HIV Infections
Conditions
Brief summary
The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of the AIDSVAX B/E vaccine and the MVA/HIV62B vaccine in healthy, HIV-1-uninfected adults who previously received MVA/HIV62B in DNA/MVA or MVA/MVA vaccine regimens in the HVTN 205 study.
Detailed description
This study will evaluate the safety, tolerability, and immunogenicity of the AIDSVAX B/E vaccine and the MVA/HIV62B vaccine in healthy, HIV-1-uninfected adults who previously received MVA/HIV62B in DNA/MVA or MVA/MVA vaccine regimens as part of the HVTN 205 study. Participants in this study will be assigned to one of five groups based on their previous vaccine regimen received in HVTN 205. Depending on their group, participants will receive the MVA/HIV62B vaccine, the AIDSVAX B/E vaccine, or both the MVA/HIV62B vaccine and the AIDSVAX B/E vaccine. All participants will receive their assigned vaccines at study entry (Day 0) and Month 4. Participants will attend several study visits through Month 10. Visits will include physical examinations, blood collection, HIV testing and risk reduction counseling, and interviews and questionnaires. Optional procedures at some visits include collection of rectal fluids, cervical fluids, and semen. Study staff will contact participants 2 years following the initial study injection for follow-up health monitoring.
Interventions
BIOLOGICALMVA/HIV62B vaccine
1×10\^8 TCID50 dose to be administered as a 1 mL intramuscular (IM) injection in the deltoid
BIOLOGICALAIDSVAX B/E vaccine
600 mcg/mL dose to be administered as a 1 mL IM injection in the deltoid
BIOLOGICALPlacebo
Sodium Chloride for Injection USP, 0.9% to be administered as a 1 mL IM injection in the deltoid
Sponsors
National Institute of Allergy and Infectious Diseases (NIAID)
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 55 Years
Healthy volunteers
Yes
Inclusion criteria
General and Demographic Criteria: * Age of 18 to 55 years * Prior participation in HVTN 205 with assignment to treatment (not placebo) arm: 1. Assigned to HVTN 205 Group 1 or Group 3, and received all 4 scheduled vaccinations (2 injections of pGA2/JS7 DNA (months 0, 2) and 2 injections of MVA/HIV62 (months 4, 6); OR 2. Assigned to HVTN 205 Group 4, and received at least vaccinations 1, 2 and 4 (3 injections of MVA/HIV62 at months 0, 2 and 6). * Access to a participating HVTN clinical research site (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; completes a questionnaire prior to first vaccination with verbal demonstration of understanding of all questionnaire items answered incorrectly * Willing to be contacted 2 years following initial study injection. * Agrees not to enroll in another study of an investigational research agent * Good general health as shown by medical history, physical exam, and screening laboratory tests HIV-Related Criteria: * Willingness to receive HIV test results * Willingness to discuss HIV infection risks and amenable to HIV risk reduction counseling. * Assessed by the clinic staff as being at low risk for HIV infection and committed to maintaining behavior consistent with low risk of HIV exposure through the last required protocol clinic visit. Laboratory Inclusion Values: Hemogram/Complete Blood Count (CBC) * Hemoglobin greater than or equal to 11.0 g/dL for volunteers who were born female, greater than or equal to 13.0 g/dL for volunteers who were born male * White blood cell count equal to 3,300 to 12,000 cells/mm\^3 * Total lymphocyte count greater than or equal to 800 cells/mm\^3 * Remaining differential either within institutional normal range or with site physician approval * Platelets equal to 125,000 to 550,000/mm\^3 Chemistry * Chemistry panel: alanine aminotransferase (ALT), aspartate aminotransferase (AST), and alkaline phosphatase less than 1.25 times the institutional upper limit of normal; creatinine less than or equal to institutional upper limit of normal. * Cardiac Troponin T or I (cTnT or cTnI) does not exceed the institutional upper limit of normal Virology * Negative HIV-1 and -2 blood test: Participants must have a negative test result for HIV infection following the HVTN Lab Program's in-study HIV testing algorithm, prior to initial enrollment. * Negative hepatitis B surface antigen (HBsAg) * Negative anti-hepatitis C virus Ab (anti-HCV), or negative HCV polymerase chain reaction (PCR) if the anti-HCV is positive Urine * Normal urine: * Negative urine glucose, and * Negative or trace urine protein, and * Negative or trace urine hemoglobin (if trace hemoglobin is present on dipstick, a microscopic urinalysis with red blood cells levels within institutional normal range). Reproductive Status * 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 (more information is available in the protocol) for sexual activity that could lead to pregnancy from at least 21 days prior to enrollment through the last required protocol clinic visit. Effective contraception is defined as using the following methods: * Condoms (male or female) with or without a spermicide, * Diaphragm or cervical cap with spermicide, * Intrauterine device (IUD), * Hormonal contraception, or * Any other contraceptive method approved by the HVTN 114 Protocol Safety Review Team (PSRT) * 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 not be of reproductive potential, such as having reached menopause (no menses for 1 year) or having undergone hysterectomy, bilateral oophorectomy, or tubal ligation; * Or be sexually abstinent. * Volunteers who were born female must also agree not to seek pregnancy through alternative methods, such as artificial insemination or in vitro fertilization until after the last required protocol clinic visit
Exclusion criteria
General * Blood products received within 120 days before first vaccination * Investigational research agents received within 30 days before first vaccination * Body mass index (BMI) greater than or equal to 40 * Volunteer has 2 or more of the following cardiac risk factors: * Participant report of history of elevated blood cholesterol defined as fasting LDL greater than 160 mg/dL; * First degree relative (eg, mother, father, brother, or sister) who had coronary artery disease before the age of 50 years; * Current smoker; or * BMI greater than or equal to 35 * Pregnant or breastfeeding * Active duty and reserve U.S. military personnel Vaccines and Other Injections * Any clinically significant AE related to vaccination in HVTN 205, for which revaccination would be a safety concern such as any grade 3 or 4 related AE * Smallpox vaccine received within the last 5 years * HIV vaccine(s) received in a prior HIV vaccine trial other than HVTN 205. For HVTN 205 participants who have subsequently received control/placebo in another HIV vaccine trial, the HVTN 114 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 by the FDA. For volunteers who have received control/placebo in an experimental vaccine trial, the HVTN 114 PSRT will determine eligibility on a case-by-case basis. For volunteers who have received an experimental vaccine(s) greater than 5 years ago, eligibility for enrollment will be determined by the HVTN 114 PSRT 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) * Allergy treatment with antigen injections within 30 days before first vaccination or that are scheduled within 14 days after first vaccination Immune System * Immunosuppressive medications received within 168 days before first vaccination. (Not exclusionary: \[1\] corticosteroid nasal spray; \[2\] inhaled corticosteroids; \[3\] topical corticosteroids for mild, uncomplicated dermatitis; or \[4\] a single course of oral/parenteral corticosteroids at doses less than 2 mg/kg/day and length of therapy less than 11 days with completion at least 30 days prior to enrollment.) * Serious adverse reactions to vaccines or to vaccine components, including history of anaphylaxis and related symptoms such as hives, respiratory difficulty, angioedema, and/or abdominal pain. (Not excluded from participation: a volunteer who had a nonanaphylactic adverse reaction to pertussis vaccine as a child.) * Hypersensitivity to eggs or egg products * Immunoglobulin received within 60 days before first vaccination * Autoimmune disease (eg, myositis) * Immunodeficiency Cardiac * History of myocarditis, pericarditis, cardiomyopathy, congestive heart failure with permanent sequelae, clinically significant arrhythmia (including any arrhythmia requiring medication, treatment, or clinical follow-up) * ECG with clinically significant findings, or features that would interfere with the assessment of myo/pericarditis, as determined by a contract ECG Lab or cardiologist, including any of the following: (1) conduction disturbance (complete left or complete right bundle branch block or nonspecific intraventricular conduction disturbance with QRS greater than or equal to 120 ms, PR interval greater than or equal to 220ms, any 2nd or 3rd degree AV block, or QTc prolongation (greater than 450ms)); (2) repolarization (ST segment or T wave) abnormality that will interfere with the assessment of myo/pericarditis; (3) significant atrial or ventricular arrhythmia; (4) frequent atrial or ventricular ectopy (eg, frequent premature atrial contractions, 2 premature ventricular contractions in a row); (5) ST elevation consistent with ischemia; (6) evidence of past or evolving myocardial infarction Clinically Significant Medical Conditions * Untreated or incompletely treated syphilis infection * 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 |
|---|---|---|
| Level of Neutralizing Ab Titers and Breadth Against the Env Vaccine Strain and Heterologous Tier 1 Strains at 2 Weeks After Each Boost | Measured at Month 0.5 and 4.5 | Neutralizing antibodies against HIV-1 were measured as a function of reductions in Tat-regulated luciferase (Luc) reporter gene expression in TZM-bl cells. The assay measured neutralization titers against a panel of autologous and heterologous Env-pseudotyped viruses. A serum neutralization titer was defined as the serum dilution that reduced relative luminescence units (RLUs) by 50% (ID50) relative to the RLUs in virus control wells (cells + virus only) after subtraction of background RLU (cells only). Titer \< 10 is truncated at 5. |
| Level of Env-specific IgG Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | Measured at Month 0.5 and 4.5 | Serum HIV-1-specific IgG responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay. 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 less than 1 is set to 1. The measure unit fluorescence units are relative to assay background, not relative to the placebo arm. Background is used here rather than negative control stimulation, since the antigens are used as bead coating rather than stimulation. The responses to the IDR of gp41 was not assayed. |
| Occurrence of Env-specific IgG3 Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | Measured at Month 0.5 and 4.5 | Serum HIV-1-specific IgG3 responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay. 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 less than 1 is set to 1. The measure unit fluorescence units are relative to assay background, not relative to the placebo arm. Background is used here rather than negative control stimulation, since the antigens are used as bead coating rather than stimulation. The responses to the IDR of gp41 was not assayed. |
| Level of Env-specific IgG3 Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | Measured at Month 0.5 and 4.5 | Serum HIV-1-specific IgG3 responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay. 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 less than 1 is set to 1. The measure unit fluorescence units are relative to assay background, not relative to the placebo arm. Background is used here rather than negative control stimulation, since the antigens are used as bead coating rather than stimulation. The responses to the IDR of gp41 was not assayed. |
| Occurrence of Env-specific IgA Responses for gp120, gp41, V1V2, and the IDR of gp41 at 2 Weeks After Each Boost | Measured at Month 0.5 and 4.5 | Serum HIV-1-specific IgA responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay. 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 less than 1 is set to 1. The measure unit fluorescence units are relative to assay background, not relative to the placebo arm. Background is used here rather than negative control stimulation, since the antigens are used as bead coating rather than stimulation. IgA responses to V1V2 and the IDR of gp41 were not assayed. |
| Level of Env-specific IgA Responses for gp120, gp41, V1V2, and the IDR of gp41 at 2 Weeks After Each Boost | Measured at Month 0.5 and 4.5 | Serum HIV-1-specific IgA responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay. 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 less than 1 is set to 1. The measure unit fluorescence units are relative to assay background, not relative to the placebo arm. Background is used here rather than negative control stimulation, since the antigens are used as bead coating rather than stimulation. IgA responses to V1V2 and the IDR of gp41 were not assayed. |
| Occurrence of Neutralizing Ab Titers and Breadth Against the Env Vaccine Strain and Heterologous Tier 1 Strains at 2 Weeks After Each Boost | Measured at Month 0.5 and 4.5 | Neutralizing antibodies against HIV-1 were measured as a function of reductions in Tat-regulated luciferase (Luc) reporter gene expression in TZM-bl cells. The assay measured neutralization titers against a panel of autologous and heterologous Env-pseudotyped viruses. |
| Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Left Arm (MVA/HIV62B or Placebo) | Measured through 3 days after the boost at Month 0 and Month 4 | Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.0 \[November 2014\], The maximum grade observed for each symptom over the time frame is presented. |
| Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Right Arm (AIDSVAX B/E or Placebo) | Measured through 3 days after the boost at Month 0 and Month 4 | Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.0 \[November 2014\], The maximum grade observed for each symptom over the time frame is presented. |
| Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Measured through Month Measured through 3 days after each boost at Month 0 and 4 | Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.0 \[November 2014\], The maximum grade observed for each symptom over the time frame is presented. |
| Number of Participants With Early Study Termination Associated With an AE or Reactogenicity | Measured through Month 10 | From the study termination form, early termination reasons associated with an AE or reactogenicity are tabulated by treatment arm |
| Number of Participants With Study Product Discontinuation Associated With an AE or Reactogenicity | Measured through the Month 4 boost | From the study product discontinuation form, study product administration reasons are tabulated by treatment arm |
| Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | Measured during screening, and 2 weeks after each boost at Month 0 and 4 | For each chemistry laboratory measure, summary statistics were presented by analyte and treatment group for the overall population. |
| Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL | Measured during screening, and 2 weeks after each boost at Month 0 and 4 | For each chemistry laboratory measure, summary statistics were presented by analyte and treatment group for the overall population. |
| Chemistry and Hematology Laboratory Measures, for Each Boost: WBC, Platelets, Lymphocytes, Neutrophils | Measured during screening, and 2 weeks after each boost at Month 0 and 4 | For each chemistry laboratory measure, summary statistics were presented by analyte and treatment group for the overall population. |
| Occurrence of Env-specific IgG Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | Measured at Month 0.5 and 4.5 | Serum HIV-1-specific IgG responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay. 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 less than 1 is set to 1. The measure unit fluorescence units are relative to assay background, not relative to the placebo arm. Background is used here rather than negative control stimulation, since the antigens are used as bead coating rather than stimulation. The responses to the IDR of gp41 was not assayed. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Measured at Month 4.5 | PBMC samples are stimulated with synthetic peptide pools or left unstimulated as a negative control. For each sample, T-cell subset, and peptide pool, response magnitude is % cells expressing markers after peptide stimulation minus % cells expressing markers after no stimulation. Response positivity is derived by testing if the number of cells expressing the marker is equal in the stimulated vs. unstimulated cells. Response is positive if the one-sided Fisher's exact test (discrete Bonferroni adjustment over the peptide pools) p\<=0.00001. The Fisher's exact test is not applied to compare between endpoints. Data are excluded if the blood draw date was outside the visit window, the participant was HIV-infected, PBMC viability or T-cell count were low, or negative control was high. The responses at month 0.5 was not assayed. |
| Occurrence of CD8+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Measured at Month 4.5 | PBMC samples are stimulated with synthetic peptide pools or left unstimulated as a negative control. For each sample, T-cell subset, and peptide pool, response magnitude is % cells expressing markers after peptide stimulation minus % cells expressing markers after no stimulation. A contingency table is constructed to assess response: stimulation (peptide/none) vs. marker expression (yes/no). A one-sided Fisher's exact test is applied, testing if the number of cells positive for the marker is equal in the stimulated vs. unstimulated cells. A discrete Bonferroni adjustment is made over the peptide pools. Response is positive if p\<=0.00001. Data are excluded if the blood draw date was outside the visit window, the participant was HIV-infected, PBMC viability or T-cell count were low, or negative control was high. The responses at month 0.5 was not assayed. |
| Level of CD8+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Measured at Month 4.5 | PBMC samples are stimulated with synthetic peptide pools or left unstimulated as a negative control. For each sample, T-cell subset, and peptide pool, response magnitude is % cells expressing markers after peptide stimulation minus % cells expressing markers after no stimulation. A contingency table is constructed to assess response: stimulation (peptide/none) vs. marker expression (yes/no). A one-sided Fisher's exact test is applied, testing if the number of cells positive for the marker is equal in the stimulated vs. unstimulated cells. A discrete Bonferroni adjustment is made over the peptide pools. Response is positive if p\<=0.00001. Data are excluded if the blood draw date was outside the visit window, the participant was HIV-infected, PBMC viability or T-cell count were low, or negative control was high. The responses at month 0.5 was not assayed. |
| Occurrence of Env-specific IgG Responses for gp120, gp140, V1/V2, and the IDR of gp41 at 6 Months After the Final Boost | Measured at Month 10 | Serum HIV-1-specific IgG responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay. 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 less than 1 is set to 1. The measure unit fluorescence units are relative to assay background, not relative to the placebo arm. Background is used here rather than negative control stimulation, since the antigens are used as bead coating rather than stimulation. The responses to the IDR of gp41 was not assayed. |
| Level of Env-specific IgG Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 6 Months After the Final Boost | Measured at Month 10 | Serum HIV-1-specific IgG responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay. 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 less than 1 is set to 1. The measure unit fluorescence units are relative to assay background, not relative to the placebo arm. Background is used here rather than negative control stimulation, since the antigens are used as bead coating rather than stimulation. The responses to the IDR of gp41 was not assayed. |
| Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Measured at Month 4.5 | PBMC samples are stimulated with synthetic peptide pools or left unstimulated as a negative control. For each sample, T-cell subset, and peptide pool, response magnitude is % cells expressing markers after peptide stimulation minus % cells expressing markers after no stimulation. Response positivity is derived by testing if the number of cells expressing the marker is equal in the stimulated vs. unstimulated cells. Response is positive if the one-sided Fisher's exact test (discrete Bonferroni adjustment over the peptide pools) p\<=0.00001. The Fisher's exact test is not applied to compare between endpoints. Data are excluded if the blood draw date was outside the visit window, the participant was HIV-infected, PBMC viability or T-cell count were low, or negative control was high. The responses at month 0.5 was not assayed. |
Countries
Peru, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Group 1: Boost MVA/HIV62B mo(0,4) post HVTN 205 MMM | 4 |
| Group 2: Boost MVA/HIV62B + AIDSVAX B/E mo(0,4) post HVTN 205 MMM | 4 |
| Group 3: Boost MVA/HIV62B mo(0,4) post HVTN 205 DDMM | 6 |
| Group 4: Boost MVA/HIV62B + AIDSVAX B/E mo(0,4) post HVTN 205 DDMM | 6 |
| Group 5: Boost AIDSVAX B/E mo(0,4) post HVTN 205 DDMM | 7 |
| Total | 27 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 0 | 0 | 0 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 0 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Group 2: Boost | Total | Group 5: Boost | Group 4: Boost | Group 1: Boost | Group 3: Boost |
|---|---|---|---|---|---|---|
| Age, Continuous | 32 years | 33 years | 36 years | 30 years | 32 years | 32 years |
| Age, Customized 18 - 20 | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Customized 21 - 30 | 2 Participants | 10 Participants | 2 Participants | 3 Participants | 2 Participants | 1 Participants |
| Age, Customized 31 - 40 | 2 Participants | 14 Participants | 3 Participants | 2 Participants | 2 Participants | 5 Participants |
| Age, Customized 41 - 50 | 0 Participants | 2 Participants | 2 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Customized Less than 18 | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Customized Over 50 | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants |
| Age, Customized Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 11 Participants | 4 Participants | 4 Participants | 0 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 4 Participants | 16 Participants | 3 Participants | 2 Participants | 4 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 3 Participants | 1 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 11 Participants | 4 Participants | 3 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 3 Participants | 12 Participants | 2 Participants | 3 Participants | 2 Participants | 2 Participants |
| Region of Enrollment Peru | 0 Participants | 10 Participants | 4 Participants | 3 Participants | 0 Participants | 3 Participants |
| Region of Enrollment United States | 4 Participants | 17 Participants | 3 Participants | 3 Participants | 4 Participants | 3 Participants |
| Sex: Female, Male Female | 3 Participants | 16 Participants | 4 Participants | 3 Participants | 2 Participants | 4 Participants |
| Sex: Female, Male Male | 1 Participants | 11 Participants | 3 Participants | 3 Participants | 2 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 4 | 0 / 4 | 0 / 6 | 0 / 6 | 0 / 7 |
| other Total, other adverse events | 2 / 4 | 4 / 4 | 3 / 6 | 2 / 6 | 7 / 7 |
| serious Total, serious adverse events | 0 / 4 | 0 / 4 | 0 / 6 | 0 / 6 | 0 / 7 |
Outcome results
Primary
Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L
For each chemistry laboratory measure, summary statistics were presented by analyte and treatment group for the overall population.
Time frame: Measured during screening, and 2 weeks after each boost at Month 0 and 4
Population: The overall number of participants analyzed represents participants enrolled and eligible for laboratory assessment. Participants do not have laboratory assessments if they attended the visit but laboratory specimens were not collected, or they missed the scheduled visit, or they terminated participation in the study prior to the scheduled visit.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Group 1: Boost | Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | AST (U/L)- Day14 | 18 U/L |
| Group 1: Boost | Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | ALT (SGPT) (U/L)- Day126 | 14 U/L |
| Group 1: Boost | Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | ALT (SGPT) (U/L)- Screening | 15.5 U/L |
| Group 1: Boost | Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | ALT (SGPT) (U/L)- Day14 | 18 U/L |
| Group 1: Boost | Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | Alkaline Phosphatase (U/L)- Day126 | 58 U/L |
| Group 1: Boost | Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | Alkaline Phosphatase (U/L)- Screening | 54.5 U/L |
| Group 1: Boost | Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | Alkaline Phosphatase (U/L)- Day14 | 59 U/L |
| Group 1: Boost | Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | AST (U/L)- Day126 | 18 U/L |
| Group 1: Boost | Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | AST (U/L)- Screening | 16.5 U/L |
| Group 2: Boost | Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | AST (U/L)- Day14 | 15.5 U/L |
| Group 2: Boost | Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | AST (U/L)- Screening | 16.5 U/L |
| Group 2: Boost | Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | Alkaline Phosphatase (U/L)- Screening | 63.5 U/L |
| Group 2: Boost | Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | ALT (SGPT) (U/L)- Day126 | 15.5 U/L |
| Group 2: Boost | Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | ALT (SGPT) (U/L)- Screening | 16.5 U/L |
| Group 2: Boost | Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | Alkaline Phosphatase (U/L)- Day14 | 68.5 U/L |
| Group 2: Boost | Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | AST (U/L)- Day126 | 19 U/L |
| Group 2: Boost | Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | Alkaline Phosphatase (U/L)- Day126 | 63 U/L |
| Group 2: Boost | Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | ALT (SGPT) (U/L)- Day14 | 16 U/L |
| Group 3: Boost | Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | Alkaline Phosphatase (U/L)- Day14 | 73 U/L |
| Group 3: Boost | Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | Alkaline Phosphatase (U/L)- Screening | 91 U/L |
| Group 3: Boost | Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | Alkaline Phosphatase (U/L)- Day126 | 69 U/L |
| Group 3: Boost | Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | AST (U/L)- Screening | 20 U/L |
| Group 3: Boost | Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | AST (U/L)- Day14 | 26 U/L |
| Group 3: Boost | Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | AST (U/L)- Day126 | 17 U/L |
| Group 3: Boost | Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | ALT (SGPT) (U/L)- Screening | 23 U/L |
| Group 3: Boost | Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | ALT (SGPT) (U/L)- Day14 | 23 U/L |
| Group 3: Boost | Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | ALT (SGPT) (U/L)- Day126 | 16.5 U/L |
| Group 4: Boost | Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | AST (U/L)- Day14 | 21 U/L |
| Group 4: Boost | Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | Alkaline Phosphatase (U/L)- Day126 | 72 U/L |
| Group 4: Boost | Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | ALT (SGPT) (U/L)- Day14 | 21.5 U/L |
| Group 4: Boost | Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | AST (U/L)- Day126 | 22.5 U/L |
| Group 4: Boost | Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | Alkaline Phosphatase (U/L)- Day14 | 57 U/L |
| Group 4: Boost | Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | ALT (SGPT) (U/L)- Screening | 14.5 U/L |
| Group 4: Boost | Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | Alkaline Phosphatase (U/L)- Screening | 78.5 U/L |
| Group 4: Boost | Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | AST (U/L)- Screening | 17.5 U/L |
| Group 4: Boost | Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | ALT (SGPT) (U/L)- Day126 | 22.5 U/L |
| Group 5: Boost | Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | AST (U/L)- Day14 | 24 U/L |
| Group 5: Boost | Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | ALT (SGPT) (U/L)- Screening | 26 U/L |
| Group 5: Boost | Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | Alkaline Phosphatase (U/L)- Day14 | 52 U/L |
| Group 5: Boost | Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | Alkaline Phosphatase (U/L)- Day126 | 53 U/L |
| Group 5: Boost | Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | ALT (SGPT) (U/L)- Day126 | 28 U/L |
| Group 5: Boost | Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | AST (U/L)- Day126 | 22 U/L |
| Group 5: Boost | Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | AST (U/L)- Screening | 24 U/L |
| Group 5: Boost | Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | Alkaline Phosphatase (U/L)- Screening | 55 U/L |
| Group 5: Boost | Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | ALT (SGPT) (U/L)- Day14 | 23 U/L |
Primary
Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL
For each chemistry laboratory measure, summary statistics were presented by analyte and treatment group for the overall population.
Time frame: Measured during screening, and 2 weeks after each boost at Month 0 and 4
Population: The overall number of participants analyzed represents participants enrolled and eligible for laboratory assessment. Participants do not have laboratory assessments if they attended the visit but laboratory specimens were not collected, or they missed the scheduled visit, or they terminated participation in the study prior to the scheduled visit.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Group 1: Boost | Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL | Creatinine (g/dL)- Screening | 0.000785 g/dL |
| Group 1: Boost | Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL | Hemoglobin (g/dL)- Day14 | 15 g/dL |
| Group 1: Boost | Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL | Creatinine (g/dL)- Day14 | 0.0008 g/dL |
| Group 1: Boost | Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL | Creatinine (g/dL)- Day126 | 0.0009 g/dL |
| Group 1: Boost | Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL | Hemoglobin (g/dL)- Screening | 14 g/dL |
| Group 1: Boost | Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL | Hemoglobin (g/dL)- Day126 | 14.9 g/dL |
| Group 2: Boost | Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL | Creatinine (g/dL)- Screening | 0.000805 g/dL |
| Group 2: Boost | Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL | Hemoglobin (g/dL)- Screening | 13.6 g/dL |
| Group 2: Boost | Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL | Creatinine (g/dL)- Day126 | 0.00075 g/dL |
| Group 2: Boost | Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL | Hemoglobin (g/dL)- Day14 | 13.55 g/dL |
| Group 2: Boost | Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL | Hemoglobin (g/dL)- Day126 | 13.9 g/dL |
| Group 2: Boost | Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL | Creatinine (g/dL)- Day14 | 0.000795 g/dL |
| Group 3: Boost | Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL | Creatinine (g/dL)- Day126 | 0.000725 g/dL |
| Group 3: Boost | Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL | Creatinine (g/dL)- Screening | 0.00072 g/dL |
| Group 3: Boost | Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL | Hemoglobin (g/dL)- Day126 | 13.2 g/dL |
| Group 3: Boost | Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL | Hemoglobin (g/dL)- Screening | 13 g/dL |
| Group 3: Boost | Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL | Hemoglobin (g/dL)- Day14 | 12.85 g/dL |
| Group 3: Boost | Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL | Creatinine (g/dL)- Day14 | 0.0008 g/dL |
| Group 4: Boost | Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL | Hemoglobin (g/dL)- Day126 | 14.65 g/dL |
| Group 4: Boost | Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL | Hemoglobin (g/dL)- Screening | 14.5 g/dL |
| Group 4: Boost | Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL | Hemoglobin (g/dL)- Day14 | 14.05 g/dL |
| Group 4: Boost | Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL | Creatinine (g/dL)- Screening | 0.000755 g/dL |
| Group 4: Boost | Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL | Creatinine (g/dL)- Day14 | 0.000835 g/dL |
| Group 4: Boost | Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL | Creatinine (g/dL)- Day126 | 0.000785 g/dL |
| Group 5: Boost | Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL | Hemoglobin (g/dL)- Day14 | 12.9 g/dL |
| Group 5: Boost | Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL | Creatinine (g/dL)- Day126 | 0.00085 g/dL |
| Group 5: Boost | Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL | Hemoglobin (g/dL)- Screening | 14 g/dL |
| Group 5: Boost | Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL | Creatinine (g/dL)- Day14 | 0.00092 g/dL |
| Group 5: Boost | Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL | Creatinine (g/dL)- Screening | 0.00085 g/dL |
| Group 5: Boost | Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL | Hemoglobin (g/dL)- Day126 | 12.8 g/dL |
Primary
Chemistry and Hematology Laboratory Measures, for Each Boost: WBC, Platelets, Lymphocytes, Neutrophils
For each chemistry laboratory measure, summary statistics were presented by analyte and treatment group for the overall population.
Time frame: Measured during screening, and 2 weeks after each boost at Month 0 and 4
Population: The overall number of participants analyzed represents participants enrolled and eligible for laboratory assessment. Participants do not have laboratory assessments if they attended the visit but laboratory specimens were not collected, or they missed the scheduled visit, or they terminated participation in the study prior to the scheduled visit.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Group 1: Boost | Chemistry and Hematology Laboratory Measures, for Each Boost: WBC, Platelets, Lymphocytes, Neutrophils | Lymphocytes (cells/cubic mm)- Day126 | 1855 thousand cells/cubic mm |
| Group 1: Boost | Chemistry and Hematology Laboratory Measures, for Each Boost: WBC, Platelets, Lymphocytes, Neutrophils | Neutrophils (cells/cubic mm)- Day14 | 4190 thousand cells/cubic mm |
| Group 1: Boost | Chemistry and Hematology Laboratory Measures, for Each Boost: WBC, Platelets, Lymphocytes, Neutrophils | Neutrophils (cells/cubic mm)- Day126 | 4473 thousand cells/cubic mm |
| Group 1: Boost | Chemistry and Hematology Laboratory Measures, for Each Boost: WBC, Platelets, Lymphocytes, Neutrophils | Platelets (1000/cubic mm)- Day14 | 251 thousand cells/cubic mm |
| Group 1: Boost | Chemistry and Hematology Laboratory Measures, for Each Boost: WBC, Platelets, Lymphocytes, Neutrophils | Platelets (1000/cubic mm)- Screening | 220.8 thousand cells/cubic mm |
| Group 1: Boost | Chemistry and Hematology Laboratory Measures, for Each Boost: WBC, Platelets, Lymphocytes, Neutrophils | Lymphocytes (cells/cubic mm)- Day14 | 1449 thousand cells/cubic mm |
| Group 1: Boost | Chemistry and Hematology Laboratory Measures, for Each Boost: WBC, Platelets, Lymphocytes, Neutrophils | WBC (1000/cubic mm)- Screening | 5.8 thousand cells/cubic mm |
| Group 1: Boost | Chemistry and Hematology Laboratory Measures, for Each Boost: WBC, Platelets, Lymphocytes, Neutrophils | WBC (1000/cubic mm)- Day14 | 6.3 thousand cells/cubic mm |
| Group 1: Boost | Chemistry and Hematology Laboratory Measures, for Each Boost: WBC, Platelets, Lymphocytes, Neutrophils | Lymphocytes (cells/cubic mm)- Screening | 1423.5 thousand cells/cubic mm |
| Group 1: Boost | Chemistry and Hematology Laboratory Measures, for Each Boost: WBC, Platelets, Lymphocytes, Neutrophils | Platelets (1000/cubic mm)- Day126 | 234.5 thousand cells/cubic mm |
| Group 1: Boost | Chemistry and Hematology Laboratory Measures, for Each Boost: WBC, Platelets, Lymphocytes, Neutrophils | Neutrophils (cells/cubic mm)- Screening | 4151.5 thousand cells/cubic mm |
| Group 1: Boost | Chemistry and Hematology Laboratory Measures, for Each Boost: WBC, Platelets, Lymphocytes, Neutrophils | WBC (1000/cubic mm)- Day126 | 7 thousand cells/cubic mm |
| Group 2: Boost | Chemistry and Hematology Laboratory Measures, for Each Boost: WBC, Platelets, Lymphocytes, Neutrophils | Neutrophils (cells/cubic mm)- Screening | 3260 thousand cells/cubic mm |
| Group 2: Boost | Chemistry and Hematology Laboratory Measures, for Each Boost: WBC, Platelets, Lymphocytes, Neutrophils | Lymphocytes (cells/cubic mm)- Day14 | 2483.5 thousand cells/cubic mm |
| Group 2: Boost | Chemistry and Hematology Laboratory Measures, for Each Boost: WBC, Platelets, Lymphocytes, Neutrophils | WBC (1000/cubic mm)- Day14 | 6.5 thousand cells/cubic mm |
| Group 2: Boost | Chemistry and Hematology Laboratory Measures, for Each Boost: WBC, Platelets, Lymphocytes, Neutrophils | Lymphocytes (cells/cubic mm)- Day126 | 2670 thousand cells/cubic mm |
| Group 2: Boost | Chemistry and Hematology Laboratory Measures, for Each Boost: WBC, Platelets, Lymphocytes, Neutrophils | Neutrophils (cells/cubic mm)- Day126 | 4162.5 thousand cells/cubic mm |
| Group 2: Boost | Chemistry and Hematology Laboratory Measures, for Each Boost: WBC, Platelets, Lymphocytes, Neutrophils | WBC (1000/cubic mm)- Day126 | 7.47 thousand cells/cubic mm |
| Group 2: Boost | Chemistry and Hematology Laboratory Measures, for Each Boost: WBC, Platelets, Lymphocytes, Neutrophils | Platelets (1000/cubic mm)- Screening | 256.5 thousand cells/cubic mm |
| Group 2: Boost | Chemistry and Hematology Laboratory Measures, for Each Boost: WBC, Platelets, Lymphocytes, Neutrophils | Neutrophils (cells/cubic mm)- Day14 | 3855 thousand cells/cubic mm |
| Group 2: Boost | Chemistry and Hematology Laboratory Measures, for Each Boost: WBC, Platelets, Lymphocytes, Neutrophils | Platelets (1000/cubic mm)- Day14 | 309.5 thousand cells/cubic mm |
| Group 2: Boost | Chemistry and Hematology Laboratory Measures, for Each Boost: WBC, Platelets, Lymphocytes, Neutrophils | WBC (1000/cubic mm)- Screening | 6.27 thousand cells/cubic mm |
| Group 2: Boost | Chemistry and Hematology Laboratory Measures, for Each Boost: WBC, Platelets, Lymphocytes, Neutrophils | Platelets (1000/cubic mm)- Day126 | 259 thousand cells/cubic mm |
| Group 2: Boost | Chemistry and Hematology Laboratory Measures, for Each Boost: WBC, Platelets, Lymphocytes, Neutrophils | Lymphocytes (cells/cubic mm)- Screening | 2426 thousand cells/cubic mm |
| Group 3: Boost | Chemistry and Hematology Laboratory Measures, for Each Boost: WBC, Platelets, Lymphocytes, Neutrophils | Lymphocytes (cells/cubic mm)- Screening | 2042 thousand cells/cubic mm |
| Group 3: Boost | Chemistry and Hematology Laboratory Measures, for Each Boost: WBC, Platelets, Lymphocytes, Neutrophils | WBC (1000/cubic mm)- Day126 | 7.25 thousand cells/cubic mm |
| Group 3: Boost | Chemistry and Hematology Laboratory Measures, for Each Boost: WBC, Platelets, Lymphocytes, Neutrophils | Neutrophils (cells/cubic mm)- Day126 | 4254.5 thousand cells/cubic mm |
| Group 3: Boost | Chemistry and Hematology Laboratory Measures, for Each Boost: WBC, Platelets, Lymphocytes, Neutrophils | Lymphocytes (cells/cubic mm)- Day126 | 2084 thousand cells/cubic mm |
| Group 3: Boost | Chemistry and Hematology Laboratory Measures, for Each Boost: WBC, Platelets, Lymphocytes, Neutrophils | Platelets (1000/cubic mm)- Day126 | 340 thousand cells/cubic mm |
| Group 3: Boost | Chemistry and Hematology Laboratory Measures, for Each Boost: WBC, Platelets, Lymphocytes, Neutrophils | WBC (1000/cubic mm)- Screening | 6.875 thousand cells/cubic mm |
| Group 3: Boost | Chemistry and Hematology Laboratory Measures, for Each Boost: WBC, Platelets, Lymphocytes, Neutrophils | Neutrophils (cells/cubic mm)- Screening | 4195 thousand cells/cubic mm |
| Group 3: Boost | Chemistry and Hematology Laboratory Measures, for Each Boost: WBC, Platelets, Lymphocytes, Neutrophils | Platelets (1000/cubic mm)- Screening | 329.85 thousand cells/cubic mm |
| Group 3: Boost | Chemistry and Hematology Laboratory Measures, for Each Boost: WBC, Platelets, Lymphocytes, Neutrophils | WBC (1000/cubic mm)- Day14 | 7.555 thousand cells/cubic mm |
| Group 3: Boost | Chemistry and Hematology Laboratory Measures, for Each Boost: WBC, Platelets, Lymphocytes, Neutrophils | Neutrophils (cells/cubic mm)- Day14 | 4759.5 thousand cells/cubic mm |
| Group 3: Boost | Chemistry and Hematology Laboratory Measures, for Each Boost: WBC, Platelets, Lymphocytes, Neutrophils | Lymphocytes (cells/cubic mm)- Day14 | 2153.5 thousand cells/cubic mm |
| Group 3: Boost | Chemistry and Hematology Laboratory Measures, for Each Boost: WBC, Platelets, Lymphocytes, Neutrophils | Platelets (1000/cubic mm)- Day14 | 325.6 thousand cells/cubic mm |
| Group 4: Boost | Chemistry and Hematology Laboratory Measures, for Each Boost: WBC, Platelets, Lymphocytes, Neutrophils | WBC (1000/cubic mm)- Day126 | 4.85 thousand cells/cubic mm |
| Group 4: Boost | Chemistry and Hematology Laboratory Measures, for Each Boost: WBC, Platelets, Lymphocytes, Neutrophils | WBC (1000/cubic mm)- Screening | 6.4 thousand cells/cubic mm |
| Group 4: Boost | Chemistry and Hematology Laboratory Measures, for Each Boost: WBC, Platelets, Lymphocytes, Neutrophils | WBC (1000/cubic mm)- Day14 | 5.65 thousand cells/cubic mm |
| Group 4: Boost | Chemistry and Hematology Laboratory Measures, for Each Boost: WBC, Platelets, Lymphocytes, Neutrophils | Platelets (1000/cubic mm)- Screening | 269.5 thousand cells/cubic mm |
| Group 4: Boost | Chemistry and Hematology Laboratory Measures, for Each Boost: WBC, Platelets, Lymphocytes, Neutrophils | Platelets (1000/cubic mm)- Day14 | 306 thousand cells/cubic mm |
| Group 4: Boost | Chemistry and Hematology Laboratory Measures, for Each Boost: WBC, Platelets, Lymphocytes, Neutrophils | Platelets (1000/cubic mm)- Day126 | 279 thousand cells/cubic mm |
| Group 4: Boost | Chemistry and Hematology Laboratory Measures, for Each Boost: WBC, Platelets, Lymphocytes, Neutrophils | Lymphocytes (cells/cubic mm)- Screening | 2055.5 thousand cells/cubic mm |
| Group 4: Boost | Chemistry and Hematology Laboratory Measures, for Each Boost: WBC, Platelets, Lymphocytes, Neutrophils | Lymphocytes (cells/cubic mm)- Day14 | 1798 thousand cells/cubic mm |
| Group 4: Boost | Chemistry and Hematology Laboratory Measures, for Each Boost: WBC, Platelets, Lymphocytes, Neutrophils | Lymphocytes (cells/cubic mm)- Day126 | 1800 thousand cells/cubic mm |
| Group 4: Boost | Chemistry and Hematology Laboratory Measures, for Each Boost: WBC, Platelets, Lymphocytes, Neutrophils | Neutrophils (cells/cubic mm)- Day126 | 2364 thousand cells/cubic mm |
| Group 4: Boost | Chemistry and Hematology Laboratory Measures, for Each Boost: WBC, Platelets, Lymphocytes, Neutrophils | Neutrophils (cells/cubic mm)- Screening | 3803 thousand cells/cubic mm |
| Group 4: Boost | Chemistry and Hematology Laboratory Measures, for Each Boost: WBC, Platelets, Lymphocytes, Neutrophils | Neutrophils (cells/cubic mm)- Day14 | 3587.5 thousand cells/cubic mm |
| Group 5: Boost | Chemistry and Hematology Laboratory Measures, for Each Boost: WBC, Platelets, Lymphocytes, Neutrophils | Neutrophils (cells/cubic mm)- Day126 | 3584 thousand cells/cubic mm |
| Group 5: Boost | Chemistry and Hematology Laboratory Measures, for Each Boost: WBC, Platelets, Lymphocytes, Neutrophils | Lymphocytes (cells/cubic mm)- Screening | 1950 thousand cells/cubic mm |
| Group 5: Boost | Chemistry and Hematology Laboratory Measures, for Each Boost: WBC, Platelets, Lymphocytes, Neutrophils | Platelets (1000/cubic mm)- Day126 | 285 thousand cells/cubic mm |
| Group 5: Boost | Chemistry and Hematology Laboratory Measures, for Each Boost: WBC, Platelets, Lymphocytes, Neutrophils | WBC (1000/cubic mm)- Screening | 5.8 thousand cells/cubic mm |
| Group 5: Boost | Chemistry and Hematology Laboratory Measures, for Each Boost: WBC, Platelets, Lymphocytes, Neutrophils | Neutrophils (cells/cubic mm)- Screening | 3229 thousand cells/cubic mm |
| Group 5: Boost | Chemistry and Hematology Laboratory Measures, for Each Boost: WBC, Platelets, Lymphocytes, Neutrophils | Platelets (1000/cubic mm)- Day14 | 267 thousand cells/cubic mm |
| Group 5: Boost | Chemistry and Hematology Laboratory Measures, for Each Boost: WBC, Platelets, Lymphocytes, Neutrophils | Platelets (1000/cubic mm)- Screening | 266 thousand cells/cubic mm |
| Group 5: Boost | Chemistry and Hematology Laboratory Measures, for Each Boost: WBC, Platelets, Lymphocytes, Neutrophils | WBC (1000/cubic mm)- Day126 | 5.6 thousand cells/cubic mm |
| Group 5: Boost | Chemistry and Hematology Laboratory Measures, for Each Boost: WBC, Platelets, Lymphocytes, Neutrophils | WBC (1000/cubic mm)- Day14 | 7.4 thousand cells/cubic mm |
| Group 5: Boost | Chemistry and Hematology Laboratory Measures, for Each Boost: WBC, Platelets, Lymphocytes, Neutrophils | Lymphocytes (cells/cubic mm)- Day126 | 1652 thousand cells/cubic mm |
| Group 5: Boost | Chemistry and Hematology Laboratory Measures, for Each Boost: WBC, Platelets, Lymphocytes, Neutrophils | Lymphocytes (cells/cubic mm)- Day14 | 2075 thousand cells/cubic mm |
| Group 5: Boost | Chemistry and Hematology Laboratory Measures, for Each Boost: WBC, Platelets, Lymphocytes, Neutrophils | Neutrophils (cells/cubic mm)- Day14 | 4187 thousand cells/cubic mm |
Primary
Level of Env-specific IgA Responses for gp120, gp41, V1V2, and the IDR of gp41 at 2 Weeks After Each Boost
Serum HIV-1-specific IgA responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay. 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 less than 1 is set to 1. The measure unit fluorescence units are relative to assay background, not relative to the placebo arm. Background is used here rather than negative control stimulation, since the antigens are used as bead coating rather than stimulation. IgA responses to V1V2 and the IDR of gp41 were not assayed.
Time frame: Measured at Month 0.5 and 4.5
Population: Overall Number of Participants Analyzed includes the HIV uninfected participants with samples collected at the months 0.5 or 4.5 immunogenicity timepoint. Number Analyzed shows the number of participants with available data after filtering for assay-specific quality control criteria.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Group 1: Boost | Level of Env-specific IgA Responses for gp120, gp41, V1V2, and the IDR of gp41 at 2 Weeks After Each Boost | gp41 at Month 4.5 | 193.125 fluorescence unit relative to background |
| Group 1: Boost | Level of Env-specific IgA Responses for gp120, gp41, V1V2, and the IDR of gp41 at 2 Weeks After Each Boost | Con 6 gp120/B at Month 4.5 | 1 fluorescence unit relative to background |
| Group 1: Boost | Level of Env-specific IgA Responses for gp120, gp41, V1V2, and the IDR of gp41 at 2 Weeks After Each Boost | Con S gp140 CFI at Month 4.5 | 161.375 fluorescence unit relative to background |
| Group 1: Boost | Level of Env-specific IgA Responses for gp120, gp41, V1V2, and the IDR of gp41 at 2 Weeks After Each Boost | Con 6 gp120/B at Month 0.5 | 1 fluorescence unit relative to background |
| Group 1: Boost | Level of Env-specific IgA Responses for gp120, gp41, V1V2, and the IDR of gp41 at 2 Weeks After Each Boost | Con S gp140 CFI at Month 0.5 | 162.5 fluorescence unit relative to background |
| Group 1: Boost | Level of Env-specific IgA Responses for gp120, gp41, V1V2, and the IDR of gp41 at 2 Weeks After Each Boost | gp41 at Month 0.5 | 235.5 fluorescence unit relative to background |
| Group 2: Boost | Level of Env-specific IgA Responses for gp120, gp41, V1V2, and the IDR of gp41 at 2 Weeks After Each Boost | Con 6 gp120/B at Month 0.5 | 3035.25 fluorescence unit relative to background |
| Group 2: Boost | Level of Env-specific IgA Responses for gp120, gp41, V1V2, and the IDR of gp41 at 2 Weeks After Each Boost | Con S gp140 CFI at Month 4.5 | 3.625 fluorescence unit relative to background |
| Group 2: Boost | Level of Env-specific IgA Responses for gp120, gp41, V1V2, and the IDR of gp41 at 2 Weeks After Each Boost | gp41 at Month 4.5 | 119.375 fluorescence unit relative to background |
| Group 2: Boost | Level of Env-specific IgA Responses for gp120, gp41, V1V2, and the IDR of gp41 at 2 Weeks After Each Boost | Con 6 gp120/B at Month 4.5 | 35.75 fluorescence unit relative to background |
| Group 2: Boost | Level of Env-specific IgA Responses for gp120, gp41, V1V2, and the IDR of gp41 at 2 Weeks After Each Boost | gp41 at Month 0.5 | 362.5 fluorescence unit relative to background |
| Group 2: Boost | Level of Env-specific IgA Responses for gp120, gp41, V1V2, and the IDR of gp41 at 2 Weeks After Each Boost | Con S gp140 CFI at Month 0.5 | 12600.125 fluorescence unit relative to background |
| Group 3: Boost | Level of Env-specific IgA Responses for gp120, gp41, V1V2, and the IDR of gp41 at 2 Weeks After Each Boost | gp41 at Month 0.5 | 72.75 fluorescence unit relative to background |
| Group 3: Boost | Level of Env-specific IgA Responses for gp120, gp41, V1V2, and the IDR of gp41 at 2 Weeks After Each Boost | Con S gp140 CFI at Month 0.5 | 1 fluorescence unit relative to background |
| Group 3: Boost | Level of Env-specific IgA Responses for gp120, gp41, V1V2, and the IDR of gp41 at 2 Weeks After Each Boost | gp41 at Month 4.5 | 30.5 fluorescence unit relative to background |
| Group 3: Boost | Level of Env-specific IgA Responses for gp120, gp41, V1V2, and the IDR of gp41 at 2 Weeks After Each Boost | Con S gp140 CFI at Month 4.5 | 1 fluorescence unit relative to background |
| Group 3: Boost | Level of Env-specific IgA Responses for gp120, gp41, V1V2, and the IDR of gp41 at 2 Weeks After Each Boost | Con 6 gp120/B at Month 0.5 | 1 fluorescence unit relative to background |
| Group 3: Boost | Level of Env-specific IgA Responses for gp120, gp41, V1V2, and the IDR of gp41 at 2 Weeks After Each Boost | Con 6 gp120/B at Month 4.5 | 1 fluorescence unit relative to background |
| Group 4: Boost | Level of Env-specific IgA Responses for gp120, gp41, V1V2, and the IDR of gp41 at 2 Weeks After Each Boost | gp41 at Month 0.5 | 484.875 fluorescence unit relative to background |
| Group 4: Boost | Level of Env-specific IgA Responses for gp120, gp41, V1V2, and the IDR of gp41 at 2 Weeks After Each Boost | Con 6 gp120/B at Month 0.5 | 4259.75 fluorescence unit relative to background |
| Group 4: Boost | Level of Env-specific IgA Responses for gp120, gp41, V1V2, and the IDR of gp41 at 2 Weeks After Each Boost | Con 6 gp120/B at Month 4.5 | 482.25 fluorescence unit relative to background |
| Group 4: Boost | Level of Env-specific IgA Responses for gp120, gp41, V1V2, and the IDR of gp41 at 2 Weeks After Each Boost | Con S gp140 CFI at Month 0.5 | 12951.625 fluorescence unit relative to background |
| Group 4: Boost | Level of Env-specific IgA Responses for gp120, gp41, V1V2, and the IDR of gp41 at 2 Weeks After Each Boost | Con S gp140 CFI at Month 4.5 | 554.75 fluorescence unit relative to background |
| Group 4: Boost | Level of Env-specific IgA Responses for gp120, gp41, V1V2, and the IDR of gp41 at 2 Weeks After Each Boost | gp41 at Month 4.5 | 206.75 fluorescence unit relative to background |
| Group 5: Boost | Level of Env-specific IgA Responses for gp120, gp41, V1V2, and the IDR of gp41 at 2 Weeks After Each Boost | Con S gp140 CFI at Month 4.5 | 711.5 fluorescence unit relative to background |
| Group 5: Boost | Level of Env-specific IgA Responses for gp120, gp41, V1V2, and the IDR of gp41 at 2 Weeks After Each Boost | Con 6 gp120/B at Month 4.5 | 571.75 fluorescence unit relative to background |
| Group 5: Boost | Level of Env-specific IgA Responses for gp120, gp41, V1V2, and the IDR of gp41 at 2 Weeks After Each Boost | gp41 at Month 0.5 | 39.25 fluorescence unit relative to background |
| Group 5: Boost | Level of Env-specific IgA Responses for gp120, gp41, V1V2, and the IDR of gp41 at 2 Weeks After Each Boost | gp41 at Month 4.5 | 46.375 fluorescence unit relative to background |
| Group 5: Boost | Level of Env-specific IgA Responses for gp120, gp41, V1V2, and the IDR of gp41 at 2 Weeks After Each Boost | Con S gp140 CFI at Month 0.5 | 1577.25 fluorescence unit relative to background |
| Group 5: Boost | Level of Env-specific IgA Responses for gp120, gp41, V1V2, and the IDR of gp41 at 2 Weeks After Each Boost | Con 6 gp120/B at Month 0.5 | 808.25 fluorescence unit relative to background |
| Group 6: Boost | Level of Env-specific IgA Responses for gp120, gp41, V1V2, and the IDR of gp41 at 2 Weeks After Each Boost | Con S gp140 CFI at Month 0.5 | 1 fluorescence unit relative to background |
| Group 6: Boost | Level of Env-specific IgA Responses for gp120, gp41, V1V2, and the IDR of gp41 at 2 Weeks After Each Boost | Con S gp140 CFI at Month 4.5 | 1 fluorescence unit relative to background |
| Group 6: Boost | Level of Env-specific IgA Responses for gp120, gp41, V1V2, and the IDR of gp41 at 2 Weeks After Each Boost | Con 6 gp120/B at Month 4.5 | 1 fluorescence unit relative to background |
| Group 6: Boost | Level of Env-specific IgA Responses for gp120, gp41, V1V2, and the IDR of gp41 at 2 Weeks After Each Boost | gp41 at Month 0.5 | 72.75 fluorescence unit relative to background |
| Group 6: Boost | Level of Env-specific IgA Responses for gp120, gp41, V1V2, and the IDR of gp41 at 2 Weeks After Each Boost | Con 6 gp120/B at Month 0.5 | 1 fluorescence unit relative to background |
| Group 6: Boost | Level of Env-specific IgA Responses for gp120, gp41, V1V2, and the IDR of gp41 at 2 Weeks After Each Boost | gp41 at Month 4.5 | 30.5 fluorescence unit relative to background |
| Group 7: Boost | Level of Env-specific IgA Responses for gp120, gp41, V1V2, and the IDR of gp41 at 2 Weeks After Each Boost | Con S gp140 CFI at Month 0.5 | 12951.625 fluorescence unit relative to background |
| Group 7: Boost | Level of Env-specific IgA Responses for gp120, gp41, V1V2, and the IDR of gp41 at 2 Weeks After Each Boost | Con 6 gp120/B at Month 4.5 | 241.5 fluorescence unit relative to background |
| Group 7: Boost | Level of Env-specific IgA Responses for gp120, gp41, V1V2, and the IDR of gp41 at 2 Weeks After Each Boost | gp41 at Month 4.5 | 206.75 fluorescence unit relative to background |
| Group 7: Boost | Level of Env-specific IgA Responses for gp120, gp41, V1V2, and the IDR of gp41 at 2 Weeks After Each Boost | Con S gp140 CFI at Month 4.5 | 304.75 fluorescence unit relative to background |
| Group 7: Boost | Level of Env-specific IgA Responses for gp120, gp41, V1V2, and the IDR of gp41 at 2 Weeks After Each Boost | gp41 at Month 0.5 | 431.875 fluorescence unit relative to background |
| Group 7: Boost | Level of Env-specific IgA Responses for gp120, gp41, V1V2, and the IDR of gp41 at 2 Weeks After Each Boost | Con 6 gp120/B at Month 0.5 | 4136.375 fluorescence unit relative to background |
Primary
Level of Env-specific IgG3 Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost
Serum HIV-1-specific IgG3 responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay. 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 less than 1 is set to 1. The measure unit fluorescence units are relative to assay background, not relative to the placebo arm. Background is used here rather than negative control stimulation, since the antigens are used as bead coating rather than stimulation. The responses to the IDR of gp41 was not assayed.
Time frame: Measured at Month 0.5 and 4.5
Population: Overall Number of Participants Analyzed includes the HIV uninfected participants with samples collected at the months 0.5 or 4.5 immunogenicity timepoint. Number Analyzed shows the number of participants with available data after filtering for assay-specific quality control criteria.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Group 1: Boost | Level of Env-specific IgG3 Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | Con S gp140 CFI at Month 0.5 | 113.75 fluorescence unit relative to background |
| Group 1: Boost | Level of Env-specific IgG3 Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | Con 6 gp120/B at Month 4.5 | 1 fluorescence unit relative to background |
| Group 1: Boost | Level of Env-specific IgG3 Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | Con 6 gp120/B at Month 0.5 | 1 fluorescence unit relative to background |
| Group 1: Boost | Level of Env-specific IgG3 Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | Con S gp140 CFI at Month 4.5 | 162.25 fluorescence unit relative to background |
| Group 1: Boost | Level of Env-specific IgG3 Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | gp41 at Month 0.5 | 4137.5 fluorescence unit relative to background |
| Group 1: Boost | Level of Env-specific IgG3 Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | gp41 at Month 4.5 | 1338.25 fluorescence unit relative to background |
| Group 1: Boost | Level of Env-specific IgG3 Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | gp70_B.CaseA_V1_V2 at Month 0.5 | 1 fluorescence unit relative to background |
| Group 1: Boost | Level of Env-specific IgG3 Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | gp70_B.CaseA_V1_V2 at Month 4.5 | 1 fluorescence unit relative to background |
| Group 2: Boost | Level of Env-specific IgG3 Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | Con 6 gp120/B at Month 4.5 | 2.75 fluorescence unit relative to background |
| Group 2: Boost | Level of Env-specific IgG3 Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | gp70_B.CaseA_V1_V2 at Month 4.5 | 92.875 fluorescence unit relative to background |
| Group 2: Boost | Level of Env-specific IgG3 Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | Con S gp140 CFI at Month 0.5 | 236.125 fluorescence unit relative to background |
| Group 2: Boost | Level of Env-specific IgG3 Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | Con S gp140 CFI at Month 4.5 | 230.125 fluorescence unit relative to background |
| Group 2: Boost | Level of Env-specific IgG3 Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | gp41 at Month 0.5 | 870.75 fluorescence unit relative to background |
| Group 2: Boost | Level of Env-specific IgG3 Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | gp41 at Month 4.5 | 770.5 fluorescence unit relative to background |
| Group 2: Boost | Level of Env-specific IgG3 Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | gp70_B.CaseA_V1_V2 at Month 0.5 | 32.5 fluorescence unit relative to background |
| Group 2: Boost | Level of Env-specific IgG3 Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | Con 6 gp120/B at Month 0.5 | 5.875 fluorescence unit relative to background |
| Group 3: Boost | Level of Env-specific IgG3 Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | Con S gp140 CFI at Month 0.5 | 218.375 fluorescence unit relative to background |
| Group 3: Boost | Level of Env-specific IgG3 Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | gp70_B.CaseA_V1_V2 at Month 4.5 | 1 fluorescence unit relative to background |
| Group 3: Boost | Level of Env-specific IgG3 Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | Con S gp140 CFI at Month 4.5 | 279.5 fluorescence unit relative to background |
| Group 3: Boost | Level of Env-specific IgG3 Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | gp41 at Month 0.5 | 525.875 fluorescence unit relative to background |
| Group 3: Boost | Level of Env-specific IgG3 Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | gp41 at Month 4.5 | 1770.5 fluorescence unit relative to background |
| Group 3: Boost | Level of Env-specific IgG3 Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | gp70_B.CaseA_V1_V2 at Month 0.5 | 1 fluorescence unit relative to background |
| Group 3: Boost | Level of Env-specific IgG3 Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | Con 6 gp120/B at Month 4.5 | 1 fluorescence unit relative to background |
| Group 3: Boost | Level of Env-specific IgG3 Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | Con 6 gp120/B at Month 0.5 | 1 fluorescence unit relative to background |
| Group 4: Boost | Level of Env-specific IgG3 Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | Con S gp140 CFI at Month 4.5 | 558.5 fluorescence unit relative to background |
| Group 4: Boost | Level of Env-specific IgG3 Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | gp70_B.CaseA_V1_V2 at Month 4.5 | 113.125 fluorescence unit relative to background |
| Group 4: Boost | Level of Env-specific IgG3 Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | gp41 at Month 0.5 | 794.375 fluorescence unit relative to background |
| Group 4: Boost | Level of Env-specific IgG3 Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | gp41 at Month 4.5 | 1942.25 fluorescence unit relative to background |
| Group 4: Boost | Level of Env-specific IgG3 Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | gp70_B.CaseA_V1_V2 at Month 0.5 | 1 fluorescence unit relative to background |
| Group 4: Boost | Level of Env-specific IgG3 Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | Con S gp140 CFI at Month 0.5 | 705.75 fluorescence unit relative to background |
| Group 4: Boost | Level of Env-specific IgG3 Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | Con 6 gp120/B at Month 0.5 | 8 fluorescence unit relative to background |
| Group 4: Boost | Level of Env-specific IgG3 Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | Con 6 gp120/B at Month 4.5 | 55.125 fluorescence unit relative to background |
| Group 5: Boost | Level of Env-specific IgG3 Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | gp41 at Month 0.5 | 41 fluorescence unit relative to background |
| Group 5: Boost | Level of Env-specific IgG3 Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | gp70_B.CaseA_V1_V2 at Month 4.5 | 9.75 fluorescence unit relative to background |
| Group 5: Boost | Level of Env-specific IgG3 Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | gp41 at Month 4.5 | 29 fluorescence unit relative to background |
| Group 5: Boost | Level of Env-specific IgG3 Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | gp70_B.CaseA_V1_V2 at Month 0.5 | 1 fluorescence unit relative to background |
| Group 5: Boost | Level of Env-specific IgG3 Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | Con S gp140 CFI at Month 4.5 | 17.5 fluorescence unit relative to background |
| Group 5: Boost | Level of Env-specific IgG3 Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | Con 6 gp120/B at Month 0.5 | 6 fluorescence unit relative to background |
| Group 5: Boost | Level of Env-specific IgG3 Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | Con 6 gp120/B at Month 4.5 | 26.25 fluorescence unit relative to background |
| Group 5: Boost | Level of Env-specific IgG3 Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | Con S gp140 CFI at Month 0.5 | 26 fluorescence unit relative to background |
| Group 6: Boost | Level of Env-specific IgG3 Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | gp41 at Month 4.5 | 1343.75 fluorescence unit relative to background |
| Group 6: Boost | Level of Env-specific IgG3 Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | gp70_B.CaseA_V1_V2 at Month 4.5 | 1 fluorescence unit relative to background |
| Group 6: Boost | Level of Env-specific IgG3 Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | gp70_B.CaseA_V1_V2 at Month 0.5 | 1 fluorescence unit relative to background |
| Group 6: Boost | Level of Env-specific IgG3 Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | gp41 at Month 0.5 | 889 fluorescence unit relative to background |
| Group 6: Boost | Level of Env-specific IgG3 Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | Con 6 gp120/B at Month 0.5 | 1 fluorescence unit relative to background |
| Group 6: Boost | Level of Env-specific IgG3 Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | Con 6 gp120/B at Month 4.5 | 1 fluorescence unit relative to background |
| Group 6: Boost | Level of Env-specific IgG3 Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | Con S gp140 CFI at Month 0.5 | 129.25 fluorescence unit relative to background |
| Group 6: Boost | Level of Env-specific IgG3 Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | Con S gp140 CFI at Month 4.5 | 162.25 fluorescence unit relative to background |
| Group 7: Boost | Level of Env-specific IgG3 Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | gp70_B.CaseA_V1_V2 at Month 0.5 | 1 fluorescence unit relative to background |
| Group 7: Boost | Level of Env-specific IgG3 Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | gp41 at Month 4.5 | 803.5 fluorescence unit relative to background |
| Group 7: Boost | Level of Env-specific IgG3 Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | gp70_B.CaseA_V1_V2 at Month 4.5 | 113.125 fluorescence unit relative to background |
| Group 7: Boost | Level of Env-specific IgG3 Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | Con 6 gp120/B at Month 0.5 | 5.875 fluorescence unit relative to background |
| Group 7: Boost | Level of Env-specific IgG3 Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | Con 6 gp120/B at Month 4.5 | 31.375 fluorescence unit relative to background |
| Group 7: Boost | Level of Env-specific IgG3 Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | Con S gp140 CFI at Month 0.5 | 236.125 fluorescence unit relative to background |
| Group 7: Boost | Level of Env-specific IgG3 Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | Con S gp140 CFI at Month 4.5 | 473.875 fluorescence unit relative to background |
| Group 7: Boost | Level of Env-specific IgG3 Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | gp41 at Month 0.5 | 845.25 fluorescence unit relative to background |
Primary
Level of Env-specific IgG Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost
Serum HIV-1-specific IgG responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay. 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 less than 1 is set to 1. The measure unit fluorescence units are relative to assay background, not relative to the placebo arm. Background is used here rather than negative control stimulation, since the antigens are used as bead coating rather than stimulation. The responses to the IDR of gp41 was not assayed.
Time frame: Measured at Month 0.5 and 4.5
Population: Overall Number of Participants Analyzed includes the HIV uninfected participants with samples collected at the months 0.5 or 4.5 immunogenicity timepoint. Number Analyzed shows the number of participants with available data after filtering for assay-specific quality control criteria.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Group 1: Boost | Level of Env-specific IgG Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | Con S gp140 CFI at Month 0.5 | 17731.875 fluorescence unit relative to background |
| Group 1: Boost | Level of Env-specific IgG Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | Con 6 gp120/B at Month 0.5 | 220.875 fluorescence unit relative to background |
| Group 1: Boost | Level of Env-specific IgG Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | Con 6 gp120/B at Month 4.5 | 83.25 fluorescence unit relative to background |
| Group 1: Boost | Level of Env-specific IgG Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | Con S gp140 CFI at Month 4.5 | 14087.75 fluorescence unit relative to background |
| Group 1: Boost | Level of Env-specific IgG Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | gp41 at Month 0.5 | 19616.625 fluorescence unit relative to background |
| Group 1: Boost | Level of Env-specific IgG Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | gp41 at Month 4.5 | 18819.125 fluorescence unit relative to background |
| Group 1: Boost | Level of Env-specific IgG Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | gp70_B.CaseA_V1_V2 at Month 0.5 | 565.125 fluorescence unit relative to background |
| Group 1: Boost | Level of Env-specific IgG Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | gp70_B.CaseA_V1_V2 at Month 4.5 | 605.5 fluorescence unit relative to background |
| Group 2: Boost | Level of Env-specific IgG Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | Con S gp140 CFI at Month 0.5 | 32346.75 fluorescence unit relative to background |
| Group 2: Boost | Level of Env-specific IgG Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | gp41 at Month 0.5 | 32345 fluorescence unit relative to background |
| Group 2: Boost | Level of Env-specific IgG Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | gp70_B.CaseA_V1_V2 at Month 4.5 | 15735 fluorescence unit relative to background |
| Group 2: Boost | Level of Env-specific IgG Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | gp41 at Month 4.5 | 31713 fluorescence unit relative to background |
| Group 2: Boost | Level of Env-specific IgG Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | gp70_B.CaseA_V1_V2 at Month 0.5 | 87.25 fluorescence unit relative to background |
| Group 2: Boost | Level of Env-specific IgG Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | Con 6 gp120/B at Month 4.5 | 5747.5 fluorescence unit relative to background |
| Group 2: Boost | Level of Env-specific IgG Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | Con S gp140 CFI at Month 4.5 | 25825.5 fluorescence unit relative to background |
| Group 2: Boost | Level of Env-specific IgG Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | Con 6 gp120/B at Month 0.5 | 8614 fluorescence unit relative to background |
| Group 3: Boost | Level of Env-specific IgG Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | Con S gp140 CFI at Month 4.5 | 23503.125 fluorescence unit relative to background |
| Group 3: Boost | Level of Env-specific IgG Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | Con 6 gp120/B at Month 4.5 | 172 fluorescence unit relative to background |
| Group 3: Boost | Level of Env-specific IgG Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | gp70_B.CaseA_V1_V2 at Month 0.5 | 1 fluorescence unit relative to background |
| Group 3: Boost | Level of Env-specific IgG Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | gp41 at Month 0.5 | 17144.25 fluorescence unit relative to background |
| Group 3: Boost | Level of Env-specific IgG Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | Con S gp140 CFI at Month 0.5 | 14689.25 fluorescence unit relative to background |
| Group 3: Boost | Level of Env-specific IgG Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | gp41 at Month 4.5 | 24536.5 fluorescence unit relative to background |
| Group 3: Boost | Level of Env-specific IgG Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | Con 6 gp120/B at Month 0.5 | 196 fluorescence unit relative to background |
| Group 3: Boost | Level of Env-specific IgG Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | gp70_B.CaseA_V1_V2 at Month 4.5 | 1 fluorescence unit relative to background |
| Group 4: Boost | Level of Env-specific IgG Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | gp41 at Month 0.5 | 27552.75 fluorescence unit relative to background |
| Group 4: Boost | Level of Env-specific IgG Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | gp41 at Month 4.5 | 27619.125 fluorescence unit relative to background |
| Group 4: Boost | Level of Env-specific IgG Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | Con S gp140 CFI at Month 0.5 | 31583.375 fluorescence unit relative to background |
| Group 4: Boost | Level of Env-specific IgG Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | Con 6 gp120/B at Month 4.5 | 24074.75 fluorescence unit relative to background |
| Group 4: Boost | Level of Env-specific IgG Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | Con 6 gp120/B at Month 0.5 | 28087 fluorescence unit relative to background |
| Group 4: Boost | Level of Env-specific IgG Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | gp70_B.CaseA_V1_V2 at Month 0.5 | 1045.875 fluorescence unit relative to background |
| Group 4: Boost | Level of Env-specific IgG Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | Con S gp140 CFI at Month 4.5 | 30404.5 fluorescence unit relative to background |
| Group 4: Boost | Level of Env-specific IgG Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | gp70_B.CaseA_V1_V2 at Month 4.5 | 4909 fluorescence unit relative to background |
| Group 5: Boost | Level of Env-specific IgG Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | gp41 at Month 0.5 | 2412.5 fluorescence unit relative to background |
| Group 5: Boost | Level of Env-specific IgG Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | Con 6 gp120/B at Month 4.5 | 18736.75 fluorescence unit relative to background |
| Group 5: Boost | Level of Env-specific IgG Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | Con S gp140 CFI at Month 0.5 | 30936.5 fluorescence unit relative to background |
| Group 5: Boost | Level of Env-specific IgG Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | Con S gp140 CFI at Month 4.5 | 28886.5 fluorescence unit relative to background |
| Group 5: Boost | Level of Env-specific IgG Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | gp70_B.CaseA_V1_V2 at Month 4.5 | 11250.75 fluorescence unit relative to background |
| Group 5: Boost | Level of Env-specific IgG Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | gp41 at Month 4.5 | 2084.25 fluorescence unit relative to background |
| Group 5: Boost | Level of Env-specific IgG Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | gp70_B.CaseA_V1_V2 at Month 0.5 | 181.75 fluorescence unit relative to background |
| Group 5: Boost | Level of Env-specific IgG Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | Con 6 gp120/B at Month 0.5 | 23785.75 fluorescence unit relative to background |
| Group 6: Boost | Level of Env-specific IgG Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | gp70_B.CaseA_V1_V2 at Month 4.5 | 3.25 fluorescence unit relative to background |
| Group 6: Boost | Level of Env-specific IgG Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | Con S gp140 CFI at Month 0.5 | 14689.25 fluorescence unit relative to background |
| Group 6: Boost | Level of Env-specific IgG Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | Con 6 gp120/B at Month 0.5 | 196 fluorescence unit relative to background |
| Group 6: Boost | Level of Env-specific IgG Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | Con 6 gp120/B at Month 4.5 | 139 fluorescence unit relative to background |
| Group 6: Boost | Level of Env-specific IgG Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | Con S gp140 CFI at Month 4.5 | 21358.125 fluorescence unit relative to background |
| Group 6: Boost | Level of Env-specific IgG Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | gp70_B.CaseA_V1_V2 at Month 0.5 | 1 fluorescence unit relative to background |
| Group 6: Boost | Level of Env-specific IgG Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | gp41 at Month 0.5 | 17144.25 fluorescence unit relative to background |
| Group 6: Boost | Level of Env-specific IgG Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | gp41 at Month 4.5 | 23852.25 fluorescence unit relative to background |
| Group 7: Boost | Level of Env-specific IgG Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | Con 6 gp120/B at Month 0.5 | 26686.25 fluorescence unit relative to background |
| Group 7: Boost | Level of Env-specific IgG Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | gp41 at Month 4.5 | 28452.25 fluorescence unit relative to background |
| Group 7: Boost | Level of Env-specific IgG Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | Con S gp140 CFI at Month 4.5 | 29998.5 fluorescence unit relative to background |
| Group 7: Boost | Level of Env-specific IgG Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | Con S gp140 CFI at Month 0.5 | 31707.5 fluorescence unit relative to background |
| Group 7: Boost | Level of Env-specific IgG Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | Con 6 gp120/B at Month 4.5 | 22439 fluorescence unit relative to background |
| Group 7: Boost | Level of Env-specific IgG Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | gp70_B.CaseA_V1_V2 at Month 0.5 | 611.75 fluorescence unit relative to background |
| Group 7: Boost | Level of Env-specific IgG Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | gp70_B.CaseA_V1_V2 at Month 4.5 | 4948.75 fluorescence unit relative to background |
| Group 7: Boost | Level of Env-specific IgG Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | gp41 at Month 0.5 | 29809 fluorescence unit relative to background |
Primary
Level of Neutralizing Ab Titers and Breadth Against the Env Vaccine Strain and Heterologous Tier 1 Strains at 2 Weeks After Each Boost
Neutralizing antibodies against HIV-1 were measured as a function of reductions in Tat-regulated luciferase (Luc) reporter gene expression in TZM-bl cells. The assay measured neutralization titers against a panel of autologous and heterologous Env-pseudotyped viruses. A serum neutralization titer was defined as the serum dilution that reduced relative luminescence units (RLUs) by 50% (ID50) relative to the RLUs in virus control wells (cells + virus only) after subtraction of background RLU (cells only). Titer \< 10 is truncated at 5.
Time frame: Measured at Month 0.5 and 4.5
Population: Overall Number of Participants Analyzed includes the HIV uninfected participants with samples collected at the months 0.5 or 4.5 immunogenicity timepoint. Number Analyzed shows the number of participants with available data after filtering for assay-specific quality control criteria.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Group 1: Boost | Level of Neutralizing Ab Titers and Breadth Against the Env Vaccine Strain and Heterologous Tier 1 Strains at 2 Weeks After Each Boost | CM244.c01 at Month 0.5 | 5 Dilution factor |
| Group 1: Boost | Level of Neutralizing Ab Titers and Breadth Against the Env Vaccine Strain and Heterologous Tier 1 Strains at 2 Weeks After Each Boost | ADA at Month 4.5 | 5 Dilution factor |
| Group 1: Boost | Level of Neutralizing Ab Titers and Breadth Against the Env Vaccine Strain and Heterologous Tier 1 Strains at 2 Weeks After Each Boost | ADA at Month 0.5 | 5 Dilution factor |
| Group 1: Boost | Level of Neutralizing Ab Titers and Breadth Against the Env Vaccine Strain and Heterologous Tier 1 Strains at 2 Weeks After Each Boost | CM244.c01 at Month 4.5 | 5 Dilution factor |
| Group 1: Boost | Level of Neutralizing Ab Titers and Breadth Against the Env Vaccine Strain and Heterologous Tier 1 Strains at 2 Weeks After Each Boost | MN.3 at Month 0.5 | 37 Dilution factor |
| Group 1: Boost | Level of Neutralizing Ab Titers and Breadth Against the Env Vaccine Strain and Heterologous Tier 1 Strains at 2 Weeks After Each Boost | MN.3 at Month 4.5 | 5 Dilution factor |
| Group 1: Boost | Level of Neutralizing Ab Titers and Breadth Against the Env Vaccine Strain and Heterologous Tier 1 Strains at 2 Weeks After Each Boost | TH023.6 at Month 0.5 | 5 Dilution factor |
| Group 1: Boost | Level of Neutralizing Ab Titers and Breadth Against the Env Vaccine Strain and Heterologous Tier 1 Strains at 2 Weeks After Each Boost | TH023.6 at Month 4.5 | 5 Dilution factor |
| Group 2: Boost | Level of Neutralizing Ab Titers and Breadth Against the Env Vaccine Strain and Heterologous Tier 1 Strains at 2 Weeks After Each Boost | ADA at Month 4.5 | 5 Dilution factor |
| Group 2: Boost | Level of Neutralizing Ab Titers and Breadth Against the Env Vaccine Strain and Heterologous Tier 1 Strains at 2 Weeks After Each Boost | TH023.6 at Month 4.5 | 80 Dilution factor |
| Group 2: Boost | Level of Neutralizing Ab Titers and Breadth Against the Env Vaccine Strain and Heterologous Tier 1 Strains at 2 Weeks After Each Boost | CM244.c01 at Month 0.5 | 5 Dilution factor |
| Group 2: Boost | Level of Neutralizing Ab Titers and Breadth Against the Env Vaccine Strain and Heterologous Tier 1 Strains at 2 Weeks After Each Boost | CM244.c01 at Month 4.5 | 5 Dilution factor |
| Group 2: Boost | Level of Neutralizing Ab Titers and Breadth Against the Env Vaccine Strain and Heterologous Tier 1 Strains at 2 Weeks After Each Boost | MN.3 at Month 0.5 | 1388.5 Dilution factor |
| Group 2: Boost | Level of Neutralizing Ab Titers and Breadth Against the Env Vaccine Strain and Heterologous Tier 1 Strains at 2 Weeks After Each Boost | MN.3 at Month 4.5 | 196 Dilution factor |
| Group 2: Boost | Level of Neutralizing Ab Titers and Breadth Against the Env Vaccine Strain and Heterologous Tier 1 Strains at 2 Weeks After Each Boost | TH023.6 at Month 0.5 | 5 Dilution factor |
| Group 2: Boost | Level of Neutralizing Ab Titers and Breadth Against the Env Vaccine Strain and Heterologous Tier 1 Strains at 2 Weeks After Each Boost | ADA at Month 0.5 | 5 Dilution factor |
| Group 3: Boost | Level of Neutralizing Ab Titers and Breadth Against the Env Vaccine Strain and Heterologous Tier 1 Strains at 2 Weeks After Each Boost | CM244.c01 at Month 0.5 | 5 Dilution factor |
| Group 3: Boost | Level of Neutralizing Ab Titers and Breadth Against the Env Vaccine Strain and Heterologous Tier 1 Strains at 2 Weeks After Each Boost | TH023.6 at Month 4.5 | 5 Dilution factor |
| Group 3: Boost | Level of Neutralizing Ab Titers and Breadth Against the Env Vaccine Strain and Heterologous Tier 1 Strains at 2 Weeks After Each Boost | CM244.c01 at Month 4.5 | 5 Dilution factor |
| Group 3: Boost | Level of Neutralizing Ab Titers and Breadth Against the Env Vaccine Strain and Heterologous Tier 1 Strains at 2 Weeks After Each Boost | MN.3 at Month 0.5 | 7.5 Dilution factor |
| Group 3: Boost | Level of Neutralizing Ab Titers and Breadth Against the Env Vaccine Strain and Heterologous Tier 1 Strains at 2 Weeks After Each Boost | MN.3 at Month 4.5 | 8.5 Dilution factor |
| Group 3: Boost | Level of Neutralizing Ab Titers and Breadth Against the Env Vaccine Strain and Heterologous Tier 1 Strains at 2 Weeks After Each Boost | TH023.6 at Month 0.5 | 5 Dilution factor |
| Group 3: Boost | Level of Neutralizing Ab Titers and Breadth Against the Env Vaccine Strain and Heterologous Tier 1 Strains at 2 Weeks After Each Boost | ADA at Month 4.5 | 5 Dilution factor |
| Group 3: Boost | Level of Neutralizing Ab Titers and Breadth Against the Env Vaccine Strain and Heterologous Tier 1 Strains at 2 Weeks After Each Boost | ADA at Month 0.5 | 5 Dilution factor |
| Group 4: Boost | Level of Neutralizing Ab Titers and Breadth Against the Env Vaccine Strain and Heterologous Tier 1 Strains at 2 Weeks After Each Boost | CM244.c01 at Month 4.5 | 5 Dilution factor |
| Group 4: Boost | Level of Neutralizing Ab Titers and Breadth Against the Env Vaccine Strain and Heterologous Tier 1 Strains at 2 Weeks After Each Boost | TH023.6 at Month 4.5 | 16 Dilution factor |
| Group 4: Boost | Level of Neutralizing Ab Titers and Breadth Against the Env Vaccine Strain and Heterologous Tier 1 Strains at 2 Weeks After Each Boost | MN.3 at Month 0.5 | 11414.5 Dilution factor |
| Group 4: Boost | Level of Neutralizing Ab Titers and Breadth Against the Env Vaccine Strain and Heterologous Tier 1 Strains at 2 Weeks After Each Boost | MN.3 at Month 4.5 | 944.5 Dilution factor |
| Group 4: Boost | Level of Neutralizing Ab Titers and Breadth Against the Env Vaccine Strain and Heterologous Tier 1 Strains at 2 Weeks After Each Boost | TH023.6 at Month 0.5 | 18 Dilution factor |
| Group 4: Boost | Level of Neutralizing Ab Titers and Breadth Against the Env Vaccine Strain and Heterologous Tier 1 Strains at 2 Weeks After Each Boost | CM244.c01 at Month 0.5 | 5 Dilution factor |
| Group 4: Boost | Level of Neutralizing Ab Titers and Breadth Against the Env Vaccine Strain and Heterologous Tier 1 Strains at 2 Weeks After Each Boost | ADA at Month 0.5 | 5 Dilution factor |
| Group 4: Boost | Level of Neutralizing Ab Titers and Breadth Against the Env Vaccine Strain and Heterologous Tier 1 Strains at 2 Weeks After Each Boost | ADA at Month 4.5 | 5 Dilution factor |
| Group 5: Boost | Level of Neutralizing Ab Titers and Breadth Against the Env Vaccine Strain and Heterologous Tier 1 Strains at 2 Weeks After Each Boost | MN.3 at Month 0.5 | 6608 Dilution factor |
| Group 5: Boost | Level of Neutralizing Ab Titers and Breadth Against the Env Vaccine Strain and Heterologous Tier 1 Strains at 2 Weeks After Each Boost | TH023.6 at Month 4.5 | 23 Dilution factor |
| Group 5: Boost | Level of Neutralizing Ab Titers and Breadth Against the Env Vaccine Strain and Heterologous Tier 1 Strains at 2 Weeks After Each Boost | MN.3 at Month 4.5 | 996 Dilution factor |
| Group 5: Boost | Level of Neutralizing Ab Titers and Breadth Against the Env Vaccine Strain and Heterologous Tier 1 Strains at 2 Weeks After Each Boost | TH023.6 at Month 0.5 | 5 Dilution factor |
| Group 5: Boost | Level of Neutralizing Ab Titers and Breadth Against the Env Vaccine Strain and Heterologous Tier 1 Strains at 2 Weeks After Each Boost | CM244.c01 at Month 4.5 | 5 Dilution factor |
| Group 5: Boost | Level of Neutralizing Ab Titers and Breadth Against the Env Vaccine Strain and Heterologous Tier 1 Strains at 2 Weeks After Each Boost | ADA at Month 0.5 | 5 Dilution factor |
| Group 5: Boost | Level of Neutralizing Ab Titers and Breadth Against the Env Vaccine Strain and Heterologous Tier 1 Strains at 2 Weeks After Each Boost | ADA at Month 4.5 | 5 Dilution factor |
| Group 5: Boost | Level of Neutralizing Ab Titers and Breadth Against the Env Vaccine Strain and Heterologous Tier 1 Strains at 2 Weeks After Each Boost | CM244.c01 at Month 0.5 | 5 Dilution factor |
| Group 6: Boost | Level of Neutralizing Ab Titers and Breadth Against the Env Vaccine Strain and Heterologous Tier 1 Strains at 2 Weeks After Each Boost | MN.3 at Month 4.5 | 5 Dilution factor |
| Group 6: Boost | Level of Neutralizing Ab Titers and Breadth Against the Env Vaccine Strain and Heterologous Tier 1 Strains at 2 Weeks After Each Boost | TH023.6 at Month 4.5 | 5 Dilution factor |
| Group 6: Boost | Level of Neutralizing Ab Titers and Breadth Against the Env Vaccine Strain and Heterologous Tier 1 Strains at 2 Weeks After Each Boost | TH023.6 at Month 0.5 | 5 Dilution factor |
| Group 6: Boost | Level of Neutralizing Ab Titers and Breadth Against the Env Vaccine Strain and Heterologous Tier 1 Strains at 2 Weeks After Each Boost | MN.3 at Month 0.5 | 10 Dilution factor |
| Group 6: Boost | Level of Neutralizing Ab Titers and Breadth Against the Env Vaccine Strain and Heterologous Tier 1 Strains at 2 Weeks After Each Boost | ADA at Month 0.5 | 5 Dilution factor |
| Group 6: Boost | Level of Neutralizing Ab Titers and Breadth Against the Env Vaccine Strain and Heterologous Tier 1 Strains at 2 Weeks After Each Boost | ADA at Month 4.5 | 5 Dilution factor |
| Group 6: Boost | Level of Neutralizing Ab Titers and Breadth Against the Env Vaccine Strain and Heterologous Tier 1 Strains at 2 Weeks After Each Boost | CM244.c01 at Month 0.5 | 5 Dilution factor |
| Group 6: Boost | Level of Neutralizing Ab Titers and Breadth Against the Env Vaccine Strain and Heterologous Tier 1 Strains at 2 Weeks After Each Boost | CM244.c01 at Month 4.5 | 5 Dilution factor |
| Group 7: Boost | Level of Neutralizing Ab Titers and Breadth Against the Env Vaccine Strain and Heterologous Tier 1 Strains at 2 Weeks After Each Boost | TH023.6 at Month 0.5 | 8.5 Dilution factor |
| Group 7: Boost | Level of Neutralizing Ab Titers and Breadth Against the Env Vaccine Strain and Heterologous Tier 1 Strains at 2 Weeks After Each Boost | MN.3 at Month 4.5 | 522.5 Dilution factor |
| Group 7: Boost | Level of Neutralizing Ab Titers and Breadth Against the Env Vaccine Strain and Heterologous Tier 1 Strains at 2 Weeks After Each Boost | TH023.6 at Month 4.5 | 16 Dilution factor |
| Group 7: Boost | Level of Neutralizing Ab Titers and Breadth Against the Env Vaccine Strain and Heterologous Tier 1 Strains at 2 Weeks After Each Boost | ADA at Month 0.5 | 5 Dilution factor |
| Group 7: Boost | Level of Neutralizing Ab Titers and Breadth Against the Env Vaccine Strain and Heterologous Tier 1 Strains at 2 Weeks After Each Boost | ADA at Month 4.5 | 5 Dilution factor |
| Group 7: Boost | Level of Neutralizing Ab Titers and Breadth Against the Env Vaccine Strain and Heterologous Tier 1 Strains at 2 Weeks After Each Boost | CM244.c01 at Month 0.5 | 5 Dilution factor |
| Group 7: Boost | Level of Neutralizing Ab Titers and Breadth Against the Env Vaccine Strain and Heterologous Tier 1 Strains at 2 Weeks After Each Boost | CM244.c01 at Month 4.5 | 5 Dilution factor |
| Group 7: Boost | Level of Neutralizing Ab Titers and Breadth Against the Env Vaccine Strain and Heterologous Tier 1 Strains at 2 Weeks After Each Boost | MN.3 at Month 0.5 | 7485 Dilution factor |
Primary
Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Left Arm (MVA/HIV62B or Placebo)
Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.0 \[November 2014\], The maximum grade observed for each symptom over the time frame is presented.
Time frame: Measured through 3 days after the boost at Month 0 and Month 4
Population: The overall number of participants analyzed represents participants enrolled and received MVA/HIV62B or placebo. However, one participant in T5 received MVA/HIV62B placebo in the right arm. Hence no left arm reactogenicity data was collected for the participant.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Group 1: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Left Arm (MVA/HIV62B or Placebo) | Pain and/or Tenderness | Mild | 1 Participants |
| Group 1: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Left Arm (MVA/HIV62B or Placebo) | Pain and/or Tenderness | None | 0 Participants |
| Group 1: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Left Arm (MVA/HIV62B or Placebo) | Tenderness | Potentially Life-threatening | 0 Participants |
| Group 1: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Left Arm (MVA/HIV62B or Placebo) | Tenderness | Severe | 0 Participants |
| Group 1: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Left Arm (MVA/HIV62B or Placebo) | Pain | Severe | 0 Participants |
| Group 1: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Left Arm (MVA/HIV62B or Placebo) | Tenderness | None | 0 Participants |
| Group 1: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Left Arm (MVA/HIV62B or Placebo) | Tenderness | Moderate | 1 Participants |
| Group 1: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Left Arm (MVA/HIV62B or Placebo) | Erythema and/or Induration | None | 4 Participants |
| Group 1: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Left Arm (MVA/HIV62B or Placebo) | Induration | Potentially Life-threatening | 0 Participants |
| Group 1: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Left Arm (MVA/HIV62B or Placebo) | Pain | Potentially Life-threatening | 0 Participants |
| Group 1: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Left Arm (MVA/HIV62B or Placebo) | Induration | Moderate | 0 Participants |
| Group 1: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Left Arm (MVA/HIV62B or Placebo) | Erythema | Severe | 0 Participants |
| Group 1: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Left Arm (MVA/HIV62B or Placebo) | Erythema | Moderate | 0 Participants |
| Group 1: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Left Arm (MVA/HIV62B or Placebo) | Erythema | Mild | 0 Participants |
| Group 1: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Left Arm (MVA/HIV62B or Placebo) | Tenderness | Mild | 3 Participants |
| Group 1: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Left Arm (MVA/HIV62B or Placebo) | Pain | Moderate | 3 Participants |
| Group 1: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Left Arm (MVA/HIV62B or Placebo) | Erythema | None | 4 Participants |
| Group 1: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Left Arm (MVA/HIV62B or Placebo) | Pain and/or Tenderness | Potentially Life-threatening | 0 Participants |
| Group 1: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Left Arm (MVA/HIV62B or Placebo) | Pain | None | 0 Participants |
| Group 1: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Left Arm (MVA/HIV62B or Placebo) | Pain and/or Tenderness | Severe | 0 Participants |
| Group 1: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Left Arm (MVA/HIV62B or Placebo) | Pain and/or Tenderness | Moderate | 3 Participants |
| Group 1: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Left Arm (MVA/HIV62B or Placebo) | Erythema and/or Induration | Moderate | 0 Participants |
| Group 1: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Left Arm (MVA/HIV62B or Placebo) | Induration | Severe | 0 Participants |
| Group 1: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Left Arm (MVA/HIV62B or Placebo) | Erythema and/or Induration | Severe | 0 Participants |
| Group 1: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Left Arm (MVA/HIV62B or Placebo) | Induration | Mild | 0 Participants |
| Group 1: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Left Arm (MVA/HIV62B or Placebo) | Erythema and/or Induration | Potentially Life-threatening | 0 Participants |
| Group 1: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Left Arm (MVA/HIV62B or Placebo) | Induration | None | 4 Participants |
| Group 1: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Left Arm (MVA/HIV62B or Placebo) | Erythema and/or Induration | Mild | 0 Participants |
| Group 1: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Left Arm (MVA/HIV62B or Placebo) | Pain | Mild | 1 Participants |
| Group 1: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Left Arm (MVA/HIV62B or Placebo) | Erythema | Potentially Life-threatening | 0 Participants |
| Group 2: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Left Arm (MVA/HIV62B or Placebo) | Tenderness | Severe | 0 Participants |
| Group 2: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Left Arm (MVA/HIV62B or Placebo) | Pain | None | 0 Participants |
| Group 2: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Left Arm (MVA/HIV62B or Placebo) | Pain | Moderate | 4 Participants |
| Group 2: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Left Arm (MVA/HIV62B or Placebo) | Tenderness | None | 0 Participants |
| Group 2: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Left Arm (MVA/HIV62B or Placebo) | Tenderness | Mild | 2 Participants |
| Group 2: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Left Arm (MVA/HIV62B or Placebo) | Induration | Severe | 0 Participants |
| Group 2: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Left Arm (MVA/HIV62B or Placebo) | Erythema and/or Induration | Severe | 0 Participants |
| Group 2: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Left Arm (MVA/HIV62B or Placebo) | Erythema and/or Induration | Potentially Life-threatening | 0 Participants |
| Group 2: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Left Arm (MVA/HIV62B or Placebo) | Pain | Mild | 0 Participants |
| Group 2: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Left Arm (MVA/HIV62B or Placebo) | Pain | Severe | 0 Participants |
| Group 2: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Left Arm (MVA/HIV62B or Placebo) | Pain | Potentially Life-threatening | 0 Participants |
| Group 2: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Left Arm (MVA/HIV62B or Placebo) | Induration | Potentially Life-threatening | 0 Participants |
| Group 2: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Left Arm (MVA/HIV62B or Placebo) | Erythema and/or Induration | None | 4 Participants |
| Group 2: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Left Arm (MVA/HIV62B or Placebo) | Tenderness | Moderate | 2 Participants |
| Group 2: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Left Arm (MVA/HIV62B or Placebo) | Tenderness | Potentially Life-threatening | 0 Participants |
| Group 2: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Left Arm (MVA/HIV62B or Placebo) | Pain and/or Tenderness | None | 0 Participants |
| Group 2: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Left Arm (MVA/HIV62B or Placebo) | Pain and/or Tenderness | Mild | 0 Participants |
| Group 2: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Left Arm (MVA/HIV62B or Placebo) | Erythema and/or Induration | Mild | 0 Participants |
| Group 2: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Left Arm (MVA/HIV62B or Placebo) | Erythema and/or Induration | Moderate | 0 Participants |
| Group 2: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Left Arm (MVA/HIV62B or Placebo) | Pain and/or Tenderness | Moderate | 4 Participants |
| Group 2: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Left Arm (MVA/HIV62B or Placebo) | Pain and/or Tenderness | Severe | 0 Participants |
| Group 2: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Left Arm (MVA/HIV62B or Placebo) | Pain and/or Tenderness | Potentially Life-threatening | 0 Participants |
| Group 2: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Left Arm (MVA/HIV62B or Placebo) | Erythema | None | 4 Participants |
| Group 2: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Left Arm (MVA/HIV62B or Placebo) | Erythema | Mild | 0 Participants |
| Group 2: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Left Arm (MVA/HIV62B or Placebo) | Erythema | Moderate | 0 Participants |
| Group 2: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Left Arm (MVA/HIV62B or Placebo) | Erythema | Severe | 0 Participants |
| Group 2: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Left Arm (MVA/HIV62B or Placebo) | Erythema | Potentially Life-threatening | 0 Participants |
| Group 2: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Left Arm (MVA/HIV62B or Placebo) | Induration | None | 4 Participants |
| Group 2: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Left Arm (MVA/HIV62B or Placebo) | Induration | Mild | 0 Participants |
| Group 2: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Left Arm (MVA/HIV62B or Placebo) | Induration | Moderate | 0 Participants |
| Group 3: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Left Arm (MVA/HIV62B or Placebo) | Erythema and/or Induration | Potentially Life-threatening | 0 Participants |
| Group 3: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Left Arm (MVA/HIV62B or Placebo) | Pain and/or Tenderness | None | 0 Participants |
| Group 3: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Left Arm (MVA/HIV62B or Placebo) | Erythema | Mild | 1 Participants |
| Group 3: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Left Arm (MVA/HIV62B or Placebo) | Tenderness | Mild | 3 Participants |
| Group 3: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Left Arm (MVA/HIV62B or Placebo) | Induration | Moderate | 2 Participants |
| Group 3: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Left Arm (MVA/HIV62B or Placebo) | Erythema | None | 3 Participants |
| Group 3: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Left Arm (MVA/HIV62B or Placebo) | Pain | Mild | 3 Participants |
| Group 3: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Left Arm (MVA/HIV62B or Placebo) | Induration | Mild | 1 Participants |
| Group 3: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Left Arm (MVA/HIV62B or Placebo) | Pain and/or Tenderness | Moderate | 3 Participants |
| Group 3: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Left Arm (MVA/HIV62B or Placebo) | Erythema and/or Induration | None | 3 Participants |
| Group 3: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Left Arm (MVA/HIV62B or Placebo) | Tenderness | Moderate | 3 Participants |
| Group 3: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Left Arm (MVA/HIV62B or Placebo) | Pain and/or Tenderness | Potentially Life-threatening | 0 Participants |
| Group 3: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Left Arm (MVA/HIV62B or Placebo) | Tenderness | Potentially Life-threatening | 0 Participants |
| Group 3: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Left Arm (MVA/HIV62B or Placebo) | Pain | Moderate | 3 Participants |
| Group 3: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Left Arm (MVA/HIV62B or Placebo) | Pain and/or Tenderness | Severe | 0 Participants |
| Group 3: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Left Arm (MVA/HIV62B or Placebo) | Pain and/or Tenderness | Mild | 3 Participants |
| Group 3: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Left Arm (MVA/HIV62B or Placebo) | Induration | Severe | 0 Participants |
| Group 3: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Left Arm (MVA/HIV62B or Placebo) | Pain | Potentially Life-threatening | 0 Participants |
| Group 3: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Left Arm (MVA/HIV62B or Placebo) | Induration | None | 3 Participants |
| Group 3: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Left Arm (MVA/HIV62B or Placebo) | Erythema and/or Induration | Mild | 1 Participants |
| Group 3: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Left Arm (MVA/HIV62B or Placebo) | Erythema | Potentially Life-threatening | 0 Participants |
| Group 3: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Left Arm (MVA/HIV62B or Placebo) | Erythema | Severe | 1 Participants |
| Group 3: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Left Arm (MVA/HIV62B or Placebo) | Pain | None | 0 Participants |
| Group 3: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Left Arm (MVA/HIV62B or Placebo) | Induration | Potentially Life-threatening | 0 Participants |
| Group 3: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Left Arm (MVA/HIV62B or Placebo) | Erythema and/or Induration | Moderate | 1 Participants |
| Group 3: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Left Arm (MVA/HIV62B or Placebo) | Tenderness | Severe | 0 Participants |
| Group 3: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Left Arm (MVA/HIV62B or Placebo) | Tenderness | None | 0 Participants |
| Group 3: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Left Arm (MVA/HIV62B or Placebo) | Erythema and/or Induration | Severe | 1 Participants |
| Group 3: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Left Arm (MVA/HIV62B or Placebo) | Pain | Severe | 0 Participants |
| Group 3: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Left Arm (MVA/HIV62B or Placebo) | Erythema | Moderate | 1 Participants |
| Group 4: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Left Arm (MVA/HIV62B or Placebo) | Induration | Mild | 0 Participants |
| Group 4: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Left Arm (MVA/HIV62B or Placebo) | Tenderness | Severe | 0 Participants |
| Group 4: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Left Arm (MVA/HIV62B or Placebo) | Pain | Mild | 5 Participants |
| Group 4: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Left Arm (MVA/HIV62B or Placebo) | Pain | Moderate | 1 Participants |
| Group 4: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Left Arm (MVA/HIV62B or Placebo) | Pain and/or Tenderness | None | 0 Participants |
| Group 4: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Left Arm (MVA/HIV62B or Placebo) | Induration | Moderate | 0 Participants |
| Group 4: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Left Arm (MVA/HIV62B or Placebo) | Erythema and/or Induration | Mild | 0 Participants |
| Group 4: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Left Arm (MVA/HIV62B or Placebo) | Induration | None | 6 Participants |
| Group 4: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Left Arm (MVA/HIV62B or Placebo) | Erythema and/or Induration | Moderate | 0 Participants |
| Group 4: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Left Arm (MVA/HIV62B or Placebo) | Erythema and/or Induration | Severe | 0 Participants |
| Group 4: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Left Arm (MVA/HIV62B or Placebo) | Erythema and/or Induration | Potentially Life-threatening | 0 Participants |
| Group 4: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Left Arm (MVA/HIV62B or Placebo) | Pain and/or Tenderness | Severe | 0 Participants |
| Group 4: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Left Arm (MVA/HIV62B or Placebo) | Pain and/or Tenderness | Mild | 5 Participants |
| Group 4: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Left Arm (MVA/HIV62B or Placebo) | Tenderness | Potentially Life-threatening | 0 Participants |
| Group 4: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Left Arm (MVA/HIV62B or Placebo) | Pain and/or Tenderness | Moderate | 1 Participants |
| Group 4: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Left Arm (MVA/HIV62B or Placebo) | Tenderness | Moderate | 1 Participants |
| Group 4: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Left Arm (MVA/HIV62B or Placebo) | Pain and/or Tenderness | Potentially Life-threatening | 0 Participants |
| Group 4: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Left Arm (MVA/HIV62B or Placebo) | Erythema | None | 6 Participants |
| Group 4: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Left Arm (MVA/HIV62B or Placebo) | Erythema | Mild | 0 Participants |
| Group 4: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Left Arm (MVA/HIV62B or Placebo) | Tenderness | None | 1 Participants |
| Group 4: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Left Arm (MVA/HIV62B or Placebo) | Pain | None | 0 Participants |
| Group 4: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Left Arm (MVA/HIV62B or Placebo) | Erythema | Moderate | 0 Participants |
| Group 4: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Left Arm (MVA/HIV62B or Placebo) | Erythema | Severe | 0 Participants |
| Group 4: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Left Arm (MVA/HIV62B or Placebo) | Pain | Potentially Life-threatening | 0 Participants |
| Group 4: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Left Arm (MVA/HIV62B or Placebo) | Induration | Severe | 0 Participants |
| Group 4: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Left Arm (MVA/HIV62B or Placebo) | Induration | Potentially Life-threatening | 0 Participants |
| Group 4: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Left Arm (MVA/HIV62B or Placebo) | Pain | Severe | 0 Participants |
| Group 4: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Left Arm (MVA/HIV62B or Placebo) | Erythema and/or Induration | None | 6 Participants |
| Group 4: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Left Arm (MVA/HIV62B or Placebo) | Tenderness | Mild | 4 Participants |
| Group 4: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Left Arm (MVA/HIV62B or Placebo) | Erythema | Potentially Life-threatening | 0 Participants |
| Group 5: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Left Arm (MVA/HIV62B or Placebo) | Tenderness | Severe | 0 Participants |
| Group 5: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Left Arm (MVA/HIV62B or Placebo) | Induration | Potentially Life-threatening | 0 Participants |
| Group 5: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Left Arm (MVA/HIV62B or Placebo) | Erythema and/or Induration | Severe | 0 Participants |
| Group 5: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Left Arm (MVA/HIV62B or Placebo) | Pain | Moderate | 0 Participants |
| Group 5: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Left Arm (MVA/HIV62B or Placebo) | Erythema | Moderate | 0 Participants |
| Group 5: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Left Arm (MVA/HIV62B or Placebo) | Erythema and/or Induration | Moderate | 0 Participants |
| Group 5: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Left Arm (MVA/HIV62B or Placebo) | Induration | Mild | 1 Participants |
| Group 5: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Left Arm (MVA/HIV62B or Placebo) | Erythema and/or Induration | Mild | 1 Participants |
| Group 5: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Left Arm (MVA/HIV62B or Placebo) | Erythema | Potentially Life-threatening | 0 Participants |
| Group 5: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Left Arm (MVA/HIV62B or Placebo) | Erythema | Severe | 0 Participants |
| Group 5: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Left Arm (MVA/HIV62B or Placebo) | Pain | Potentially Life-threatening | 0 Participants |
| Group 5: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Left Arm (MVA/HIV62B or Placebo) | Pain | None | 2 Participants |
| Group 5: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Left Arm (MVA/HIV62B or Placebo) | Pain | Mild | 4 Participants |
| Group 5: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Left Arm (MVA/HIV62B or Placebo) | Erythema and/or Induration | None | 5 Participants |
| Group 5: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Left Arm (MVA/HIV62B or Placebo) | Tenderness | Mild | 1 Participants |
| Group 5: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Left Arm (MVA/HIV62B or Placebo) | Induration | Severe | 0 Participants |
| Group 5: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Left Arm (MVA/HIV62B or Placebo) | Induration | Moderate | 0 Participants |
| Group 5: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Left Arm (MVA/HIV62B or Placebo) | Pain and/or Tenderness | Severe | 0 Participants |
| Group 5: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Left Arm (MVA/HIV62B or Placebo) | Pain | Severe | 0 Participants |
| Group 5: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Left Arm (MVA/HIV62B or Placebo) | Pain and/or Tenderness | Potentially Life-threatening | 0 Participants |
| Group 5: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Left Arm (MVA/HIV62B or Placebo) | Pain and/or Tenderness | Moderate | 1 Participants |
| Group 5: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Left Arm (MVA/HIV62B or Placebo) | Induration | None | 5 Participants |
| Group 5: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Left Arm (MVA/HIV62B or Placebo) | Pain and/or Tenderness | Mild | 3 Participants |
| Group 5: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Left Arm (MVA/HIV62B or Placebo) | Pain and/or Tenderness | None | 2 Participants |
| Group 5: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Left Arm (MVA/HIV62B or Placebo) | Erythema | None | 6 Participants |
| Group 5: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Left Arm (MVA/HIV62B or Placebo) | Tenderness | None | 4 Participants |
| Group 5: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Left Arm (MVA/HIV62B or Placebo) | Tenderness | Moderate | 1 Participants |
| Group 5: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Left Arm (MVA/HIV62B or Placebo) | Erythema and/or Induration | Potentially Life-threatening | 0 Participants |
| Group 5: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Left Arm (MVA/HIV62B or Placebo) | Tenderness | Potentially Life-threatening | 0 Participants |
| Group 5: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Left Arm (MVA/HIV62B or Placebo) | Erythema | Mild | 0 Participants |
Primary
Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Right Arm (AIDSVAX B/E or Placebo)
Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.0 \[November 2014\], The maximum grade observed for each symptom over the time frame is presented.
Time frame: Measured through 3 days after the boost at Month 0 and Month 4
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Group 1: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Right Arm (AIDSVAX B/E or Placebo) | Pain | None | 3 Participants |
| Group 1: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Right Arm (AIDSVAX B/E or Placebo) | Tenderness | Mild | 1 Participants |
| Group 1: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Right Arm (AIDSVAX B/E or Placebo) | Tenderness | None | 3 Participants |
| Group 1: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Right Arm (AIDSVAX B/E or Placebo) | Pain | Severe | 0 Participants |
| Group 1: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Right Arm (AIDSVAX B/E or Placebo) | Pain | Potentially Life-threatening | 0 Participants |
| Group 1: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Right Arm (AIDSVAX B/E or Placebo) | Pain | Moderate | 1 Participants |
| Group 1: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Right Arm (AIDSVAX B/E or Placebo) | Induration | Moderate | 0 Participants |
| Group 1: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Right Arm (AIDSVAX B/E or Placebo) | Induration | Mild | 0 Participants |
| Group 1: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Right Arm (AIDSVAX B/E or Placebo) | Induration | None | 4 Participants |
| Group 1: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Right Arm (AIDSVAX B/E or Placebo) | Pain and/or Tenderness | Moderate | 1 Participants |
| Group 1: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Right Arm (AIDSVAX B/E or Placebo) | Erythema | Potentially Life-threatening | 0 Participants |
| Group 1: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Right Arm (AIDSVAX B/E or Placebo) | Pain and/or Tenderness | Potentially Life-threatening | 0 Participants |
| Group 1: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Right Arm (AIDSVAX B/E or Placebo) | Erythema | Moderate | 0 Participants |
| Group 1: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Right Arm (AIDSVAX B/E or Placebo) | Erythema | Severe | 0 Participants |
| Group 1: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Right Arm (AIDSVAX B/E or Placebo) | Erythema and/or Induration | Potentially Life-threatening | 0 Participants |
| Group 1: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Right Arm (AIDSVAX B/E or Placebo) | Erythema | Mild | 0 Participants |
| Group 1: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Right Arm (AIDSVAX B/E or Placebo) | Induration | Severe | 0 Participants |
| Group 1: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Right Arm (AIDSVAX B/E or Placebo) | Erythema and/or Induration | None | 4 Participants |
| Group 1: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Right Arm (AIDSVAX B/E or Placebo) | Pain | Mild | 0 Participants |
| Group 1: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Right Arm (AIDSVAX B/E or Placebo) | Erythema | None | 4 Participants |
| Group 1: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Right Arm (AIDSVAX B/E or Placebo) | Pain and/or Tenderness | Severe | 0 Participants |
| Group 1: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Right Arm (AIDSVAX B/E or Placebo) | Erythema and/or Induration | Mild | 0 Participants |
| Group 1: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Right Arm (AIDSVAX B/E or Placebo) | Pain and/or Tenderness | Mild | 0 Participants |
| Group 1: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Right Arm (AIDSVAX B/E or Placebo) | Pain and/or Tenderness | None | 3 Participants |
| Group 1: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Right Arm (AIDSVAX B/E or Placebo) | Erythema and/or Induration | Moderate | 0 Participants |
| Group 1: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Right Arm (AIDSVAX B/E or Placebo) | Erythema and/or Induration | Severe | 0 Participants |
| Group 1: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Right Arm (AIDSVAX B/E or Placebo) | Tenderness | Potentially Life-threatening | 0 Participants |
| Group 1: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Right Arm (AIDSVAX B/E or Placebo) | Induration | Potentially Life-threatening | 0 Participants |
| Group 1: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Right Arm (AIDSVAX B/E or Placebo) | Tenderness | Severe | 0 Participants |
| Group 1: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Right Arm (AIDSVAX B/E or Placebo) | Tenderness | Moderate | 0 Participants |
| Group 2: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Right Arm (AIDSVAX B/E or Placebo) | Pain | None | 0 Participants |
| Group 2: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Right Arm (AIDSVAX B/E or Placebo) | Erythema | Severe | 0 Participants |
| Group 2: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Right Arm (AIDSVAX B/E or Placebo) | Erythema and/or Induration | None | 4 Participants |
| Group 2: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Right Arm (AIDSVAX B/E or Placebo) | Erythema and/or Induration | Moderate | 0 Participants |
| Group 2: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Right Arm (AIDSVAX B/E or Placebo) | Erythema and/or Induration | Potentially Life-threatening | 0 Participants |
| Group 2: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Right Arm (AIDSVAX B/E or Placebo) | Pain | Mild | 4 Participants |
| Group 2: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Right Arm (AIDSVAX B/E or Placebo) | Pain | Moderate | 0 Participants |
| Group 2: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Right Arm (AIDSVAX B/E or Placebo) | Pain | Severe | 0 Participants |
| Group 2: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Right Arm (AIDSVAX B/E or Placebo) | Pain | Potentially Life-threatening | 0 Participants |
| Group 2: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Right Arm (AIDSVAX B/E or Placebo) | Tenderness | None | 0 Participants |
| Group 2: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Right Arm (AIDSVAX B/E or Placebo) | Tenderness | Mild | 2 Participants |
| Group 2: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Right Arm (AIDSVAX B/E or Placebo) | Tenderness | Moderate | 2 Participants |
| Group 2: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Right Arm (AIDSVAX B/E or Placebo) | Tenderness | Severe | 0 Participants |
| Group 2: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Right Arm (AIDSVAX B/E or Placebo) | Tenderness | Potentially Life-threatening | 0 Participants |
| Group 2: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Right Arm (AIDSVAX B/E or Placebo) | Pain and/or Tenderness | None | 0 Participants |
| Group 2: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Right Arm (AIDSVAX B/E or Placebo) | Pain and/or Tenderness | Mild | 2 Participants |
| Group 2: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Right Arm (AIDSVAX B/E or Placebo) | Pain and/or Tenderness | Moderate | 2 Participants |
| Group 2: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Right Arm (AIDSVAX B/E or Placebo) | Pain and/or Tenderness | Severe | 0 Participants |
| Group 2: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Right Arm (AIDSVAX B/E or Placebo) | Pain and/or Tenderness | Potentially Life-threatening | 0 Participants |
| Group 2: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Right Arm (AIDSVAX B/E or Placebo) | Erythema | None | 4 Participants |
| Group 2: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Right Arm (AIDSVAX B/E or Placebo) | Erythema | Mild | 0 Participants |
| Group 2: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Right Arm (AIDSVAX B/E or Placebo) | Erythema | Moderate | 0 Participants |
| Group 2: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Right Arm (AIDSVAX B/E or Placebo) | Erythema | Potentially Life-threatening | 0 Participants |
| Group 2: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Right Arm (AIDSVAX B/E or Placebo) | Induration | None | 4 Participants |
| Group 2: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Right Arm (AIDSVAX B/E or Placebo) | Induration | Mild | 0 Participants |
| Group 2: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Right Arm (AIDSVAX B/E or Placebo) | Induration | Moderate | 0 Participants |
| Group 2: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Right Arm (AIDSVAX B/E or Placebo) | Induration | Severe | 0 Participants |
| Group 2: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Right Arm (AIDSVAX B/E or Placebo) | Induration | Potentially Life-threatening | 0 Participants |
| Group 2: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Right Arm (AIDSVAX B/E or Placebo) | Erythema and/or Induration | Mild | 0 Participants |
| Group 2: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Right Arm (AIDSVAX B/E or Placebo) | Erythema and/or Induration | Severe | 0 Participants |
| Group 3: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Right Arm (AIDSVAX B/E or Placebo) | Pain and/or Tenderness | Potentially Life-threatening | 0 Participants |
| Group 3: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Right Arm (AIDSVAX B/E or Placebo) | Tenderness | Potentially Life-threatening | 0 Participants |
| Group 3: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Right Arm (AIDSVAX B/E or Placebo) | Induration | None | 6 Participants |
| Group 3: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Right Arm (AIDSVAX B/E or Placebo) | Erythema and/or Induration | None | 6 Participants |
| Group 3: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Right Arm (AIDSVAX B/E or Placebo) | Erythema | Potentially Life-threatening | 0 Participants |
| Group 3: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Right Arm (AIDSVAX B/E or Placebo) | Erythema | None | 6 Participants |
| Group 3: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Right Arm (AIDSVAX B/E or Placebo) | Pain | Potentially Life-threatening | 0 Participants |
| Group 3: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Right Arm (AIDSVAX B/E or Placebo) | Erythema | Severe | 0 Participants |
| Group 3: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Right Arm (AIDSVAX B/E or Placebo) | Erythema | Moderate | 0 Participants |
| Group 3: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Right Arm (AIDSVAX B/E or Placebo) | Pain | Mild | 2 Participants |
| Group 3: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Right Arm (AIDSVAX B/E or Placebo) | Erythema | Mild | 0 Participants |
| Group 3: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Right Arm (AIDSVAX B/E or Placebo) | Pain | Severe | 0 Participants |
| Group 3: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Right Arm (AIDSVAX B/E or Placebo) | Erythema and/or Induration | Moderate | 0 Participants |
| Group 3: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Right Arm (AIDSVAX B/E or Placebo) | Pain and/or Tenderness | None | 4 Participants |
| Group 3: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Right Arm (AIDSVAX B/E or Placebo) | Tenderness | Mild | 1 Participants |
| Group 3: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Right Arm (AIDSVAX B/E or Placebo) | Induration | Moderate | 0 Participants |
| Group 3: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Right Arm (AIDSVAX B/E or Placebo) | Erythema and/or Induration | Mild | 0 Participants |
| Group 3: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Right Arm (AIDSVAX B/E or Placebo) | Induration | Potentially Life-threatening | 0 Participants |
| Group 3: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Right Arm (AIDSVAX B/E or Placebo) | Pain and/or Tenderness | Mild | 2 Participants |
| Group 3: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Right Arm (AIDSVAX B/E or Placebo) | Tenderness | Severe | 0 Participants |
| Group 3: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Right Arm (AIDSVAX B/E or Placebo) | Pain | Moderate | 0 Participants |
| Group 3: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Right Arm (AIDSVAX B/E or Placebo) | Tenderness | Moderate | 0 Participants |
| Group 3: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Right Arm (AIDSVAX B/E or Placebo) | Pain and/or Tenderness | Moderate | 0 Participants |
| Group 3: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Right Arm (AIDSVAX B/E or Placebo) | Induration | Severe | 0 Participants |
| Group 3: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Right Arm (AIDSVAX B/E or Placebo) | Erythema and/or Induration | Severe | 0 Participants |
| Group 3: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Right Arm (AIDSVAX B/E or Placebo) | Tenderness | None | 5 Participants |
| Group 3: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Right Arm (AIDSVAX B/E or Placebo) | Induration | Mild | 0 Participants |
| Group 3: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Right Arm (AIDSVAX B/E or Placebo) | Pain and/or Tenderness | Severe | 0 Participants |
| Group 3: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Right Arm (AIDSVAX B/E or Placebo) | Erythema and/or Induration | Potentially Life-threatening | 0 Participants |
| Group 3: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Right Arm (AIDSVAX B/E or Placebo) | Pain | None | 4 Participants |
| Group 4: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Right Arm (AIDSVAX B/E or Placebo) | Pain | Mild | 4 Participants |
| Group 4: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Right Arm (AIDSVAX B/E or Placebo) | Tenderness | Severe | 0 Participants |
| Group 4: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Right Arm (AIDSVAX B/E or Placebo) | Erythema and/or Induration | Moderate | 0 Participants |
| Group 4: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Right Arm (AIDSVAX B/E or Placebo) | Pain and/or Tenderness | None | 1 Participants |
| Group 4: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Right Arm (AIDSVAX B/E or Placebo) | Pain and/or Tenderness | Mild | 4 Participants |
| Group 4: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Right Arm (AIDSVAX B/E or Placebo) | Induration | Potentially Life-threatening | 0 Participants |
| Group 4: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Right Arm (AIDSVAX B/E or Placebo) | Pain and/or Tenderness | Moderate | 1 Participants |
| Group 4: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Right Arm (AIDSVAX B/E or Placebo) | Pain and/or Tenderness | Severe | 0 Participants |
| Group 4: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Right Arm (AIDSVAX B/E or Placebo) | Erythema and/or Induration | None | 6 Participants |
| Group 4: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Right Arm (AIDSVAX B/E or Placebo) | Pain and/or Tenderness | Potentially Life-threatening | 0 Participants |
| Group 4: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Right Arm (AIDSVAX B/E or Placebo) | Erythema | None | 6 Participants |
| Group 4: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Right Arm (AIDSVAX B/E or Placebo) | Erythema and/or Induration | Mild | 0 Participants |
| Group 4: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Right Arm (AIDSVAX B/E or Placebo) | Erythema | Mild | 0 Participants |
| Group 4: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Right Arm (AIDSVAX B/E or Placebo) | Erythema | Moderate | 0 Participants |
| Group 4: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Right Arm (AIDSVAX B/E or Placebo) | Erythema | Severe | 0 Participants |
| Group 4: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Right Arm (AIDSVAX B/E or Placebo) | Erythema | Potentially Life-threatening | 0 Participants |
| Group 4: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Right Arm (AIDSVAX B/E or Placebo) | Tenderness | Potentially Life-threatening | 0 Participants |
| Group 4: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Right Arm (AIDSVAX B/E or Placebo) | Pain | Moderate | 0 Participants |
| Group 4: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Right Arm (AIDSVAX B/E or Placebo) | Induration | None | 6 Participants |
| Group 4: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Right Arm (AIDSVAX B/E or Placebo) | Tenderness | None | 3 Participants |
| Group 4: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Right Arm (AIDSVAX B/E or Placebo) | Erythema and/or Induration | Potentially Life-threatening | 0 Participants |
| Group 4: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Right Arm (AIDSVAX B/E or Placebo) | Induration | Mild | 0 Participants |
| Group 4: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Right Arm (AIDSVAX B/E or Placebo) | Tenderness | Moderate | 1 Participants |
| Group 4: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Right Arm (AIDSVAX B/E or Placebo) | Pain | Severe | 0 Participants |
| Group 4: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Right Arm (AIDSVAX B/E or Placebo) | Induration | Moderate | 0 Participants |
| Group 4: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Right Arm (AIDSVAX B/E or Placebo) | Pain | Potentially Life-threatening | 0 Participants |
| Group 4: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Right Arm (AIDSVAX B/E or Placebo) | Pain | None | 2 Participants |
| Group 4: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Right Arm (AIDSVAX B/E or Placebo) | Erythema and/or Induration | Severe | 0 Participants |
| Group 4: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Right Arm (AIDSVAX B/E or Placebo) | Tenderness | Mild | 2 Participants |
| Group 4: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Right Arm (AIDSVAX B/E or Placebo) | Induration | Severe | 0 Participants |
| Group 5: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Right Arm (AIDSVAX B/E or Placebo) | Tenderness | Mild | 4 Participants |
| Group 5: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Right Arm (AIDSVAX B/E or Placebo) | Erythema and/or Induration | Potentially Life-threatening | 0 Participants |
| Group 5: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Right Arm (AIDSVAX B/E or Placebo) | Induration | Potentially Life-threatening | 0 Participants |
| Group 5: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Right Arm (AIDSVAX B/E or Placebo) | Tenderness | None | 1 Participants |
| Group 5: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Right Arm (AIDSVAX B/E or Placebo) | Induration | Mild | 1 Participants |
| Group 5: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Right Arm (AIDSVAX B/E or Placebo) | Erythema and/or Induration | None | 6 Participants |
| Group 5: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Right Arm (AIDSVAX B/E or Placebo) | Pain | Mild | 5 Participants |
| Group 5: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Right Arm (AIDSVAX B/E or Placebo) | Pain | Moderate | 1 Participants |
| Group 5: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Right Arm (AIDSVAX B/E or Placebo) | Pain and/or Tenderness | Moderate | 2 Participants |
| Group 5: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Right Arm (AIDSVAX B/E or Placebo) | Pain and/or Tenderness | Mild | 4 Participants |
| Group 5: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Right Arm (AIDSVAX B/E or Placebo) | Pain and/or Tenderness | None | 1 Participants |
| Group 5: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Right Arm (AIDSVAX B/E or Placebo) | Erythema and/or Induration | Severe | 0 Participants |
| Group 5: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Right Arm (AIDSVAX B/E or Placebo) | Tenderness | Severe | 0 Participants |
| Group 5: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Right Arm (AIDSVAX B/E or Placebo) | Erythema | Moderate | 0 Participants |
| Group 5: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Right Arm (AIDSVAX B/E or Placebo) | Erythema | Mild | 0 Participants |
| Group 5: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Right Arm (AIDSVAX B/E or Placebo) | Induration | Moderate | 0 Participants |
| Group 5: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Right Arm (AIDSVAX B/E or Placebo) | Pain | Severe | 0 Participants |
| Group 5: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Right Arm (AIDSVAX B/E or Placebo) | Erythema | None | 7 Participants |
| Group 5: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Right Arm (AIDSVAX B/E or Placebo) | Erythema and/or Induration | Mild | 1 Participants |
| Group 5: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Right Arm (AIDSVAX B/E or Placebo) | Erythema | Severe | 0 Participants |
| Group 5: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Right Arm (AIDSVAX B/E or Placebo) | Pain and/or Tenderness | Severe | 0 Participants |
| Group 5: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Right Arm (AIDSVAX B/E or Placebo) | Erythema and/or Induration | Moderate | 0 Participants |
| Group 5: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Right Arm (AIDSVAX B/E or Placebo) | Pain | None | 1 Participants |
| Group 5: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Right Arm (AIDSVAX B/E or Placebo) | Induration | Severe | 0 Participants |
| Group 5: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Right Arm (AIDSVAX B/E or Placebo) | Erythema | Potentially Life-threatening | 0 Participants |
| Group 5: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Right Arm (AIDSVAX B/E or Placebo) | Tenderness | Potentially Life-threatening | 0 Participants |
| Group 5: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Right Arm (AIDSVAX B/E or Placebo) | Tenderness | Moderate | 2 Participants |
| Group 5: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Right Arm (AIDSVAX B/E or Placebo) | Pain and/or Tenderness | Potentially Life-threatening | 0 Participants |
| Group 5: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Right Arm (AIDSVAX B/E or Placebo) | Pain | Potentially Life-threatening | 0 Participants |
| Group 5: Boost | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Right Arm (AIDSVAX B/E or Placebo) | Induration | None | 6 Participants |
Primary
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen
Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.0 \[November 2014\], The maximum grade observed for each symptom over the time frame is presented.
Time frame: Measured through Month Measured through 3 days after each boost at Month 0 and 4
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Group 1: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Temperature | Mild | 1 Participants |
| Group 1: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Chills | None | 2 Participants |
| Group 1: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Nausea | Moderate | 0 Participants |
| Group 1: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Vomiting | Potentially Life-threatening | 0 Participants |
| Group 1: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Nausea | Severe | 0 Participants |
| Group 1: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Nausea | Potentially Life-threatening | 0 Participants |
| Group 1: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Temperature | None | 3 Participants |
| Group 1: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Vomiting | Severe | 0 Participants |
| Group 1: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Vomiting | None | 4 Participants |
| Group 1: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Vomiting | Moderate | 0 Participants |
| Group 1: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Vomiting | Mild | 0 Participants |
| Group 1: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Nausea | None | 3 Participants |
| Group 1: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Max. Systemic Symptoms | Potentially Life-threatening | 0 Participants |
| Group 1: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Temperature | Moderate | 0 Participants |
| Group 1: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Max. Systemic Symptoms | Severe | 0 Participants |
| Group 1: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Max. Systemic Symptoms | Moderate | 3 Participants |
| Group 1: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Malaise and/or fatigue | Mild | 1 Participants |
| Group 1: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Max. Systemic Symptoms | Mild | 1 Participants |
| Group 1: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Malaise and/or fatigue | Moderate | 2 Participants |
| Group 1: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Max. Systemic Symptoms | None | 0 Participants |
| Group 1: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Malaise and/or fatigue | Severe | 0 Participants |
| Group 1: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Malaise and/or fatigue | Potentially Life-threatening | 0 Participants |
| Group 1: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Arthralgia | Potentially Life-threatening | 0 Participants |
| Group 1: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Myalgia | None | 1 Participants |
| Group 1: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Arthralgia | Severe | 0 Participants |
| Group 1: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Malaise and/or fatigue | None | 1 Participants |
| Group 1: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Myalgia | Mild | 0 Participants |
| Group 1: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Arthralgia | Moderate | 2 Participants |
| Group 1: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Myalgia | Moderate | 3 Participants |
| Group 1: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Temperature | Potentially Life-threatening | 0 Participants |
| Group 1: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Arthralgia | Mild | 0 Participants |
| Group 1: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Myalgia | Severe | 0 Participants |
| Group 1: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Arthralgia | None | 2 Participants |
| Group 1: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Myalgia | Potentially Life-threatening | 0 Participants |
| Group 1: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Headache | Potentially Life-threatening | 0 Participants |
| Group 1: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Chills | Potentially Life-threatening | 0 Participants |
| Group 1: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Headache | None | 1 Participants |
| Group 1: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Chills | Severe | 0 Participants |
| Group 1: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Headache | Mild | 2 Participants |
| Group 1: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Chills | Moderate | 1 Participants |
| Group 1: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Headache | Moderate | 1 Participants |
| Group 1: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Temperature | Severe | 0 Participants |
| Group 1: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Headache | Severe | 0 Participants |
| Group 1: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Chills | Mild | 1 Participants |
| Group 1: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Nausea | Mild | 1 Participants |
| Group 2: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Chills | Potentially Life-threatening | 0 Participants |
| Group 2: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Arthralgia | Severe | 0 Participants |
| Group 2: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Vomiting | Potentially Life-threatening | 0 Participants |
| Group 2: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Nausea | Mild | 2 Participants |
| Group 2: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Nausea | Moderate | 0 Participants |
| Group 2: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Temperature | Mild | 0 Participants |
| Group 2: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Malaise and/or fatigue | Mild | 2 Participants |
| Group 2: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Vomiting | Severe | 0 Participants |
| Group 2: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Chills | Mild | 3 Participants |
| Group 2: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Nausea | Severe | 0 Participants |
| Group 2: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Temperature | None | 3 Participants |
| Group 2: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Headache | None | 2 Participants |
| Group 2: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Nausea | Potentially Life-threatening | 0 Participants |
| Group 2: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Headache | Potentially Life-threatening | 0 Participants |
| Group 2: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Arthralgia | Moderate | 2 Participants |
| Group 2: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Vomiting | Moderate | 0 Participants |
| Group 2: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Chills | Severe | 0 Participants |
| Group 2: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Vomiting | None | 4 Participants |
| Group 2: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Max. Systemic Symptoms | Potentially Life-threatening | 0 Participants |
| Group 2: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Chills | None | 0 Participants |
| Group 2: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Vomiting | Mild | 0 Participants |
| Group 2: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Myalgia | Moderate | 2 Participants |
| Group 2: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Headache | Severe | 0 Participants |
| Group 2: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Arthralgia | Mild | 2 Participants |
| Group 2: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Max. Systemic Symptoms | Severe | 0 Participants |
| Group 2: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Myalgia | None | 1 Participants |
| Group 2: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Chills | Moderate | 1 Participants |
| Group 2: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Malaise and/or fatigue | None | 0 Participants |
| Group 2: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Myalgia | Mild | 1 Participants |
| Group 2: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Max. Systemic Symptoms | Moderate | 2 Participants |
| Group 2: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Myalgia | Severe | 0 Participants |
| Group 2: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Temperature | Severe | 0 Participants |
| Group 2: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Malaise and/or fatigue | Severe | 0 Participants |
| Group 2: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Max. Systemic Symptoms | Mild | 2 Participants |
| Group 2: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Arthralgia | None | 0 Participants |
| Group 2: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Nausea | None | 2 Participants |
| Group 2: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Malaise and/or fatigue | Moderate | 2 Participants |
| Group 2: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Headache | Mild | 1 Participants |
| Group 2: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Max. Systemic Symptoms | None | 0 Participants |
| Group 2: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Temperature | Moderate | 0 Participants |
| Group 2: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Myalgia | Potentially Life-threatening | 0 Participants |
| Group 2: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Arthralgia | Potentially Life-threatening | 0 Participants |
| Group 2: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Headache | Moderate | 1 Participants |
| Group 2: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Malaise and/or fatigue | Potentially Life-threatening | 0 Participants |
| Group 2: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Temperature | Potentially Life-threatening | 1 Participants |
| Group 3: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Arthralgia | Moderate | 1 Participants |
| Group 3: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Malaise and/or fatigue | Severe | 0 Participants |
| Group 3: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Myalgia | Mild | 0 Participants |
| Group 3: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Headache | Severe | 0 Participants |
| Group 3: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Headache | Potentially Life-threatening | 0 Participants |
| Group 3: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Malaise and/or fatigue | None | 2 Participants |
| Group 3: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Malaise and/or fatigue | Mild | 1 Participants |
| Group 3: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Malaise and/or fatigue | Moderate | 3 Participants |
| Group 3: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Malaise and/or fatigue | Potentially Life-threatening | 0 Participants |
| Group 3: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Myalgia | None | 2 Participants |
| Group 3: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Myalgia | Moderate | 4 Participants |
| Group 3: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Myalgia | Severe | 0 Participants |
| Group 3: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Myalgia | Potentially Life-threatening | 0 Participants |
| Group 3: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Headache | None | 2 Participants |
| Group 3: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Headache | Mild | 1 Participants |
| Group 3: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Headache | Moderate | 3 Participants |
| Group 3: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Nausea | None | 6 Participants |
| Group 3: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Nausea | Mild | 0 Participants |
| Group 3: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Nausea | Moderate | 0 Participants |
| Group 3: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Nausea | Severe | 0 Participants |
| Group 3: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Nausea | Potentially Life-threatening | 0 Participants |
| Group 3: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Vomiting | None | 6 Participants |
| Group 3: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Vomiting | Mild | 0 Participants |
| Group 3: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Vomiting | Moderate | 0 Participants |
| Group 3: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Vomiting | Severe | 0 Participants |
| Group 3: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Vomiting | Potentially Life-threatening | 0 Participants |
| Group 3: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Chills | None | 3 Participants |
| Group 3: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Chills | Mild | 0 Participants |
| Group 3: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Chills | Moderate | 3 Participants |
| Group 3: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Chills | Severe | 0 Participants |
| Group 3: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Chills | Potentially Life-threatening | 0 Participants |
| Group 3: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Arthralgia | None | 4 Participants |
| Group 3: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Arthralgia | Mild | 1 Participants |
| Group 3: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Arthralgia | Severe | 0 Participants |
| Group 3: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Arthralgia | Potentially Life-threatening | 0 Participants |
| Group 3: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Max. Systemic Symptoms | None | 1 Participants |
| Group 3: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Max. Systemic Symptoms | Mild | 1 Participants |
| Group 3: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Max. Systemic Symptoms | Moderate | 4 Participants |
| Group 3: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Max. Systemic Symptoms | Severe | 0 Participants |
| Group 3: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Max. Systemic Symptoms | Potentially Life-threatening | 0 Participants |
| Group 3: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Temperature | None | 3 Participants |
| Group 3: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Temperature | Mild | 2 Participants |
| Group 3: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Temperature | Moderate | 1 Participants |
| Group 3: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Temperature | Severe | 0 Participants |
| Group 3: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Temperature | Potentially Life-threatening | 0 Participants |
| Group 4: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Myalgia | Severe | 1 Participants |
| Group 4: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Chills | Mild | 2 Participants |
| Group 4: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Malaise and/or fatigue | Moderate | 1 Participants |
| Group 4: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Headache | Potentially Life-threatening | 0 Participants |
| Group 4: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Max. Systemic Symptoms | None | 1 Participants |
| Group 4: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Arthralgia | None | 4 Participants |
| Group 4: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Headache | None | 2 Participants |
| Group 4: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Malaise and/or fatigue | Mild | 2 Participants |
| Group 4: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Nausea | Severe | 0 Participants |
| Group 4: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Max. Systemic Symptoms | Mild | 1 Participants |
| Group 4: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Myalgia | Moderate | 2 Participants |
| Group 4: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Chills | Severe | 1 Participants |
| Group 4: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Malaise and/or fatigue | None | 2 Participants |
| Group 4: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Temperature | Potentially Life-threatening | 0 Participants |
| Group 4: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Max. Systemic Symptoms | Moderate | 3 Participants |
| Group 4: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Arthralgia | Mild | 1 Participants |
| Group 4: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Headache | Mild | 2 Participants |
| Group 4: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Headache | Severe | 1 Participants |
| Group 4: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Temperature | Severe | 0 Participants |
| Group 4: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Max. Systemic Symptoms | Severe | 1 Participants |
| Group 4: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Myalgia | Mild | 1 Participants |
| Group 4: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Temperature | Mild | 0 Participants |
| Group 4: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Myalgia | Potentially Life-threatening | 0 Participants |
| Group 4: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Arthralgia | Moderate | 1 Participants |
| Group 4: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Vomiting | Mild | 0 Participants |
| Group 4: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Headache | Moderate | 1 Participants |
| Group 4: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Vomiting | None | 6 Participants |
| Group 4: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Myalgia | None | 2 Participants |
| Group 4: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Chills | Potentially Life-threatening | 0 Participants |
| Group 4: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Vomiting | Moderate | 0 Participants |
| Group 4: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Temperature | Moderate | 2 Participants |
| Group 4: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Nausea | Potentially Life-threatening | 0 Participants |
| Group 4: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Arthralgia | Severe | 0 Participants |
| Group 4: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Max. Systemic Symptoms | Potentially Life-threatening | 0 Participants |
| Group 4: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Vomiting | Severe | 0 Participants |
| Group 4: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Chills | Moderate | 2 Participants |
| Group 4: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Nausea | Moderate | 0 Participants |
| Group 4: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Malaise and/or fatigue | Potentially Life-threatening | 0 Participants |
| Group 4: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Malaise and/or fatigue | Severe | 1 Participants |
| Group 4: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Vomiting | Potentially Life-threatening | 0 Participants |
| Group 4: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Nausea | None | 5 Participants |
| Group 4: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Nausea | Mild | 1 Participants |
| Group 4: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Arthralgia | Potentially Life-threatening | 0 Participants |
| Group 4: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Temperature | None | 4 Participants |
| Group 4: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Chills | None | 1 Participants |
| Group 5: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Malaise and/or fatigue | None | 6 Participants |
| Group 5: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Headache | Moderate | 0 Participants |
| Group 5: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Nausea | Severe | 0 Participants |
| Group 5: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Chills | Mild | 0 Participants |
| Group 5: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Headache | Mild | 0 Participants |
| Group 5: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Chills | Moderate | 1 Participants |
| Group 5: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Headache | None | 7 Participants |
| Group 5: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Chills | Severe | 0 Participants |
| Group 5: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Myalgia | Potentially Life-threatening | 0 Participants |
| Group 5: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Chills | Potentially Life-threatening | 0 Participants |
| Group 5: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Myalgia | Severe | 0 Participants |
| Group 5: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Headache | Potentially Life-threatening | 0 Participants |
| Group 5: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Arthralgia | None | 6 Participants |
| Group 5: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Myalgia | Moderate | 0 Participants |
| Group 5: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Temperature | Potentially Life-threatening | 0 Participants |
| Group 5: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Arthralgia | Mild | 1 Participants |
| Group 5: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Myalgia | Mild | 2 Participants |
| Group 5: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Myalgia | None | 5 Participants |
| Group 5: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Arthralgia | Moderate | 0 Participants |
| Group 5: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Malaise and/or fatigue | Potentially Life-threatening | 0 Participants |
| Group 5: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Arthralgia | Severe | 0 Participants |
| Group 5: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Temperature | Moderate | 0 Participants |
| Group 5: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Arthralgia | Potentially Life-threatening | 0 Participants |
| Group 5: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Malaise and/or fatigue | Moderate | 1 Participants |
| Group 5: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Max. Systemic Symptoms | None | 4 Participants |
| Group 5: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Malaise and/or fatigue | Mild | 0 Participants |
| Group 5: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Headache | Severe | 0 Participants |
| Group 5: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Max. Systemic Symptoms | Mild | 1 Participants |
| Group 5: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Chills | None | 6 Participants |
| Group 5: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Max. Systemic Symptoms | Moderate | 2 Participants |
| Group 5: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Malaise and/or fatigue | Severe | 0 Participants |
| Group 5: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Temperature | Mild | 1 Participants |
| Group 5: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Max. Systemic Symptoms | Severe | 0 Participants |
| Group 5: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Vomiting | None | 7 Participants |
| Group 5: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Temperature | None | 6 Participants |
| Group 5: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Vomiting | Mild | 0 Participants |
| Group 5: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Nausea | Potentially Life-threatening | 0 Participants |
| Group 5: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Temperature | Severe | 0 Participants |
| Group 5: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Vomiting | Moderate | 0 Participants |
| Group 5: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Nausea | Moderate | 0 Participants |
| Group 5: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Vomiting | Severe | 0 Participants |
| Group 5: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Nausea | Mild | 0 Participants |
| Group 5: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Max. Systemic Symptoms | Potentially Life-threatening | 0 Participants |
| Group 5: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Vomiting | Potentially Life-threatening | 0 Participants |
| Group 5: Boost | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Nausea | None | 7 Participants |
Primary
Number of Participants With Early Study Termination Associated With an AE or Reactogenicity
From the study termination form, early termination reasons associated with an AE or reactogenicity are tabulated by treatment arm
Time frame: Measured through Month 10
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1: Boost | Number of Participants With Early Study Termination Associated With an AE or Reactogenicity | Adverse event or reactogenicity | 0 Participants |
| Group 1: Boost | Number of Participants With Early Study Termination Associated With an AE or Reactogenicity | No adverse event or reactogenicity | 0 Participants |
| Group 1: Boost | Number of Participants With Early Study Termination Associated With an AE or Reactogenicity | Do not know | 1 Participants |
| Group 1: Boost | Number of Participants With Early Study Termination Associated With an AE or Reactogenicity | No termination | 3 Participants |
| Group 2: Boost | Number of Participants With Early Study Termination Associated With an AE or Reactogenicity | Adverse event or reactogenicity | 0 Participants |
| Group 2: Boost | Number of Participants With Early Study Termination Associated With an AE or Reactogenicity | No termination | 4 Participants |
| Group 2: Boost | Number of Participants With Early Study Termination Associated With an AE or Reactogenicity | No adverse event or reactogenicity | 0 Participants |
| Group 2: Boost | Number of Participants With Early Study Termination Associated With an AE or Reactogenicity | Do not know | 0 Participants |
| Group 3: Boost | Number of Participants With Early Study Termination Associated With an AE or Reactogenicity | No termination | 6 Participants |
| Group 3: Boost | Number of Participants With Early Study Termination Associated With an AE or Reactogenicity | No adverse event or reactogenicity | 0 Participants |
| Group 3: Boost | Number of Participants With Early Study Termination Associated With an AE or Reactogenicity | Do not know | 0 Participants |
| Group 3: Boost | Number of Participants With Early Study Termination Associated With an AE or Reactogenicity | Adverse event or reactogenicity | 0 Participants |
| Group 4: Boost | Number of Participants With Early Study Termination Associated With an AE or Reactogenicity | Adverse event or reactogenicity | 0 Participants |
| Group 4: Boost | Number of Participants With Early Study Termination Associated With an AE or Reactogenicity | No adverse event or reactogenicity | 0 Participants |
| Group 4: Boost | Number of Participants With Early Study Termination Associated With an AE or Reactogenicity | No termination | 6 Participants |
| Group 4: Boost | Number of Participants With Early Study Termination Associated With an AE or Reactogenicity | Do not know | 0 Participants |
| Group 5: Boost | Number of Participants With Early Study Termination Associated With an AE or Reactogenicity | No termination | 7 Participants |
| Group 5: Boost | Number of Participants With Early Study Termination Associated With an AE or Reactogenicity | Do not know | 0 Participants |
| Group 5: Boost | Number of Participants With Early Study Termination Associated With an AE or Reactogenicity | No adverse event or reactogenicity | 0 Participants |
| Group 5: Boost | Number of Participants With Early Study Termination Associated With an AE or Reactogenicity | Adverse event or reactogenicity | 0 Participants |
Primary
Number of Participants With Study Product Discontinuation Associated With an AE or Reactogenicity
From the study product discontinuation form, study product administration reasons are tabulated by treatment arm
Time frame: Measured through the Month 4 boost
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1: Boost | Number of Participants With Study Product Discontinuation Associated With an AE or Reactogenicity | Clinical Event | 0 Participants |
| Group 1: Boost | Number of Participants With Study Product Discontinuation Associated With an AE or Reactogenicity | Reactogenicity | 0 Participants |
| Group 1: Boost | Number of Participants With Study Product Discontinuation Associated With an AE or Reactogenicity | Other reason | 1 Participants |
| Group 1: Boost | Number of Participants With Study Product Discontinuation Associated With an AE or Reactogenicity | No discontinuation | 3 Participants |
| Group 2: Boost | Number of Participants With Study Product Discontinuation Associated With an AE or Reactogenicity | Clinical Event | 0 Participants |
| Group 2: Boost | Number of Participants With Study Product Discontinuation Associated With an AE or Reactogenicity | No discontinuation | 3 Participants |
| Group 2: Boost | Number of Participants With Study Product Discontinuation Associated With an AE or Reactogenicity | Reactogenicity | 1 Participants |
| Group 2: Boost | Number of Participants With Study Product Discontinuation Associated With an AE or Reactogenicity | Other reason | 0 Participants |
| Group 3: Boost | Number of Participants With Study Product Discontinuation Associated With an AE or Reactogenicity | No discontinuation | 6 Participants |
| Group 3: Boost | Number of Participants With Study Product Discontinuation Associated With an AE or Reactogenicity | Reactogenicity | 0 Participants |
| Group 3: Boost | Number of Participants With Study Product Discontinuation Associated With an AE or Reactogenicity | Other reason | 0 Participants |
| Group 3: Boost | Number of Participants With Study Product Discontinuation Associated With an AE or Reactogenicity | Clinical Event | 0 Participants |
| Group 4: Boost | Number of Participants With Study Product Discontinuation Associated With an AE or Reactogenicity | Clinical Event | 0 Participants |
| Group 4: Boost | Number of Participants With Study Product Discontinuation Associated With an AE or Reactogenicity | Reactogenicity | 0 Participants |
| Group 4: Boost | Number of Participants With Study Product Discontinuation Associated With an AE or Reactogenicity | No discontinuation | 6 Participants |
| Group 4: Boost | Number of Participants With Study Product Discontinuation Associated With an AE or Reactogenicity | Other reason | 0 Participants |
| Group 5: Boost | Number of Participants With Study Product Discontinuation Associated With an AE or Reactogenicity | No discontinuation | 7 Participants |
| Group 5: Boost | Number of Participants With Study Product Discontinuation Associated With an AE or Reactogenicity | Other reason | 0 Participants |
| Group 5: Boost | Number of Participants With Study Product Discontinuation Associated With an AE or Reactogenicity | Reactogenicity | 0 Participants |
| Group 5: Boost | Number of Participants With Study Product Discontinuation Associated With an AE or Reactogenicity | Clinical Event | 0 Participants |
Primary
Occurrence of Env-specific IgA Responses for gp120, gp41, V1V2, and the IDR of gp41 at 2 Weeks After Each Boost
Serum HIV-1-specific IgA responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay. 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 less than 1 is set to 1. The measure unit fluorescence units are relative to assay background, not relative to the placebo arm. Background is used here rather than negative control stimulation, since the antigens are used as bead coating rather than stimulation. IgA responses to V1V2 and the IDR of gp41 were not assayed.
Time frame: Measured at Month 0.5 and 4.5
Population: Overall Number of Participants Analyzed includes the HIV uninfected participants with samples collected at the months 0.5 or 4.5 immunogenicity timepoint. Number Analyzed shows the number of participants with available data after filtering for assay-specific quality control criteria.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1: Boost | Occurrence of Env-specific IgA Responses for gp120, gp41, V1V2, and the IDR of gp41 at 2 Weeks After Each Boost | Con S gp140 CFI at Month 0.5 | 1 Participants |
| Group 1: Boost | Occurrence of Env-specific IgA Responses for gp120, gp41, V1V2, and the IDR of gp41 at 2 Weeks After Each Boost | gp41 at Month 4.5 | 0 Participants |
| Group 1: Boost | Occurrence of Env-specific IgA Responses for gp120, gp41, V1V2, and the IDR of gp41 at 2 Weeks After Each Boost | Con 6 gp120/B at Month 4.5 | 0 Participants |
| Group 1: Boost | Occurrence of Env-specific IgA Responses for gp120, gp41, V1V2, and the IDR of gp41 at 2 Weeks After Each Boost | Con 6 gp120/B at Month 0.5 | 0 Participants |
| Group 1: Boost | Occurrence of Env-specific IgA Responses for gp120, gp41, V1V2, and the IDR of gp41 at 2 Weeks After Each Boost | Con S gp140 CFI at Month 4.5 | 1 Participants |
| Group 1: Boost | Occurrence of Env-specific IgA Responses for gp120, gp41, V1V2, and the IDR of gp41 at 2 Weeks After Each Boost | gp41 at Month 0.5 | 1 Participants |
| Group 2: Boost | Occurrence of Env-specific IgA Responses for gp120, gp41, V1V2, and the IDR of gp41 at 2 Weeks After Each Boost | Con 6 gp120/B at Month 0.5 | 3 Participants |
| Group 2: Boost | Occurrence of Env-specific IgA Responses for gp120, gp41, V1V2, and the IDR of gp41 at 2 Weeks After Each Boost | gp41 at Month 0.5 | 1 Participants |
| Group 2: Boost | Occurrence of Env-specific IgA Responses for gp120, gp41, V1V2, and the IDR of gp41 at 2 Weeks After Each Boost | Con S gp140 CFI at Month 0.5 | 3 Participants |
| Group 2: Boost | Occurrence of Env-specific IgA Responses for gp120, gp41, V1V2, and the IDR of gp41 at 2 Weeks After Each Boost | gp41 at Month 4.5 | 2 Participants |
| Group 2: Boost | Occurrence of Env-specific IgA Responses for gp120, gp41, V1V2, and the IDR of gp41 at 2 Weeks After Each Boost | Con 6 gp120/B at Month 4.5 | 1 Participants |
| Group 2: Boost | Occurrence of Env-specific IgA Responses for gp120, gp41, V1V2, and the IDR of gp41 at 2 Weeks After Each Boost | Con S gp140 CFI at Month 4.5 | 1 Participants |
| Group 3: Boost | Occurrence of Env-specific IgA Responses for gp120, gp41, V1V2, and the IDR of gp41 at 2 Weeks After Each Boost | Con S gp140 CFI at Month 0.5 | 0 Participants |
| Group 3: Boost | Occurrence of Env-specific IgA Responses for gp120, gp41, V1V2, and the IDR of gp41 at 2 Weeks After Each Boost | Con S gp140 CFI at Month 4.5 | 0 Participants |
| Group 3: Boost | Occurrence of Env-specific IgA Responses for gp120, gp41, V1V2, and the IDR of gp41 at 2 Weeks After Each Boost | gp41 at Month 4.5 | 0 Participants |
| Group 3: Boost | Occurrence of Env-specific IgA Responses for gp120, gp41, V1V2, and the IDR of gp41 at 2 Weeks After Each Boost | Con 6 gp120/B at Month 4.5 | 0 Participants |
| Group 3: Boost | Occurrence of Env-specific IgA Responses for gp120, gp41, V1V2, and the IDR of gp41 at 2 Weeks After Each Boost | gp41 at Month 0.5 | 0 Participants |
| Group 3: Boost | Occurrence of Env-specific IgA Responses for gp120, gp41, V1V2, and the IDR of gp41 at 2 Weeks After Each Boost | Con 6 gp120/B at Month 0.5 | 0 Participants |
| Group 4: Boost | Occurrence of Env-specific IgA Responses for gp120, gp41, V1V2, and the IDR of gp41 at 2 Weeks After Each Boost | gp41 at Month 0.5 | 2 Participants |
| Group 4: Boost | Occurrence of Env-specific IgA Responses for gp120, gp41, V1V2, and the IDR of gp41 at 2 Weeks After Each Boost | Con 6 gp120/B at Month 0.5 | 4 Participants |
| Group 4: Boost | Occurrence of Env-specific IgA Responses for gp120, gp41, V1V2, and the IDR of gp41 at 2 Weeks After Each Boost | Con 6 gp120/B at Month 4.5 | 4 Participants |
| Group 4: Boost | Occurrence of Env-specific IgA Responses for gp120, gp41, V1V2, and the IDR of gp41 at 2 Weeks After Each Boost | Con S gp140 CFI at Month 0.5 | 5 Participants |
| Group 4: Boost | Occurrence of Env-specific IgA Responses for gp120, gp41, V1V2, and the IDR of gp41 at 2 Weeks After Each Boost | Con S gp140 CFI at Month 4.5 | 5 Participants |
| Group 4: Boost | Occurrence of Env-specific IgA Responses for gp120, gp41, V1V2, and the IDR of gp41 at 2 Weeks After Each Boost | gp41 at Month 4.5 | 2 Participants |
| Group 5: Boost | Occurrence of Env-specific IgA Responses for gp120, gp41, V1V2, and the IDR of gp41 at 2 Weeks After Each Boost | Con S gp140 CFI at Month 4.5 | 4 Participants |
| Group 5: Boost | Occurrence of Env-specific IgA Responses for gp120, gp41, V1V2, and the IDR of gp41 at 2 Weeks After Each Boost | Con 6 gp120/B at Month 4.5 | 3 Participants |
| Group 5: Boost | Occurrence of Env-specific IgA Responses for gp120, gp41, V1V2, and the IDR of gp41 at 2 Weeks After Each Boost | gp41 at Month 0.5 | 2 Participants |
| Group 5: Boost | Occurrence of Env-specific IgA Responses for gp120, gp41, V1V2, and the IDR of gp41 at 2 Weeks After Each Boost | gp41 at Month 4.5 | 0 Participants |
| Group 5: Boost | Occurrence of Env-specific IgA Responses for gp120, gp41, V1V2, and the IDR of gp41 at 2 Weeks After Each Boost | Con S gp140 CFI at Month 0.5 | 7 Participants |
| Group 5: Boost | Occurrence of Env-specific IgA Responses for gp120, gp41, V1V2, and the IDR of gp41 at 2 Weeks After Each Boost | Con 6 gp120/B at Month 0.5 | 6 Participants |
| Group 6: Boost | Occurrence of Env-specific IgA Responses for gp120, gp41, V1V2, and the IDR of gp41 at 2 Weeks After Each Boost | Con S gp140 CFI at Month 0.5 | 1 Participants |
| Group 6: Boost | Occurrence of Env-specific IgA Responses for gp120, gp41, V1V2, and the IDR of gp41 at 2 Weeks After Each Boost | Con S gp140 CFI at Month 4.5 | 1 Participants |
| Group 6: Boost | Occurrence of Env-specific IgA Responses for gp120, gp41, V1V2, and the IDR of gp41 at 2 Weeks After Each Boost | Con 6 gp120/B at Month 4.5 | 0 Participants |
| Group 6: Boost | Occurrence of Env-specific IgA Responses for gp120, gp41, V1V2, and the IDR of gp41 at 2 Weeks After Each Boost | gp41 at Month 0.5 | 1 Participants |
| Group 6: Boost | Occurrence of Env-specific IgA Responses for gp120, gp41, V1V2, and the IDR of gp41 at 2 Weeks After Each Boost | Con 6 gp120/B at Month 0.5 | 0 Participants |
| Group 6: Boost | Occurrence of Env-specific IgA Responses for gp120, gp41, V1V2, and the IDR of gp41 at 2 Weeks After Each Boost | gp41 at Month 4.5 | 0 Participants |
| Group 7: Boost | Occurrence of Env-specific IgA Responses for gp120, gp41, V1V2, and the IDR of gp41 at 2 Weeks After Each Boost | Con S gp140 CFI at Month 0.5 | 8 Participants |
| Group 7: Boost | Occurrence of Env-specific IgA Responses for gp120, gp41, V1V2, and the IDR of gp41 at 2 Weeks After Each Boost | Con 6 gp120/B at Month 4.5 | 5 Participants |
| Group 7: Boost | Occurrence of Env-specific IgA Responses for gp120, gp41, V1V2, and the IDR of gp41 at 2 Weeks After Each Boost | gp41 at Month 4.5 | 4 Participants |
| Group 7: Boost | Occurrence of Env-specific IgA Responses for gp120, gp41, V1V2, and the IDR of gp41 at 2 Weeks After Each Boost | Con S gp140 CFI at Month 4.5 | 6 Participants |
| Group 7: Boost | Occurrence of Env-specific IgA Responses for gp120, gp41, V1V2, and the IDR of gp41 at 2 Weeks After Each Boost | gp41 at Month 0.5 | 3 Participants |
| Group 7: Boost | Occurrence of Env-specific IgA Responses for gp120, gp41, V1V2, and the IDR of gp41 at 2 Weeks After Each Boost | Con 6 gp120/B at Month 0.5 | 7 Participants |
Primary
Occurrence of Env-specific IgG3 Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost
Serum HIV-1-specific IgG3 responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay. 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 less than 1 is set to 1. The measure unit fluorescence units are relative to assay background, not relative to the placebo arm. Background is used here rather than negative control stimulation, since the antigens are used as bead coating rather than stimulation. The responses to the IDR of gp41 was not assayed.
Time frame: Measured at Month 0.5 and 4.5
Population: Overall Number of Participants Analyzed includes the HIV uninfected participants with samples collected at the months 0.5 or 4.5 immunogenicity timepoint. Number Analyzed shows the number of participants with available data after filtering for assay-specific quality control criteria.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1: Boost | Occurrence of Env-specific IgG3 Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | Con S gp140 CFI at Month 0.5 | 2 Participants |
| Group 1: Boost | Occurrence of Env-specific IgG3 Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | Con 6 gp120/B at Month 4.5 | 0 Participants |
| Group 1: Boost | Occurrence of Env-specific IgG3 Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | Con 6 gp120/B at Month 0.5 | 0 Participants |
| Group 1: Boost | Occurrence of Env-specific IgG3 Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | Con S gp140 CFI at Month 4.5 | 2 Participants |
| Group 1: Boost | Occurrence of Env-specific IgG3 Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | gp41 at Month 0.5 | 2 Participants |
| Group 1: Boost | Occurrence of Env-specific IgG3 Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | gp41 at Month 4.5 | 2 Participants |
| Group 1: Boost | Occurrence of Env-specific IgG3 Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | gp70_B.CaseA_V1_V2 at Month 0.5 | 0 Participants |
| Group 1: Boost | Occurrence of Env-specific IgG3 Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | gp70_B.CaseA_V1_V2 at Month 4.5 | 0 Participants |
| Group 2: Boost | Occurrence of Env-specific IgG3 Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | Con 6 gp120/B at Month 4.5 | 1 Participants |
| Group 2: Boost | Occurrence of Env-specific IgG3 Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | gp70_B.CaseA_V1_V2 at Month 4.5 | 2 Participants |
| Group 2: Boost | Occurrence of Env-specific IgG3 Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | Con S gp140 CFI at Month 0.5 | 3 Participants |
| Group 2: Boost | Occurrence of Env-specific IgG3 Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | Con S gp140 CFI at Month 4.5 | 2 Participants |
| Group 2: Boost | Occurrence of Env-specific IgG3 Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | gp41 at Month 0.5 | 4 Participants |
| Group 2: Boost | Occurrence of Env-specific IgG3 Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | gp41 at Month 4.5 | 2 Participants |
| Group 2: Boost | Occurrence of Env-specific IgG3 Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | gp70_B.CaseA_V1_V2 at Month 0.5 | 1 Participants |
| Group 2: Boost | Occurrence of Env-specific IgG3 Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | Con 6 gp120/B at Month 0.5 | 0 Participants |
| Group 3: Boost | Occurrence of Env-specific IgG3 Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | Con S gp140 CFI at Month 0.5 | 4 Participants |
| Group 3: Boost | Occurrence of Env-specific IgG3 Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | gp70_B.CaseA_V1_V2 at Month 4.5 | 0 Participants |
| Group 3: Boost | Occurrence of Env-specific IgG3 Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | Con S gp140 CFI at Month 4.5 | 4 Participants |
| Group 3: Boost | Occurrence of Env-specific IgG3 Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | gp41 at Month 0.5 | 3 Participants |
| Group 3: Boost | Occurrence of Env-specific IgG3 Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | gp41 at Month 4.5 | 4 Participants |
| Group 3: Boost | Occurrence of Env-specific IgG3 Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | gp70_B.CaseA_V1_V2 at Month 0.5 | 0 Participants |
| Group 3: Boost | Occurrence of Env-specific IgG3 Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | Con 6 gp120/B at Month 4.5 | 0 Participants |
| Group 3: Boost | Occurrence of Env-specific IgG3 Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | Con 6 gp120/B at Month 0.5 | 0 Participants |
| Group 4: Boost | Occurrence of Env-specific IgG3 Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | Con S gp140 CFI at Month 4.5 | 4 Participants |
| Group 4: Boost | Occurrence of Env-specific IgG3 Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | gp70_B.CaseA_V1_V2 at Month 4.5 | 4 Participants |
| Group 4: Boost | Occurrence of Env-specific IgG3 Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | gp41 at Month 0.5 | 5 Participants |
| Group 4: Boost | Occurrence of Env-specific IgG3 Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | gp41 at Month 4.5 | 5 Participants |
| Group 4: Boost | Occurrence of Env-specific IgG3 Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | gp70_B.CaseA_V1_V2 at Month 0.5 | 1 Participants |
| Group 4: Boost | Occurrence of Env-specific IgG3 Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | Con S gp140 CFI at Month 0.5 | 4 Participants |
| Group 4: Boost | Occurrence of Env-specific IgG3 Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | Con 6 gp120/B at Month 0.5 | 2 Participants |
| Group 4: Boost | Occurrence of Env-specific IgG3 Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | Con 6 gp120/B at Month 4.5 | 2 Participants |
| Group 5: Boost | Occurrence of Env-specific IgG3 Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | gp41 at Month 0.5 | 0 Participants |
| Group 5: Boost | Occurrence of Env-specific IgG3 Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | gp70_B.CaseA_V1_V2 at Month 4.5 | 1 Participants |
| Group 5: Boost | Occurrence of Env-specific IgG3 Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | gp41 at Month 4.5 | 0 Participants |
| Group 5: Boost | Occurrence of Env-specific IgG3 Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | gp70_B.CaseA_V1_V2 at Month 0.5 | 0 Participants |
| Group 5: Boost | Occurrence of Env-specific IgG3 Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | Con S gp140 CFI at Month 4.5 | 1 Participants |
| Group 5: Boost | Occurrence of Env-specific IgG3 Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | Con 6 gp120/B at Month 0.5 | 2 Participants |
| Group 5: Boost | Occurrence of Env-specific IgG3 Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | Con 6 gp120/B at Month 4.5 | 2 Participants |
| Group 5: Boost | Occurrence of Env-specific IgG3 Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | Con S gp140 CFI at Month 0.5 | 2 Participants |
| Group 6: Boost | Occurrence of Env-specific IgG3 Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | gp41 at Month 4.5 | 6 Participants |
| Group 6: Boost | Occurrence of Env-specific IgG3 Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | gp70_B.CaseA_V1_V2 at Month 4.5 | 0 Participants |
| Group 6: Boost | Occurrence of Env-specific IgG3 Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | gp70_B.CaseA_V1_V2 at Month 0.5 | 0 Participants |
| Group 6: Boost | Occurrence of Env-specific IgG3 Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | gp41 at Month 0.5 | 5 Participants |
| Group 6: Boost | Occurrence of Env-specific IgG3 Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | Con 6 gp120/B at Month 0.5 | 0 Participants |
| Group 6: Boost | Occurrence of Env-specific IgG3 Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | Con 6 gp120/B at Month 4.5 | 0 Participants |
| Group 6: Boost | Occurrence of Env-specific IgG3 Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | Con S gp140 CFI at Month 0.5 | 6 Participants |
| Group 6: Boost | Occurrence of Env-specific IgG3 Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | Con S gp140 CFI at Month 4.5 | 6 Participants |
| Group 7: Boost | Occurrence of Env-specific IgG3 Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | gp70_B.CaseA_V1_V2 at Month 0.5 | 2 Participants |
| Group 7: Boost | Occurrence of Env-specific IgG3 Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | gp41 at Month 4.5 | 7 Participants |
| Group 7: Boost | Occurrence of Env-specific IgG3 Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | gp70_B.CaseA_V1_V2 at Month 4.5 | 6 Participants |
| Group 7: Boost | Occurrence of Env-specific IgG3 Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | Con 6 gp120/B at Month 0.5 | 2 Participants |
| Group 7: Boost | Occurrence of Env-specific IgG3 Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | Con 6 gp120/B at Month 4.5 | 3 Participants |
| Group 7: Boost | Occurrence of Env-specific IgG3 Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | Con S gp140 CFI at Month 0.5 | 7 Participants |
| Group 7: Boost | Occurrence of Env-specific IgG3 Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | Con S gp140 CFI at Month 4.5 | 6 Participants |
| Group 7: Boost | Occurrence of Env-specific IgG3 Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | gp41 at Month 0.5 | 9 Participants |
Primary
Occurrence of Env-specific IgG Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost
Serum HIV-1-specific IgG responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay. 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 less than 1 is set to 1. The measure unit fluorescence units are relative to assay background, not relative to the placebo arm. Background is used here rather than negative control stimulation, since the antigens are used as bead coating rather than stimulation. The responses to the IDR of gp41 was not assayed.
Time frame: Measured at Month 0.5 and 4.5
Population: Overall Number of Participants Analyzed includes the HIV uninfected participants with samples collected at the months 0.5 or 4.5 immunogenicity timepoint. Number Analyzed shows the number of participants with available data after filtering for assay-specific quality control criteria.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1: Boost | Occurrence of Env-specific IgG Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | gp70_B.CaseA_V1_V2 at Month 0.5 | 1 Participants |
| Group 1: Boost | Occurrence of Env-specific IgG Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | Con 6 gp120/B at Month 4.5 | 0 Participants |
| Group 1: Boost | Occurrence of Env-specific IgG Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | Con S gp140 CFI at Month 4.5 | 2 Participants |
| Group 1: Boost | Occurrence of Env-specific IgG Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | gp70_B.CaseA_V1_V2 at Month 4.5 | 2 Participants |
| Group 1: Boost | Occurrence of Env-specific IgG Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | gp41 at Month 4.5 | 2 Participants |
| Group 1: Boost | Occurrence of Env-specific IgG Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | gp41 at Month 0.5 | 2 Participants |
| Group 1: Boost | Occurrence of Env-specific IgG Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | Con S gp140 CFI at Month 0.5 | 2 Participants |
| Group 1: Boost | Occurrence of Env-specific IgG Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | Con 6 gp120/B at Month 0.5 | 1 Participants |
| Group 2: Boost | Occurrence of Env-specific IgG Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | gp41 at Month 0.5 | 3 Participants |
| Group 2: Boost | Occurrence of Env-specific IgG Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | gp41 at Month 4.5 | 3 Participants |
| Group 2: Boost | Occurrence of Env-specific IgG Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | Con 6 gp120/B at Month 4.5 | 3 Participants |
| Group 2: Boost | Occurrence of Env-specific IgG Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | gp70_B.CaseA_V1_V2 at Month 0.5 | 1 Participants |
| Group 2: Boost | Occurrence of Env-specific IgG Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | Con S gp140 CFI at Month 0.5 | 3 Participants |
| Group 2: Boost | Occurrence of Env-specific IgG Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | Con S gp140 CFI at Month 4.5 | 3 Participants |
| Group 2: Boost | Occurrence of Env-specific IgG Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | Con 6 gp120/B at Month 0.5 | 3 Participants |
| Group 2: Boost | Occurrence of Env-specific IgG Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | gp70_B.CaseA_V1_V2 at Month 4.5 | 2 Participants |
| Group 3: Boost | Occurrence of Env-specific IgG Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | gp41 at Month 4.5 | 4 Participants |
| Group 3: Boost | Occurrence of Env-specific IgG Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | Con S gp140 CFI at Month 0.5 | 4 Participants |
| Group 3: Boost | Occurrence of Env-specific IgG Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | gp70_B.CaseA_V1_V2 at Month 0.5 | 0 Participants |
| Group 3: Boost | Occurrence of Env-specific IgG Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | Con 6 gp120/B at Month 0.5 | 2 Participants |
| Group 3: Boost | Occurrence of Env-specific IgG Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | gp70_B.CaseA_V1_V2 at Month 4.5 | 0 Participants |
| Group 3: Boost | Occurrence of Env-specific IgG Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | gp41 at Month 0.5 | 4 Participants |
| Group 3: Boost | Occurrence of Env-specific IgG Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | Con S gp140 CFI at Month 4.5 | 4 Participants |
| Group 3: Boost | Occurrence of Env-specific IgG Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | Con 6 gp120/B at Month 4.5 | 2 Participants |
| Group 4: Boost | Occurrence of Env-specific IgG Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | gp70_B.CaseA_V1_V2 at Month 0.5 | 4 Participants |
| Group 4: Boost | Occurrence of Env-specific IgG Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | Con 6 gp120/B at Month 0.5 | 4 Participants |
| Group 4: Boost | Occurrence of Env-specific IgG Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | gp41 at Month 4.5 | 4 Participants |
| Group 4: Boost | Occurrence of Env-specific IgG Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | Con S gp140 CFI at Month 0.5 | 4 Participants |
| Group 4: Boost | Occurrence of Env-specific IgG Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | Con S gp140 CFI at Month 4.5 | 4 Participants |
| Group 4: Boost | Occurrence of Env-specific IgG Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | gp41 at Month 0.5 | 4 Participants |
| Group 4: Boost | Occurrence of Env-specific IgG Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | Con 6 gp120/B at Month 4.5 | 4 Participants |
| Group 4: Boost | Occurrence of Env-specific IgG Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | gp70_B.CaseA_V1_V2 at Month 4.5 | 6 Participants |
| Group 5: Boost | Occurrence of Env-specific IgG Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | Con S gp140 CFI at Month 0.5 | 7 Participants |
| Group 5: Boost | Occurrence of Env-specific IgG Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | Con 6 gp120/B at Month 0.5 | 7 Participants |
| Group 5: Boost | Occurrence of Env-specific IgG Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | gp70_B.CaseA_V1_V2 at Month 4.5 | 6 Participants |
| Group 5: Boost | Occurrence of Env-specific IgG Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | Con 6 gp120/B at Month 4.5 | 7 Participants |
| Group 5: Boost | Occurrence of Env-specific IgG Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | gp70_B.CaseA_V1_V2 at Month 0.5 | 4 Participants |
| Group 5: Boost | Occurrence of Env-specific IgG Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | gp41 at Month 4.5 | 1 Participants |
| Group 5: Boost | Occurrence of Env-specific IgG Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | Con S gp140 CFI at Month 4.5 | 7 Participants |
| Group 5: Boost | Occurrence of Env-specific IgG Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | gp41 at Month 0.5 | 1 Participants |
| Group 6: Boost | Occurrence of Env-specific IgG Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | gp41 at Month 4.5 | 6 Participants |
| Group 6: Boost | Occurrence of Env-specific IgG Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | gp41 at Month 0.5 | 6 Participants |
| Group 6: Boost | Occurrence of Env-specific IgG Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | Con 6 gp120/B at Month 0.5 | 3 Participants |
| Group 6: Boost | Occurrence of Env-specific IgG Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | Con 6 gp120/B at Month 4.5 | 2 Participants |
| Group 6: Boost | Occurrence of Env-specific IgG Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | Con S gp140 CFI at Month 0.5 | 6 Participants |
| Group 6: Boost | Occurrence of Env-specific IgG Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | Con S gp140 CFI at Month 4.5 | 6 Participants |
| Group 6: Boost | Occurrence of Env-specific IgG Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | gp70_B.CaseA_V1_V2 at Month 0.5 | 1 Participants |
| Group 6: Boost | Occurrence of Env-specific IgG Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | gp70_B.CaseA_V1_V2 at Month 4.5 | 2 Participants |
| Group 7: Boost | Occurrence of Env-specific IgG Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | gp41 at Month 0.5 | 7 Participants |
| Group 7: Boost | Occurrence of Env-specific IgG Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | Con S gp140 CFI at Month 4.5 | 7 Participants |
| Group 7: Boost | Occurrence of Env-specific IgG Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | Con S gp140 CFI at Month 0.5 | 7 Participants |
| Group 7: Boost | Occurrence of Env-specific IgG Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | Con 6 gp120/B at Month 4.5 | 7 Participants |
| Group 7: Boost | Occurrence of Env-specific IgG Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | gp70_B.CaseA_V1_V2 at Month 4.5 | 8 Participants |
| Group 7: Boost | Occurrence of Env-specific IgG Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | Con 6 gp120/B at Month 0.5 | 7 Participants |
| Group 7: Boost | Occurrence of Env-specific IgG Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | gp41 at Month 4.5 | 7 Participants |
| Group 7: Boost | Occurrence of Env-specific IgG Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | gp70_B.CaseA_V1_V2 at Month 0.5 | 5 Participants |
Primary
Occurrence of Neutralizing Ab Titers and Breadth Against the Env Vaccine Strain and Heterologous Tier 1 Strains at 2 Weeks After Each Boost
Neutralizing antibodies against HIV-1 were measured as a function of reductions in Tat-regulated luciferase (Luc) reporter gene expression in TZM-bl cells. The assay measured neutralization titers against a panel of autologous and heterologous Env-pseudotyped viruses.
Time frame: Measured at Month 0.5 and 4.5
Population: Overall Number of Participants Analyzed includes the HIV uninfected participants with samples collected at the months 0.5 or 4.5 immunogenicity timepoint. Number Analyzed shows the number of participants with available data after filtering for assay-specific quality control criteria.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1: Boost | Occurrence of Neutralizing Ab Titers and Breadth Against the Env Vaccine Strain and Heterologous Tier 1 Strains at 2 Weeks After Each Boost | CM244.c01 at Month 0.5 | 0 Participants |
| Group 1: Boost | Occurrence of Neutralizing Ab Titers and Breadth Against the Env Vaccine Strain and Heterologous Tier 1 Strains at 2 Weeks After Each Boost | ADA at Month 4.5 | 0 Participants |
| Group 1: Boost | Occurrence of Neutralizing Ab Titers and Breadth Against the Env Vaccine Strain and Heterologous Tier 1 Strains at 2 Weeks After Each Boost | ADA at Month 0.5 | 0 Participants |
| Group 1: Boost | Occurrence of Neutralizing Ab Titers and Breadth Against the Env Vaccine Strain and Heterologous Tier 1 Strains at 2 Weeks After Each Boost | CM244.c01 at Month 4.5 | 0 Participants |
| Group 1: Boost | Occurrence of Neutralizing Ab Titers and Breadth Against the Env Vaccine Strain and Heterologous Tier 1 Strains at 2 Weeks After Each Boost | MN.3 at Month 0.5 | 2 Participants |
| Group 1: Boost | Occurrence of Neutralizing Ab Titers and Breadth Against the Env Vaccine Strain and Heterologous Tier 1 Strains at 2 Weeks After Each Boost | MN.3 at Month 4.5 | 1 Participants |
| Group 1: Boost | Occurrence of Neutralizing Ab Titers and Breadth Against the Env Vaccine Strain and Heterologous Tier 1 Strains at 2 Weeks After Each Boost | TH023.6 at Month 0.5 | 0 Participants |
| Group 1: Boost | Occurrence of Neutralizing Ab Titers and Breadth Against the Env Vaccine Strain and Heterologous Tier 1 Strains at 2 Weeks After Each Boost | TH023.6 at Month 4.5 | 0 Participants |
| Group 2: Boost | Occurrence of Neutralizing Ab Titers and Breadth Against the Env Vaccine Strain and Heterologous Tier 1 Strains at 2 Weeks After Each Boost | ADA at Month 4.5 | 0 Participants |
| Group 2: Boost | Occurrence of Neutralizing Ab Titers and Breadth Against the Env Vaccine Strain and Heterologous Tier 1 Strains at 2 Weeks After Each Boost | TH023.6 at Month 4.5 | 2 Participants |
| Group 2: Boost | Occurrence of Neutralizing Ab Titers and Breadth Against the Env Vaccine Strain and Heterologous Tier 1 Strains at 2 Weeks After Each Boost | CM244.c01 at Month 0.5 | 0 Participants |
| Group 2: Boost | Occurrence of Neutralizing Ab Titers and Breadth Against the Env Vaccine Strain and Heterologous Tier 1 Strains at 2 Weeks After Each Boost | CM244.c01 at Month 4.5 | 0 Participants |
| Group 2: Boost | Occurrence of Neutralizing Ab Titers and Breadth Against the Env Vaccine Strain and Heterologous Tier 1 Strains at 2 Weeks After Each Boost | MN.3 at Month 0.5 | 4 Participants |
| Group 2: Boost | Occurrence of Neutralizing Ab Titers and Breadth Against the Env Vaccine Strain and Heterologous Tier 1 Strains at 2 Weeks After Each Boost | MN.3 at Month 4.5 | 3 Participants |
| Group 2: Boost | Occurrence of Neutralizing Ab Titers and Breadth Against the Env Vaccine Strain and Heterologous Tier 1 Strains at 2 Weeks After Each Boost | TH023.6 at Month 0.5 | 1 Participants |
| Group 2: Boost | Occurrence of Neutralizing Ab Titers and Breadth Against the Env Vaccine Strain and Heterologous Tier 1 Strains at 2 Weeks After Each Boost | ADA at Month 0.5 | 0 Participants |
| Group 3: Boost | Occurrence of Neutralizing Ab Titers and Breadth Against the Env Vaccine Strain and Heterologous Tier 1 Strains at 2 Weeks After Each Boost | CM244.c01 at Month 0.5 | 0 Participants |
| Group 3: Boost | Occurrence of Neutralizing Ab Titers and Breadth Against the Env Vaccine Strain and Heterologous Tier 1 Strains at 2 Weeks After Each Boost | TH023.6 at Month 4.5 | 0 Participants |
| Group 3: Boost | Occurrence of Neutralizing Ab Titers and Breadth Against the Env Vaccine Strain and Heterologous Tier 1 Strains at 2 Weeks After Each Boost | CM244.c01 at Month 4.5 | 0 Participants |
| Group 3: Boost | Occurrence of Neutralizing Ab Titers and Breadth Against the Env Vaccine Strain and Heterologous Tier 1 Strains at 2 Weeks After Each Boost | MN.3 at Month 0.5 | 2 Participants |
| Group 3: Boost | Occurrence of Neutralizing Ab Titers and Breadth Against the Env Vaccine Strain and Heterologous Tier 1 Strains at 2 Weeks After Each Boost | MN.3 at Month 4.5 | 3 Participants |
| Group 3: Boost | Occurrence of Neutralizing Ab Titers and Breadth Against the Env Vaccine Strain and Heterologous Tier 1 Strains at 2 Weeks After Each Boost | TH023.6 at Month 0.5 | 0 Participants |
| Group 3: Boost | Occurrence of Neutralizing Ab Titers and Breadth Against the Env Vaccine Strain and Heterologous Tier 1 Strains at 2 Weeks After Each Boost | ADA at Month 4.5 | 0 Participants |
| Group 3: Boost | Occurrence of Neutralizing Ab Titers and Breadth Against the Env Vaccine Strain and Heterologous Tier 1 Strains at 2 Weeks After Each Boost | ADA at Month 0.5 | 0 Participants |
| Group 4: Boost | Occurrence of Neutralizing Ab Titers and Breadth Against the Env Vaccine Strain and Heterologous Tier 1 Strains at 2 Weeks After Each Boost | CM244.c01 at Month 4.5 | 0 Participants |
| Group 4: Boost | Occurrence of Neutralizing Ab Titers and Breadth Against the Env Vaccine Strain and Heterologous Tier 1 Strains at 2 Weeks After Each Boost | TH023.6 at Month 4.5 | 3 Participants |
| Group 4: Boost | Occurrence of Neutralizing Ab Titers and Breadth Against the Env Vaccine Strain and Heterologous Tier 1 Strains at 2 Weeks After Each Boost | MN.3 at Month 0.5 | 6 Participants |
| Group 4: Boost | Occurrence of Neutralizing Ab Titers and Breadth Against the Env Vaccine Strain and Heterologous Tier 1 Strains at 2 Weeks After Each Boost | MN.3 at Month 4.5 | 6 Participants |
| Group 4: Boost | Occurrence of Neutralizing Ab Titers and Breadth Against the Env Vaccine Strain and Heterologous Tier 1 Strains at 2 Weeks After Each Boost | TH023.6 at Month 0.5 | 4 Participants |
| Group 4: Boost | Occurrence of Neutralizing Ab Titers and Breadth Against the Env Vaccine Strain and Heterologous Tier 1 Strains at 2 Weeks After Each Boost | CM244.c01 at Month 0.5 | 0 Participants |
| Group 4: Boost | Occurrence of Neutralizing Ab Titers and Breadth Against the Env Vaccine Strain and Heterologous Tier 1 Strains at 2 Weeks After Each Boost | ADA at Month 0.5 | 0 Participants |
| Group 4: Boost | Occurrence of Neutralizing Ab Titers and Breadth Against the Env Vaccine Strain and Heterologous Tier 1 Strains at 2 Weeks After Each Boost | ADA at Month 4.5 | 0 Participants |
| Group 5: Boost | Occurrence of Neutralizing Ab Titers and Breadth Against the Env Vaccine Strain and Heterologous Tier 1 Strains at 2 Weeks After Each Boost | MN.3 at Month 0.5 | 7 Participants |
| Group 5: Boost | Occurrence of Neutralizing Ab Titers and Breadth Against the Env Vaccine Strain and Heterologous Tier 1 Strains at 2 Weeks After Each Boost | TH023.6 at Month 4.5 | 4 Participants |
| Group 5: Boost | Occurrence of Neutralizing Ab Titers and Breadth Against the Env Vaccine Strain and Heterologous Tier 1 Strains at 2 Weeks After Each Boost | MN.3 at Month 4.5 | 7 Participants |
| Group 5: Boost | Occurrence of Neutralizing Ab Titers and Breadth Against the Env Vaccine Strain and Heterologous Tier 1 Strains at 2 Weeks After Each Boost | TH023.6 at Month 0.5 | 2 Participants |
| Group 5: Boost | Occurrence of Neutralizing Ab Titers and Breadth Against the Env Vaccine Strain and Heterologous Tier 1 Strains at 2 Weeks After Each Boost | CM244.c01 at Month 4.5 | 0 Participants |
| Group 5: Boost | Occurrence of Neutralizing Ab Titers and Breadth Against the Env Vaccine Strain and Heterologous Tier 1 Strains at 2 Weeks After Each Boost | ADA at Month 0.5 | 0 Participants |
| Group 5: Boost | Occurrence of Neutralizing Ab Titers and Breadth Against the Env Vaccine Strain and Heterologous Tier 1 Strains at 2 Weeks After Each Boost | ADA at Month 4.5 | 0 Participants |
| Group 5: Boost | Occurrence of Neutralizing Ab Titers and Breadth Against the Env Vaccine Strain and Heterologous Tier 1 Strains at 2 Weeks After Each Boost | CM244.c01 at Month 0.5 | 0 Participants |
| Group 6: Boost | Occurrence of Neutralizing Ab Titers and Breadth Against the Env Vaccine Strain and Heterologous Tier 1 Strains at 2 Weeks After Each Boost | MN.3 at Month 4.5 | 4 Participants |
| Group 6: Boost | Occurrence of Neutralizing Ab Titers and Breadth Against the Env Vaccine Strain and Heterologous Tier 1 Strains at 2 Weeks After Each Boost | TH023.6 at Month 4.5 | 0 Participants |
| Group 6: Boost | Occurrence of Neutralizing Ab Titers and Breadth Against the Env Vaccine Strain and Heterologous Tier 1 Strains at 2 Weeks After Each Boost | TH023.6 at Month 0.5 | 0 Participants |
| Group 6: Boost | Occurrence of Neutralizing Ab Titers and Breadth Against the Env Vaccine Strain and Heterologous Tier 1 Strains at 2 Weeks After Each Boost | MN.3 at Month 0.5 | 4 Participants |
| Group 6: Boost | Occurrence of Neutralizing Ab Titers and Breadth Against the Env Vaccine Strain and Heterologous Tier 1 Strains at 2 Weeks After Each Boost | ADA at Month 0.5 | 0 Participants |
| Group 6: Boost | Occurrence of Neutralizing Ab Titers and Breadth Against the Env Vaccine Strain and Heterologous Tier 1 Strains at 2 Weeks After Each Boost | ADA at Month 4.5 | 0 Participants |
| Group 6: Boost | Occurrence of Neutralizing Ab Titers and Breadth Against the Env Vaccine Strain and Heterologous Tier 1 Strains at 2 Weeks After Each Boost | CM244.c01 at Month 0.5 | 0 Participants |
| Group 6: Boost | Occurrence of Neutralizing Ab Titers and Breadth Against the Env Vaccine Strain and Heterologous Tier 1 Strains at 2 Weeks After Each Boost | CM244.c01 at Month 4.5 | 0 Participants |
| Group 7: Boost | Occurrence of Neutralizing Ab Titers and Breadth Against the Env Vaccine Strain and Heterologous Tier 1 Strains at 2 Weeks After Each Boost | TH023.6 at Month 0.5 | 5 Participants |
| Group 7: Boost | Occurrence of Neutralizing Ab Titers and Breadth Against the Env Vaccine Strain and Heterologous Tier 1 Strains at 2 Weeks After Each Boost | MN.3 at Month 4.5 | 9 Participants |
| Group 7: Boost | Occurrence of Neutralizing Ab Titers and Breadth Against the Env Vaccine Strain and Heterologous Tier 1 Strains at 2 Weeks After Each Boost | TH023.6 at Month 4.5 | 5 Participants |
| Group 7: Boost | Occurrence of Neutralizing Ab Titers and Breadth Against the Env Vaccine Strain and Heterologous Tier 1 Strains at 2 Weeks After Each Boost | ADA at Month 0.5 | 0 Participants |
| Group 7: Boost | Occurrence of Neutralizing Ab Titers and Breadth Against the Env Vaccine Strain and Heterologous Tier 1 Strains at 2 Weeks After Each Boost | ADA at Month 4.5 | 0 Participants |
| Group 7: Boost | Occurrence of Neutralizing Ab Titers and Breadth Against the Env Vaccine Strain and Heterologous Tier 1 Strains at 2 Weeks After Each Boost | CM244.c01 at Month 0.5 | 0 Participants |
| Group 7: Boost | Occurrence of Neutralizing Ab Titers and Breadth Against the Env Vaccine Strain and Heterologous Tier 1 Strains at 2 Weeks After Each Boost | CM244.c01 at Month 4.5 | 0 Participants |
| Group 7: Boost | Occurrence of Neutralizing Ab Titers and Breadth Against the Env Vaccine Strain and Heterologous Tier 1 Strains at 2 Weeks After Each Boost | MN.3 at Month 0.5 | 10 Participants |
Secondary
Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost
PBMC samples are stimulated with synthetic peptide pools or left unstimulated as a negative control. For each sample, T-cell subset, and peptide pool, response magnitude is % cells expressing markers after peptide stimulation minus % cells expressing markers after no stimulation. Response positivity is derived by testing if the number of cells expressing the marker is equal in the stimulated vs. unstimulated cells. Response is positive if the one-sided Fisher's exact test (discrete Bonferroni adjustment over the peptide pools) p\<=0.00001. The Fisher's exact test is not applied to compare between endpoints. Data are excluded if the blood draw date was outside the visit window, the participant was HIV-infected, PBMC viability or T-cell count were low, or negative control was high. The responses at month 0.5 was not assayed.
Time frame: Measured at Month 4.5
Population: Overall Number of Participants Analyzed includes the HIV uninfected participants with samples collected at the month 4.5 immunogenicity timepoint. Number Analyzed shows the number of participants with available data after filtering for assay-specific quality control criteria.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Group 1: Boost | Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Any PTEg | 0.074 % CD4+ T-cells |
| Group 1: Boost | Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Any Env PTEg | 0.032 % CD4+ T-cells |
| Group 1: Boost | Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Any Gag PTEg | 0.06 % CD4+ T-cells |
| Group 1: Boost | Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Env-1-PTEg | 0.007 % CD4+ T-cells |
| Group 1: Boost | Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Env-2-PTEg | 0.032 % CD4+ T-cells |
| Group 1: Boost | Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Env-3-PTEg | 0.005 % CD4+ T-cells |
| Group 1: Boost | Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Gag-1-PTEg | 0.06 % CD4+ T-cells |
| Group 1: Boost | Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Gag-2-PTEg | 0.039 % CD4+ T-cells |
| Group 2: Boost | Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Any Gag PTEg | 0.054 % CD4+ T-cells |
| Group 2: Boost | Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Gag-1-PTEg | 0.054 % CD4+ T-cells |
| Group 2: Boost | Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Env-3-PTEg | 0.008 % CD4+ T-cells |
| Group 2: Boost | Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Any PTEg | 0.129 % CD4+ T-cells |
| Group 2: Boost | Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Any Env PTEg | 0.074 % CD4+ T-cells |
| Group 2: Boost | Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Env-1-PTEg | 0.057 % CD4+ T-cells |
| Group 2: Boost | Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Gag-2-PTEg | 0.011 % CD4+ T-cells |
| Group 2: Boost | Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Env-2-PTEg | 0.036 % CD4+ T-cells |
| Group 3: Boost | Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Any PTEg | 0.218 % CD4+ T-cells |
| Group 3: Boost | Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Any Gag PTEg | 0.163 % CD4+ T-cells |
| Group 3: Boost | Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Any Env PTEg | 0.048 % CD4+ T-cells |
| Group 3: Boost | Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Gag-2-PTEg | 0.068 % CD4+ T-cells |
| Group 3: Boost | Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Env-1-PTEg | 0.043 % CD4+ T-cells |
| Group 3: Boost | Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Env-2-PTEg | 0.029 % CD4+ T-cells |
| Group 3: Boost | Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Env-3-PTEg | 0.025 % CD4+ T-cells |
| Group 3: Boost | Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Gag-1-PTEg | 0.163 % CD4+ T-cells |
| Group 4: Boost | Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Env-1-PTEg | 0.093 % CD4+ T-cells |
| Group 4: Boost | Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Any PTEg | 0.338 % CD4+ T-cells |
| Group 4: Boost | Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Any Gag PTEg | 0.196 % CD4+ T-cells |
| Group 4: Boost | Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Env-3-PTEg | 0.07 % CD4+ T-cells |
| Group 4: Boost | Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Gag-2-PTEg | 0.134 % CD4+ T-cells |
| Group 4: Boost | Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Any Env PTEg | 0.142 % CD4+ T-cells |
| Group 4: Boost | Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Env-2-PTEg | 0.057 % CD4+ T-cells |
| Group 4: Boost | Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Gag-1-PTEg | 0.196 % CD4+ T-cells |
| Group 5: Boost | Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Env-2-PTEg | 0.077 % CD4+ T-cells |
| Group 5: Boost | Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Any Gag PTEg | 0.015 % CD4+ T-cells |
| Group 5: Boost | Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Any Env PTEg | 0.083 % CD4+ T-cells |
| Group 5: Boost | Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Any PTEg | 0.085 % CD4+ T-cells |
| Group 5: Boost | Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Env-1-PTEg | 0.045 % CD4+ T-cells |
| Group 5: Boost | Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Gag-2-PTEg | 0.002 % CD4+ T-cells |
| Group 5: Boost | Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Env-3-PTEg | 0.031 % CD4+ T-cells |
| Group 5: Boost | Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Gag-1-PTEg | 0.015 % CD4+ T-cells |
| Group 6: Boost | Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Env-2-PTEg | 0.032 % CD4+ T-cells |
| Group 6: Boost | Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Gag-2-PTEg | 0.059 % CD4+ T-cells |
| Group 6: Boost | Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Env-1-PTEg | 0.033 % CD4+ T-cells |
| Group 6: Boost | Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Any PTEg | 0.142 % CD4+ T-cells |
| Group 6: Boost | Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Any Gag PTEg | 0.108 % CD4+ T-cells |
| Group 6: Boost | Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Any Env PTEg | 0.04 % CD4+ T-cells |
| Group 6: Boost | Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Gag-1-PTEg | 0.108 % CD4+ T-cells |
| Group 6: Boost | Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Env-3-PTEg | 0.01 % CD4+ T-cells |
| Group 7: Boost | Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Any Env PTEg | 0.082 % CD4+ T-cells |
| Group 7: Boost | Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Env-3-PTEg | 0.037 % CD4+ T-cells |
| Group 7: Boost | Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Env-1-PTEg | 0.075 % CD4+ T-cells |
| Group 7: Boost | Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Gag-1-PTEg | 0.062 % CD4+ T-cells |
| Group 7: Boost | Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Gag-2-PTEg | 0.017 % CD4+ T-cells |
| Group 7: Boost | Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Any PTEg | 0.138 % CD4+ T-cells |
| Group 7: Boost | Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Any Gag PTEg | 0.062 % CD4+ T-cells |
| Group 7: Boost | Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Env-2-PTEg | 0.049 % CD4+ T-cells |
Secondary
Level of CD8+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost
PBMC samples are stimulated with synthetic peptide pools or left unstimulated as a negative control. For each sample, T-cell subset, and peptide pool, response magnitude is % cells expressing markers after peptide stimulation minus % cells expressing markers after no stimulation. A contingency table is constructed to assess response: stimulation (peptide/none) vs. marker expression (yes/no). A one-sided Fisher's exact test is applied, testing if the number of cells positive for the marker is equal in the stimulated vs. unstimulated cells. A discrete Bonferroni adjustment is made over the peptide pools. Response is positive if p\<=0.00001. Data are excluded if the blood draw date was outside the visit window, the participant was HIV-infected, PBMC viability or T-cell count were low, or negative control was high. The responses at month 0.5 was not assayed.
Time frame: Measured at Month 4.5
Population: Overall Number of Participants Analyzed includes the HIV uninfected participants with samples collected at the month 4.5 immunogenicity timepoint. Number Analyzed shows the number of participants with available data after filtering for assay-specific quality control criteria.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Group 1: Boost | Level of CD8+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Any PTEg | 0.02 % CD8+ T-cells |
| Group 1: Boost | Level of CD8+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Any Gag PTEg | 0.011 % CD8+ T-cells |
| Group 1: Boost | Level of CD8+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Any Env PTEg | 0.008 % CD8+ T-cells |
| Group 1: Boost | Level of CD8+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Env-1-PTEg | -0.003 % CD8+ T-cells |
| Group 1: Boost | Level of CD8+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Env-2-PTEg | 0.008 % CD8+ T-cells |
| Group 1: Boost | Level of CD8+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Env-3-PTEg | 0.004 % CD8+ T-cells |
| Group 1: Boost | Level of CD8+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Gag-1-PTEg | 0.011 % CD8+ T-cells |
| Group 1: Boost | Level of CD8+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Gag-2-PTEg | 0.011 % CD8+ T-cells |
| Group 2: Boost | Level of CD8+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Any Gag PTEg | 0.006 % CD8+ T-cells |
| Group 2: Boost | Level of CD8+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Gag-2-PTEg | -0.003 % CD8+ T-cells |
| Group 2: Boost | Level of CD8+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Any PTEg | 0.009 % CD8+ T-cells |
| Group 2: Boost | Level of CD8+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Env-1-PTEg | 0.001 % CD8+ T-cells |
| Group 2: Boost | Level of CD8+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Env-2-PTEg | 0.006 % CD8+ T-cells |
| Group 2: Boost | Level of CD8+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Env-3-PTEg | -0.002 % CD8+ T-cells |
| Group 2: Boost | Level of CD8+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Gag-1-PTEg | 0.006 % CD8+ T-cells |
| Group 2: Boost | Level of CD8+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Any Env PTEg | 0.006 % CD8+ T-cells |
| Group 3: Boost | Level of CD8+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Any PTEg | 0.013 % CD8+ T-cells |
| Group 3: Boost | Level of CD8+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Gag-2-PTEg | 0 % CD8+ T-cells |
| Group 3: Boost | Level of CD8+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Env-1-PTEg | -0.005 % CD8+ T-cells |
| Group 3: Boost | Level of CD8+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Env-2-PTEg | 0.003 % CD8+ T-cells |
| Group 3: Boost | Level of CD8+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Env-3-PTEg | -0.003 % CD8+ T-cells |
| Group 3: Boost | Level of CD8+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Gag-1-PTEg | 0 % CD8+ T-cells |
| Group 3: Boost | Level of CD8+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Any Gag PTEg | 0.004 % CD8+ T-cells |
| Group 3: Boost | Level of CD8+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Any Env PTEg | 0.004 % CD8+ T-cells |
| Group 4: Boost | Level of CD8+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Env-1-PTEg | -0.002 % CD8+ T-cells |
| Group 4: Boost | Level of CD8+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Gag-2-PTEg | 0.001 % CD8+ T-cells |
| Group 4: Boost | Level of CD8+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Env-2-PTEg | 0.01 % CD8+ T-cells |
| Group 4: Boost | Level of CD8+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Env-3-PTEg | -0.001 % CD8+ T-cells |
| Group 4: Boost | Level of CD8+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Gag-1-PTEg | 0.004 % CD8+ T-cells |
| Group 4: Boost | Level of CD8+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Any PTEg | 0.031 % CD8+ T-cells |
| Group 4: Boost | Level of CD8+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Any Env PTEg | 0.015 % CD8+ T-cells |
| Group 4: Boost | Level of CD8+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Any Gag PTEg | 0.005 % CD8+ T-cells |
| Group 5: Boost | Level of CD8+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Env-2-PTEg | 0.002 % CD8+ T-cells |
| Group 5: Boost | Level of CD8+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Gag-2-PTEg | -0.006 % CD8+ T-cells |
| Group 5: Boost | Level of CD8+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Env-3-PTEg | -0.005 % CD8+ T-cells |
| Group 5: Boost | Level of CD8+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Gag-1-PTEg | -0.001 % CD8+ T-cells |
| Group 5: Boost | Level of CD8+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Env-1-PTEg | -0.005 % CD8+ T-cells |
| Group 5: Boost | Level of CD8+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Any Env PTEg | 0.002 % CD8+ T-cells |
| Group 5: Boost | Level of CD8+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Any Gag PTEg | 0 % CD8+ T-cells |
| Group 5: Boost | Level of CD8+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Any PTEg | 0.002 % CD8+ T-cells |
| Group 6: Boost | Level of CD8+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Env-3-PTEg | -0.003 % CD8+ T-cells |
| Group 6: Boost | Level of CD8+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Gag-2-PTEg | 0.001 % CD8+ T-cells |
| Group 6: Boost | Level of CD8+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Gag-1-PTEg | 0.002 % CD8+ T-cells |
| Group 6: Boost | Level of CD8+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Env-2-PTEg | 0.003 % CD8+ T-cells |
| Group 6: Boost | Level of CD8+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Any Env PTEg | 0.005 % CD8+ T-cells |
| Group 6: Boost | Level of CD8+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Any Gag PTEg | 0.006 % CD8+ T-cells |
| Group 6: Boost | Level of CD8+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Any PTEg | 0.018 % CD8+ T-cells |
| Group 6: Boost | Level of CD8+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Env-1-PTEg | -0.003 % CD8+ T-cells |
| Group 7: Boost | Level of CD8+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Gag-1-PTEg | 0.006 % CD8+ T-cells |
| Group 7: Boost | Level of CD8+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Env-3-PTEg | -0.001 % CD8+ T-cells |
| Group 7: Boost | Level of CD8+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Gag-2-PTEg | -0.001 % CD8+ T-cells |
| Group 7: Boost | Level of CD8+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Any Env PTEg | 0.01 % CD8+ T-cells |
| Group 7: Boost | Level of CD8+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Any Gag PTEg | 0.006 % CD8+ T-cells |
| Group 7: Boost | Level of CD8+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Any PTEg | 0.02 % CD8+ T-cells |
| Group 7: Boost | Level of CD8+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Env-1-PTEg | -0.002 % CD8+ T-cells |
| Group 7: Boost | Level of CD8+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Env-2-PTEg | 0.01 % CD8+ T-cells |
Secondary
Level of Env-specific IgG Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 6 Months After the Final Boost
Serum HIV-1-specific IgG responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay. 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 less than 1 is set to 1. The measure unit fluorescence units are relative to assay background, not relative to the placebo arm. Background is used here rather than negative control stimulation, since the antigens are used as bead coating rather than stimulation. The responses to the IDR of gp41 was not assayed.
Time frame: Measured at Month 10
Population: Overall Number of Participants Analyzed includes the HIV uninfected participants with samples collected at the month 10 immunogenicity timepoint. Number Analyzed shows the number of participants with available data after filtering for assay-specific quality control criteria.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Group 1: Boost | Level of Env-specific IgG Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 6 Months After the Final Boost | Con 6 gp120/B at Month 10 | 19 fluorescence unit relative to background |
| Group 1: Boost | Level of Env-specific IgG Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 6 Months After the Final Boost | gp70_B.CaseA_V1_V2 at Month 10 | 1 fluorescence unit relative to background |
| Group 1: Boost | Level of Env-specific IgG Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 6 Months After the Final Boost | gp41 at Month 10 | 7121.875 fluorescence unit relative to background |
| Group 1: Boost | Level of Env-specific IgG Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 6 Months After the Final Boost | Con S gp140 CFI at Month 10 | 6233.25 fluorescence unit relative to background |
| Group 2: Boost | Level of Env-specific IgG Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 6 Months After the Final Boost | Con S gp140 CFI at Month 10 | 5508 fluorescence unit relative to background |
| Group 2: Boost | Level of Env-specific IgG Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 6 Months After the Final Boost | gp70_B.CaseA_V1_V2 at Month 10 | 132.875 fluorescence unit relative to background |
| Group 2: Boost | Level of Env-specific IgG Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 6 Months After the Final Boost | Con 6 gp120/B at Month 10 | 443.5 fluorescence unit relative to background |
| Group 2: Boost | Level of Env-specific IgG Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 6 Months After the Final Boost | gp41 at Month 10 | 15477.25 fluorescence unit relative to background |
| Group 3: Boost | Level of Env-specific IgG Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 6 Months After the Final Boost | gp70_B.CaseA_V1_V2 at Month 10 | 1 fluorescence unit relative to background |
| Group 3: Boost | Level of Env-specific IgG Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 6 Months After the Final Boost | Con S gp140 CFI at Month 10 | 9032.375 fluorescence unit relative to background |
| Group 3: Boost | Level of Env-specific IgG Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 6 Months After the Final Boost | gp41 at Month 10 | 9732 fluorescence unit relative to background |
| Group 3: Boost | Level of Env-specific IgG Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 6 Months After the Final Boost | Con 6 gp120/B at Month 10 | 26.25 fluorescence unit relative to background |
| Group 4: Boost | Level of Env-specific IgG Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 6 Months After the Final Boost | Con S gp140 CFI at Month 10 | 13888.25 fluorescence unit relative to background |
| Group 4: Boost | Level of Env-specific IgG Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 6 Months After the Final Boost | Con 6 gp120/B at Month 10 | 2206.25 fluorescence unit relative to background |
| Group 4: Boost | Level of Env-specific IgG Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 6 Months After the Final Boost | gp41 at Month 10 | 14437.5 fluorescence unit relative to background |
| Group 4: Boost | Level of Env-specific IgG Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 6 Months After the Final Boost | gp70_B.CaseA_V1_V2 at Month 10 | 14.25 fluorescence unit relative to background |
| Group 5: Boost | Level of Env-specific IgG Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 6 Months After the Final Boost | gp70_B.CaseA_V1_V2 at Month 10 | 2.5 fluorescence unit relative to background |
| Group 5: Boost | Level of Env-specific IgG Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 6 Months After the Final Boost | Con S gp140 CFI at Month 10 | 8258.5 fluorescence unit relative to background |
| Group 5: Boost | Level of Env-specific IgG Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 6 Months After the Final Boost | Con 6 gp120/B at Month 10 | 758.25 fluorescence unit relative to background |
| Group 5: Boost | Level of Env-specific IgG Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 6 Months After the Final Boost | gp41 at Month 10 | 492.5 fluorescence unit relative to background |
| Group 6: Boost | Level of Env-specific IgG Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 6 Months After the Final Boost | Con 6 gp120/B at Month 10 | 26.25 fluorescence unit relative to background |
| Group 6: Boost | Level of Env-specific IgG Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 6 Months After the Final Boost | gp41 at Month 10 | 7995.875 fluorescence unit relative to background |
| Group 6: Boost | Level of Env-specific IgG Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 6 Months After the Final Boost | Con S gp140 CFI at Month 10 | 8910 fluorescence unit relative to background |
| Group 6: Boost | Level of Env-specific IgG Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 6 Months After the Final Boost | gp70_B.CaseA_V1_V2 at Month 10 | 1 fluorescence unit relative to background |
| Group 7: Boost | Level of Env-specific IgG Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 6 Months After the Final Boost | gp70_B.CaseA_V1_V2 at Month 10 | 14.25 fluorescence unit relative to background |
| Group 7: Boost | Level of Env-specific IgG Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 6 Months After the Final Boost | Con 6 gp120/B at Month 10 | 718.25 fluorescence unit relative to background |
| Group 7: Boost | Level of Env-specific IgG Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 6 Months After the Final Boost | Con S gp140 CFI at Month 10 | 13564.75 fluorescence unit relative to background |
| Group 7: Boost | Level of Env-specific IgG Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 6 Months After the Final Boost | gp41 at Month 10 | 14437.5 fluorescence unit relative to background |
Secondary
Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost
PBMC samples are stimulated with synthetic peptide pools or left unstimulated as a negative control. For each sample, T-cell subset, and peptide pool, response magnitude is % cells expressing markers after peptide stimulation minus % cells expressing markers after no stimulation. Response positivity is derived by testing if the number of cells expressing the marker is equal in the stimulated vs. unstimulated cells. Response is positive if the one-sided Fisher's exact test (discrete Bonferroni adjustment over the peptide pools) p\<=0.00001. The Fisher's exact test is not applied to compare between endpoints. Data are excluded if the blood draw date was outside the visit window, the participant was HIV-infected, PBMC viability or T-cell count were low, or negative control was high. The responses at month 0.5 was not assayed.
Time frame: Measured at Month 4.5
Population: Overall Number of Participants Analyzed includes the HIV uninfected participants with samples collected at the month 4.5 immunogenicity timepoint. Number Analyzed shows the number of participants with available data after filtering for assay-specific quality control criteria.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1: Boost | Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Any PTEg | 2 Participants |
| Group 1: Boost | Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Any Gag PTEg | 2 Participants |
| Group 1: Boost | Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Any Env PTEg | 0 Participants |
| Group 1: Boost | Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Env-1-PTEg | 0 Participants |
| Group 1: Boost | Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Env-2-PTEg | 0 Participants |
| Group 1: Boost | Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Env-3-PTEg | 0 Participants |
| Group 1: Boost | Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Gag-1-PTEg | 2 Participants |
| Group 1: Boost | Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Gag-2-PTEg | 0 Participants |
| Group 2: Boost | Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Any Gag PTEg | 2 Participants |
| Group 2: Boost | Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Gag-2-PTEg | 0 Participants |
| Group 2: Boost | Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Any PTEg | 2 Participants |
| Group 2: Boost | Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Env-1-PTEg | 2 Participants |
| Group 2: Boost | Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Env-2-PTEg | 0 Participants |
| Group 2: Boost | Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Env-3-PTEg | 1 Participants |
| Group 2: Boost | Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Gag-1-PTEg | 2 Participants |
| Group 2: Boost | Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Any Env PTEg | 2 Participants |
| Group 3: Boost | Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Any PTEg | 6 Participants |
| Group 3: Boost | Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Gag-2-PTEg | 3 Participants |
| Group 3: Boost | Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Env-1-PTEg | 2 Participants |
| Group 3: Boost | Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Env-2-PTEg | 1 Participants |
| Group 3: Boost | Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Env-3-PTEg | 0 Participants |
| Group 3: Boost | Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Gag-1-PTEg | 6 Participants |
| Group 3: Boost | Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Any Gag PTEg | 6 Participants |
| Group 3: Boost | Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Any Env PTEg | 2 Participants |
| Group 4: Boost | Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Env-1-PTEg | 5 Participants |
| Group 4: Boost | Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Gag-2-PTEg | 4 Participants |
| Group 4: Boost | Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Env-2-PTEg | 3 Participants |
| Group 4: Boost | Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Env-3-PTEg | 3 Participants |
| Group 4: Boost | Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Gag-1-PTEg | 5 Participants |
| Group 4: Boost | Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Any PTEg | 5 Participants |
| Group 4: Boost | Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Any Env PTEg | 5 Participants |
| Group 4: Boost | Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Any Gag PTEg | 5 Participants |
| Group 5: Boost | Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Env-2-PTEg | 3 Participants |
| Group 5: Boost | Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Gag-2-PTEg | 0 Participants |
| Group 5: Boost | Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Env-3-PTEg | 1 Participants |
| Group 5: Boost | Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Gag-1-PTEg | 1 Participants |
| Group 5: Boost | Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Env-1-PTEg | 3 Participants |
| Group 5: Boost | Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Any Env PTEg | 4 Participants |
| Group 5: Boost | Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Any Gag PTEg | 1 Participants |
| Group 5: Boost | Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Any PTEg | 4 Participants |
| Group 6: Boost | Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Env-3-PTEg | 0 Participants |
| Group 6: Boost | Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Gag-2-PTEg | 3 Participants |
| Group 6: Boost | Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Gag-1-PTEg | 8 Participants |
| Group 6: Boost | Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Env-2-PTEg | 1 Participants |
| Group 6: Boost | Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Any Env PTEg | 2 Participants |
| Group 6: Boost | Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Any Gag PTEg | 8 Participants |
| Group 6: Boost | Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Any PTEg | 8 Participants |
| Group 6: Boost | Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Env-1-PTEg | 2 Participants |
| Group 7: Boost | Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Gag-1-PTEg | 7 Participants |
| Group 7: Boost | Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Env-3-PTEg | 4 Participants |
| Group 7: Boost | Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Gag-2-PTEg | 4 Participants |
| Group 7: Boost | Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Any Env PTEg | 7 Participants |
| Group 7: Boost | Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Any Gag PTEg | 7 Participants |
| Group 7: Boost | Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Any PTEg | 7 Participants |
| Group 7: Boost | Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Env-1-PTEg | 7 Participants |
| Group 7: Boost | Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Env-2-PTEg | 3 Participants |
Secondary
Occurrence of CD8+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost
PBMC samples are stimulated with synthetic peptide pools or left unstimulated as a negative control. For each sample, T-cell subset, and peptide pool, response magnitude is % cells expressing markers after peptide stimulation minus % cells expressing markers after no stimulation. A contingency table is constructed to assess response: stimulation (peptide/none) vs. marker expression (yes/no). A one-sided Fisher's exact test is applied, testing if the number of cells positive for the marker is equal in the stimulated vs. unstimulated cells. A discrete Bonferroni adjustment is made over the peptide pools. Response is positive if p\<=0.00001. Data are excluded if the blood draw date was outside the visit window, the participant was HIV-infected, PBMC viability or T-cell count were low, or negative control was high. The responses at month 0.5 was not assayed.
Time frame: Measured at Month 4.5
Population: Overall Number of Participants Analyzed includes the HIV uninfected participants with samples collected at the month 4.5 immunogenicity timepoint. Number Analyzed shows the number of participants with available data after filtering for assay-specific quality control criteria.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1: Boost | Occurrence of CD8+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Any PTEg | 1 Participants |
| Group 1: Boost | Occurrence of CD8+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Any Gag PTEg | 1 Participants |
| Group 1: Boost | Occurrence of CD8+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Any Env PTEg | 0 Participants |
| Group 1: Boost | Occurrence of CD8+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Env-1-PTEg | 0 Participants |
| Group 1: Boost | Occurrence of CD8+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Env-2-PTEg | 0 Participants |
| Group 1: Boost | Occurrence of CD8+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Env-3-PTEg | 0 Participants |
| Group 1: Boost | Occurrence of CD8+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Gag-1-PTEg | 1 Participants |
| Group 1: Boost | Occurrence of CD8+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Gag-2-PTEg | 1 Participants |
| Group 2: Boost | Occurrence of CD8+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Any Gag PTEg | 0 Participants |
| Group 2: Boost | Occurrence of CD8+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Gag-2-PTEg | 0 Participants |
| Group 2: Boost | Occurrence of CD8+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Any PTEg | 0 Participants |
| Group 2: Boost | Occurrence of CD8+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Env-1-PTEg | 0 Participants |
| Group 2: Boost | Occurrence of CD8+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Env-2-PTEg | 0 Participants |
| Group 2: Boost | Occurrence of CD8+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Env-3-PTEg | 0 Participants |
| Group 2: Boost | Occurrence of CD8+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Gag-1-PTEg | 0 Participants |
| Group 2: Boost | Occurrence of CD8+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Any Env PTEg | 0 Participants |
| Group 3: Boost | Occurrence of CD8+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Any PTEg | 0 Participants |
| Group 3: Boost | Occurrence of CD8+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Gag-2-PTEg | 0 Participants |
| Group 3: Boost | Occurrence of CD8+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Env-1-PTEg | 0 Participants |
| Group 3: Boost | Occurrence of CD8+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Env-2-PTEg | 0 Participants |
| Group 3: Boost | Occurrence of CD8+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Env-3-PTEg | 0 Participants |
| Group 3: Boost | Occurrence of CD8+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Gag-1-PTEg | 0 Participants |
| Group 3: Boost | Occurrence of CD8+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Any Gag PTEg | 0 Participants |
| Group 3: Boost | Occurrence of CD8+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Any Env PTEg | 0 Participants |
| Group 4: Boost | Occurrence of CD8+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Env-1-PTEg | 0 Participants |
| Group 4: Boost | Occurrence of CD8+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Gag-2-PTEg | 0 Participants |
| Group 4: Boost | Occurrence of CD8+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Env-2-PTEg | 1 Participants |
| Group 4: Boost | Occurrence of CD8+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Env-3-PTEg | 0 Participants |
| Group 4: Boost | Occurrence of CD8+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Gag-1-PTEg | 1 Participants |
| Group 4: Boost | Occurrence of CD8+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Any PTEg | 2 Participants |
| Group 4: Boost | Occurrence of CD8+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Any Env PTEg | 1 Participants |
| Group 4: Boost | Occurrence of CD8+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Any Gag PTEg | 1 Participants |
| Group 5: Boost | Occurrence of CD8+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Env-2-PTEg | 0 Participants |
| Group 5: Boost | Occurrence of CD8+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Gag-2-PTEg | 0 Participants |
| Group 5: Boost | Occurrence of CD8+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Env-3-PTEg | 0 Participants |
| Group 5: Boost | Occurrence of CD8+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Gag-1-PTEg | 0 Participants |
| Group 5: Boost | Occurrence of CD8+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Env-1-PTEg | 0 Participants |
| Group 5: Boost | Occurrence of CD8+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Any Env PTEg | 0 Participants |
| Group 5: Boost | Occurrence of CD8+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Any Gag PTEg | 0 Participants |
| Group 5: Boost | Occurrence of CD8+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Any PTEg | 0 Participants |
| Group 6: Boost | Occurrence of CD8+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Env-3-PTEg | 0 Participants |
| Group 6: Boost | Occurrence of CD8+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Gag-2-PTEg | 1 Participants |
| Group 6: Boost | Occurrence of CD8+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Gag-1-PTEg | 1 Participants |
| Group 6: Boost | Occurrence of CD8+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Env-2-PTEg | 0 Participants |
| Group 6: Boost | Occurrence of CD8+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Any Env PTEg | 0 Participants |
| Group 6: Boost | Occurrence of CD8+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Any Gag PTEg | 1 Participants |
| Group 6: Boost | Occurrence of CD8+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Any PTEg | 1 Participants |
| Group 6: Boost | Occurrence of CD8+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Env-1-PTEg | 0 Participants |
| Group 7: Boost | Occurrence of CD8+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Gag-1-PTEg | 1 Participants |
| Group 7: Boost | Occurrence of CD8+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Env-3-PTEg | 0 Participants |
| Group 7: Boost | Occurrence of CD8+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Gag-2-PTEg | 0 Participants |
| Group 7: Boost | Occurrence of CD8+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Any Env PTEg | 1 Participants |
| Group 7: Boost | Occurrence of CD8+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Any Gag PTEg | 1 Participants |
| Group 7: Boost | Occurrence of CD8+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Any PTEg | 2 Participants |
| Group 7: Boost | Occurrence of CD8+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Env-1-PTEg | 0 Participants |
| Group 7: Boost | Occurrence of CD8+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | Env-2-PTEg | 1 Participants |
Secondary
Occurrence of Env-specific IgG Responses for gp120, gp140, V1/V2, and the IDR of gp41 at 6 Months After the Final Boost
Serum HIV-1-specific IgG responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay. 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 less than 1 is set to 1. The measure unit fluorescence units are relative to assay background, not relative to the placebo arm. Background is used here rather than negative control stimulation, since the antigens are used as bead coating rather than stimulation. The responses to the IDR of gp41 was not assayed.
Time frame: Measured at Month 10
Population: Overall Number of Participants Analyzed includes the HIV uninfected participants with samples collected at the month 10 immunogenicity timepoint. Number Analyzed shows the number of participants with available data after filtering for assay-specific quality control criteria.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1: Boost | Occurrence of Env-specific IgG Responses for gp120, gp140, V1/V2, and the IDR of gp41 at 6 Months After the Final Boost | Con 6 gp120/B at Month 10 | 0 Participants |
| Group 1: Boost | Occurrence of Env-specific IgG Responses for gp120, gp140, V1/V2, and the IDR of gp41 at 6 Months After the Final Boost | Con S gp140 CFI at Month 10 | 2 Participants |
| Group 1: Boost | Occurrence of Env-specific IgG Responses for gp120, gp140, V1/V2, and the IDR of gp41 at 6 Months After the Final Boost | gp41 at Month 10 | 2 Participants |
| Group 1: Boost | Occurrence of Env-specific IgG Responses for gp120, gp140, V1/V2, and the IDR of gp41 at 6 Months After the Final Boost | gp70_B.CaseA_V1_V2 at Month 10 | 0 Participants |
| Group 2: Boost | Occurrence of Env-specific IgG Responses for gp120, gp140, V1/V2, and the IDR of gp41 at 6 Months After the Final Boost | gp70_B.CaseA_V1_V2 at Month 10 | 1 Participants |
| Group 2: Boost | Occurrence of Env-specific IgG Responses for gp120, gp140, V1/V2, and the IDR of gp41 at 6 Months After the Final Boost | gp41 at Month 10 | 2 Participants |
| Group 2: Boost | Occurrence of Env-specific IgG Responses for gp120, gp140, V1/V2, and the IDR of gp41 at 6 Months After the Final Boost | Con 6 gp120/B at Month 10 | 1 Participants |
| Group 2: Boost | Occurrence of Env-specific IgG Responses for gp120, gp140, V1/V2, and the IDR of gp41 at 6 Months After the Final Boost | Con S gp140 CFI at Month 10 | 2 Participants |
| Group 3: Boost | Occurrence of Env-specific IgG Responses for gp120, gp140, V1/V2, and the IDR of gp41 at 6 Months After the Final Boost | gp41 at Month 10 | 3 Participants |
| Group 3: Boost | Occurrence of Env-specific IgG Responses for gp120, gp140, V1/V2, and the IDR of gp41 at 6 Months After the Final Boost | Con S gp140 CFI at Month 10 | 4 Participants |
| Group 3: Boost | Occurrence of Env-specific IgG Responses for gp120, gp140, V1/V2, and the IDR of gp41 at 6 Months After the Final Boost | Con 6 gp120/B at Month 10 | 0 Participants |
| Group 3: Boost | Occurrence of Env-specific IgG Responses for gp120, gp140, V1/V2, and the IDR of gp41 at 6 Months After the Final Boost | gp70_B.CaseA_V1_V2 at Month 10 | 0 Participants |
| Group 4: Boost | Occurrence of Env-specific IgG Responses for gp120, gp140, V1/V2, and the IDR of gp41 at 6 Months After the Final Boost | Con 6 gp120/B at Month 10 | 3 Participants |
| Group 4: Boost | Occurrence of Env-specific IgG Responses for gp120, gp140, V1/V2, and the IDR of gp41 at 6 Months After the Final Boost | Con S gp140 CFI at Month 10 | 3 Participants |
| Group 4: Boost | Occurrence of Env-specific IgG Responses for gp120, gp140, V1/V2, and the IDR of gp41 at 6 Months After the Final Boost | gp41 at Month 10 | 2 Participants |
| Group 4: Boost | Occurrence of Env-specific IgG Responses for gp120, gp140, V1/V2, and the IDR of gp41 at 6 Months After the Final Boost | gp70_B.CaseA_V1_V2 at Month 10 | 1 Participants |
| Group 5: Boost | Occurrence of Env-specific IgG Responses for gp120, gp140, V1/V2, and the IDR of gp41 at 6 Months After the Final Boost | Con 6 gp120/B at Month 10 | 6 Participants |
| Group 5: Boost | Occurrence of Env-specific IgG Responses for gp120, gp140, V1/V2, and the IDR of gp41 at 6 Months After the Final Boost | gp70_B.CaseA_V1_V2 at Month 10 | 1 Participants |
| Group 5: Boost | Occurrence of Env-specific IgG Responses for gp120, gp140, V1/V2, and the IDR of gp41 at 6 Months After the Final Boost | Con S gp140 CFI at Month 10 | 7 Participants |
| Group 5: Boost | Occurrence of Env-specific IgG Responses for gp120, gp140, V1/V2, and the IDR of gp41 at 6 Months After the Final Boost | gp41 at Month 10 | 0 Participants |
| Group 6: Boost | Occurrence of Env-specific IgG Responses for gp120, gp140, V1/V2, and the IDR of gp41 at 6 Months After the Final Boost | Con S gp140 CFI at Month 10 | 6 Participants |
| Group 6: Boost | Occurrence of Env-specific IgG Responses for gp120, gp140, V1/V2, and the IDR of gp41 at 6 Months After the Final Boost | Con 6 gp120/B at Month 10 | 0 Participants |
| Group 6: Boost | Occurrence of Env-specific IgG Responses for gp120, gp140, V1/V2, and the IDR of gp41 at 6 Months After the Final Boost | gp41 at Month 10 | 5 Participants |
| Group 6: Boost | Occurrence of Env-specific IgG Responses for gp120, gp140, V1/V2, and the IDR of gp41 at 6 Months After the Final Boost | gp70_B.CaseA_V1_V2 at Month 10 | 0 Participants |
| Group 7: Boost | Occurrence of Env-specific IgG Responses for gp120, gp140, V1/V2, and the IDR of gp41 at 6 Months After the Final Boost | gp41 at Month 10 | 4 Participants |
| Group 7: Boost | Occurrence of Env-specific IgG Responses for gp120, gp140, V1/V2, and the IDR of gp41 at 6 Months After the Final Boost | Con 6 gp120/B at Month 10 | 4 Participants |
| Group 7: Boost | Occurrence of Env-specific IgG Responses for gp120, gp140, V1/V2, and the IDR of gp41 at 6 Months After the Final Boost | Con S gp140 CFI at Month 10 | 5 Participants |
| Group 7: Boost | Occurrence of Env-specific IgG Responses for gp120, gp140, V1/V2, and the IDR of gp41 at 6 Months After the Final Boost | gp70_B.CaseA_V1_V2 at Month 10 | 2 Participants |