HIV Infection
Conditions
Keywords
HIV, AIDS, Vaccine
Brief summary
The HIV Vaccine Trials Network (HVTN) is doing a study to test a new HIV vaccine combination. HIV is the virus that causes AIDS. 252 people are taking part in this study at multiple sites. The US National Institutes of Health (NIH) is paying for the study. The investigators are doing this study to answer several questions. * Are the study vaccines safe to give to people? * Are people able to take the study vaccines without becoming too uncomfortable? * How do people's immune systems respond to the study vaccines? (Your immune system protects you from disease.)
Detailed description
The HIV Vaccine Trials Network (HVTN) is doing a study to test a new HIV vaccine combination. HIV is the virus that causes AIDS. The investigators are doing this study to answer several questions: * Are the study vaccines safe to give to people? * Are people able to take the study vaccines without becoming too uncomfortable? * How do people's immune systems respond to the study vaccines? (Your immune system protects you from disease.) The study uses 2 different vaccines: ALVAC-HIV (vCP2438) and bivalent gp120/MF59. These are experimental HIV vaccines -- the investigators do not know whether the vaccines will be safe to use in people, or whether they will work to prevent HIV infection. These vaccines are used only in research studies. The ALVAC vaccine is made out of canarypox virus, which infects birds but cannot grow in human cells. This virus has small bits of man-made DNA inserted into it. DNA is a natural substance found in all living things, including people and some viruses. The canarypox virus helps get the DNA into the body's cells. The DNA then tells those cells to make small amounts of proteins that look like some of the ones found in HIV. A study in South Africa, HVTN 097, gave a similar ALVAC vaccine to about 80 participants. So far, no one has had serious health problems. The Protein vaccine has man-made pieces of a protein found on the outside of HIV. These protein pieces are mixed with an adjuvant called MF59. An adjuvant is something added to the vaccine to help the immune system respond better. MF59 has been included with other vaccines that have been given to over 50,000 people in clinical trials without causing any serious health problems. This combination of study vaccines has not been given to people before. However, similar ALVAC and protein vaccines have been given to more than 10,000 people in clinical trials without causing any serious health problems. Also, over 300 people have received a similar combination of ALVAC and protein vaccines with the MF59 adjuvant in clinical trials without having any serious health problems. The study is in 2 parts, Part A and Part B. Part B continues the study in order to learn how well boosting the study vaccines improves immune responses. 252 people took part in Part A of this study at multiple sites. Those who continue to meet eligibility requirements are invited to continue in Part B. The US National Institutes of Health (NIH) is paying for the study. For people who continue to Part B, the study requires about 23 clinic visits in 4 years.
Interventions
BIOLOGICALALVAC-HIV
a lyophilized vaccine for injection at a viral titer ≥ 1 × 10E6 cell culture infectious dose (CCID)50 and \< 1 × 10E8 CCID50 (nominal dose of 10E7 CCID50) and is reconstituted with 1mL of sterile sodium chloride solution (NaCl 0.4%) for intramuscular (IM) injection as a single dose.
BIOLOGICALBivalent Subtype C gp120/MF59®
2 recombinant monomeric proteins, each at a dose of 100 mcg, mixed with MF59® adjuvant (an oil-in-water emulsion) delivered as a 0.5 mL IM injection
BIOLOGICALALVAC-HIV (vCP2438) Placebo
a sterile, lyophilized product that consists of a mixture of virus stabilizer, and freeze drying medium and is reconstituted with 1mL of sterile sodium chloride solution (NaCl 0.4%) for injection as a single dose IM
BIOLOGICALBivalent gp120/MF59® Placebo
Sodium chloride for injection, 0,9% delivered as a 0.5 mL IM injection
Sponsors
HIV Vaccine Trials Network
Bill and Melinda Gates Foundation
Medical Research Council
Sanofi Pasteur, a Sanofi Company
GlaxoSmithKline
National Institute of Allergy and Infectious Diseases (NIAID)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* Age of 18 to 40 years * Access to a participating HVTN CRS and willingness to be followed for the planned duration of the study * Ability and willingness to provide informed consent * Assessment of understanding: volunteer demonstrates understanding of this study; completes a questionnaire prior to first vaccination with verbal demonstration of understanding of all questionnaire items answered incorrectly * 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 * 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 (per Low Risk Guidelines for South African sites) and committed to maintaining behavior consistent with low risk of HIV exposure through the last required protocol clinic visit * Hemoglobin ≥ 11.0 g/dL for volunteers who were born female, ≥ 13.0 g/dL for volunteers who were born male * WBC = 3,300 to 12,000 cells/mm3 * Total lymphocyte count ≥ 800 cells/mm3 * Remaining differential either within institutional normal range or with site physician approval * Platelets = 125,000 to 550,000/mm3 * Chemistry panel: ALT, AST, and ALP \< 1.25 times the institutional upper limit of normal; creatinine ≤ institutional upper limit of normal. * Negative HIV-1 and -2 blood test: Sites may use locally available assays that have been approved by HVTN Laboratory Operations. * Negative Hepatitis B surface antigen (HBsAg) * Negative anti-Hepatitis C virus antibodies (anti-HCV), or negative HCV polymerase chain reaction (PCR) if the anti-HCV is positive * 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). * Volunteers who were born female: negative urine beta human chorionic gonadotropin (β-HCG) pregnancy test performed prior to vaccination on the day of initial vaccination or negative serum beta human chorionic gonadotropin (β-HCG) pregnancy test within 24 hours prior to initial vaccination. Persons who are NOT of reproductive potential due to having undergone total hysterectomy with 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 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 for participants in South Africa is defined as using 2 methods, including the following: * Condoms (male or female), or * Diaphragm or cervical cap, PLUS 1 of the following methods: * Intrauterine device (IUD), * Hormonal contraception (in accordance with Republic of South Africa: National Contraception Clinical Guidelines), * Successful vasectomy in the male partner (considered successful if a volunteer reports that a male partner has \[1\] documentation of azoospermia by microscopy, or \[2\] a vasectomy more than 2 years ago with no resultant pregnancy despite sexual activity postvasectomy); or * Any other contraceptive method approved by the HVTN 100 PSRT * 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
* Blood products received within 120 days before first vaccination * Investigational research agents received within 30 days before first vaccination * Body mass index (BMI) ≥ 40; or BMI ≥ 35 with 2 or more of the following: systolic blood pressure \> 140 mm Hg, diastolic blood pressure \> 90 mm Hg, current smoker, known hyperlipidemia * Intent to participate in another study of an investigational research agent or any study that includes HIV testing during the planned duration of the HVTN 100 study * Pregnant, breastfeeding, or lactating * HIV vaccine(s) received in a prior HIV vaccine trial. For volunteers who have received control/placebo in an HIV vaccine trial, the HVTN 100 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 South Africa Medicines Control Council (MCC). For volunteers who have received control/placebo in an experimental vaccine trial, the HVTN 100 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 100 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 * Immunosuppressive medications received within 168 days before first vaccination. (Not excluded from participation: \[1\] corticosteroid nasal spray; \[2\] inhaled corticosteroids; \[3\] topical corticosteroids for mild, uncomplicated dermatitis; or \[4\] a single course of oral/parenteral corticosteroids at doses \< 2 mg/kg/day and length of therapy \< 11 days with completion at least 30 days prior to enrollment.) * Serious adverse reactions to vaccines or to vaccine components such as eggs, egg products, or neomycin, including history of anaphylaxis and related symptoms such as hives, respiratory difficulty, angioedema, and/or abdominal pain. (Not excluded from participation: a volunteer who had a nonanaphylactic adverse reaction to pertussis vaccine as a child.) * Immunoglobulin received within 60 days before first vaccination * Autoimmune disease * Immunodeficiency * 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 |
|---|---|---|
| Part B: Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine in the Extension Study | Measured at Month 30.5 | Measured by flow cytometry ICS assay: refer to earlier description for assay methods and analysis variable derivation. Percentage of T-cells expressing cytokines are summarized for positive responders only. |
| Part A: Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine After the Primary Vaccine Regimen. Measured by Flow Cytometry. | Measured at Month 6.5 | 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. |
| Part A: Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine After the Primary Vaccine Regimen. | Measured at Month 6.5 | Measured by flow cytometry ICS assay: refer to earlier description for assay methods and analysis variable derivation. Percentage of T-cells expressing cytokines are summarized for positive responders only. |
| Part B: Number of Participants Reporting Local Reactogenicity Signs and Symptoms in the Extension Study | Measured through 3 days after the Month 30 vaccination | Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 \[March 2017\]. For each participant, the maximum grade observed for each symptom over the time frame is presented. |
| Part B: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms in the Extension Study | Measured through 3 days after the Month 30 vaccination | Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 \[March 2017\]. For each participant, the maximum grade observed for each symptom over the time frame is presented. |
| Part B: Number of Participants With Early Study Termination Associated With an AE or Reactogenicity | Measured through Month 36 | From the study termination form, early termination reasons associated with an AE are tabulated by treatment arm |
| Part B: Chemistry and Hematology Laboratory Results of Grade 1 or Higher | Time Frame: Measured during screening for part B, and 2 weeks after vaccination at Month 30 | Laboratory results are summarized by analyte and timepoint. Analytes and timepoint combinations with no grade 1 or higher results are not shown. |
| Part B Chemistry Laboratory Measures: Alkaline Phosphatase, AST, and ALT | Measured during screening for part B, and 2 weeks after vaccination at Month 30 | For each chemistry laboratory measure, summary statistics were presented by analyte and treatment group for the overall population. |
| Part B Chemistry Laboratory Measures: Hemoglobin, Creatinine | Measured during screening for part B, and 2 weeks after vaccination at Month 30 | For each chemistry laboratory measure, summary statistics were presented by analyte and treatment group for the overall population. |
| Part B Chemistry Laboratory Measures: WBC, Platelets, Lymphocytes, Neutrophils | Measured during screening for part B, and 2 weeks after vaccination at Month 30 | For each chemistry laboratory measure, summary statistics were presented by analyte and treatment group for the overall population. |
| Part B: Occurrence of IgG Binding Antibodies to 3 V1V2-scaffolded Env Proteins in the Extension Study | Measured at Month 30.5 | Measured by HIV-1 multiplex Ab assay: refer to earlier description for assay methods and analysis variable derivation. The number and percentage of participants with positive responses are summarized by antigen. |
| Part B: Level of IgG Binding Antibodies to 3 V1V2-scaffolded Env Proteins in the Extension Study | Measured at Month 30.5 | 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. |
| Part B: Occurrence of IgG Ab Binding to gp120 Env Proteins Contained in the Vaccine (ZM96, TV1.C, 1086.C) in the Extension Study | Measured at Month 30.5 | Measured by HIV-1 multiplex Ab assay: refer to earlier description for assay methods and analysis variable derivation. The number and percentage of participants with positive responses are summarized by antigen. |
| Part B: Level of IgG Ab Binding to gp120 Env Proteins Contained in the Vaccine (ZM96, TV1.C, 1086.C) in the Extension Study | Measured at Month 30.5 | 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. |
| Part B: Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine in the Extension Study | Measured at Month 30.5 | Measured by flow cytometry ICS assay: refer to earlier description for assay methods and analysis variable derivation. The number and percentage of participants with positive responses are summarized by peptide pool. |
| Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Measured through 3 days after participants' last vaccination at Month 0,1,3, and 6 | Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 \[March 2017\] The maximum grade observed for each symptom over the time frame is presented. |
| Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Measured through 3 days after each vaccination at Month 0, 1, 3, and 6 | Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 \[March 2017\] |
| Part A: Number of Participants With Early Study Termination Associated With an AE or Reactogenicity | Measured through Month 18 | From the study termination form, early termination reasons associated with an AE or reactogenicity are tabulated by treatment arm |
| Part A: Number of Participants With Study Product Discontinuation Associated With an AE or Reactogenicity | Measured through the Month 12 vaccination | From the study product discontinuation form, study product administration reasons are tabulated by treatment arm |
| Part A: Chemistry and Hematology Laboratory Results With Grade 1 or Higher | Measured during screening for part A, and 2 weeks after each vaccination at Month 0, 1, 3, 6, and 12 | Laboratory results are summarized by analyte and timepoint. Analytes and timepoint combinations with no grade 1 or higher results are not shown. |
| Part A Chemistry Laboratory Measures: Alkaline Phosphatase, AST, and ALT | Time Frame: Measured during screening for part A, and 2 weeks after each vaccination at Month 0, 1, 3, 6, and 12 | For each chemistry laboratory measure, summary statistics were presented by analyte and treatment group for the overall population. |
| Part A Chemistry Laboratory Measures: Hemoglobin, Creatinine | Time Frame: Measured during screening for part A, and 2 weeks after each vaccination at Month 0, 1, 3, 6, and 12 | For each chemistry laboratory measure, summary statistics were presented by analyte and treatment group for the overall population. |
| Part A Hematology Laboratory Measures: WBC, Platelets, Lymphocytes, Neutrophils | Measured during screening for part A, and 2 weeks after each vaccination at Month 0, 1, 3, 6, and 12 | For each chemistry laboratory measure, summary statistics were presented by analyte and treatment group for the overall population. |
| Part A: Occurrence of IgG Ab Binding to gp120 Env Proteins Contained in the Vaccine (ZM96, TV1.C, 1086.C) After the Primary Vaccine Regimen, Measured by HIV-1 Multiplex Antibody Assay | Measured at Month 6.5 | 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. Samples from post-enrollment visits have positive responses if they meet three conditions: (1) net MFI greater than or equal to an antigen-specific response threshold (defined as the maximum of 100 and the 95th percentile of pre-vaccination net MFI), (2) net MFI values are greater than 3 times pre-vaccination net MFI, and (3) experimental antigen MFI values are greater than 3 times pre-vaccination MFI. Data are excluded if the blood draw date was outside the allowable window, a participant was HIV-infected, or the reference antigen exceeds 5000 MFI. |
| Part A: Level of IgG Ab Binding to gp120 Env Proteins Contained in the Vaccine (ZM96, TV1.C, 1086.C) After the Primary Vaccine Regimen, Measured by HIV-1 Multiplex Antibody Assay | Measured at Month 6.5 | 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. |
| Part A: Occurrence of IgG Binding Antibodies to 3 V1V2-scaffolded Env Proteins After the Primary Vaccine Regimen | Measured at Month 6.5 | Measured by HIV-1 multiplex Ab assay: refer to earlier description for assay methods and analysis variable derivation. The number and percentage of participants with positive responses are summarized by antigen. |
| Part A: Level of IgG Binding Antibodies to 3 V1V2-scaffolded Env Proteins After the Primary Vaccine Regimen | Measured at Month 6.5 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Part A: Frequency of Severe Systemic Reactogenicity Signs and Symptoms, Through the Fifth Vaccination | Measured through 3 days after each vaccination at Month 0, 1, 3, 6, and 12 | Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 \[March 2017\]. The maximum grade observed for each symptom over the time frame is presented. |
| Part A: Compare the Occurrence of IgG Ab Binding to gp120 Env Proteins Contained in the Vaccine (ZM96, TV1.C, 1086.C) After the Fourth Versus the Fifth Vaccination | Measured at Month 6.5 and 12.5 | 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. Samples from post-enrollment visits have positive responses if they meet three conditions: (1) net MFI greater than or equal to an antigen-specific response threshold (defined as the maximum of 100 and the 95th percentile of pre-vaccination net MFI), (2) net MFI values are greater than 3 times pre-vaccination net MFI, and (3) experimental antigen MFI values are greater than 3 times pre-vaccination MFI. Data are excluded if the blood draw date was outside the allowable window, a participant was HIV-infected, or the reference antigen exceeds 5000 MFI. |
| Part A: Compare the Level of IgG Ab Binding to gp120 Env Proteins Contained in the Vaccine (ZM96, TV1.C, 1086.C) After the Fourth Versus the Fifth Vaccination | Measured at Month 6.5 and 12.5 | 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. Comparisons were performed among positive responders only (positivity criteria is described in Outcome 30). |
| Part A: Compare the Occurrence of IgG Binding Antibodies to 3 V1V2-scaffolded Env Proteins After the Fourth Versus the Fifth Vaccination | Measured at Month 6.5 and 12.5 | 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. Samples from post-enrollment visits have positive responses if they meet three conditions: (1) net MFI greater than or equal to an antigen-specific response threshold (defined as the maximum of 100 and the 95th percentile of pre-vaccination net MFI), (2) net MFI values are greater than 3 times pre-vaccination net MFI, and (3) experimental antigen MFI values are greater than 3 times pre-vaccination MFI. Data are excluded if the blood draw date was outside the allowable window, a participant was HIV-infected, or the reference antigen exceeds 5000 MFI. |
| Part A: Compare the Level of IgG Binding Antibodies to 3 V1V2-scaffolded Env Proteins After the Fourth Versus the Fifth Vaccination | Measured at Month 6.5 and 12.5 | 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. Comparisons were performed among positive responders only (positivity criteria is described in Outcome 32). |
| Part A: Compare the Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine After the Fourth Versus the Fifth Vaccinations | Measured at Month 6.5 and 12.5 | 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. |
| Part A: Compare the Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine After the Fourth Versus the Fifth Vaccinations | Measured at Month 6.5 and 12.5 | 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. Comparisons were performed among positive responders only. |
| Part B: Occurrence of IgG Ab Binding to gp120 Env Proteins Contained in the Vaccine (ZM96, TV1.C, 1086.C) in the Extension Study, at 6 Months After the Month 30 Vaccination | Measured at Month 30 and 36 | 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. Samples from post-enrollment visits have positive responses if they meet three conditions: (1) net MFI greater than or equal to an antigen-specific response threshold (defined as the maximum of 100 and the 95th percentile of pre-vaccination net MFI), (2) net MFI values are greater than 3 times pre-vaccination net MFI, and (3) experimental antigen MFI values are greater than 3 times pre-vaccination MFI. Data are excluded if the blood draw date was outside the allowable window, a participant was HIV-infected, or the reference antigen exceeds 5000 MFI. |
| Part B: Level of IgG Ab Binding to gp120 Env Proteins Contained in the Vaccine (ZM96, TV1.C, 1086.C) in the Extension Study, at 6 Months After the Month 30 Vaccination | Measured at Month 30 and 36 | 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. |
| Part B: Occurrence of IgG Binding Antibodies to 3 V1V2-scaffolded Env Proteins in the Extension Study, at 6 Months After the Month 30 Vaccination | Measured at Month 30 and 36 | 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. Samples from post-enrollment visits have positive responses if they meet three conditions: (1) net MFI greater than or equal to an antigen-specific response threshold (defined as the maximum of 100 and the 95th percentile of pre-vaccination net MFI), (2) net MFI values are greater than 3 times pre-vaccination net MFI, and (3) experimental antigen MFI values are greater than 3 times pre-vaccination MFI. Data are excluded if the blood draw date was outside the allowable window, a participant was HIV-infected, or the reference antigen exceeds 5000 MFI. |
| Part B: Level of IgG Binding Antibodies to 3 V1V2-scaffolded Env Proteins in the Extension Study, at 6 Months After the Month 30 Vaccination | Measured at Month 30 and 36 | 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. |
| Part B: Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine in the Extension Study, at 6 Months After the Month 30 Vaccination | Measured at Month 30 and 36 | 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. |
| Part B: Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine in the Extension Study, at 6 Months After the Month 30 Vaccination | Measured at Month 30 and 36 | 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. |
| Part A: Frequency of Severe Local Reactogenicity Signs and Symptoms, Through the Fifth Vaccination | Measured through 3 days after each vaccination at Month 0, 1, 3, 6, and 12 | Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 \[March 2017\]. The maximum grade observed for each symptom over the time frame is presented. |
Countries
South Africa
Participant flow
Pre-assignment details
Participants who received all vaccinations in Part A and completed Part A as scheduled were eligible for the Part B extension study. N=63 vaccination recipients in Part A (Group 1) were re-randomized to Part B Group 1a or 1b with a 1:1 ratio, while N=7 placebo recipients from Part A (Group 2) re-enrolled to receive placebo injections in Part B.
Participants by arm
| Arm | Count |
|---|---|
| Part A Only: Group 1 (Vaccine) Participants did not go on to Part B. In Part A, participants received ALVAC-HIV at months 0 and 1, and ALVAC-HIV + bivalent subtype C gp120/MF59 at months 3, 6, and 12 | 147 |
| Part A Only: Group 2 (Placebo) Participants did not go on to Part B. In Part A, participants received Placebo for ALVAC-HIV at months 0 and 1, and placebo for ALVAC-HIV + placebo for bivalent subtype C gp120/MF59 at months 3, 6, and 12 | 35 |
| Part A, Group 1 (Vaccine) + Part B, Group 1a (Vaccine) Participants completed Part A in Group 1 (Vaccine), joined Part B and were randomized to Group 1a (Vaccine): ALVAC-HIV + bivalent subtype C gp120/MF59 at month 30 | 32 |
| Part A, Group 1 (Vaccine) + Part B, Group 1b: Vaccine/Placeb Participants completed Part A in Group 1 (Vaccine), joined Part B and were randomized to Group 1b (Vaccine/Placebo ): placebo for ALVAC-HIV + bivalent subtype C gp120/MF59 at month 30 | 31 |
| Part A, Group 2 (Placebo) + Part B, Group 2 (Placebo) Participants completed Part A in Group 2 (Placebo), joined Part B and received placebo for ALVAC-HIV + placebo for bivalent subtype C gp120/MF59 at month 30 | 7 |
| Total | 252 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Part A: Month 0-18 | Death | 2 | 0 | 0 | 0 | 0 |
| Part A: Month 0-18 | HIV Infection | 6 | 2 | 0 | 0 | 0 |
| Part A: Month 0-18 | Lost to Follow-up | 4 | 2 | 0 | 0 | 0 |
| Part A: Month 0-18 | Participant unable to adhere | 7 | 0 | 0 | 0 | 0 |
| Part A: Month 0-18 | Physician Decision | 1 | 0 | 0 | 0 | 0 |
| Part A: Month 0-18 | Withdrawal by Subject | 6 | 2 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Total | Part A Only: Group 2 (Placebo) | Part A, Group 1 (Vaccine) + Part B, Group 1a (Vaccine) | Part A Only: Group 1 (Vaccine) | Part A, Group 1 (Vaccine) + Part B, Group 1b: Vaccine/Placeb | Part A, Group 2 (Placebo) + Part B, Group 2 (Placebo) |
|---|---|---|---|---|---|---|
| Age, Continuous | 23 years | 23 years | 25 years | 23 years | 23 years | 24 years |
| Age, Customized 18 - 20 years | 56 Participants | 7 Participants | 7 Participants | 38 Participants | 3 Participants | 1 Participants |
| Age, Customized 21 - 30 years | 167 Participants | 24 Participants | 17 Participants | 95 Participants | 26 Participants | 5 Participants |
| Age, Customized 31 - 40 years | 29 Participants | 4 Participants | 8 Participants | 14 Participants | 2 Participants | 1 Participants |
| Age, Customized 41 - 50 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Customized Above 50 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Customized Less than 18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Customized Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 252 Participants | 35 Participants | 32 Participants | 147 Participants | 31 Participants | 7 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 | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 246 Participants | 34 Participants | 31 Participants | 143 Participants | 31 Participants | 7 Participants |
| Race (NIH/OMB) More than one race | 5 Participants | 1 Participants | 1 Participants | 3 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment South Africa | 252 Participants | 35 Participants | 32 Participants | 147 Participants | 31 Participants | 7 Participants |
| Sex: Female, Male Female | 109 Participants | 18 Participants | 12 Participants | 64 Participants | 12 Participants | 3 Participants |
| Sex: Female, Male Male | 143 Participants | 17 Participants | 20 Participants | 83 Participants | 19 Participants | 4 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 | 2 / 210 | 0 / 42 | 0 / 32 | 0 / 31 | 0 / 7 |
| other Total, other adverse events | 147 / 210 | 34 / 42 | 15 / 32 | 18 / 31 | 1 / 7 |
| serious Total, serious adverse events | 7 / 210 | 0 / 42 | 0 / 32 | 0 / 31 | 0 / 7 |
Outcome results
Primary
Part A: Chemistry and Hematology Laboratory Results With Grade 1 or Higher
Laboratory results are summarized by analyte and timepoint. Analytes and timepoint combinations with no grade 1 or higher results are not shown.
Time frame: Measured during screening for part A, and 2 weeks after each vaccination at Month 0, 1, 3, 6, and 12
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 (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A, Group 1: Vaccine | Part A: Chemistry and Hematology Laboratory Results With Grade 1 or Higher | Hemoglobin (g/dL)-Day 42 | 0 Participants |
| Part A, Group 1: Vaccine | Part A: Chemistry and Hematology Laboratory Results With Grade 1 or Higher | Platelets (1000/cubic mm)-Day 98 | 0 Participants |
| Part A, Group 1: Vaccine | Part A: Chemistry and Hematology Laboratory Results With Grade 1 or Higher | WBC (1000/cubic mm)-Day 182 | 0 Participants |
| Part A, Group 1: Vaccine | Part A: Chemistry and Hematology Laboratory Results With Grade 1 or Higher | Platelets (1000/cubic mm)-Day 182 | 0 Participants |
| Part A, Group 1: Vaccine | Part A: Chemistry and Hematology Laboratory Results With Grade 1 or Higher | Hemoglobin (g/dL)-Day 98 | 0 Participants |
| Part A, Group 1: Vaccine | Part A: Chemistry and Hematology Laboratory Results With Grade 1 or Higher | Platelets (1000/cubic mm)-Day 378 | 0 Participants |
| Part A, Group 1: Vaccine | Part A: Chemistry and Hematology Laboratory Results With Grade 1 or Higher | Neutrophils (1000/cubic mm)-Day 42 | 0 Participants |
| Part A, Group 1: Vaccine | Part A: Chemistry and Hematology Laboratory Results With Grade 1 or Higher | ALT (SGPT) (U/L)-Screening | 0 Participants |
| Part A, Group 1: Vaccine | Part A: Chemistry and Hematology Laboratory Results With Grade 1 or Higher | ALT (SGPT) (U/L)-Day 14 | 0 Participants |
| Part A, Group 1: Vaccine | Part A: Chemistry and Hematology Laboratory Results With Grade 1 or Higher | Hemoglobin (g/dL)-Day 182 | 0 Participants |
| Part A, Group 1: Vaccine | Part A: Chemistry and Hematology Laboratory Results With Grade 1 or Higher | ALT (SGPT) (U/L)-Day 42 | 1 Participants |
| Part A, Group 1: Vaccine | Part A: Chemistry and Hematology Laboratory Results With Grade 1 or Higher | WBC (1000/cubic mm)-Day 14 | 0 Participants |
| Part A, Group 1: Vaccine | Part A: Chemistry and Hematology Laboratory Results With Grade 1 or Higher | ALT (SGPT) (U/L)-Day 98 | 1 Participants |
| Part A, Group 1: Vaccine | Part A: Chemistry and Hematology Laboratory Results With Grade 1 or Higher | Neutrophils (1000/cubic mm)-Day 98 | 0 Participants |
| Part A, Group 1: Vaccine | Part A: Chemistry and Hematology Laboratory Results With Grade 1 or Higher | ALT (SGPT) (U/L)-Day 182 | 0 Participants |
| Part A, Group 1: Vaccine | Part A: Chemistry and Hematology Laboratory Results With Grade 1 or Higher | Hemoglobin (g/dL)-Day 378 | 1 Participants |
| Part A, Group 1: Vaccine | Part A: Chemistry and Hematology Laboratory Results With Grade 1 or Higher | ALT (SGPT) (U/L)-Day 378 | 1 Participants |
| Part A, Group 1: Vaccine | Part A: Chemistry and Hematology Laboratory Results With Grade 1 or Higher | WBC (1000/cubic mm)-Day 378 | 0 Participants |
| Part A, Group 1: Vaccine | Part A: Chemistry and Hematology Laboratory Results With Grade 1 or Higher | AST (U/L)-Screening | 0 Participants |
| Part A, Group 1: Vaccine | Part A: Chemistry and Hematology Laboratory Results With Grade 1 or Higher | Lymphocytes (1000/cubic mm)-Screening | 0 Participants |
| Part A, Group 1: Vaccine | Part A: Chemistry and Hematology Laboratory Results With Grade 1 or Higher | AST (U/L)-Day 14 | 0 Participants |
| Part A, Group 1: Vaccine | Part A: Chemistry and Hematology Laboratory Results With Grade 1 or Higher | Neutrophils (1000/cubic mm)-Day 182 | 0 Participants |
| Part A, Group 1: Vaccine | Part A: Chemistry and Hematology Laboratory Results With Grade 1 or Higher | AST (U/L)-Day 42 | 2 Participants |
| Part A, Group 1: Vaccine | Part A: Chemistry and Hematology Laboratory Results With Grade 1 or Higher | Lymphocytes (1000/cubic mm)-Day 14 | 0 Participants |
| Part A, Group 1: Vaccine | Part A: Chemistry and Hematology Laboratory Results With Grade 1 or Higher | AST (U/L)-Day 98 | 0 Participants |
| Part A, Group 1: Vaccine | Part A: Chemistry and Hematology Laboratory Results With Grade 1 or Higher | WBC (1000/cubic mm)-Day 98 | 0 Participants |
| Part A, Group 1: Vaccine | Part A: Chemistry and Hematology Laboratory Results With Grade 1 or Higher | AST (U/L)-Day 182 | 0 Participants |
| Part A, Group 1: Vaccine | Part A: Chemistry and Hematology Laboratory Results With Grade 1 or Higher | Lymphocytes (1000/cubic mm)-Day 42 | 0 Participants |
| Part A, Group 1: Vaccine | Part A: Chemistry and Hematology Laboratory Results With Grade 1 or Higher | AST (U/L)-Day 378 | 1 Participants |
| Part A, Group 1: Vaccine | Part A: Chemistry and Hematology Laboratory Results With Grade 1 or Higher | Neutrophils (1000/cubic mm)-Day 378 | 0 Participants |
| Part A, Group 1: Vaccine | Part A: Chemistry and Hematology Laboratory Results With Grade 1 or Higher | Alkaline Phosphatase (U/L)-Screening | 0 Participants |
| Part A, Group 1: Vaccine | Part A: Chemistry and Hematology Laboratory Results With Grade 1 or Higher | Lymphocytes (1000/cubic mm)-Day 98 | 0 Participants |
| Part A, Group 1: Vaccine | Part A: Chemistry and Hematology Laboratory Results With Grade 1 or Higher | Alkaline Phosphatase (U/L)-Day 14 | 0 Participants |
| Part A, Group 1: Vaccine | Part A: Chemistry and Hematology Laboratory Results With Grade 1 or Higher | Neutrophils (1000/cubic mm)-Screening | 0 Participants |
| Part A, Group 1: Vaccine | Part A: Chemistry and Hematology Laboratory Results With Grade 1 or Higher | Alkaline Phosphatase (U/L)-Day 42 | 0 Participants |
| Part A, Group 1: Vaccine | Part A: Chemistry and Hematology Laboratory Results With Grade 1 or Higher | Lymphocytes (1000/cubic mm)-Day 182 | 0 Participants |
| Part A, Group 1: Vaccine | Part A: Chemistry and Hematology Laboratory Results With Grade 1 or Higher | Alkaline Phosphatase (U/L)-Day 98 | 0 Participants |
| Part A, Group 1: Vaccine | Part A: Chemistry and Hematology Laboratory Results With Grade 1 or Higher | Hemoglobin (g/dL)-Screening | 0 Participants |
| Part A, Group 1: Vaccine | Part A: Chemistry and Hematology Laboratory Results With Grade 1 or Higher | Alkaline Phosphatase (U/L)-Day 182 | 0 Participants |
| Part A, Group 1: Vaccine | Part A: Chemistry and Hematology Laboratory Results With Grade 1 or Higher | Lymphocytes (1000/cubic mm)-Day 378 | 0 Participants |
| Part A, Group 1: Vaccine | Part A: Chemistry and Hematology Laboratory Results With Grade 1 or Higher | Alkaline Phosphatase (U/L)-Day 378 | 0 Participants |
| Part A, Group 1: Vaccine | Part A: Chemistry and Hematology Laboratory Results With Grade 1 or Higher | WBC (1000/cubic mm)-Day 42 | 0 Participants |
| Part A, Group 1: Vaccine | Part A: Chemistry and Hematology Laboratory Results With Grade 1 or Higher | Creatinine (g/dL)-Screening | 0 Participants |
| Part A, Group 1: Vaccine | Part A: Chemistry and Hematology Laboratory Results With Grade 1 or Higher | Platelets (1000/cubic mm)-Screening | 0 Participants |
| Part A, Group 1: Vaccine | Part A: Chemistry and Hematology Laboratory Results With Grade 1 or Higher | Creatinine (g/dL)-Day 14 | 0 Participants |
| Part A, Group 1: Vaccine | Part A: Chemistry and Hematology Laboratory Results With Grade 1 or Higher | Hemoglobin (g/dL)-Day 14 | 0 Participants |
| Part A, Group 1: Vaccine | Part A: Chemistry and Hematology Laboratory Results With Grade 1 or Higher | Creatinine (g/dL)-Day 42 | 1 Participants |
| Part A, Group 1: Vaccine | Part A: Chemistry and Hematology Laboratory Results With Grade 1 or Higher | Platelets (1000/cubic mm)-Day 14 | 0 Participants |
| Part A, Group 1: Vaccine | Part A: Chemistry and Hematology Laboratory Results With Grade 1 or Higher | Creatinine (g/dL)-Day 98 | 0 Participants |
| Part A, Group 1: Vaccine | Part A: Chemistry and Hematology Laboratory Results With Grade 1 or Higher | Neutrophils (1000/cubic mm)-Day 14 | 0 Participants |
| Part A, Group 1: Vaccine | Part A: Chemistry and Hematology Laboratory Results With Grade 1 or Higher | Creatinine (g/dL)-Day 182 | 0 Participants |
| Part A, Group 1: Vaccine | Part A: Chemistry and Hematology Laboratory Results With Grade 1 or Higher | Platelets (1000/cubic mm)-Day 42 | 0 Participants |
| Part A, Group 1: Vaccine | Part A: Chemistry and Hematology Laboratory Results With Grade 1 or Higher | Creatinine (g/dL)-Day 378 | 3 Participants |
| Part A, Group 1: Vaccine | Part A: Chemistry and Hematology Laboratory Results With Grade 1 or Higher | WBC (1000/cubic mm)-Screening | 0 Participants |
| Part A, Group 2: Placebo | Part A: Chemistry and Hematology Laboratory Results With Grade 1 or Higher | Creatinine (g/dL)-Day 378 | 0 Participants |
| Part A, Group 2: Placebo | Part A: Chemistry and Hematology Laboratory Results With Grade 1 or Higher | WBC (1000/cubic mm)-Screening | 0 Participants |
| Part A, Group 2: Placebo | Part A: Chemistry and Hematology Laboratory Results With Grade 1 or Higher | WBC (1000/cubic mm)-Day 14 | 0 Participants |
| Part A, Group 2: Placebo | Part A: Chemistry and Hematology Laboratory Results With Grade 1 or Higher | WBC (1000/cubic mm)-Day 42 | 0 Participants |
| Part A, Group 2: Placebo | Part A: Chemistry and Hematology Laboratory Results With Grade 1 or Higher | WBC (1000/cubic mm)-Day 98 | 0 Participants |
| Part A, Group 2: Placebo | Part A: Chemistry and Hematology Laboratory Results With Grade 1 or Higher | WBC (1000/cubic mm)-Day 182 | 0 Participants |
| Part A, Group 2: Placebo | Part A: Chemistry and Hematology Laboratory Results With Grade 1 or Higher | WBC (1000/cubic mm)-Day 378 | 0 Participants |
| Part A, Group 2: Placebo | Part A: Chemistry and Hematology Laboratory Results With Grade 1 or Higher | Neutrophils (1000/cubic mm)-Screening | 0 Participants |
| Part A, Group 2: Placebo | Part A: Chemistry and Hematology Laboratory Results With Grade 1 or Higher | Neutrophils (1000/cubic mm)-Day 14 | 0 Participants |
| Part A, Group 2: Placebo | Part A: Chemistry and Hematology Laboratory Results With Grade 1 or Higher | Neutrophils (1000/cubic mm)-Day 42 | 0 Participants |
| Part A, Group 2: Placebo | Part A: Chemistry and Hematology Laboratory Results With Grade 1 or Higher | Neutrophils (1000/cubic mm)-Day 98 | 0 Participants |
| Part A, Group 2: Placebo | Part A: Chemistry and Hematology Laboratory Results With Grade 1 or Higher | Neutrophils (1000/cubic mm)-Day 182 | 0 Participants |
| Part A, Group 2: Placebo | Part A: Chemistry and Hematology Laboratory Results With Grade 1 or Higher | Neutrophils (1000/cubic mm)-Day 378 | 0 Participants |
| Part A, Group 2: Placebo | Part A: Chemistry and Hematology Laboratory Results With Grade 1 or Higher | Hemoglobin (g/dL)-Screening | 0 Participants |
| Part A, Group 2: Placebo | Part A: Chemistry and Hematology Laboratory Results With Grade 1 or Higher | Hemoglobin (g/dL)-Day 14 | 0 Participants |
| Part A, Group 2: Placebo | Part A: Chemistry and Hematology Laboratory Results With Grade 1 or Higher | Hemoglobin (g/dL)-Day 42 | 0 Participants |
| Part A, Group 2: Placebo | Part A: Chemistry and Hematology Laboratory Results With Grade 1 or Higher | Hemoglobin (g/dL)-Day 98 | 0 Participants |
| Part A, Group 2: Placebo | Part A: Chemistry and Hematology Laboratory Results With Grade 1 or Higher | Hemoglobin (g/dL)-Day 182 | 0 Participants |
| Part A, Group 2: Placebo | Part A: Chemistry and Hematology Laboratory Results With Grade 1 or Higher | ALT (SGPT) (U/L)-Screening | 0 Participants |
| Part A, Group 2: Placebo | Part A: Chemistry and Hematology Laboratory Results With Grade 1 or Higher | Hemoglobin (g/dL)-Day 378 | 0 Participants |
| Part A, Group 2: Placebo | Part A: Chemistry and Hematology Laboratory Results With Grade 1 or Higher | Lymphocytes (1000/cubic mm)-Screening | 0 Participants |
| Part A, Group 2: Placebo | Part A: Chemistry and Hematology Laboratory Results With Grade 1 or Higher | Lymphocytes (1000/cubic mm)-Day 14 | 0 Participants |
| Part A, Group 2: Placebo | Part A: Chemistry and Hematology Laboratory Results With Grade 1 or Higher | Lymphocytes (1000/cubic mm)-Day 42 | 0 Participants |
| Part A, Group 2: Placebo | Part A: Chemistry and Hematology Laboratory Results With Grade 1 or Higher | Lymphocytes (1000/cubic mm)-Day 98 | 0 Participants |
| Part A, Group 2: Placebo | Part A: Chemistry and Hematology Laboratory Results With Grade 1 or Higher | Lymphocytes (1000/cubic mm)-Day 182 | 0 Participants |
| Part A, Group 2: Placebo | Part A: Chemistry and Hematology Laboratory Results With Grade 1 or Higher | Lymphocytes (1000/cubic mm)-Day 378 | 0 Participants |
| Part A, Group 2: Placebo | Part A: Chemistry and Hematology Laboratory Results With Grade 1 or Higher | Platelets (1000/cubic mm)-Screening | 0 Participants |
| Part A, Group 2: Placebo | Part A: Chemistry and Hematology Laboratory Results With Grade 1 or Higher | Platelets (1000/cubic mm)-Day 14 | 0 Participants |
| Part A, Group 2: Placebo | Part A: Chemistry and Hematology Laboratory Results With Grade 1 or Higher | Platelets (1000/cubic mm)-Day 42 | 0 Participants |
| Part A, Group 2: Placebo | Part A: Chemistry and Hematology Laboratory Results With Grade 1 or Higher | Platelets (1000/cubic mm)-Day 98 | 0 Participants |
| Part A, Group 2: Placebo | Part A: Chemistry and Hematology Laboratory Results With Grade 1 or Higher | Platelets (1000/cubic mm)-Day 182 | 0 Participants |
| Part A, Group 2: Placebo | Part A: Chemistry and Hematology Laboratory Results With Grade 1 or Higher | Platelets (1000/cubic mm)-Day 378 | 0 Participants |
| Part A, Group 2: Placebo | Part A: Chemistry and Hematology Laboratory Results With Grade 1 or Higher | ALT (SGPT) (U/L)-Day 14 | 0 Participants |
| Part A, Group 2: Placebo | Part A: Chemistry and Hematology Laboratory Results With Grade 1 or Higher | ALT (SGPT) (U/L)-Day 42 | 0 Participants |
| Part A, Group 2: Placebo | Part A: Chemistry and Hematology Laboratory Results With Grade 1 or Higher | ALT (SGPT) (U/L)-Day 98 | 0 Participants |
| Part A, Group 2: Placebo | Part A: Chemistry and Hematology Laboratory Results With Grade 1 or Higher | ALT (SGPT) (U/L)-Day 182 | 0 Participants |
| Part A, Group 2: Placebo | Part A: Chemistry and Hematology Laboratory Results With Grade 1 or Higher | ALT (SGPT) (U/L)-Day 378 | 0 Participants |
| Part A, Group 2: Placebo | Part A: Chemistry and Hematology Laboratory Results With Grade 1 or Higher | AST (U/L)-Screening | 0 Participants |
| Part A, Group 2: Placebo | Part A: Chemistry and Hematology Laboratory Results With Grade 1 or Higher | AST (U/L)-Day 14 | 0 Participants |
| Part A, Group 2: Placebo | Part A: Chemistry and Hematology Laboratory Results With Grade 1 or Higher | AST (U/L)-Day 42 | 0 Participants |
| Part A, Group 2: Placebo | Part A: Chemistry and Hematology Laboratory Results With Grade 1 or Higher | AST (U/L)-Day 98 | 0 Participants |
| Part A, Group 2: Placebo | Part A: Chemistry and Hematology Laboratory Results With Grade 1 or Higher | AST (U/L)-Day 182 | 0 Participants |
| Part A, Group 2: Placebo | Part A: Chemistry and Hematology Laboratory Results With Grade 1 or Higher | AST (U/L)-Day 378 | 0 Participants |
| Part A, Group 2: Placebo | Part A: Chemistry and Hematology Laboratory Results With Grade 1 or Higher | Alkaline Phosphatase (U/L)-Screening | 0 Participants |
| Part A, Group 2: Placebo | Part A: Chemistry and Hematology Laboratory Results With Grade 1 or Higher | Alkaline Phosphatase (U/L)-Day 14 | 0 Participants |
| Part A, Group 2: Placebo | Part A: Chemistry and Hematology Laboratory Results With Grade 1 or Higher | Alkaline Phosphatase (U/L)-Day 42 | 0 Participants |
| Part A, Group 2: Placebo | Part A: Chemistry and Hematology Laboratory Results With Grade 1 or Higher | Alkaline Phosphatase (U/L)-Day 98 | 0 Participants |
| Part A, Group 2: Placebo | Part A: Chemistry and Hematology Laboratory Results With Grade 1 or Higher | Alkaline Phosphatase (U/L)-Day 182 | 0 Participants |
| Part A, Group 2: Placebo | Part A: Chemistry and Hematology Laboratory Results With Grade 1 or Higher | Alkaline Phosphatase (U/L)-Day 378 | 0 Participants |
| Part A, Group 2: Placebo | Part A: Chemistry and Hematology Laboratory Results With Grade 1 or Higher | Creatinine (g/dL)-Screening | 0 Participants |
| Part A, Group 2: Placebo | Part A: Chemistry and Hematology Laboratory Results With Grade 1 or Higher | Creatinine (g/dL)-Day 14 | 0 Participants |
| Part A, Group 2: Placebo | Part A: Chemistry and Hematology Laboratory Results With Grade 1 or Higher | Creatinine (g/dL)-Day 42 | 0 Participants |
| Part A, Group 2: Placebo | Part A: Chemistry and Hematology Laboratory Results With Grade 1 or Higher | Creatinine (g/dL)-Day 98 | 0 Participants |
| Part A, Group 2: Placebo | Part A: Chemistry and Hematology Laboratory Results With Grade 1 or Higher | Creatinine (g/dL)-Day 182 | 0 Participants |
Primary
Part A Chemistry Laboratory Measures: Alkaline Phosphatase, AST, and ALT
For each chemistry laboratory measure, summary statistics were presented by analyte and treatment group for the overall population.
Time frame: Time Frame: Measured during screening for part A, and 2 weeks after each vaccination at Month 0, 1, 3, 6, and 12
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) |
|---|---|---|---|
| Part A, Group 1: Vaccine | Part A Chemistry Laboratory Measures: Alkaline Phosphatase, AST, and ALT | ALT (SGPT) (U/L)-Screening | 17 U/L |
| Part A, Group 1: Vaccine | Part A Chemistry Laboratory Measures: Alkaline Phosphatase, AST, and ALT | ALT (SGPT) (U/L)-Day 14 | 17 U/L |
| Part A, Group 1: Vaccine | Part A Chemistry Laboratory Measures: Alkaline Phosphatase, AST, and ALT | ALT (SGPT) (U/L)-Day 42 | 19 U/L |
| Part A, Group 1: Vaccine | Part A Chemistry Laboratory Measures: Alkaline Phosphatase, AST, and ALT | ALT (SGPT) (U/L)-Day 98 | 18.5 U/L |
| Part A, Group 1: Vaccine | Part A Chemistry Laboratory Measures: Alkaline Phosphatase, AST, and ALT | ALT (SGPT) (U/L)-Day 182 | 19 U/L |
| Part A, Group 1: Vaccine | Part A Chemistry Laboratory Measures: Alkaline Phosphatase, AST, and ALT | ALT (SGPT) (U/L)-Day 378 | 20 U/L |
| Part A, Group 1: Vaccine | Part A Chemistry Laboratory Measures: Alkaline Phosphatase, AST, and ALT | AST (U/L)-Screening | 22 U/L |
| Part A, Group 1: Vaccine | Part A Chemistry Laboratory Measures: Alkaline Phosphatase, AST, and ALT | AST (U/L)-Day 14 | 22 U/L |
| Part A, Group 1: Vaccine | Part A Chemistry Laboratory Measures: Alkaline Phosphatase, AST, and ALT | AST (U/L)-Day 42 | 23 U/L |
| Part A, Group 1: Vaccine | Part A Chemistry Laboratory Measures: Alkaline Phosphatase, AST, and ALT | AST (U/L)-Day 98 | 23 U/L |
| Part A, Group 1: Vaccine | Part A Chemistry Laboratory Measures: Alkaline Phosphatase, AST, and ALT | AST (U/L)-Day 182 | 24 U/L |
| Part A, Group 1: Vaccine | Part A Chemistry Laboratory Measures: Alkaline Phosphatase, AST, and ALT | AST (U/L)-Day 378 | 24 U/L |
| Part A, Group 1: Vaccine | Part A Chemistry Laboratory Measures: Alkaline Phosphatase, AST, and ALT | Alkaline Phosphatase (U/L)-Screening | 71.5 U/L |
| Part A, Group 1: Vaccine | Part A Chemistry Laboratory Measures: Alkaline Phosphatase, AST, and ALT | Alkaline Phosphatase (U/L)-Day 14 | 69 U/L |
| Part A, Group 1: Vaccine | Part A Chemistry Laboratory Measures: Alkaline Phosphatase, AST, and ALT | Alkaline Phosphatase (U/L)-Day 42 | 70 U/L |
| Part A, Group 1: Vaccine | Part A Chemistry Laboratory Measures: Alkaline Phosphatase, AST, and ALT | Alkaline Phosphatase (U/L)-Day 98 | 73 U/L |
| Part A, Group 1: Vaccine | Part A Chemistry Laboratory Measures: Alkaline Phosphatase, AST, and ALT | Alkaline Phosphatase (U/L)-Day 182 | 69 U/L |
| Part A, Group 1: Vaccine | Part A Chemistry Laboratory Measures: Alkaline Phosphatase, AST, and ALT | Alkaline Phosphatase (U/L)-Day 378 | 72 U/L |
| Part A, Group 2: Placebo | Part A Chemistry Laboratory Measures: Alkaline Phosphatase, AST, and ALT | Alkaline Phosphatase (U/L)-Day 14 | 71 U/L |
| Part A, Group 2: Placebo | Part A Chemistry Laboratory Measures: Alkaline Phosphatase, AST, and ALT | ALT (SGPT) (U/L)-Screening | 19 U/L |
| Part A, Group 2: Placebo | Part A Chemistry Laboratory Measures: Alkaline Phosphatase, AST, and ALT | AST (U/L)-Day 98 | 23 U/L |
| Part A, Group 2: Placebo | Part A Chemistry Laboratory Measures: Alkaline Phosphatase, AST, and ALT | ALT (SGPT) (U/L)-Day 14 | 19 U/L |
| Part A, Group 2: Placebo | Part A Chemistry Laboratory Measures: Alkaline Phosphatase, AST, and ALT | Alkaline Phosphatase (U/L)-Day 378 | 74.5 U/L |
| Part A, Group 2: Placebo | Part A Chemistry Laboratory Measures: Alkaline Phosphatase, AST, and ALT | ALT (SGPT) (U/L)-Day 42 | 21 U/L |
| Part A, Group 2: Placebo | Part A Chemistry Laboratory Measures: Alkaline Phosphatase, AST, and ALT | AST (U/L)-Day 182 | 25 U/L |
| Part A, Group 2: Placebo | Part A Chemistry Laboratory Measures: Alkaline Phosphatase, AST, and ALT | ALT (SGPT) (U/L)-Day 98 | 18 U/L |
| Part A, Group 2: Placebo | Part A Chemistry Laboratory Measures: Alkaline Phosphatase, AST, and ALT | Alkaline Phosphatase (U/L)-Day 42 | 71 U/L |
| Part A, Group 2: Placebo | Part A Chemistry Laboratory Measures: Alkaline Phosphatase, AST, and ALT | ALT (SGPT) (U/L)-Day 182 | 19 U/L |
| Part A, Group 2: Placebo | Part A Chemistry Laboratory Measures: Alkaline Phosphatase, AST, and ALT | AST (U/L)-Day 378 | 22.5 U/L |
| Part A, Group 2: Placebo | Part A Chemistry Laboratory Measures: Alkaline Phosphatase, AST, and ALT | ALT (SGPT) (U/L)-Day 378 | 21 U/L |
| Part A, Group 2: Placebo | Part A Chemistry Laboratory Measures: Alkaline Phosphatase, AST, and ALT | Alkaline Phosphatase (U/L)-Day 182 | 70 U/L |
| Part A, Group 2: Placebo | Part A Chemistry Laboratory Measures: Alkaline Phosphatase, AST, and ALT | AST (U/L)-Screening | 22 U/L |
| Part A, Group 2: Placebo | Part A Chemistry Laboratory Measures: Alkaline Phosphatase, AST, and ALT | Alkaline Phosphatase (U/L)-Screening | 72.5 U/L |
| Part A, Group 2: Placebo | Part A Chemistry Laboratory Measures: Alkaline Phosphatase, AST, and ALT | AST (U/L)-Day 14 | 21 U/L |
| Part A, Group 2: Placebo | Part A Chemistry Laboratory Measures: Alkaline Phosphatase, AST, and ALT | Alkaline Phosphatase (U/L)-Day 98 | 74 U/L |
| Part A, Group 2: Placebo | Part A Chemistry Laboratory Measures: Alkaline Phosphatase, AST, and ALT | AST (U/L)-Day 42 | 23 U/L |
Primary
Part A Chemistry Laboratory Measures: Hemoglobin, Creatinine
For each chemistry laboratory measure, summary statistics were presented by analyte and treatment group for the overall population.
Time frame: Time Frame: Measured during screening for part A, and 2 weeks after each vaccination at Month 0, 1, 3, 6, and 12
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) |
|---|---|---|---|
| Part A, Group 1: Vaccine | Part A Chemistry Laboratory Measures: Hemoglobin, Creatinine | Hemoglobin (g/dL)-Screening | 14.7 g/dL |
| Part A, Group 1: Vaccine | Part A Chemistry Laboratory Measures: Hemoglobin, Creatinine | Hemoglobin (g/dL)-Day 14 | 14.1 g/dL |
| Part A, Group 1: Vaccine | Part A Chemistry Laboratory Measures: Hemoglobin, Creatinine | Hemoglobin (g/dL)-Day 42 | 14.4 g/dL |
| Part A, Group 1: Vaccine | Part A Chemistry Laboratory Measures: Hemoglobin, Creatinine | Hemoglobin (g/dL)-Day 98 | 14.3 g/dL |
| Part A, Group 1: Vaccine | Part A Chemistry Laboratory Measures: Hemoglobin, Creatinine | Hemoglobin (g/dL)-Day 182 | 14.1 g/dL |
| Part A, Group 1: Vaccine | Part A Chemistry Laboratory Measures: Hemoglobin, Creatinine | Hemoglobin (g/dL)-Day 378 | 13.9 g/dL |
| Part A, Group 1: Vaccine | Part A Chemistry Laboratory Measures: Hemoglobin, Creatinine | Creatinine (g/dL)-Screening | 0.0007 g/dL |
| Part A, Group 1: Vaccine | Part A Chemistry Laboratory Measures: Hemoglobin, Creatinine | Creatinine (g/dL)-Day 14 | 0.00077 g/dL |
| Part A, Group 1: Vaccine | Part A Chemistry Laboratory Measures: Hemoglobin, Creatinine | Creatinine (g/dL)-Day 42 | 0.0007 g/dL |
| Part A, Group 1: Vaccine | Part A Chemistry Laboratory Measures: Hemoglobin, Creatinine | Creatinine (g/dL)-Day 98 | 0.00073 g/dL |
| Part A, Group 1: Vaccine | Part A Chemistry Laboratory Measures: Hemoglobin, Creatinine | Creatinine (g/dL)-Day 182 | 0.0008 g/dL |
| Part A, Group 1: Vaccine | Part A Chemistry Laboratory Measures: Hemoglobin, Creatinine | Creatinine (g/dL)-Day 378 | 0.0008 g/dL |
| Part A, Group 2: Placebo | Part A Chemistry Laboratory Measures: Hemoglobin, Creatinine | Creatinine (g/dL)-Day 182 | 0.0007 g/dL |
| Part A, Group 2: Placebo | Part A Chemistry Laboratory Measures: Hemoglobin, Creatinine | Hemoglobin (g/dL)-Screening | 14.4 g/dL |
| Part A, Group 2: Placebo | Part A Chemistry Laboratory Measures: Hemoglobin, Creatinine | Creatinine (g/dL)-Screening | 0.0007 g/dL |
| Part A, Group 2: Placebo | Part A Chemistry Laboratory Measures: Hemoglobin, Creatinine | Hemoglobin (g/dL)-Day 14 | 13.4 g/dL |
| Part A, Group 2: Placebo | Part A Chemistry Laboratory Measures: Hemoglobin, Creatinine | Creatinine (g/dL)-Day 98 | 0.00077 g/dL |
| Part A, Group 2: Placebo | Part A Chemistry Laboratory Measures: Hemoglobin, Creatinine | Hemoglobin (g/dL)-Day 42 | 13.75 g/dL |
| Part A, Group 2: Placebo | Part A Chemistry Laboratory Measures: Hemoglobin, Creatinine | Creatinine (g/dL)-Day 14 | 0.0007 g/dL |
| Part A, Group 2: Placebo | Part A Chemistry Laboratory Measures: Hemoglobin, Creatinine | Hemoglobin (g/dL)-Day 98 | 13.5 g/dL |
| Part A, Group 2: Placebo | Part A Chemistry Laboratory Measures: Hemoglobin, Creatinine | Creatinine (g/dL)-Day 378 | 0.0007 g/dL |
| Part A, Group 2: Placebo | Part A Chemistry Laboratory Measures: Hemoglobin, Creatinine | Hemoglobin (g/dL)-Day 182 | 13.9 g/dL |
| Part A, Group 2: Placebo | Part A Chemistry Laboratory Measures: Hemoglobin, Creatinine | Creatinine (g/dL)-Day 42 | 0.0007 g/dL |
| Part A, Group 2: Placebo | Part A Chemistry Laboratory Measures: Hemoglobin, Creatinine | Hemoglobin (g/dL)-Day 378 | 13.4 g/dL |
Primary
Part A Hematology Laboratory Measures: 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 for part A, and 2 weeks after each vaccination at Month 0, 1, 3, 6, and 12
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) |
|---|---|---|---|
| Part A, Group 1: Vaccine | Part A Hematology Laboratory Measures: WBC, Platelets, Lymphocytes, Neutrophils | Lymphocytes (1000/cubic mm)-Day 378 | 2 thousand cells/cubic mm |
| Part A, Group 1: Vaccine | Part A Hematology Laboratory Measures: WBC, Platelets, Lymphocytes, Neutrophils | WBC (1000/cubic mm)-Day 378 | 5.69 thousand cells/cubic mm |
| Part A, Group 1: Vaccine | Part A Hematology Laboratory Measures: WBC, Platelets, Lymphocytes, Neutrophils | Platelets (1000/cubic mm)-Day 378 | 273 thousand cells/cubic mm |
| Part A, Group 1: Vaccine | Part A Hematology Laboratory Measures: WBC, Platelets, Lymphocytes, Neutrophils | Neutrophils (1000/cubic mm)-Screening | 3.23 thousand cells/cubic mm |
| Part A, Group 1: Vaccine | Part A Hematology Laboratory Measures: WBC, Platelets, Lymphocytes, Neutrophils | Platelets (1000/cubic mm)-Day 14 | 265 thousand cells/cubic mm |
| Part A, Group 1: Vaccine | Part A Hematology Laboratory Measures: WBC, Platelets, Lymphocytes, Neutrophils | Neutrophils (1000/cubic mm)-Day 14 | 3.18 thousand cells/cubic mm |
| Part A, Group 1: Vaccine | Part A Hematology Laboratory Measures: WBC, Platelets, Lymphocytes, Neutrophils | WBC (1000/cubic mm)-Screening | 6.135 thousand cells/cubic mm |
| Part A, Group 1: Vaccine | Part A Hematology Laboratory Measures: WBC, Platelets, Lymphocytes, Neutrophils | Neutrophils (1000/cubic mm)-Day 42 | 3.057 thousand cells/cubic mm |
| Part A, Group 1: Vaccine | Part A Hematology Laboratory Measures: WBC, Platelets, Lymphocytes, Neutrophils | Platelets (1000/cubic mm)-Day 182 | 259.5 thousand cells/cubic mm |
| Part A, Group 1: Vaccine | Part A Hematology Laboratory Measures: WBC, Platelets, Lymphocytes, Neutrophils | Neutrophils (1000/cubic mm)-Day 98 | 3.284 thousand cells/cubic mm |
| Part A, Group 1: Vaccine | Part A Hematology Laboratory Measures: WBC, Platelets, Lymphocytes, Neutrophils | WBC (1000/cubic mm)-Day 14 | 6 thousand cells/cubic mm |
| Part A, Group 1: Vaccine | Part A Hematology Laboratory Measures: WBC, Platelets, Lymphocytes, Neutrophils | Neutrophils (1000/cubic mm)-Day 182 | 2.927 thousand cells/cubic mm |
| Part A, Group 1: Vaccine | Part A Hematology Laboratory Measures: WBC, Platelets, Lymphocytes, Neutrophils | Platelets (1000/cubic mm)-Day 42 | 267 thousand cells/cubic mm |
| Part A, Group 1: Vaccine | Part A Hematology Laboratory Measures: WBC, Platelets, Lymphocytes, Neutrophils | Neutrophils (1000/cubic mm)-Day 378 | 3.08 thousand cells/cubic mm |
| Part A, Group 1: Vaccine | Part A Hematology Laboratory Measures: WBC, Platelets, Lymphocytes, Neutrophils | WBC (1000/cubic mm)-Day 42 | 5.87 thousand cells/cubic mm |
| Part A, Group 1: Vaccine | Part A Hematology Laboratory Measures: WBC, Platelets, Lymphocytes, Neutrophils | Lymphocytes (1000/cubic mm)-Screening | 2.182 thousand cells/cubic mm |
| Part A, Group 1: Vaccine | Part A Hematology Laboratory Measures: WBC, Platelets, Lymphocytes, Neutrophils | Platelets (1000/cubic mm)-Screening | 250.5 thousand cells/cubic mm |
| Part A, Group 1: Vaccine | Part A Hematology Laboratory Measures: WBC, Platelets, Lymphocytes, Neutrophils | Lymphocytes (1000/cubic mm)-Day 14 | 2.102 thousand cells/cubic mm |
| Part A, Group 1: Vaccine | Part A Hematology Laboratory Measures: WBC, Platelets, Lymphocytes, Neutrophils | WBC (1000/cubic mm)-Day 98 | 6.055 thousand cells/cubic mm |
| Part A, Group 1: Vaccine | Part A Hematology Laboratory Measures: WBC, Platelets, Lymphocytes, Neutrophils | Lymphocytes (1000/cubic mm)-Day 42 | 2.0545 thousand cells/cubic mm |
| Part A, Group 1: Vaccine | Part A Hematology Laboratory Measures: WBC, Platelets, Lymphocytes, Neutrophils | Platelets (1000/cubic mm)-Day 98 | 267 thousand cells/cubic mm |
| Part A, Group 1: Vaccine | Part A Hematology Laboratory Measures: WBC, Platelets, Lymphocytes, Neutrophils | Lymphocytes (1000/cubic mm)-Day 98 | 1.9435 thousand cells/cubic mm |
| Part A, Group 1: Vaccine | Part A Hematology Laboratory Measures: WBC, Platelets, Lymphocytes, Neutrophils | WBC (1000/cubic mm)-Day 182 | 5.67 thousand cells/cubic mm |
| Part A, Group 1: Vaccine | Part A Hematology Laboratory Measures: WBC, Platelets, Lymphocytes, Neutrophils | Lymphocytes (1000/cubic mm)-Day 182 | 2.004 thousand cells/cubic mm |
| Part A, Group 2: Placebo | Part A Hematology Laboratory Measures: WBC, Platelets, Lymphocytes, Neutrophils | Neutrophils (1000/cubic mm)-Day 14 | 3.08 thousand cells/cubic mm |
| Part A, Group 2: Placebo | Part A Hematology Laboratory Measures: WBC, Platelets, Lymphocytes, Neutrophils | Lymphocytes (1000/cubic mm)-Day 182 | 1.96 thousand cells/cubic mm |
| Part A, Group 2: Placebo | Part A Hematology Laboratory Measures: WBC, Platelets, Lymphocytes, Neutrophils | Lymphocytes (1000/cubic mm)-Day 378 | 1.975 thousand cells/cubic mm |
| Part A, Group 2: Placebo | Part A Hematology Laboratory Measures: WBC, Platelets, Lymphocytes, Neutrophils | Platelets (1000/cubic mm)-Screening | 275 thousand cells/cubic mm |
| Part A, Group 2: Placebo | Part A Hematology Laboratory Measures: WBC, Platelets, Lymphocytes, Neutrophils | Platelets (1000/cubic mm)-Day 14 | 272 thousand cells/cubic mm |
| Part A, Group 2: Placebo | Part A Hematology Laboratory Measures: WBC, Platelets, Lymphocytes, Neutrophils | Platelets (1000/cubic mm)-Day 42 | 270 thousand cells/cubic mm |
| Part A, Group 2: Placebo | Part A Hematology Laboratory Measures: WBC, Platelets, Lymphocytes, Neutrophils | Platelets (1000/cubic mm)-Day 182 | 267 thousand cells/cubic mm |
| Part A, Group 2: Placebo | Part A Hematology Laboratory Measures: WBC, Platelets, Lymphocytes, Neutrophils | Platelets (1000/cubic mm)-Day 378 | 264.5 thousand cells/cubic mm |
| Part A, Group 2: Placebo | Part A Hematology Laboratory Measures: WBC, Platelets, Lymphocytes, Neutrophils | WBC (1000/cubic mm)-Screening | 6.3 thousand cells/cubic mm |
| Part A, Group 2: Placebo | Part A Hematology Laboratory Measures: WBC, Platelets, Lymphocytes, Neutrophils | WBC (1000/cubic mm)-Day 14 | 5.9 thousand cells/cubic mm |
| Part A, Group 2: Placebo | Part A Hematology Laboratory Measures: WBC, Platelets, Lymphocytes, Neutrophils | WBC (1000/cubic mm)-Day 42 | 5.425 thousand cells/cubic mm |
| Part A, Group 2: Placebo | Part A Hematology Laboratory Measures: WBC, Platelets, Lymphocytes, Neutrophils | WBC (1000/cubic mm)-Day 98 | 5.9 thousand cells/cubic mm |
| Part A, Group 2: Placebo | Part A Hematology Laboratory Measures: WBC, Platelets, Lymphocytes, Neutrophils | WBC (1000/cubic mm)-Day 182 | 5.63 thousand cells/cubic mm |
| Part A, Group 2: Placebo | Part A Hematology Laboratory Measures: WBC, Platelets, Lymphocytes, Neutrophils | WBC (1000/cubic mm)-Day 378 | 5.815 thousand cells/cubic mm |
| Part A, Group 2: Placebo | Part A Hematology Laboratory Measures: WBC, Platelets, Lymphocytes, Neutrophils | Neutrophils (1000/cubic mm)-Screening | 3.265 thousand cells/cubic mm |
| Part A, Group 2: Placebo | Part A Hematology Laboratory Measures: WBC, Platelets, Lymphocytes, Neutrophils | Platelets (1000/cubic mm)-Day 98 | 276 thousand cells/cubic mm |
| Part A, Group 2: Placebo | Part A Hematology Laboratory Measures: WBC, Platelets, Lymphocytes, Neutrophils | Neutrophils (1000/cubic mm)-Day 42 | 2.9015 thousand cells/cubic mm |
| Part A, Group 2: Placebo | Part A Hematology Laboratory Measures: WBC, Platelets, Lymphocytes, Neutrophils | Neutrophils (1000/cubic mm)-Day 98 | 3.25 thousand cells/cubic mm |
| Part A, Group 2: Placebo | Part A Hematology Laboratory Measures: WBC, Platelets, Lymphocytes, Neutrophils | Neutrophils (1000/cubic mm)-Day 182 | 2.629 thousand cells/cubic mm |
| Part A, Group 2: Placebo | Part A Hematology Laboratory Measures: WBC, Platelets, Lymphocytes, Neutrophils | Neutrophils (1000/cubic mm)-Day 378 | 3.089 thousand cells/cubic mm |
| Part A, Group 2: Placebo | Part A Hematology Laboratory Measures: WBC, Platelets, Lymphocytes, Neutrophils | Lymphocytes (1000/cubic mm)-Screening | 2.299 thousand cells/cubic mm |
| Part A, Group 2: Placebo | Part A Hematology Laboratory Measures: WBC, Platelets, Lymphocytes, Neutrophils | Lymphocytes (1000/cubic mm)-Day 14 | 2.064 thousand cells/cubic mm |
| Part A, Group 2: Placebo | Part A Hematology Laboratory Measures: WBC, Platelets, Lymphocytes, Neutrophils | Lymphocytes (1000/cubic mm)-Day 42 | 2.031 thousand cells/cubic mm |
| Part A, Group 2: Placebo | Part A Hematology Laboratory Measures: WBC, Platelets, Lymphocytes, Neutrophils | Lymphocytes (1000/cubic mm)-Day 98 | 2.02 thousand cells/cubic mm |
Primary
Part A: Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine After the Primary Vaccine Regimen.
Measured by flow cytometry ICS assay: refer to earlier description for assay methods and analysis variable derivation. Percentage of T-cells expressing cytokines are summarized for positive responders only.
Time frame: Measured at Month 6.5
Population: Overall Number of Participants Analyzed includes those with samples collected at the month 6.5 immunogenicity timepoint, who were HIV-uninfected and received the first 4 vaccinations. Number Analyzed shows the number of participants with available data after filtering for assay-specific quality control criteria.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Part A, Group 1: Vaccine | Part A: Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine After the Primary Vaccine Regimen. | Any gp120 | 0.11501130 % CD4+ T-cells |
| Part A, Group 1: Vaccine | Part A: Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine After the Primary Vaccine Regimen. | 1086 gp120 | 0.06613413 % CD4+ T-cells |
| Part A, Group 1: Vaccine | Part A: Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine After the Primary Vaccine Regimen. | TV1 gp120 | 0.09629575 % CD4+ T-cells |
| Part A, Group 1: Vaccine | Part A: Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine After the Primary Vaccine Regimen. | ZM96 gp120 | 0.0889934 % CD4+ T-cells |
| Part A, Group 2: Placebo | Part A: Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine After the Primary Vaccine Regimen. | ZM96 gp120 | -0.002505630 % CD4+ T-cells |
| Part A, Group 2: Placebo | Part A: Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine After the Primary Vaccine Regimen. | Any gp120 | 0.003579320 % CD4+ T-cells |
| Part A, Group 2: Placebo | Part A: Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine After the Primary Vaccine Regimen. | TV1 gp120 | -0.002244635 % CD4+ T-cells |
| Part A, Group 2: Placebo | Part A: Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine After the Primary Vaccine Regimen. | 1086 gp120 | -0.00296204 % CD4+ T-cells |
Primary
Part A: Level of IgG Ab Binding to gp120 Env Proteins Contained in the Vaccine (ZM96, TV1.C, 1086.C) After the Primary Vaccine Regimen, Measured by HIV-1 Multiplex Antibody Assay
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.
Time frame: Measured at Month 6.5
Population: Overall Number of Participants Analyzed includes those with samples collected at the month 6.5 immunogenicity timepoint, who were HIV-uninfected and received the first 4 vaccinations. Number Analyzed shows the number of participants with available data after filtering for assay-specific quality control criteria.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Part A, Group 1: Vaccine | Part A: Level of IgG Ab Binding to gp120 Env Proteins Contained in the Vaccine (ZM96, TV1.C, 1086.C) After the Primary Vaccine Regimen, Measured by HIV-1 Multiplex Antibody Assay | 1086C_D7gp120.avi/293F | 28359.5 fluorescence unit relative to background |
| Part A, Group 1: Vaccine | Part A: Level of IgG Ab Binding to gp120 Env Proteins Contained in the Vaccine (ZM96, TV1.C, 1086.C) After the Primary Vaccine Regimen, Measured by HIV-1 Multiplex Antibody Assay | 96ZM651.D11gp120.avi | 2650 fluorescence unit relative to background |
| Part A, Group 1: Vaccine | Part A: Level of IgG Ab Binding to gp120 Env Proteins Contained in the Vaccine (ZM96, TV1.C, 1086.C) After the Primary Vaccine Regimen, Measured by HIV-1 Multiplex Antibody Assay | TV1c8_D11gp120.avi/293F | 12883.5 fluorescence unit relative to background |
| Part A, Group 2: Placebo | Part A: Level of IgG Ab Binding to gp120 Env Proteins Contained in the Vaccine (ZM96, TV1.C, 1086.C) After the Primary Vaccine Regimen, Measured by HIV-1 Multiplex Antibody Assay | 1086C_D7gp120.avi/293F | 1 fluorescence unit relative to background |
| Part A, Group 2: Placebo | Part A: Level of IgG Ab Binding to gp120 Env Proteins Contained in the Vaccine (ZM96, TV1.C, 1086.C) After the Primary Vaccine Regimen, Measured by HIV-1 Multiplex Antibody Assay | 96ZM651.D11gp120.avi | 1 fluorescence unit relative to background |
| Part A, Group 2: Placebo | Part A: Level of IgG Ab Binding to gp120 Env Proteins Contained in the Vaccine (ZM96, TV1.C, 1086.C) After the Primary Vaccine Regimen, Measured by HIV-1 Multiplex Antibody Assay | TV1c8_D11gp120.avi/293F | 1 fluorescence unit relative to background |
Primary
Part A: Level of IgG Binding Antibodies to 3 V1V2-scaffolded Env Proteins After the Primary Vaccine Regimen
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.
Time frame: Measured at Month 6.5
Population: Overall Number of Participants Analyzed includes those with samples collected at the month 6.5 immunogenicity timepoint, who were HIV-uninfected and received the first 4 vaccinations. Number Analyzed shows the number of participants with available data after filtering for assay-specific quality control criteria.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Part A, Group 1: Vaccine | Part A: Level of IgG Binding Antibodies to 3 V1V2-scaffolded Env Proteins After the Primary Vaccine Regimen | C.1086C_V1_V2 Tags | 562 fluorescence unit relative to background |
| Part A, Group 1: Vaccine | Part A: Level of IgG Binding Antibodies to 3 V1V2-scaffolded Env Proteins After the Primary Vaccine Regimen | gp70-96ZM651.02 V1v2 | 392.5 fluorescence unit relative to background |
| Part A, Group 1: Vaccine | Part A: Level of IgG Binding Antibodies to 3 V1V2-scaffolded Env Proteins After the Primary Vaccine Regimen | gp70-TV1.21 V1V2 | 338.25 fluorescence unit relative to background |
| Part A, Group 2: Placebo | Part A: Level of IgG Binding Antibodies to 3 V1V2-scaffolded Env Proteins After the Primary Vaccine Regimen | C.1086C_V1_V2 Tags | 1 fluorescence unit relative to background |
| Part A, Group 2: Placebo | Part A: Level of IgG Binding Antibodies to 3 V1V2-scaffolded Env Proteins After the Primary Vaccine Regimen | gp70-96ZM651.02 V1v2 | 1 fluorescence unit relative to background |
| Part A, Group 2: Placebo | Part A: Level of IgG Binding Antibodies to 3 V1V2-scaffolded Env Proteins After the Primary Vaccine Regimen | gp70-TV1.21 V1V2 | 1 fluorescence unit relative to background |
Primary
Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen
Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 \[March 2017\] The maximum grade observed for each symptom over the time frame is presented.
Time frame: Measured through 3 days after participants' last vaccination at Month 0,1,3, and 6
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Part A, Group 1: Vaccine | Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Erythema | None | 201 Participants |
| Part A, Group 1: Vaccine | Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Tenderness | Severe | 1 Participants |
| Part A, Group 1: Vaccine | Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Erythema | Mild | 6 Participants |
| Part A, Group 1: Vaccine | Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Pain | Mild | 126 Participants |
| Part A, Group 1: Vaccine | Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Erythema | Moderate | 2 Participants |
| Part A, Group 1: Vaccine | Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Tenderness | Life Threatening | 0 Participants |
| Part A, Group 1: Vaccine | Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Erythema | Severe | 1 Participants |
| Part A, Group 1: Vaccine | Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Tenderness | None | 69 Participants |
| Part A, Group 1: Vaccine | Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Erythema | Life Threatening | 0 Participants |
| Part A, Group 1: Vaccine | Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Pain and/or Tenderness | None | 35 Participants |
| Part A, Group 1: Vaccine | Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Induration | None | 187 Participants |
| Part A, Group 1: Vaccine | Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Pain | Severe | 2 Participants |
| Part A, Group 1: Vaccine | Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Induration | Mild | 13 Participants |
| Part A, Group 1: Vaccine | Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Pain and/or Tenderness | Mild | 131 Participants |
| Part A, Group 1: Vaccine | Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Induration | Moderate | 9 Participants |
| Part A, Group 1: Vaccine | Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Tenderness | Mild | 114 Participants |
| Part A, Group 1: Vaccine | Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Induration | Severe | 1 Participants |
| Part A, Group 1: Vaccine | Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Pain and/or Tenderness | Moderate | 42 Participants |
| Part A, Group 1: Vaccine | Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Induration | Life Threatening | 0 Participants |
| Part A, Group 1: Vaccine | Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Pain | Moderate | 40 Participants |
| Part A, Group 1: Vaccine | Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Erythema and/or Induration | None | 185 Participants |
| Part A, Group 1: Vaccine | Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Pain and/or Tenderness | Severe | 2 Participants |
| Part A, Group 1: Vaccine | Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Erythema and/or Induration | Mild | 14 Participants |
| Part A, Group 1: Vaccine | Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Tenderness | Moderate | 26 Participants |
| Part A, Group 1: Vaccine | Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Erythema and/or Induration | Moderate | 10 Participants |
| Part A, Group 1: Vaccine | Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Pain and/or Tenderness | Life Threatening | 0 Participants |
| Part A, Group 1: Vaccine | Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Erythema and/or Induration | Severe | 1 Participants |
| Part A, Group 1: Vaccine | Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Pain | Life Threatening | 0 Participants |
| Part A, Group 1: Vaccine | Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Erythema and/or Induration | Life Threatening | 0 Participants |
| Part A, Group 1: Vaccine | Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Pain | None | 42 Participants |
| Part A, Group 2: Placebo | Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Erythema and/or Induration | Life Threatening | 0 Participants |
| Part A, Group 2: Placebo | Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Pain | None | 26 Participants |
| Part A, Group 2: Placebo | Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Pain | Mild | 16 Participants |
| Part A, Group 2: Placebo | Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Pain | Moderate | 0 Participants |
| Part A, Group 2: Placebo | Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Pain | Severe | 0 Participants |
| Part A, Group 2: Placebo | Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Pain | Life Threatening | 0 Participants |
| Part A, Group 2: Placebo | Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Tenderness | None | 34 Participants |
| Part A, Group 2: Placebo | Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Tenderness | Mild | 8 Participants |
| Part A, Group 2: Placebo | Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Tenderness | Moderate | 0 Participants |
| Part A, Group 2: Placebo | Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Tenderness | Severe | 0 Participants |
| Part A, Group 2: Placebo | Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Tenderness | Life Threatening | 0 Participants |
| Part A, Group 2: Placebo | Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Pain and/or Tenderness | None | 26 Participants |
| Part A, Group 2: Placebo | Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Pain and/or Tenderness | Mild | 16 Participants |
| Part A, Group 2: Placebo | Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Pain and/or Tenderness | Moderate | 0 Participants |
| Part A, Group 2: Placebo | Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Pain and/or Tenderness | Severe | 0 Participants |
| Part A, Group 2: Placebo | Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Pain and/or Tenderness | Life Threatening | 0 Participants |
| Part A, Group 2: Placebo | Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Erythema | None | 42 Participants |
| Part A, Group 2: Placebo | Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Erythema | Mild | 0 Participants |
| Part A, Group 2: Placebo | Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Erythema | Moderate | 0 Participants |
| Part A, Group 2: Placebo | Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Erythema | Severe | 0 Participants |
| Part A, Group 2: Placebo | Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Erythema | Life Threatening | 0 Participants |
| Part A, Group 2: Placebo | Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Induration | None | 42 Participants |
| Part A, Group 2: Placebo | Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Induration | Mild | 0 Participants |
| Part A, Group 2: Placebo | Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Induration | Moderate | 0 Participants |
| Part A, Group 2: Placebo | Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Induration | Severe | 0 Participants |
| Part A, Group 2: Placebo | Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Induration | Life Threatening | 0 Participants |
| Part A, Group 2: Placebo | Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Erythema and/or Induration | None | 42 Participants |
| Part A, Group 2: Placebo | Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Erythema and/or Induration | Mild | 0 Participants |
| Part A, Group 2: Placebo | Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Erythema and/or Induration | Moderate | 0 Participants |
| Part A, Group 2: Placebo | Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Erythema and/or Induration | Severe | 0 Participants |
Primary
Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen
Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 \[March 2017\]
Time frame: Measured through 3 days after each vaccination at Month 0, 1, 3, and 6
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Part A, Group 1: Vaccine | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Malaise and/or fatigue | None | 125 Participants |
| Part A, Group 1: Vaccine | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Malaise and/or fatigue | Mild | 76 Participants |
| Part A, Group 1: Vaccine | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Malaise and/or fatigue | Moderate | 9 Participants |
| Part A, Group 1: Vaccine | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Malaise and/or fatigue | Severe | 0 Participants |
| Part A, Group 1: Vaccine | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Malaise and/or fatigue | Potentially Life-threatening | 0 Participants |
| Part A, Group 1: Vaccine | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Myalgia | None | 132 Participants |
| Part A, Group 1: Vaccine | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Myalgia | Mild | 60 Participants |
| Part A, Group 1: Vaccine | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Myalgia | Moderate | 18 Participants |
| Part A, Group 1: Vaccine | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Myalgia | Severe | 0 Participants |
| Part A, Group 1: Vaccine | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Myalgia | Potentially Life-threatening | 0 Participants |
| Part A, Group 1: Vaccine | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Headache | None | 139 Participants |
| Part A, Group 1: Vaccine | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Headache | Mild | 56 Participants |
| Part A, Group 1: Vaccine | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Headache | Moderate | 15 Participants |
| Part A, Group 1: Vaccine | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Headache | Severe | 0 Participants |
| Part A, Group 1: Vaccine | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Headache | Potentially Life-threatening | 0 Participants |
| Part A, Group 1: Vaccine | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Nausea | None | 179 Participants |
| Part A, Group 1: Vaccine | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Nausea | Mild | 29 Participants |
| Part A, Group 1: Vaccine | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Nausea | Moderate | 2 Participants |
| Part A, Group 1: Vaccine | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Nausea | Severe | 0 Participants |
| Part A, Group 1: Vaccine | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Nausea | Potentially Life-threatening | 0 Participants |
| Part A, Group 1: Vaccine | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Vomiting | None | 200 Participants |
| Part A, Group 1: Vaccine | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Vomiting | Mild | 9 Participants |
| Part A, Group 1: Vaccine | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Vomiting | Moderate | 1 Participants |
| Part A, Group 1: Vaccine | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Vomiting | Severe | 0 Participants |
| Part A, Group 1: Vaccine | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Vomiting | Potentially Life-threatening | 0 Participants |
| Part A, Group 1: Vaccine | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Chills | None | 195 Participants |
| Part A, Group 1: Vaccine | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Chills | Mild | 14 Participants |
| Part A, Group 1: Vaccine | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Chills | Moderate | 1 Participants |
| Part A, Group 1: Vaccine | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Chills | Severe | 0 Participants |
| Part A, Group 1: Vaccine | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Chills | Potentially Life-threatening | 0 Participants |
| Part A, Group 1: Vaccine | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Arthralgia | None | 151 Participants |
| Part A, Group 1: Vaccine | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Arthralgia | Mild | 53 Participants |
| Part A, Group 1: Vaccine | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Arthralgia | Moderate | 4 Participants |
| Part A, Group 1: Vaccine | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Arthralgia | Severe | 2 Participants |
| Part A, Group 1: Vaccine | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Arthralgia | Potentially Life-threatening | 0 Participants |
| Part A, Group 1: Vaccine | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Max. Systemic Symptoms | None | 68 Participants |
| Part A, Group 1: Vaccine | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Max. Systemic Symptoms | Mild | 109 Participants |
| Part A, Group 1: Vaccine | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Max. Systemic Symptoms | Moderate | 31 Participants |
| Part A, Group 1: Vaccine | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Max. Systemic Symptoms | Severe | 2 Participants |
| Part A, Group 1: Vaccine | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Max. Systemic Symptoms | Potentially Life-threatening | 0 Participants |
| Part A, Group 1: Vaccine | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Temperature | None | 195 Participants |
| Part A, Group 1: Vaccine | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Temperature | Mild | 8 Participants |
| Part A, Group 1: Vaccine | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Temperature | Moderate | 7 Participants |
| Part A, Group 1: Vaccine | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Temperature | Severe | 0 Participants |
| Part A, Group 1: Vaccine | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Temperature | Potentially Life-threatening | 0 Participants |
| Part A, Group 2: Placebo | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Vomiting | Moderate | 0 Participants |
| Part A, Group 2: Placebo | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Malaise and/or fatigue | None | 28 Participants |
| Part A, Group 2: Placebo | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Max. Systemic Symptoms | Potentially Life-threatening | 0 Participants |
| Part A, Group 2: Placebo | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Malaise and/or fatigue | Mild | 13 Participants |
| Part A, Group 2: Placebo | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Vomiting | Severe | 0 Participants |
| Part A, Group 2: Placebo | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Malaise and/or fatigue | Moderate | 1 Participants |
| Part A, Group 2: Placebo | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Arthralgia | Potentially Life-threatening | 0 Participants |
| Part A, Group 2: Placebo | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Malaise and/or fatigue | Severe | 0 Participants |
| Part A, Group 2: Placebo | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Vomiting | Potentially Life-threatening | 0 Participants |
| Part A, Group 2: Placebo | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Malaise and/or fatigue | Potentially Life-threatening | 0 Participants |
| Part A, Group 2: Placebo | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Temperature | Moderate | 1 Participants |
| Part A, Group 2: Placebo | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Myalgia | None | 34 Participants |
| Part A, Group 2: Placebo | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Chills | None | 40 Participants |
| Part A, Group 2: Placebo | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Myalgia | Mild | 7 Participants |
| Part A, Group 2: Placebo | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Max. Systemic Symptoms | None | 16 Participants |
| Part A, Group 2: Placebo | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Myalgia | Moderate | 1 Participants |
| Part A, Group 2: Placebo | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Chills | Mild | 2 Participants |
| Part A, Group 2: Placebo | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Myalgia | Severe | 0 Participants |
| Part A, Group 2: Placebo | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Temperature | None | 41 Participants |
| Part A, Group 2: Placebo | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Myalgia | Potentially Life-threatening | 0 Participants |
| Part A, Group 2: Placebo | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Chills | Moderate | 0 Participants |
| Part A, Group 2: Placebo | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Headache | None | 21 Participants |
| Part A, Group 2: Placebo | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Max. Systemic Symptoms | Mild | 18 Participants |
| Part A, Group 2: Placebo | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Headache | Mild | 15 Participants |
| Part A, Group 2: Placebo | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Chills | Severe | 0 Participants |
| Part A, Group 2: Placebo | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Headache | Moderate | 6 Participants |
| Part A, Group 2: Placebo | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Temperature | Potentially Life-threatening | 0 Participants |
| Part A, Group 2: Placebo | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Headache | Severe | 0 Participants |
| Part A, Group 2: Placebo | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Chills | Potentially Life-threatening | 0 Participants |
| Part A, Group 2: Placebo | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Headache | Potentially Life-threatening | 0 Participants |
| Part A, Group 2: Placebo | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Max. Systemic Symptoms | Moderate | 8 Participants |
| Part A, Group 2: Placebo | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Nausea | None | 39 Participants |
| Part A, Group 2: Placebo | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Arthralgia | None | 33 Participants |
| Part A, Group 2: Placebo | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Nausea | Mild | 3 Participants |
| Part A, Group 2: Placebo | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Temperature | Mild | 0 Participants |
| Part A, Group 2: Placebo | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Nausea | Moderate | 0 Participants |
| Part A, Group 2: Placebo | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Arthralgia | Mild | 8 Participants |
| Part A, Group 2: Placebo | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Nausea | Severe | 0 Participants |
| Part A, Group 2: Placebo | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Max. Systemic Symptoms | Severe | 0 Participants |
| Part A, Group 2: Placebo | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Nausea | Potentially Life-threatening | 0 Participants |
| Part A, Group 2: Placebo | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Arthralgia | Moderate | 1 Participants |
| Part A, Group 2: Placebo | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Vomiting | None | 41 Participants |
| Part A, Group 2: Placebo | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Temperature | Severe | 0 Participants |
| Part A, Group 2: Placebo | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Vomiting | Mild | 1 Participants |
| Part A, Group 2: Placebo | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Arthralgia | Severe | 0 Participants |
Primary
Part A: 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 18
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A, Group 1: Vaccine | Part A: Number of Participants With Early Study Termination Associated With an AE or Reactogenicity | Termination due to AE/Reactogenicity | 4 Participants |
| Part A, Group 1: Vaccine | Part A: Number of Participants With Early Study Termination Associated With an AE or Reactogenicity | Other Reasons | 206 Participants |
| Part A, Group 2: Placebo | Part A: Number of Participants With Early Study Termination Associated With an AE or Reactogenicity | Termination due to AE/Reactogenicity | 2 Participants |
| Part A, Group 2: Placebo | Part A: Number of Participants With Early Study Termination Associated With an AE or Reactogenicity | Other Reasons | 40 Participants |
Primary
Part A: 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 12 vaccination
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A, Group 1: Vaccine | Part A: Number of Participants With Study Product Discontinuation Associated With an AE or Reactogenicity | Clinical Event | 1 Participants |
| Part A, Group 1: Vaccine | Part A: Number of Participants With Study Product Discontinuation Associated With an AE or Reactogenicity | Reactogenicity | 1 Participants |
| Part A, Group 1: Vaccine | Part A: Number of Participants With Study Product Discontinuation Associated With an AE or Reactogenicity | Other Reasons | 19 Participants |
| Part A, Group 1: Vaccine | Part A: Number of Participants With Study Product Discontinuation Associated With an AE or Reactogenicity | No Discontinuation | 189 Participants |
| Part A, Group 2: Placebo | Part A: Number of Participants With Study Product Discontinuation Associated With an AE or Reactogenicity | No Discontinuation | 39 Participants |
| Part A, Group 2: Placebo | Part A: Number of Participants With Study Product Discontinuation Associated With an AE or Reactogenicity | Clinical Event | 0 Participants |
| Part A, Group 2: Placebo | Part A: Number of Participants With Study Product Discontinuation Associated With an AE or Reactogenicity | Other Reasons | 3 Participants |
| Part A, Group 2: Placebo | Part A: Number of Participants With Study Product Discontinuation Associated With an AE or Reactogenicity | Reactogenicity | 0 Participants |
Primary
Part A: Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine After the Primary Vaccine Regimen. Measured by Flow Cytometry.
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.
Time frame: Measured at Month 6.5
Population: Overall Number of Participants Analyzed includes those with samples collected at the month 6.5 immunogenicity timepoint, who were HIV-uninfected and received the first 4 vaccinations. Number Analyzed shows the number of participants with available data after filtering for assay-specific quality control criteria.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A, Group 1: Vaccine | Part A: Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine After the Primary Vaccine Regimen. Measured by Flow Cytometry. | Any gp120 | 120 Participants |
| Part A, Group 1: Vaccine | Part A: Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine After the Primary Vaccine Regimen. Measured by Flow Cytometry. | 1086 gp120 | 82 Participants |
| Part A, Group 1: Vaccine | Part A: Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine After the Primary Vaccine Regimen. Measured by Flow Cytometry. | TV1 gp120 | 112 Participants |
| Part A, Group 1: Vaccine | Part A: Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine After the Primary Vaccine Regimen. Measured by Flow Cytometry. | ZM96 gp120 | 102 Participants |
| Part A, Group 2: Placebo | Part A: Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine After the Primary Vaccine Regimen. Measured by Flow Cytometry. | ZM96 gp120 | 0 Participants |
| Part A, Group 2: Placebo | Part A: Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine After the Primary Vaccine Regimen. Measured by Flow Cytometry. | Any gp120 | 1 Participants |
| Part A, Group 2: Placebo | Part A: Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine After the Primary Vaccine Regimen. Measured by Flow Cytometry. | TV1 gp120 | 1 Participants |
| Part A, Group 2: Placebo | Part A: Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine After the Primary Vaccine Regimen. Measured by Flow Cytometry. | 1086 gp120 | 1 Participants |
Primary
Part A: Occurrence of IgG Ab Binding to gp120 Env Proteins Contained in the Vaccine (ZM96, TV1.C, 1086.C) After the Primary Vaccine Regimen, Measured by HIV-1 Multiplex Antibody Assay
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. Samples from post-enrollment visits have positive responses if they meet three conditions: (1) net MFI greater than or equal to an antigen-specific response threshold (defined as the maximum of 100 and the 95th percentile of pre-vaccination net MFI), (2) net MFI values are greater than 3 times pre-vaccination net MFI, and (3) experimental antigen MFI values are greater than 3 times pre-vaccination MFI. Data are excluded if the blood draw date was outside the allowable window, a participant was HIV-infected, or the reference antigen exceeds 5000 MFI.
Time frame: Measured at Month 6.5
Population: Overall Number of Participants Analyzed includes those with samples collected at the month 6.5 immunogenicity timepoint, who were HIV-uninfected and received the first 4 vaccinations. Number Analyzed shows the number of participants with available data after filtering for assay-specific quality control criteria.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A, Group 1: Vaccine | Part A: Occurrence of IgG Ab Binding to gp120 Env Proteins Contained in the Vaccine (ZM96, TV1.C, 1086.C) After the Primary Vaccine Regimen, Measured by HIV-1 Multiplex Antibody Assay | 1086C_D7gp120.avi/293F | 185 Participants |
| Part A, Group 1: Vaccine | Part A: Occurrence of IgG Ab Binding to gp120 Env Proteins Contained in the Vaccine (ZM96, TV1.C, 1086.C) After the Primary Vaccine Regimen, Measured by HIV-1 Multiplex Antibody Assay | 96ZM651.D11gp120.avi | 185 Participants |
| Part A, Group 1: Vaccine | Part A: Occurrence of IgG Ab Binding to gp120 Env Proteins Contained in the Vaccine (ZM96, TV1.C, 1086.C) After the Primary Vaccine Regimen, Measured by HIV-1 Multiplex Antibody Assay | TV1c8_D11gp120.avi/293F | 185 Participants |
| Part A, Group 2: Placebo | Part A: Occurrence of IgG Ab Binding to gp120 Env Proteins Contained in the Vaccine (ZM96, TV1.C, 1086.C) After the Primary Vaccine Regimen, Measured by HIV-1 Multiplex Antibody Assay | 1086C_D7gp120.avi/293F | 0 Participants |
| Part A, Group 2: Placebo | Part A: Occurrence of IgG Ab Binding to gp120 Env Proteins Contained in the Vaccine (ZM96, TV1.C, 1086.C) After the Primary Vaccine Regimen, Measured by HIV-1 Multiplex Antibody Assay | 96ZM651.D11gp120.avi | 0 Participants |
| Part A, Group 2: Placebo | Part A: Occurrence of IgG Ab Binding to gp120 Env Proteins Contained in the Vaccine (ZM96, TV1.C, 1086.C) After the Primary Vaccine Regimen, Measured by HIV-1 Multiplex Antibody Assay | TV1c8_D11gp120.avi/293F | 0 Participants |
Primary
Part A: Occurrence of IgG Binding Antibodies to 3 V1V2-scaffolded Env Proteins After the Primary Vaccine Regimen
Measured by HIV-1 multiplex Ab assay: refer to earlier description for assay methods and analysis variable derivation. The number and percentage of participants with positive responses are summarized by antigen.
Time frame: Measured at Month 6.5
Population: Overall Number of Participants Analyzed includes those with samples collected at the month 6.5 immunogenicity timepoint, who were HIV-uninfected and received the first 4 vaccinations. Number Analyzed shows the number of participants with available data after filtering for assay-specific quality control criteria.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A, Group 1: Vaccine | Part A: Occurrence of IgG Binding Antibodies to 3 V1V2-scaffolded Env Proteins After the Primary Vaccine Regimen | C.1086C_V1_V2 Tags | 129 Participants |
| Part A, Group 1: Vaccine | Part A: Occurrence of IgG Binding Antibodies to 3 V1V2-scaffolded Env Proteins After the Primary Vaccine Regimen | gp70-96ZM651.02 V1v2 | 88 Participants |
| Part A, Group 1: Vaccine | Part A: Occurrence of IgG Binding Antibodies to 3 V1V2-scaffolded Env Proteins After the Primary Vaccine Regimen | gp70-TV1.21 V1V2 | 113 Participants |
| Part A, Group 2: Placebo | Part A: Occurrence of IgG Binding Antibodies to 3 V1V2-scaffolded Env Proteins After the Primary Vaccine Regimen | C.1086C_V1_V2 Tags | 0 Participants |
| Part A, Group 2: Placebo | Part A: Occurrence of IgG Binding Antibodies to 3 V1V2-scaffolded Env Proteins After the Primary Vaccine Regimen | gp70-96ZM651.02 V1v2 | 0 Participants |
| Part A, Group 2: Placebo | Part A: Occurrence of IgG Binding Antibodies to 3 V1V2-scaffolded Env Proteins After the Primary Vaccine Regimen | gp70-TV1.21 V1V2 | 0 Participants |
Primary
Part B: Chemistry and Hematology Laboratory Results of Grade 1 or Higher
Laboratory results are summarized by analyte and timepoint. Analytes and timepoint combinations with no grade 1 or higher results are not shown.
Time frame: Time Frame: Measured during screening for part B, and 2 weeks after vaccination at Month 30
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 (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A, Group 1: Vaccine | Part B: Chemistry and Hematology Laboratory Results of Grade 1 or Higher | Hemoglobin (g/dL)-Part B Screening | 0 Participants |
| Part A, Group 1: Vaccine | Part B: Chemistry and Hematology Laboratory Results of Grade 1 or Higher | WBC (1000/cubic mm)-Day 924 | 0 Participants |
| Part A, Group 1: Vaccine | Part B: Chemistry and Hematology Laboratory Results of Grade 1 or Higher | Neutrophils (1000/cubic mm)-Part B Screening | 0 Participants |
| Part A, Group 1: Vaccine | Part B: Chemistry and Hematology Laboratory Results of Grade 1 or Higher | Neutrophils (1000/cubic mm)-Day 924 | 0 Participants |
| Part A, Group 1: Vaccine | Part B: Chemistry and Hematology Laboratory Results of Grade 1 or Higher | WBC (1000/cubic mm)-Part B Screening | 0 Participants |
| Part A, Group 1: Vaccine | Part B: Chemistry and Hematology Laboratory Results of Grade 1 or Higher | Hemoglobin (g/dL)-Day 924 | 0 Participants |
| Part A, Group 1: Vaccine | Part B: Chemistry and Hematology Laboratory Results of Grade 1 or Higher | Lymphocytes (1000/cubic mm)-Part B Screening | 0 Participants |
| Part A, Group 1: Vaccine | Part B: Chemistry and Hematology Laboratory Results of Grade 1 or Higher | Lymphocytes (1000/cubic mm)-Day 924 | 0 Participants |
| Part A, Group 1: Vaccine | Part B: Chemistry and Hematology Laboratory Results of Grade 1 or Higher | Platelets (1000/cubic mm)-Part B Screening | 0 Participants |
| Part A, Group 1: Vaccine | Part B: Chemistry and Hematology Laboratory Results of Grade 1 or Higher | Platelets (1000/cubic mm)-Day 924 | 0 Participants |
| Part A, Group 1: Vaccine | Part B: Chemistry and Hematology Laboratory Results of Grade 1 or Higher | ALT (SGPT) (U/L)-Part B Screening | 0 Participants |
| Part A, Group 1: Vaccine | Part B: Chemistry and Hematology Laboratory Results of Grade 1 or Higher | ALT (SGPT) (U/L)-Day 924 | 0 Participants |
| Part A, Group 1: Vaccine | Part B: Chemistry and Hematology Laboratory Results of Grade 1 or Higher | AST (U/L)-Part B Screening | 0 Participants |
| Part A, Group 1: Vaccine | Part B: Chemistry and Hematology Laboratory Results of Grade 1 or Higher | AST (U/L)-Day 924 | 0 Participants |
| Part A, Group 1: Vaccine | Part B: Chemistry and Hematology Laboratory Results of Grade 1 or Higher | Alkaline Phosphatase (U/L)-Part B Screening | 0 Participants |
| Part A, Group 1: Vaccine | Part B: Chemistry and Hematology Laboratory Results of Grade 1 or Higher | Alkaline Phosphatase (U/L)-Day 924 | 0 Participants |
| Part A, Group 1: Vaccine | Part B: Chemistry and Hematology Laboratory Results of Grade 1 or Higher | Creatinine (g/dL)-Part B Screening | 1 Participants |
| Part A, Group 1: Vaccine | Part B: Chemistry and Hematology Laboratory Results of Grade 1 or Higher | Creatinine (g/dL)-Day 924 | 1 Participants |
| Part A, Group 2: Placebo | Part B: Chemistry and Hematology Laboratory Results of Grade 1 or Higher | Creatinine (g/dL)-Day 924 | 6 Participants |
| Part A, Group 2: Placebo | Part B: Chemistry and Hematology Laboratory Results of Grade 1 or Higher | WBC (1000/cubic mm)-Part B Screening | 0 Participants |
| Part A, Group 2: Placebo | Part B: Chemistry and Hematology Laboratory Results of Grade 1 or Higher | Platelets (1000/cubic mm)-Day 924 | 0 Participants |
| Part A, Group 2: Placebo | Part B: Chemistry and Hematology Laboratory Results of Grade 1 or Higher | AST (U/L)-Part B Screening | 0 Participants |
| Part A, Group 2: Placebo | Part B: Chemistry and Hematology Laboratory Results of Grade 1 or Higher | WBC (1000/cubic mm)-Day 924 | 0 Participants |
| Part A, Group 2: Placebo | Part B: Chemistry and Hematology Laboratory Results of Grade 1 or Higher | Alkaline Phosphatase (U/L)-Part B Screening | 0 Participants |
| Part A, Group 2: Placebo | Part B: Chemistry and Hematology Laboratory Results of Grade 1 or Higher | Alkaline Phosphatase (U/L)-Day 924 | 0 Participants |
| Part A, Group 2: Placebo | Part B: Chemistry and Hematology Laboratory Results of Grade 1 or Higher | Neutrophils (1000/cubic mm)-Part B Screening | 0 Participants |
| Part A, Group 2: Placebo | Part B: Chemistry and Hematology Laboratory Results of Grade 1 or Higher | ALT (SGPT) (U/L)-Part B Screening | 0 Participants |
| Part A, Group 2: Placebo | Part B: Chemistry and Hematology Laboratory Results of Grade 1 or Higher | Creatinine (g/dL)-Part B Screening | 2 Participants |
| Part A, Group 2: Placebo | Part B: Chemistry and Hematology Laboratory Results of Grade 1 or Higher | Neutrophils (1000/cubic mm)-Day 924 | 0 Participants |
| Part A, Group 2: Placebo | Part B: Chemistry and Hematology Laboratory Results of Grade 1 or Higher | Platelets (1000/cubic mm)-Part B Screening | 0 Participants |
| Part A, Group 2: Placebo | Part B: Chemistry and Hematology Laboratory Results of Grade 1 or Higher | AST (U/L)-Day 924 | 0 Participants |
| Part A, Group 2: Placebo | Part B: Chemistry and Hematology Laboratory Results of Grade 1 or Higher | Hemoglobin (g/dL)-Part B Screening | 0 Participants |
| Part A, Group 2: Placebo | Part B: Chemistry and Hematology Laboratory Results of Grade 1 or Higher | Lymphocytes (1000/cubic mm)-Day 924 | 0 Participants |
| Part A, Group 2: Placebo | Part B: Chemistry and Hematology Laboratory Results of Grade 1 or Higher | ALT (SGPT) (U/L)-Day 924 | 0 Participants |
| Part A, Group 2: Placebo | Part B: Chemistry and Hematology Laboratory Results of Grade 1 or Higher | Hemoglobin (g/dL)-Day 924 | 0 Participants |
| Part A, Group 2: Placebo | Part B: Chemistry and Hematology Laboratory Results of Grade 1 or Higher | Lymphocytes (1000/cubic mm)-Part B Screening | 0 Participants |
| Part B, Group 2: Placebo | Part B: Chemistry and Hematology Laboratory Results of Grade 1 or Higher | Hemoglobin (g/dL)-Day 924 | 0 Participants |
| Part B, Group 2: Placebo | Part B: Chemistry and Hematology Laboratory Results of Grade 1 or Higher | Lymphocytes (1000/cubic mm)-Part B Screening | 0 Participants |
| Part B, Group 2: Placebo | Part B: Chemistry and Hematology Laboratory Results of Grade 1 or Higher | Lymphocytes (1000/cubic mm)-Day 924 | 0 Participants |
| Part B, Group 2: Placebo | Part B: Chemistry and Hematology Laboratory Results of Grade 1 or Higher | Alkaline Phosphatase (U/L)-Part B Screening | 0 Participants |
| Part B, Group 2: Placebo | Part B: Chemistry and Hematology Laboratory Results of Grade 1 or Higher | Platelets (1000/cubic mm)-Part B Screening | 0 Participants |
| Part B, Group 2: Placebo | Part B: Chemistry and Hematology Laboratory Results of Grade 1 or Higher | Creatinine (g/dL)-Day 924 | 1 Participants |
| Part B, Group 2: Placebo | Part B: Chemistry and Hematology Laboratory Results of Grade 1 or Higher | Platelets (1000/cubic mm)-Day 924 | 0 Participants |
| Part B, Group 2: Placebo | Part B: Chemistry and Hematology Laboratory Results of Grade 1 or Higher | ALT (SGPT) (U/L)-Part B Screening | 0 Participants |
| Part B, Group 2: Placebo | Part B: Chemistry and Hematology Laboratory Results of Grade 1 or Higher | Alkaline Phosphatase (U/L)-Day 924 | 0 Participants |
| Part B, Group 2: Placebo | Part B: Chemistry and Hematology Laboratory Results of Grade 1 or Higher | ALT (SGPT) (U/L)-Day 924 | 0 Participants |
| Part B, Group 2: Placebo | Part B: Chemistry and Hematology Laboratory Results of Grade 1 or Higher | WBC (1000/cubic mm)-Part B Screening | 0 Participants |
| Part B, Group 2: Placebo | Part B: Chemistry and Hematology Laboratory Results of Grade 1 or Higher | WBC (1000/cubic mm)-Day 924 | 0 Participants |
| Part B, Group 2: Placebo | Part B: Chemistry and Hematology Laboratory Results of Grade 1 or Higher | AST (U/L)-Part B Screening | 0 Participants |
| Part B, Group 2: Placebo | Part B: Chemistry and Hematology Laboratory Results of Grade 1 or Higher | Neutrophils (1000/cubic mm)-Part B Screening | 0 Participants |
| Part B, Group 2: Placebo | Part B: Chemistry and Hematology Laboratory Results of Grade 1 or Higher | Neutrophils (1000/cubic mm)-Day 924 | 0 Participants |
| Part B, Group 2: Placebo | Part B: Chemistry and Hematology Laboratory Results of Grade 1 or Higher | Hemoglobin (g/dL)-Part B Screening | 0 Participants |
| Part B, Group 2: Placebo | Part B: Chemistry and Hematology Laboratory Results of Grade 1 or Higher | AST (U/L)-Day 924 | 0 Participants |
| Part B, Group 2: Placebo | Part B: Chemistry and Hematology Laboratory Results of Grade 1 or Higher | Creatinine (g/dL)-Part B Screening | 0 Participants |
Primary
Part B Chemistry Laboratory Measures: Alkaline Phosphatase, AST, and ALT
For each chemistry laboratory measure, summary statistics were presented by analyte and treatment group for the overall population.
Time frame: Measured during screening for part B, and 2 weeks after vaccination at Month 30
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) |
|---|---|---|---|
| Part A, Group 1: Vaccine | Part B Chemistry Laboratory Measures: Alkaline Phosphatase, AST, and ALT | ALT (SGPT) (U/L)-Part B Screening | 17 U/L |
| Part A, Group 1: Vaccine | Part B Chemistry Laboratory Measures: Alkaline Phosphatase, AST, and ALT | ALT (SGPT) (U/L)-Day 924 | 16 U/L |
| Part A, Group 1: Vaccine | Part B Chemistry Laboratory Measures: Alkaline Phosphatase, AST, and ALT | AST (U/L)-Part B Screening | 22.5 U/L |
| Part A, Group 1: Vaccine | Part B Chemistry Laboratory Measures: Alkaline Phosphatase, AST, and ALT | AST (U/L)-Day 924 | 20.5 U/L |
| Part A, Group 1: Vaccine | Part B Chemistry Laboratory Measures: Alkaline Phosphatase, AST, and ALT | Alkaline Phosphatase (U/L)-Part B Screening | 73 U/L |
| Part A, Group 1: Vaccine | Part B Chemistry Laboratory Measures: Alkaline Phosphatase, AST, and ALT | Alkaline Phosphatase (U/L)-Day 924 | 76.5 U/L |
| Part A, Group 2: Placebo | Part B Chemistry Laboratory Measures: Alkaline Phosphatase, AST, and ALT | Alkaline Phosphatase (U/L)-Day 924 | 69 U/L |
| Part A, Group 2: Placebo | Part B Chemistry Laboratory Measures: Alkaline Phosphatase, AST, and ALT | ALT (SGPT) (U/L)-Part B Screening | 18 U/L |
| Part A, Group 2: Placebo | Part B Chemistry Laboratory Measures: Alkaline Phosphatase, AST, and ALT | AST (U/L)-Day 924 | 21 U/L |
| Part A, Group 2: Placebo | Part B Chemistry Laboratory Measures: Alkaline Phosphatase, AST, and ALT | Alkaline Phosphatase (U/L)-Part B Screening | 74 U/L |
| Part A, Group 2: Placebo | Part B Chemistry Laboratory Measures: Alkaline Phosphatase, AST, and ALT | ALT (SGPT) (U/L)-Day 924 | 15 U/L |
| Part A, Group 2: Placebo | Part B Chemistry Laboratory Measures: Alkaline Phosphatase, AST, and ALT | AST (U/L)-Part B Screening | 23 U/L |
| Part B, Group 2: Placebo | Part B Chemistry Laboratory Measures: Alkaline Phosphatase, AST, and ALT | ALT (SGPT) (U/L)-Day 924 | 16.5 U/L |
| Part B, Group 2: Placebo | Part B Chemistry Laboratory Measures: Alkaline Phosphatase, AST, and ALT | AST (U/L)-Part B Screening | 20 U/L |
| Part B, Group 2: Placebo | Part B Chemistry Laboratory Measures: Alkaline Phosphatase, AST, and ALT | Alkaline Phosphatase (U/L)-Day 924 | 59.5 U/L |
| Part B, Group 2: Placebo | Part B Chemistry Laboratory Measures: Alkaline Phosphatase, AST, and ALT | AST (U/L)-Day 924 | 22 U/L |
| Part B, Group 2: Placebo | Part B Chemistry Laboratory Measures: Alkaline Phosphatase, AST, and ALT | ALT (SGPT) (U/L)-Part B Screening | 20 U/L |
| Part B, Group 2: Placebo | Part B Chemistry Laboratory Measures: Alkaline Phosphatase, AST, and ALT | Alkaline Phosphatase (U/L)-Part B Screening | 68 U/L |
Primary
Part B Chemistry Laboratory Measures: Hemoglobin, Creatinine
For each chemistry laboratory measure, summary statistics were presented by analyte and treatment group for the overall population.
Time frame: Measured during screening for part B, and 2 weeks after vaccination at Month 30
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) |
|---|---|---|---|
| Part A, Group 1: Vaccine | Part B Chemistry Laboratory Measures: Hemoglobin, Creatinine | Hemoglobin (g/dL)-Part B Screening | 14.85 g/dL |
| Part A, Group 1: Vaccine | Part B Chemistry Laboratory Measures: Hemoglobin, Creatinine | Hemoglobin (g/dL)-Day 924 | 14.65 g/dL |
| Part A, Group 1: Vaccine | Part B Chemistry Laboratory Measures: Hemoglobin, Creatinine | Creatinine (g/dL)-Part B Screening | 0.00085 g/dL |
| Part A, Group 1: Vaccine | Part B Chemistry Laboratory Measures: Hemoglobin, Creatinine | Creatinine (g/dL)-Day 924 | 0.0009 g/dL |
| Part A, Group 2: Placebo | Part B Chemistry Laboratory Measures: Hemoglobin, Creatinine | Creatinine (g/dL)-Day 924 | 0.0008 g/dL |
| Part A, Group 2: Placebo | Part B Chemistry Laboratory Measures: Hemoglobin, Creatinine | Hemoglobin (g/dL)-Part B Screening | 14.6 g/dL |
| Part A, Group 2: Placebo | Part B Chemistry Laboratory Measures: Hemoglobin, Creatinine | Creatinine (g/dL)-Part B Screening | 0.0007 g/dL |
| Part A, Group 2: Placebo | Part B Chemistry Laboratory Measures: Hemoglobin, Creatinine | Hemoglobin (g/dL)-Day 924 | 13.965 g/dL |
| Part B, Group 2: Placebo | Part B Chemistry Laboratory Measures: Hemoglobin, Creatinine | Creatinine (g/dL)-Day 924 | 0.00075 g/dL |
| Part B, Group 2: Placebo | Part B Chemistry Laboratory Measures: Hemoglobin, Creatinine | Hemoglobin (g/dL)-Day 924 | 13.7 g/dL |
| Part B, Group 2: Placebo | Part B Chemistry Laboratory Measures: Hemoglobin, Creatinine | Creatinine (g/dL)-Part B Screening | 0.0007 g/dL |
| Part B, Group 2: Placebo | Part B Chemistry Laboratory Measures: Hemoglobin, Creatinine | Hemoglobin (g/dL)-Part B Screening | 13.8 g/dL |
Primary
Part B Chemistry Laboratory Measures: 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 for part B, and 2 weeks after vaccination at Month 30
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) |
|---|---|---|---|
| Part A, Group 1: Vaccine | Part B Chemistry Laboratory Measures: WBC, Platelets, Lymphocytes, Neutrophils | WBC (1000/cubic mm)-Part B Screening | 6.4 thousand cells/cubic mm |
| Part A, Group 1: Vaccine | Part B Chemistry Laboratory Measures: WBC, Platelets, Lymphocytes, Neutrophils | WBC (1000/cubic mm)-Day 924 | 6.28 thousand cells/cubic mm |
| Part A, Group 1: Vaccine | Part B Chemistry Laboratory Measures: WBC, Platelets, Lymphocytes, Neutrophils | Neutrophils (1000/cubic mm)-Part B Screening | 3.499 thousand cells/cubic mm |
| Part A, Group 1: Vaccine | Part B Chemistry Laboratory Measures: WBC, Platelets, Lymphocytes, Neutrophils | Neutrophils (1000/cubic mm)-Day 924 | 3.577 thousand cells/cubic mm |
| Part A, Group 1: Vaccine | Part B Chemistry Laboratory Measures: WBC, Platelets, Lymphocytes, Neutrophils | Lymphocytes (1000/cubic mm)-Part B Screening | 2.2295 thousand cells/cubic mm |
| Part A, Group 1: Vaccine | Part B Chemistry Laboratory Measures: WBC, Platelets, Lymphocytes, Neutrophils | Lymphocytes (1000/cubic mm)-Day 924 | 2.031 thousand cells/cubic mm |
| Part A, Group 1: Vaccine | Part B Chemistry Laboratory Measures: WBC, Platelets, Lymphocytes, Neutrophils | Platelets (1000/cubic mm)-Part B Screening | 264 thousand cells/cubic mm |
| Part A, Group 1: Vaccine | Part B Chemistry Laboratory Measures: WBC, Platelets, Lymphocytes, Neutrophils | Platelets (1000/cubic mm)-Day 924 | 279 thousand cells/cubic mm |
| Part A, Group 2: Placebo | Part B Chemistry Laboratory Measures: WBC, Platelets, Lymphocytes, Neutrophils | Neutrophils (1000/cubic mm)-Part B Screening | 3.41 thousand cells/cubic mm |
| Part A, Group 2: Placebo | Part B Chemistry Laboratory Measures: WBC, Platelets, Lymphocytes, Neutrophils | Platelets (1000/cubic mm)-Part B Screening | 256 thousand cells/cubic mm |
| Part A, Group 2: Placebo | Part B Chemistry Laboratory Measures: WBC, Platelets, Lymphocytes, Neutrophils | Neutrophils (1000/cubic mm)-Day 924 | 3.7825 thousand cells/cubic mm |
| Part A, Group 2: Placebo | Part B Chemistry Laboratory Measures: WBC, Platelets, Lymphocytes, Neutrophils | Lymphocytes (1000/cubic mm)-Part B Screening | 1.941 thousand cells/cubic mm |
| Part A, Group 2: Placebo | Part B Chemistry Laboratory Measures: WBC, Platelets, Lymphocytes, Neutrophils | Lymphocytes (1000/cubic mm)-Day 924 | 1.9295 thousand cells/cubic mm |
| Part A, Group 2: Placebo | Part B Chemistry Laboratory Measures: WBC, Platelets, Lymphocytes, Neutrophils | WBC (1000/cubic mm)-Part B Screening | 6.59 thousand cells/cubic mm |
| Part A, Group 2: Placebo | Part B Chemistry Laboratory Measures: WBC, Platelets, Lymphocytes, Neutrophils | WBC (1000/cubic mm)-Day 924 | 6.355 thousand cells/cubic mm |
| Part A, Group 2: Placebo | Part B Chemistry Laboratory Measures: WBC, Platelets, Lymphocytes, Neutrophils | Platelets (1000/cubic mm)-Day 924 | 248.5 thousand cells/cubic mm |
| Part B, Group 2: Placebo | Part B Chemistry Laboratory Measures: WBC, Platelets, Lymphocytes, Neutrophils | Neutrophils (1000/cubic mm)-Part B Screening | 3.38 thousand cells/cubic mm |
| Part B, Group 2: Placebo | Part B Chemistry Laboratory Measures: WBC, Platelets, Lymphocytes, Neutrophils | WBC (1000/cubic mm)-Day 924 | 6.505 thousand cells/cubic mm |
| Part B, Group 2: Placebo | Part B Chemistry Laboratory Measures: WBC, Platelets, Lymphocytes, Neutrophils | WBC (1000/cubic mm)-Part B Screening | 7.1 thousand cells/cubic mm |
| Part B, Group 2: Placebo | Part B Chemistry Laboratory Measures: WBC, Platelets, Lymphocytes, Neutrophils | Neutrophils (1000/cubic mm)-Day 924 | 3.031 thousand cells/cubic mm |
| Part B, Group 2: Placebo | Part B Chemistry Laboratory Measures: WBC, Platelets, Lymphocytes, Neutrophils | Platelets (1000/cubic mm)-Part B Screening | 311 thousand cells/cubic mm |
| Part B, Group 2: Placebo | Part B Chemistry Laboratory Measures: WBC, Platelets, Lymphocytes, Neutrophils | Lymphocytes (1000/cubic mm)-Day 924 | 2.541 thousand cells/cubic mm |
| Part B, Group 2: Placebo | Part B Chemistry Laboratory Measures: WBC, Platelets, Lymphocytes, Neutrophils | Lymphocytes (1000/cubic mm)-Part B Screening | 2.559 thousand cells/cubic mm |
| Part B, Group 2: Placebo | Part B Chemistry Laboratory Measures: WBC, Platelets, Lymphocytes, Neutrophils | Platelets (1000/cubic mm)-Day 924 | 281.5 thousand cells/cubic mm |
Primary
Part B: Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine in the Extension Study
Measured by flow cytometry ICS assay: refer to earlier description for assay methods and analysis variable derivation. Percentage of T-cells expressing cytokines are summarized for positive responders only.
Time frame: Measured at Month 30.5
Population: Overall Number of Participants Analyzed includes those with samples collected at month 30.5, who were HIV-uninfected and received the all vaccinations. Number Analyzed counts participants with available data after filtering for assay-specific quality control criteria.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Part A, Group 1: Vaccine | Part B: Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine in the Extension Study | Any gp120 | 0.284956245 % of CD4+ T-cells |
| Part A, Group 1: Vaccine | Part B: Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine in the Extension Study | 1086 gp120 | 0.1299094 % of CD4+ T-cells |
| Part A, Group 1: Vaccine | Part B: Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine in the Extension Study | TV1 gp120 | 0.23924445 % of CD4+ T-cells |
| Part A, Group 1: Vaccine | Part B: Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine in the Extension Study | ZM96 gp120 | 0.25434725 % of CD4+ T-cells |
| Part A, Group 2: Placebo | Part B: Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine in the Extension Study | ZM96 gp120 | 0.13517637 % of CD4+ T-cells |
| Part A, Group 2: Placebo | Part B: Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine in the Extension Study | Any gp120 | 0.18676016 % of CD4+ T-cells |
| Part A, Group 2: Placebo | Part B: Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine in the Extension Study | TV1 gp120 | 0.180244495 % of CD4+ T-cells |
| Part A, Group 2: Placebo | Part B: Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine in the Extension Study | 1086 gp120 | 0.11812899 % of CD4+ T-cells |
| Part B, Group 2: Placebo | Part B: Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine in the Extension Study | ZM96 gp120 | -0.00325229 % of CD4+ T-cells |
| Part B, Group 2: Placebo | Part B: Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine in the Extension Study | 1086 gp120 | -0.00507644 % of CD4+ T-cells |
| Part B, Group 2: Placebo | Part B: Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine in the Extension Study | TV1 gp120 | 0.00889506 % of CD4+ T-cells |
| Part B, Group 2: Placebo | Part B: Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine in the Extension Study | Any gp120 | 0.00889506 % of CD4+ T-cells |
Primary
Part B: Level of IgG Ab Binding to gp120 Env Proteins Contained in the Vaccine (ZM96, TV1.C, 1086.C) in the Extension Study
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.
Time frame: Measured at Month 30.5
Population: Overall Number of Participants Analyzed includes those with samples collected at month 30.5, who were HIV-uninfected and received the all vaccinations. Number Analyzed counts participants with available data after filtering for assay-specific quality control criteria.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Part A, Group 1: Vaccine | Part B: Level of IgG Ab Binding to gp120 Env Proteins Contained in the Vaccine (ZM96, TV1.C, 1086.C) in the Extension Study | 96ZM651.D11gp120.avi | 30006.875 fluorescence unit relative to background |
| Part A, Group 1: Vaccine | Part B: Level of IgG Ab Binding to gp120 Env Proteins Contained in the Vaccine (ZM96, TV1.C, 1086.C) in the Extension Study | 1086C_D7gp120.avi/293F | 31063.875 fluorescence unit relative to background |
| Part A, Group 1: Vaccine | Part B: Level of IgG Ab Binding to gp120 Env Proteins Contained in the Vaccine (ZM96, TV1.C, 1086.C) in the Extension Study | TV1c8_D11gp120.avi/293F | 30864.875 fluorescence unit relative to background |
| Part A, Group 2: Placebo | Part B: Level of IgG Ab Binding to gp120 Env Proteins Contained in the Vaccine (ZM96, TV1.C, 1086.C) in the Extension Study | 96ZM651.D11gp120.avi | 30137.5 fluorescence unit relative to background |
| Part A, Group 2: Placebo | Part B: Level of IgG Ab Binding to gp120 Env Proteins Contained in the Vaccine (ZM96, TV1.C, 1086.C) in the Extension Study | 1086C_D7gp120.avi/293F | 30887.75 fluorescence unit relative to background |
| Part A, Group 2: Placebo | Part B: Level of IgG Ab Binding to gp120 Env Proteins Contained in the Vaccine (ZM96, TV1.C, 1086.C) in the Extension Study | TV1c8_D11gp120.avi/293F | 30674.125 fluorescence unit relative to background |
| Part B, Group 2: Placebo | Part B: Level of IgG Ab Binding to gp120 Env Proteins Contained in the Vaccine (ZM96, TV1.C, 1086.C) in the Extension Study | 1086C_D7gp120.avi/293F | 1 fluorescence unit relative to background |
| Part B, Group 2: Placebo | Part B: Level of IgG Ab Binding to gp120 Env Proteins Contained in the Vaccine (ZM96, TV1.C, 1086.C) in the Extension Study | TV1c8_D11gp120.avi/293F | 1 fluorescence unit relative to background |
| Part B, Group 2: Placebo | Part B: Level of IgG Ab Binding to gp120 Env Proteins Contained in the Vaccine (ZM96, TV1.C, 1086.C) in the Extension Study | 96ZM651.D11gp120.avi | 1 fluorescence unit relative to background |
Primary
Part B: Level of IgG Binding Antibodies to 3 V1V2-scaffolded Env Proteins in the Extension Study
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.
Time frame: Measured at Month 30.5
Population: Overall Number of Participants Analyzed includes those with samples collected at month 30.5, who were HIV-uninfected and received the all vaccinations. Number Analyzed counts participants with available data after filtering for assay-specific quality control criteria.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Part A, Group 1: Vaccine | Part B: Level of IgG Binding Antibodies to 3 V1V2-scaffolded Env Proteins in the Extension Study | gp70-96ZM651.02 V1v2 | 858.125 fluorescence unit relative to background |
| Part A, Group 1: Vaccine | Part B: Level of IgG Binding Antibodies to 3 V1V2-scaffolded Env Proteins in the Extension Study | C.1086C_V1_V2 Tags | 527.375 fluorescence unit relative to background |
| Part A, Group 1: Vaccine | Part B: Level of IgG Binding Antibodies to 3 V1V2-scaffolded Env Proteins in the Extension Study | gp70-TV1.GSKvacV1V2/293F | 924.75 fluorescence unit relative to background |
| Part A, Group 2: Placebo | Part B: Level of IgG Binding Antibodies to 3 V1V2-scaffolded Env Proteins in the Extension Study | gp70-96ZM651.02 V1v2 | 1015.625 fluorescence unit relative to background |
| Part A, Group 2: Placebo | Part B: Level of IgG Binding Antibodies to 3 V1V2-scaffolded Env Proteins in the Extension Study | C.1086C_V1_V2 Tags | 562.25 fluorescence unit relative to background |
| Part A, Group 2: Placebo | Part B: Level of IgG Binding Antibodies to 3 V1V2-scaffolded Env Proteins in the Extension Study | gp70-TV1.GSKvacV1V2/293F | 1537 fluorescence unit relative to background |
| Part B, Group 2: Placebo | Part B: Level of IgG Binding Antibodies to 3 V1V2-scaffolded Env Proteins in the Extension Study | C.1086C_V1_V2 Tags | 1 fluorescence unit relative to background |
| Part B, Group 2: Placebo | Part B: Level of IgG Binding Antibodies to 3 V1V2-scaffolded Env Proteins in the Extension Study | gp70-TV1.GSKvacV1V2/293F | 1 fluorescence unit relative to background |
| Part B, Group 2: Placebo | Part B: Level of IgG Binding Antibodies to 3 V1V2-scaffolded Env Proteins in the Extension Study | gp70-96ZM651.02 V1v2 | 1 fluorescence unit relative to background |
Primary
Part B: Number of Participants Reporting Local Reactogenicity Signs and Symptoms in the Extension Study
Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 \[March 2017\]. For each participant, the maximum grade observed for each symptom over the time frame is presented.
Time frame: Measured through 3 days after the Month 30 vaccination
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Part A, Group 1: Vaccine | Part B: Number of Participants Reporting Local Reactogenicity Signs and Symptoms in the Extension Study | Pain and/or Tenderness | None | 14 Participants |
| Part A, Group 1: Vaccine | Part B: Number of Participants Reporting Local Reactogenicity Signs and Symptoms in the Extension Study | Erythema and/or Induration | Mild | 0 Participants |
| Part A, Group 1: Vaccine | Part B: Number of Participants Reporting Local Reactogenicity Signs and Symptoms in the Extension Study | Erythema | Life Threatening | 0 Participants |
| Part A, Group 1: Vaccine | Part B: Number of Participants Reporting Local Reactogenicity Signs and Symptoms in the Extension Study | Pain and/or Tenderness | Mild | 11 Participants |
| Part A, Group 1: Vaccine | Part B: Number of Participants Reporting Local Reactogenicity Signs and Symptoms in the Extension Study | Pain | Life Threatening | 0 Participants |
| Part A, Group 1: Vaccine | Part B: Number of Participants Reporting Local Reactogenicity Signs and Symptoms in the Extension Study | Pain | None | 16 Participants |
| Part A, Group 1: Vaccine | Part B: Number of Participants Reporting Local Reactogenicity Signs and Symptoms in the Extension Study | Pain and/or Tenderness | Moderate | 7 Participants |
| Part A, Group 1: Vaccine | Part B: Number of Participants Reporting Local Reactogenicity Signs and Symptoms in the Extension Study | Erythema and/or Induration | Severe | 1 Participants |
| Part A, Group 1: Vaccine | Part B: Number of Participants Reporting Local Reactogenicity Signs and Symptoms in the Extension Study | Erythema | Severe | 0 Participants |
| Part A, Group 1: Vaccine | Part B: Number of Participants Reporting Local Reactogenicity Signs and Symptoms in the Extension Study | Pain and/or Tenderness | Severe | 0 Participants |
| Part A, Group 1: Vaccine | Part B: Number of Participants Reporting Local Reactogenicity Signs and Symptoms in the Extension Study | Erythema and/or Induration | None | 28 Participants |
| Part A, Group 1: Vaccine | Part B: Number of Participants Reporting Local Reactogenicity Signs and Symptoms in the Extension Study | Erythema | Moderate | 3 Participants |
| Part A, Group 1: Vaccine | Part B: Number of Participants Reporting Local Reactogenicity Signs and Symptoms in the Extension Study | Pain and/or Tenderness | Life Threatening | 0 Participants |
| Part A, Group 1: Vaccine | Part B: Number of Participants Reporting Local Reactogenicity Signs and Symptoms in the Extension Study | Tenderness | None | 21 Participants |
| Part A, Group 1: Vaccine | Part B: Number of Participants Reporting Local Reactogenicity Signs and Symptoms in the Extension Study | Erythema | Mild | 1 Participants |
| Part A, Group 1: Vaccine | Part B: Number of Participants Reporting Local Reactogenicity Signs and Symptoms in the Extension Study | Erythema | None | 28 Participants |
| Part A, Group 1: Vaccine | Part B: Number of Participants Reporting Local Reactogenicity Signs and Symptoms in the Extension Study | Pain | Moderate | 4 Participants |
| Part A, Group 1: Vaccine | Part B: Number of Participants Reporting Local Reactogenicity Signs and Symptoms in the Extension Study | Induration | Life Threatening | 0 Participants |
| Part A, Group 1: Vaccine | Part B: Number of Participants Reporting Local Reactogenicity Signs and Symptoms in the Extension Study | Tenderness | Mild | 7 Participants |
| Part A, Group 1: Vaccine | Part B: Number of Participants Reporting Local Reactogenicity Signs and Symptoms in the Extension Study | Pain | Mild | 12 Participants |
| Part A, Group 1: Vaccine | Part B: Number of Participants Reporting Local Reactogenicity Signs and Symptoms in the Extension Study | Induration | Severe | 1 Participants |
| Part A, Group 1: Vaccine | Part B: Number of Participants Reporting Local Reactogenicity Signs and Symptoms in the Extension Study | Tenderness | Moderate | 4 Participants |
| Part A, Group 1: Vaccine | Part B: Number of Participants Reporting Local Reactogenicity Signs and Symptoms in the Extension Study | Erythema and/or Induration | Moderate | 3 Participants |
| Part A, Group 1: Vaccine | Part B: Number of Participants Reporting Local Reactogenicity Signs and Symptoms in the Extension Study | Induration | Moderate | 2 Participants |
| Part A, Group 1: Vaccine | Part B: Number of Participants Reporting Local Reactogenicity Signs and Symptoms in the Extension Study | Tenderness | Severe | 0 Participants |
| Part A, Group 1: Vaccine | Part B: Number of Participants Reporting Local Reactogenicity Signs and Symptoms in the Extension Study | Pain | Severe | 0 Participants |
| Part A, Group 1: Vaccine | Part B: Number of Participants Reporting Local Reactogenicity Signs and Symptoms in the Extension Study | Induration | Mild | 1 Participants |
| Part A, Group 1: Vaccine | Part B: Number of Participants Reporting Local Reactogenicity Signs and Symptoms in the Extension Study | Tenderness | Life Threatening | 0 Participants |
| Part A, Group 1: Vaccine | Part B: Number of Participants Reporting Local Reactogenicity Signs and Symptoms in the Extension Study | Erythema and/or Induration | Life Threatening | 0 Participants |
| Part A, Group 1: Vaccine | Part B: Number of Participants Reporting Local Reactogenicity Signs and Symptoms in the Extension Study | Induration | None | 28 Participants |
| Part A, Group 2: Placebo | Part B: Number of Participants Reporting Local Reactogenicity Signs and Symptoms in the Extension Study | Erythema | Severe | 0 Participants |
| Part A, Group 2: Placebo | Part B: Number of Participants Reporting Local Reactogenicity Signs and Symptoms in the Extension Study | Pain | None | 18 Participants |
| Part A, Group 2: Placebo | Part B: Number of Participants Reporting Local Reactogenicity Signs and Symptoms in the Extension Study | Pain | Mild | 11 Participants |
| Part A, Group 2: Placebo | Part B: Number of Participants Reporting Local Reactogenicity Signs and Symptoms in the Extension Study | Pain | Moderate | 2 Participants |
| Part A, Group 2: Placebo | Part B: Number of Participants Reporting Local Reactogenicity Signs and Symptoms in the Extension Study | Pain | Severe | 0 Participants |
| Part A, Group 2: Placebo | Part B: Number of Participants Reporting Local Reactogenicity Signs and Symptoms in the Extension Study | Pain | Life Threatening | 0 Participants |
| Part A, Group 2: Placebo | Part B: Number of Participants Reporting Local Reactogenicity Signs and Symptoms in the Extension Study | Tenderness | None | 25 Participants |
| Part A, Group 2: Placebo | Part B: Number of Participants Reporting Local Reactogenicity Signs and Symptoms in the Extension Study | Tenderness | Mild | 5 Participants |
| Part A, Group 2: Placebo | Part B: Number of Participants Reporting Local Reactogenicity Signs and Symptoms in the Extension Study | Tenderness | Moderate | 1 Participants |
| Part A, Group 2: Placebo | Part B: Number of Participants Reporting Local Reactogenicity Signs and Symptoms in the Extension Study | Tenderness | Severe | 0 Participants |
| Part A, Group 2: Placebo | Part B: Number of Participants Reporting Local Reactogenicity Signs and Symptoms in the Extension Study | Tenderness | Life Threatening | 0 Participants |
| Part A, Group 2: Placebo | Part B: Number of Participants Reporting Local Reactogenicity Signs and Symptoms in the Extension Study | Pain and/or Tenderness | None | 17 Participants |
| Part A, Group 2: Placebo | Part B: Number of Participants Reporting Local Reactogenicity Signs and Symptoms in the Extension Study | Pain and/or Tenderness | Mild | 12 Participants |
| Part A, Group 2: Placebo | Part B: Number of Participants Reporting Local Reactogenicity Signs and Symptoms in the Extension Study | Pain and/or Tenderness | Moderate | 2 Participants |
| Part A, Group 2: Placebo | Part B: Number of Participants Reporting Local Reactogenicity Signs and Symptoms in the Extension Study | Pain and/or Tenderness | Severe | 0 Participants |
| Part A, Group 2: Placebo | Part B: Number of Participants Reporting Local Reactogenicity Signs and Symptoms in the Extension Study | Pain and/or Tenderness | Life Threatening | 0 Participants |
| Part A, Group 2: Placebo | Part B: Number of Participants Reporting Local Reactogenicity Signs and Symptoms in the Extension Study | Erythema | None | 27 Participants |
| Part A, Group 2: Placebo | Part B: Number of Participants Reporting Local Reactogenicity Signs and Symptoms in the Extension Study | Erythema | Mild | 3 Participants |
| Part A, Group 2: Placebo | Part B: Number of Participants Reporting Local Reactogenicity Signs and Symptoms in the Extension Study | Erythema | Moderate | 1 Participants |
| Part A, Group 2: Placebo | Part B: Number of Participants Reporting Local Reactogenicity Signs and Symptoms in the Extension Study | Erythema | Life Threatening | 0 Participants |
| Part A, Group 2: Placebo | Part B: Number of Participants Reporting Local Reactogenicity Signs and Symptoms in the Extension Study | Induration | None | 25 Participants |
| Part A, Group 2: Placebo | Part B: Number of Participants Reporting Local Reactogenicity Signs and Symptoms in the Extension Study | Induration | Mild | 4 Participants |
| Part A, Group 2: Placebo | Part B: Number of Participants Reporting Local Reactogenicity Signs and Symptoms in the Extension Study | Induration | Moderate | 1 Participants |
| Part A, Group 2: Placebo | Part B: Number of Participants Reporting Local Reactogenicity Signs and Symptoms in the Extension Study | Induration | Severe | 1 Participants |
| Part A, Group 2: Placebo | Part B: Number of Participants Reporting Local Reactogenicity Signs and Symptoms in the Extension Study | Induration | Life Threatening | 0 Participants |
| Part A, Group 2: Placebo | Part B: Number of Participants Reporting Local Reactogenicity Signs and Symptoms in the Extension Study | Erythema and/or Induration | None | 24 Participants |
| Part A, Group 2: Placebo | Part B: Number of Participants Reporting Local Reactogenicity Signs and Symptoms in the Extension Study | Erythema and/or Induration | Mild | 4 Participants |
| Part A, Group 2: Placebo | Part B: Number of Participants Reporting Local Reactogenicity Signs and Symptoms in the Extension Study | Erythema and/or Induration | Moderate | 2 Participants |
| Part A, Group 2: Placebo | Part B: Number of Participants Reporting Local Reactogenicity Signs and Symptoms in the Extension Study | Erythema and/or Induration | Severe | 1 Participants |
| Part A, Group 2: Placebo | Part B: Number of Participants Reporting Local Reactogenicity Signs and Symptoms in the Extension Study | Erythema and/or Induration | Life Threatening | 0 Participants |
| Part B, Group 2: Placebo | Part B: Number of Participants Reporting Local Reactogenicity Signs and Symptoms in the Extension Study | Erythema | Life Threatening | 0 Participants |
| Part B, Group 2: Placebo | Part B: Number of Participants Reporting Local Reactogenicity Signs and Symptoms in the Extension Study | Tenderness | Life Threatening | 0 Participants |
| Part B, Group 2: Placebo | Part B: Number of Participants Reporting Local Reactogenicity Signs and Symptoms in the Extension Study | Erythema and/or Induration | Mild | 0 Participants |
| Part B, Group 2: Placebo | Part B: Number of Participants Reporting Local Reactogenicity Signs and Symptoms in the Extension Study | Induration | None | 7 Participants |
| Part B, Group 2: Placebo | Part B: Number of Participants Reporting Local Reactogenicity Signs and Symptoms in the Extension Study | Tenderness | Severe | 0 Participants |
| Part B, Group 2: Placebo | Part B: Number of Participants Reporting Local Reactogenicity Signs and Symptoms in the Extension Study | Pain | Moderate | 0 Participants |
| Part B, Group 2: Placebo | Part B: Number of Participants Reporting Local Reactogenicity Signs and Symptoms in the Extension Study | Induration | Mild | 0 Participants |
| Part B, Group 2: Placebo | Part B: Number of Participants Reporting Local Reactogenicity Signs and Symptoms in the Extension Study | Tenderness | Moderate | 0 Participants |
| Part B, Group 2: Placebo | Part B: Number of Participants Reporting Local Reactogenicity Signs and Symptoms in the Extension Study | Pain | None | 7 Participants |
| Part B, Group 2: Placebo | Part B: Number of Participants Reporting Local Reactogenicity Signs and Symptoms in the Extension Study | Tenderness | Mild | 0 Participants |
| Part B, Group 2: Placebo | Part B: Number of Participants Reporting Local Reactogenicity Signs and Symptoms in the Extension Study | Erythema and/or Induration | Moderate | 0 Participants |
| Part B, Group 2: Placebo | Part B: Number of Participants Reporting Local Reactogenicity Signs and Symptoms in the Extension Study | Induration | Severe | 0 Participants |
| Part B, Group 2: Placebo | Part B: Number of Participants Reporting Local Reactogenicity Signs and Symptoms in the Extension Study | Tenderness | None | 7 Participants |
| Part B, Group 2: Placebo | Part B: Number of Participants Reporting Local Reactogenicity Signs and Symptoms in the Extension Study | Pain | Mild | 0 Participants |
| Part B, Group 2: Placebo | Part B: Number of Participants Reporting Local Reactogenicity Signs and Symptoms in the Extension Study | Induration | Life Threatening | 0 Participants |
| Part B, Group 2: Placebo | Part B: Number of Participants Reporting Local Reactogenicity Signs and Symptoms in the Extension Study | Pain | Life Threatening | 0 Participants |
| Part B, Group 2: Placebo | Part B: Number of Participants Reporting Local Reactogenicity Signs and Symptoms in the Extension Study | Erythema and/or Induration | Life Threatening | 0 Participants |
| Part B, Group 2: Placebo | Part B: Number of Participants Reporting Local Reactogenicity Signs and Symptoms in the Extension Study | Erythema | None | 7 Participants |
| Part B, Group 2: Placebo | Part B: Number of Participants Reporting Local Reactogenicity Signs and Symptoms in the Extension Study | Pain and/or Tenderness | Life Threatening | 0 Participants |
| Part B, Group 2: Placebo | Part B: Number of Participants Reporting Local Reactogenicity Signs and Symptoms in the Extension Study | Induration | Moderate | 0 Participants |
| Part B, Group 2: Placebo | Part B: Number of Participants Reporting Local Reactogenicity Signs and Symptoms in the Extension Study | Erythema and/or Induration | None | 7 Participants |
| Part B, Group 2: Placebo | Part B: Number of Participants Reporting Local Reactogenicity Signs and Symptoms in the Extension Study | Erythema | Mild | 0 Participants |
| Part B, Group 2: Placebo | Part B: Number of Participants Reporting Local Reactogenicity Signs and Symptoms in the Extension Study | Pain and/or Tenderness | Severe | 0 Participants |
| Part B, Group 2: Placebo | Part B: Number of Participants Reporting Local Reactogenicity Signs and Symptoms in the Extension Study | Pain | Severe | 0 Participants |
| Part B, Group 2: Placebo | Part B: Number of Participants Reporting Local Reactogenicity Signs and Symptoms in the Extension Study | Erythema | Moderate | 0 Participants |
| Part B, Group 2: Placebo | Part B: Number of Participants Reporting Local Reactogenicity Signs and Symptoms in the Extension Study | Pain and/or Tenderness | Moderate | 0 Participants |
| Part B, Group 2: Placebo | Part B: Number of Participants Reporting Local Reactogenicity Signs and Symptoms in the Extension Study | Pain and/or Tenderness | Mild | 0 Participants |
| Part B, Group 2: Placebo | Part B: Number of Participants Reporting Local Reactogenicity Signs and Symptoms in the Extension Study | Erythema | Severe | 0 Participants |
| Part B, Group 2: Placebo | Part B: Number of Participants Reporting Local Reactogenicity Signs and Symptoms in the Extension Study | Pain and/or Tenderness | None | 7 Participants |
| Part B, Group 2: Placebo | Part B: Number of Participants Reporting Local Reactogenicity Signs and Symptoms in the Extension Study | Erythema and/or Induration | Severe | 0 Participants |
Primary
Part B: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms in the Extension Study
Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 \[March 2017\]. For each participant, the maximum grade observed for each symptom over the time frame is presented.
Time frame: Measured through 3 days after the Month 30 vaccination
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Part A, Group 1: Vaccine | Part B: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms in the Extension Study | Nausea | None | 31 Participants |
| Part A, Group 1: Vaccine | Part B: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms in the Extension Study | Malaise and/or fatigue | Moderate | 2 Participants |
| Part A, Group 1: Vaccine | Part B: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms in the Extension Study | Arthralgia | None | 25 Participants |
| Part A, Group 1: Vaccine | Part B: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms in the Extension Study | Nausea | Mild | 1 Participants |
| Part A, Group 1: Vaccine | Part B: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms in the Extension Study | Malaise and/or fatigue | None | 21 Participants |
| Part A, Group 1: Vaccine | Part B: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms in the Extension Study | Chills | Potentially Life-threatening | 0 Participants |
| Part A, Group 1: Vaccine | Part B: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms in the Extension Study | Nausea | Moderate | 0 Participants |
| Part A, Group 1: Vaccine | Part B: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms in the Extension Study | Myalgia | Mild | 7 Participants |
| Part A, Group 1: Vaccine | Part B: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms in the Extension Study | Chills | Severe | 0 Participants |
| Part A, Group 1: Vaccine | Part B: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms in the Extension Study | Nausea | Severe | 0 Participants |
| Part A, Group 1: Vaccine | Part B: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms in the Extension Study | Malaise and/or fatigue | Mild | 9 Participants |
| Part A, Group 1: Vaccine | Part B: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms in the Extension Study | Chills | Moderate | 0 Participants |
| Part A, Group 1: Vaccine | Part B: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms in the Extension Study | Nausea | Potentially Life-threatening | 0 Participants |
| Part A, Group 1: Vaccine | Part B: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms in the Extension Study | Max. Systemic Symptoms | Potentially Life-threatening | 0 Participants |
| Part A, Group 1: Vaccine | Part B: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms in the Extension Study | Chills | Mild | 4 Participants |
| Part A, Group 1: Vaccine | Part B: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms in the Extension Study | Vomiting | None | 32 Participants |
| Part A, Group 1: Vaccine | Part B: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms in the Extension Study | Myalgia | Moderate | 4 Participants |
| Part A, Group 1: Vaccine | Part B: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms in the Extension Study | Chills | None | 28 Participants |
| Part A, Group 1: Vaccine | Part B: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms in the Extension Study | Vomiting | Mild | 0 Participants |
| Part A, Group 1: Vaccine | Part B: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms in the Extension Study | Vomiting | Moderate | 0 Participants |
| Part A, Group 1: Vaccine | Part B: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms in the Extension Study | Temperature | Moderate | 0 Participants |
| Part A, Group 1: Vaccine | Part B: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms in the Extension Study | Vomiting | Potentially Life-threatening | 0 Participants |
| Part A, Group 1: Vaccine | Part B: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms in the Extension Study | Max. Systemic Symptoms | Severe | 0 Participants |
| Part A, Group 1: Vaccine | Part B: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms in the Extension Study | Vomiting | Severe | 0 Participants |
| Part A, Group 1: Vaccine | Part B: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms in the Extension Study | Myalgia | Severe | 0 Participants |
| Part A, Group 1: Vaccine | Part B: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms in the Extension Study | Malaise and/or fatigue | Severe | 0 Participants |
| Part A, Group 1: Vaccine | Part B: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms in the Extension Study | Max. Systemic Symptoms | Moderate | 5 Participants |
| Part A, Group 1: Vaccine | Part B: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms in the Extension Study | Myalgia | Potentially Life-threatening | 0 Participants |
| Part A, Group 1: Vaccine | Part B: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms in the Extension Study | Temperature | Potentially Life-threatening | 0 Participants |
| Part A, Group 1: Vaccine | Part B: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms in the Extension Study | Max. Systemic Symptoms | Mild | 11 Participants |
| Part A, Group 1: Vaccine | Part B: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms in the Extension Study | Headache | None | 26 Participants |
| Part A, Group 1: Vaccine | Part B: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms in the Extension Study | Temperature | Mild | 0 Participants |
| Part A, Group 1: Vaccine | Part B: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms in the Extension Study | Max. Systemic Symptoms | None | 16 Participants |
| Part A, Group 1: Vaccine | Part B: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms in the Extension Study | Headache | Mild | 6 Participants |
| Part A, Group 1: Vaccine | Part B: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms in the Extension Study | Malaise and/or fatigue | Potentially Life-threatening | 0 Participants |
| Part A, Group 1: Vaccine | Part B: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms in the Extension Study | Arthralgia | Potentially Life-threatening | 0 Participants |
| Part A, Group 1: Vaccine | Part B: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms in the Extension Study | Headache | Moderate | 0 Participants |
| Part A, Group 1: Vaccine | Part B: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms in the Extension Study | Temperature | Severe | 0 Participants |
| Part A, Group 1: Vaccine | Part B: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms in the Extension Study | Arthralgia | Severe | 0 Participants |
| Part A, Group 1: Vaccine | Part B: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms in the Extension Study | Headache | Severe | 0 Participants |
| Part A, Group 1: Vaccine | Part B: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms in the Extension Study | Temperature | None | 32 Participants |
| Part A, Group 1: Vaccine | Part B: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms in the Extension Study | Arthralgia | Moderate | 1 Participants |
| Part A, Group 1: Vaccine | Part B: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms in the Extension Study | Headache | Potentially Life-threatening | 0 Participants |
| Part A, Group 1: Vaccine | Part B: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms in the Extension Study | Myalgia | None | 21 Participants |
| Part A, Group 1: Vaccine | Part B: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms in the Extension Study | Arthralgia | Mild | 6 Participants |
| Part A, Group 2: Placebo | Part B: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms in the Extension Study | Max. Systemic Symptoms | Potentially Life-threatening | 0 Participants |
| Part A, Group 2: Placebo | Part B: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms in the Extension Study | Malaise and/or fatigue | None | 24 Participants |
| Part A, Group 2: Placebo | Part B: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms in the Extension Study | Malaise and/or fatigue | Mild | 7 Participants |
| Part A, Group 2: Placebo | Part B: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms in the Extension Study | Malaise and/or fatigue | Moderate | 0 Participants |
| Part A, Group 2: Placebo | Part B: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms in the Extension Study | Malaise and/or fatigue | Severe | 0 Participants |
| Part A, Group 2: Placebo | Part B: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms in the Extension Study | Malaise and/or fatigue | Potentially Life-threatening | 0 Participants |
| Part A, Group 2: Placebo | Part B: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms in the Extension Study | Myalgia | None | 24 Participants |
| Part A, Group 2: Placebo | Part B: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms in the Extension Study | Myalgia | Mild | 7 Participants |
| Part A, Group 2: Placebo | Part B: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms in the Extension Study | Myalgia | Moderate | 0 Participants |
| Part A, Group 2: Placebo | Part B: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms in the Extension Study | Myalgia | Severe | 0 Participants |
| Part A, Group 2: Placebo | Part B: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms in the Extension Study | Myalgia | Potentially Life-threatening | 0 Participants |
| Part A, Group 2: Placebo | Part B: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms in the Extension Study | Headache | None | 29 Participants |
| Part A, Group 2: Placebo | Part B: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms in the Extension Study | Headache | Mild | 2 Participants |
| Part A, Group 2: Placebo | Part B: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms in the Extension Study | Headache | Moderate | 0 Participants |
| Part A, Group 2: Placebo | Part B: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms in the Extension Study | Headache | Severe | 0 Participants |
| Part A, Group 2: Placebo | Part B: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms in the Extension Study | Headache | Potentially Life-threatening | 0 Participants |
| Part A, Group 2: Placebo | Part B: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms in the Extension Study | Nausea | None | 30 Participants |
| Part A, Group 2: Placebo | Part B: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms in the Extension Study | Nausea | Mild | 1 Participants |
| Part A, Group 2: Placebo | Part B: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms in the Extension Study | Nausea | Moderate | 0 Participants |
| Part A, Group 2: Placebo | Part B: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms in the Extension Study | Nausea | Severe | 0 Participants |
| Part A, Group 2: Placebo | Part B: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms in the Extension Study | Nausea | Potentially Life-threatening | 0 Participants |
| Part A, Group 2: Placebo | Part B: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms in the Extension Study | Vomiting | None | 30 Participants |
| Part A, Group 2: Placebo | Part B: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms in the Extension Study | Vomiting | Mild | 1 Participants |
| Part A, Group 2: Placebo | Part B: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms in the Extension Study | Vomiting | Moderate | 0 Participants |
| Part A, Group 2: Placebo | Part B: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms in the Extension Study | Vomiting | Severe | 0 Participants |
| Part A, Group 2: Placebo | Part B: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms in the Extension Study | Vomiting | Potentially Life-threatening | 0 Participants |
| Part A, Group 2: Placebo | Part B: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms in the Extension Study | Chills | None | 29 Participants |
| Part A, Group 2: Placebo | Part B: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms in the Extension Study | Chills | Mild | 2 Participants |
| Part A, Group 2: Placebo | Part B: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms in the Extension Study | Chills | Moderate | 0 Participants |
| Part A, Group 2: Placebo | Part B: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms in the Extension Study | Chills | Severe | 0 Participants |
| Part A, Group 2: Placebo | Part B: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms in the Extension Study | Chills | Potentially Life-threatening | 0 Participants |
| Part A, Group 2: Placebo | Part B: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms in the Extension Study | Arthralgia | None | 28 Participants |
| Part A, Group 2: Placebo | Part B: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms in the Extension Study | Arthralgia | Mild | 3 Participants |
| Part A, Group 2: Placebo | Part B: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms in the Extension Study | Arthralgia | Moderate | 0 Participants |
| Part A, Group 2: Placebo | Part B: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms in the Extension Study | Arthralgia | Severe | 0 Participants |
| Part A, Group 2: Placebo | Part B: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms in the Extension Study | Arthralgia | Potentially Life-threatening | 0 Participants |
| Part A, Group 2: Placebo | Part B: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms in the Extension Study | Max. Systemic Symptoms | None | 21 Participants |
| Part A, Group 2: Placebo | Part B: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms in the Extension Study | Max. Systemic Symptoms | Mild | 10 Participants |
| Part A, Group 2: Placebo | Part B: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms in the Extension Study | Max. Systemic Symptoms | Moderate | 0 Participants |
| Part A, Group 2: Placebo | Part B: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms in the Extension Study | Max. Systemic Symptoms | Severe | 0 Participants |
| Part A, Group 2: Placebo | Part B: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms in the Extension Study | Temperature | None | 31 Participants |
| Part A, Group 2: Placebo | Part B: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms in the Extension Study | Temperature | Mild | 0 Participants |
| Part A, Group 2: Placebo | Part B: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms in the Extension Study | Temperature | Moderate | 0 Participants |
| Part A, Group 2: Placebo | Part B: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms in the Extension Study | Temperature | Severe | 0 Participants |
| Part A, Group 2: Placebo | Part B: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms in the Extension Study | Temperature | Potentially Life-threatening | 0 Participants |
| Part B, Group 2: Placebo | Part B: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms in the Extension Study | Nausea | None | 7 Participants |
| Part B, Group 2: Placebo | Part B: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms in the Extension Study | Temperature | Potentially Life-threatening | 0 Participants |
| Part B, Group 2: Placebo | Part B: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms in the Extension Study | Arthralgia | None | 7 Participants |
| Part B, Group 2: Placebo | Part B: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms in the Extension Study | Headache | Potentially Life-threatening | 0 Participants |
| Part B, Group 2: Placebo | Part B: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms in the Extension Study | Temperature | None | 7 Participants |
| Part B, Group 2: Placebo | Part B: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms in the Extension Study | Arthralgia | Mild | 0 Participants |
| Part B, Group 2: Placebo | Part B: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms in the Extension Study | Headache | Severe | 0 Participants |
| Part B, Group 2: Placebo | Part B: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms in the Extension Study | Malaise and/or fatigue | Severe | 0 Participants |
| Part B, Group 2: Placebo | Part B: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms in the Extension Study | Arthralgia | Moderate | 0 Participants |
| Part B, Group 2: Placebo | Part B: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms in the Extension Study | Headache | Moderate | 0 Participants |
| Part B, Group 2: Placebo | Part B: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms in the Extension Study | Temperature | Severe | 0 Participants |
| Part B, Group 2: Placebo | Part B: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms in the Extension Study | Arthralgia | Severe | 0 Participants |
| Part B, Group 2: Placebo | Part B: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms in the Extension Study | Headache | Mild | 1 Participants |
| Part B, Group 2: Placebo | Part B: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms in the Extension Study | Temperature | Mild | 0 Participants |
| Part B, Group 2: Placebo | Part B: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms in the Extension Study | Arthralgia | Potentially Life-threatening | 0 Participants |
| Part B, Group 2: Placebo | Part B: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms in the Extension Study | Headache | None | 6 Participants |
| Part B, Group 2: Placebo | Part B: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms in the Extension Study | Malaise and/or fatigue | Moderate | 0 Participants |
| Part B, Group 2: Placebo | Part B: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms in the Extension Study | Max. Systemic Symptoms | None | 6 Participants |
| Part B, Group 2: Placebo | Part B: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms in the Extension Study | Myalgia | Potentially Life-threatening | 0 Participants |
| Part B, Group 2: Placebo | Part B: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms in the Extension Study | Malaise and/or fatigue | None | 7 Participants |
| Part B, Group 2: Placebo | Part B: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms in the Extension Study | Max. Systemic Symptoms | Mild | 1 Participants |
| Part B, Group 2: Placebo | Part B: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms in the Extension Study | Myalgia | Severe | 0 Participants |
| Part B, Group 2: Placebo | Part B: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms in the Extension Study | Temperature | Moderate | 0 Participants |
| Part B, Group 2: Placebo | Part B: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms in the Extension Study | Max. Systemic Symptoms | Moderate | 0 Participants |
| Part B, Group 2: Placebo | Part B: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms in the Extension Study | Vomiting | Moderate | 0 Participants |
| Part B, Group 2: Placebo | Part B: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms in the Extension Study | Myalgia | Moderate | 0 Participants |
| Part B, Group 2: Placebo | Part B: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms in the Extension Study | Vomiting | Severe | 0 Participants |
| Part B, Group 2: Placebo | Part B: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms in the Extension Study | Vomiting | Mild | 0 Participants |
| Part B, Group 2: Placebo | Part B: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms in the Extension Study | Malaise and/or fatigue | Mild | 0 Participants |
| Part B, Group 2: Placebo | Part B: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms in the Extension Study | Vomiting | Potentially Life-threatening | 0 Participants |
| Part B, Group 2: Placebo | Part B: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms in the Extension Study | Vomiting | None | 7 Participants |
| Part B, Group 2: Placebo | Part B: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms in the Extension Study | Max. Systemic Symptoms | Severe | 0 Participants |
| Part B, Group 2: Placebo | Part B: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms in the Extension Study | Chills | None | 7 Participants |
| Part B, Group 2: Placebo | Part B: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms in the Extension Study | Nausea | Potentially Life-threatening | 0 Participants |
| Part B, Group 2: Placebo | Part B: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms in the Extension Study | Myalgia | Mild | 0 Participants |
| Part B, Group 2: Placebo | Part B: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms in the Extension Study | Chills | Mild | 0 Participants |
| Part B, Group 2: Placebo | Part B: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms in the Extension Study | Nausea | Severe | 0 Participants |
| Part B, Group 2: Placebo | Part B: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms in the Extension Study | Myalgia | None | 7 Participants |
| Part B, Group 2: Placebo | Part B: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms in the Extension Study | Chills | Moderate | 0 Participants |
| Part B, Group 2: Placebo | Part B: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms in the Extension Study | Nausea | Moderate | 0 Participants |
| Part B, Group 2: Placebo | Part B: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms in the Extension Study | Max. Systemic Symptoms | Potentially Life-threatening | 0 Participants |
| Part B, Group 2: Placebo | Part B: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms in the Extension Study | Chills | Severe | 0 Participants |
| Part B, Group 2: Placebo | Part B: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms in the Extension Study | Nausea | Mild | 0 Participants |
| Part B, Group 2: Placebo | Part B: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms in the Extension Study | Malaise and/or fatigue | Potentially Life-threatening | 0 Participants |
| Part B, Group 2: Placebo | Part B: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms in the Extension Study | Chills | Potentially Life-threatening | 0 Participants |
Primary
Part B: 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 are tabulated by treatment arm
Time frame: Measured through Month 36
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A, Group 1: Vaccine | Part B: Number of Participants With Early Study Termination Associated With an AE or Reactogenicity | Termination not due to AE/Reactogenicity | 0 Participants |
| Part A, Group 1: Vaccine | Part B: Number of Participants With Early Study Termination Associated With an AE or Reactogenicity | Other reason | 32 Participants |
| Part A, Group 2: Placebo | Part B: Number of Participants With Early Study Termination Associated With an AE or Reactogenicity | Termination not due to AE/Reactogenicity | 0 Participants |
| Part A, Group 2: Placebo | Part B: Number of Participants With Early Study Termination Associated With an AE or Reactogenicity | Other reason | 31 Participants |
| Part B, Group 2: Placebo | Part B: Number of Participants With Early Study Termination Associated With an AE or Reactogenicity | Termination not due to AE/Reactogenicity | 0 Participants |
| Part B, Group 2: Placebo | Part B: Number of Participants With Early Study Termination Associated With an AE or Reactogenicity | Other reason | 7 Participants |
Primary
Part B: Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine in the Extension Study
Measured by flow cytometry ICS assay: refer to earlier description for assay methods and analysis variable derivation. The number and percentage of participants with positive responses are summarized by peptide pool.
Time frame: Measured at Month 30.5
Population: Overall Number of Participants Analyzed includes those with samples collected at month 30.5, who were HIV-uninfected and received the all vaccinations. Number Analyzed counts participants with available data after filtering for assay-specific quality control criteria.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A, Group 1: Vaccine | Part B: Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine in the Extension Study | Any gp120 | 25 Participants |
| Part A, Group 1: Vaccine | Part B: Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine in the Extension Study | 1086 gp120 | 22 Participants |
| Part A, Group 1: Vaccine | Part B: Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine in the Extension Study | TV1 gp120 | 24 Participants |
| Part A, Group 1: Vaccine | Part B: Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine in the Extension Study | ZM96 gp120 | 23 Participants |
| Part A, Group 2: Placebo | Part B: Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine in the Extension Study | ZM96 gp120 | 22 Participants |
| Part A, Group 2: Placebo | Part B: Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine in the Extension Study | Any gp120 | 26 Participants |
| Part A, Group 2: Placebo | Part B: Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine in the Extension Study | TV1 gp120 | 25 Participants |
| Part A, Group 2: Placebo | Part B: Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine in the Extension Study | 1086 gp120 | 23 Participants |
| Part B, Group 2: Placebo | Part B: Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine in the Extension Study | ZM96 gp120 | 0 Participants |
| Part B, Group 2: Placebo | Part B: Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine in the Extension Study | 1086 gp120 | 0 Participants |
| Part B, Group 2: Placebo | Part B: Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine in the Extension Study | TV1 gp120 | 0 Participants |
| Part B, Group 2: Placebo | Part B: Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine in the Extension Study | Any gp120 | 0 Participants |
Primary
Part B: Occurrence of IgG Ab Binding to gp120 Env Proteins Contained in the Vaccine (ZM96, TV1.C, 1086.C) in the Extension Study
Measured by HIV-1 multiplex Ab assay: refer to earlier description for assay methods and analysis variable derivation. The number and percentage of participants with positive responses are summarized by antigen.
Time frame: Measured at Month 30.5
Population: Overall Number of Participants Analyzed includes those with samples collected at month 30.5, who were HIV-uninfected and received the all vaccinations. Number Analyzed counts participants with available data after filtering for assay-specific quality control criteria.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A, Group 1: Vaccine | Part B: Occurrence of IgG Ab Binding to gp120 Env Proteins Contained in the Vaccine (ZM96, TV1.C, 1086.C) in the Extension Study | TV1c8_D11gp120.avi/293F | 26 Participants |
| Part A, Group 1: Vaccine | Part B: Occurrence of IgG Ab Binding to gp120 Env Proteins Contained in the Vaccine (ZM96, TV1.C, 1086.C) in the Extension Study | 96ZM651.D11gp120.avi | 25 Participants |
| Part A, Group 1: Vaccine | Part B: Occurrence of IgG Ab Binding to gp120 Env Proteins Contained in the Vaccine (ZM96, TV1.C, 1086.C) in the Extension Study | 1086C_D7gp120.avi/293F | 26 Participants |
| Part A, Group 2: Placebo | Part B: Occurrence of IgG Ab Binding to gp120 Env Proteins Contained in the Vaccine (ZM96, TV1.C, 1086.C) in the Extension Study | TV1c8_D11gp120.avi/293F | 30 Participants |
| Part A, Group 2: Placebo | Part B: Occurrence of IgG Ab Binding to gp120 Env Proteins Contained in the Vaccine (ZM96, TV1.C, 1086.C) in the Extension Study | 1086C_D7gp120.avi/293F | 30 Participants |
| Part A, Group 2: Placebo | Part B: Occurrence of IgG Ab Binding to gp120 Env Proteins Contained in the Vaccine (ZM96, TV1.C, 1086.C) in the Extension Study | 96ZM651.D11gp120.avi | 29 Participants |
| Part B, Group 2: Placebo | Part B: Occurrence of IgG Ab Binding to gp120 Env Proteins Contained in the Vaccine (ZM96, TV1.C, 1086.C) in the Extension Study | TV1c8_D11gp120.avi/293F | 0 Participants |
| Part B, Group 2: Placebo | Part B: Occurrence of IgG Ab Binding to gp120 Env Proteins Contained in the Vaccine (ZM96, TV1.C, 1086.C) in the Extension Study | 96ZM651.D11gp120.avi | 0 Participants |
| Part B, Group 2: Placebo | Part B: Occurrence of IgG Ab Binding to gp120 Env Proteins Contained in the Vaccine (ZM96, TV1.C, 1086.C) in the Extension Study | 1086C_D7gp120.avi/293F | 0 Participants |
Primary
Part B: Occurrence of IgG Binding Antibodies to 3 V1V2-scaffolded Env Proteins in the Extension Study
Measured by HIV-1 multiplex Ab assay: refer to earlier description for assay methods and analysis variable derivation. The number and percentage of participants with positive responses are summarized by antigen.
Time frame: Measured at Month 30.5
Population: Overall Number of Participants Analyzed includes those with samples collected at month 30.5, who were HIV-uninfected and received the all vaccinations. Number Analyzed counts participants with available data after filtering for assay-specific quality control criteria.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A, Group 1: Vaccine | Part B: Occurrence of IgG Binding Antibodies to 3 V1V2-scaffolded Env Proteins in the Extension Study | gp70-TV1.GSKvacV1V2/293F | 15 Participants |
| Part A, Group 1: Vaccine | Part B: Occurrence of IgG Binding Antibodies to 3 V1V2-scaffolded Env Proteins in the Extension Study | C.1086C_V1_V2 Tags | 19 Participants |
| Part A, Group 1: Vaccine | Part B: Occurrence of IgG Binding Antibodies to 3 V1V2-scaffolded Env Proteins in the Extension Study | gp70-96ZM651.02 V1v2 | 14 Participants |
| Part A, Group 2: Placebo | Part B: Occurrence of IgG Binding Antibodies to 3 V1V2-scaffolded Env Proteins in the Extension Study | gp70-96ZM651.02 V1v2 | 15 Participants |
| Part A, Group 2: Placebo | Part B: Occurrence of IgG Binding Antibodies to 3 V1V2-scaffolded Env Proteins in the Extension Study | gp70-TV1.GSKvacV1V2/293F | 18 Participants |
| Part A, Group 2: Placebo | Part B: Occurrence of IgG Binding Antibodies to 3 V1V2-scaffolded Env Proteins in the Extension Study | C.1086C_V1_V2 Tags | 23 Participants |
| Part B, Group 2: Placebo | Part B: Occurrence of IgG Binding Antibodies to 3 V1V2-scaffolded Env Proteins in the Extension Study | C.1086C_V1_V2 Tags | 0 Participants |
| Part B, Group 2: Placebo | Part B: Occurrence of IgG Binding Antibodies to 3 V1V2-scaffolded Env Proteins in the Extension Study | gp70-TV1.GSKvacV1V2/293F | 0 Participants |
| Part B, Group 2: Placebo | Part B: Occurrence of IgG Binding Antibodies to 3 V1V2-scaffolded Env Proteins in the Extension Study | gp70-96ZM651.02 V1v2 | 0 Participants |
Secondary
Part A: Compare the Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine After the Fourth Versus the Fifth Vaccinations
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. Comparisons were performed among positive responders only.
Time frame: Measured at Month 6.5 and 12.5
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Part A, Group 1: Vaccine | Part A: Compare the Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine After the Fourth Versus the Fifth Vaccinations | 1086 gp120 (Month 6.5) | 0.17577251 % CD4+ T-cells |
| Part A, Group 1: Vaccine | Part A: Compare the Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine After the Fourth Versus the Fifth Vaccinations | 1086 gp120 (Month 12.5) | 0.14932756 % CD4+ T-cells |
| Part A, Group 1: Vaccine | Part A: Compare the Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine After the Fourth Versus the Fifth Vaccinations | TV1 gp120 (Month 6.5) | 0.158423055 % CD4+ T-cells |
| Part A, Group 1: Vaccine | Part A: Compare the Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine After the Fourth Versus the Fifth Vaccinations | TV1 gp120 (Month 12.5) | 0.22183561 % CD4+ T-cells |
| Part A, Group 1: Vaccine | Part A: Compare the Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine After the Fourth Versus the Fifth Vaccinations | ZM96 gp120 (Month 6.5) | 0.17436147 % CD4+ T-cells |
| Part A, Group 1: Vaccine | Part A: Compare the Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine After the Fourth Versus the Fifth Vaccinations | ZM96 gp120 (Month 12.5) | 0.203201925 % CD4+ T-cells |
Comparison: CD4+ T Cell Responses to 1086 gp120 after the fourth (month 6.5) versus the fifth vaccination (month 12.5)p-value: 0.9661Wilcoxon Signed-Rank
Comparison: CD4+ T Cell Responses to TV1 gp120 after the fourth (month 6.5) versus the fifth vaccination (month 12.5)p-value: 0.8593Wilcoxon Signed-Rank
Comparison: CD4+ T Cell Responses to ZM96 gp120 after the fourth (month 6.5) versus the fifth vaccination (month 12.5)p-value: 0.4396Wilcoxon Signed-Rank
Secondary
Part A: Compare the Level of IgG Ab Binding to gp120 Env Proteins Contained in the Vaccine (ZM96, TV1.C, 1086.C) After the Fourth Versus the Fifth Vaccination
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. Comparisons were performed among positive responders only (positivity criteria is described in Outcome 30).
Time frame: Measured at Month 6.5 and 12.5
Population: The durability cohort was randomly selected from those in the month 6.5 cohort with samples collected at month 12.5. Selection was stratified by gender to match the overall protocol. Overall Number of Participants Analyzed represents the durability cohort. Number Analyzed counts participants with data meeting assay-specific quality criteria.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Part A, Group 1: Vaccine | Part A: Compare the Level of IgG Ab Binding to gp120 Env Proteins Contained in the Vaccine (ZM96, TV1.C, 1086.C) After the Fourth Versus the Fifth Vaccination | 1086C_D7gp120.avi/293F (Month 6.5) | 29317.375 fluorescence unit relative to background |
| Part A, Group 1: Vaccine | Part A: Compare the Level of IgG Ab Binding to gp120 Env Proteins Contained in the Vaccine (ZM96, TV1.C, 1086.C) After the Fourth Versus the Fifth Vaccination | 1086C_D7gp120.avi/293F (Month 12.5) | 31407.349999 fluorescence unit relative to background |
| Part A, Group 1: Vaccine | Part A: Compare the Level of IgG Ab Binding to gp120 Env Proteins Contained in the Vaccine (ZM96, TV1.C, 1086.C) After the Fourth Versus the Fifth Vaccination | 96ZM651.D11gp120.avi (Month 6.5) | 26437.25 fluorescence unit relative to background |
| Part A, Group 1: Vaccine | Part A: Compare the Level of IgG Ab Binding to gp120 Env Proteins Contained in the Vaccine (ZM96, TV1.C, 1086.C) After the Fourth Versus the Fifth Vaccination | 96ZM651.D11gp120.avi (Month 12.5) | 31378.5 fluorescence unit relative to background |
| Part A, Group 1: Vaccine | Part A: Compare the Level of IgG Ab Binding to gp120 Env Proteins Contained in the Vaccine (ZM96, TV1.C, 1086.C) After the Fourth Versus the Fifth Vaccination | TV1c8_D11gp120.avi/293F (Month 6.5) | 28365.625 fluorescence unit relative to background |
| Part A, Group 1: Vaccine | Part A: Compare the Level of IgG Ab Binding to gp120 Env Proteins Contained in the Vaccine (ZM96, TV1.C, 1086.C) After the Fourth Versus the Fifth Vaccination | TV1c8_D11gp120.avi/293F (Month 12.5) | 31425.5 fluorescence unit relative to background |
Comparison: IgG Ab binding to 1086C\_D7gp120.avi/293F after the fourth (month 6.5) versus the fifth vaccination (month 12.5)p-value: <0.0001Wilcoxon Signed-Rank
Comparison: IgG Ab binding to 96ZM651.D11gp120.avi after the fourth (month 6.5) versus the fifth vaccination (month 12.5)p-value: <0.0001Wilcoxon Signed-Rank
Comparison: IgG Ab binding to TV1c8\_D11gp120.avi/293F after the fourth (month 6.5) versus the fifth vaccination (month 12.5)p-value: <0.0001Wilcoxon Signed-Rank
Secondary
Part A: Compare the Level of IgG Binding Antibodies to 3 V1V2-scaffolded Env Proteins After the Fourth Versus the Fifth Vaccination
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. Comparisons were performed among positive responders only (positivity criteria is described in Outcome 32).
Time frame: Measured at Month 6.5 and 12.5
Population: The durability cohort was randomly selected from those in the month 6.5 cohort with samples collected at month 12.5. Selection was stratified by gender to match the overall protocol. Overall Number of Participants Analyzed represents the durability cohort. Number Analyzed counts participants with data meeting assay-specific quality criteria.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Part A, Group 1: Vaccine | Part A: Compare the Level of IgG Binding Antibodies to 3 V1V2-scaffolded Env Proteins After the Fourth Versus the Fifth Vaccination | C.1086C_V1_V2 Tags (Month 6.5) | 1281.5 fluorescence unit relative to background |
| Part A, Group 1: Vaccine | Part A: Compare the Level of IgG Binding Antibodies to 3 V1V2-scaffolded Env Proteins After the Fourth Versus the Fifth Vaccination | C.1086C_V1_V2 Tags (Month 12.5) | 2938.5 fluorescence unit relative to background |
| Part A, Group 1: Vaccine | Part A: Compare the Level of IgG Binding Antibodies to 3 V1V2-scaffolded Env Proteins After the Fourth Versus the Fifth Vaccination | gp70-96ZM651.02 V1v2 (Month 6.5) | 1747.5 fluorescence unit relative to background |
| Part A, Group 1: Vaccine | Part A: Compare the Level of IgG Binding Antibodies to 3 V1V2-scaffolded Env Proteins After the Fourth Versus the Fifth Vaccination | gp70-96ZM651.02 V1v2 (Month 12.5) | 3821.75 fluorescence unit relative to background |
| Part A, Group 1: Vaccine | Part A: Compare the Level of IgG Binding Antibodies to 3 V1V2-scaffolded Env Proteins After the Fourth Versus the Fifth Vaccination | gp70-TV1.GSKvacV1V2/293F (Month 6.5) | 3082.625 fluorescence unit relative to background |
| Part A, Group 1: Vaccine | Part A: Compare the Level of IgG Binding Antibodies to 3 V1V2-scaffolded Env Proteins After the Fourth Versus the Fifth Vaccination | gp70-TV1.GSKvacV1V2/293F (Month 12.5) | 4207.8499015 fluorescence unit relative to background |
Comparison: IgG Ab binding to C.1086C\_V1\_V2 Tags after the fourth (month 6.5) versus the fifth vaccination (month 12.5)p-value: <0.0001Wilcoxon Signed-Rank
Comparison: IgG Ab binding to gp70-96ZM651.02 V1v2 after the fourth (month 6.5) versus the fifth vaccination (month 12.5)p-value: <0.0001Wilcoxon Signed-Rank
Comparison: IgG Ab binding to gp70-TV1.GSKvacV1V2/293F after the fourth (month 6.5) versus the fifth vaccination (month 12.5)p-value: 0.0002Wilcoxon Signed-Rank
Secondary
Part A: Compare the Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine After the Fourth Versus the Fifth Vaccinations
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.
Time frame: Measured at Month 6.5 and 12.5
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A, Group 1: Vaccine | Part A: Compare the Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine After the Fourth Versus the Fifth Vaccinations | 1086 gp120 (Month 6.5) | 24 Participants |
| Part A, Group 1: Vaccine | Part A: Compare the Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine After the Fourth Versus the Fifth Vaccinations | 1086 gp120 (Month 12.5) | 23 Participants |
| Part A, Group 1: Vaccine | Part A: Compare the Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine After the Fourth Versus the Fifth Vaccinations | TV1 gp120 (Month 6.5) | 32 Participants |
| Part A, Group 1: Vaccine | Part A: Compare the Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine After the Fourth Versus the Fifth Vaccinations | TV1 gp120 (Month 12.5) | 31 Participants |
| Part A, Group 1: Vaccine | Part A: Compare the Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine After the Fourth Versus the Fifth Vaccinations | ZM96 gp120 (Month 6.5) | 30 Participants |
| Part A, Group 1: Vaccine | Part A: Compare the Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine After the Fourth Versus the Fifth Vaccinations | ZM96 gp120 (Month 12.5) | 34 Participants |
Comparison: CD4+ T Cell Responses to 1086 gp120 after the fourth (month 6.5) versus the fifth vaccination (month 12.5)p-value: 1McNemar
Comparison: CD4+ T Cell Responses to TV1 gp120 after the fourth (month 6.5) versus the fifth vaccination (month 12.5)p-value: 0.6698McNemar
Comparison: CD4+ T Cell Responses to ZM96 gp120 after the fourth (month 6.5) versus the fifth vaccination (month 12.5)p-value: 0.1435McNemar
Secondary
Part A: Compare the Occurrence of IgG Ab Binding to gp120 Env Proteins Contained in the Vaccine (ZM96, TV1.C, 1086.C) After the Fourth Versus the Fifth Vaccination
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. Samples from post-enrollment visits have positive responses if they meet three conditions: (1) net MFI greater than or equal to an antigen-specific response threshold (defined as the maximum of 100 and the 95th percentile of pre-vaccination net MFI), (2) net MFI values are greater than 3 times pre-vaccination net MFI, and (3) experimental antigen MFI values are greater than 3 times pre-vaccination MFI. Data are excluded if the blood draw date was outside the allowable window, a participant was HIV-infected, or the reference antigen exceeds 5000 MFI.
Time frame: Measured at Month 6.5 and 12.5
Population: The durability cohort was randomly selected from those in the month 6.5 cohort with samples collected at month 12.5. Selection was stratified by gender to match the overall protocol. Overall Number of Participants Analyzed represents the durability cohort. Number Analyzed counts participants with data meeting assay-specific quality criteria.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A, Group 1: Vaccine | Part A: Compare the Occurrence of IgG Ab Binding to gp120 Env Proteins Contained in the Vaccine (ZM96, TV1.C, 1086.C) After the Fourth Versus the Fifth Vaccination | 1086C_D7gp120.avi/293F (Month 6.5) | 64 Participants |
| Part A, Group 1: Vaccine | Part A: Compare the Occurrence of IgG Ab Binding to gp120 Env Proteins Contained in the Vaccine (ZM96, TV1.C, 1086.C) After the Fourth Versus the Fifth Vaccination | 1086C_D7gp120.avi/293F (Month 12.5) | 64 Participants |
| Part A, Group 1: Vaccine | Part A: Compare the Occurrence of IgG Ab Binding to gp120 Env Proteins Contained in the Vaccine (ZM96, TV1.C, 1086.C) After the Fourth Versus the Fifth Vaccination | 96ZM651.D11gp120.avi (Month 6.5) | 59 Participants |
| Part A, Group 1: Vaccine | Part A: Compare the Occurrence of IgG Ab Binding to gp120 Env Proteins Contained in the Vaccine (ZM96, TV1.C, 1086.C) After the Fourth Versus the Fifth Vaccination | 96ZM651.D11gp120.avi (Month 12.5) | 59 Participants |
| Part A, Group 1: Vaccine | Part A: Compare the Occurrence of IgG Ab Binding to gp120 Env Proteins Contained in the Vaccine (ZM96, TV1.C, 1086.C) After the Fourth Versus the Fifth Vaccination | TV1c8_D11gp120.avi/293F (Month 6.5) | 64 Participants |
| Part A, Group 1: Vaccine | Part A: Compare the Occurrence of IgG Ab Binding to gp120 Env Proteins Contained in the Vaccine (ZM96, TV1.C, 1086.C) After the Fourth Versus the Fifth Vaccination | TV1c8_D11gp120.avi/293F (Month 12.5) | 64 Participants |
Comparison: IgG Ab binding to 1086C\_D7gp120.avi/293F after the fourth (month 6.5) versus the fifth vaccination (month 12.5)p-value: 1McNemar
Comparison: IgG Ab binding to 96ZM651.D11gp120.avi after the fourth (month 6.5) versus the fifth vaccination (month 12.5)p-value: 1McNemar
Comparison: IgG Ab binding to TV1c8\_D11gp120.avi/293F after the fourth (month 6.5) versus the fifth vaccination (month 12.5)p-value: 1McNemar
Secondary
Part A: Compare the Occurrence of IgG Binding Antibodies to 3 V1V2-scaffolded Env Proteins After the Fourth Versus the Fifth Vaccination
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. Samples from post-enrollment visits have positive responses if they meet three conditions: (1) net MFI greater than or equal to an antigen-specific response threshold (defined as the maximum of 100 and the 95th percentile of pre-vaccination net MFI), (2) net MFI values are greater than 3 times pre-vaccination net MFI, and (3) experimental antigen MFI values are greater than 3 times pre-vaccination MFI. Data are excluded if the blood draw date was outside the allowable window, a participant was HIV-infected, or the reference antigen exceeds 5000 MFI.
Time frame: Measured at Month 6.5 and 12.5
Population: The durability cohort was randomly selected from those in the month 6.5 cohort with samples collected at month 12.5. Selection was stratified by gender to match the overall protocol. Overall Number of Participants Analyzed represents the durability cohort. Number Analyzed counts participants with data meeting assay-specific quality criteria.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A, Group 1: Vaccine | Part A: Compare the Occurrence of IgG Binding Antibodies to 3 V1V2-scaffolded Env Proteins After the Fourth Versus the Fifth Vaccination | C.1086C_V1_V2 Tags (Month 6.5) | 49 Participants |
| Part A, Group 1: Vaccine | Part A: Compare the Occurrence of IgG Binding Antibodies to 3 V1V2-scaffolded Env Proteins After the Fourth Versus the Fifth Vaccination | C.1086C_V1_V2 Tags (Month 12.5) | 57 Participants |
| Part A, Group 1: Vaccine | Part A: Compare the Occurrence of IgG Binding Antibodies to 3 V1V2-scaffolded Env Proteins After the Fourth Versus the Fifth Vaccination | gp70-96ZM651.02 V1v2 (Month 6.5) | 29 Participants |
| Part A, Group 1: Vaccine | Part A: Compare the Occurrence of IgG Binding Antibodies to 3 V1V2-scaffolded Env Proteins After the Fourth Versus the Fifth Vaccination | gp70-96ZM651.02 V1v2 (Month 12.5) | 44 Participants |
| Part A, Group 1: Vaccine | Part A: Compare the Occurrence of IgG Binding Antibodies to 3 V1V2-scaffolded Env Proteins After the Fourth Versus the Fifth Vaccination | gp70-TV1.GSKvacV1V2/293F (Month 6.5) | 36 Participants |
| Part A, Group 1: Vaccine | Part A: Compare the Occurrence of IgG Binding Antibodies to 3 V1V2-scaffolded Env Proteins After the Fourth Versus the Fifth Vaccination | gp70-TV1.GSKvacV1V2/293F (Month 12.5) | 50 Participants |
Comparison: IgG Ab binding to C.1086C\_V1\_V2 Tags after the fourth (month 6.5) versus the fifth vaccination (month 12.5)p-value: 0.0215McNemar
Comparison: IgG Ab binding to gp70-96ZM651.02 V1v2 after the fourth (month 6.5) versus the fifth vaccination (month 12.5)p-value: 0.0003McNemar
Comparison: IgG Ab binding to gp70-TV1.GSKvacV1V2/293F after the fourth (month 6.5) versus the fifth vaccination (month 12.5)p-value: 0.001McNemar
Secondary
Part A: Frequency of Severe Local Reactogenicity Signs and Symptoms, Through the Fifth Vaccination
Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 \[March 2017\]. The maximum grade observed for each symptom over the time frame is presented.
Time frame: Measured through 3 days after each vaccination at Month 0, 1, 3, 6, and 12
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Part A, Group 1: Vaccine | Part A: Frequency of Severe Local Reactogenicity Signs and Symptoms, Through the Fifth Vaccination | Tenderness | Moderate | 35 Participants |
| Part A, Group 1: Vaccine | Part A: Frequency of Severe Local Reactogenicity Signs and Symptoms, Through the Fifth Vaccination | Pain and/or Tenderness | Life Threatening | 0 Participants |
| Part A, Group 1: Vaccine | Part A: Frequency of Severe Local Reactogenicity Signs and Symptoms, Through the Fifth Vaccination | Pain | None | 37 Participants |
| Part A, Group 1: Vaccine | Part A: Frequency of Severe Local Reactogenicity Signs and Symptoms, Through the Fifth Vaccination | Erythema | None | 196 Participants |
| Part A, Group 1: Vaccine | Part A: Frequency of Severe Local Reactogenicity Signs and Symptoms, Through the Fifth Vaccination | Tenderness | Severe | 1 Participants |
| Part A, Group 1: Vaccine | Part A: Frequency of Severe Local Reactogenicity Signs and Symptoms, Through the Fifth Vaccination | Erythema | Mild | 8 Participants |
| Part A, Group 1: Vaccine | Part A: Frequency of Severe Local Reactogenicity Signs and Symptoms, Through the Fifth Vaccination | Pain | Life Threatening | 0 Participants |
| Part A, Group 1: Vaccine | Part A: Frequency of Severe Local Reactogenicity Signs and Symptoms, Through the Fifth Vaccination | Erythema | Moderate | 3 Participants |
| Part A, Group 1: Vaccine | Part A: Frequency of Severe Local Reactogenicity Signs and Symptoms, Through the Fifth Vaccination | Tenderness | Life Threatening | 0 Participants |
| Part A, Group 1: Vaccine | Part A: Frequency of Severe Local Reactogenicity Signs and Symptoms, Through the Fifth Vaccination | Erythema | Severe | 3 Participants |
| Part A, Group 1: Vaccine | Part A: Frequency of Severe Local Reactogenicity Signs and Symptoms, Through the Fifth Vaccination | Pain | Moderate | 50 Participants |
| Part A, Group 1: Vaccine | Part A: Frequency of Severe Local Reactogenicity Signs and Symptoms, Through the Fifth Vaccination | Erythema | Life Threatening | 0 Participants |
| Part A, Group 1: Vaccine | Part A: Frequency of Severe Local Reactogenicity Signs and Symptoms, Through the Fifth Vaccination | Tenderness | None | 60 Participants |
| Part A, Group 1: Vaccine | Part A: Frequency of Severe Local Reactogenicity Signs and Symptoms, Through the Fifth Vaccination | Induration | None | 178 Participants |
| Part A, Group 1: Vaccine | Part A: Frequency of Severe Local Reactogenicity Signs and Symptoms, Through the Fifth Vaccination | Pain and/or Tenderness | None | 30 Participants |
| Part A, Group 1: Vaccine | Part A: Frequency of Severe Local Reactogenicity Signs and Symptoms, Through the Fifth Vaccination | Induration | Mild | 17 Participants |
| Part A, Group 1: Vaccine | Part A: Frequency of Severe Local Reactogenicity Signs and Symptoms, Through the Fifth Vaccination | Pain | Mild | 120 Participants |
| Part A, Group 1: Vaccine | Part A: Frequency of Severe Local Reactogenicity Signs and Symptoms, Through the Fifth Vaccination | Induration | Moderate | 12 Participants |
| Part A, Group 1: Vaccine | Part A: Frequency of Severe Local Reactogenicity Signs and Symptoms, Through the Fifth Vaccination | Pain and/or Tenderness | Mild | 123 Participants |
| Part A, Group 1: Vaccine | Part A: Frequency of Severe Local Reactogenicity Signs and Symptoms, Through the Fifth Vaccination | Induration | Severe | 3 Participants |
| Part A, Group 1: Vaccine | Part A: Frequency of Severe Local Reactogenicity Signs and Symptoms, Through the Fifth Vaccination | Tenderness | Mild | 114 Participants |
| Part A, Group 1: Vaccine | Part A: Frequency of Severe Local Reactogenicity Signs and Symptoms, Through the Fifth Vaccination | Induration | Life Threatening | 0 Participants |
| Part A, Group 1: Vaccine | Part A: Frequency of Severe Local Reactogenicity Signs and Symptoms, Through the Fifth Vaccination | Pain and/or Tenderness | Moderate | 54 Participants |
| Part A, Group 1: Vaccine | Part A: Frequency of Severe Local Reactogenicity Signs and Symptoms, Through the Fifth Vaccination | Erythema and/or Induration | None | 176 Participants |
| Part A, Group 1: Vaccine | Part A: Frequency of Severe Local Reactogenicity Signs and Symptoms, Through the Fifth Vaccination | Erythema and/or Induration | Severe | 3 Participants |
| Part A, Group 1: Vaccine | Part A: Frequency of Severe Local Reactogenicity Signs and Symptoms, Through the Fifth Vaccination | Erythema and/or Induration | Mild | 17 Participants |
| Part A, Group 1: Vaccine | Part A: Frequency of Severe Local Reactogenicity Signs and Symptoms, Through the Fifth Vaccination | Pain | Severe | 3 Participants |
| Part A, Group 1: Vaccine | Part A: Frequency of Severe Local Reactogenicity Signs and Symptoms, Through the Fifth Vaccination | Erythema and/or Induration | Moderate | 14 Participants |
| Part A, Group 1: Vaccine | Part A: Frequency of Severe Local Reactogenicity Signs and Symptoms, Through the Fifth Vaccination | Pain and/or Tenderness | Severe | 3 Participants |
| Part A, Group 1: Vaccine | Part A: Frequency of Severe Local Reactogenicity Signs and Symptoms, Through the Fifth Vaccination | Erythema and/or Induration | Life Threatening | 0 Participants |
| Part A, Group 2: Placebo | Part A: Frequency of Severe Local Reactogenicity Signs and Symptoms, Through the Fifth Vaccination | Pain and/or Tenderness | Severe | 0 Participants |
| Part A, Group 2: Placebo | Part A: Frequency of Severe Local Reactogenicity Signs and Symptoms, Through the Fifth Vaccination | Pain | None | 24 Participants |
| Part A, Group 2: Placebo | Part A: Frequency of Severe Local Reactogenicity Signs and Symptoms, Through the Fifth Vaccination | Pain | Mild | 17 Participants |
| Part A, Group 2: Placebo | Part A: Frequency of Severe Local Reactogenicity Signs and Symptoms, Through the Fifth Vaccination | Pain | Moderate | 1 Participants |
| Part A, Group 2: Placebo | Part A: Frequency of Severe Local Reactogenicity Signs and Symptoms, Through the Fifth Vaccination | Pain | Severe | 0 Participants |
| Part A, Group 2: Placebo | Part A: Frequency of Severe Local Reactogenicity Signs and Symptoms, Through the Fifth Vaccination | Pain | Life Threatening | 0 Participants |
| Part A, Group 2: Placebo | Part A: Frequency of Severe Local Reactogenicity Signs and Symptoms, Through the Fifth Vaccination | Tenderness | None | 33 Participants |
| Part A, Group 2: Placebo | Part A: Frequency of Severe Local Reactogenicity Signs and Symptoms, Through the Fifth Vaccination | Tenderness | Mild | 8 Participants |
| Part A, Group 2: Placebo | Part A: Frequency of Severe Local Reactogenicity Signs and Symptoms, Through the Fifth Vaccination | Tenderness | Moderate | 1 Participants |
| Part A, Group 2: Placebo | Part A: Frequency of Severe Local Reactogenicity Signs and Symptoms, Through the Fifth Vaccination | Tenderness | Severe | 0 Participants |
| Part A, Group 2: Placebo | Part A: Frequency of Severe Local Reactogenicity Signs and Symptoms, Through the Fifth Vaccination | Erythema and/or Induration | Moderate | 0 Participants |
| Part A, Group 2: Placebo | Part A: Frequency of Severe Local Reactogenicity Signs and Symptoms, Through the Fifth Vaccination | Tenderness | Life Threatening | 0 Participants |
| Part A, Group 2: Placebo | Part A: Frequency of Severe Local Reactogenicity Signs and Symptoms, Through the Fifth Vaccination | Pain and/or Tenderness | None | 24 Participants |
| Part A, Group 2: Placebo | Part A: Frequency of Severe Local Reactogenicity Signs and Symptoms, Through the Fifth Vaccination | Pain and/or Tenderness | Mild | 17 Participants |
| Part A, Group 2: Placebo | Part A: Frequency of Severe Local Reactogenicity Signs and Symptoms, Through the Fifth Vaccination | Pain and/or Tenderness | Moderate | 1 Participants |
| Part A, Group 2: Placebo | Part A: Frequency of Severe Local Reactogenicity Signs and Symptoms, Through the Fifth Vaccination | Erythema and/or Induration | Life Threatening | 0 Participants |
| Part A, Group 2: Placebo | Part A: Frequency of Severe Local Reactogenicity Signs and Symptoms, Through the Fifth Vaccination | Pain and/or Tenderness | Life Threatening | 0 Participants |
| Part A, Group 2: Placebo | Part A: Frequency of Severe Local Reactogenicity Signs and Symptoms, Through the Fifth Vaccination | Erythema | None | 42 Participants |
| Part A, Group 2: Placebo | Part A: Frequency of Severe Local Reactogenicity Signs and Symptoms, Through the Fifth Vaccination | Erythema | Mild | 0 Participants |
| Part A, Group 2: Placebo | Part A: Frequency of Severe Local Reactogenicity Signs and Symptoms, Through the Fifth Vaccination | Erythema | Moderate | 0 Participants |
| Part A, Group 2: Placebo | Part A: Frequency of Severe Local Reactogenicity Signs and Symptoms, Through the Fifth Vaccination | Erythema | Severe | 0 Participants |
| Part A, Group 2: Placebo | Part A: Frequency of Severe Local Reactogenicity Signs and Symptoms, Through the Fifth Vaccination | Erythema | Life Threatening | 0 Participants |
| Part A, Group 2: Placebo | Part A: Frequency of Severe Local Reactogenicity Signs and Symptoms, Through the Fifth Vaccination | Induration | None | 42 Participants |
| Part A, Group 2: Placebo | Part A: Frequency of Severe Local Reactogenicity Signs and Symptoms, Through the Fifth Vaccination | Induration | Mild | 0 Participants |
| Part A, Group 2: Placebo | Part A: Frequency of Severe Local Reactogenicity Signs and Symptoms, Through the Fifth Vaccination | Induration | Moderate | 0 Participants |
| Part A, Group 2: Placebo | Part A: Frequency of Severe Local Reactogenicity Signs and Symptoms, Through the Fifth Vaccination | Induration | Severe | 0 Participants |
| Part A, Group 2: Placebo | Part A: Frequency of Severe Local Reactogenicity Signs and Symptoms, Through the Fifth Vaccination | Induration | Life Threatening | 0 Participants |
| Part A, Group 2: Placebo | Part A: Frequency of Severe Local Reactogenicity Signs and Symptoms, Through the Fifth Vaccination | Erythema and/or Induration | None | 42 Participants |
| Part A, Group 2: Placebo | Part A: Frequency of Severe Local Reactogenicity Signs and Symptoms, Through the Fifth Vaccination | Erythema and/or Induration | Mild | 0 Participants |
| Part A, Group 2: Placebo | Part A: Frequency of Severe Local Reactogenicity Signs and Symptoms, Through the Fifth Vaccination | Erythema and/or Induration | Severe | 0 Participants |
Secondary
Part A: Frequency of Severe Systemic Reactogenicity Signs and Symptoms, Through the Fifth Vaccination
Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 \[March 2017\]. The maximum grade observed for each symptom over the time frame is presented.
Time frame: Measured through 3 days after each vaccination at Month 0, 1, 3, 6, and 12
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Part A, Group 1: Vaccine | Part A: Frequency of Severe Systemic Reactogenicity Signs and Symptoms, Through the Fifth Vaccination | Vomiting | Moderate | 1 Participants |
| Part A, Group 1: Vaccine | Part A: Frequency of Severe Systemic Reactogenicity Signs and Symptoms, Through the Fifth Vaccination | Headache | Mild | 62 Participants |
| Part A, Group 1: Vaccine | Part A: Frequency of Severe Systemic Reactogenicity Signs and Symptoms, Through the Fifth Vaccination | Vomiting | Severe | 0 Participants |
| Part A, Group 1: Vaccine | Part A: Frequency of Severe Systemic Reactogenicity Signs and Symptoms, Through the Fifth Vaccination | Myalgia | None | 124 Participants |
| Part A, Group 1: Vaccine | Part A: Frequency of Severe Systemic Reactogenicity Signs and Symptoms, Through the Fifth Vaccination | Vomiting | Potentially Life-threatening | 0 Participants |
| Part A, Group 1: Vaccine | Part A: Frequency of Severe Systemic Reactogenicity Signs and Symptoms, Through the Fifth Vaccination | Headache | Moderate | 17 Participants |
| Part A, Group 1: Vaccine | Part A: Frequency of Severe Systemic Reactogenicity Signs and Symptoms, Through the Fifth Vaccination | Chills | None | 187 Participants |
| Part A, Group 1: Vaccine | Part A: Frequency of Severe Systemic Reactogenicity Signs and Symptoms, Through the Fifth Vaccination | Malaise and/or fatigue | Mild | 74 Participants |
| Part A, Group 1: Vaccine | Part A: Frequency of Severe Systemic Reactogenicity Signs and Symptoms, Through the Fifth Vaccination | Chills | Mild | 21 Participants |
| Part A, Group 1: Vaccine | Part A: Frequency of Severe Systemic Reactogenicity Signs and Symptoms, Through the Fifth Vaccination | Headache | Severe | 1 Participants |
| Part A, Group 1: Vaccine | Part A: Frequency of Severe Systemic Reactogenicity Signs and Symptoms, Through the Fifth Vaccination | Chills | Moderate | 2 Participants |
| Part A, Group 1: Vaccine | Part A: Frequency of Severe Systemic Reactogenicity Signs and Symptoms, Through the Fifth Vaccination | Myalgia | Mild | 64 Participants |
| Part A, Group 1: Vaccine | Part A: Frequency of Severe Systemic Reactogenicity Signs and Symptoms, Through the Fifth Vaccination | Chills | Severe | 0 Participants |
| Part A, Group 1: Vaccine | Part A: Frequency of Severe Systemic Reactogenicity Signs and Symptoms, Through the Fifth Vaccination | Headache | Potentially Life-threatening | 0 Participants |
| Part A, Group 1: Vaccine | Part A: Frequency of Severe Systemic Reactogenicity Signs and Symptoms, Through the Fifth Vaccination | Chills | Potentially Life-threatening | 0 Participants |
| Part A, Group 1: Vaccine | Part A: Frequency of Severe Systemic Reactogenicity Signs and Symptoms, Through the Fifth Vaccination | Malaise and/or fatigue | Severe | 0 Participants |
| Part A, Group 1: Vaccine | Part A: Frequency of Severe Systemic Reactogenicity Signs and Symptoms, Through the Fifth Vaccination | Arthralgia | None | 143 Participants |
| Part A, Group 1: Vaccine | Part A: Frequency of Severe Systemic Reactogenicity Signs and Symptoms, Through the Fifth Vaccination | Nausea | None | 174 Participants |
| Part A, Group 1: Vaccine | Part A: Frequency of Severe Systemic Reactogenicity Signs and Symptoms, Through the Fifth Vaccination | Arthralgia | Mild | 57 Participants |
| Part A, Group 1: Vaccine | Part A: Frequency of Severe Systemic Reactogenicity Signs and Symptoms, Through the Fifth Vaccination | Myalgia | Moderate | 22 Participants |
| Part A, Group 1: Vaccine | Part A: Frequency of Severe Systemic Reactogenicity Signs and Symptoms, Through the Fifth Vaccination | Arthralgia | Moderate | 8 Participants |
| Part A, Group 1: Vaccine | Part A: Frequency of Severe Systemic Reactogenicity Signs and Symptoms, Through the Fifth Vaccination | Nausea | Mild | 34 Participants |
| Part A, Group 1: Vaccine | Part A: Frequency of Severe Systemic Reactogenicity Signs and Symptoms, Through the Fifth Vaccination | Arthralgia | Severe | 2 Participants |
| Part A, Group 1: Vaccine | Part A: Frequency of Severe Systemic Reactogenicity Signs and Symptoms, Through the Fifth Vaccination | Myalgia | Severe | 0 Participants |
| Part A, Group 1: Vaccine | Part A: Frequency of Severe Systemic Reactogenicity Signs and Symptoms, Through the Fifth Vaccination | Arthralgia | Potentially Life-threatening | 0 Participants |
| Part A, Group 1: Vaccine | Part A: Frequency of Severe Systemic Reactogenicity Signs and Symptoms, Through the Fifth Vaccination | Nausea | Moderate | 2 Participants |
| Part A, Group 1: Vaccine | Part A: Frequency of Severe Systemic Reactogenicity Signs and Symptoms, Through the Fifth Vaccination | Max. Systemic Symptoms | None | 63 Participants |
| Part A, Group 1: Vaccine | Part A: Frequency of Severe Systemic Reactogenicity Signs and Symptoms, Through the Fifth Vaccination | Malaise and/or fatigue | None | 121 Participants |
| Part A, Group 1: Vaccine | Part A: Frequency of Severe Systemic Reactogenicity Signs and Symptoms, Through the Fifth Vaccination | Max. Systemic Symptoms | Mild | 104 Participants |
| Part A, Group 1: Vaccine | Part A: Frequency of Severe Systemic Reactogenicity Signs and Symptoms, Through the Fifth Vaccination | Nausea | Severe | 0 Participants |
| Part A, Group 1: Vaccine | Part A: Frequency of Severe Systemic Reactogenicity Signs and Symptoms, Through the Fifth Vaccination | Max. Systemic Symptoms | Moderate | 40 Participants |
| Part A, Group 1: Vaccine | Part A: Frequency of Severe Systemic Reactogenicity Signs and Symptoms, Through the Fifth Vaccination | Myalgia | Potentially Life-threatening | 0 Participants |
| Part A, Group 1: Vaccine | Part A: Frequency of Severe Systemic Reactogenicity Signs and Symptoms, Through the Fifth Vaccination | Max. Systemic Symptoms | Severe | 3 Participants |
| Part A, Group 1: Vaccine | Part A: Frequency of Severe Systemic Reactogenicity Signs and Symptoms, Through the Fifth Vaccination | Nausea | Potentially Life-threatening | 0 Participants |
| Part A, Group 1: Vaccine | Part A: Frequency of Severe Systemic Reactogenicity Signs and Symptoms, Through the Fifth Vaccination | Max. Systemic Symptoms | Potentially Life-threatening | 0 Participants |
| Part A, Group 1: Vaccine | Part A: Frequency of Severe Systemic Reactogenicity Signs and Symptoms, Through the Fifth Vaccination | Malaise and/or fatigue | Potentially Life-threatening | 0 Participants |
| Part A, Group 1: Vaccine | Part A: Frequency of Severe Systemic Reactogenicity Signs and Symptoms, Through the Fifth Vaccination | Temperature | None | 192 Participants |
| Part A, Group 1: Vaccine | Part A: Frequency of Severe Systemic Reactogenicity Signs and Symptoms, Through the Fifth Vaccination | Vomiting | None | 200 Participants |
| Part A, Group 1: Vaccine | Part A: Frequency of Severe Systemic Reactogenicity Signs and Symptoms, Through the Fifth Vaccination | Temperature | Mild | 11 Participants |
| Part A, Group 1: Vaccine | Part A: Frequency of Severe Systemic Reactogenicity Signs and Symptoms, Through the Fifth Vaccination | Headache | None | 130 Participants |
| Part A, Group 1: Vaccine | Part A: Frequency of Severe Systemic Reactogenicity Signs and Symptoms, Through the Fifth Vaccination | Temperature | Moderate | 7 Participants |
| Part A, Group 1: Vaccine | Part A: Frequency of Severe Systemic Reactogenicity Signs and Symptoms, Through the Fifth Vaccination | Vomiting | Mild | 9 Participants |
| Part A, Group 1: Vaccine | Part A: Frequency of Severe Systemic Reactogenicity Signs and Symptoms, Through the Fifth Vaccination | Temperature | Severe | 0 Participants |
| Part A, Group 1: Vaccine | Part A: Frequency of Severe Systemic Reactogenicity Signs and Symptoms, Through the Fifth Vaccination | Malaise and/or fatigue | Moderate | 15 Participants |
| Part A, Group 1: Vaccine | Part A: Frequency of Severe Systemic Reactogenicity Signs and Symptoms, Through the Fifth Vaccination | Temperature | Potentially Life-threatening | 0 Participants |
| Part A, Group 2: Placebo | Part A: Frequency of Severe Systemic Reactogenicity Signs and Symptoms, Through the Fifth Vaccination | Chills | Moderate | 0 Participants |
| Part A, Group 2: Placebo | Part A: Frequency of Severe Systemic Reactogenicity Signs and Symptoms, Through the Fifth Vaccination | Myalgia | Moderate | 1 Participants |
| Part A, Group 2: Placebo | Part A: Frequency of Severe Systemic Reactogenicity Signs and Symptoms, Through the Fifth Vaccination | Malaise and/or fatigue | None | 26 Participants |
| Part A, Group 2: Placebo | Part A: Frequency of Severe Systemic Reactogenicity Signs and Symptoms, Through the Fifth Vaccination | Malaise and/or fatigue | Mild | 14 Participants |
| Part A, Group 2: Placebo | Part A: Frequency of Severe Systemic Reactogenicity Signs and Symptoms, Through the Fifth Vaccination | Malaise and/or fatigue | Moderate | 1 Participants |
| Part A, Group 2: Placebo | Part A: Frequency of Severe Systemic Reactogenicity Signs and Symptoms, Through the Fifth Vaccination | Malaise and/or fatigue | Severe | 1 Participants |
| Part A, Group 2: Placebo | Part A: Frequency of Severe Systemic Reactogenicity Signs and Symptoms, Through the Fifth Vaccination | Malaise and/or fatigue | Potentially Life-threatening | 0 Participants |
| Part A, Group 2: Placebo | Part A: Frequency of Severe Systemic Reactogenicity Signs and Symptoms, Through the Fifth Vaccination | Myalgia | None | 34 Participants |
| Part A, Group 2: Placebo | Part A: Frequency of Severe Systemic Reactogenicity Signs and Symptoms, Through the Fifth Vaccination | Myalgia | Mild | 7 Participants |
| Part A, Group 2: Placebo | Part A: Frequency of Severe Systemic Reactogenicity Signs and Symptoms, Through the Fifth Vaccination | Myalgia | Severe | 0 Participants |
| Part A, Group 2: Placebo | Part A: Frequency of Severe Systemic Reactogenicity Signs and Symptoms, Through the Fifth Vaccination | Myalgia | Potentially Life-threatening | 0 Participants |
| Part A, Group 2: Placebo | Part A: Frequency of Severe Systemic Reactogenicity Signs and Symptoms, Through the Fifth Vaccination | Headache | None | 19 Participants |
| Part A, Group 2: Placebo | Part A: Frequency of Severe Systemic Reactogenicity Signs and Symptoms, Through the Fifth Vaccination | Headache | Mild | 17 Participants |
| Part A, Group 2: Placebo | Part A: Frequency of Severe Systemic Reactogenicity Signs and Symptoms, Through the Fifth Vaccination | Headache | Moderate | 6 Participants |
| Part A, Group 2: Placebo | Part A: Frequency of Severe Systemic Reactogenicity Signs and Symptoms, Through the Fifth Vaccination | Headache | Severe | 0 Participants |
| Part A, Group 2: Placebo | Part A: Frequency of Severe Systemic Reactogenicity Signs and Symptoms, Through the Fifth Vaccination | Headache | Potentially Life-threatening | 0 Participants |
| Part A, Group 2: Placebo | Part A: Frequency of Severe Systemic Reactogenicity Signs and Symptoms, Through the Fifth Vaccination | Nausea | None | 38 Participants |
| Part A, Group 2: Placebo | Part A: Frequency of Severe Systemic Reactogenicity Signs and Symptoms, Through the Fifth Vaccination | Nausea | Mild | 4 Participants |
| Part A, Group 2: Placebo | Part A: Frequency of Severe Systemic Reactogenicity Signs and Symptoms, Through the Fifth Vaccination | Nausea | Moderate | 0 Participants |
| Part A, Group 2: Placebo | Part A: Frequency of Severe Systemic Reactogenicity Signs and Symptoms, Through the Fifth Vaccination | Nausea | Severe | 0 Participants |
| Part A, Group 2: Placebo | Part A: Frequency of Severe Systemic Reactogenicity Signs and Symptoms, Through the Fifth Vaccination | Nausea | Potentially Life-threatening | 0 Participants |
| Part A, Group 2: Placebo | Part A: Frequency of Severe Systemic Reactogenicity Signs and Symptoms, Through the Fifth Vaccination | Vomiting | None | 41 Participants |
| Part A, Group 2: Placebo | Part A: Frequency of Severe Systemic Reactogenicity Signs and Symptoms, Through the Fifth Vaccination | Vomiting | Mild | 1 Participants |
| Part A, Group 2: Placebo | Part A: Frequency of Severe Systemic Reactogenicity Signs and Symptoms, Through the Fifth Vaccination | Vomiting | Moderate | 0 Participants |
| Part A, Group 2: Placebo | Part A: Frequency of Severe Systemic Reactogenicity Signs and Symptoms, Through the Fifth Vaccination | Vomiting | Severe | 0 Participants |
| Part A, Group 2: Placebo | Part A: Frequency of Severe Systemic Reactogenicity Signs and Symptoms, Through the Fifth Vaccination | Vomiting | Potentially Life-threatening | 0 Participants |
| Part A, Group 2: Placebo | Part A: Frequency of Severe Systemic Reactogenicity Signs and Symptoms, Through the Fifth Vaccination | Chills | None | 40 Participants |
| Part A, Group 2: Placebo | Part A: Frequency of Severe Systemic Reactogenicity Signs and Symptoms, Through the Fifth Vaccination | Chills | Mild | 2 Participants |
| Part A, Group 2: Placebo | Part A: Frequency of Severe Systemic Reactogenicity Signs and Symptoms, Through the Fifth Vaccination | Temperature | Potentially Life-threatening | 0 Participants |
| Part A, Group 2: Placebo | Part A: Frequency of Severe Systemic Reactogenicity Signs and Symptoms, Through the Fifth Vaccination | Chills | Severe | 0 Participants |
| Part A, Group 2: Placebo | Part A: Frequency of Severe Systemic Reactogenicity Signs and Symptoms, Through the Fifth Vaccination | Chills | Potentially Life-threatening | 0 Participants |
| Part A, Group 2: Placebo | Part A: Frequency of Severe Systemic Reactogenicity Signs and Symptoms, Through the Fifth Vaccination | Arthralgia | None | 33 Participants |
| Part A, Group 2: Placebo | Part A: Frequency of Severe Systemic Reactogenicity Signs and Symptoms, Through the Fifth Vaccination | Arthralgia | Mild | 8 Participants |
| Part A, Group 2: Placebo | Part A: Frequency of Severe Systemic Reactogenicity Signs and Symptoms, Through the Fifth Vaccination | Arthralgia | Moderate | 1 Participants |
| Part A, Group 2: Placebo | Part A: Frequency of Severe Systemic Reactogenicity Signs and Symptoms, Through the Fifth Vaccination | Arthralgia | Severe | 0 Participants |
| Part A, Group 2: Placebo | Part A: Frequency of Severe Systemic Reactogenicity Signs and Symptoms, Through the Fifth Vaccination | Arthralgia | Potentially Life-threatening | 0 Participants |
| Part A, Group 2: Placebo | Part A: Frequency of Severe Systemic Reactogenicity Signs and Symptoms, Through the Fifth Vaccination | Max. Systemic Symptoms | None | 14 Participants |
| Part A, Group 2: Placebo | Part A: Frequency of Severe Systemic Reactogenicity Signs and Symptoms, Through the Fifth Vaccination | Max. Systemic Symptoms | Mild | 19 Participants |
| Part A, Group 2: Placebo | Part A: Frequency of Severe Systemic Reactogenicity Signs and Symptoms, Through the Fifth Vaccination | Max. Systemic Symptoms | Moderate | 8 Participants |
| Part A, Group 2: Placebo | Part A: Frequency of Severe Systemic Reactogenicity Signs and Symptoms, Through the Fifth Vaccination | Max. Systemic Symptoms | Severe | 1 Participants |
| Part A, Group 2: Placebo | Part A: Frequency of Severe Systemic Reactogenicity Signs and Symptoms, Through the Fifth Vaccination | Max. Systemic Symptoms | Potentially Life-threatening | 0 Participants |
| Part A, Group 2: Placebo | Part A: Frequency of Severe Systemic Reactogenicity Signs and Symptoms, Through the Fifth Vaccination | Temperature | None | 41 Participants |
| Part A, Group 2: Placebo | Part A: Frequency of Severe Systemic Reactogenicity Signs and Symptoms, Through the Fifth Vaccination | Temperature | Mild | 0 Participants |
| Part A, Group 2: Placebo | Part A: Frequency of Severe Systemic Reactogenicity Signs and Symptoms, Through the Fifth Vaccination | Temperature | Moderate | 1 Participants |
| Part A, Group 2: Placebo | Part A: Frequency of Severe Systemic Reactogenicity Signs and Symptoms, Through the Fifth Vaccination | Temperature | Severe | 0 Participants |
Secondary
Part B: Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine in the Extension Study, at 6 Months After the Month 30 Vaccination
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.
Time frame: Measured at Month 30 and 36
Population: Overall Number of Participants Analyzed represents Part B participants. Number Analyzed counts participants with data meeting assay-specific quality criteria.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Part A, Group 1: Vaccine | Part B: Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine in the Extension Study, at 6 Months After the Month 30 Vaccination | Any gp120 (Month 30) | 0.128764915 % CD4+ T-cells |
| Part A, Group 1: Vaccine | Part B: Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine in the Extension Study, at 6 Months After the Month 30 Vaccination | Any gp120 (Month 36) | 0.115994935 % CD4+ T-cells |
| Part A, Group 1: Vaccine | Part B: Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine in the Extension Study, at 6 Months After the Month 30 Vaccination | 1086 gp120 (Month 30) | 0.07396858 % CD4+ T-cells |
| Part A, Group 1: Vaccine | Part B: Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine in the Extension Study, at 6 Months After the Month 30 Vaccination | 1086 gp120 (Month 36) | 0.064916705 % CD4+ T-cells |
| Part A, Group 1: Vaccine | Part B: Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine in the Extension Study, at 6 Months After the Month 30 Vaccination | TV1 gp120 (Month 30) | 0.114625195 % CD4+ T-cells |
| Part A, Group 1: Vaccine | Part B: Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine in the Extension Study, at 6 Months After the Month 30 Vaccination | TV1 gp120 (Month 36) | 0.106333215 % CD4+ T-cells |
| Part A, Group 1: Vaccine | Part B: Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine in the Extension Study, at 6 Months After the Month 30 Vaccination | ZM96 gp120 (Month 30) | 0.09879441 % CD4+ T-cells |
| Part A, Group 1: Vaccine | Part B: Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine in the Extension Study, at 6 Months After the Month 30 Vaccination | ZM96 gp120 (Month 36) | 0.104756745 % CD4+ T-cells |
| Part A, Group 2: Placebo | Part B: Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine in the Extension Study, at 6 Months After the Month 30 Vaccination | 1086 gp120 (Month 30) | 0.05696544 % CD4+ T-cells |
| Part A, Group 2: Placebo | Part B: Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine in the Extension Study, at 6 Months After the Month 30 Vaccination | ZM96 gp120 (Month 30) | 0.08841848 % CD4+ T-cells |
| Part A, Group 2: Placebo | Part B: Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine in the Extension Study, at 6 Months After the Month 30 Vaccination | 1086 gp120 (Month 36) | 0.06119621 % CD4+ T-cells |
| Part A, Group 2: Placebo | Part B: Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine in the Extension Study, at 6 Months After the Month 30 Vaccination | TV1 gp120 (Month 30) | 0.077949675 % CD4+ T-cells |
| Part A, Group 2: Placebo | Part B: Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine in the Extension Study, at 6 Months After the Month 30 Vaccination | TV1 gp120 (Month 36) | 0.04974197 % CD4+ T-cells |
| Part A, Group 2: Placebo | Part B: Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine in the Extension Study, at 6 Months After the Month 30 Vaccination | Any gp120 (Month 30) | 0.10384047 % CD4+ T-cells |
| Part A, Group 2: Placebo | Part B: Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine in the Extension Study, at 6 Months After the Month 30 Vaccination | Any gp120 (Month 36) | 0.09751639 % CD4+ T-cells |
| Part A, Group 2: Placebo | Part B: Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine in the Extension Study, at 6 Months After the Month 30 Vaccination | ZM96 gp120 (Month 36) | 0.10113899 % CD4+ T-cells |
| Part B, Group 2: Placebo | Part B: Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine in the Extension Study, at 6 Months After the Month 30 Vaccination | 1086 gp120 (Month 30) | 0.00878693 % CD4+ T-cells |
| Part B, Group 2: Placebo | Part B: Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine in the Extension Study, at 6 Months After the Month 30 Vaccination | Any gp120 (Month 36) | 0.007663255 % CD4+ T-cells |
| Part B, Group 2: Placebo | Part B: Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine in the Extension Study, at 6 Months After the Month 30 Vaccination | Any gp120 (Month 30) | 0.00929931 % CD4+ T-cells |
| Part B, Group 2: Placebo | Part B: Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine in the Extension Study, at 6 Months After the Month 30 Vaccination | 1086 gp120 (Month 36) | 0.001323895 % CD4+ T-cells |
| Part B, Group 2: Placebo | Part B: Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine in the Extension Study, at 6 Months After the Month 30 Vaccination | ZM96 gp120 (Month 30) | -0.006057945 % CD4+ T-cells |
| Part B, Group 2: Placebo | Part B: Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine in the Extension Study, at 6 Months After the Month 30 Vaccination | TV1 gp120 (Month 36) | -0.00506502 % CD4+ T-cells |
| Part B, Group 2: Placebo | Part B: Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine in the Extension Study, at 6 Months After the Month 30 Vaccination | TV1 gp120 (Month 30) | -0.00139331 % CD4+ T-cells |
| Part B, Group 2: Placebo | Part B: Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine in the Extension Study, at 6 Months After the Month 30 Vaccination | ZM96 gp120 (Month 36) | -0.001777015 % CD4+ T-cells |
Secondary
Part B: Level of IgG Ab Binding to gp120 Env Proteins Contained in the Vaccine (ZM96, TV1.C, 1086.C) in the Extension Study, at 6 Months After the Month 30 Vaccination
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.
Time frame: Measured at Month 30 and 36
Population: Overall Number of Participants Analyzed represents Part B participants. Number Analyzed counts participants with data meeting assay-specific quality criteria.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Part A, Group 1: Vaccine | Part B: Level of IgG Ab Binding to gp120 Env Proteins Contained in the Vaccine (ZM96, TV1.C, 1086.C) in the Extension Study, at 6 Months After the Month 30 Vaccination | 1086C_D7gp120.avi/293F (Month 30) | 6664 fluorescence unit relative to background |
| Part A, Group 1: Vaccine | Part B: Level of IgG Ab Binding to gp120 Env Proteins Contained in the Vaccine (ZM96, TV1.C, 1086.C) in the Extension Study, at 6 Months After the Month 30 Vaccination | 1086C_D7gp120.avi/293F (Month 36) | 25399 fluorescence unit relative to background |
| Part A, Group 1: Vaccine | Part B: Level of IgG Ab Binding to gp120 Env Proteins Contained in the Vaccine (ZM96, TV1.C, 1086.C) in the Extension Study, at 6 Months After the Month 30 Vaccination | 96ZM651.D11gp120.avi (Month 30) | 895.25 fluorescence unit relative to background |
| Part A, Group 1: Vaccine | Part B: Level of IgG Ab Binding to gp120 Env Proteins Contained in the Vaccine (ZM96, TV1.C, 1086.C) in the Extension Study, at 6 Months After the Month 30 Vaccination | 96ZM651.D11gp120.avi (Month 36) | 9750 fluorescence unit relative to background |
| Part A, Group 1: Vaccine | Part B: Level of IgG Ab Binding to gp120 Env Proteins Contained in the Vaccine (ZM96, TV1.C, 1086.C) in the Extension Study, at 6 Months After the Month 30 Vaccination | TV1c8_D11gp120.avi/293F (Month 30) | 937 fluorescence unit relative to background |
| Part A, Group 1: Vaccine | Part B: Level of IgG Ab Binding to gp120 Env Proteins Contained in the Vaccine (ZM96, TV1.C, 1086.C) in the Extension Study, at 6 Months After the Month 30 Vaccination | TV1c8_D11gp120.avi/293F (Month 36) | 17175.5 fluorescence unit relative to background |
| Part A, Group 2: Placebo | Part B: Level of IgG Ab Binding to gp120 Env Proteins Contained in the Vaccine (ZM96, TV1.C, 1086.C) in the Extension Study, at 6 Months After the Month 30 Vaccination | TV1c8_D11gp120.avi/293F (Month 36) | 17192.375 fluorescence unit relative to background |
| Part A, Group 2: Placebo | Part B: Level of IgG Ab Binding to gp120 Env Proteins Contained in the Vaccine (ZM96, TV1.C, 1086.C) in the Extension Study, at 6 Months After the Month 30 Vaccination | 1086C_D7gp120.avi/293F (Month 30) | 4415 fluorescence unit relative to background |
| Part A, Group 2: Placebo | Part B: Level of IgG Ab Binding to gp120 Env Proteins Contained in the Vaccine (ZM96, TV1.C, 1086.C) in the Extension Study, at 6 Months After the Month 30 Vaccination | 96ZM651.D11gp120.avi (Month 36) | 7324.75 fluorescence unit relative to background |
| Part A, Group 2: Placebo | Part B: Level of IgG Ab Binding to gp120 Env Proteins Contained in the Vaccine (ZM96, TV1.C, 1086.C) in the Extension Study, at 6 Months After the Month 30 Vaccination | TV1c8_D11gp120.avi/293F (Month 30) | 616.25 fluorescence unit relative to background |
| Part A, Group 2: Placebo | Part B: Level of IgG Ab Binding to gp120 Env Proteins Contained in the Vaccine (ZM96, TV1.C, 1086.C) in the Extension Study, at 6 Months After the Month 30 Vaccination | 1086C_D7gp120.avi/293F (Month 36) | 24763.625 fluorescence unit relative to background |
| Part A, Group 2: Placebo | Part B: Level of IgG Ab Binding to gp120 Env Proteins Contained in the Vaccine (ZM96, TV1.C, 1086.C) in the Extension Study, at 6 Months After the Month 30 Vaccination | 96ZM651.D11gp120.avi (Month 30) | 706.5 fluorescence unit relative to background |
| Part B, Group 2: Placebo | Part B: Level of IgG Ab Binding to gp120 Env Proteins Contained in the Vaccine (ZM96, TV1.C, 1086.C) in the Extension Study, at 6 Months After the Month 30 Vaccination | 1086C_D7gp120.avi/293F (Month 36) | 1 fluorescence unit relative to background |
| Part B, Group 2: Placebo | Part B: Level of IgG Ab Binding to gp120 Env Proteins Contained in the Vaccine (ZM96, TV1.C, 1086.C) in the Extension Study, at 6 Months After the Month 30 Vaccination | 96ZM651.D11gp120.avi (Month 30) | 1 fluorescence unit relative to background |
| Part B, Group 2: Placebo | Part B: Level of IgG Ab Binding to gp120 Env Proteins Contained in the Vaccine (ZM96, TV1.C, 1086.C) in the Extension Study, at 6 Months After the Month 30 Vaccination | TV1c8_D11gp120.avi/293F (Month 36) | 1 fluorescence unit relative to background |
| Part B, Group 2: Placebo | Part B: Level of IgG Ab Binding to gp120 Env Proteins Contained in the Vaccine (ZM96, TV1.C, 1086.C) in the Extension Study, at 6 Months After the Month 30 Vaccination | 96ZM651.D11gp120.avi (Month 36) | 2.75 fluorescence unit relative to background |
| Part B, Group 2: Placebo | Part B: Level of IgG Ab Binding to gp120 Env Proteins Contained in the Vaccine (ZM96, TV1.C, 1086.C) in the Extension Study, at 6 Months After the Month 30 Vaccination | 1086C_D7gp120.avi/293F (Month 30) | 1 fluorescence unit relative to background |
| Part B, Group 2: Placebo | Part B: Level of IgG Ab Binding to gp120 Env Proteins Contained in the Vaccine (ZM96, TV1.C, 1086.C) in the Extension Study, at 6 Months After the Month 30 Vaccination | TV1c8_D11gp120.avi/293F (Month 30) | 1 fluorescence unit relative to background |
Secondary
Part B: Level of IgG Binding Antibodies to 3 V1V2-scaffolded Env Proteins in the Extension Study, at 6 Months After the Month 30 Vaccination
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.
Time frame: Measured at Month 30 and 36
Population: Overall Number of Participants Analyzed represents Part B participants. Number Analyzed counts participants with data meeting assay-specific quality criteria.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Part A, Group 1: Vaccine | Part B: Level of IgG Binding Antibodies to 3 V1V2-scaffolded Env Proteins in the Extension Study, at 6 Months After the Month 30 Vaccination | C.1086C_V1_V2 Tags (Month 30) | 13.5 fluorescence unit relative to background |
| Part A, Group 1: Vaccine | Part B: Level of IgG Binding Antibodies to 3 V1V2-scaffolded Env Proteins in the Extension Study, at 6 Months After the Month 30 Vaccination | C.1086C_V1_V2 Tags (Month 36) | 47.25 fluorescence unit relative to background |
| Part A, Group 1: Vaccine | Part B: Level of IgG Binding Antibodies to 3 V1V2-scaffolded Env Proteins in the Extension Study, at 6 Months After the Month 30 Vaccination | gp70-96ZM651.02 V1v2 (Month 30) | 1 fluorescence unit relative to background |
| Part A, Group 1: Vaccine | Part B: Level of IgG Binding Antibodies to 3 V1V2-scaffolded Env Proteins in the Extension Study, at 6 Months After the Month 30 Vaccination | gp70-96ZM651.02 V1v2 (Month 36) | 19.75 fluorescence unit relative to background |
| Part A, Group 1: Vaccine | Part B: Level of IgG Binding Antibodies to 3 V1V2-scaffolded Env Proteins in the Extension Study, at 6 Months After the Month 30 Vaccination | gp70-TV1.GSKvacV1V2/293F (Month 30) | 1 fluorescence unit relative to background |
| Part A, Group 1: Vaccine | Part B: Level of IgG Binding Antibodies to 3 V1V2-scaffolded Env Proteins in the Extension Study, at 6 Months After the Month 30 Vaccination | gp70-TV1.GSKvacV1V2/293F (Month 36) | 1 fluorescence unit relative to background |
| Part A, Group 2: Placebo | Part B: Level of IgG Binding Antibodies to 3 V1V2-scaffolded Env Proteins in the Extension Study, at 6 Months After the Month 30 Vaccination | gp70-TV1.GSKvacV1V2/293F (Month 36) | 7.625 fluorescence unit relative to background |
| Part A, Group 2: Placebo | Part B: Level of IgG Binding Antibodies to 3 V1V2-scaffolded Env Proteins in the Extension Study, at 6 Months After the Month 30 Vaccination | C.1086C_V1_V2 Tags (Month 30) | 23 fluorescence unit relative to background |
| Part A, Group 2: Placebo | Part B: Level of IgG Binding Antibodies to 3 V1V2-scaffolded Env Proteins in the Extension Study, at 6 Months After the Month 30 Vaccination | gp70-96ZM651.02 V1v2 (Month 36) | 35.375 fluorescence unit relative to background |
| Part A, Group 2: Placebo | Part B: Level of IgG Binding Antibodies to 3 V1V2-scaffolded Env Proteins in the Extension Study, at 6 Months After the Month 30 Vaccination | gp70-TV1.GSKvacV1V2/293F (Month 30) | 1 fluorescence unit relative to background |
| Part A, Group 2: Placebo | Part B: Level of IgG Binding Antibodies to 3 V1V2-scaffolded Env Proteins in the Extension Study, at 6 Months After the Month 30 Vaccination | C.1086C_V1_V2 Tags (Month 36) | 79.25 fluorescence unit relative to background |
| Part A, Group 2: Placebo | Part B: Level of IgG Binding Antibodies to 3 V1V2-scaffolded Env Proteins in the Extension Study, at 6 Months After the Month 30 Vaccination | gp70-96ZM651.02 V1v2 (Month 30) | 1 fluorescence unit relative to background |
| Part B, Group 2: Placebo | Part B: Level of IgG Binding Antibodies to 3 V1V2-scaffolded Env Proteins in the Extension Study, at 6 Months After the Month 30 Vaccination | C.1086C_V1_V2 Tags (Month 36) | 4.75 fluorescence unit relative to background |
| Part B, Group 2: Placebo | Part B: Level of IgG Binding Antibodies to 3 V1V2-scaffolded Env Proteins in the Extension Study, at 6 Months After the Month 30 Vaccination | gp70-96ZM651.02 V1v2 (Month 30) | 1 fluorescence unit relative to background |
| Part B, Group 2: Placebo | Part B: Level of IgG Binding Antibodies to 3 V1V2-scaffolded Env Proteins in the Extension Study, at 6 Months After the Month 30 Vaccination | gp70-TV1.GSKvacV1V2/293F (Month 36) | 1 fluorescence unit relative to background |
| Part B, Group 2: Placebo | Part B: Level of IgG Binding Antibodies to 3 V1V2-scaffolded Env Proteins in the Extension Study, at 6 Months After the Month 30 Vaccination | gp70-96ZM651.02 V1v2 (Month 36) | 1 fluorescence unit relative to background |
| Part B, Group 2: Placebo | Part B: Level of IgG Binding Antibodies to 3 V1V2-scaffolded Env Proteins in the Extension Study, at 6 Months After the Month 30 Vaccination | C.1086C_V1_V2 Tags (Month 30) | 2.75 fluorescence unit relative to background |
| Part B, Group 2: Placebo | Part B: Level of IgG Binding Antibodies to 3 V1V2-scaffolded Env Proteins in the Extension Study, at 6 Months After the Month 30 Vaccination | gp70-TV1.GSKvacV1V2/293F (Month 30) | 1 fluorescence unit relative to background |
Secondary
Part B: Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine in the Extension Study, at 6 Months After the Month 30 Vaccination
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.
Time frame: Measured at Month 30 and 36
Population: Overall Number of Participants Analyzed represents Part B participants. Number Analyzed counts participants with data meeting assay-specific quality criteria.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A, Group 1: Vaccine | Part B: Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine in the Extension Study, at 6 Months After the Month 30 Vaccination | Any gp120 (Month 30) | 18 Participants |
| Part A, Group 1: Vaccine | Part B: Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine in the Extension Study, at 6 Months After the Month 30 Vaccination | Any gp120 (Month 36) | 18 Participants |
| Part A, Group 1: Vaccine | Part B: Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine in the Extension Study, at 6 Months After the Month 30 Vaccination | 1086 gp120 (Month 30) | 12 Participants |
| Part A, Group 1: Vaccine | Part B: Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine in the Extension Study, at 6 Months After the Month 30 Vaccination | 1086 gp120 (Month 36) | 11 Participants |
| Part A, Group 1: Vaccine | Part B: Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine in the Extension Study, at 6 Months After the Month 30 Vaccination | TV1 gp120 (Month 30) | 16 Participants |
| Part A, Group 1: Vaccine | Part B: Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine in the Extension Study, at 6 Months After the Month 30 Vaccination | TV1 gp120 (Month 36) | 17 Participants |
| Part A, Group 1: Vaccine | Part B: Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine in the Extension Study, at 6 Months After the Month 30 Vaccination | ZM96 gp120 (Month 30) | 15 Participants |
| Part A, Group 1: Vaccine | Part B: Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine in the Extension Study, at 6 Months After the Month 30 Vaccination | ZM96 gp120 (Month 36) | 15 Participants |
| Part A, Group 2: Placebo | Part B: Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine in the Extension Study, at 6 Months After the Month 30 Vaccination | 1086 gp120 (Month 30) | 8 Participants |
| Part A, Group 2: Placebo | Part B: Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine in the Extension Study, at 6 Months After the Month 30 Vaccination | ZM96 gp120 (Month 30) | 14 Participants |
| Part A, Group 2: Placebo | Part B: Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine in the Extension Study, at 6 Months After the Month 30 Vaccination | 1086 gp120 (Month 36) | 12 Participants |
| Part A, Group 2: Placebo | Part B: Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine in the Extension Study, at 6 Months After the Month 30 Vaccination | TV1 gp120 (Month 30) | 15 Participants |
| Part A, Group 2: Placebo | Part B: Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine in the Extension Study, at 6 Months After the Month 30 Vaccination | TV1 gp120 (Month 36) | 12 Participants |
| Part A, Group 2: Placebo | Part B: Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine in the Extension Study, at 6 Months After the Month 30 Vaccination | Any gp120 (Month 30) | 17 Participants |
| Part A, Group 2: Placebo | Part B: Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine in the Extension Study, at 6 Months After the Month 30 Vaccination | Any gp120 (Month 36) | 16 Participants |
| Part A, Group 2: Placebo | Part B: Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine in the Extension Study, at 6 Months After the Month 30 Vaccination | ZM96 gp120 (Month 36) | 13 Participants |
| Part B, Group 2: Placebo | Part B: Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine in the Extension Study, at 6 Months After the Month 30 Vaccination | 1086 gp120 (Month 30) | 0 Participants |
| Part B, Group 2: Placebo | Part B: Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine in the Extension Study, at 6 Months After the Month 30 Vaccination | Any gp120 (Month 36) | 0 Participants |
| Part B, Group 2: Placebo | Part B: Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine in the Extension Study, at 6 Months After the Month 30 Vaccination | Any gp120 (Month 30) | 0 Participants |
| Part B, Group 2: Placebo | Part B: Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine in the Extension Study, at 6 Months After the Month 30 Vaccination | 1086 gp120 (Month 36) | 0 Participants |
| Part B, Group 2: Placebo | Part B: Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine in the Extension Study, at 6 Months After the Month 30 Vaccination | ZM96 gp120 (Month 30) | 0 Participants |
| Part B, Group 2: Placebo | Part B: Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine in the Extension Study, at 6 Months After the Month 30 Vaccination | TV1 gp120 (Month 36) | 0 Participants |
| Part B, Group 2: Placebo | Part B: Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine in the Extension Study, at 6 Months After the Month 30 Vaccination | TV1 gp120 (Month 30) | 0 Participants |
| Part B, Group 2: Placebo | Part B: Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine in the Extension Study, at 6 Months After the Month 30 Vaccination | ZM96 gp120 (Month 36) | 0 Participants |
Secondary
Part B: Occurrence of IgG Ab Binding to gp120 Env Proteins Contained in the Vaccine (ZM96, TV1.C, 1086.C) in the Extension Study, at 6 Months After the Month 30 Vaccination
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. Samples from post-enrollment visits have positive responses if they meet three conditions: (1) net MFI greater than or equal to an antigen-specific response threshold (defined as the maximum of 100 and the 95th percentile of pre-vaccination net MFI), (2) net MFI values are greater than 3 times pre-vaccination net MFI, and (3) experimental antigen MFI values are greater than 3 times pre-vaccination MFI. Data are excluded if the blood draw date was outside the allowable window, a participant was HIV-infected, or the reference antigen exceeds 5000 MFI.
Time frame: Measured at Month 30 and 36
Population: Overall Number of Participants Analyzed represents Part B participants. Number Analyzed counts participants with data meeting assay-specific quality criteria.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A, Group 1: Vaccine | Part B: Occurrence of IgG Ab Binding to gp120 Env Proteins Contained in the Vaccine (ZM96, TV1.C, 1086.C) in the Extension Study, at 6 Months After the Month 30 Vaccination | 1086C_D7gp120.avi/293F (Month 30) | 31 Participants |
| Part A, Group 1: Vaccine | Part B: Occurrence of IgG Ab Binding to gp120 Env Proteins Contained in the Vaccine (ZM96, TV1.C, 1086.C) in the Extension Study, at 6 Months After the Month 30 Vaccination | 1086C_D7gp120.avi/293F (Month 36) | 31 Participants |
| Part A, Group 1: Vaccine | Part B: Occurrence of IgG Ab Binding to gp120 Env Proteins Contained in the Vaccine (ZM96, TV1.C, 1086.C) in the Extension Study, at 6 Months After the Month 30 Vaccination | 96ZM651.D11gp120.avi (Month 30) | 2 Participants |
| Part A, Group 1: Vaccine | Part B: Occurrence of IgG Ab Binding to gp120 Env Proteins Contained in the Vaccine (ZM96, TV1.C, 1086.C) in the Extension Study, at 6 Months After the Month 30 Vaccination | 96ZM651.D11gp120.avi (Month 36) | 24 Participants |
| Part A, Group 1: Vaccine | Part B: Occurrence of IgG Ab Binding to gp120 Env Proteins Contained in the Vaccine (ZM96, TV1.C, 1086.C) in the Extension Study, at 6 Months After the Month 30 Vaccination | TV1c8_D11gp120.avi/293F (Month 30) | 27 Participants |
| Part A, Group 1: Vaccine | Part B: Occurrence of IgG Ab Binding to gp120 Env Proteins Contained in the Vaccine (ZM96, TV1.C, 1086.C) in the Extension Study, at 6 Months After the Month 30 Vaccination | TV1c8_D11gp120.avi/293F (Month 36) | 31 Participants |
| Part A, Group 2: Placebo | Part B: Occurrence of IgG Ab Binding to gp120 Env Proteins Contained in the Vaccine (ZM96, TV1.C, 1086.C) in the Extension Study, at 6 Months After the Month 30 Vaccination | TV1c8_D11gp120.avi/293F (Month 36) | 30 Participants |
| Part A, Group 2: Placebo | Part B: Occurrence of IgG Ab Binding to gp120 Env Proteins Contained in the Vaccine (ZM96, TV1.C, 1086.C) in the Extension Study, at 6 Months After the Month 30 Vaccination | 1086C_D7gp120.avi/293F (Month 30) | 30 Participants |
| Part A, Group 2: Placebo | Part B: Occurrence of IgG Ab Binding to gp120 Env Proteins Contained in the Vaccine (ZM96, TV1.C, 1086.C) in the Extension Study, at 6 Months After the Month 30 Vaccination | 96ZM651.D11gp120.avi (Month 36) | 25 Participants |
| Part A, Group 2: Placebo | Part B: Occurrence of IgG Ab Binding to gp120 Env Proteins Contained in the Vaccine (ZM96, TV1.C, 1086.C) in the Extension Study, at 6 Months After the Month 30 Vaccination | TV1c8_D11gp120.avi/293F (Month 30) | 30 Participants |
| Part A, Group 2: Placebo | Part B: Occurrence of IgG Ab Binding to gp120 Env Proteins Contained in the Vaccine (ZM96, TV1.C, 1086.C) in the Extension Study, at 6 Months After the Month 30 Vaccination | 1086C_D7gp120.avi/293F (Month 36) | 30 Participants |
| Part A, Group 2: Placebo | Part B: Occurrence of IgG Ab Binding to gp120 Env Proteins Contained in the Vaccine (ZM96, TV1.C, 1086.C) in the Extension Study, at 6 Months After the Month 30 Vaccination | 96ZM651.D11gp120.avi (Month 30) | 2 Participants |
| Part B, Group 2: Placebo | Part B: Occurrence of IgG Ab Binding to gp120 Env Proteins Contained in the Vaccine (ZM96, TV1.C, 1086.C) in the Extension Study, at 6 Months After the Month 30 Vaccination | 1086C_D7gp120.avi/293F (Month 36) | 0 Participants |
| Part B, Group 2: Placebo | Part B: Occurrence of IgG Ab Binding to gp120 Env Proteins Contained in the Vaccine (ZM96, TV1.C, 1086.C) in the Extension Study, at 6 Months After the Month 30 Vaccination | 96ZM651.D11gp120.avi (Month 30) | 0 Participants |
| Part B, Group 2: Placebo | Part B: Occurrence of IgG Ab Binding to gp120 Env Proteins Contained in the Vaccine (ZM96, TV1.C, 1086.C) in the Extension Study, at 6 Months After the Month 30 Vaccination | TV1c8_D11gp120.avi/293F (Month 36) | 0 Participants |
| Part B, Group 2: Placebo | Part B: Occurrence of IgG Ab Binding to gp120 Env Proteins Contained in the Vaccine (ZM96, TV1.C, 1086.C) in the Extension Study, at 6 Months After the Month 30 Vaccination | 96ZM651.D11gp120.avi (Month 36) | 0 Participants |
| Part B, Group 2: Placebo | Part B: Occurrence of IgG Ab Binding to gp120 Env Proteins Contained in the Vaccine (ZM96, TV1.C, 1086.C) in the Extension Study, at 6 Months After the Month 30 Vaccination | 1086C_D7gp120.avi/293F (Month 30) | 0 Participants |
| Part B, Group 2: Placebo | Part B: Occurrence of IgG Ab Binding to gp120 Env Proteins Contained in the Vaccine (ZM96, TV1.C, 1086.C) in the Extension Study, at 6 Months After the Month 30 Vaccination | TV1c8_D11gp120.avi/293F (Month 30) | 0 Participants |
Secondary
Part B: Occurrence of IgG Binding Antibodies to 3 V1V2-scaffolded Env Proteins in the Extension Study, at 6 Months After the Month 30 Vaccination
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. Samples from post-enrollment visits have positive responses if they meet three conditions: (1) net MFI greater than or equal to an antigen-specific response threshold (defined as the maximum of 100 and the 95th percentile of pre-vaccination net MFI), (2) net MFI values are greater than 3 times pre-vaccination net MFI, and (3) experimental antigen MFI values are greater than 3 times pre-vaccination MFI. Data are excluded if the blood draw date was outside the allowable window, a participant was HIV-infected, or the reference antigen exceeds 5000 MFI.
Time frame: Measured at Month 30 and 36
Population: Overall Number of Participants Analyzed represents Part B participants. Number Analyzed counts participants with data meeting assay-specific quality criteria.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A, Group 1: Vaccine | Part B: Occurrence of IgG Binding Antibodies to 3 V1V2-scaffolded Env Proteins in the Extension Study, at 6 Months After the Month 30 Vaccination | C.1086C_V1_V2 Tags (Month 30) | 7 Participants |
| Part A, Group 1: Vaccine | Part B: Occurrence of IgG Binding Antibodies to 3 V1V2-scaffolded Env Proteins in the Extension Study, at 6 Months After the Month 30 Vaccination | C.1086C_V1_V2 Tags (Month 36) | 9 Participants |
| Part A, Group 1: Vaccine | Part B: Occurrence of IgG Binding Antibodies to 3 V1V2-scaffolded Env Proteins in the Extension Study, at 6 Months After the Month 30 Vaccination | gp70-96ZM651.02 V1v2 (Month 30) | 2 Participants |
| Part A, Group 1: Vaccine | Part B: Occurrence of IgG Binding Antibodies to 3 V1V2-scaffolded Env Proteins in the Extension Study, at 6 Months After the Month 30 Vaccination | gp70-96ZM651.02 V1v2 (Month 36) | 7 Participants |
| Part A, Group 1: Vaccine | Part B: Occurrence of IgG Binding Antibodies to 3 V1V2-scaffolded Env Proteins in the Extension Study, at 6 Months After the Month 30 Vaccination | gp70-TV1.GSKvacV1V2/293F (Month 30) | 0 Participants |
| Part A, Group 1: Vaccine | Part B: Occurrence of IgG Binding Antibodies to 3 V1V2-scaffolded Env Proteins in the Extension Study, at 6 Months After the Month 30 Vaccination | gp70-TV1.GSKvacV1V2/293F (Month 36) | 4 Participants |
| Part A, Group 2: Placebo | Part B: Occurrence of IgG Binding Antibodies to 3 V1V2-scaffolded Env Proteins in the Extension Study, at 6 Months After the Month 30 Vaccination | gp70-TV1.GSKvacV1V2/293F (Month 36) | 4 Participants |
| Part A, Group 2: Placebo | Part B: Occurrence of IgG Binding Antibodies to 3 V1V2-scaffolded Env Proteins in the Extension Study, at 6 Months After the Month 30 Vaccination | C.1086C_V1_V2 Tags (Month 30) | 6 Participants |
| Part A, Group 2: Placebo | Part B: Occurrence of IgG Binding Antibodies to 3 V1V2-scaffolded Env Proteins in the Extension Study, at 6 Months After the Month 30 Vaccination | gp70-96ZM651.02 V1v2 (Month 36) | 3 Participants |
| Part A, Group 2: Placebo | Part B: Occurrence of IgG Binding Antibodies to 3 V1V2-scaffolded Env Proteins in the Extension Study, at 6 Months After the Month 30 Vaccination | gp70-TV1.GSKvacV1V2/293F (Month 30) | 2 Participants |
| Part A, Group 2: Placebo | Part B: Occurrence of IgG Binding Antibodies to 3 V1V2-scaffolded Env Proteins in the Extension Study, at 6 Months After the Month 30 Vaccination | C.1086C_V1_V2 Tags (Month 36) | 12 Participants |
| Part A, Group 2: Placebo | Part B: Occurrence of IgG Binding Antibodies to 3 V1V2-scaffolded Env Proteins in the Extension Study, at 6 Months After the Month 30 Vaccination | gp70-96ZM651.02 V1v2 (Month 30) | 1 Participants |
| Part B, Group 2: Placebo | Part B: Occurrence of IgG Binding Antibodies to 3 V1V2-scaffolded Env Proteins in the Extension Study, at 6 Months After the Month 30 Vaccination | C.1086C_V1_V2 Tags (Month 36) | 1 Participants |
| Part B, Group 2: Placebo | Part B: Occurrence of IgG Binding Antibodies to 3 V1V2-scaffolded Env Proteins in the Extension Study, at 6 Months After the Month 30 Vaccination | gp70-96ZM651.02 V1v2 (Month 30) | 0 Participants |
| Part B, Group 2: Placebo | Part B: Occurrence of IgG Binding Antibodies to 3 V1V2-scaffolded Env Proteins in the Extension Study, at 6 Months After the Month 30 Vaccination | gp70-TV1.GSKvacV1V2/293F (Month 36) | 0 Participants |
| Part B, Group 2: Placebo | Part B: Occurrence of IgG Binding Antibodies to 3 V1V2-scaffolded Env Proteins in the Extension Study, at 6 Months After the Month 30 Vaccination | gp70-96ZM651.02 V1v2 (Month 36) | 1 Participants |
| Part B, Group 2: Placebo | Part B: Occurrence of IgG Binding Antibodies to 3 V1V2-scaffolded Env Proteins in the Extension Study, at 6 Months After the Month 30 Vaccination | C.1086C_V1_V2 Tags (Month 30) | 0 Participants |
| Part B, Group 2: Placebo | Part B: Occurrence of IgG Binding Antibodies to 3 V1V2-scaffolded Env Proteins in the Extension Study, at 6 Months After the Month 30 Vaccination | gp70-TV1.GSKvacV1V2/293F (Month 30) | 0 Participants |