HIV Infections
Conditions
Brief summary
The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of env (A,B,C,A/E)/gag (C) DNA and gp120 (A,B,C,A/E) protein/GLA-SE HIV-1 vaccines (PDPHV-201401) as a prime-boost regimen or co-administered in repeated doses, in healthy, HIV-1-uninfected adults.
Detailed description
This study will evaluate the safety, tolerability, and immunogenicity of env (A,B,C,A/E)/gag (C) DNA and gp120 (A,B,C,A/E) protein/GLA-SE HIV-1 vaccines (PDPHV-201401) as a prime-boost regimen or co-administered in repeated doses, in healthy, HIV-1-uninfected adults. The study will be conducted in two parts (Part A and Part B). Participants in Part A will be randomly assigned to either Group 1 (Treatment) or Group 1 (Control). Participants in Group 1 (Treatment) will receive the gp120 (A,B,C,A/E) protein vaccine admixed with GLA-SE adjuvant on Day 0 and Month 2. Participants in Group 1 (Control) will receive placebo on Day 0 and Month 2. Researchers will evaluate study data from Part A before enrolling participants in Part B. Participants in Part B will be enrolled in either Groups 2 or 3. Within Group 2, participants will be randomly assigned to either Group 2 (Treatment) or Group 2 (Control). Participants in Group 2 (Treatment) will receive the env (A,B,C,A/E)/gag (C) DNA vaccine and placebo on Day 0 and Months 1 and 3. At Months 6 and 8, participants will receive the gp120 (A,B,C,A/E) protein vaccine admixed with GLA-SE adjuvant and a placebo vaccine. Participants in Group 2 (Control) will receive placebo on Day 0 and Months 1, 3, 6, and 8. Participants in Group 3 will be randomly assigned to either Group 3 (Treatment) or Group 3 (Control). Participants in Group 3 (Treatment) will receive the env (A,B,C,A/E)/gag (C) DNA vaccine and the gp120 (A,B,C,A/E) protein vaccine admixed with GLA-SE adjuvant on Day 0 and Months 1, 3, 6, and 8. Participants in Group 3 (Control) will receive placebo on Day 0 and Months 1, 3, 6, and 8. Study visits for participants in Part A will occur on Day 0, Week 2, and Months 2, 2.5, 5, and 8. Study visits for participants in Part B will occur on Day 0, Week 2, and Months 1, 1.5, 3, 3.5, 6, 6.5, 8, 8 + 1 Week, 8.5, 11, and 14. Visits may include physical examinations, blood and urine collection, HIV testing, risk reduction counseling, and questionnaires. Participants in Part B may also have optional saliva, semen, cervical fluid, rectal fluid, and stool sample collection. Study staff will contact all participants 12 months after the last vaccination for follow-up health monitoring.
Interventions
BIOLOGICALenv (A,B,C,A/E)/gag (C) DNA Vaccine
Administered by intramuscular injection in the deltoid.
BIOLOGICALgp120 (A,B,C,A/E) Protein Vaccine
Administered by intramuscular injection in the deltoid.
BIOLOGICALPlacebo
Sodium Chloride for Injection, USP 0.9%; Administered by intramuscular injection in the deltoid.
BIOLOGICALGLA-SE adjuvant
Administered by intramuscular injection in the deltoid.
Sponsors
National Institute of Allergy and Infectious Diseases (NIAID)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
General and Demographic Criteria * Age of 18 to 50 years * Access to a participating HIV Vaccine Trials Network (HVTN) clinical research site (CRS) and willingness to be followed for the planned duration of the study * Ability and willingness to provide informed consent * Assessment of understanding: volunteer demonstrates understanding of this study; completes a questionnaire prior to first vaccination with verbal demonstration of understanding of all questionnaire items answered incorrectly * Willing to be contacted 12 months after the last vaccination * Agrees not to enroll in another study of an investigational research agent * Good general health as shown by medical history, physical exam, and screening laboratory tests HIV-Related Criteria: * Willingness to receive HIV test results * Willingness to discuss HIV infection risks and amenable to HIV risk reduction counseling. * Assessed by the clinic staff as being at low risk for HIV infection and committed to maintaining behavior consistent with low risk of HIV exposure through the last required protocol clinic visit. Laboratory Inclusion Values Hemogram/Complete Blood Count (CBC) * Hemoglobin greater than or equal to 11.0 g/dL for volunteers who were born female, greater than or equal to 13.0 g/dL for volunteers who were born male * White blood cell count equal to 3,300 to 12,000 cells/mm\^3 * Total lymphocyte count greater than or equal to 800 cells/mm\^3 * Remaining differential either within institutional normal range or with site physician approval * Platelets equal to 125,000/mm\^3 to 450,000/mm\^3 Chemistry * Chemistry panel: Alanine aminotransferase (ALT), aspartate aminotransferase (AST), and alkaline phosphatase less than 1.25 times the institutional upper limit of normal; creatinine less than or equal to institutional upper limit of normal. Virology * Negative HIV-1 and -2 blood test: US volunteers must have a negative US Food and Drug Administration (FDA)-approved enzyme immunoassay (EIA). * 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 Urine * Normal urine: * Negative urine glucose, and * Negative or trace urine protein, and * Negative or trace urine hemoglobin (if trace hemoglobin is present on dipstick, a microscopic urinalysis with red blood cells levels within institutional normal range). Reproductive Status * Volunteers who were born female: negative serum or urine beta human chorionic gonadotropin (β-HCG) pregnancy test performed prior to vaccination on the day of initial vaccination. Persons who are NOT of reproductive potential due to having undergone total hysterectomy or bilateral oophorectomy (verified by medical records), are not required to undergo pregnancy testing. * Reproductive status: A volunteer who was born female must: * Agree to consistently use effective contraception (see the protocol for more information) for sexual activity that could lead to pregnancy from at least 21 days prior to enrollment until after the last required protocol clinic visit. Effective contraception is defined as using the following methods: * Condoms (male or female) with or without a spermicide, * Diaphragm or cervical cap with spermicide, * Intrauterine device (IUD), * Hormonal contraception, or * Any other contraceptive method approved by the HVTN 124 Protocol Safety Review Team (PSRT) * Successful vasectomy in the male partner (considered successful if a volunteer reports that a male partner has \[1\] documentation of azoospermia by microscopy, or \[2\] a vasectomy more than 2 years ago with no resultant pregnancy despite sexual activity postvasectomy); * Or not be of reproductive potential, such as having reached menopause (no menses for 1 year) or having undergone hysterectomy, bilateral oophorectomy, or tubal ligation; * Or be sexually abstinent. * Volunteers who were born female must also agree not to seek pregnancy through alternative methods, such as artificial insemination or in vitro fertilization until after the last required protocol clinic visit
Exclusion criteria
General * Blood products received within 120 days before first vaccination * Investigational research agents received within 30 days before first vaccination * Body mass index (BMI) greater than or equal to 40; or BMI greater than or equal to 35 with 2 or more of the following: age greater than 45, systolic blood pressure greater than 140 mm Hg, diastolic blood pressure greater than 90 mm Hg, current smoker, known hyperlipidemia * Intent to participate in another study of an investigational research agent or any other study that requires non-HVTN HIV antibody testing during the planned duration of the HVTN 124 study * Pregnant or breastfeeding * Active duty and reserve US military personnel Vaccines and other Injections * HIV vaccine(s) received in a prior HIV vaccine trial. For volunteers who have received control/placebo in an HIV vaccine trial, the HVTN 124 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 by the HVTN 124 PSRT for vaccines that have subsequently undergone licensure by the FDA. For volunteers who have received control/placebo in an experimental vaccine trial, the HVTN 124 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 124 PSRT on a case-by-case basis. * Live attenuated vaccines 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) * Any vaccines that are not live attenuated vaccines and were received within 14 days prior to first vaccination (eg, tetanus, pneumococcal, Hepatitis A or B) * Allergy treatment with antigen injections within 30 days before first vaccination or that are scheduled within 14 days after first vaccination Immune System * Immunosuppressive medications received within 168 days before first vaccination (Not exclusionary: \[1\] corticosteroid nasal spray; \[2\] inhaled corticosteroids; \[3\] topical corticosteroids for mild, uncomplicated dermatitis; or \[4\] a single course of oral/parenteral prednisone or equivalent at doses less than 60 mg/day and length of therapy less than 11 days with completion at least 30 days prior to enrollment.) * Serious adverse reactions to vaccines or to vaccine components including history of anaphylaxis and related symptoms such as hives, respiratory difficulty, angioedema, and/or abdominal pain. (Not excluded from participation: a volunteer who had a nonanaphylactic adverse reaction to pertussis vaccine as a child.) * Immunoglobulin received within 60 days before first vaccination * Autoimmune disease, connective tissue disease, or history of vasculitis, e.g., leukocytoclastic vasculitis, Henoch-Schonlein purpura * Immunodeficiency Clinically significant medical conditions * Untreated or incompletely treated syphilis infection * Clinically significant medical condition, physical examination findings, clinically significant abnormal laboratory results, or past medical history with clinically significant implications for current health. A clinically significant condition or process includes but is not limited to: * A process that would affect the immune response, * A process that would require medication that affects the immune response, * Any contraindication to repeated injections or blood draws, * A condition that requires active medical intervention or monitoring to avert grave danger to the volunteer's health or well-being during the study period, * A condition or process for which signs or symptoms could be confused with reactions to vaccine, or * Any condition specifically listed among the
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation | Measured through study completion, up to 31 months | From the study product discontinuation form, study product administration reasons are tabulated by treatment arm |
| Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Measured through 3 days after participants' each vaccination at Months 0, 2 for part A and Months 0, 1, 3, 6, 8 for part B | Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1, July 2017. The maximum grade observed for each symptom over the time frame is presented. |
| Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Measured through 3 days after participants' each vaccination at Months 0, 2 for part A and Months 0, 1, 3, 6, 8 for part B | Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1, July 2017. The maximum grade observed for each symptom over the time frame is presented. |
| Number of Participants Reporting Adverse Events (AEs), by Relationship to Study Product | Measured through 30 days after each vaccine dose at Months 0, 2 for part A and Months 0, 1, 3, 6, 8 for part B | For participants reporting multiple AEs over the time frame, the maximum relationship is counted. |
| Number of Participants Reporting Adverse Events (AEs), by Severity Grade | Measured through 30 days after each vaccine dose at Months 0, 2 for part A and Months 0, 1, 3, 6, 8 for part B | For participants reporting multiple AEs over the time frame, the maximum severity grade is counted. |
| Number of Participants Reporting Serious Adverse Events (SAEs) | Measured through Month 8 for part A and Month 14 for part B | Measured as outlined in Version 2.0 (January 2010) of the Manual for Expedited Reporting of Adverse Events to DAIDS (DAIDS EAE Manual). |
| Number of Participants Reporting Adverse Events of Special Interest (AESIs) | Measured through Month 8 for part A and Month 14 for part B | Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases. There were no adverse events of special interest reported by any participant. |
| Numbers of Participants With Grade 1 or Higher Local Laboratory Results | Measured during Screening, Day 14, Day 70, Day140 for part A and visits Screening, Day 14, Day 42, Day 98, Day 182, Day 238 and Day 334 for part B | The number (percentage) of participants with local laboratory values recorded as meeting Grade 1 AE criteria or above as specified in the DAIDS AE Grading Table were tabulated by treatment arm for each post-vaccination time point. Laboratory results are summarized by analyte and timepoint. Analytes and timepoint combinations with no grade 1 or higher results are not shown. |
| Alk Phos, AST, ALT in UL | Measured through Screening, Day 14, Day 70, Day140 for part A and visits Screening, Day 14, Day 42, Day 98, Day 182, Day 238 and Day 334 for part B | Laboratory results are summarized by analyte and timepoint. |
| Hemoglobin, Creatinine in g/dL | Measured through Screening, Day 14, Day 70, Day140 for part A and visits Screening, Day 14, Day 42, Day 98, Day 182, Day 238 and Day 334 for part B | Laboratory results are summarized by analyte and timepoint. |
| WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm | Measured through Screening, Day 14, Day 70, Day140 for part A and visits Screening, Day 14, Day 42, Day 98, Day 182, Day 238 and Day 334 for part B | Laboratory results are summarized by analyte and timepoint. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Levels of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | Measured at Month 2.5 for part A and 8.5 for part B | Serum 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, and net MFI \> 22,000 is set to 22,000. Data are excluded if blood draw date was outside the allowable window, a participant was HIV-infected, reference antigen \> 5,000 MFI, or baseline net MFI \> 6,500. Summary was calculated among positive responders only (positivity criteria are described in Outcome 12). |
| Breadth of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | Measured at Month 2.5 for part A and 8.5 for part B | Serum IgG responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay. Magnitude-breadth (MB) curves characterized the magnitude (Binding antibody MFI\* at 1:50 dilution and titer) and breadth (number of antigens with positive response at given MFI\* or titer) of each individual plasma sample assayed against a panel of antigens. The x-axis represents the response magnitude and the y-axis represents the fraction of antigens with response magnitude greater than the x-axis value. In addition to the individual sample specific curves, the group-specific curve displayed the average MB across all participants in that group. The area-under-the-magnitude-breadth curve (AUC-MB) was calculated as the average of the log10 MFI\* (log10 titer) over the panel of antigens. |
| Part B: Occurrence of Serum Neutralizing Antibody Responses Against Tier 1A, Tier 1B, and Selected Tier 2 Viruses Two Weeks After the Last Vaccination | Measured at Month 8.5 for part B only | Neutralizing antibodies against HIV1were measured as a function of reductions in Tat-regulatedluciferase (Luc) reporter gene expression in TZM-blcells. The assay performed in TZM-bl cells measured neutralization titers against a panel of Env-pseudotyped viruses that exhibit the following naturalization phenotypes. Response to a virus/isolate was considered positive if the neutralization titer was above a prespecified cutoff. A titer was defined as the serum dilution that reduced relative luminescence units (RLUs) by 50% and 80% relative to the RLUs in virus control wells (cells + virus only) after subtraction of background RLU (ID50 and ID80, cells only). The prespecified cutoff was 20 for MW965.26 (Tier 1a) and 10 for other viruses. |
| Part B: Levels of Serum Neutralizing Antibody Responses Against Tier 1A, Tier 1B, and Selected Tier 2 Viruses Two Weeks After the Last Vaccination | Measured at Month 8.5 for part B only | Neutralizing antibodies against HIV1were measured as a function of reductions in Tat-regulatedluciferase (Luc) reporter gene expression in TZM-blcells. The assay performed in TZM-bl cells measured neutralization titers against a panel of Env-pseudotyped viruses that exhibit the following naturalization phenotypes. Response to a virus/isolate was considered positive if the neutralization titer was above a prespecified cutoff. A titer was defined as the serum dilution that reduced relative luminescence units (RLUs) by 50% and 80% relative to the RLUs in virus control wells (cells + virus only) after subtraction of background RLU (ID50 and ID80, cells only). The prespecified cutoff was 20 for MW965.26 (Tier 1a) and 10 for other viruses. |
| Breadth of gp70-V1V2 IgG and gp120 IgA, Assessed by Binding Antibody Multiplex Assay, and ADCC Activities Against HIV-1 Subtypes A, B, C and A/E Two Weeks After the Last Vaccination in Part B | Measured at Month 8.5 for part B only | For Binding Antibody Multiplex Assay, gp70-V1V2 IgG, the area-under-the-magnitude-breadth curve (AUC-MB) was calculated as the average of the log10 MFI\* (log10 titer) over the panel of antigens. For ADCC GranToxiLux, AUC-MB was calculated as the average of the AUC over the panel of antigens, where AUC is defined as nonparametric area under the net percent granzyme B activity vs log10 (dilution) curve (AUC), calculated using the trapezoidal rule, and setting any net percent granzyme B activity below 0% to 0%. For ADCC Luciferase, (AUC-MB) was calculated as the average of the pAUC over the panel of antigens, where pAUC is defined as nonparametric partial area under the baseline subtracted curves (pAUC), calculated using the trapezoidal rule on the first four dilutions of the baseline subtracted curves, setting baseline subtracted loss Luciferase activity less than 0% to zero. |
| Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine Two Weeks After the Last Vaccination. Measured by Flow Cytometry. | Measured at Month 8.5 for part B only | PBMC samples are stimulated with synthetic peptide pools or left unstimulated as a negative control. For each sample, T-cell subset, and peptide pool, response magnitude is % cells expressing markers (IFNg and/or IL-2) after peptide stimulation minus % cells expressing markers after no stimulation. A contingency table is constructed to assess response: stimulation (peptide/none) vs. marker expression (yes/no). A one-sided Fisher's exact test is applied, testing if the number of cells positive for the marker is equal in the stimulated vs. unstimulated cells. A discrete Bonferroni adjustment is made over the peptide pools. Response is positive if adjusted p-value \<=0.00001. Please note the above analyses were applied by the lab to determine the response positivity, not the planned analyses for the study outcome measures. Data are excluded if blood draw date was outside the visit window, participant was HIV-infected, PBMC viability or T-cell count were low, or negative control was high. |
| Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine Two Weeks After the Last Vaccination. Measured by Flow Cytometry. | Measured at Month 8.5 for part B only | PBMC samples are stimulated with synthetic peptide pools or left unstimulated as a negative control. For each sample, T-cell subset, and peptide pool, response magnitude is % cells expressing markers (IFNg and/or IL-2) after peptide stimulation minus % cells expressing markers after no stimulation. A contingency table is constructed to assess response: stimulation (peptide/none) vs. marker expression (yes/no). A one-sided Fisher's exact test is applied, testing if the number of cells positive for the marker is equal in the stimulated vs. unstimulated cells. A discrete Bonferroni adjustment is made over the peptide pools. Response is positive if adjusted p-value \<=0.00001. Please note the above analyses were applied by the lab to determine the response positivity, not the planned analyses for the study outcome measures. Data are excluded if blood draw date was outside the visit window, participant was HIV-infected, PBMC viability or T-cell count were low, or negative control was high. |
| Occurrence of CD8+ T Cell Responses to the HIV Proteins Included in the Vaccine Two Weeks After the Last Vaccination. Measured by Flow Cytometry. | Measured at Month 8.5 for part B only | PBMC samples are stimulated with synthetic peptide pools or left unstimulated as a negative control. For each sample, T-cell subset, and peptide pool, response magnitude is % cells expressing markers (IFNg and/or IL-2) after peptide stimulation minus % cells expressing markers after no stimulation. A contingency table is constructed to assess response: stimulation (peptide/none) vs. marker expression (yes/no). A one-sided Fisher's exact test is applied, testing if the number of cells positive for the marker is equal in the stimulated vs. unstimulated cells. A discrete Bonferroni adjustment is made over the peptide pools. Response is positive if adjusted p-value \<=0.00001. Please note the above analyses were applied by the lab to determine the response positivity, not the planned analyses for the study outcome measures. Data are excluded if blood draw date was outside the visit window, participant was HIV-infected, PBMC viability or T-cell count were low, or negative control was high. |
| Level of CD8+ T Cell Responses to the HIV Proteins Included in the Vaccine Two Weeks After the Last Vaccination. Measured by Flow Cytometry. | Measured at Month 8.5 for part B only | PBMC samples are stimulated with synthetic peptide pools or left unstimulated as a negative control. For each sample, T-cell subset, and peptide pool, response magnitude is % cells expressing markers (IFNg and/or IL-2) after peptide stimulation minus % cells expressing markers after no stimulation. A contingency table is constructed to assess response: stimulation (peptide/none) vs. marker expression (yes/no). A one-sided Fisher's exact test is applied, testing if the number of cells positive for the marker is equal in the stimulated vs. unstimulated cells. A discrete Bonferroni adjustment is made over the peptide pools. Response is positive if adjusted p-value \<=0.00001. Please note the above analyses were applied by the lab to determine the response positivity, not the planned analyses for the study outcome measures. Data are excluded if blood draw date was outside the visit window, participant was HIV-infected, PBMC viability or T-cell count were low, or negative control was high. |
| Occurrence of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | Measured at Month 2.5 for part A and 8.5 for part B | Serum 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, and net MFI \> 22,000 is set to 22,000. Samples from post-enrollment visits have positive responses if they meet three criteria: (1) net MFI greater than or equal to an antigen-specific response threshold (defined as the maximum of 100 and the 95th percentile of baseline net MFI), (2) net MFI values are greater than 3 times baseline net MFI, and (3) experimental antigen MFI values are greater than 3 times baseline MFI. Data are excluded if blood draw date was outside the allowable window, a participant was HIV-infected, reference antigen \> 5,000 MFI, or baseline net MFI \> 6,500. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Part A: Placebo Placebo: Sodium Chloride USP 0.9% at Month (0, 2) | 2 |
| Part A: Vaccine Protein/ GLA-SE at Month (0, 2) | 10 |
| Part B: Placebo Placebo: Sodium Chloride USP 0.9% at Month (0, 1, 3, 6, 8) | 6 |
| Part B: Vaccine 1 DNA+Placebo for protein at Month(0, 1, 3), Protein/GLA-SE+Placebo for DNA at Month (6, 8) | 21 |
| Part B: Vaccine 2 DNA+Protein/GLA-SE at Month (0, 1, 3, 6, 8) | 21 |
| Total | 60 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 0 | 0 | 2 | 2 |
| Overall Study | Withdrawal by Subject | 0 | 0 | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | Total | Part A: Vaccine | Part B: Placebo | Part A: Placebo | Part B: Vaccine 1 | Part B: Vaccine 2 |
|---|---|---|---|---|---|---|
| Age, Continuous | 26.5 years | 22.5 years | 29 years | 36.5 years | 25 years | 31 years |
| Age, Customized 18 - 20 years | 7 Participants | 4 Participants | 0 Participants | 0 Participants | 3 Participants | 0 Participants |
| Age, Customized 21 - 30 years | 30 Participants | 3 Participants | 4 Participants | 1 Participants | 12 Participants | 10 Participants |
| Age, Customized 31 - 40 years | 18 Participants | 1 Participants | 2 Participants | 0 Participants | 6 Participants | 9 Participants |
| Age, Customized 41 - 50 years | 5 Participants | 2 Participants | 0 Participants | 1 Participants | 0 Participants | 2 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 | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 58 Participants | 10 Participants | 6 Participants | 2 Participants | 20 Participants | 20 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 6 Participants | 2 Participants | 0 Participants | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants | 0 Participants | 1 Participants | 1 Participants | 3 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 5 Participants | 1 Participants | 1 Participants | 0 Participants | 2 Participants | 1 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 | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) White | 43 Participants | 7 Participants | 4 Participants | 1 Participants | 14 Participants | 17 Participants |
| Region of Enrollment USA | 60 Participants | 10 Participants | 6 Participants | 2 Participants | 21 Participants | 21 Participants |
| Sex: Female, Male Female | 34 Participants | 6 Participants | 3 Participants | 1 Participants | 13 Participants | 11 Participants |
| Sex: Female, Male Male | 26 Participants | 4 Participants | 3 Participants | 1 Participants | 8 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 2 | 0 / 10 | 0 / 6 | 0 / 21 | 0 / 21 |
| other Total, other adverse events | 2 / 2 | 6 / 10 | 5 / 6 | 19 / 21 | 18 / 21 |
| serious Total, serious adverse events | 0 / 2 | 0 / 10 | 0 / 6 | 0 / 21 | 0 / 21 |
Outcome results
Primary
Alk Phos, AST, ALT in UL
Laboratory results are summarized by analyte and timepoint.
Time frame: Measured through Screening, Day 14, Day 70, Day140 for part A and visits Screening, Day 14, Day 42, Day 98, Day 182, Day 238 and Day 334 for part B
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: Placebo | Alk Phos, AST, ALT in UL | Alkaline Phosphatase (U/L)- Day70 | 54 U/L |
| Part A: Placebo | Alk Phos, AST, ALT in UL | AST (U/L)- Day140 | 13.5 U/L |
| Part A: Placebo | Alk Phos, AST, ALT in UL | AST (U/L)- Screening | 18 U/L |
| Part A: Placebo | Alk Phos, AST, ALT in UL | ALT (SGPT) (U/L)- Day14 | 21.5 U/L |
| Part A: Placebo | Alk Phos, AST, ALT in UL | AST (U/L)- Day70 | 13 U/L |
| Part A: Placebo | Alk Phos, AST, ALT in UL | Alkaline Phosphatase (U/L)- Day14 | 57.5 U/L |
| Part A: Placebo | Alk Phos, AST, ALT in UL | Alkaline Phosphatase (U/L)- Screening | 61 U/L |
| Part A: Placebo | Alk Phos, AST, ALT in UL | ALT (SGPT) (U/L)- Screening | 22 U/L |
| Part A: Placebo | Alk Phos, AST, ALT in UL | AST (U/L)- Day14 | 19 U/L |
| Part A: Placebo | Alk Phos, AST, ALT in UL | ALT (SGPT) (U/L)- Day70 | 18 U/L |
| Part A: Placebo | Alk Phos, AST, ALT in UL | ALT (SGPT) (U/L)- Day140 | 21 U/L |
| Part A: Placebo | Alk Phos, AST, ALT in UL | Alkaline Phosphatase (U/L)- Day140 | 57.5 U/L |
| Part A: Vaccine | Alk Phos, AST, ALT in UL | AST (U/L)- Day140 | 17 U/L |
| Part A: Vaccine | Alk Phos, AST, ALT in UL | Alkaline Phosphatase (U/L)- Day140 | 59 U/L |
| Part A: Vaccine | Alk Phos, AST, ALT in UL | AST (U/L)- Day70 | 17 U/L |
| Part A: Vaccine | Alk Phos, AST, ALT in UL | Alkaline Phosphatase (U/L)- Day14 | 56 U/L |
| Part A: Vaccine | Alk Phos, AST, ALT in UL | ALT (SGPT) (U/L)- Day14 | 10 U/L |
| Part A: Vaccine | Alk Phos, AST, ALT in UL | Alkaline Phosphatase (U/L)- Day70 | 55 U/L |
| Part A: Vaccine | Alk Phos, AST, ALT in UL | Alkaline Phosphatase (U/L)- Screening | 59.5 U/L |
| Part A: Vaccine | Alk Phos, AST, ALT in UL | AST (U/L)- Screening | 19 U/L |
| Part A: Vaccine | Alk Phos, AST, ALT in UL | ALT (SGPT) (U/L)- Day140 | 14.5 U/L |
| Part A: Vaccine | Alk Phos, AST, ALT in UL | ALT (SGPT) (U/L)- Screening | 14.5 U/L |
| Part A: Vaccine | Alk Phos, AST, ALT in UL | AST (U/L)- Day14 | 15 U/L |
| Part A: Vaccine | Alk Phos, AST, ALT in UL | ALT (SGPT) (U/L)- Day70 | 14.5 U/L |
| Part B: Placebo | Alk Phos, AST, ALT in UL | ALT (SGPT) (U/L)- Day334 | 17 U/L |
| Part B: Placebo | Alk Phos, AST, ALT in UL | Alkaline Phosphatase (U/L)- Screening | 54.5 U/L |
| Part B: Placebo | Alk Phos, AST, ALT in UL | Alkaline Phosphatase (U/L)- Day14 | 53 U/L |
| Part B: Placebo | Alk Phos, AST, ALT in UL | Alkaline Phosphatase (U/L)- Day98 | 54 U/L |
| Part B: Placebo | Alk Phos, AST, ALT in UL | AST (U/L)- Screening | 16.5 U/L |
| Part B: Placebo | Alk Phos, AST, ALT in UL | AST (U/L)- Day14 | 19.5 U/L |
| Part B: Placebo | Alk Phos, AST, ALT in UL | ALT (SGPT) (U/L)- Day182 | 12.5 U/L |
| Part B: Placebo | Alk Phos, AST, ALT in UL | ALT (SGPT) (U/L)- Day238 | 15.5 U/L |
| Part B: Placebo | Alk Phos, AST, ALT in UL | AST (U/L)- Day98 | 16 U/L |
| Part B: Placebo | Alk Phos, AST, ALT in UL | AST (U/L)- Day42 | 17 U/L |
| Part B: Placebo | Alk Phos, AST, ALT in UL | Alkaline Phosphatase (U/L)- Day42 | 56 U/L |
| Part B: Placebo | Alk Phos, AST, ALT in UL | Alkaline Phosphatase (U/L)- Day182 | 59.5 U/L |
| Part B: Placebo | Alk Phos, AST, ALT in UL | Alkaline Phosphatase (U/L)- Day238 | 52 U/L |
| Part B: Placebo | Alk Phos, AST, ALT in UL | Alkaline Phosphatase (U/L)- Day334 | 52.5 U/L |
| Part B: Placebo | Alk Phos, AST, ALT in UL | AST (U/L)- Day182 | 14.5 U/L |
| Part B: Placebo | Alk Phos, AST, ALT in UL | AST (U/L)- Day238 | 15.5 U/L |
| Part B: Placebo | Alk Phos, AST, ALT in UL | AST (U/L)- Day334 | 15.5 U/L |
| Part B: Placebo | Alk Phos, AST, ALT in UL | ALT (SGPT) (U/L)- Screening | 22.5 U/L |
| Part B: Placebo | Alk Phos, AST, ALT in UL | ALT (SGPT) (U/L)- Day14 | 19.5 U/L |
| Part B: Placebo | Alk Phos, AST, ALT in UL | ALT (SGPT) (U/L)- Day42 | 17 U/L |
| Part B: Placebo | Alk Phos, AST, ALT in UL | ALT (SGPT) (U/L)- Day98 | 15 U/L |
| Part B: Vaccine 1 | Alk Phos, AST, ALT in UL | Alkaline Phosphatase (U/L)- Day334 | 62.5 U/L |
| Part B: Vaccine 1 | Alk Phos, AST, ALT in UL | ALT (SGPT) (U/L)- Day42 | 14 U/L |
| Part B: Vaccine 1 | Alk Phos, AST, ALT in UL | AST (U/L)- Screening | 16 U/L |
| Part B: Vaccine 1 | Alk Phos, AST, ALT in UL | ALT (SGPT) (U/L)- Day98 | 14 U/L |
| Part B: Vaccine 1 | Alk Phos, AST, ALT in UL | ALT (SGPT) (U/L)- Screening | 13 U/L |
| Part B: Vaccine 1 | Alk Phos, AST, ALT in UL | ALT (SGPT) (U/L)- Day182 | 12 U/L |
| Part B: Vaccine 1 | Alk Phos, AST, ALT in UL | Alkaline Phosphatase (U/L)- Day98 | 64 U/L |
| Part B: Vaccine 1 | Alk Phos, AST, ALT in UL | AST (U/L)- Day14 | 17 U/L |
| Part B: Vaccine 1 | Alk Phos, AST, ALT in UL | Alkaline Phosphatase (U/L)- Day42 | 69 U/L |
| Part B: Vaccine 1 | Alk Phos, AST, ALT in UL | AST (U/L)- Day42 | 15 U/L |
| Part B: Vaccine 1 | Alk Phos, AST, ALT in UL | AST (U/L)- Day182 | 16 U/L |
| Part B: Vaccine 1 | Alk Phos, AST, ALT in UL | Alkaline Phosphatase (U/L)- Day238 | 61.5 U/L |
| Part B: Vaccine 1 | Alk Phos, AST, ALT in UL | AST (U/L)- Day98 | 17 U/L |
| Part B: Vaccine 1 | Alk Phos, AST, ALT in UL | Alkaline Phosphatase (U/L)- Day182 | 63 U/L |
| Part B: Vaccine 1 | Alk Phos, AST, ALT in UL | AST (U/L)- Day238 | 16 U/L |
| Part B: Vaccine 1 | Alk Phos, AST, ALT in UL | Alkaline Phosphatase (U/L)- Screening | 61 U/L |
| Part B: Vaccine 1 | Alk Phos, AST, ALT in UL | ALT (SGPT) (U/L)- Day14 | 14 U/L |
| Part B: Vaccine 1 | Alk Phos, AST, ALT in UL | Alkaline Phosphatase (U/L)- Day14 | 62 U/L |
| Part B: Vaccine 1 | Alk Phos, AST, ALT in UL | ALT (SGPT) (U/L)- Day334 | 13 U/L |
| Part B: Vaccine 1 | Alk Phos, AST, ALT in UL | AST (U/L)- Day334 | 16 U/L |
| Part B: Vaccine 1 | Alk Phos, AST, ALT in UL | ALT (SGPT) (U/L)- Day238 | 11.5 U/L |
| Part B: Vaccine 2 | Alk Phos, AST, ALT in UL | Alkaline Phosphatase (U/L)- Day98 | 61 U/L |
| Part B: Vaccine 2 | Alk Phos, AST, ALT in UL | ALT (SGPT) (U/L)- Day182 | 15.5 U/L |
| Part B: Vaccine 2 | Alk Phos, AST, ALT in UL | Alkaline Phosphatase (U/L)- Day182 | 60.5 U/L |
| Part B: Vaccine 2 | Alk Phos, AST, ALT in UL | Alkaline Phosphatase (U/L)- Day238 | 58.5 U/L |
| Part B: Vaccine 2 | Alk Phos, AST, ALT in UL | ALT (SGPT) (U/L)- Day42 | 15 U/L |
| Part B: Vaccine 2 | Alk Phos, AST, ALT in UL | Alkaline Phosphatase (U/L)- Day334 | 62 U/L |
| Part B: Vaccine 2 | Alk Phos, AST, ALT in UL | AST (U/L)- Day182 | 17.5 U/L |
| Part B: Vaccine 2 | Alk Phos, AST, ALT in UL | Alkaline Phosphatase (U/L)- Screening | 59 U/L |
| Part B: Vaccine 2 | Alk Phos, AST, ALT in UL | AST (U/L)- Day238 | 16 U/L |
| Part B: Vaccine 2 | Alk Phos, AST, ALT in UL | AST (U/L)- Day334 | 19 U/L |
| Part B: Vaccine 2 | Alk Phos, AST, ALT in UL | AST (U/L)- Screening | 19 U/L |
| Part B: Vaccine 2 | Alk Phos, AST, ALT in UL | ALT (SGPT) (U/L)- Screening | 16 U/L |
| Part B: Vaccine 2 | Alk Phos, AST, ALT in UL | Alkaline Phosphatase (U/L)- Day42 | 57 U/L |
| Part B: Vaccine 2 | Alk Phos, AST, ALT in UL | AST (U/L)- Day42 | 17 U/L |
| Part B: Vaccine 2 | Alk Phos, AST, ALT in UL | ALT (SGPT) (U/L)- Day334 | 15.5 U/L |
| Part B: Vaccine 2 | Alk Phos, AST, ALT in UL | ALT (SGPT) (U/L)- Day98 | 15 U/L |
| Part B: Vaccine 2 | Alk Phos, AST, ALT in UL | AST (U/L)- Day98 | 18 U/L |
| Part B: Vaccine 2 | Alk Phos, AST, ALT in UL | ALT (SGPT) (U/L)- Day238 | 12.5 U/L |
| Part B: Vaccine 2 | Alk Phos, AST, ALT in UL | AST (U/L)- Day14 | 19 U/L |
| Part B: Vaccine 2 | Alk Phos, AST, ALT in UL | Alkaline Phosphatase (U/L)- Day14 | 60 U/L |
| Part B: Vaccine 2 | Alk Phos, AST, ALT in UL | ALT (SGPT) (U/L)- Day14 | 15 U/L |
Primary
Hemoglobin, Creatinine in g/dL
Laboratory results are summarized by analyte and timepoint.
Time frame: Measured through Screening, Day 14, Day 70, Day140 for part A and visits Screening, Day 14, Day 42, Day 98, Day 182, Day 238 and Day 334 for part B
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: Placebo | Hemoglobin, Creatinine in g/dL | Hemoglobin (g/dL)- Day70 | 13.25 g/dL |
| Part A: Placebo | Hemoglobin, Creatinine in g/dL | Creatinine (g/dL)- Day140 | 0.000935 g/dL |
| Part A: Placebo | Hemoglobin, Creatinine in g/dL | Creatinine (g/dL)- Screening | 0.00094 g/dL |
| Part A: Placebo | Hemoglobin, Creatinine in g/dL | Creatinine (g/dL)- Day70 | 0.00088 g/dL |
| Part A: Placebo | Hemoglobin, Creatinine in g/dL | Hemoglobin (g/dL)- Screening | 14.7 g/dL |
| Part A: Placebo | Hemoglobin, Creatinine in g/dL | Hemoglobin (g/dL)- Day14 | 14.65 g/dL |
| Part A: Placebo | Hemoglobin, Creatinine in g/dL | Hemoglobin (g/dL)- Day140 | 14.35 g/dL |
| Part A: Placebo | Hemoglobin, Creatinine in g/dL | Creatinine (g/dL)- Day14 | 0.00102 g/dL |
| Part A: Vaccine | Hemoglobin, Creatinine in g/dL | Creatinine (g/dL)- Screening | 0.00077 g/dL |
| Part A: Vaccine | Hemoglobin, Creatinine in g/dL | Hemoglobin (g/dL)- Screening | 13.75 g/dL |
| Part A: Vaccine | Hemoglobin, Creatinine in g/dL | Creatinine (g/dL)- Day14 | 0.000815 g/dL |
| Part A: Vaccine | Hemoglobin, Creatinine in g/dL | Creatinine (g/dL)- Day140 | 0.000765 g/dL |
| Part A: Vaccine | Hemoglobin, Creatinine in g/dL | Hemoglobin (g/dL)- Day14 | 13.45 g/dL |
| Part A: Vaccine | Hemoglobin, Creatinine in g/dL | Creatinine (g/dL)- Day70 | 0.00075 g/dL |
| Part A: Vaccine | Hemoglobin, Creatinine in g/dL | Hemoglobin (g/dL)- Day70 | 14.1 g/dL |
| Part A: Vaccine | Hemoglobin, Creatinine in g/dL | Hemoglobin (g/dL)- Day140 | 13.65 g/dL |
| Part B: Placebo | Hemoglobin, Creatinine in g/dL | Creatinine (g/dL)- Day334 | 0.00082 g/dL |
| Part B: Placebo | Hemoglobin, Creatinine in g/dL | Hemoglobin (g/dL)- Day334 | 14.25 g/dL |
| Part B: Placebo | Hemoglobin, Creatinine in g/dL | Hemoglobin (g/dL)- Day182 | 13.6 g/dL |
| Part B: Placebo | Hemoglobin, Creatinine in g/dL | Hemoglobin (g/dL)- Day238 | 13.5 g/dL |
| Part B: Placebo | Hemoglobin, Creatinine in g/dL | Creatinine (g/dL)- Day182 | 0.00085 g/dL |
| Part B: Placebo | Hemoglobin, Creatinine in g/dL | Hemoglobin (g/dL)- Day42 | 13.9 g/dL |
| Part B: Placebo | Hemoglobin, Creatinine in g/dL | Hemoglobin (g/dL)- Screening | 13.85 g/dL |
| Part B: Placebo | Hemoglobin, Creatinine in g/dL | Hemoglobin (g/dL)- Day98 | 13.2 g/dL |
| Part B: Placebo | Hemoglobin, Creatinine in g/dL | Creatinine (g/dL)- Screening | 0.000795 g/dL |
| Part B: Placebo | Hemoglobin, Creatinine in g/dL | Creatinine (g/dL)- Day238 | 0.000815 g/dL |
| Part B: Placebo | Hemoglobin, Creatinine in g/dL | Creatinine (g/dL)- Day14 | 0.000835 g/dL |
| Part B: Placebo | Hemoglobin, Creatinine in g/dL | Creatinine (g/dL)- Day98 | 0.00083 g/dL |
| Part B: Placebo | Hemoglobin, Creatinine in g/dL | Creatinine (g/dL)- Day42 | 0.00081 g/dL |
| Part B: Placebo | Hemoglobin, Creatinine in g/dL | Hemoglobin (g/dL)- Day14 | 13.5 g/dL |
| Part B: Vaccine 1 | Hemoglobin, Creatinine in g/dL | Hemoglobin (g/dL)- Day182 | 13.4 g/dL |
| Part B: Vaccine 1 | Hemoglobin, Creatinine in g/dL | Hemoglobin (g/dL)- Day14 | 13.5 g/dL |
| Part B: Vaccine 1 | Hemoglobin, Creatinine in g/dL | Hemoglobin (g/dL)- Day42 | 13.8 g/dL |
| Part B: Vaccine 1 | Hemoglobin, Creatinine in g/dL | Creatinine (g/dL)- Screening | 0.00078 g/dL |
| Part B: Vaccine 1 | Hemoglobin, Creatinine in g/dL | Creatinine (g/dL)- Day14 | 0.00075 g/dL |
| Part B: Vaccine 1 | Hemoglobin, Creatinine in g/dL | Creatinine (g/dL)- Day42 | 0.00079 g/dL |
| Part B: Vaccine 1 | Hemoglobin, Creatinine in g/dL | Hemoglobin (g/dL)- Screening | 14.7 g/dL |
| Part B: Vaccine 1 | Hemoglobin, Creatinine in g/dL | Hemoglobin (g/dL)- Day98 | 14 g/dL |
| Part B: Vaccine 1 | Hemoglobin, Creatinine in g/dL | Hemoglobin (g/dL)- Day238 | 13.2 g/dL |
| Part B: Vaccine 1 | Hemoglobin, Creatinine in g/dL | Hemoglobin (g/dL)- Day334 | 12.75 g/dL |
| Part B: Vaccine 1 | Hemoglobin, Creatinine in g/dL | Creatinine (g/dL)- Day98 | 0.0008 g/dL |
| Part B: Vaccine 1 | Hemoglobin, Creatinine in g/dL | Creatinine (g/dL)- Day182 | 0.00088 g/dL |
| Part B: Vaccine 1 | Hemoglobin, Creatinine in g/dL | Creatinine (g/dL)- Day238 | 0.00076 g/dL |
| Part B: Vaccine 1 | Hemoglobin, Creatinine in g/dL | Creatinine (g/dL)- Day334 | 0.00081 g/dL |
| Part B: Vaccine 2 | Hemoglobin, Creatinine in g/dL | Creatinine (g/dL)- Day42 | 0.00087 g/dL |
| Part B: Vaccine 2 | Hemoglobin, Creatinine in g/dL | Creatinine (g/dL)- Day14 | 0.000835 g/dL |
| Part B: Vaccine 2 | Hemoglobin, Creatinine in g/dL | Creatinine (g/dL)- Day334 | 0.000895 g/dL |
| Part B: Vaccine 2 | Hemoglobin, Creatinine in g/dL | Creatinine (g/dL)- Day98 | 0.00084 g/dL |
| Part B: Vaccine 2 | Hemoglobin, Creatinine in g/dL | Creatinine (g/dL)- Screening | 0.0008 g/dL |
| Part B: Vaccine 2 | Hemoglobin, Creatinine in g/dL | Hemoglobin (g/dL)- Day42 | 13.8 g/dL |
| Part B: Vaccine 2 | Hemoglobin, Creatinine in g/dL | Hemoglobin (g/dL)- Day14 | 13.95 g/dL |
| Part B: Vaccine 2 | Hemoglobin, Creatinine in g/dL | Creatinine (g/dL)- Day238 | 0.000845 g/dL |
| Part B: Vaccine 2 | Hemoglobin, Creatinine in g/dL | Hemoglobin (g/dL)- Day182 | 14 g/dL |
| Part B: Vaccine 2 | Hemoglobin, Creatinine in g/dL | Creatinine (g/dL)- Day182 | 0.000855 g/dL |
| Part B: Vaccine 2 | Hemoglobin, Creatinine in g/dL | Hemoglobin (g/dL)- Day238 | 14 g/dL |
| Part B: Vaccine 2 | Hemoglobin, Creatinine in g/dL | Hemoglobin (g/dL)- Day98 | 14.8 g/dL |
| Part B: Vaccine 2 | Hemoglobin, Creatinine in g/dL | Hemoglobin (g/dL)- Screening | 14.8 g/dL |
| Part B: Vaccine 2 | Hemoglobin, Creatinine in g/dL | Hemoglobin (g/dL)- Day334 | 14.15 g/dL |
Primary
Number of Participants Reporting Adverse Events (AEs), by Relationship to Study Product
For participants reporting multiple AEs over the time frame, the maximum relationship is counted.
Time frame: Measured through 30 days after each vaccine dose at Months 0, 2 for part A and Months 0, 1, 3, 6, 8 for part B
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A: Placebo | Number of Participants Reporting Adverse Events (AEs), by Relationship to Study Product | Related | 0 Participants |
| Part A: Placebo | Number of Participants Reporting Adverse Events (AEs), by Relationship to Study Product | No AE reported | 0 Participants |
| Part A: Placebo | Number of Participants Reporting Adverse Events (AEs), by Relationship to Study Product | Not Related | 2 Participants |
| Part A: Vaccine | Number of Participants Reporting Adverse Events (AEs), by Relationship to Study Product | Not Related | 6 Participants |
| Part A: Vaccine | Number of Participants Reporting Adverse Events (AEs), by Relationship to Study Product | Related | 0 Participants |
| Part A: Vaccine | Number of Participants Reporting Adverse Events (AEs), by Relationship to Study Product | No AE reported | 4 Participants |
| Part B: Placebo | Number of Participants Reporting Adverse Events (AEs), by Relationship to Study Product | Not Related | 5 Participants |
| Part B: Placebo | Number of Participants Reporting Adverse Events (AEs), by Relationship to Study Product | Related | 0 Participants |
| Part B: Placebo | Number of Participants Reporting Adverse Events (AEs), by Relationship to Study Product | No AE reported | 1 Participants |
| Part B: Vaccine 1 | Number of Participants Reporting Adverse Events (AEs), by Relationship to Study Product | Related | 5 Participants |
| Part B: Vaccine 1 | Number of Participants Reporting Adverse Events (AEs), by Relationship to Study Product | No AE reported | 2 Participants |
| Part B: Vaccine 1 | Number of Participants Reporting Adverse Events (AEs), by Relationship to Study Product | Not Related | 14 Participants |
| Part B: Vaccine 2 | Number of Participants Reporting Adverse Events (AEs), by Relationship to Study Product | Not Related | 16 Participants |
| Part B: Vaccine 2 | Number of Participants Reporting Adverse Events (AEs), by Relationship to Study Product | Related | 2 Participants |
| Part B: Vaccine 2 | Number of Participants Reporting Adverse Events (AEs), by Relationship to Study Product | No AE reported | 3 Participants |
Primary
Number of Participants Reporting Adverse Events (AEs), by Severity Grade
For participants reporting multiple AEs over the time frame, the maximum severity grade is counted.
Time frame: Measured through 30 days after each vaccine dose at Months 0, 2 for part A and Months 0, 1, 3, 6, 8 for part B
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A: Placebo | Number of Participants Reporting Adverse Events (AEs), by Severity Grade | Severe | 0 Participants |
| Part A: Placebo | Number of Participants Reporting Adverse Events (AEs), by Severity Grade | Mild | 0 Participants |
| Part A: Placebo | Number of Participants Reporting Adverse Events (AEs), by Severity Grade | Moderate | 2 Participants |
| Part A: Placebo | Number of Participants Reporting Adverse Events (AEs), by Severity Grade | No AE reported | 0 Participants |
| Part A: Vaccine | Number of Participants Reporting Adverse Events (AEs), by Severity Grade | Moderate | 4 Participants |
| Part A: Vaccine | Number of Participants Reporting Adverse Events (AEs), by Severity Grade | Mild | 2 Participants |
| Part A: Vaccine | Number of Participants Reporting Adverse Events (AEs), by Severity Grade | Severe | 0 Participants |
| Part A: Vaccine | Number of Participants Reporting Adverse Events (AEs), by Severity Grade | No AE reported | 4 Participants |
| Part B: Placebo | Number of Participants Reporting Adverse Events (AEs), by Severity Grade | Mild | 1 Participants |
| Part B: Placebo | Number of Participants Reporting Adverse Events (AEs), by Severity Grade | No AE reported | 1 Participants |
| Part B: Placebo | Number of Participants Reporting Adverse Events (AEs), by Severity Grade | Moderate | 4 Participants |
| Part B: Placebo | Number of Participants Reporting Adverse Events (AEs), by Severity Grade | Severe | 0 Participants |
| Part B: Vaccine 1 | Number of Participants Reporting Adverse Events (AEs), by Severity Grade | Mild | 0 Participants |
| Part B: Vaccine 1 | Number of Participants Reporting Adverse Events (AEs), by Severity Grade | No AE reported | 2 Participants |
| Part B: Vaccine 1 | Number of Participants Reporting Adverse Events (AEs), by Severity Grade | Severe | 1 Participants |
| Part B: Vaccine 1 | Number of Participants Reporting Adverse Events (AEs), by Severity Grade | Moderate | 18 Participants |
| Part B: Vaccine 2 | Number of Participants Reporting Adverse Events (AEs), by Severity Grade | Moderate | 14 Participants |
| Part B: Vaccine 2 | Number of Participants Reporting Adverse Events (AEs), by Severity Grade | Mild | 2 Participants |
| Part B: Vaccine 2 | Number of Participants Reporting Adverse Events (AEs), by Severity Grade | No AE reported | 3 Participants |
| Part B: Vaccine 2 | Number of Participants Reporting Adverse Events (AEs), by Severity Grade | Severe | 2 Participants |
Primary
Number of Participants Reporting Adverse Events of Special Interest (AESIs)
Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases. There were no adverse events of special interest reported by any participant.
Time frame: Measured through Month 8 for part A and Month 14 for part B
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part A: Placebo | Number of Participants Reporting Adverse Events of Special Interest (AESIs) | 0 Participants |
| Part A: Vaccine | Number of Participants Reporting Adverse Events of Special Interest (AESIs) | 0 Participants |
| Part B: Placebo | Number of Participants Reporting Adverse Events of Special Interest (AESIs) | 0 Participants |
| Part B: Vaccine 1 | Number of Participants Reporting Adverse Events of Special Interest (AESIs) | 0 Participants |
| Part B: Vaccine 2 | Number of Participants Reporting Adverse Events of Special Interest (AESIs) | 0 Participants |
Primary
Number of Participants Reporting Local Reactogenicity Signs and Symptoms
Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1, July 2017. The maximum grade observed for each symptom over the time frame is presented.
Time frame: Measured through 3 days after participants' each vaccination at Months 0, 2 for part A and Months 0, 1, 3, 6, 8 for part B
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Part A: Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Induration | Moderate | 0 Participants |
| Part A: Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Tenderness | Potentially Life-threatening | 0 Participants |
| Part A: Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Induration | Potentially Life-threatening | 0 Participants |
| Part A: Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Erythema and/or Induration | Potentially Life-threatening | 0 Participants |
| Part A: Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Tenderness | Severe | 0 Participants |
| Part A: Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Tenderness | None | 2 Participants |
| Part A: Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Induration | Mild | 0 Participants |
| Part A: Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Erythema and/or Induration | Severe | 0 Participants |
| Part A: Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Pain | Mild | 0 Participants |
| Part A: Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Erythema | Potentially Life-threatening | 0 Participants |
| Part A: Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Pain | Severe | 0 Participants |
| Part A: Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Erythema | Mild | 0 Participants |
| Part A: Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Pain and/or Tenderness | Moderate | 0 Participants |
| Part A: Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Tenderness | Mild | 0 Participants |
| Part A: Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Pain | Moderate | 0 Participants |
| Part A: Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Pain | None | 2 Participants |
| Part A: Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Erythema | Severe | 0 Participants |
| Part A: Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Pain and/or Tenderness | Severe | 0 Participants |
| Part A: Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Erythema and/or Induration | None | 2 Participants |
| Part A: Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Tenderness | Moderate | 0 Participants |
| Part A: Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Pain | Potentially Life-threatening | 0 Participants |
| Part A: Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Erythema and/or Induration | Moderate | 0 Participants |
| Part A: Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Pain and/or Tenderness | Potentially Life-threatening | 0 Participants |
| Part A: Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Induration | None | 2 Participants |
| Part A: Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Erythema | None | 2 Participants |
| Part A: Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Pain and/or Tenderness | Mild | 0 Participants |
| Part A: Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Erythema and/or Induration | Mild | 0 Participants |
| Part A: Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Pain and/or Tenderness | None | 2 Participants |
| Part A: Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Induration | Severe | 0 Participants |
| Part A: Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Erythema | Moderate | 0 Participants |
| Part A: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Tenderness | Severe | 0 Participants |
| Part A: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Induration | Moderate | 0 Participants |
| Part A: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Erythema | Severe | 0 Participants |
| Part A: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Induration | Mild | 0 Participants |
| Part A: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Erythema | Potentially Life-threatening | 0 Participants |
| Part A: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Pain | Potentially Life-threatening | 0 Participants |
| Part A: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Induration | None | 10 Participants |
| Part A: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Induration | Potentially Life-threatening | 0 Participants |
| Part A: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Tenderness | None | 3 Participants |
| Part A: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Erythema | Mild | 0 Participants |
| Part A: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Tenderness | Mild | 6 Participants |
| Part A: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Erythema | None | 10 Participants |
| Part A: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Tenderness | Moderate | 1 Participants |
| Part A: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Pain | Mild | 4 Participants |
| Part A: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Erythema | Moderate | 0 Participants |
| Part A: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Tenderness | Potentially Life-threatening | 0 Participants |
| Part A: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Pain | Severe | 0 Participants |
| Part A: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Pain and/or Tenderness | None | 3 Participants |
| Part A: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Pain and/or Tenderness | Mild | 6 Participants |
| Part A: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Erythema and/or Induration | None | 10 Participants |
| Part A: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Pain | None | 5 Participants |
| Part A: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Pain and/or Tenderness | Moderate | 1 Participants |
| Part A: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Erythema and/or Induration | Potentially Life-threatening | 0 Participants |
| Part A: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Pain and/or Tenderness | Severe | 0 Participants |
| Part A: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Pain | Moderate | 1 Participants |
| Part A: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Erythema and/or Induration | Moderate | 0 Participants |
| Part A: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Pain and/or Tenderness | Potentially Life-threatening | 0 Participants |
| Part A: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Erythema and/or Induration | Severe | 0 Participants |
| Part A: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Erythema and/or Induration | Mild | 0 Participants |
| Part A: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Induration | Severe | 0 Participants |
| Part B: Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Tenderness | None | 4 Participants |
| Part B: Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Pain | Mild | 1 Participants |
| Part B: Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Pain | Moderate | 0 Participants |
| Part B: Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Pain | None | 5 Participants |
| Part B: Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Tenderness | Moderate | 0 Participants |
| Part B: Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Tenderness | Potentially Life-threatening | 0 Participants |
| Part B: Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Pain and/or Tenderness | None | 4 Participants |
| Part B: Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Pain and/or Tenderness | Mild | 2 Participants |
| Part B: Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Pain and/or Tenderness | Moderate | 0 Participants |
| Part B: Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Pain and/or Tenderness | Severe | 0 Participants |
| Part B: Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Pain and/or Tenderness | Potentially Life-threatening | 0 Participants |
| Part B: Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Erythema | Moderate | 0 Participants |
| Part B: Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Erythema | Severe | 0 Participants |
| Part B: Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Erythema | Potentially Life-threatening | 0 Participants |
| Part B: Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Induration | None | 6 Participants |
| Part B: Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Induration | Mild | 0 Participants |
| Part B: Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Induration | Moderate | 0 Participants |
| Part B: Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Induration | Severe | 0 Participants |
| Part B: Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Erythema and/or Induration | Mild | 0 Participants |
| Part B: Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Erythema and/or Induration | Moderate | 0 Participants |
| Part B: Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Erythema and/or Induration | Potentially Life-threatening | 0 Participants |
| Part B: Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Pain | Severe | 0 Participants |
| Part B: Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Pain | Potentially Life-threatening | 0 Participants |
| Part B: Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Tenderness | Mild | 2 Participants |
| Part B: Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Tenderness | Severe | 0 Participants |
| Part B: Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Erythema | None | 6 Participants |
| Part B: Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Erythema | Mild | 0 Participants |
| Part B: Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Induration | Potentially Life-threatening | 0 Participants |
| Part B: Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Erythema and/or Induration | None | 6 Participants |
| Part B: Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Erythema and/or Induration | Severe | 0 Participants |
| Part B: Vaccine 1 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Pain | Moderate | 5 Participants |
| Part B: Vaccine 1 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Induration | Severe | 4 Participants |
| Part B: Vaccine 1 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Erythema and/or Induration | None | 14 Participants |
| Part B: Vaccine 1 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Pain and/or Tenderness | Potentially Life-threatening | 0 Participants |
| Part B: Vaccine 1 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Pain and/or Tenderness | Severe | 1 Participants |
| Part B: Vaccine 1 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Erythema and/or Induration | Mild | 0 Participants |
| Part B: Vaccine 1 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Erythema and/or Induration | Potentially Life-threatening | 0 Participants |
| Part B: Vaccine 1 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Pain and/or Tenderness | Moderate | 6 Participants |
| Part B: Vaccine 1 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Pain and/or Tenderness | Mild | 13 Participants |
| Part B: Vaccine 1 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Pain | Severe | 1 Participants |
| Part B: Vaccine 1 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Erythema and/or Induration | Moderate | 2 Participants |
| Part B: Vaccine 1 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Tenderness | Mild | 15 Participants |
| Part B: Vaccine 1 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Tenderness | Potentially Life-threatening | 0 Participants |
| Part B: Vaccine 1 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Pain | Mild | 12 Participants |
| Part B: Vaccine 1 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Tenderness | Severe | 1 Participants |
| Part B: Vaccine 1 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Pain and/or Tenderness | None | 1 Participants |
| Part B: Vaccine 1 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Tenderness | Moderate | 4 Participants |
| Part B: Vaccine 1 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Erythema | None | 14 Participants |
| Part B: Vaccine 1 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Tenderness | None | 1 Participants |
| Part B: Vaccine 1 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Pain | None | 3 Participants |
| Part B: Vaccine 1 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Induration | Mild | 1 Participants |
| Part B: Vaccine 1 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Pain | Potentially Life-threatening | 0 Participants |
| Part B: Vaccine 1 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Erythema | Potentially Life-threatening | 0 Participants |
| Part B: Vaccine 1 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Erythema and/or Induration | Severe | 5 Participants |
| Part B: Vaccine 1 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Induration | None | 16 Participants |
| Part B: Vaccine 1 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Erythema | Severe | 5 Participants |
| Part B: Vaccine 1 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Induration | Potentially Life-threatening | 0 Participants |
| Part B: Vaccine 1 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Erythema | Moderate | 2 Participants |
| Part B: Vaccine 1 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Induration | Moderate | 0 Participants |
| Part B: Vaccine 1 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Erythema | Mild | 0 Participants |
| Part B: Vaccine 2 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Pain and/or Tenderness | None | 0 Participants |
| Part B: Vaccine 2 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Tenderness | Moderate | 3 Participants |
| Part B: Vaccine 2 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Erythema | Moderate | 4 Participants |
| Part B: Vaccine 2 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Erythema and/or Induration | None | 12 Participants |
| Part B: Vaccine 2 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Pain and/or Tenderness | Potentially Life-threatening | 0 Participants |
| Part B: Vaccine 2 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Tenderness | Mild | 17 Participants |
| Part B: Vaccine 2 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Pain | Mild | 15 Participants |
| Part B: Vaccine 2 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Pain and/or Tenderness | Severe | 1 Participants |
| Part B: Vaccine 2 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Pain | None | 1 Participants |
| Part B: Vaccine 2 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Erythema and/or Induration | Severe | 2 Participants |
| Part B: Vaccine 2 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Pain and/or Tenderness | Moderate | 5 Participants |
| Part B: Vaccine 2 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Induration | Moderate | 2 Participants |
| Part B: Vaccine 2 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Erythema | None | 13 Participants |
| Part B: Vaccine 2 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Erythema and/or Induration | Potentially Life-threatening | 0 Participants |
| Part B: Vaccine 2 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Tenderness | None | 0 Participants |
| Part B: Vaccine 2 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Pain and/or Tenderness | Mild | 15 Participants |
| Part B: Vaccine 2 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Pain | Moderate | 4 Participants |
| Part B: Vaccine 2 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Induration | None | 14 Participants |
| Part B: Vaccine 2 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Tenderness | Potentially Life-threatening | 0 Participants |
| Part B: Vaccine 2 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Erythema and/or Induration | Mild | 3 Participants |
| Part B: Vaccine 2 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Erythema | Severe | 2 Participants |
| Part B: Vaccine 2 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Pain | Severe | 1 Participants |
| Part B: Vaccine 2 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Induration | Potentially Life-threatening | 0 Participants |
| Part B: Vaccine 2 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Erythema and/or Induration | Moderate | 4 Participants |
| Part B: Vaccine 2 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Induration | Severe | 2 Participants |
| Part B: Vaccine 2 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Pain | Potentially Life-threatening | 0 Participants |
| Part B: Vaccine 2 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Tenderness | Severe | 1 Participants |
| Part B: Vaccine 2 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Erythema | Mild | 2 Participants |
| Part B: Vaccine 2 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Erythema | Potentially Life-threatening | 0 Participants |
| Part B: Vaccine 2 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms | Induration | Mild | 3 Participants |
Primary
Number of Participants Reporting Serious Adverse Events (SAEs)
Measured as outlined in Version 2.0 (January 2010) of the Manual for Expedited Reporting of Adverse Events to DAIDS (DAIDS EAE Manual).
Time frame: Measured through Month 8 for part A and Month 14 for part B
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part A: Placebo | Number of Participants Reporting Serious Adverse Events (SAEs) | 0 Participants |
| Part A: Vaccine | Number of Participants Reporting Serious Adverse Events (SAEs) | 0 Participants |
| Part B: Placebo | Number of Participants Reporting Serious Adverse Events (SAEs) | 0 Participants |
| Part B: Vaccine 1 | Number of Participants Reporting Serious Adverse Events (SAEs) | 0 Participants |
| Part B: Vaccine 2 | Number of Participants Reporting Serious Adverse Events (SAEs) | 0 Participants |
Primary
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1, July 2017. The maximum grade observed for each symptom over the time frame is presented.
Time frame: Measured through 3 days after participants' each vaccination at Months 0, 2 for part A and Months 0, 1, 3, 6, 8 for part B
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Part A: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Severe | 0 Participants |
| Part A: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Severe | 0 Participants |
| Part A: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Moderate | 0 Participants |
| Part A: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | None | 1 Participants |
| Part A: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Mild | 1 Participants |
| Part A: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Potentially Life-threatening | 0 Participants |
| Part A: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Severe | 0 Participants |
| Part A: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Severe | 0 Participants |
| Part A: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | None | 1 Participants |
| Part A: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Moderate | 0 Participants |
| Part A: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Severe | 0 Participants |
| Part A: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | None | 1 Participants |
| Part A: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Moderate | 0 Participants |
| Part A: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Vomiting | None | 2 Participants |
| Part A: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Mild | 1 Participants |
| Part A: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Potentially Life-threatening | 0 Participants |
| Part A: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Vomiting | Severe | 0 Participants |
| Part A: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Mild | 0 Participants |
| Part A: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Vomiting | Mild | 0 Participants |
| Part A: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Mild | 1 Participants |
| Part A: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | None | 2 Participants |
| Part A: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Severe | 0 Participants |
| Part A: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Mild | 1 Participants |
| Part A: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Potentially Life-threatening | 0 Participants |
| Part A: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | None | 1 Participants |
| Part A: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Potentially Life-threatening | 0 Participants |
| Part A: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Moderate | 0 Participants |
| Part A: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Moderate | 0 Participants |
| Part A: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Moderate | 0 Participants |
| Part A: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Mild | 0 Participants |
| Part A: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | None | 2 Participants |
| Part A: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Vomiting | Potentially Life-threatening | 0 Participants |
| Part A: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Mild | 0 Participants |
| Part A: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Potentially Life-threatening | 0 Participants |
| Part A: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Mild | 1 Participants |
| Part A: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | None | 2 Participants |
| Part A: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Moderate | 0 Participants |
| Part A: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Moderate | 0 Participants |
| Part A: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Severe | 0 Participants |
| Part A: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Vomiting | Moderate | 0 Participants |
| Part A: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Severe | 0 Participants |
| Part A: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Potentially Life-threatening | 0 Participants |
| Part A: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Potentially Life-threatening | 0 Participants |
| Part A: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Potentially Life-threatening | 0 Participants |
| Part A: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | None | 1 Participants |
| Part A: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | None | 5 Participants |
| Part A: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Severe | 0 Participants |
| Part A: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Potentially Life-threatening | 0 Participants |
| Part A: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Mild | 4 Participants |
| Part A: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Moderate | 0 Participants |
| Part A: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Moderate | 0 Participants |
| Part A: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Severe | 0 Participants |
| Part A: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Mild | 5 Participants |
| Part A: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Moderate | 0 Participants |
| Part A: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Potentially Life-threatening | 0 Participants |
| Part A: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | None | 8 Participants |
| Part A: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Moderate | 0 Participants |
| Part A: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Mild | 2 Participants |
| Part A: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Mild | 5 Participants |
| Part A: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Severe | 0 Participants |
| Part A: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Potentially Life-threatening | 0 Participants |
| Part A: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Potentially Life-threatening | 0 Participants |
| Part A: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Severe | 0 Participants |
| Part A: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Severe | 0 Participants |
| Part A: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Vomiting | None | 10 Participants |
| Part A: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Moderate | 0 Participants |
| Part A: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Vomiting | Potentially Life-threatening | 0 Participants |
| Part A: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | None | 5 Participants |
| Part A: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Mild | 6 Participants |
| Part A: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Mild | 0 Participants |
| Part A: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Moderate | 0 Participants |
| Part A: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Severe | 0 Participants |
| Part A: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Potentially Life-threatening | 0 Participants |
| Part A: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Severe | 0 Participants |
| Part A: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | None | 10 Participants |
| Part A: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | None | 8 Participants |
| Part A: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Mild | 1 Participants |
| Part A: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Moderate | 1 Participants |
| Part A: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Vomiting | Severe | 0 Participants |
| Part A: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Severe | 0 Participants |
| Part A: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Potentially Life-threatening | 0 Participants |
| Part A: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Potentially Life-threatening | 0 Participants |
| Part A: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | None | 3 Participants |
| Part A: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Moderate | 1 Participants |
| Part A: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Potentially Life-threatening | 0 Participants |
| Part A: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Vomiting | Moderate | 0 Participants |
| Part A: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | None | 10 Participants |
| Part A: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | None | 6 Participants |
| Part A: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Mild | 0 Participants |
| Part A: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Vomiting | Mild | 0 Participants |
| Part B: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Severe | 0 Participants |
| Part B: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Moderate | 1 Participants |
| Part B: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Potentially Life-threatening | 0 Participants |
| Part B: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | None | 6 Participants |
| Part B: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Severe | 1 Participants |
| Part B: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | None | 4 Participants |
| Part B: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Mild | 1 Participants |
| Part B: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Potentially Life-threatening | 0 Participants |
| Part B: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Mild | 0 Participants |
| Part B: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Potentially Life-threatening | 0 Participants |
| Part B: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Vomiting | Severe | 0 Participants |
| Part B: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Mild | 3 Participants |
| Part B: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Moderate | 0 Participants |
| Part B: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Moderate | 0 Participants |
| Part B: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Severe | 0 Participants |
| Part B: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Moderate | 0 Participants |
| Part B: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Mild | 2 Participants |
| Part B: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Severe | 0 Participants |
| Part B: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Potentially Life-threatening | 0 Participants |
| Part B: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Severe | 0 Participants |
| Part B: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Moderate | 1 Participants |
| Part B: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Mild | 0 Participants |
| Part B: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Vomiting | Potentially Life-threatening | 0 Participants |
| Part B: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Potentially Life-threatening | 0 Participants |
| Part B: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | None | 6 Participants |
| Part B: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Moderate | 2 Participants |
| Part B: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Vomiting | Mild | 0 Participants |
| Part B: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Mild | 0 Participants |
| Part B: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Vomiting | Moderate | 0 Participants |
| Part B: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Mild | 0 Participants |
| Part B: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Vomiting | None | 6 Participants |
| Part B: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Severe | 0 Participants |
| Part B: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Severe | 1 Participants |
| Part B: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | None | 2 Participants |
| Part B: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Moderate | 0 Participants |
| Part B: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | None | 2 Participants |
| Part B: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | None | 2 Participants |
| Part B: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Severe | 0 Participants |
| Part B: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Potentially Life-threatening | 0 Participants |
| Part B: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | None | 6 Participants |
| Part B: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Mild | 1 Participants |
| Part B: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Potentially Life-threatening | 0 Participants |
| Part B: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Potentially Life-threatening | 0 Participants |
| Part B: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | None | 4 Participants |
| Part B: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Moderate | 3 Participants |
| Part B: Vaccine 1 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Potentially Life-threatening | 0 Participants |
| Part B: Vaccine 1 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | None | 4 Participants |
| Part B: Vaccine 1 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Mild | 8 Participants |
| Part B: Vaccine 1 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Moderate | 7 Participants |
| Part B: Vaccine 1 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Severe | 2 Participants |
| Part B: Vaccine 1 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | None | 3 Participants |
| Part B: Vaccine 1 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Moderate | 8 Participants |
| Part B: Vaccine 1 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Severe | 0 Participants |
| Part B: Vaccine 1 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Potentially Life-threatening | 0 Participants |
| Part B: Vaccine 1 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Moderate | 3 Participants |
| Part B: Vaccine 1 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Severe | 0 Participants |
| Part B: Vaccine 1 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Vomiting | None | 17 Participants |
| Part B: Vaccine 1 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Vomiting | Mild | 3 Participants |
| Part B: Vaccine 1 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Vomiting | Potentially Life-threatening | 0 Participants |
| Part B: Vaccine 1 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Mild | 4 Participants |
| Part B: Vaccine 1 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Severe | 2 Participants |
| Part B: Vaccine 1 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Potentially Life-threatening | 0 Participants |
| Part B: Vaccine 1 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | None | 10 Participants |
| Part B: Vaccine 1 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Mild | 8 Participants |
| Part B: Vaccine 1 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Moderate | 1 Participants |
| Part B: Vaccine 1 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Severe | 2 Participants |
| Part B: Vaccine 1 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Potentially Life-threatening | 0 Participants |
| Part B: Vaccine 1 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | None | 3 Participants |
| Part B: Vaccine 1 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Potentially Life-threatening | 0 Participants |
| Part B: Vaccine 1 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | None | 15 Participants |
| Part B: Vaccine 1 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Mild | 2 Participants |
| Part B: Vaccine 1 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Moderate | 3 Participants |
| Part B: Vaccine 1 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Potentially Life-threatening | 0 Participants |
| Part B: Vaccine 1 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | None | 8 Participants |
| Part B: Vaccine 1 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Mild | 9 Participants |
| Part B: Vaccine 1 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Moderate | 2 Participants |
| Part B: Vaccine 1 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Severe | 2 Participants |
| Part B: Vaccine 1 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Potentially Life-threatening | 0 Participants |
| Part B: Vaccine 1 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Mild | 10 Participants |
| Part B: Vaccine 1 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | None | 12 Participants |
| Part B: Vaccine 1 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Mild | 6 Participants |
| Part B: Vaccine 1 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Vomiting | Moderate | 1 Participants |
| Part B: Vaccine 1 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Vomiting | Severe | 0 Participants |
| Part B: Vaccine 1 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | None | 11 Participants |
| Part B: Vaccine 1 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Moderate | 4 Participants |
| Part B: Vaccine 1 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Mild | 8 Participants |
| Part B: Vaccine 1 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Moderate | 8 Participants |
| Part B: Vaccine 1 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Severe | 2 Participants |
| Part B: Vaccine 1 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Severe | 0 Participants |
| Part B: Vaccine 1 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Potentially Life-threatening | 1 Participants |
| Part B: Vaccine 2 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Moderate | 2 Participants |
| Part B: Vaccine 2 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Vomiting | Mild | 1 Participants |
| Part B: Vaccine 2 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | None | 16 Participants |
| Part B: Vaccine 2 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Potentially Life-threatening | 0 Participants |
| Part B: Vaccine 2 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Potentially Life-threatening | 0 Participants |
| Part B: Vaccine 2 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | None | 9 Participants |
| Part B: Vaccine 2 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Vomiting | Moderate | 2 Participants |
| Part B: Vaccine 2 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Severe | 1 Participants |
| Part B: Vaccine 2 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Moderate | 1 Participants |
| Part B: Vaccine 2 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Mild | 2 Participants |
| Part B: Vaccine 2 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Severe | 1 Participants |
| Part B: Vaccine 2 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Vomiting | Severe | 0 Participants |
| Part B: Vaccine 2 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | None | 17 Participants |
| Part B: Vaccine 2 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Potentially Life-threatening | 0 Participants |
| Part B: Vaccine 2 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Severe | 2 Participants |
| Part B: Vaccine 2 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Potentially Life-threatening | 0 Participants |
| Part B: Vaccine 2 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Moderate | 0 Participants |
| Part B: Vaccine 2 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Severe | 0 Participants |
| Part B: Vaccine 2 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Mild | 4 Participants |
| Part B: Vaccine 2 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | None | 5 Participants |
| Part B: Vaccine 2 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | None | 15 Participants |
| Part B: Vaccine 2 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Vomiting | Potentially Life-threatening | 0 Participants |
| Part B: Vaccine 2 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Vomiting | None | 18 Participants |
| Part B: Vaccine 2 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Moderate | 6 Participants |
| Part B: Vaccine 2 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Mild | 8 Participants |
| Part B: Vaccine 2 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Potentially Life-threatening | 0 Participants |
| Part B: Vaccine 2 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Mild | 8 Participants |
| Part B: Vaccine 2 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Moderate | 6 Participants |
| Part B: Vaccine 2 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Severe | 0 Participants |
| Part B: Vaccine 2 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Moderate | 2 Participants |
| Part B: Vaccine 2 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Potentially Life-threatening | 0 Participants |
| Part B: Vaccine 2 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | None | 6 Participants |
| Part B: Vaccine 2 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Severe | 2 Participants |
| Part B: Vaccine 2 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Severe | 2 Participants |
| Part B: Vaccine 2 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Mild | 3 Participants |
| Part B: Vaccine 2 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | None | 15 Participants |
| Part B: Vaccine 2 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Mild | 8 Participants |
| Part B: Vaccine 2 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Moderate | 2 Participants |
| Part B: Vaccine 2 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Mild | 4 Participants |
| Part B: Vaccine 2 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Potentially Life-threatening | 0 Participants |
| Part B: Vaccine 2 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Severe | 2 Participants |
| Part B: Vaccine 2 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Moderate | 1 Participants |
| Part B: Vaccine 2 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Mild | 7 Participants |
| Part B: Vaccine 2 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | None | 11 Participants |
| Part B: Vaccine 2 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Potentially Life-threatening | 0 Participants |
Primary
Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation
From the study product discontinuation form, study product administration reasons are tabulated by treatment arm
Time frame: Measured through study completion, up to 31 months
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A: Placebo | Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation | Unable to Contact/Out of Window | 0 Participants |
| Part A: Placebo | Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation | No Discontinuation | 2 Participants |
| Part A: Placebo | Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation | Participant Refused Vaccination | 0 Participants |
| Part A: Placebo | Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation | Adverse Experience | 0 Participants |
| Part A: Placebo | Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation | Reactogenicity Symptom | 0 Participants |
| Part A: Vaccine | Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation | Unable to Contact/Out of Window | 0 Participants |
| Part A: Vaccine | Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation | Reactogenicity Symptom | 0 Participants |
| Part A: Vaccine | Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation | Adverse Experience | 0 Participants |
| Part A: Vaccine | Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation | Participant Refused Vaccination | 0 Participants |
| Part A: Vaccine | Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation | No Discontinuation | 10 Participants |
| Part B: Placebo | Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation | Reactogenicity Symptom | 0 Participants |
| Part B: Placebo | Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation | No Discontinuation | 6 Participants |
| Part B: Placebo | Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation | Adverse Experience | 0 Participants |
| Part B: Placebo | Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation | Unable to Contact/Out of Window | 0 Participants |
| Part B: Placebo | Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation | Participant Refused Vaccination | 0 Participants |
| Part B: Vaccine 1 | Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation | Participant Refused Vaccination | 1 Participants |
| Part B: Vaccine 1 | Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation | No Discontinuation | 19 Participants |
| Part B: Vaccine 1 | Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation | Unable to Contact/Out of Window | 0 Participants |
| Part B: Vaccine 1 | Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation | Reactogenicity Symptom | 1 Participants |
| Part B: Vaccine 1 | Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation | Adverse Experience | 0 Participants |
| Part B: Vaccine 2 | Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation | Reactogenicity Symptom | 0 Participants |
| Part B: Vaccine 2 | Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation | Unable to Contact/Out of Window | 5 Participants |
| Part B: Vaccine 2 | Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation | No Discontinuation | 14 Participants |
| Part B: Vaccine 2 | Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation | Participant Refused Vaccination | 1 Participants |
| Part B: Vaccine 2 | Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation | Adverse Experience | 1 Participants |
Primary
Numbers of Participants With Grade 1 or Higher Local Laboratory Results
The number (percentage) of participants with local laboratory values recorded as meeting Grade 1 AE criteria or above as specified in the DAIDS AE Grading Table were tabulated by treatment arm for each post-vaccination time point. 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, Day 14, Day 70, Day140 for part A and visits Screening, Day 14, Day 42, Day 98, Day 182, Day 238 and Day 334 for part B
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: Placebo | Numbers of Participants With Grade 1 or Higher Local Laboratory Results | AST (U/L)- Day140 | 0 Participants |
| Part A: Placebo | Numbers of Participants With Grade 1 or Higher Local Laboratory Results | Creatinine (g/dL)- Day14 | 0 Participants |
| Part A: Vaccine | Numbers of Participants With Grade 1 or Higher Local Laboratory Results | Creatinine (g/dL)- Day14 | 2 Participants |
| Part A: Vaccine | Numbers of Participants With Grade 1 or Higher Local Laboratory Results | AST (U/L)- Day140 | 1 Participants |
| Part B: Placebo | Numbers of Participants With Grade 1 or Higher Local Laboratory Results | Creatinine (g/dL)- Day334 | 1 Participants |
| Part B: Placebo | Numbers of Participants With Grade 1 or Higher Local Laboratory Results | Creatinine (g/dL)- Day98 | 0 Participants |
| Part B: Placebo | Numbers of Participants With Grade 1 or Higher Local Laboratory Results | Hemoglobin (g/dL)- Day182 | 0 Participants |
| Part B: Placebo | Numbers of Participants With Grade 1 or Higher Local Laboratory Results | Creatinine (g/dL)- Day182 | 0 Participants |
| Part B: Placebo | Numbers of Participants With Grade 1 or Higher Local Laboratory Results | Hemoglobin (g/dL)- Day334 | 0 Participants |
| Part B: Placebo | Numbers of Participants With Grade 1 or Higher Local Laboratory Results | ALT (SGPT) (U/L)- Day42 | 0 Participants |
| Part B: Placebo | Numbers of Participants With Grade 1 or Higher Local Laboratory Results | AST (U/L)- Day98 | 0 Participants |
| Part B: Placebo | Numbers of Participants With Grade 1 or Higher Local Laboratory Results | Creatinine (g/dL)- Day14 | 0 Participants |
| Part B: Placebo | Numbers of Participants With Grade 1 or Higher Local Laboratory Results | AST (U/L)- Day42 | 0 Participants |
| Part B: Placebo | Numbers of Participants With Grade 1 or Higher Local Laboratory Results | Creatinine (g/dL)- Day42 | 0 Participants |
| Part B: Placebo | Numbers of Participants With Grade 1 or Higher Local Laboratory Results | Hemoglobin (g/dL)- Day238 | 0 Participants |
| Part B: Vaccine 1 | Numbers of Participants With Grade 1 or Higher Local Laboratory Results | Creatinine (g/dL)- Day334 | 0 Participants |
| Part B: Vaccine 1 | Numbers of Participants With Grade 1 or Higher Local Laboratory Results | ALT (SGPT) (U/L)- Day42 | 1 Participants |
| Part B: Vaccine 1 | Numbers of Participants With Grade 1 or Higher Local Laboratory Results | Hemoglobin (g/dL)- Day182 | 2 Participants |
| Part B: Vaccine 1 | Numbers of Participants With Grade 1 or Higher Local Laboratory Results | Hemoglobin (g/dL)- Day238 | 1 Participants |
| Part B: Vaccine 1 | Numbers of Participants With Grade 1 or Higher Local Laboratory Results | Hemoglobin (g/dL)- Day334 | 1 Participants |
| Part B: Vaccine 1 | Numbers of Participants With Grade 1 or Higher Local Laboratory Results | Creatinine (g/dL)- Day14 | 0 Participants |
| Part B: Vaccine 1 | Numbers of Participants With Grade 1 or Higher Local Laboratory Results | Creatinine (g/dL)- Day42 | 0 Participants |
| Part B: Vaccine 1 | Numbers of Participants With Grade 1 or Higher Local Laboratory Results | Creatinine (g/dL)- Day98 | 2 Participants |
| Part B: Vaccine 1 | Numbers of Participants With Grade 1 or Higher Local Laboratory Results | Creatinine (g/dL)- Day182 | 2 Participants |
| Part B: Vaccine 1 | Numbers of Participants With Grade 1 or Higher Local Laboratory Results | AST (U/L)- Day42 | 1 Participants |
| Part B: Vaccine 1 | Numbers of Participants With Grade 1 or Higher Local Laboratory Results | AST (U/L)- Day98 | 0 Participants |
| Part B: Vaccine 2 | Numbers of Participants With Grade 1 or Higher Local Laboratory Results | Creatinine (g/dL)- Day42 | 1 Participants |
| Part B: Vaccine 2 | Numbers of Participants With Grade 1 or Higher Local Laboratory Results | Creatinine (g/dL)- Day334 | 1 Participants |
| Part B: Vaccine 2 | Numbers of Participants With Grade 1 or Higher Local Laboratory Results | Creatinine (g/dL)- Day14 | 0 Participants |
| Part B: Vaccine 2 | Numbers of Participants With Grade 1 or Higher Local Laboratory Results | Hemoglobin (g/dL)- Day182 | 0 Participants |
| Part B: Vaccine 2 | Numbers of Participants With Grade 1 or Higher Local Laboratory Results | AST (U/L)- Day42 | 0 Participants |
| Part B: Vaccine 2 | Numbers of Participants With Grade 1 or Higher Local Laboratory Results | Hemoglobin (g/dL)- Day334 | 0 Participants |
| Part B: Vaccine 2 | Numbers of Participants With Grade 1 or Higher Local Laboratory Results | ALT (SGPT) (U/L)- Day42 | 0 Participants |
| Part B: Vaccine 2 | Numbers of Participants With Grade 1 or Higher Local Laboratory Results | AST (U/L)- Day98 | 1 Participants |
| Part B: Vaccine 2 | Numbers of Participants With Grade 1 or Higher Local Laboratory Results | Creatinine (g/dL)- Day98 | 0 Participants |
| Part B: Vaccine 2 | Numbers of Participants With Grade 1 or Higher Local Laboratory Results | Hemoglobin (g/dL)- Day238 | 0 Participants |
| Part B: Vaccine 2 | Numbers of Participants With Grade 1 or Higher Local Laboratory Results | Creatinine (g/dL)- Day182 | 2 Participants |
Primary
WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm
Laboratory results are summarized by analyte and timepoint.
Time frame: Measured through Screening, Day 14, Day 70, Day140 for part A and visits Screening, Day 14, Day 42, Day 98, Day 182, Day 238 and Day 334 for part B
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: Placebo | WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm | Platelets (1000/cubic mm)- Day70 | 277.5 thousand cells/cubic mm |
| Part A: Placebo | WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm | Neutrophils (1000/cubic mm)- Screening | 2.22 thousand cells/cubic mm |
| Part A: Placebo | WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm | Lymphocytes (1000/cubic mm)- Screening | 2.189 thousand cells/cubic mm |
| Part A: Placebo | WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm | Neutrophils (1000/cubic mm)- Day14 | 1.7345 thousand cells/cubic mm |
| Part A: Placebo | WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm | Neutrophils (1000/cubic mm)- Day70 | 3.072 thousand cells/cubic mm |
| Part A: Placebo | WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm | Lymphocytes (1000/cubic mm)- Day14 | 2.037 thousand cells/cubic mm |
| Part A: Placebo | WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm | Platelets (1000/cubic mm)- Screening | 288 thousand cells/cubic mm |
| Part A: Placebo | WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm | Neutrophils (1000/cubic mm)- Day140 | 2.01 thousand cells/cubic mm |
| Part A: Placebo | WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm | WBC (1000/cubic mm)- Screening | 5.1 thousand cells/cubic mm |
| Part A: Placebo | WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm | Platelets (1000/cubic mm)- Day140 | 264.5 thousand cells/cubic mm |
| Part A: Placebo | WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm | Platelets (1000/cubic mm)- Day14 | 297 thousand cells/cubic mm |
| Part A: Placebo | WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm | Lymphocytes (1000/cubic mm)- Day140 | 1.574 thousand cells/cubic mm |
| Part A: Placebo | WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm | WBC (1000/cubic mm)- Day14 | 4.35 thousand cells/cubic mm |
| Part A: Placebo | WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm | Lymphocytes (1000/cubic mm)- Day70 | 2.0955 thousand cells/cubic mm |
| Part A: Placebo | WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm | WBC (1000/cubic mm)- Day70 | 5.8 thousand cells/cubic mm |
| Part A: Placebo | WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm | WBC (1000/cubic mm)- Day140 | 4.15 thousand cells/cubic mm |
| Part A: Vaccine | WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm | Platelets (1000/cubic mm)- Screening | 296 thousand cells/cubic mm |
| Part A: Vaccine | WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm | Lymphocytes (1000/cubic mm)- Screening | 1.942 thousand cells/cubic mm |
| Part A: Vaccine | WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm | WBC (1000/cubic mm)- Day140 | 6.26 thousand cells/cubic mm |
| Part A: Vaccine | WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm | Neutrophils (1000/cubic mm)- Screening | 3.848 thousand cells/cubic mm |
| Part A: Vaccine | WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm | WBC (1000/cubic mm)- Day70 | 6.12 thousand cells/cubic mm |
| Part A: Vaccine | WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm | Platelets (1000/cubic mm)- Day70 | 286 thousand cells/cubic mm |
| Part A: Vaccine | WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm | Neutrophils (1000/cubic mm)- Day14 | 3.322 thousand cells/cubic mm |
| Part A: Vaccine | WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm | WBC (1000/cubic mm)- Day14 | 5.62 thousand cells/cubic mm |
| Part A: Vaccine | WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm | Platelets (1000/cubic mm)- Day140 | 287 thousand cells/cubic mm |
| Part A: Vaccine | WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm | Neutrophils (1000/cubic mm)- Day70 | 3.9035 thousand cells/cubic mm |
| Part A: Vaccine | WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm | Platelets (1000/cubic mm)- Day14 | 297.5 thousand cells/cubic mm |
| Part A: Vaccine | WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm | Lymphocytes (1000/cubic mm)- Day14 | 1.7895 thousand cells/cubic mm |
| Part A: Vaccine | WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm | Neutrophils (1000/cubic mm)- Day140 | 3.7175 thousand cells/cubic mm |
| Part A: Vaccine | WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm | Lymphocytes (1000/cubic mm)- Day140 | 1.9625 thousand cells/cubic mm |
| Part A: Vaccine | WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm | WBC (1000/cubic mm)- Screening | 6.305 thousand cells/cubic mm |
| Part A: Vaccine | WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm | Lymphocytes (1000/cubic mm)- Day70 | 2.1495 thousand cells/cubic mm |
| Part B: Placebo | WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm | WBC (1000/cubic mm)- Day98 | 5.8 thousand cells/cubic mm |
| Part B: Placebo | WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm | Neutrophils (1000/cubic mm)- Day334 | 3.3185 thousand cells/cubic mm |
| Part B: Placebo | WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm | WBC (1000/cubic mm)- Day238 | 6 thousand cells/cubic mm |
| Part B: Placebo | WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm | Neutrophils (1000/cubic mm)- Day182 | 3.821 thousand cells/cubic mm |
| Part B: Placebo | WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm | Lymphocytes (1000/cubic mm)- Day14 | 1.8115 thousand cells/cubic mm |
| Part B: Placebo | WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm | WBC (1000/cubic mm)- Day334 | 5.4 thousand cells/cubic mm |
| Part B: Placebo | WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm | Platelets (1000/cubic mm)- Day42 | 238 thousand cells/cubic mm |
| Part B: Placebo | WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm | Platelets (1000/cubic mm)- Day182 | 215.5 thousand cells/cubic mm |
| Part B: Placebo | WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm | Platelets (1000/cubic mm)- Day238 | 234.5 thousand cells/cubic mm |
| Part B: Placebo | WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm | Lymphocytes (1000/cubic mm)- Screening | 1.7635 thousand cells/cubic mm |
| Part B: Placebo | WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm | Platelets (1000/cubic mm)- Day334 | 253.5 thousand cells/cubic mm |
| Part B: Placebo | WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm | Platelets (1000/cubic mm)- Day98 | 223 thousand cells/cubic mm |
| Part B: Placebo | WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm | Neutrophils (1000/cubic mm)- Day42 | 3.7595 thousand cells/cubic mm |
| Part B: Placebo | WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm | Neutrophils (1000/cubic mm)- Day14 | 3.2585 thousand cells/cubic mm |
| Part B: Placebo | WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm | Lymphocytes (1000/cubic mm)- Day42 | 1.583 thousand cells/cubic mm |
| Part B: Placebo | WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm | Lymphocytes (1000/cubic mm)- Day182 | 1.659 thousand cells/cubic mm |
| Part B: Placebo | WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm | Lymphocytes (1000/cubic mm)- Day238 | 1.679 thousand cells/cubic mm |
| Part B: Placebo | WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm | Platelets (1000/cubic mm)- Screening | 229 thousand cells/cubic mm |
| Part B: Placebo | WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm | Neutrophils (1000/cubic mm)- Screening | 3.568 thousand cells/cubic mm |
| Part B: Placebo | WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm | WBC (1000/cubic mm)- Day182 | 6 thousand cells/cubic mm |
| Part B: Placebo | WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm | Neutrophils (1000/cubic mm)- Day98 | 3.492 thousand cells/cubic mm |
| Part B: Placebo | WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm | Neutrophils (1000/cubic mm)- Day238 | 3.349 thousand cells/cubic mm |
| Part B: Placebo | WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm | Lymphocytes (1000/cubic mm)- Day334 | 1.5425 thousand cells/cubic mm |
| Part B: Placebo | WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm | WBC (1000/cubic mm)- Screening | 5.9 thousand cells/cubic mm |
| Part B: Placebo | WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm | WBC (1000/cubic mm)- Day14 | 5.65 thousand cells/cubic mm |
| Part B: Placebo | WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm | Lymphocytes (1000/cubic mm)- Day98 | 1.589 thousand cells/cubic mm |
| Part B: Placebo | WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm | WBC (1000/cubic mm)- Day42 | 6.45 thousand cells/cubic mm |
| Part B: Placebo | WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm | Platelets (1000/cubic mm)- Day14 | 236 thousand cells/cubic mm |
| Part B: Vaccine 1 | WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm | Lymphocytes (1000/cubic mm)- Day42 | 1.85 thousand cells/cubic mm |
| Part B: Vaccine 1 | WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm | WBC (1000/cubic mm)- Day98 | 6.11 thousand cells/cubic mm |
| Part B: Vaccine 1 | WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm | Platelets (1000/cubic mm)- Screening | 250 thousand cells/cubic mm |
| Part B: Vaccine 1 | WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm | Platelets (1000/cubic mm)- Day14 | 244 thousand cells/cubic mm |
| Part B: Vaccine 1 | WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm | Platelets (1000/cubic mm)- Day42 | 243 thousand cells/cubic mm |
| Part B: Vaccine 1 | WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm | Platelets (1000/cubic mm)- Day98 | 244 thousand cells/cubic mm |
| Part B: Vaccine 1 | WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm | Lymphocytes (1000/cubic mm)- Day182 | 2.076 thousand cells/cubic mm |
| Part B: Vaccine 1 | WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm | Lymphocytes (1000/cubic mm)- Day238 | 1.928 thousand cells/cubic mm |
| Part B: Vaccine 1 | WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm | Neutrophils (1000/cubic mm)- Screening | 3.648 thousand cells/cubic mm |
| Part B: Vaccine 1 | WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm | Neutrophils (1000/cubic mm)- Day98 | 3.67 thousand cells/cubic mm |
| Part B: Vaccine 1 | WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm | WBC (1000/cubic mm)- Screening | 5.7 thousand cells/cubic mm |
| Part B: Vaccine 1 | WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm | WBC (1000/cubic mm)- Day14 | 6 thousand cells/cubic mm |
| Part B: Vaccine 1 | WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm | WBC (1000/cubic mm)- Day42 | 6.2 thousand cells/cubic mm |
| Part B: Vaccine 1 | WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm | WBC (1000/cubic mm)- Day182 | 5.6 thousand cells/cubic mm |
| Part B: Vaccine 1 | WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm | WBC (1000/cubic mm)- Day238 | 6 thousand cells/cubic mm |
| Part B: Vaccine 1 | WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm | WBC (1000/cubic mm)- Day334 | 5.6 thousand cells/cubic mm |
| Part B: Vaccine 1 | WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm | Platelets (1000/cubic mm)- Day182 | 278 thousand cells/cubic mm |
| Part B: Vaccine 1 | WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm | Platelets (1000/cubic mm)- Day238 | 266.1 thousand cells/cubic mm |
| Part B: Vaccine 1 | WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm | Platelets (1000/cubic mm)- Day334 | 280 thousand cells/cubic mm |
| Part B: Vaccine 1 | WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm | Lymphocytes (1000/cubic mm)- Screening | 1.918 thousand cells/cubic mm |
| Part B: Vaccine 1 | WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm | Lymphocytes (1000/cubic mm)- Day14 | 1.848 thousand cells/cubic mm |
| Part B: Vaccine 1 | WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm | Lymphocytes (1000/cubic mm)- Day98 | 1.8 thousand cells/cubic mm |
| Part B: Vaccine 1 | WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm | Lymphocytes (1000/cubic mm)- Day334 | 1.96 thousand cells/cubic mm |
| Part B: Vaccine 1 | WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm | Neutrophils (1000/cubic mm)- Day14 | 3.397 thousand cells/cubic mm |
| Part B: Vaccine 1 | WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm | Neutrophils (1000/cubic mm)- Day42 | 3.66 thousand cells/cubic mm |
| Part B: Vaccine 1 | WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm | Neutrophils (1000/cubic mm)- Day182 | 3.264 thousand cells/cubic mm |
| Part B: Vaccine 1 | WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm | Neutrophils (1000/cubic mm)- Day238 | 3.413 thousand cells/cubic mm |
| Part B: Vaccine 1 | WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm | Neutrophils (1000/cubic mm)- Day334 | 3.135 thousand cells/cubic mm |
| Part B: Vaccine 2 | WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm | WBC (1000/cubic mm)- Day182 | 6.25 thousand cells/cubic mm |
| Part B: Vaccine 2 | WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm | WBC (1000/cubic mm)- Day42 | 6.3 thousand cells/cubic mm |
| Part B: Vaccine 2 | WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm | WBC (1000/cubic mm)- Day14 | 6.4 thousand cells/cubic mm |
| Part B: Vaccine 2 | WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm | Neutrophils (1000/cubic mm)- Day182 | 3.684 thousand cells/cubic mm |
| Part B: Vaccine 2 | WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm | Lymphocytes (1000/cubic mm)- Day98 | 1.98 thousand cells/cubic mm |
| Part B: Vaccine 2 | WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm | WBC (1000/cubic mm)- Screening | 6.4 thousand cells/cubic mm |
| Part B: Vaccine 2 | WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm | Lymphocytes (1000/cubic mm)- Day238 | 1.6865 thousand cells/cubic mm |
| Part B: Vaccine 2 | WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm | Neutrophils (1000/cubic mm)- Day98 | 3.101 thousand cells/cubic mm |
| Part B: Vaccine 2 | WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm | Platelets (1000/cubic mm)- Screening | 246 thousand cells/cubic mm |
| Part B: Vaccine 2 | WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm | Lymphocytes (1000/cubic mm)- Day334 | 1.745 thousand cells/cubic mm |
| Part B: Vaccine 2 | WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm | Neutrophils (1000/cubic mm)- Screening | 3.41 thousand cells/cubic mm |
| Part B: Vaccine 2 | WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm | Lymphocytes (1000/cubic mm)- Day14 | 1.935 thousand cells/cubic mm |
| Part B: Vaccine 2 | WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm | Neutrophils (1000/cubic mm)- Day334 | 3.395 thousand cells/cubic mm |
| Part B: Vaccine 2 | WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm | Neutrophils (1000/cubic mm)- Day14 | 3.4945 thousand cells/cubic mm |
| Part B: Vaccine 2 | WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm | Lymphocytes (1000/cubic mm)- Day182 | 1.945 thousand cells/cubic mm |
| Part B: Vaccine 2 | WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm | Neutrophils (1000/cubic mm)- Day238 | 3.9935 thousand cells/cubic mm |
| Part B: Vaccine 2 | WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm | Neutrophils (1000/cubic mm)- Day42 | 3.317 thousand cells/cubic mm |
| Part B: Vaccine 2 | WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm | Platelets (1000/cubic mm)- Day98 | 224 thousand cells/cubic mm |
| Part B: Vaccine 2 | WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm | Platelets (1000/cubic mm)- Day42 | 260.5 thousand cells/cubic mm |
| Part B: Vaccine 2 | WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm | Platelets (1000/cubic mm)- Day334 | 239.05 thousand cells/cubic mm |
| Part B: Vaccine 2 | WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm | Platelets (1000/cubic mm)- Day238 | 239.8 thousand cells/cubic mm |
| Part B: Vaccine 2 | WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm | Platelets (1000/cubic mm)- Day14 | 226.5 thousand cells/cubic mm |
| Part B: Vaccine 2 | WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm | Lymphocytes (1000/cubic mm)- Screening | 2.134 thousand cells/cubic mm |
| Part B: Vaccine 2 | WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm | Platelets (1000/cubic mm)- Day182 | 232 thousand cells/cubic mm |
| Part B: Vaccine 2 | WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm | WBC (1000/cubic mm)- Day334 | 5.88 thousand cells/cubic mm |
| Part B: Vaccine 2 | WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm | WBC (1000/cubic mm)- Day238 | 6.15 thousand cells/cubic mm |
| Part B: Vaccine 2 | WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm | WBC (1000/cubic mm)- Day98 | 5.7 thousand cells/cubic mm |
| Part B: Vaccine 2 | WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm | Lymphocytes (1000/cubic mm)- Day42 | 1.93 thousand cells/cubic mm |
Secondary
Breadth of gp70-V1V2 IgG and gp120 IgA, Assessed by Binding Antibody Multiplex Assay, and ADCC Activities Against HIV-1 Subtypes A, B, C and A/E Two Weeks After the Last Vaccination in Part B
For Binding Antibody Multiplex Assay, gp70-V1V2 IgG, the area-under-the-magnitude-breadth curve (AUC-MB) was calculated as the average of the log10 MFI\* (log10 titer) over the panel of antigens. For ADCC GranToxiLux, AUC-MB was calculated as the average of the AUC over the panel of antigens, where AUC is defined as nonparametric area under the net percent granzyme B activity vs log10 (dilution) curve (AUC), calculated using the trapezoidal rule, and setting any net percent granzyme B activity below 0% to 0%. For ADCC Luciferase, (AUC-MB) was calculated as the average of the pAUC over the panel of antigens, where pAUC is defined as nonparametric partial area under the baseline subtracted curves (pAUC), calculated using the trapezoidal rule on the first four dilutions of the baseline subtracted curves, setting baseline subtracted loss Luciferase activity less than 0% to zero.
Time frame: Measured at Month 8.5 for part B only
Population: In this report, Overall Number of Participants Analyzed represents the HIV-uninfected participants who received the last vaccination with specimens at Month 8.5 for part B. The Number Analyzed in the Outcome Measure Data Table shows the number of participants with available BAMA, or ADCC data after filtering for assay specific quality control criteria. Assay data were not collected for gp120 IgA per lab study plan.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Part A: Placebo | Breadth of gp70-V1V2 IgG and gp120 IgA, Assessed by Binding Antibody Multiplex Assay, and ADCC Activities Against HIV-1 Subtypes A, B, C and A/E Two Weeks After the Last Vaccination in Part B | ADCC GranToxiLux against HIV-1 subtypes A, B, C and A/E | 0.2 log10 titer* proportion of antigens |
| Part A: Placebo | Breadth of gp70-V1V2 IgG and gp120 IgA, Assessed by Binding Antibody Multiplex Assay, and ADCC Activities Against HIV-1 Subtypes A, B, C and A/E Two Weeks After the Last Vaccination in Part B | ADCC Luciferase against HIV-1 subtypes A, B, C and A/E | 2.2 log10 titer* proportion of antigens |
| Part A: Placebo | Breadth of gp70-V1V2 IgG and gp120 IgA, Assessed by Binding Antibody Multiplex Assay, and ADCC Activities Against HIV-1 Subtypes A, B, C and A/E Two Weeks After the Last Vaccination in Part B | gp70 V1V2 IgG | 2 log10 titer* proportion of antigens |
| Part A: Vaccine | Breadth of gp70-V1V2 IgG and gp120 IgA, Assessed by Binding Antibody Multiplex Assay, and ADCC Activities Against HIV-1 Subtypes A, B, C and A/E Two Weeks After the Last Vaccination in Part B | ADCC Luciferase against HIV-1 subtypes A, B, C and A/E | 31.8 log10 titer* proportion of antigens |
| Part A: Vaccine | Breadth of gp70-V1V2 IgG and gp120 IgA, Assessed by Binding Antibody Multiplex Assay, and ADCC Activities Against HIV-1 Subtypes A, B, C and A/E Two Weeks After the Last Vaccination in Part B | gp70 V1V2 IgG | 3.3 log10 titer* proportion of antigens |
| Part A: Vaccine | Breadth of gp70-V1V2 IgG and gp120 IgA, Assessed by Binding Antibody Multiplex Assay, and ADCC Activities Against HIV-1 Subtypes A, B, C and A/E Two Weeks After the Last Vaccination in Part B | ADCC GranToxiLux against HIV-1 subtypes A, B, C and A/E | 19 log10 titer* proportion of antigens |
| Part B: Placebo | Breadth of gp70-V1V2 IgG and gp120 IgA, Assessed by Binding Antibody Multiplex Assay, and ADCC Activities Against HIV-1 Subtypes A, B, C and A/E Two Weeks After the Last Vaccination in Part B | ADCC GranToxiLux against HIV-1 subtypes A, B, C and A/E | 11.4 log10 titer* proportion of antigens |
| Part B: Placebo | Breadth of gp70-V1V2 IgG and gp120 IgA, Assessed by Binding Antibody Multiplex Assay, and ADCC Activities Against HIV-1 Subtypes A, B, C and A/E Two Weeks After the Last Vaccination in Part B | gp70 V1V2 IgG | 3.2 log10 titer* proportion of antigens |
| Part B: Placebo | Breadth of gp70-V1V2 IgG and gp120 IgA, Assessed by Binding Antibody Multiplex Assay, and ADCC Activities Against HIV-1 Subtypes A, B, C and A/E Two Weeks After the Last Vaccination in Part B | ADCC Luciferase against HIV-1 subtypes A, B, C and A/E | 17.8 log10 titer* proportion of antigens |
Secondary
Breadth of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination
Serum IgG responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay. Magnitude-breadth (MB) curves characterized the magnitude (Binding antibody MFI\* at 1:50 dilution and titer) and breadth (number of antigens with positive response at given MFI\* or titer) of each individual plasma sample assayed against a panel of antigens. The x-axis represents the response magnitude and the y-axis represents the fraction of antigens with response magnitude greater than the x-axis value. In addition to the individual sample specific curves, the group-specific curve displayed the average MB across all participants in that group. The area-under-the-magnitude-breadth curve (AUC-MB) was calculated as the average of the log10 MFI\* (log10 titer) over the panel of antigens.
Time frame: Measured at Month 2.5 for part A and 8.5 for part B
Population: In this report, Overall Number of Participants Analyzed represents the HIV-uninfected participants who received the last vaccination with specimens at Month 2.5 for part A and Month 8.5 for part B. The Number Analyzed in the Outcome Measure Data Table shows the number of participants with available BAMA data after filtering for assay specific quality control criteria (excluding the reference antigen record which exceeds 5000 MFI etc.).
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Part A: Placebo | Breadth of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | gp120 Breadth Panel | 2 log10 titer* proportion of antigens |
| Part A: Placebo | Breadth of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | gp70 V1V2 Breadth Panel | 2 log10 titer* proportion of antigens |
| Part A: Vaccine | Breadth of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | gp70 V1V2 Breadth Panel | 2.7 log10 titer* proportion of antigens |
| Part A: Vaccine | Breadth of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | gp120 Breadth Panel | 4 log10 titer* proportion of antigens |
| Part B: Placebo | Breadth of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | gp70 V1V2 Breadth Panel | 2 log10 titer* proportion of antigens |
| Part B: Placebo | Breadth of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | gp120 Breadth Panel | 2 log10 titer* proportion of antigens |
| Part B: Vaccine 1 | Breadth of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | gp120 Breadth Panel | 4.2 log10 titer* proportion of antigens |
| Part B: Vaccine 1 | Breadth of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | gp70 V1V2 Breadth Panel | 3.3 log10 titer* proportion of antigens |
| Part B: Vaccine 2 | Breadth of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | gp70 V1V2 Breadth Panel | 3.2 log10 titer* proportion of antigens |
| Part B: Vaccine 2 | Breadth of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | gp120 Breadth Panel | 4 log10 titer* proportion of antigens |
Secondary
Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine Two Weeks After the Last Vaccination. 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 (IFNg and/or IL-2) after peptide stimulation minus % cells expressing markers after no stimulation. A contingency table is constructed to assess response: stimulation (peptide/none) vs. marker expression (yes/no). A one-sided Fisher's exact test is applied, testing if the number of cells positive for the marker is equal in the stimulated vs. unstimulated cells. A discrete Bonferroni adjustment is made over the peptide pools. Response is positive if adjusted p-value \<=0.00001. Please note the above analyses were applied by the lab to determine the response positivity, not the planned analyses for the study outcome measures. Data are excluded if blood draw date was outside the visit window, participant was HIV-infected, PBMC viability or T-cell count were low, or negative control was high.
Time frame: Measured at Month 8.5 for part B only
Population: In this report, Overall Number of Participants Analyzed represents the HIV-uninfected participants who received the last vaccination with specimens at Month 8.5 for part B. The Number Analyzed in the Outcome Measure Data Table shows the number of participants with available ICS data after filtering for assay specific quality control criteria.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Part A: Placebo | Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine Two Weeks After the Last Vaccination. Measured by Flow Cytometry. | GAG-1-PTEG-SEQ | -0.001 % CD4+ T-cells |
| Part A: Placebo | Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine Two Weeks After the Last Vaccination. Measured by Flow Cytometry. | ANY ENV PTEG | -0.011 % CD4+ T-cells |
| Part A: Placebo | Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine Two Weeks After the Last Vaccination. Measured by Flow Cytometry. | ANY GAG PTEG | -0.001 % CD4+ T-cells |
| Part A: Placebo | Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine Two Weeks After the Last Vaccination. Measured by Flow Cytometry. | GAG-2-PTEG-SEQ | -0.002 % CD4+ T-cells |
| Part A: Placebo | Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine Two Weeks After the Last Vaccination. Measured by Flow Cytometry. | ENV-2-PTEG-SEQ | -0.007 % CD4+ T-cells |
| Part A: Placebo | Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine Two Weeks After the Last Vaccination. Measured by Flow Cytometry. | ENV-1-PTEG-SEQ | -0.005 % CD4+ T-cells |
| Part A: Vaccine | Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine Two Weeks After the Last Vaccination. Measured by Flow Cytometry. | ENV-2-PTEG-SEQ | 0.142 % CD4+ T-cells |
| Part A: Vaccine | Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine Two Weeks After the Last Vaccination. Measured by Flow Cytometry. | GAG-1-PTEG-SEQ | 0.004 % CD4+ T-cells |
| Part A: Vaccine | Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine Two Weeks After the Last Vaccination. Measured by Flow Cytometry. | ANY GAG PTEG | 0.017 % CD4+ T-cells |
| Part A: Vaccine | Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine Two Weeks After the Last Vaccination. Measured by Flow Cytometry. | ENV-1-PTEG-SEQ | 0.166 % CD4+ T-cells |
| Part A: Vaccine | Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine Two Weeks After the Last Vaccination. Measured by Flow Cytometry. | ANY ENV PTEG | 0.313 % CD4+ T-cells |
| Part A: Vaccine | Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine Two Weeks After the Last Vaccination. Measured by Flow Cytometry. | GAG-2-PTEG-SEQ | 0.009 % CD4+ T-cells |
| Part B: Placebo | Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine Two Weeks After the Last Vaccination. Measured by Flow Cytometry. | GAG-2-PTEG-SEQ | 0.003 % CD4+ T-cells |
| Part B: Placebo | Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine Two Weeks After the Last Vaccination. Measured by Flow Cytometry. | ANY ENV PTEG | 0.102 % CD4+ T-cells |
| Part B: Placebo | Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine Two Weeks After the Last Vaccination. Measured by Flow Cytometry. | ANY GAG PTEG | 0.001 % CD4+ T-cells |
| Part B: Placebo | Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine Two Weeks After the Last Vaccination. Measured by Flow Cytometry. | ENV-1-PTEG-SEQ | 0.052 % CD4+ T-cells |
| Part B: Placebo | Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine Two Weeks After the Last Vaccination. Measured by Flow Cytometry. | ENV-2-PTEG-SEQ | 0.037 % CD4+ T-cells |
| Part B: Placebo | Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine Two Weeks After the Last Vaccination. Measured by Flow Cytometry. | GAG-1-PTEG-SEQ | -0.002 % CD4+ T-cells |
Secondary
Level of CD8+ T Cell Responses to the HIV Proteins Included in the Vaccine Two Weeks After the Last Vaccination. 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 (IFNg and/or IL-2) after peptide stimulation minus % cells expressing markers after no stimulation. A contingency table is constructed to assess response: stimulation (peptide/none) vs. marker expression (yes/no). A one-sided Fisher's exact test is applied, testing if the number of cells positive for the marker is equal in the stimulated vs. unstimulated cells. A discrete Bonferroni adjustment is made over the peptide pools. Response is positive if adjusted p-value \<=0.00001. Please note the above analyses were applied by the lab to determine the response positivity, not the planned analyses for the study outcome measures. Data are excluded if blood draw date was outside the visit window, participant was HIV-infected, PBMC viability or T-cell count were low, or negative control was high.
Time frame: Measured at Month 8.5 for part B only
Population: In this report, Overall Number of Participants Analyzed represents the HIV-uninfected participants who received the last vaccination with specimens at Month 8.5 for part B. The Number Analyzed in the Outcome Measure Data Table shows the number of participants with available ICS data after filtering for assay specific quality control criteria.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Part A: Placebo | Level of CD8+ T Cell Responses to the HIV Proteins Included in the Vaccine Two Weeks After the Last Vaccination. Measured by Flow Cytometry. | GAG-2-PTEG-SEQ | 0 % CD8+ T-cells |
| Part A: Placebo | Level of CD8+ T Cell Responses to the HIV Proteins Included in the Vaccine Two Weeks After the Last Vaccination. Measured by Flow Cytometry. | ANY GAG PTEG | 0.002 % CD8+ T-cells |
| Part A: Placebo | Level of CD8+ T Cell Responses to the HIV Proteins Included in the Vaccine Two Weeks After the Last Vaccination. Measured by Flow Cytometry. | GAG-1-PTEG-SEQ | 0.002 % CD8+ T-cells |
| Part A: Placebo | Level of CD8+ T Cell Responses to the HIV Proteins Included in the Vaccine Two Weeks After the Last Vaccination. Measured by Flow Cytometry. | ANY ENV PTEG | -0.003 % CD8+ T-cells |
| Part A: Placebo | Level of CD8+ T Cell Responses to the HIV Proteins Included in the Vaccine Two Weeks After the Last Vaccination. Measured by Flow Cytometry. | ENV-2-PTEG-SEQ | -0.002 % CD8+ T-cells |
| Part A: Placebo | Level of CD8+ T Cell Responses to the HIV Proteins Included in the Vaccine Two Weeks After the Last Vaccination. Measured by Flow Cytometry. | ENV-1-PTEG-SEQ | 0.001 % CD8+ T-cells |
| Part A: Vaccine | Level of CD8+ T Cell Responses to the HIV Proteins Included in the Vaccine Two Weeks After the Last Vaccination. Measured by Flow Cytometry. | ENV-2-PTEG-SEQ | 0 % CD8+ T-cells |
| Part A: Vaccine | Level of CD8+ T Cell Responses to the HIV Proteins Included in the Vaccine Two Weeks After the Last Vaccination. Measured by Flow Cytometry. | GAG-1-PTEG-SEQ | 0 % CD8+ T-cells |
| Part A: Vaccine | Level of CD8+ T Cell Responses to the HIV Proteins Included in the Vaccine Two Weeks After the Last Vaccination. Measured by Flow Cytometry. | GAG-2-PTEG-SEQ | -0.004 % CD8+ T-cells |
| Part A: Vaccine | Level of CD8+ T Cell Responses to the HIV Proteins Included in the Vaccine Two Weeks After the Last Vaccination. Measured by Flow Cytometry. | ANY ENV PTEG | 0.007 % CD8+ T-cells |
| Part A: Vaccine | Level of CD8+ T Cell Responses to the HIV Proteins Included in the Vaccine Two Weeks After the Last Vaccination. Measured by Flow Cytometry. | ENV-1-PTEG-SEQ | 0.006 % CD8+ T-cells |
| Part A: Vaccine | Level of CD8+ T Cell Responses to the HIV Proteins Included in the Vaccine Two Weeks After the Last Vaccination. Measured by Flow Cytometry. | ANY GAG PTEG | -0.006 % CD8+ T-cells |
| Part B: Placebo | Level of CD8+ T Cell Responses to the HIV Proteins Included in the Vaccine Two Weeks After the Last Vaccination. Measured by Flow Cytometry. | GAG-2-PTEG-SEQ | 0 % CD8+ T-cells |
| Part B: Placebo | Level of CD8+ T Cell Responses to the HIV Proteins Included in the Vaccine Two Weeks After the Last Vaccination. Measured by Flow Cytometry. | ANY GAG PTEG | -0.004 % CD8+ T-cells |
| Part B: Placebo | Level of CD8+ T Cell Responses to the HIV Proteins Included in the Vaccine Two Weeks After the Last Vaccination. Measured by Flow Cytometry. | ENV-1-PTEG-SEQ | -0.002 % CD8+ T-cells |
| Part B: Placebo | Level of CD8+ T Cell Responses to the HIV Proteins Included in the Vaccine Two Weeks After the Last Vaccination. Measured by Flow Cytometry. | ENV-2-PTEG-SEQ | -0.004 % CD8+ T-cells |
| Part B: Placebo | Level of CD8+ T Cell Responses to the HIV Proteins Included in the Vaccine Two Weeks After the Last Vaccination. Measured by Flow Cytometry. | GAG-1-PTEG-SEQ | -0.005 % CD8+ T-cells |
| Part B: Placebo | Level of CD8+ T Cell Responses to the HIV Proteins Included in the Vaccine Two Weeks After the Last Vaccination. Measured by Flow Cytometry. | ANY ENV PTEG | -0.007 % CD8+ T-cells |
Secondary
Levels of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination
Serum 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, and net MFI \> 22,000 is set to 22,000. Data are excluded if blood draw date was outside the allowable window, a participant was HIV-infected, reference antigen \> 5,000 MFI, or baseline net MFI \> 6,500. Summary was calculated among positive responders only (positivity criteria are described in Outcome 12).
Time frame: Measured at Month 2.5 for part A and 8.5 for part B
Population: In this report, Overall Number of Participants Analyzed represents the HIV-uninfected participants who received the last vaccination with specimens at Month 2.5 for part A and Month 8.5 for part B. The Number Analyzed in the Outcome Measure Data Table shows the number of participants with available BAMA data after filtering for assay specific quality control criteria (excluding the reference antigen record which exceeds 5000 MFI etc.).
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Part A: Placebo | Levels of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | gp70-001428.2.42 V1V2 | 4214.6 relative fluorescence units |
| Part A: Placebo | Levels of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | gp70-Ce1086_B2 V1V2 | 22000 relative fluorescence units |
| Part A: Placebo | Levels of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | gp70_B.CaseA_V1_V2 | 1177 relative fluorescence units |
| Part A: Placebo | Levels of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | gp70-191084_B7 V1V2 | 14985 relative fluorescence units |
| Part A: Placebo | Levels of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | BJOX002_D11gp120.avi/293F | 11645.2 relative fluorescence units |
| Part A: Placebo | Levels of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | gp70-TT31P.2F10.2792 V1V2 | 2308.4 relative fluorescence units |
| Part A: Placebo | Levels of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | gp70-62357.14 V1V2 | 764.8 relative fluorescence units |
| Part A: Placebo | Levels of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | A244 D11gp120_avi | 22000 relative fluorescence units |
| Part A: Placebo | Levels of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | gp70-BJOX002000.03.2 V1V2 | 6452.2 relative fluorescence units |
| Part A: Placebo | Levels of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | gp70-700010058 V1V2 | 3103 relative fluorescence units |
| Part A: Placebo | Levels of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | gp70-CM244.ec1 V1V2 | 22000 relative fluorescence units |
| Part A: Placebo | Levels of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | gp70-96ZM651.02 V1v2 | 10010.6 relative fluorescence units |
| Part A: Placebo | Levels of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | BORI_D11gp120.avi/293F | 5944.5 relative fluorescence units |
| Part A: Placebo | Levels of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | 51802_D11gp120.avi/293F | 13847.8 relative fluorescence units |
| Part A: Placebo | Levels of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | CNE20_D11gp120.avi/293F | 22000 relative fluorescence units |
| Part A: Placebo | Levels of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | gp70-CAP210.2.00.E8 V1V2 | 1596.2 relative fluorescence units |
| Part A: Placebo | Levels of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | gp70-RHPA4259.7 V1V2 | 782.5 relative fluorescence units |
| Part A: Placebo | Levels of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | gp70-C2101.c01_V1V2 | 14362 relative fluorescence units |
| Part A: Placebo | Levels of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | gp120-A | 13589.6 relative fluorescence units |
| Part A: Placebo | Levels of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | gp70-BF1266_431a_V1V2 | 808 relative fluorescence units |
| Part A: Placebo | Levels of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | gp120-AE | 11629.5 relative fluorescence units |
| Part A: Placebo | Levels of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | B.6240_D11gp120/293F | 12265 relative fluorescence units |
| Part A: Placebo | Levels of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | gp70-7060101641 V1V2 | 402.6 relative fluorescence units |
| Part A: Placebo | Levels of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | gp120-B | 3895.2 relative fluorescence units |
| Part A: Placebo | Levels of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | gp70-TV1.21 V1V2 | 1249.8 relative fluorescence units |
| Part A: Placebo | Levels of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | TT31P.2792_D11gp120.avi/293F | 22000 relative fluorescence units |
| Part A: Placebo | Levels of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | gp120-C | 12084.8 relative fluorescence units |
| Part A: Placebo | Levels of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | 254008_D11gp120.avi/293F | 22000 relative fluorescence units |
| Part A: Vaccine | Levels of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | gp120-C | 22000 relative fluorescence units |
| Part A: Vaccine | Levels of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | A244 D11gp120_avi | 22000 relative fluorescence units |
| Part A: Vaccine | Levels of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | B.6240_D11gp120/293F | 22000 relative fluorescence units |
| Part A: Vaccine | Levels of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | BJOX002_D11gp120.avi/293F | 22000 relative fluorescence units |
| Part A: Vaccine | Levels of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | BORI_D11gp120.avi/293F | 16031.8 relative fluorescence units |
| Part A: Vaccine | Levels of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | TT31P.2792_D11gp120.avi/293F | 22000 relative fluorescence units |
| Part A: Vaccine | Levels of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | gp120-AE | 18609 relative fluorescence units |
| Part A: Vaccine | Levels of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | gp120-B | 10957.1 relative fluorescence units |
| Part A: Vaccine | Levels of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | gp70-001428.2.42 V1V2 | 3180 relative fluorescence units |
| Part A: Vaccine | Levels of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | gp70-191084_B7 V1V2 | 21866.8 relative fluorescence units |
| Part A: Vaccine | Levels of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | gp70-62357.14 V1V2 | 1399.8 relative fluorescence units |
| Part A: Vaccine | Levels of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | gp70-700010058 V1V2 | 2172.2 relative fluorescence units |
| Part A: Vaccine | Levels of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | gp70-7060101641 V1V2 | 1176.2 relative fluorescence units |
| Part A: Vaccine | Levels of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | gp70-BF1266_431a_V1V2 | 3456 relative fluorescence units |
| Part A: Vaccine | Levels of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | gp70-C2101.c01_V1V2 | 11920.5 relative fluorescence units |
| Part A: Vaccine | Levels of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | gp70-CAP210.2.00.E8 V1V2 | 1571.4 relative fluorescence units |
| Part A: Vaccine | Levels of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | 254008_D11gp120.avi/293F | 22000 relative fluorescence units |
| Part A: Vaccine | Levels of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | 51802_D11gp120.avi/293F | 22000 relative fluorescence units |
| Part A: Vaccine | Levels of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | CNE20_D11gp120.avi/293F | 22000 relative fluorescence units |
| Part A: Vaccine | Levels of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | gp120-A | 22000 relative fluorescence units |
| Part A: Vaccine | Levels of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | gp70-96ZM651.02 V1v2 | 12543.9 relative fluorescence units |
| Part A: Vaccine | Levels of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | gp70-BJOX002000.03.2 V1V2 | 17549.8 relative fluorescence units |
| Part A: Vaccine | Levels of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | gp70-CM244.ec1 V1V2 | 22000 relative fluorescence units |
| Part A: Vaccine | Levels of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | gp70-Ce1086_B2 V1V2 | 22000 relative fluorescence units |
| Part A: Vaccine | Levels of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | gp70-RHPA4259.7 V1V2 | 2845.1 relative fluorescence units |
| Part A: Vaccine | Levels of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | gp70-TT31P.2F10.2792 V1V2 | 1821.8 relative fluorescence units |
| Part A: Vaccine | Levels of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | gp70-TV1.21 V1V2 | 3075.2 relative fluorescence units |
| Part A: Vaccine | Levels of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | gp70_B.CaseA_V1_V2 | 4071 relative fluorescence units |
| Part B: Placebo | Levels of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | gp120-C | 15846.6 relative fluorescence units |
| Part B: Placebo | Levels of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | gp70-TT31P.2F10.2792 V1V2 | 1712.5 relative fluorescence units |
| Part B: Placebo | Levels of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | gp70-CM244.ec1 V1V2 | 22000 relative fluorescence units |
| Part B: Placebo | Levels of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | BORI_D11gp120.avi/293F | 7429.2 relative fluorescence units |
| Part B: Placebo | Levels of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | B.6240_D11gp120/293F | 22000 relative fluorescence units |
| Part B: Placebo | Levels of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | gp120-B | 13483 relative fluorescence units |
| Part B: Placebo | Levels of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | 51802_D11gp120.avi/293F | 12427.5 relative fluorescence units |
| Part B: Placebo | Levels of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | 254008_D11gp120.avi/293F | 22000 relative fluorescence units |
| Part B: Placebo | Levels of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | gp120-AE | 11534.5 relative fluorescence units |
| Part B: Placebo | Levels of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | gp70-Ce1086_B2 V1V2 | 22000 relative fluorescence units |
| Part B: Placebo | Levels of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | gp120-A | 18287.8 relative fluorescence units |
| Part B: Placebo | Levels of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | A244 D11gp120_avi | 22000 relative fluorescence units |
| Part B: Placebo | Levels of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | TT31P.2792_D11gp120.avi/293F | 22000 relative fluorescence units |
| Part B: Placebo | Levels of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | gp70-7060101641 V1V2 | 1217.4 relative fluorescence units |
| Part B: Placebo | Levels of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | gp70-700010058 V1V2 | 11938.2 relative fluorescence units |
| Part B: Placebo | Levels of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | gp70-96ZM651.02 V1v2 | 11192.5 relative fluorescence units |
| Part B: Placebo | Levels of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | CNE20_D11gp120.avi/293F | 22000 relative fluorescence units |
| Part B: Placebo | Levels of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | gp70-BF1266_431a_V1V2 | 2003.5 relative fluorescence units |
| Part B: Placebo | Levels of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | gp70-62357.14 V1V2 | 2140.8 relative fluorescence units |
| Part B: Placebo | Levels of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | gp70-BJOX002000.03.2 V1V2 | 7962.2 relative fluorescence units |
| Part B: Placebo | Levels of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | gp70-CAP210.2.00.E8 V1V2 | 1641 relative fluorescence units |
| Part B: Placebo | Levels of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | gp70-C2101.c01_V1V2 | 7065.8 relative fluorescence units |
| Part B: Placebo | Levels of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | BJOX002_D11gp120.avi/293F | 14547.1 relative fluorescence units |
| Part B: Placebo | Levels of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | gp70-RHPA4259.7 V1V2 | 1575.6 relative fluorescence units |
| Part B: Placebo | Levels of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | gp70-191084_B7 V1V2 | 21177.8 relative fluorescence units |
| Part B: Placebo | Levels of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | gp70-TV1.21 V1V2 | 2528.5 relative fluorescence units |
| Part B: Placebo | Levels of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | gp70-001428.2.42 V1V2 | 7208.8 relative fluorescence units |
| Part B: Placebo | Levels of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | gp70_B.CaseA_V1_V2 | 4955.8 relative fluorescence units |
Secondary
Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine Two Weeks After the Last Vaccination. 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 (IFNg and/or IL-2) after peptide stimulation minus % cells expressing markers after no stimulation. A contingency table is constructed to assess response: stimulation (peptide/none) vs. marker expression (yes/no). A one-sided Fisher's exact test is applied, testing if the number of cells positive for the marker is equal in the stimulated vs. unstimulated cells. A discrete Bonferroni adjustment is made over the peptide pools. Response is positive if adjusted p-value \<=0.00001. Please note the above analyses were applied by the lab to determine the response positivity, not the planned analyses for the study outcome measures. Data are excluded if blood draw date was outside the visit window, participant was HIV-infected, PBMC viability or T-cell count were low, or negative control was high.
Time frame: Measured at Month 8.5 for part B only
Population: In this report, Overall Number of Participants Analyzed represents the HIV-uninfected participants who received the last vaccination with specimens at Month 8.5 for part B. The Number Analyzed in the Outcome Measure Data Table shows the number of participants with available ICS data after filtering for assay specific quality control criteria.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A: Placebo | Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine Two Weeks After the Last Vaccination. Measured by Flow Cytometry. | GAG-1-PTEG-SEQ | 0 Participants |
| Part A: Placebo | Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine Two Weeks After the Last Vaccination. Measured by Flow Cytometry. | ENV-1-PTEG-SEQ | 0 Participants |
| Part A: Placebo | Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine Two Weeks After the Last Vaccination. Measured by Flow Cytometry. | ENV-2-PTEG-SEQ | 0 Participants |
| Part A: Placebo | Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine Two Weeks After the Last Vaccination. Measured by Flow Cytometry. | ANY ENV PTEG | 0 Participants |
| Part A: Placebo | Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine Two Weeks After the Last Vaccination. Measured by Flow Cytometry. | ANY GAG PTEG | 0 Participants |
| Part A: Placebo | Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine Two Weeks After the Last Vaccination. Measured by Flow Cytometry. | GAG-2-PTEG-SEQ | 0 Participants |
| Part A: Vaccine | Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine Two Weeks After the Last Vaccination. Measured by Flow Cytometry. | ANY ENV PTEG | 19 Participants |
| Part A: Vaccine | Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine Two Weeks After the Last Vaccination. Measured by Flow Cytometry. | ENV-1-PTEG-SEQ | 17 Participants |
| Part A: Vaccine | Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine Two Weeks After the Last Vaccination. Measured by Flow Cytometry. | ANY GAG PTEG | 1 Participants |
| Part A: Vaccine | Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine Two Weeks After the Last Vaccination. Measured by Flow Cytometry. | ENV-2-PTEG-SEQ | 16 Participants |
| Part A: Vaccine | Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine Two Weeks After the Last Vaccination. Measured by Flow Cytometry. | GAG-1-PTEG-SEQ | 0 Participants |
| Part A: Vaccine | Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine Two Weeks After the Last Vaccination. Measured by Flow Cytometry. | GAG-2-PTEG-SEQ | 1 Participants |
| Part B: Placebo | Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine Two Weeks After the Last Vaccination. Measured by Flow Cytometry. | ANY GAG PTEG | 0 Participants |
| Part B: Placebo | Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine Two Weeks After the Last Vaccination. Measured by Flow Cytometry. | GAG-2-PTEG-SEQ | 0 Participants |
| Part B: Placebo | Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine Two Weeks After the Last Vaccination. Measured by Flow Cytometry. | GAG-1-PTEG-SEQ | 0 Participants |
| Part B: Placebo | Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine Two Weeks After the Last Vaccination. Measured by Flow Cytometry. | ENV-1-PTEG-SEQ | 7 Participants |
| Part B: Placebo | Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine Two Weeks After the Last Vaccination. Measured by Flow Cytometry. | ANY ENV PTEG | 7 Participants |
| Part B: Placebo | Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine Two Weeks After the Last Vaccination. Measured by Flow Cytometry. | ENV-2-PTEG-SEQ | 4 Participants |
Secondary
Occurrence of CD8+ T Cell Responses to the HIV Proteins Included in the Vaccine Two Weeks After the Last Vaccination. 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 (IFNg and/or IL-2) after peptide stimulation minus % cells expressing markers after no stimulation. A contingency table is constructed to assess response: stimulation (peptide/none) vs. marker expression (yes/no). A one-sided Fisher's exact test is applied, testing if the number of cells positive for the marker is equal in the stimulated vs. unstimulated cells. A discrete Bonferroni adjustment is made over the peptide pools. Response is positive if adjusted p-value \<=0.00001. Please note the above analyses were applied by the lab to determine the response positivity, not the planned analyses for the study outcome measures. Data are excluded if blood draw date was outside the visit window, participant was HIV-infected, PBMC viability or T-cell count were low, or negative control was high.
Time frame: Measured at Month 8.5 for part B only
Population: In this report, Overall Number of Participants Analyzed represents the HIV-uninfected participants who received the last vaccination with specimens at Month 8.5 for part B. The Number Analyzed in the Outcome Measure Data Table shows the number of participants with available ICS data after filtering for assay specific quality control criteria.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A: Placebo | Occurrence of CD8+ T Cell Responses to the HIV Proteins Included in the Vaccine Two Weeks After the Last Vaccination. Measured by Flow Cytometry. | GAG-2-PTEG-SEQ | 0 Participants |
| Part A: Placebo | Occurrence of CD8+ T Cell Responses to the HIV Proteins Included in the Vaccine Two Weeks After the Last Vaccination. Measured by Flow Cytometry. | ENV-1-PTEG-SEQ | 0 Participants |
| Part A: Placebo | Occurrence of CD8+ T Cell Responses to the HIV Proteins Included in the Vaccine Two Weeks After the Last Vaccination. Measured by Flow Cytometry. | GAG-1-PTEG-SEQ | 0 Participants |
| Part A: Placebo | Occurrence of CD8+ T Cell Responses to the HIV Proteins Included in the Vaccine Two Weeks After the Last Vaccination. Measured by Flow Cytometry. | ANY ENV PTEG | 0 Participants |
| Part A: Placebo | Occurrence of CD8+ T Cell Responses to the HIV Proteins Included in the Vaccine Two Weeks After the Last Vaccination. Measured by Flow Cytometry. | ENV-2-PTEG-SEQ | 0 Participants |
| Part A: Placebo | Occurrence of CD8+ T Cell Responses to the HIV Proteins Included in the Vaccine Two Weeks After the Last Vaccination. Measured by Flow Cytometry. | ANY GAG PTEG | 0 Participants |
| Part A: Vaccine | Occurrence of CD8+ T Cell Responses to the HIV Proteins Included in the Vaccine Two Weeks After the Last Vaccination. Measured by Flow Cytometry. | ENV-2-PTEG-SEQ | 0 Participants |
| Part A: Vaccine | Occurrence of CD8+ T Cell Responses to the HIV Proteins Included in the Vaccine Two Weeks After the Last Vaccination. Measured by Flow Cytometry. | GAG-1-PTEG-SEQ | 0 Participants |
| Part A: Vaccine | Occurrence of CD8+ T Cell Responses to the HIV Proteins Included in the Vaccine Two Weeks After the Last Vaccination. Measured by Flow Cytometry. | ANY GAG PTEG | 0 Participants |
| Part A: Vaccine | Occurrence of CD8+ T Cell Responses to the HIV Proteins Included in the Vaccine Two Weeks After the Last Vaccination. Measured by Flow Cytometry. | GAG-2-PTEG-SEQ | 0 Participants |
| Part A: Vaccine | Occurrence of CD8+ T Cell Responses to the HIV Proteins Included in the Vaccine Two Weeks After the Last Vaccination. Measured by Flow Cytometry. | ANY ENV PTEG | 0 Participants |
| Part A: Vaccine | Occurrence of CD8+ T Cell Responses to the HIV Proteins Included in the Vaccine Two Weeks After the Last Vaccination. Measured by Flow Cytometry. | ENV-1-PTEG-SEQ | 0 Participants |
| Part B: Placebo | Occurrence of CD8+ T Cell Responses to the HIV Proteins Included in the Vaccine Two Weeks After the Last Vaccination. Measured by Flow Cytometry. | GAG-2-PTEG-SEQ | 0 Participants |
| Part B: Placebo | Occurrence of CD8+ T Cell Responses to the HIV Proteins Included in the Vaccine Two Weeks After the Last Vaccination. Measured by Flow Cytometry. | ANY ENV PTEG | 0 Participants |
| Part B: Placebo | Occurrence of CD8+ T Cell Responses to the HIV Proteins Included in the Vaccine Two Weeks After the Last Vaccination. Measured by Flow Cytometry. | ANY GAG PTEG | 0 Participants |
| Part B: Placebo | Occurrence of CD8+ T Cell Responses to the HIV Proteins Included in the Vaccine Two Weeks After the Last Vaccination. Measured by Flow Cytometry. | ENV-1-PTEG-SEQ | 0 Participants |
| Part B: Placebo | Occurrence of CD8+ T Cell Responses to the HIV Proteins Included in the Vaccine Two Weeks After the Last Vaccination. Measured by Flow Cytometry. | ENV-2-PTEG-SEQ | 0 Participants |
| Part B: Placebo | Occurrence of CD8+ T Cell Responses to the HIV Proteins Included in the Vaccine Two Weeks After the Last Vaccination. Measured by Flow Cytometry. | GAG-1-PTEG-SEQ | 0 Participants |
Secondary
Occurrence of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination
Serum 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, and net MFI \> 22,000 is set to 22,000. Samples from post-enrollment visits have positive responses if they meet three criteria: (1) net MFI greater than or equal to an antigen-specific response threshold (defined as the maximum of 100 and the 95th percentile of baseline net MFI), (2) net MFI values are greater than 3 times baseline net MFI, and (3) experimental antigen MFI values are greater than 3 times baseline MFI. Data are excluded if blood draw date was outside the allowable window, a participant was HIV-infected, reference antigen \> 5,000 MFI, or baseline net MFI \> 6,500.
Time frame: Measured at Month 2.5 for part A and 8.5 for part B
Population: In this report, Overall Number of Participants Analyzed represents the HIV-uninfected participants who received the last vaccination with specimens at Month 2.5 for part A and Month 8.5 for part B. The Number Analyzed in the Outcome Measure Data Table shows the number of participants with available BAMA data after filtering for assay specific quality control criteria (excluding the reference antigen record which exceeds 5000 MFI etc.).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A: Placebo | Occurrence of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | gp120-A | 0 Participants |
| Part A: Placebo | Occurrence of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | gp70-RHPA4259.7 V1V2 | 0 Participants |
| Part A: Placebo | Occurrence of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | gp70-Ce1086_B2 V1V2 | 0 Participants |
| Part A: Placebo | Occurrence of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | gp70-CM244.ec1 V1V2 | 0 Participants |
| Part A: Placebo | Occurrence of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | gp70-CAP210.2.00.E8 V1V2 | 0 Participants |
| Part A: Placebo | Occurrence of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | gp70-C2101.c01_V1V2 | 0 Participants |
| Part A: Placebo | Occurrence of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | gp70-BJOX002000.03.2 V1V2 | 0 Participants |
| Part A: Placebo | Occurrence of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | gp70-BF1266_431a_V1V2 | 0 Participants |
| Part A: Placebo | Occurrence of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | gp70-7060101641 V1V2 | 0 Participants |
| Part A: Placebo | Occurrence of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | CNE20_D11gp120.avi/293F | 0 Participants |
| Part A: Placebo | Occurrence of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | TT31P.2792_D11gp120.avi/293F | 0 Participants |
| Part A: Placebo | Occurrence of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | gp70-191084_B7 V1V2 | 0 Participants |
| Part A: Placebo | Occurrence of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | gp70-001428.2.42 V1V2 | 0 Participants |
| Part A: Placebo | Occurrence of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | gp70-700010058 V1V2 | 0 Participants |
| Part A: Placebo | Occurrence of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | BORI_D11gp120.avi/293F | 0 Participants |
| Part A: Placebo | Occurrence of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | gp70-96ZM651.02 V1v2 | 0 Participants |
| Part A: Placebo | Occurrence of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | gp120-C | 0 Participants |
| Part A: Placebo | Occurrence of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | BJOX002_D11gp120.avi/293F | 0 Participants |
| Part A: Placebo | Occurrence of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | B.6240_D11gp120/293F | 0 Participants |
| Part A: Placebo | Occurrence of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | gp120-B | 0 Participants |
| Part A: Placebo | Occurrence of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | A244 D11gp120_avi | 0 Participants |
| Part A: Placebo | Occurrence of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | 51802_D11gp120.avi/293F | 0 Participants |
| Part A: Placebo | Occurrence of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | gp120-AE | 0 Participants |
| Part A: Placebo | Occurrence of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | 254008_D11gp120.avi/293F | 0 Participants |
| Part A: Placebo | Occurrence of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | gp70_B.CaseA_V1_V2 | 0 Participants |
| Part A: Placebo | Occurrence of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | gp70-62357.14 V1V2 | 0 Participants |
| Part A: Placebo | Occurrence of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | gp70-TV1.21 V1V2 | 0 Participants |
| Part A: Placebo | Occurrence of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | gp70-TT31P.2F10.2792 V1V2 | 0 Participants |
| Part A: Vaccine | Occurrence of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | gp70-700010058 V1V2 | 1 Participants |
| Part A: Vaccine | Occurrence of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | CNE20_D11gp120.avi/293F | 8 Participants |
| Part A: Vaccine | Occurrence of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | TT31P.2792_D11gp120.avi/293F | 8 Participants |
| Part A: Vaccine | Occurrence of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | gp120-AE | 9 Participants |
| Part A: Vaccine | Occurrence of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | gp70-BJOX002000.03.2 V1V2 | 8 Participants |
| Part A: Vaccine | Occurrence of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | gp70-C2101.c01_V1V2 | 6 Participants |
| Part A: Vaccine | Occurrence of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | gp70-CAP210.2.00.E8 V1V2 | 6 Participants |
| Part A: Vaccine | Occurrence of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | gp70-RHPA4259.7 V1V2 | 5 Participants |
| Part A: Vaccine | Occurrence of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | gp70-TT31P.2F10.2792 V1V2 | 4 Participants |
| Part A: Vaccine | Occurrence of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | gp70-7060101641 V1V2 | 6 Participants |
| Part A: Vaccine | Occurrence of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | gp70-96ZM651.02 V1v2 | 8 Participants |
| Part A: Vaccine | Occurrence of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | gp70-BF1266_431a_V1V2 | 5 Participants |
| Part A: Vaccine | Occurrence of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | gp70-CM244.ec1 V1V2 | 8 Participants |
| Part A: Vaccine | Occurrence of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | gp70-Ce1086_B2 V1V2 | 8 Participants |
| Part A: Vaccine | Occurrence of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | gp70-TV1.21 V1V2 | 7 Participants |
| Part A: Vaccine | Occurrence of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | gp70_B.CaseA_V1_V2 | 6 Participants |
| Part A: Vaccine | Occurrence of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | 254008_D11gp120.avi/293F | 8 Participants |
| Part A: Vaccine | Occurrence of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | 51802_D11gp120.avi/293F | 9 Participants |
| Part A: Vaccine | Occurrence of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | B.6240_D11gp120/293F | 9 Participants |
| Part A: Vaccine | Occurrence of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | BJOX002_D11gp120.avi/293F | 9 Participants |
| Part A: Vaccine | Occurrence of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | BORI_D11gp120.avi/293F | 9 Participants |
| Part A: Vaccine | Occurrence of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | gp120-A | 8 Participants |
| Part A: Vaccine | Occurrence of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | gp120-B | 9 Participants |
| Part A: Vaccine | Occurrence of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | gp120-C | 9 Participants |
| Part A: Vaccine | Occurrence of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | gp70-001428.2.42 V1V2 | 6 Participants |
| Part A: Vaccine | Occurrence of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | gp70-191084_B7 V1V2 | 9 Participants |
| Part A: Vaccine | Occurrence of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | gp70-62357.14 V1V2 | 5 Participants |
| Part A: Vaccine | Occurrence of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | A244 D11gp120_avi | 8 Participants |
| Part B: Placebo | Occurrence of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | 51802_D11gp120.avi/293F | 0 Participants |
| Part B: Placebo | Occurrence of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | gp70-TT31P.2F10.2792 V1V2 | 0 Participants |
| Part B: Placebo | Occurrence of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | gp120-B | 0 Participants |
| Part B: Placebo | Occurrence of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | gp70-C2101.c01_V1V2 | 0 Participants |
| Part B: Placebo | Occurrence of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | A244 D11gp120_avi | 0 Participants |
| Part B: Placebo | Occurrence of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | gp120-AE | 0 Participants |
| Part B: Placebo | Occurrence of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | gp70_B.CaseA_V1_V2 | 0 Participants |
| Part B: Placebo | Occurrence of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | gp70-CAP210.2.00.E8 V1V2 | 0 Participants |
| Part B: Placebo | Occurrence of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | gp120-A | 0 Participants |
| Part B: Placebo | Occurrence of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | gp70-700010058 V1V2 | 0 Participants |
| Part B: Placebo | Occurrence of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | gp70-191084_B7 V1V2 | 0 Participants |
| Part B: Placebo | Occurrence of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | TT31P.2792_D11gp120.avi/293F | 0 Participants |
| Part B: Placebo | Occurrence of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | CNE20_D11gp120.avi/293F | 0 Participants |
| Part B: Placebo | Occurrence of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | gp70-RHPA4259.7 V1V2 | 0 Participants |
| Part B: Placebo | Occurrence of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | BORI_D11gp120.avi/293F | 0 Participants |
| Part B: Placebo | Occurrence of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | gp70-001428.2.42 V1V2 | 0 Participants |
| Part B: Placebo | Occurrence of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | gp70-TV1.21 V1V2 | 0 Participants |
| Part B: Placebo | Occurrence of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | gp70-BJOX002000.03.2 V1V2 | 0 Participants |
| Part B: Placebo | Occurrence of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | gp70-BF1266_431a_V1V2 | 0 Participants |
| Part B: Placebo | Occurrence of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | B.6240_D11gp120/293F | 0 Participants |
| Part B: Placebo | Occurrence of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | gp70-62357.14 V1V2 | 0 Participants |
| Part B: Placebo | Occurrence of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | gp70-Ce1086_B2 V1V2 | 0 Participants |
| Part B: Placebo | Occurrence of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | gp70-96ZM651.02 V1v2 | 0 Participants |
| Part B: Placebo | Occurrence of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | 254008_D11gp120.avi/293F | 0 Participants |
| Part B: Placebo | Occurrence of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | gp70-CM244.ec1 V1V2 | 0 Participants |
| Part B: Placebo | Occurrence of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | gp70-7060101641 V1V2 | 0 Participants |
| Part B: Placebo | Occurrence of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | gp120-C | 0 Participants |
| Part B: Placebo | Occurrence of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | BJOX002_D11gp120.avi/293F | 0 Participants |
| Part B: Vaccine 1 | Occurrence of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | gp70-CAP210.2.00.E8 V1V2 | 16 Participants |
| Part B: Vaccine 1 | Occurrence of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | gp70-CM244.ec1 V1V2 | 18 Participants |
| Part B: Vaccine 1 | Occurrence of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | gp70-TV1.21 V1V2 | 17 Participants |
| Part B: Vaccine 1 | Occurrence of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | gp70-Ce1086_B2 V1V2 | 18 Participants |
| Part B: Vaccine 1 | Occurrence of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | gp70-RHPA4259.7 V1V2 | 16 Participants |
| Part B: Vaccine 1 | Occurrence of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | gp70-TT31P.2F10.2792 V1V2 | 13 Participants |
| Part B: Vaccine 1 | Occurrence of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | gp70-001428.2.42 V1V2 | 17 Participants |
| Part B: Vaccine 1 | Occurrence of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | gp70_B.CaseA_V1_V2 | 17 Participants |
| Part B: Vaccine 1 | Occurrence of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | 254008_D11gp120.avi/293F | 18 Participants |
| Part B: Vaccine 1 | Occurrence of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | 51802_D11gp120.avi/293F | 18 Participants |
| Part B: Vaccine 1 | Occurrence of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | gp70-C2101.c01_V1V2 | 17 Participants |
| Part B: Vaccine 1 | Occurrence of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | gp70-62357.14 V1V2 | 14 Participants |
| Part B: Vaccine 1 | Occurrence of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | B.6240_D11gp120/293F | 17 Participants |
| Part B: Vaccine 1 | Occurrence of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | gp70-BJOX002000.03.2 V1V2 | 17 Participants |
| Part B: Vaccine 1 | Occurrence of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | gp70-191084_B7 V1V2 | 17 Participants |
| Part B: Vaccine 1 | Occurrence of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | TT31P.2792_D11gp120.avi/293F | 18 Participants |
| Part B: Vaccine 1 | Occurrence of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | CNE20_D11gp120.avi/293F | 18 Participants |
| Part B: Vaccine 1 | Occurrence of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | gp120-A | 18 Participants |
| Part B: Vaccine 1 | Occurrence of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | BORI_D11gp120.avi/293F | 15 Participants |
| Part B: Vaccine 1 | Occurrence of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | gp120-AE | 17 Participants |
| Part B: Vaccine 1 | Occurrence of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | BJOX002_D11gp120.avi/293F | 16 Participants |
| Part B: Vaccine 1 | Occurrence of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | A244 D11gp120_avi | 18 Participants |
| Part B: Vaccine 1 | Occurrence of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | gp120-B | 18 Participants |
| Part B: Vaccine 1 | Occurrence of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | gp70-7060101641 V1V2 | 17 Participants |
| Part B: Vaccine 1 | Occurrence of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | gp120-C | 17 Participants |
| Part B: Vaccine 1 | Occurrence of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | gp70-96ZM651.02 V1v2 | 16 Participants |
| Part B: Vaccine 1 | Occurrence of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | gp70-BF1266_431a_V1V2 | 17 Participants |
| Part B: Vaccine 1 | Occurrence of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | gp70-700010058 V1V2 | 15 Participants |
| Part B: Vaccine 2 | Occurrence of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | gp70-CM244.ec1 V1V2 | 11 Participants |
| Part B: Vaccine 2 | Occurrence of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | gp120-AE | 13 Participants |
| Part B: Vaccine 2 | Occurrence of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | gp70-BF1266_431a_V1V2 | 8 Participants |
| Part B: Vaccine 2 | Occurrence of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | gp70-CAP210.2.00.E8 V1V2 | 8 Participants |
| Part B: Vaccine 2 | Occurrence of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | 51802_D11gp120.avi/293F | 13 Participants |
| Part B: Vaccine 2 | Occurrence of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | gp70-TV1.21 V1V2 | 9 Participants |
| Part B: Vaccine 2 | Occurrence of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | gp120-B | 11 Participants |
| Part B: Vaccine 2 | Occurrence of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | A244 D11gp120_avi | 13 Participants |
| Part B: Vaccine 2 | Occurrence of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | gp70-62357.14 V1V2 | 9 Participants |
| Part B: Vaccine 2 | Occurrence of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | gp70-C2101.c01_V1V2 | 11 Participants |
| Part B: Vaccine 2 | Occurrence of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | 254008_D11gp120.avi/293F | 13 Participants |
| Part B: Vaccine 2 | Occurrence of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | gp70-TT31P.2F10.2792 V1V2 | 9 Participants |
| Part B: Vaccine 2 | Occurrence of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | gp70-RHPA4259.7 V1V2 | 8 Participants |
| Part B: Vaccine 2 | Occurrence of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | gp70-001428.2.42 V1V2 | 11 Participants |
| Part B: Vaccine 2 | Occurrence of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | gp70_B.CaseA_V1_V2 | 11 Participants |
| Part B: Vaccine 2 | Occurrence of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | BORI_D11gp120.avi/293F | 11 Participants |
| Part B: Vaccine 2 | Occurrence of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | CNE20_D11gp120.avi/293F | 13 Participants |
| Part B: Vaccine 2 | Occurrence of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | gp70-7060101641 V1V2 | 10 Participants |
| Part B: Vaccine 2 | Occurrence of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | BJOX002_D11gp120.avi/293F | 12 Participants |
| Part B: Vaccine 2 | Occurrence of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | gp70-96ZM651.02 V1v2 | 11 Participants |
| Part B: Vaccine 2 | Occurrence of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | TT31P.2792_D11gp120.avi/293F | 13 Participants |
| Part B: Vaccine 2 | Occurrence of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | gp70-700010058 V1V2 | 11 Participants |
| Part B: Vaccine 2 | Occurrence of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | gp70-191084_B7 V1V2 | 11 Participants |
| Part B: Vaccine 2 | Occurrence of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | B.6240_D11gp120/293F | 13 Participants |
| Part B: Vaccine 2 | Occurrence of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | gp120-C | 12 Participants |
| Part B: Vaccine 2 | Occurrence of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | gp120-A | 12 Participants |
| Part B: Vaccine 2 | Occurrence of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | gp70-Ce1086_B2 V1V2 | 13 Participants |
| Part B: Vaccine 2 | Occurrence of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination | gp70-BJOX002000.03.2 V1V2 | 11 Participants |
Secondary
Part B: Levels of Serum Neutralizing Antibody Responses Against Tier 1A, Tier 1B, and Selected Tier 2 Viruses Two Weeks After the Last Vaccination
Neutralizing antibodies against HIV1were measured as a function of reductions in Tat-regulatedluciferase (Luc) reporter gene expression in TZM-blcells. The assay performed in TZM-bl cells measured neutralization titers against a panel of Env-pseudotyped viruses that exhibit the following naturalization phenotypes. Response to a virus/isolate was considered positive if the neutralization titer was above a prespecified cutoff. A titer was defined as the serum dilution that reduced relative luminescence units (RLUs) by 50% and 80% relative to the RLUs in virus control wells (cells + virus only) after subtraction of background RLU (ID50 and ID80, cells only). The prespecified cutoff was 20 for MW965.26 (Tier 1a) and 10 for other viruses.
Time frame: Measured at Month 8.5 for part B only
Population: In this report, Overall Number of Participants Analyzed represents the HIV-uninfected participants who received the last vaccination with specimens at Month 2.5 for part A and Month 8.5 for part B. The Number Analyzed in the Outcome Measure Data Table shows the number of participants with available Neutralizing Antibody data after filtering for assay specific quality control criteria.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Part A: Placebo | Part B: Levels of Serum Neutralizing Antibody Responses Against Tier 1A, Tier 1B, and Selected Tier 2 Viruses Two Weeks After the Last Vaccination | Bx08.16 (ID50) | 5 Titers |
| Part A: Placebo | Part B: Levels of Serum Neutralizing Antibody Responses Against Tier 1A, Tier 1B, and Selected Tier 2 Viruses Two Weeks After the Last Vaccination | JR-FL (ID80) | 5 Titers |
| Part A: Placebo | Part B: Levels of Serum Neutralizing Antibody Responses Against Tier 1A, Tier 1B, and Selected Tier 2 Viruses Two Weeks After the Last Vaccination | JR-FL (ID50) | 5 Titers |
| Part A: Placebo | Part B: Levels of Serum Neutralizing Antibody Responses Against Tier 1A, Tier 1B, and Selected Tier 2 Viruses Two Weeks After the Last Vaccination | Q23.17 (ID50) | 5 Titers |
| Part A: Placebo | Part B: Levels of Serum Neutralizing Antibody Responses Against Tier 1A, Tier 1B, and Selected Tier 2 Viruses Two Weeks After the Last Vaccination | 92UG037.1 (ID50) | 5 Titers |
| Part A: Placebo | Part B: Levels of Serum Neutralizing Antibody Responses Against Tier 1A, Tier 1B, and Selected Tier 2 Viruses Two Weeks After the Last Vaccination | ZM197M.PB7 (ID50) | 5 Titers |
| Part A: Placebo | Part B: Levels of Serum Neutralizing Antibody Responses Against Tier 1A, Tier 1B, and Selected Tier 2 Viruses Two Weeks After the Last Vaccination | 92UG037.1 (ID80) | 5 Titers |
| Part A: Placebo | Part B: Levels of Serum Neutralizing Antibody Responses Against Tier 1A, Tier 1B, and Selected Tier 2 Viruses Two Weeks After the Last Vaccination | ZM197M.PB7 (ID80) | 5 Titers |
| Part A: Placebo | Part B: Levels of Serum Neutralizing Antibody Responses Against Tier 1A, Tier 1B, and Selected Tier 2 Viruses Two Weeks After the Last Vaccination | Q23.17 (ID80) | 5 Titers |
| Part A: Placebo | Part B: Levels of Serum Neutralizing Antibody Responses Against Tier 1A, Tier 1B, and Selected Tier 2 Viruses Two Weeks After the Last Vaccination | MW965.26 (ID50) | 10 Titers |
| Part A: Placebo | Part B: Levels of Serum Neutralizing Antibody Responses Against Tier 1A, Tier 1B, and Selected Tier 2 Viruses Two Weeks After the Last Vaccination | 1056-10.TA11.1826 (ID80) | 5 Titers |
| Part A: Placebo | Part B: Levels of Serum Neutralizing Antibody Responses Against Tier 1A, Tier 1B, and Selected Tier 2 Viruses Two Weeks After the Last Vaccination | Bx08.16 (ID80) | 5 Titers |
| Part A: Placebo | Part B: Levels of Serum Neutralizing Antibody Responses Against Tier 1A, Tier 1B, and Selected Tier 2 Viruses Two Weeks After the Last Vaccination | 1056-10.TA11.1826 (ID50) | 5 Titers |
| Part A: Placebo | Part B: Levels of Serum Neutralizing Antibody Responses Against Tier 1A, Tier 1B, and Selected Tier 2 Viruses Two Weeks After the Last Vaccination | MW965.26 (ID80) | 10 Titers |
| Part A: Placebo | Part B: Levels of Serum Neutralizing Antibody Responses Against Tier 1A, Tier 1B, and Selected Tier 2 Viruses Two Weeks After the Last Vaccination | 6535.3 (ID50) | 5 Titers |
| Part A: Placebo | Part B: Levels of Serum Neutralizing Antibody Responses Against Tier 1A, Tier 1B, and Selected Tier 2 Viruses Two Weeks After the Last Vaccination | 6535.3 (ID80) | 5 Titers |
| Part A: Vaccine | Part B: Levels of Serum Neutralizing Antibody Responses Against Tier 1A, Tier 1B, and Selected Tier 2 Viruses Two Weeks After the Last Vaccination | ZM197M.PB7 (ID80) | 5 Titers |
| Part A: Vaccine | Part B: Levels of Serum Neutralizing Antibody Responses Against Tier 1A, Tier 1B, and Selected Tier 2 Viruses Two Weeks After the Last Vaccination | Q23.17 (ID50) | 5 Titers |
| Part A: Vaccine | Part B: Levels of Serum Neutralizing Antibody Responses Against Tier 1A, Tier 1B, and Selected Tier 2 Viruses Two Weeks After the Last Vaccination | 6535.3 (ID80) | 5 Titers |
| Part A: Vaccine | Part B: Levels of Serum Neutralizing Antibody Responses Against Tier 1A, Tier 1B, and Selected Tier 2 Viruses Two Weeks After the Last Vaccination | MW965.26 (ID50) | 681.2 Titers |
| Part A: Vaccine | Part B: Levels of Serum Neutralizing Antibody Responses Against Tier 1A, Tier 1B, and Selected Tier 2 Viruses Two Weeks After the Last Vaccination | 6535.3 (ID50) | 5 Titers |
| Part A: Vaccine | Part B: Levels of Serum Neutralizing Antibody Responses Against Tier 1A, Tier 1B, and Selected Tier 2 Viruses Two Weeks After the Last Vaccination | Bx08.16 (ID50) | 5 Titers |
| Part A: Vaccine | Part B: Levels of Serum Neutralizing Antibody Responses Against Tier 1A, Tier 1B, and Selected Tier 2 Viruses Two Weeks After the Last Vaccination | ZM197M.PB7 (ID50) | 5 Titers |
| Part A: Vaccine | Part B: Levels of Serum Neutralizing Antibody Responses Against Tier 1A, Tier 1B, and Selected Tier 2 Viruses Two Weeks After the Last Vaccination | 92UG037.1 (ID50) | 5 Titers |
| Part A: Vaccine | Part B: Levels of Serum Neutralizing Antibody Responses Against Tier 1A, Tier 1B, and Selected Tier 2 Viruses Two Weeks After the Last Vaccination | JR-FL (ID50) | 5 Titers |
| Part A: Vaccine | Part B: Levels of Serum Neutralizing Antibody Responses Against Tier 1A, Tier 1B, and Selected Tier 2 Viruses Two Weeks After the Last Vaccination | MW965.26 (ID80) | 233.7 Titers |
| Part A: Vaccine | Part B: Levels of Serum Neutralizing Antibody Responses Against Tier 1A, Tier 1B, and Selected Tier 2 Viruses Two Weeks After the Last Vaccination | 1056-10.TA11.1826 (ID80) | 5 Titers |
| Part A: Vaccine | Part B: Levels of Serum Neutralizing Antibody Responses Against Tier 1A, Tier 1B, and Selected Tier 2 Viruses Two Weeks After the Last Vaccination | Bx08.16 (ID80) | 5 Titers |
| Part A: Vaccine | Part B: Levels of Serum Neutralizing Antibody Responses Against Tier 1A, Tier 1B, and Selected Tier 2 Viruses Two Weeks After the Last Vaccination | Q23.17 (ID80) | 5 Titers |
| Part A: Vaccine | Part B: Levels of Serum Neutralizing Antibody Responses Against Tier 1A, Tier 1B, and Selected Tier 2 Viruses Two Weeks After the Last Vaccination | 1056-10.TA11.1826 (ID50) | 5 Titers |
| Part A: Vaccine | Part B: Levels of Serum Neutralizing Antibody Responses Against Tier 1A, Tier 1B, and Selected Tier 2 Viruses Two Weeks After the Last Vaccination | 92UG037.1 (ID80) | 5 Titers |
| Part A: Vaccine | Part B: Levels of Serum Neutralizing Antibody Responses Against Tier 1A, Tier 1B, and Selected Tier 2 Viruses Two Weeks After the Last Vaccination | JR-FL (ID80) | 5 Titers |
| Part B: Placebo | Part B: Levels of Serum Neutralizing Antibody Responses Against Tier 1A, Tier 1B, and Selected Tier 2 Viruses Two Weeks After the Last Vaccination | MW965.26 (ID80) | 181 Titers |
| Part B: Placebo | Part B: Levels of Serum Neutralizing Antibody Responses Against Tier 1A, Tier 1B, and Selected Tier 2 Viruses Two Weeks After the Last Vaccination | 6535.3 (ID80) | 5 Titers |
| Part B: Placebo | Part B: Levels of Serum Neutralizing Antibody Responses Against Tier 1A, Tier 1B, and Selected Tier 2 Viruses Two Weeks After the Last Vaccination | 1056-10.TA11.1826 (ID80) | 5 Titers |
| Part B: Placebo | Part B: Levels of Serum Neutralizing Antibody Responses Against Tier 1A, Tier 1B, and Selected Tier 2 Viruses Two Weeks After the Last Vaccination | MW965.26 (ID50) | 583.5 Titers |
| Part B: Placebo | Part B: Levels of Serum Neutralizing Antibody Responses Against Tier 1A, Tier 1B, and Selected Tier 2 Viruses Two Weeks After the Last Vaccination | JR-FL (ID80) | 5 Titers |
| Part B: Placebo | Part B: Levels of Serum Neutralizing Antibody Responses Against Tier 1A, Tier 1B, and Selected Tier 2 Viruses Two Weeks After the Last Vaccination | Bx08.16 (ID80) | 5 Titers |
| Part B: Placebo | Part B: Levels of Serum Neutralizing Antibody Responses Against Tier 1A, Tier 1B, and Selected Tier 2 Viruses Two Weeks After the Last Vaccination | ZM197M.PB7 (ID80) | 5 Titers |
| Part B: Placebo | Part B: Levels of Serum Neutralizing Antibody Responses Against Tier 1A, Tier 1B, and Selected Tier 2 Viruses Two Weeks After the Last Vaccination | ZM197M.PB7 (ID50) | 5 Titers |
| Part B: Placebo | Part B: Levels of Serum Neutralizing Antibody Responses Against Tier 1A, Tier 1B, and Selected Tier 2 Viruses Two Weeks After the Last Vaccination | Q23.17 (ID50) | 5 Titers |
| Part B: Placebo | Part B: Levels of Serum Neutralizing Antibody Responses Against Tier 1A, Tier 1B, and Selected Tier 2 Viruses Two Weeks After the Last Vaccination | 92UG037.1 (ID80) | 5 Titers |
| Part B: Placebo | Part B: Levels of Serum Neutralizing Antibody Responses Against Tier 1A, Tier 1B, and Selected Tier 2 Viruses Two Weeks After the Last Vaccination | 92UG037.1 (ID50) | 5 Titers |
| Part B: Placebo | Part B: Levels of Serum Neutralizing Antibody Responses Against Tier 1A, Tier 1B, and Selected Tier 2 Viruses Two Weeks After the Last Vaccination | Bx08.16 (ID50) | 5 Titers |
| Part B: Placebo | Part B: Levels of Serum Neutralizing Antibody Responses Against Tier 1A, Tier 1B, and Selected Tier 2 Viruses Two Weeks After the Last Vaccination | Q23.17 (ID80) | 5 Titers |
| Part B: Placebo | Part B: Levels of Serum Neutralizing Antibody Responses Against Tier 1A, Tier 1B, and Selected Tier 2 Viruses Two Weeks After the Last Vaccination | JR-FL (ID50) | 5 Titers |
| Part B: Placebo | Part B: Levels of Serum Neutralizing Antibody Responses Against Tier 1A, Tier 1B, and Selected Tier 2 Viruses Two Weeks After the Last Vaccination | 1056-10.TA11.1826 (ID50) | 5 Titers |
| Part B: Placebo | Part B: Levels of Serum Neutralizing Antibody Responses Against Tier 1A, Tier 1B, and Selected Tier 2 Viruses Two Weeks After the Last Vaccination | 6535.3 (ID50) | 5 Titers |
Secondary
Part B: Occurrence of Serum Neutralizing Antibody Responses Against Tier 1A, Tier 1B, and Selected Tier 2 Viruses Two Weeks After the Last Vaccination
Neutralizing antibodies against HIV1were measured as a function of reductions in Tat-regulatedluciferase (Luc) reporter gene expression in TZM-blcells. The assay performed in TZM-bl cells measured neutralization titers against a panel of Env-pseudotyped viruses that exhibit the following naturalization phenotypes. Response to a virus/isolate was considered positive if the neutralization titer was above a prespecified cutoff. A titer was defined as the serum dilution that reduced relative luminescence units (RLUs) by 50% and 80% relative to the RLUs in virus control wells (cells + virus only) after subtraction of background RLU (ID50 and ID80, cells only). The prespecified cutoff was 20 for MW965.26 (Tier 1a) and 10 for other viruses.
Time frame: Measured at Month 8.5 for part B only
Population: In this report, Overall Number of Participants Analyzed represents the HIV-uninfected participants who received the last vaccination with specimens at Month 2.5 for part A and Month 8.5 for part B. The Number Analyzed in the Outcome Measure Data Table shows the number of participants with available Neutralizing Antibody data after filtering for assay specific quality control criteria.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A: Placebo | Part B: Occurrence of Serum Neutralizing Antibody Responses Against Tier 1A, Tier 1B, and Selected Tier 2 Viruses Two Weeks After the Last Vaccination | MW965.26 (ID50) | 0 Participants |
| Part A: Placebo | Part B: Occurrence of Serum Neutralizing Antibody Responses Against Tier 1A, Tier 1B, and Selected Tier 2 Viruses Two Weeks After the Last Vaccination | 6535.3 (ID50) | 0 Participants |
| Part A: Placebo | Part B: Occurrence of Serum Neutralizing Antibody Responses Against Tier 1A, Tier 1B, and Selected Tier 2 Viruses Two Weeks After the Last Vaccination | Bx08.16 (ID50) | 0 Participants |
| Part A: Placebo | Part B: Occurrence of Serum Neutralizing Antibody Responses Against Tier 1A, Tier 1B, and Selected Tier 2 Viruses Two Weeks After the Last Vaccination | ZM197M.PB7 (ID50) | 0 Participants |
| Part A: Placebo | Part B: Occurrence of Serum Neutralizing Antibody Responses Against Tier 1A, Tier 1B, and Selected Tier 2 Viruses Two Weeks After the Last Vaccination | 92UG037.1 (ID50) | 0 Participants |
| Part A: Placebo | Part B: Occurrence of Serum Neutralizing Antibody Responses Against Tier 1A, Tier 1B, and Selected Tier 2 Viruses Two Weeks After the Last Vaccination | MW965.26 (ID80) | 0 Participants |
| Part A: Placebo | Part B: Occurrence of Serum Neutralizing Antibody Responses Against Tier 1A, Tier 1B, and Selected Tier 2 Viruses Two Weeks After the Last Vaccination | 1056-10.TA11.1826 (ID80) | 0 Participants |
| Part A: Placebo | Part B: Occurrence of Serum Neutralizing Antibody Responses Against Tier 1A, Tier 1B, and Selected Tier 2 Viruses Two Weeks After the Last Vaccination | Bx08.16 (ID80) | 0 Participants |
| Part A: Placebo | Part B: Occurrence of Serum Neutralizing Antibody Responses Against Tier 1A, Tier 1B, and Selected Tier 2 Viruses Two Weeks After the Last Vaccination | Q23.17 (ID80) | 0 Participants |
| Part A: Placebo | Part B: Occurrence of Serum Neutralizing Antibody Responses Against Tier 1A, Tier 1B, and Selected Tier 2 Viruses Two Weeks After the Last Vaccination | 92UG037.1 (ID80) | 0 Participants |
| Part A: Placebo | Part B: Occurrence of Serum Neutralizing Antibody Responses Against Tier 1A, Tier 1B, and Selected Tier 2 Viruses Two Weeks After the Last Vaccination | 1056-10.TA11.1826 (ID50) | 0 Participants |
| Part A: Placebo | Part B: Occurrence of Serum Neutralizing Antibody Responses Against Tier 1A, Tier 1B, and Selected Tier 2 Viruses Two Weeks After the Last Vaccination | Q23.17 (ID50) | 0 Participants |
| Part A: Placebo | Part B: Occurrence of Serum Neutralizing Antibody Responses Against Tier 1A, Tier 1B, and Selected Tier 2 Viruses Two Weeks After the Last Vaccination | JR-FL (ID50) | 0 Participants |
| Part A: Placebo | Part B: Occurrence of Serum Neutralizing Antibody Responses Against Tier 1A, Tier 1B, and Selected Tier 2 Viruses Two Weeks After the Last Vaccination | 6535.3 (ID80) | 0 Participants |
| Part A: Placebo | Part B: Occurrence of Serum Neutralizing Antibody Responses Against Tier 1A, Tier 1B, and Selected Tier 2 Viruses Two Weeks After the Last Vaccination | ZM197M.PB7 (ID80) | 0 Participants |
| Part A: Placebo | Part B: Occurrence of Serum Neutralizing Antibody Responses Against Tier 1A, Tier 1B, and Selected Tier 2 Viruses Two Weeks After the Last Vaccination | JR-FL (ID80) | 0 Participants |
| Part A: Vaccine | Part B: Occurrence of Serum Neutralizing Antibody Responses Against Tier 1A, Tier 1B, and Selected Tier 2 Viruses Two Weeks After the Last Vaccination | JR-FL (ID50) | 0 Participants |
| Part A: Vaccine | Part B: Occurrence of Serum Neutralizing Antibody Responses Against Tier 1A, Tier 1B, and Selected Tier 2 Viruses Two Weeks After the Last Vaccination | MW965.26 (ID80) | 16 Participants |
| Part A: Vaccine | Part B: Occurrence of Serum Neutralizing Antibody Responses Against Tier 1A, Tier 1B, and Selected Tier 2 Viruses Two Weeks After the Last Vaccination | 1056-10.TA11.1826 (ID80) | 0 Participants |
| Part A: Vaccine | Part B: Occurrence of Serum Neutralizing Antibody Responses Against Tier 1A, Tier 1B, and Selected Tier 2 Viruses Two Weeks After the Last Vaccination | 6535.3 (ID80) | 0 Participants |
| Part A: Vaccine | Part B: Occurrence of Serum Neutralizing Antibody Responses Against Tier 1A, Tier 1B, and Selected Tier 2 Viruses Two Weeks After the Last Vaccination | Q23.17 (ID80) | 0 Participants |
| Part A: Vaccine | Part B: Occurrence of Serum Neutralizing Antibody Responses Against Tier 1A, Tier 1B, and Selected Tier 2 Viruses Two Weeks After the Last Vaccination | Bx08.16 (ID80) | 0 Participants |
| Part A: Vaccine | Part B: Occurrence of Serum Neutralizing Antibody Responses Against Tier 1A, Tier 1B, and Selected Tier 2 Viruses Two Weeks After the Last Vaccination | JR-FL (ID80) | 0 Participants |
| Part A: Vaccine | Part B: Occurrence of Serum Neutralizing Antibody Responses Against Tier 1A, Tier 1B, and Selected Tier 2 Viruses Two Weeks After the Last Vaccination | ZM197M.PB7 (ID80) | 0 Participants |
| Part A: Vaccine | Part B: Occurrence of Serum Neutralizing Antibody Responses Against Tier 1A, Tier 1B, and Selected Tier 2 Viruses Two Weeks After the Last Vaccination | 1056-10.TA11.1826 (ID50) | 0 Participants |
| Part A: Vaccine | Part B: Occurrence of Serum Neutralizing Antibody Responses Against Tier 1A, Tier 1B, and Selected Tier 2 Viruses Two Weeks After the Last Vaccination | Bx08.16 (ID50) | 3 Participants |
| Part A: Vaccine | Part B: Occurrence of Serum Neutralizing Antibody Responses Against Tier 1A, Tier 1B, and Selected Tier 2 Viruses Two Weeks After the Last Vaccination | MW965.26 (ID50) | 16 Participants |
| Part A: Vaccine | Part B: Occurrence of Serum Neutralizing Antibody Responses Against Tier 1A, Tier 1B, and Selected Tier 2 Viruses Two Weeks After the Last Vaccination | 92UG037.1 (ID80) | 0 Participants |
| Part A: Vaccine | Part B: Occurrence of Serum Neutralizing Antibody Responses Against Tier 1A, Tier 1B, and Selected Tier 2 Viruses Two Weeks After the Last Vaccination | 6535.3 (ID50) | 0 Participants |
| Part A: Vaccine | Part B: Occurrence of Serum Neutralizing Antibody Responses Against Tier 1A, Tier 1B, and Selected Tier 2 Viruses Two Weeks After the Last Vaccination | Q23.17 (ID50) | 0 Participants |
| Part A: Vaccine | Part B: Occurrence of Serum Neutralizing Antibody Responses Against Tier 1A, Tier 1B, and Selected Tier 2 Viruses Two Weeks After the Last Vaccination | ZM197M.PB7 (ID50) | 0 Participants |
| Part A: Vaccine | Part B: Occurrence of Serum Neutralizing Antibody Responses Against Tier 1A, Tier 1B, and Selected Tier 2 Viruses Two Weeks After the Last Vaccination | 92UG037.1 (ID50) | 0 Participants |
| Part B: Placebo | Part B: Occurrence of Serum Neutralizing Antibody Responses Against Tier 1A, Tier 1B, and Selected Tier 2 Viruses Two Weeks After the Last Vaccination | JR-FL (ID50) | 0 Participants |
| Part B: Placebo | Part B: Occurrence of Serum Neutralizing Antibody Responses Against Tier 1A, Tier 1B, and Selected Tier 2 Viruses Two Weeks After the Last Vaccination | 1056-10.TA11.1826 (ID80) | 0 Participants |
| Part B: Placebo | Part B: Occurrence of Serum Neutralizing Antibody Responses Against Tier 1A, Tier 1B, and Selected Tier 2 Viruses Two Weeks After the Last Vaccination | 92UG037.1 (ID50) | 2 Participants |
| Part B: Placebo | Part B: Occurrence of Serum Neutralizing Antibody Responses Against Tier 1A, Tier 1B, and Selected Tier 2 Viruses Two Weeks After the Last Vaccination | MW965.26 (ID80) | 14 Participants |
| Part B: Placebo | Part B: Occurrence of Serum Neutralizing Antibody Responses Against Tier 1A, Tier 1B, and Selected Tier 2 Viruses Two Weeks After the Last Vaccination | JR-FL (ID80) | 0 Participants |
| Part B: Placebo | Part B: Occurrence of Serum Neutralizing Antibody Responses Against Tier 1A, Tier 1B, and Selected Tier 2 Viruses Two Weeks After the Last Vaccination | MW965.26 (ID50) | 15 Participants |
| Part B: Placebo | Part B: Occurrence of Serum Neutralizing Antibody Responses Against Tier 1A, Tier 1B, and Selected Tier 2 Viruses Two Weeks After the Last Vaccination | 1056-10.TA11.1826 (ID50) | 0 Participants |
| Part B: Placebo | Part B: Occurrence of Serum Neutralizing Antibody Responses Against Tier 1A, Tier 1B, and Selected Tier 2 Viruses Two Weeks After the Last Vaccination | 6535.3 (ID80) | 0 Participants |
| Part B: Placebo | Part B: Occurrence of Serum Neutralizing Antibody Responses Against Tier 1A, Tier 1B, and Selected Tier 2 Viruses Two Weeks After the Last Vaccination | ZM197M.PB7 (ID50) | 0 Participants |
| Part B: Placebo | Part B: Occurrence of Serum Neutralizing Antibody Responses Against Tier 1A, Tier 1B, and Selected Tier 2 Viruses Two Weeks After the Last Vaccination | 92UG037.1 (ID80) | 0 Participants |
| Part B: Placebo | Part B: Occurrence of Serum Neutralizing Antibody Responses Against Tier 1A, Tier 1B, and Selected Tier 2 Viruses Two Weeks After the Last Vaccination | Bx08.16 (ID80) | 0 Participants |
| Part B: Placebo | Part B: Occurrence of Serum Neutralizing Antibody Responses Against Tier 1A, Tier 1B, and Selected Tier 2 Viruses Two Weeks After the Last Vaccination | 6535.3 (ID50) | 0 Participants |
| Part B: Placebo | Part B: Occurrence of Serum Neutralizing Antibody Responses Against Tier 1A, Tier 1B, and Selected Tier 2 Viruses Two Weeks After the Last Vaccination | Q23.17 (ID80) | 0 Participants |
| Part B: Placebo | Part B: Occurrence of Serum Neutralizing Antibody Responses Against Tier 1A, Tier 1B, and Selected Tier 2 Viruses Two Weeks After the Last Vaccination | Q23.17 (ID50) | 0 Participants |
| Part B: Placebo | Part B: Occurrence of Serum Neutralizing Antibody Responses Against Tier 1A, Tier 1B, and Selected Tier 2 Viruses Two Weeks After the Last Vaccination | ZM197M.PB7 (ID80) | 0 Participants |
| Part B: Placebo | Part B: Occurrence of Serum Neutralizing Antibody Responses Against Tier 1A, Tier 1B, and Selected Tier 2 Viruses Two Weeks After the Last Vaccination | Bx08.16 (ID50) | 0 Participants |