA Primary gp120 Score : HV 13700 AE.con.env03 140 CF | 117 Participants |
| Vaccine | Number of Participants With Occurrence of Vaccine-induced IgG Binding Antibodies to HIV Proteins at Month 6.5 | RV144 CoR IgA : Bio-92TH023 C1_HS | 96 Participants |
| Vaccine | Number of Participants With Occurrence of Vaccine-induced IgG Binding Antibodies to HIV Proteins at Month 6.5 | RV144 CoR IgA Primary gp120 Score : 00MSA 4076 gp140 | 117 Participants |
| Vaccine | Number of Participants With Occurrence of Vaccine-induced IgG Binding Antibodies to HIV Proteins at Month 6.5 | RV144 CoR IgA : Bio-96ZM651 C1_HS | 92 Participants |
| Vaccine | Number of Participants With Occurrence of Vaccine-induced IgG Binding Antibodies to HIV Proteins at Month 6.5 | RV144 CoR IgA Primary gp120 Score : HV 14000 (DRCBL) gp140 | 117 Participants |
| Vaccine | Number of Participants With Occurrence of Vaccine-induced IgG Binding Antibodies to HIV Proteins at Month 6.5 | RV144 CoR IgA : Bio-TV1 C1_HS | 42 Participants |
| Vaccine | Number of Participants With Occurrence of Vaccine-induced IgG Binding Antibodies to HIV Proteins at Month 6.5 | RV144 CoR IgA Primary gp120 Score : C.con.env03 140 CF_avi | 117 Participants |
| Vaccine | Number of Participants With Occurrence of Vaccine-induced IgG Binding Antibodies to HIV Proteins at Month 6.5 | Vaccine Matched Env : 1086C_D7gp120.avi/293F | 114 Participants |
| Vaccine | Number of Participants With Occurrence of Vaccine-induced IgG Binding Antibodies to HIV Proteins at Month 6.5 | RV144 CoR IgG : 92TH023 gp120 gDneg 293F mon | 117 Participants |
| Vaccine | Number of Participants With Occurrence of Vaccine-induced IgG Binding Antibodies to HIV Proteins at Month 6.5 | Vaccine Matched Env : 96ZM651.D11gp120.avi | 113 Participants |
| Vaccine | Number of Participants With Occurrence of Vaccine-induced IgG Binding Antibodies to HIV Proteins at Month 6.5 | HVTN 505 Env Breadth Panel : VRC C_avi | 117 Participants |
| Vaccine | Number of Participants With Occurrence of Vaccine-induced IgG Binding Antibodies to HIV Proteins at Month 6.5 | Vaccine Matched Env : TV1c8_D11gp120.avi/293F | 114 Participants |
| Vaccine | Number of Participants With Occurrence of Vaccine-induced IgG Binding Antibodies to HIV Proteins at Month 6.5 | RV144 CoR IgG : A1.con.env03 140 CF | 117 Participants |
| Vaccine | Number of Participants With Occurrence of Vaccine-induced IgG Binding Antibodies to HIV Proteins at Month 6.5 | Vaccine Strain Matched V1V2 : gp70-96ZM651.02 V1v2 | 61 Participants |
| Vaccine | Number of Participants With Occurrence of Vaccine-induced IgG Binding Antibodies to HIV Proteins at Month 6.5 | RV144 CoR IgA Primary gp120 Score : Con 6 gp120/B | 114 Participants |
| Vaccine | Number of Participants With Occurrence of Vaccine-induced IgG Binding Antibodies to HIV Proteins at Month 6.5 | Vaccine Strain Matched V1V2 : gp70-TV1.GSKvacV1V2/293F | 73 Participants |
| Vaccine | Number of Participants With Occurrence of Vaccine-induced IgG Binding Antibodies to HIV Proteins at Month 6.5 | RV144 CoR IgG : AE.A244 V1V2 Tags/293F | 103 Participants |
| Vaccine | Number of Participants With Occurrence of Vaccine-induced IgG Binding Antibodies to HIV Proteins at Month 6.5 | Vaccine Strain Matched V1V2 : gp70_C.1086C V1/V2/293F | 103 Participants |
| Vaccine | Number of Participants With Occurrence of Vaccine-induced IgG Binding Antibodies to HIV Proteins at Month 6.5 | RV144 CoR IgA Primary gp120 Score : A244 gp 120 gDneg/293F/mon | 117 Participants |
| Vaccine | Number of Participants With Occurrence of Vaccine-induced IgG Binding Antibodies to HIV Proteins at Month 6.5 | gp41 | 1 Participants |
| Vaccine | Number of Participants With Occurrence of Vaccine-induced IgG Binding Antibodies to HIV Proteins at Month 6.5 | HVTN 505 Env Breadth Panel : VRC A_avi | 117 Participants |
| Placebo | Number of Participants With Occurrence of Vaccine-induced IgG Binding Antibodies to HIV Proteins at Month 6.5 | gp41 | 0 Participants |
| Placebo | Number of Participants With Occurrence of Vaccine-induced IgG Binding Antibodies to HIV Proteins at Month 6.5 | HVTN 505 Env Breadth Panel : VRC A_avi | 0 Participants |
| Placebo | Number of Participants With Occurrence of Vaccine-induced IgG Binding Antibodies to HIV Proteins at Month 6.5 | HVTN 505 Env Breadth Panel : VRC B gp140 | 0 Participants |
| Placebo | Number of Participants With Occurrence of Vaccine-induced IgG Binding Antibodies to HIV Proteins at Month 6.5 | HVTN 505 Env Breadth Panel : VRC C_avi | 0 Participants |
| Placebo | Number of Participants With Occurrence of Vaccine-induced IgG Binding Antibodies to HIV Proteins at Month 6.5 | RV144 CoR IgA Primary gp120 Score : 00MSA 4076 gp140 | 0 Participants |
| Placebo | Number of Participants With Occurrence of Vaccine-induced IgG Binding Antibodies to HIV Proteins at Month 6.5 | RV144 CoR IgA Primary gp120 Score : A244 gp 120 gDneg/293F/mon | 0 Participants |
| Placebo | Number of Participants With Occurrence of Vaccine-induced IgG Binding Antibodies to HIV Proteins at Month 6.5 | RV144 CoR IgA Primary gp120 Score : B.con.env03 140 CF | 0 Participants |
| Placebo | Number of Participants With Occurrence of Vaccine-induced IgG Binding Antibodies to HIV Proteins at Month 6.5 | RV144 CoR IgA Primary gp120 Score : C.con.env03 140 CF_avi | 0 Participants |
| Placebo | Number of Participants With Occurrence of Vaccine-induced IgG Binding Antibodies to HIV Proteins at Month 6.5 | RV144 CoR IgA Primary gp120 Score : Con 6 gp120/B | 0 Participants |
| Placebo | Number of Participants With Occurrence of Vaccine-induced IgG Binding Antibodies to HIV Proteins at Month 6.5 | RV144 CoR IgA Primary gp120 Score : Con S gp140 CFI | 0 Participants |
| Placebo | Number of Participants With Occurrence of Vaccine-induced IgG Binding Antibodies to HIV Proteins at Month 6.5 | RV144 CoR IgA Primary gp120 Score : G.con.env03 140 CF | 0 Participants |
| Placebo | Number of Participants With Occurrence of Vaccine-induced IgG Binding Antibodies to HIV Proteins at Month 6.5 | RV144 CoR IgA Primary gp120 Score : HV 13700 AE.con.env03 140 CF | 0 Participants |
| Placebo | Number of Participants With Occurrence of Vaccine-induced IgG Binding Antibodies to HIV Proteins at Month 6.5 | RV144 CoR IgA Primary gp120 Score : HV 14000 (DRCBL) gp140 | 0 Participants |
| Placebo | Number of Participants With Occurrence of Vaccine-induced IgG Binding Antibodies to HIV Proteins at Month 6.5 | RV144 CoR IgG : 92TH023 gp120 gDneg 293F mon | 0 Participants |
| Placebo | Number of Participants With Occurrence of Vaccine-induced IgG Binding Antibodies to HIV Proteins at Month 6.5 | RV144 CoR IgG : A1.con.env03 140 CF | 0 Participants |
| Placebo | Number of Participants With Occurrence of Vaccine-induced IgG Binding Antibodies to HIV Proteins at Month 6.5 | RV144 CoR IgG : AE.A244 V1V2 Tags/293F | 0 Participants |
| Placebo | Number of Participants With Occurrence of Vaccine-induced IgG Binding Antibodies to HIV Proteins at Month 6.5 | RV144 CoR IgG : C.1086C_V1_V2 Tags | 0 Participants |
| Placebo | Number of Participants With Occurrence of Vaccine-induced IgG Binding Antibodies to HIV Proteins at Month 6.5 | RV144 CoR IgG : gp70-92TH023 V1V2 | 0 Participants |
| Placebo | Number of Participants With Occurrence of Vaccine-induced IgG Binding Antibodies to HIV Proteins at Month 6.5 | RV144 CoR IgG : gp70_B.CaseA_V1_V2 | 0 Participants |
| Placebo | Number of Participants With Occurrence of Vaccine-induced IgG Binding Antibodies to HIV Proteins at Month 6.5 | RV144 CoR IgG3 : gp70_B.CaseA2 V1/V2/169K | 0 Participants |
| Placebo | Number of Participants With Occurrence of Vaccine-induced IgG Binding Antibodies to HIV Proteins at Month 6.5 | RV144 CoR IgA : Bio-1086C C1_HS | 0 Participants |
| Placebo | Number of Participants With Occurrence of Vaccine-induced IgG Binding Antibodies to HIV Proteins at Month 6.5 | RV144 CoR IgA : Bio-92TH023 C1_HS | 0 Participants |
| Placebo | Number of Participants With Occurrence of Vaccine-induced IgG Binding Antibodies to HIV Proteins at Month 6.5 | RV144 CoR IgA : Bio-96ZM651 C1_HS | 0 Participants |
| Placebo | Number of Participants With Occurrence of Vaccine-induced IgG Binding Antibodies to HIV Proteins at Month 6.5 | RV144 CoR IgA : Bio-TV1 C1_HS | 0 Participants |
| Placebo | Number of Participants With Occurrence of Vaccine-induced IgG Binding Antibodies to HIV Proteins at Month 6.5 | Vaccine Matched Env : 1086C_D7gp120.avi/293F | 0 Participants |
| Placebo | Number of Participants With Occurrence of Vaccine-induced IgG Binding Antibodies to HIV Proteins at Month 6.5 | Vaccine Matched Env : 96ZM651.D11gp120.avi | 0 Participants |
| Placebo | Number of Participants With Occurrence of Vaccine-induced IgG Binding Antibodies to HIV Proteins at Month 6.5 | Vaccine Matched Env : TV1c8_D11gp120.avi/293F | 0 Participants |
| Placebo | Number of Participants With Occurrence of Vaccine-induced IgG Binding Antibodies to HIV Proteins at Month 6.5 | Vaccine Strain Matched V1V2 : gp70-96ZM651.02 V1v2 | 0 Participants |
| Placebo | Number of Participants With Occurrence of Vaccine-induced IgG Binding Antibodies to HIV Proteins at Month 6.5 | Vaccine Strain Matched V1V2 : gp70-TV1.GSKvacV1V2/293F | 0 Participants |
| Placebo | Number of Participants With Occurrence of Vaccine-induced IgG Binding Antibodies to HIV Proteins at Month 6.5 | Vaccine Strain Matched V1V2 : gp70_C.1086C V1/V2/293F | 0 Participants |
Secondary
Number of Participants With Viral Sequences at HIV-1 Diagnosis
Number of participants in the female mITT cohort with viral sequences were reported. Viral sequencing was conducted on the earliest available plasma specimens with positive HIV-1 RNA PCR tests from study participants who are diagnosed with HIV-1 infection.
Time frame: Measured through 24 months after first vaccination
Population: The female mITT cohort was the group of participants used in sieve analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Vaccine | Number of Participants With Viral Sequences at HIV-1 Diagnosis | 119 Participants |
| Placebo | Number of Participants With Viral Sequences at HIV-1 Diagnosis | 115 Participants |