HIV Infections
Conditions
Brief summary
The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of an HIV vaccine (gp145 C.6980) with aluminum hydroxide adjuvant in healthy, HIV-1-uninfected adults in the United States.
Detailed description
This study will evaluate the safety, tolerability, and immunogenicity of an HIV vaccine (gp145 C.6980) with aluminum hydroxide adjuvant in healthy, HIV-1-uninfected adults in the United States. Participants will be randomly assigned to one of three groups. Participants in Group 1 will receive 300 mcg of gp145 C.6980 and aluminum hydroxide adjuvant on Day 0 and Months 2 and 6. Participants in Group 2 will receive 100 mcg of gp145 C.6980 and aluminum hydroxide adjuvant on Day 0 and Months 2 and 6. Participants in Group 3 will receive placebo on Day 0 and Months 2 and 6. Study visits will occur at Day 0 (study entry), Weeks 1 and 2, and Months 2, 2.5, 6, 6.25, 6.5, 9, and 12. Visits may include physical examinations, blood and urine collection, HIV testing, risk reduction counseling, and questionnaires.
Interventions
BIOLOGICALgp145 C.6980 Vaccine
Administered by intramuscular injection in the deltoid.
BIOLOGICALPlacebo
Sodium Chloride for Injection, 0.9%; Administered by intramuscular injection in the deltoid.
BIOLOGICALAluminum Hydroxide 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 and completes a questionnaire prior to first vaccination with verbal demonstration of understanding of all questionnaire items initially answered incorrectly * Agrees not to enroll in another study of an investigational research agent before the last scheduled protocol clinic visit * 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. Low risk guidelines are found on the protocol web page under Study Materials on the HVTN Members' site (https://members.hvtn.org/protocols/hvtn122). Laboratory Inclusion Values Hemogram/Complete Blood Count (CBC) * Hemoglobin greater than or equal to 11.0 g/dL for volunteers who were born female, greater than or equal to 13.0 g/dL for volunteers who were born male * White blood cell count equal to 3,300 to 12,000 cells/mm\^3 * Total lymphocyte count greater than or equal to 800 cells/mm\^3 * Remaining differential either within institutional normal range or with site physician approval * Platelets equal to 125,000 to 550,000/mm\^3 Chemistry * Chemistry panel: Alanine aminotransferase (ALT), aspartate aminotransferase (AST), and alkaline phosphatase less than 1.25 times the institutional upper limit of normal; creatinine less than or equal to institutional upper limit of normal. 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 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 122 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 122 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 122 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 122 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 122 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 122 PSRT on a case-by-case basis. * Live attenuated vaccines other than influenza vaccine received within 30 days before or scheduled and intended to be received within 14 days after the first vaccination (eg, measles, mumps, and rubella \[MMR\]; oral polio vaccine \[OPV\]; varicella; yellow fever) * Influenza vaccine or any vaccines that are not live attenuated vaccines and were received within 14 days prior to first vaccination (eg, tetanus, pneumococcal, Hepatitis A or B) * Allergy treatment with antigen injections within 30 days before first vaccination or that are scheduled and intended to be received 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 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 * 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 Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Measured through 7 days after first vaccination at Month 0 | Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events. Corrected Version 2.1, dated July 2017. The maximum grade observed for each symptom over the time frame is presented. |
| Number of Participants Reporting Local Reactogenicity Signs and Symptoms：Erythema and/or Induration | Measured through 7 days after first vaccination at Month 0 | Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events. Corrected Version 2.1, dated 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 7 days after first vaccination at Month 0 | Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events. Corrected Version 2.1, dated July 2017. The following symptoms are considered as systemic reactogenicity if the onset date was within the periods of assessment specified in the protocol: malaise and/or fatigue, myalgia, headache, nausea, vomiting, chills, arthralgia, and body temperature. The item Max. Systemic Reaction is the maximum of the individual systemic variables for a participant. It does not include temperature. |
| Number of Participants Reporting Adverse Events (AEs), by Severity Grade | Measured through 30 days after first vaccination at Month 0 | Severity definitions are found in The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Corrected Version 2.1, dated July 2017); For participants reporting multiple AEs over the time frame, the maximum severity grade is counted. |
| Number of Participants Reporting Adverse Events (AEs), by Relationship to Study Product | Measured through 30 days after first vaccination at Month 0 | Severity definitions are found in The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Corrected Version 2.1, dated July 2017); 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 30 days after first vaccination at Month 0 | Measured as outlined in Version 2.0 (January 2010) of the Manual for Expedited Reporting of Adverse Events to DAIDS (DAIDS EAE Manual) |
| Chemistry and Hematology Laboratory Measures With Grade 1 or Higher, Through First Vaccination | Measured at 2 weeks after first vaccination | Laboratory results are summarized by analyte and timepoint. Analytes and timepoint combinations with grade 1 or higher results are shown. |
| Hematology Laboratory Measures: WBC, Neutrophils , Lymphocytes and Platelets | Measured at 2 weeks after first vaccination | For each chemistry laboratory measure, summary statistics were presented by analyte and treatment group for the overall population. |
| Chemistry Laboratory Measures: Hemoglobin, Creatinine | Measured at 2 weeks after first vaccination | For each chemistry laboratory measure, summary statistics were presented by analyte and treatment group for the overall population. |
| Chemistry Laboratory Measures: ALT | Measured at 2 weeks after first vaccination | For each chemistry laboratory measure, summary statistics were presented by analyte and treatment group for the overall population. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of Vaccine-induced Binding Antibodies to HIV Proteins Measured by the Binding Antibody Multiplex Assay (BAMA) | Measured at 2 weeks after the first vaccination | Serum HIV-1-specific IgG responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay. The readout is background-subtracted mean fluorescent intensity (MFI), with background adjustment for an antigen-specific plate level control. For each sample, response magnitude is net MFI, defined as experimental antigen MFI minus reference antigen MFI. Net MFI less than 1 is set to 1. Samples from post-enrollment visits have positive responses if they meet three conditions: (1) net MFI greater than or equal to an antigen-specific response threshold (defined as the maximum of 100 and the 95th percentile of pre-vaccination net MFI), (2) net MFI values are greater than 3 times pre-vaccination net MFI, and (3) experimental antigen MFI values are greater than 3 times pre-vaccination MFI. Data are excluded if the blood draw date was outside the allowable window, a participant was HIV-infected, or the reference antigen exceeds 5000 MFI. |
| Level of Vaccine-induced Binding Antibodies to HIV Proteins Measured by the Binding Antibody Multiplex Assay (BAMA) | Measured at 2 weeks after the first vaccination | Serum HIV-1-specific IgG responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay. The readout is background-subtracted mean fluorescent intensity (MFI), with background adjustment for an antigen-specific plate level control. For each sample, response magnitude is net MFI, defined as experimental antigen MFI minus reference antigen MFI. Net MFI less than 1 is set to 1. Samples from post-enrollment visits have positive responses if they meet three conditions: (1) net MFI greater than or equal to an antigen-specific response threshold (defined as the maximum of 100 and the 95th percentile of pre-vaccination net MFI), (2) net MFI values are greater than 3 times pre-vaccination net MFI, and (3) experimental antigen MFI values are greater than 3 times pre-vaccination MFI. Data are excluded if the blood draw date was outside the allowable window, a participant was HIV-infected, or the reference antigen exceeds 5000 MFI. |
| Occurrence of HIV-specific CD4+ and CD8+ T-cell Responses to the HIV Proteins Included in the Vaccine. Measured by Flow Cytometry. | Measured at 2 weeks after the third vaccination | PBMC samples are stimulated with synthetic peptide pools or left unstimulated as a negative control. For each sample, T-cell subset, and peptide pool, response magnitude is % cells expressing markers after peptide stimulation minus % cells expressing markers after no stimulation. A contingency table is constructed to assess response: stimulation (peptide/none) vs. marker expression (yes/no). A one-sided Fisher's exact test is applied, testing if the number of cells positive for the marker is equal in the stimulated vs. unstimulated cells. A discrete Bonferroni adjustment is made over the peptide pools. Response is positive if p\<=0.00001. Data are excluded if the blood draw date was outside the visit window, the participant was HIV-infected, PBMC viability or T-cell count were low, or negative control was high. |
| Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Measured through Month 6.5 | Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events. Corrected Version 2.1, dated July 2017. The maximum grade observed for each symptom over the time frame is presented. |
| Occurrence of Neutralizing Antibody Responses Against HIV-1 Isolates | Measured at 2 weeks after the third vaccination | Assessed by multiplex assay. Response to a virus/isolate in the TZM-bl assay is considered positive if the neutralization titer is above a pre-specified cutoff (one-half the lowest dilution tested). A titer is defined as the serum dilution that reduces relative luminescence units (RLUs) by 50% relative to the RLUs in virus control wells (cells + virus only) after subtraction of background RLU (cells only). The pre-specified cutoff is 10 for TZM-bl cells. |
| Level of Neutralizing Antibody Responses Against HIV-1 Isolates | Measured at 2 weeks after the third vaccination | Assessed by multiplex assay. Response to a virus/isolate in the TZM-bl assay is considered positive if the neutralization titer is above a pre-specified cutoff (one-half the lowest dilution tested). A titer is defined as the serum dilution that reduces relative luminescence units (RLUs) by 50% relative to the RLUs in virus control wells (cells + virus only) after subtraction of background RLU (cells only). The pre-specified cutoff is 10 for TZM-bl cells. Titers below the limit of detection (\<10) were set to 5. |
| Levels of CD4+ and CD8+ T Cells Responses to the HIV Proteins Included in the Vaccine. Measured by Flow Cytometry. | Measured at 2 weeks after the third vaccination | PBMC samples are stimulated with synthetic peptide pools or left unstimulated as a negative control. For each sample, T-cell subset, and peptide pool, response magnitude is % cells expressing markers after peptide stimulation minus % cells expressing markers after no stimulation. A contingency table is constructed to assess response: stimulation (peptide/none) vs. marker expression (yes/no). A one-sided Fisher's exact test is applied, testing if the number of cells positive for the marker is equal in the stimulated vs. unstimulated cells. A discrete Bonferroni adjustment is made over the peptide pools. Response is positive if p\<=0.00001. Data are excluded if the blood draw date was outside the visit window, the participant was HIV-infected, PBMC viability or T-cell count were low, or negative control was high. |
| Number of Participants Reporting Local Reactogenicity Signs and Symptoms：Erythema and/or Induration | Measured through Month 6.5 | Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events. Corrected Version 2.1, dated 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 Month 6.5 | Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events. Corrected Version 2.1, dated July 2017. The following symptoms are considered as systemic reactogenicity if the onset date was within the periods of assessment specified in the protocol: malaise and/or fatigue, myalgia, headache, nausea, vomiting, chills, arthralgia, and body temperature. The item Max. Systemic Reaction is the maximum of the individual systemic variables for a participant. It does not include temperature. |
| Number of Participants Reporting Adverse Events (AEs), by Relationship to Study Product | Measured through Month 7 | Severity definitions are found in The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Corrected Version 2.1, dated July 2017); For participants reporting multiple AEs over the time frame, the maximum severity grade is counted. |
| Number of Participants Reporting Adverse Events (AEs), by Severity Grade | Measured through Month 7 | Severity definitions are found in The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Corrected Version 2.1, dated July 2017); for participants reporting multiple AEs over the time frame, the maximum severity grade is counted. |
| Frequency of Serious Adverse Events (SAEs) | Measured through Month 12 | Measured as outlined in Version 2.0 (January 2010) of the Manual for Expedited Reporting of Adverse Events to DAIDS (DAIDS EAE Manual) |
| Chemistry and Hematology Laboratory Results With Grade 1 or Higher, Through All Vaccinations | Measured during Screening, Month 0.5, 2.5, 6.5 and 9 | Laboratory results are summarized by analyte and timepoint. Analytes and timepoint combinations with no grade 1 or higher results are not shown. |
| Hematology Laboratory Measures: WBC, Platelets, Lymphocytes, Neutrophils , Through All Vaccinations | Measured during Screening, Month 0.5, 2.5, 6.5 and 9 | For each chemistry laboratory measure, summary statistics were presented by analyte and treatment group for the overall population. |
| Chemistry Laboratory Measures: Hemoglobin, Creatinine, Through All Vaccinations | Measured during Screening, Month 0.5, 2.5, 6.5 and 9 | For each chemistry laboratory measure, summary statistics were presented by analyte and treatment group for the overall population. |
| Chemistry Laboratory Measures: ALT, Through All Vaccinations | Measured during Screening, Month 0.5, 2.5, 6.5 and 9 | For each chemistry laboratory measure, summary statistics were presented by analyte and treatment group for the overall population. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Group 1: Vaccine gp145 C.6980 300 mcg, admixed with Aluminum Hydroxide Suspension to be administered as 1 mL IM in the deltoid at Months 0, 2, and 6 | 25 |
| Group 2: Vaccine gp145 C.6980, 100 mcg, admixed with Aluminum Hydroxide Suspension to be administered as 1 mL IM in the deltoid at Months 0, 2, and 6 | 15 |
| Group 3: Placebo Placebo for gp145 C.6980 (Sodium Chloride for Injection, 0.9%) to be administered as 1 mL IM in the deltoid at months 0, 2, and 6 | 5 |
| Total | 45 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 2 | 3 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | Group 1: Vaccine | Group 2: Vaccine | Group 3: Placebo | Total |
|---|---|---|---|---|
| Age, Continuous | 26 years | 27 years | 25 years | 26 years |
| Age, Customized 18 - 20 years | 4 Participants | 1 Participants | 1 Participants | 6 Participants |
| Age, Customized 21 - 30 years | 14 Participants | 9 Participants | 2 Participants | 25 Participants |
| Age, Customized 31 - 40 years | 4 Participants | 2 Participants | 2 Participants | 8 Participants |
| Age, Customized 41 - 50 years | 3 Participants | 3 Participants | 0 Participants | 6 Participants |
| Age, Customized Less than 18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Customized Over 50 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 1 Participants | 1 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 22 Participants | 14 Participants | 4 Participants | 40 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 7 Participants | 3 Participants | 0 Participants | 10 Participants |
| Race (NIH/OMB) Black or African American | 8 Participants | 4 Participants | 0 Participants | 12 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 1 Participants | 1 Participants | 4 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 8 Participants | 7 Participants | 4 Participants | 19 Participants |
| Region of Enrollment United States | 25 Participants | 15 Participants | 5 Participants | 45 Participants |
| Sex: Female, Male Female | 15 Participants | 10 Participants | 4 Participants | 29 Participants |
| Sex: Female, Male Male | 10 Participants | 5 Participants | 1 Participants | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 25 | 0 / 15 | 0 / 5 |
| other Total, other adverse events | 15 / 25 | 8 / 15 | 4 / 5 |
| serious Total, serious adverse events | 1 / 25 | 0 / 15 | 0 / 5 |
Outcome results
Primary
Chemistry and Hematology Laboratory Measures With Grade 1 or Higher, Through First Vaccination
Laboratory results are summarized by analyte and timepoint. Analytes and timepoint combinations with grade 1 or higher results are shown.
Time frame: Measured at 2 weeks after first vaccination
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) |
|---|---|---|---|
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures With Grade 1 or Higher, Through First Vaccination | Platelets (1000/cubic mm) | 0 Participants |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures With Grade 1 or Higher, Through First Vaccination | WBC (1000/cubic mm) | 0 Participants |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures With Grade 1 or Higher, Through First Vaccination | Creatinine (g/dL) | 0 Participants |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures With Grade 1 or Higher, Through First Vaccination | Lymphocytes (1000/cubic mm) | 0 Participants |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures With Grade 1 or Higher, Through First Vaccination | Neutrophils (1000/cubic mm) | 0 Participants |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures With Grade 1 or Higher, Through First Vaccination | ALT (SGPT) (U/L) | 0 Participants |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures With Grade 1 or Higher, Through First Vaccination | Hemoglobin (g/dL) | 0 Participants |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures With Grade 1 or Higher, Through First Vaccination | ALT (SGPT) (U/L) | 0 Participants |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures With Grade 1 or Higher, Through First Vaccination | Hemoglobin (g/dL) | 0 Participants |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures With Grade 1 or Higher, Through First Vaccination | Platelets (1000/cubic mm) | 0 Participants |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures With Grade 1 or Higher, Through First Vaccination | Creatinine (g/dL) | 0 Participants |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures With Grade 1 or Higher, Through First Vaccination | WBC (1000/cubic mm) | 0 Participants |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures With Grade 1 or Higher, Through First Vaccination | Neutrophils (1000/cubic mm) | 0 Participants |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures With Grade 1 or Higher, Through First Vaccination | Lymphocytes (1000/cubic mm) | 0 Participants |
| Group 3: Placebo | Chemistry and Hematology Laboratory Measures With Grade 1 or Higher, Through First Vaccination | Creatinine (g/dL) | 0 Participants |
| Group 3: Placebo | Chemistry and Hematology Laboratory Measures With Grade 1 or Higher, Through First Vaccination | Hemoglobin (g/dL) | 0 Participants |
| Group 3: Placebo | Chemistry and Hematology Laboratory Measures With Grade 1 or Higher, Through First Vaccination | ALT (SGPT) (U/L) | 0 Participants |
| Group 3: Placebo | Chemistry and Hematology Laboratory Measures With Grade 1 or Higher, Through First Vaccination | WBC (1000/cubic mm) | 0 Participants |
| Group 3: Placebo | Chemistry and Hematology Laboratory Measures With Grade 1 or Higher, Through First Vaccination | Neutrophils (1000/cubic mm) | 0 Participants |
| Group 3: Placebo | Chemistry and Hematology Laboratory Measures With Grade 1 or Higher, Through First Vaccination | Lymphocytes (1000/cubic mm) | 0 Participants |
| Group 3: Placebo | Chemistry and Hematology Laboratory Measures With Grade 1 or Higher, Through First Vaccination | Platelets (1000/cubic mm) | 0 Participants |
Primary
Chemistry Laboratory Measures: ALT
For each chemistry laboratory measure, summary statistics were presented by analyte and treatment group for the overall population.
Time frame: Measured at 2 weeks after first vaccination
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 | Value (MEDIAN) |
|---|---|---|
| Group 1: Vaccine | Chemistry Laboratory Measures: ALT | 14 U/L |
| Group 2: Vaccine | Chemistry Laboratory Measures: ALT | 15 U/L |
| Group 3: Placebo | Chemistry Laboratory Measures: ALT | 14 U/L |
Primary
Chemistry Laboratory Measures: Hemoglobin, Creatinine
For each chemistry laboratory measure, summary statistics were presented by analyte and treatment group for the overall population.
Time frame: Measured at 2 weeks after first vaccination
Population: The overall number of participants analyzed represents participants enrolled and eligible for laboratory assessment. Participants do not have laboratory assessments if they attended the visit but laboratory specimens were not collected, or they missed the scheduled visit, or they terminated participation in the study prior to the scheduled visit.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Group 1: Vaccine | Chemistry Laboratory Measures: Hemoglobin, Creatinine | Hemoglobin (g/dL) | 13.50 g/dL |
| Group 1: Vaccine | Chemistry Laboratory Measures: Hemoglobin, Creatinine | Creatinine (g/dL) | 0.00086 g/dL |
| Group 2: Vaccine | Chemistry Laboratory Measures: Hemoglobin, Creatinine | Hemoglobin (g/dL) | 12.75 g/dL |
| Group 2: Vaccine | Chemistry Laboratory Measures: Hemoglobin, Creatinine | Creatinine (g/dL) | 0.00087 g/dL |
| Group 3: Placebo | Chemistry Laboratory Measures: Hemoglobin, Creatinine | Hemoglobin (g/dL) | 12.90 g/dL |
| Group 3: Placebo | Chemistry Laboratory Measures: Hemoglobin, Creatinine | Creatinine (g/dL) | 0.00076 g/dL |
Primary
Hematology Laboratory Measures: WBC, Neutrophils , Lymphocytes and Platelets
For each chemistry laboratory measure, summary statistics were presented by analyte and treatment group for the overall population.
Time frame: Measured at 2 weeks after first vaccination
Population: The overall number of participants analyzed represents participants enrolled and eligible for laboratory assessment. Participants do not have laboratory assessments if they attended the visit but laboratory specimens were not collected, or they missed the scheduled visit, or they terminated participation in the study prior to the scheduled visit.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Group 1: Vaccine | Hematology Laboratory Measures: WBC, Neutrophils , Lymphocytes and Platelets | Neutrophils (1000/cubic mm) | 3.802 thousand cells/cubic mm |
| Group 1: Vaccine | Hematology Laboratory Measures: WBC, Neutrophils , Lymphocytes and Platelets | WBC (1000/cubic mm) | 6.10 thousand cells/cubic mm |
| Group 1: Vaccine | Hematology Laboratory Measures: WBC, Neutrophils , Lymphocytes and Platelets | Lymphocytes (1000/cubic mm) | 1.750 thousand cells/cubic mm |
| Group 1: Vaccine | Hematology Laboratory Measures: WBC, Neutrophils , Lymphocytes and Platelets | Platelets (1000/cubic mm) | 262 thousand cells/cubic mm |
| Group 2: Vaccine | Hematology Laboratory Measures: WBC, Neutrophils , Lymphocytes and Platelets | Platelets (1000/cubic mm) | 245.5 thousand cells/cubic mm |
| Group 2: Vaccine | Hematology Laboratory Measures: WBC, Neutrophils , Lymphocytes and Platelets | Lymphocytes (1000/cubic mm) | 1.483 thousand cells/cubic mm |
| Group 2: Vaccine | Hematology Laboratory Measures: WBC, Neutrophils , Lymphocytes and Platelets | WBC (1000/cubic mm) | 5.95 thousand cells/cubic mm |
| Group 2: Vaccine | Hematology Laboratory Measures: WBC, Neutrophils , Lymphocytes and Platelets | Neutrophils (1000/cubic mm) | 3.523 thousand cells/cubic mm |
| Group 3: Placebo | Hematology Laboratory Measures: WBC, Neutrophils , Lymphocytes and Platelets | WBC (1000/cubic mm) | 6.80 thousand cells/cubic mm |
| Group 3: Placebo | Hematology Laboratory Measures: WBC, Neutrophils , Lymphocytes and Platelets | Neutrophils (1000/cubic mm) | 4.114 thousand cells/cubic mm |
| Group 3: Placebo | Hematology Laboratory Measures: WBC, Neutrophils , Lymphocytes and Platelets | Lymphocytes (1000/cubic mm) | 1.780 thousand cells/cubic mm |
| Group 3: Placebo | Hematology Laboratory Measures: WBC, Neutrophils , Lymphocytes and Platelets | Platelets (1000/cubic mm) | 326 thousand cells/cubic mm |
Primary
Number of Participants Reporting Adverse Events (AEs), by Relationship to Study Product
Severity definitions are found in The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Corrected Version 2.1, dated July 2017); For participants reporting multiple AEs over the time frame, the maximum severity grade is counted.
Time frame: Measured through 30 days after first vaccination at Month 0
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1: Vaccine | Number of Participants Reporting Adverse Events (AEs), by Relationship to Study Product | No AE Reported | 16 Participants |
| Group 1: Vaccine | Number of Participants Reporting Adverse Events (AEs), by Relationship to Study Product | Related | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Adverse Events (AEs), by Relationship to Study Product | Not Related | 9 Participants |
| Group 2: Vaccine | Number of Participants Reporting Adverse Events (AEs), by Relationship to Study Product | No AE Reported | 12 Participants |
| Group 2: Vaccine | Number of Participants Reporting Adverse Events (AEs), by Relationship to Study Product | Not Related | 3 Participants |
| Group 2: Vaccine | Number of Participants Reporting Adverse Events (AEs), by Relationship to Study Product | Related | 0 Participants |
| Group 3: Placebo | Number of Participants Reporting Adverse Events (AEs), by Relationship to Study Product | No AE Reported | 5 Participants |
| Group 3: Placebo | Number of Participants Reporting Adverse Events (AEs), by Relationship to Study Product | Not Related | 0 Participants |
| Group 3: Placebo | Number of Participants Reporting Adverse Events (AEs), by Relationship to Study Product | Related | 0 Participants |
Primary
Number of Participants Reporting Adverse Events (AEs), by Severity Grade
Severity definitions are found in The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Corrected Version 2.1, dated July 2017); For participants reporting multiple AEs over the time frame, the maximum severity grade is counted.
Time frame: Measured through 30 days after first vaccination at Month 0
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1: Vaccine | Number of Participants Reporting Adverse Events (AEs), by Severity Grade | Potentially Life-threatening | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Adverse Events (AEs), by Severity Grade | Severe | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Adverse Events (AEs), by Severity Grade | Mild | 6 Participants |
| Group 1: Vaccine | Number of Participants Reporting Adverse Events (AEs), by Severity Grade | Moderate | 3 Participants |
| Group 1: Vaccine | Number of Participants Reporting Adverse Events (AEs), by Severity Grade | No AE Reported | 16 Participants |
| Group 2: Vaccine | Number of Participants Reporting Adverse Events (AEs), by Severity Grade | Severe | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Adverse Events (AEs), by Severity Grade | Mild | 1 Participants |
| Group 2: Vaccine | Number of Participants Reporting Adverse Events (AEs), by Severity Grade | Moderate | 2 Participants |
| Group 2: Vaccine | Number of Participants Reporting Adverse Events (AEs), by Severity Grade | Potentially Life-threatening | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Adverse Events (AEs), by Severity Grade | No AE Reported | 12 Participants |
| Group 3: Placebo | Number of Participants Reporting Adverse Events (AEs), by Severity Grade | No AE Reported | 5 Participants |
| Group 3: Placebo | Number of Participants Reporting Adverse Events (AEs), by Severity Grade | Potentially Life-threatening | 0 Participants |
| Group 3: Placebo | Number of Participants Reporting Adverse Events (AEs), by Severity Grade | Mild | 0 Participants |
| Group 3: Placebo | Number of Participants Reporting Adverse Events (AEs), by Severity Grade | Severe | 0 Participants |
| Group 3: Placebo | Number of Participants Reporting Adverse Events (AEs), by Severity Grade | Moderate | 0 Participants |
Primary
Number of Participants Reporting Local Reactogenicity Signs and Symptoms：Erythema and/or Induration
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events. Corrected Version 2.1, dated July 2017. The maximum grade observed for each symptom over the time frame is presented.
Time frame: Measured through 7 days after first vaccination at Month 0
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms：Erythema and/or Induration | Erythema and/or Induration | Grade 1: Less than 5 cm diameter | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms：Erythema and/or Induration | Erythema | Grade 4: complications | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms：Erythema and/or Induration | Induration | None | 25 Participants |
| Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms：Erythema and/or Induration | Erythema and/or Induration | Not Gradable | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms：Erythema and/or Induration | Erythema and/or Induration | None | 25 Participants |
| Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms：Erythema and/or Induration | Induration | Not Gradable | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms：Erythema and/or Induration | Erythema and/or Induration | Grade 3: Greater or equal to 100 cm sq | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms：Erythema and/or Induration | Induration | Grade 4: complications | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms：Erythema and/or Induration | Induration | Grade 1: Less than 5 cm diameter | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms：Erythema and/or Induration | Erythema | Grade 1: Between 6.25 to 25 cm sq area | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms：Erythema and/or Induration | Induration | Grade 3: complications | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms：Erythema and/or Induration | Induration | Grade 1: Between 6.25 to 25 cm sq area | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms：Erythema and/or Induration | Induration | Grade 3: Greater or equal to 100 cm sq | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms：Erythema and/or Induration | Induration | Grade 2: Between 5 to 10 cm diameter | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms：Erythema and/or Induration | Erythema and/or Induration | Grade 4: complications | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms：Erythema and/or Induration | Induration | Grade 3: Greater or equal to 10 cm | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms：Erythema and/or Induration | Induration | Grade 2: Between 25 to 100 cm sq area | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms：Erythema and/or Induration | Erythema and/or Induration | Grade 3: Greater or equal to 10 cm | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms：Erythema and/or Induration | Erythema and/or Induration | Grade 2: Between 25 to 100 cm sq area | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms：Erythema and/or Induration | Erythema | Grade 2: Between 25 to 100 cm sq area | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms：Erythema and/or Induration | Erythema | Not Gradable | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms：Erythema and/or Induration | Erythema and/or Induration | Grade 2: Between 5 to 10 cm diameter | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms：Erythema and/or Induration | Erythema | Grade 3: Greater or equal to 10 cm | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms：Erythema and/or Induration | Erythema | None | 25 Participants |
| Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms：Erythema and/or Induration | Erythema and/or Induration | Grade 1: Between 6.25 to 25 cm sq area | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms：Erythema and/or Induration | Erythema | Grade 3: Greater or equal to 100 cm sq | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms：Erythema and/or Induration | Erythema and/or Induration | Grade 3: complications | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms：Erythema and/or Induration | Erythema | Grade 2: Between 5 to 10 cm diameter | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms：Erythema and/or Induration | Erythema | Grade 3: complications | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms：Erythema and/or Induration | Erythema | Grade 1: Less than 5 cm diameter | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms：Erythema and/or Induration | Erythema and/or Induration | Grade 1: Less than 5 cm diameter | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms：Erythema and/or Induration | Erythema | Grade 2: Between 5 to 10 cm diameter | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms：Erythema and/or Induration | Induration | None | 15 Participants |
| Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms：Erythema and/or Induration | Induration | Grade 1: Between 6.25 to 25 cm sq area | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms：Erythema and/or Induration | Erythema and/or Induration | None | 15 Participants |
| Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms：Erythema and/or Induration | Erythema | None | 15 Participants |
| Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms：Erythema and/or Induration | Erythema | Not Gradable | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms：Erythema and/or Induration | Erythema | Grade 1: Less than 5 cm diameter | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms：Erythema and/or Induration | Erythema | Grade 1: Between 6.25 to 25 cm sq area | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms：Erythema and/or Induration | Erythema | Grade 2: Between 25 to 100 cm sq area | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms：Erythema and/or Induration | Erythema | Grade 3: Greater or equal to 10 cm | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms：Erythema and/or Induration | Erythema | Grade 3: Greater or equal to 100 cm sq | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms：Erythema and/or Induration | Erythema | Grade 3: complications | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms：Erythema and/or Induration | Erythema | Grade 4: complications | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms：Erythema and/or Induration | Induration | Not Gradable | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms：Erythema and/or Induration | Induration | Grade 1: Less than 5 cm diameter | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms：Erythema and/or Induration | Induration | Grade 2: Between 5 to 10 cm diameter | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms：Erythema and/or Induration | Induration | Grade 2: Between 25 to 100 cm sq area | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms：Erythema and/or Induration | Induration | Grade 3: Greater or equal to 10 cm | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms：Erythema and/or Induration | Induration | Grade 3: Greater or equal to 100 cm sq | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms：Erythema and/or Induration | Induration | Grade 3: complications | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms：Erythema and/or Induration | Induration | Grade 4: complications | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms：Erythema and/or Induration | Erythema and/or Induration | Not Gradable | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms：Erythema and/or Induration | Erythema and/or Induration | Grade 1: Between 6.25 to 25 cm sq area | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms：Erythema and/or Induration | Erythema and/or Induration | Grade 2: Between 5 to 10 cm diameter | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms：Erythema and/or Induration | Erythema and/or Induration | Grade 2: Between 25 to 100 cm sq area | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms：Erythema and/or Induration | Erythema and/or Induration | Grade 3: Greater or equal to 10 cm | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms：Erythema and/or Induration | Erythema and/or Induration | Grade 3: Greater or equal to 100 cm sq | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms：Erythema and/or Induration | Erythema and/or Induration | Grade 3: complications | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms：Erythema and/or Induration | Erythema and/or Induration | Grade 4: complications | 0 Participants |
| Group 3: Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms：Erythema and/or Induration | Induration | Grade 4: complications | 0 Participants |
| Group 3: Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms：Erythema and/or Induration | Induration | None | 5 Participants |
| Group 3: Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms：Erythema and/or Induration | Erythema and/or Induration | None | 5 Participants |
| Group 3: Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms：Erythema and/or Induration | Erythema | Grade 4: complications | 0 Participants |
| Group 3: Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms：Erythema and/or Induration | Erythema | None | 5 Participants |
| Group 3: Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms：Erythema and/or Induration | Erythema and/or Induration | Not Gradable | 0 Participants |
| Group 3: Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms：Erythema and/or Induration | Erythema | Grade 3: complications | 0 Participants |
| Group 3: Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms：Erythema and/or Induration | Erythema | Grade 3: Greater or equal to 100 cm sq | 0 Participants |
| Group 3: Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms：Erythema and/or Induration | Erythema and/or Induration | Grade 1: Less than 5 cm diameter | 0 Participants |
| Group 3: Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms：Erythema and/or Induration | Erythema | Grade 3: Greater or equal to 10 cm | 0 Participants |
| Group 3: Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms：Erythema and/or Induration | Erythema and/or Induration | Grade 3: Greater or equal to 100 cm sq | 0 Participants |
| Group 3: Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms：Erythema and/or Induration | Erythema and/or Induration | Grade 1: Between 6.25 to 25 cm sq area | 0 Participants |
| Group 3: Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms：Erythema and/or Induration | Erythema | Grade 2: Between 25 to 100 cm sq area | 0 Participants |
| Group 3: Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms：Erythema and/or Induration | Erythema | Not Gradable | 0 Participants |
| Group 3: Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms：Erythema and/or Induration | Erythema and/or Induration | Grade 2: Between 5 to 10 cm diameter | 0 Participants |
| Group 3: Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms：Erythema and/or Induration | Erythema | Grade 2: Between 5 to 10 cm diameter | 0 Participants |
| Group 3: Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms：Erythema and/or Induration | Erythema and/or Induration | Grade 4: complications | 0 Participants |
| Group 3: Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms：Erythema and/or Induration | Erythema and/or Induration | Grade 2: Between 25 to 100 cm sq area | 0 Participants |
| Group 3: Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms：Erythema and/or Induration | Induration | Grade 2: Between 25 to 100 cm sq area | 0 Participants |
| Group 3: Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms：Erythema and/or Induration | Induration | Grade 2: Between 5 to 10 cm diameter | 0 Participants |
| Group 3: Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms：Erythema and/or Induration | Erythema | Grade 1: Between 6.25 to 25 cm sq area | 0 Participants |
| Group 3: Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms：Erythema and/or Induration | Induration | Grade 3: Greater or equal to 10 cm | 0 Participants |
| Group 3: Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms：Erythema and/or Induration | Induration | Grade 1: Between 6.25 to 25 cm sq area | 0 Participants |
| Group 3: Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms：Erythema and/or Induration | Erythema and/or Induration | Grade 3: complications | 0 Participants |
| Group 3: Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms：Erythema and/or Induration | Induration | Grade 3: Greater or equal to 100 cm sq | 0 Participants |
| Group 3: Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms：Erythema and/or Induration | Induration | Grade 1: Less than 5 cm diameter | 0 Participants |
| Group 3: Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms：Erythema and/or Induration | Erythema and/or Induration | Grade 3: Greater or equal to 10 cm | 0 Participants |
| Group 3: Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms：Erythema and/or Induration | Induration | Grade 3: complications | 0 Participants |
| Group 3: Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms：Erythema and/or Induration | Induration | Not Gradable | 0 Participants |
| Group 3: Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms：Erythema and/or Induration | Erythema | Grade 1: Less than 5 cm diameter | 0 Participants |
Primary
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events. Corrected Version 2.1, dated July 2017. The maximum grade observed for each symptom over the time frame is presented.
Time frame: Measured through 7 days after first vaccination at Month 0
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Severe | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Moderate | 2 Participants |
| Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Pain and/or Tenderness None | 9 Participants |
| Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Mild | 14 Participants |
| Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Life Threatening | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Moderate | 1 Participants |
| Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Pain and/or Tenderness None | 4 Participants |
| Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Mild | 10 Participants |
| Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Severe | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Life Threatening | 0 Participants |
| Group 3: Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Life Threatening | 0 Participants |
| Group 3: Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Severe | 0 Participants |
| Group 3: Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Pain and/or Tenderness None | 4 Participants |
| Group 3: Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Moderate | 0 Participants |
| Group 3: Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Mild | 1 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 30 days after first vaccination at Month 0
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1: Vaccine | Number of Participants Reporting Serious Adverse Events (SAEs) | Non-SAE | 9 Participants |
| Group 1: Vaccine | Number of Participants Reporting Serious Adverse Events (SAEs) | SAE | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Serious Adverse Events (SAEs) | No AE Reported | 16 Participants |
| Group 2: Vaccine | Number of Participants Reporting Serious Adverse Events (SAEs) | Non-SAE | 3 Participants |
| Group 2: Vaccine | Number of Participants Reporting Serious Adverse Events (SAEs) | SAE | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Serious Adverse Events (SAEs) | No AE Reported | 12 Participants |
| Group 3: Placebo | Number of Participants Reporting Serious Adverse Events (SAEs) | SAE | 0 Participants |
| Group 3: Placebo | Number of Participants Reporting Serious Adverse Events (SAEs) | No AE Reported | 5 Participants |
| Group 3: Placebo | Number of Participants Reporting Serious Adverse Events (SAEs) | Non-SAE | 0 Participants |
Primary
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events. Corrected Version 2.1, dated July 2017. The following symptoms are considered as systemic reactogenicity if the onset date was within the periods of assessment specified in the protocol: malaise and/or fatigue, myalgia, headache, nausea, vomiting, chills, arthralgia, and body temperature. The item Max. Systemic Reaction is the maximum of the individual systemic variables for a participant. It does not include temperature.
Time frame: Measured through 7 days after first vaccination at Month 0
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Vomiting | Moderate | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Moderate | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Severe | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Vomiting | Mild | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Severe | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Moderate | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Vomiting | None | 25 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Life Threatening | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Mild | 6 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Life Threatening | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | None | 20 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Moderate | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Severe | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Mild | 5 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Severe | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Moderate | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Moderate | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Mild | 1 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Mild | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Severe | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Life Threatening | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | None | 25 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Life Threatening | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Life Threatening | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Life Threatening | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | None | 18 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | None | 24 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Severe | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Mild | 5 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | None | 17 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Moderate | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Moderate | 2 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | None | 24 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Mild | 1 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Severe | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Severe | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | None | 24 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Life Threatening | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Life Threatening | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Vomiting | Life Threatening | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | None | 23 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Mild | 1 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Vomiting | Severe | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Mild | 2 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Moderate | 2 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Severe | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Moderate | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Mild | 6 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Severe | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Life Threatening | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | None | 15 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Mild | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Moderate | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Life Threatening | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | None | 9 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Mild | 5 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Moderate | 1 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Severe | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Life Threatening | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | None | 11 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Mild | 4 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Moderate | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Severe | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Life Threatening | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | None | 13 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Mild | 2 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Moderate | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Severe | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Life Threatening | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | None | 15 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Mild | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Moderate | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Severe | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Life Threatening | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Vomiting | None | 15 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Vomiting | Mild | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Vomiting | Moderate | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Vomiting | Severe | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Vomiting | Life Threatening | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | None | 15 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Mild | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Severe | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Life Threatening | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | None | 14 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Mild | 1 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Moderate | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Severe | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Life Threatening | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | None | 8 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Moderate | 1 Participants |
| Group 3: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Mild | 0 Participants |
| Group 3: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Severe | 0 Participants |
| Group 3: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Vomiting | Moderate | 0 Participants |
| Group 3: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | None | 5 Participants |
| Group 3: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | None | 5 Participants |
| Group 3: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Vomiting | Severe | 0 Participants |
| Group 3: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Life Threatening | 0 Participants |
| Group 3: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Moderate | 1 Participants |
| Group 3: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Vomiting | Life Threatening | 0 Participants |
| Group 3: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Severe | 0 Participants |
| Group 3: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Life Threatening | 0 Participants |
| Group 3: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | None | 5 Participants |
| Group 3: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Moderate | 1 Participants |
| Group 3: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Life Threatening | 0 Participants |
| Group 3: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Mild | 0 Participants |
| Group 3: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Mild | 0 Participants |
| Group 3: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | None | 4 Participants |
| Group 3: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Moderate | 0 Participants |
| Group 3: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Severe | 0 Participants |
| Group 3: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Life Threatening | 0 Participants |
| Group 3: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | None | 2 Participants |
| Group 3: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Severe | 0 Participants |
| Group 3: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | None | 5 Participants |
| Group 3: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Severe | 0 Participants |
| Group 3: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Life Threatening | 0 Participants |
| Group 3: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Severe | 0 Participants |
| Group 3: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Mild | 2 Participants |
| Group 3: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | None | 4 Participants |
| Group 3: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Moderate | 0 Participants |
| Group 3: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Mild | 0 Participants |
| Group 3: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Mild | 1 Participants |
| Group 3: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Mild | 1 Participants |
| Group 3: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Moderate | 0 Participants |
| Group 3: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Moderate | 0 Participants |
| Group 3: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | None | 4 Participants |
| Group 3: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Life Threatening | 0 Participants |
| Group 3: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Severe | 0 Participants |
| Group 3: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Life Threatening | 0 Participants |
| Group 3: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Moderate | 0 Participants |
| Group 3: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Severe | 0 Participants |
| Group 3: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Mild | 0 Participants |
| Group 3: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Vomiting | None | 5 Participants |
| Group 3: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Moderate | 0 Participants |
| Group 3: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Life Threatening | 0 Participants |
| Group 3: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Vomiting | Mild | 0 Participants |
Secondary
Chemistry and Hematology Laboratory Results With Grade 1 or Higher, Through All Vaccinations
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, Month 0.5, 2.5, 6.5 and 9
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) |
|---|---|---|---|
| Group 1: Vaccine | Chemistry and Hematology Laboratory Results With Grade 1 or Higher, Through All Vaccinations | Lymphocytes (1000/cubic mm)-Day 14 | 0 Participants |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Results With Grade 1 or Higher, Through All Vaccinations | ALT (SGPT) (U/L)-Day 182 | 0 Participants |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Results With Grade 1 or Higher, Through All Vaccinations | Hemoglobin (g/dL)-Day 273 | 0 Participants |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Results With Grade 1 or Higher, Through All Vaccinations | Platelets (1000/cubic mm)-Day 273 | 0 Participants |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Results With Grade 1 or Higher, Through All Vaccinations | ALT (SGPT) (U/L)-Day 273 | 0 Participants |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Results With Grade 1 or Higher, Through All Vaccinations | Hemoglobin (g/dL)-Day 14 | 0 Participants |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Results With Grade 1 or Higher, Through All Vaccinations | Neutrophils (1000/cubic mm)-Day 182 | 0 Participants |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Results With Grade 1 or Higher, Through All Vaccinations | Creatinine (g/dL)-Screening | 0 Participants |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Results With Grade 1 or Higher, Through All Vaccinations | ALT (SGPT) (U/L)-Day 14 | 0 Participants |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Results With Grade 1 or Higher, Through All Vaccinations | Lymphocytes (1000/cubic mm)-Day 70 | 0 Participants |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Results With Grade 1 or Higher, Through All Vaccinations | Creatinine (g/dL)-Day 14 | 0 Participants |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Results With Grade 1 or Higher, Through All Vaccinations | Lymphocytes (1000/cubic mm)-Screening | 0 Participants |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Results With Grade 1 or Higher, Through All Vaccinations | Lymphocytes (1000/cubic mm)-Day 182 | 0 Participants |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Results With Grade 1 or Higher, Through All Vaccinations | Creatinine (g/dL)-Day 70 | 1 Participants |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Results With Grade 1 or Higher, Through All Vaccinations | Lymphocytes (1000/cubic mm)-Day 273 | 0 Participants |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Results With Grade 1 or Higher, Through All Vaccinations | Hemoglobin (g/dL)-Day 70 | 0 Participants |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Results With Grade 1 or Higher, Through All Vaccinations | Creatinine (g/dL)-Day 182 | 0 Participants |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Results With Grade 1 or Higher, Through All Vaccinations | Creatinine (g/dL)-Day 273 | 1 Participants |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Results With Grade 1 or Higher, Through All Vaccinations | WBC (1000/cubic mm)-Day 70 | 0 Participants |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Results With Grade 1 or Higher, Through All Vaccinations | WBC (1000/cubic mm)-Day 14 | 0 Participants |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Results With Grade 1 or Higher, Through All Vaccinations | WBC (1000/cubic mm)-Screening | 0 Participants |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Results With Grade 1 or Higher, Through All Vaccinations | Platelets (1000/cubic mm)-Screening | 0 Participants |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Results With Grade 1 or Higher, Through All Vaccinations | Hemoglobin (g/dL)-Screening | 0 Participants |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Results With Grade 1 or Higher, Through All Vaccinations | ALT (SGPT) (U/L)-Day 70 | 0 Participants |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Results With Grade 1 or Higher, Through All Vaccinations | Platelets (1000/cubic mm)-Day 70 | 0 Participants |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Results With Grade 1 or Higher, Through All Vaccinations | WBC (1000/cubic mm)-Day 182 | 0 Participants |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Results With Grade 1 or Higher, Through All Vaccinations | Neutrophils (1000/cubic mm)-Day 70 | 0 Participants |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Results With Grade 1 or Higher, Through All Vaccinations | Platelets (1000/cubic mm)-Day 14 | 0 Participants |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Results With Grade 1 or Higher, Through All Vaccinations | WBC (1000/cubic mm)-Day 273 | 0 Participants |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Results With Grade 1 or Higher, Through All Vaccinations | ALT (SGPT) (U/L)-Screening | 0 Participants |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Results With Grade 1 or Higher, Through All Vaccinations | Neutrophils (1000/cubic mm)-Day 273 | 0 Participants |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Results With Grade 1 or Higher, Through All Vaccinations | Neutrophils (1000/cubic mm)-Screening | 0 Participants |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Results With Grade 1 or Higher, Through All Vaccinations | Platelets (1000/cubic mm)-Day 182 | 0 Participants |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Results With Grade 1 or Higher, Through All Vaccinations | Hemoglobin (g/dL)-Day 182 | 0 Participants |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Results With Grade 1 or Higher, Through All Vaccinations | Neutrophils (1000/cubic mm)-Day 14 | 0 Participants |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Results With Grade 1 or Higher, Through All Vaccinations | WBC (1000/cubic mm)-Day 182 | 0 Participants |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Results With Grade 1 or Higher, Through All Vaccinations | Neutrophils (1000/cubic mm)-Day 70 | 0 Participants |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Results With Grade 1 or Higher, Through All Vaccinations | Neutrophils (1000/cubic mm)-Day 182 | 0 Participants |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Results With Grade 1 or Higher, Through All Vaccinations | Platelets (1000/cubic mm)-Day 273 | 0 Participants |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Results With Grade 1 or Higher, Through All Vaccinations | Neutrophils (1000/cubic mm)-Day 273 | 0 Participants |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Results With Grade 1 or Higher, Through All Vaccinations | Hemoglobin (g/dL)-Day 182 | 0 Participants |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Results With Grade 1 or Higher, Through All Vaccinations | Hemoglobin (g/dL)-Screening | 0 Participants |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Results With Grade 1 or Higher, Through All Vaccinations | Creatinine (g/dL)-Day 182 | 0 Participants |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Results With Grade 1 or Higher, Through All Vaccinations | Hemoglobin (g/dL)-Day 14 | 0 Participants |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Results With Grade 1 or Higher, Through All Vaccinations | Hemoglobin (g/dL)-Day 70 | 0 Participants |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Results With Grade 1 or Higher, Through All Vaccinations | ALT (SGPT) (U/L)-Screening | 0 Participants |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Results With Grade 1 or Higher, Through All Vaccinations | Hemoglobin (g/dL)-Day 273 | 0 Participants |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Results With Grade 1 or Higher, Through All Vaccinations | Lymphocytes (1000/cubic mm)-Screening | 0 Participants |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Results With Grade 1 or Higher, Through All Vaccinations | Lymphocytes (1000/cubic mm)-Day 70 | 0 Participants |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Results With Grade 1 or Higher, Through All Vaccinations | ALT (SGPT) (U/L)-Day 14 | 0 Participants |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Results With Grade 1 or Higher, Through All Vaccinations | Lymphocytes (1000/cubic mm)-Day 273 | 0 Participants |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Results With Grade 1 or Higher, Through All Vaccinations | Platelets (1000/cubic mm)-Screening | 0 Participants |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Results With Grade 1 or Higher, Through All Vaccinations | Platelets (1000/cubic mm)-Day 14 | 0 Participants |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Results With Grade 1 or Higher, Through All Vaccinations | ALT (SGPT) (U/L)-Day 70 | 0 Participants |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Results With Grade 1 or Higher, Through All Vaccinations | ALT (SGPT) (U/L)-Day 182 | 1 Participants |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Results With Grade 1 or Higher, Through All Vaccinations | Lymphocytes (1000/cubic mm)-Day 14 | 0 Participants |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Results With Grade 1 or Higher, Through All Vaccinations | ALT (SGPT) (U/L)-Day 273 | 0 Participants |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Results With Grade 1 or Higher, Through All Vaccinations | Neutrophils (1000/cubic mm)-Day 14 | 0 Participants |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Results With Grade 1 or Higher, Through All Vaccinations | Creatinine (g/dL)-Screening | 0 Participants |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Results With Grade 1 or Higher, Through All Vaccinations | Creatinine (g/dL)-Day 14 | 0 Participants |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Results With Grade 1 or Higher, Through All Vaccinations | Creatinine (g/dL)-Day 70 | 0 Participants |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Results With Grade 1 or Higher, Through All Vaccinations | Lymphocytes (1000/cubic mm)-Day 182 | 0 Participants |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Results With Grade 1 or Higher, Through All Vaccinations | Creatinine (g/dL)-Day 273 | 0 Participants |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Results With Grade 1 or Higher, Through All Vaccinations | WBC (1000/cubic mm)-Screening | 0 Participants |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Results With Grade 1 or Higher, Through All Vaccinations | WBC (1000/cubic mm)-Day 14 | 0 Participants |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Results With Grade 1 or Higher, Through All Vaccinations | WBC (1000/cubic mm)-Day 70 | 0 Participants |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Results With Grade 1 or Higher, Through All Vaccinations | Platelets (1000/cubic mm)-Day 70 | 0 Participants |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Results With Grade 1 or Higher, Through All Vaccinations | WBC (1000/cubic mm)-Day 273 | 0 Participants |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Results With Grade 1 or Higher, Through All Vaccinations | Platelets (1000/cubic mm)-Day 182 | 0 Participants |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Results With Grade 1 or Higher, Through All Vaccinations | Neutrophils (1000/cubic mm)-Screening | 0 Participants |
| Group 3: Placebo | Chemistry and Hematology Laboratory Results With Grade 1 or Higher, Through All Vaccinations | Hemoglobin (g/dL)-Day 273 | 0 Participants |
| Group 3: Placebo | Chemistry and Hematology Laboratory Results With Grade 1 or Higher, Through All Vaccinations | WBC (1000/cubic mm)-Day 14 | 0 Participants |
| Group 3: Placebo | Chemistry and Hematology Laboratory Results With Grade 1 or Higher, Through All Vaccinations | Neutrophils (1000/cubic mm)-Day 14 | 0 Participants |
| Group 3: Placebo | Chemistry and Hematology Laboratory Results With Grade 1 or Higher, Through All Vaccinations | Lymphocytes (1000/cubic mm)-Screening | 0 Participants |
| Group 3: Placebo | Chemistry and Hematology Laboratory Results With Grade 1 or Higher, Through All Vaccinations | Lymphocytes (1000/cubic mm)-Day 14 | 0 Participants |
| Group 3: Placebo | Chemistry and Hematology Laboratory Results With Grade 1 or Higher, Through All Vaccinations | Platelets (1000/cubic mm)-Day 14 | 0 Participants |
| Group 3: Placebo | Chemistry and Hematology Laboratory Results With Grade 1 or Higher, Through All Vaccinations | Platelets (1000/cubic mm)-Day 182 | 0 Participants |
| Group 3: Placebo | Chemistry and Hematology Laboratory Results With Grade 1 or Higher, Through All Vaccinations | Platelets (1000/cubic mm)-Day 273 | 0 Participants |
| Group 3: Placebo | Chemistry and Hematology Laboratory Results With Grade 1 or Higher, Through All Vaccinations | Creatinine (g/dL)-Day 182 | 0 Participants |
| Group 3: Placebo | Chemistry and Hematology Laboratory Results With Grade 1 or Higher, Through All Vaccinations | ALT (SGPT) (U/L)-Screening | 0 Participants |
| Group 3: Placebo | Chemistry and Hematology Laboratory Results With Grade 1 or Higher, Through All Vaccinations | ALT (SGPT) (U/L)-Day 14 | 0 Participants |
| Group 3: Placebo | Chemistry and Hematology Laboratory Results With Grade 1 or Higher, Through All Vaccinations | ALT (SGPT) (U/L)-Day 70 | 0 Participants |
| Group 3: Placebo | Chemistry and Hematology Laboratory Results With Grade 1 or Higher, Through All Vaccinations | ALT (SGPT) (U/L)-Day 182 | 0 Participants |
| Group 3: Placebo | Chemistry and Hematology Laboratory Results With Grade 1 or Higher, Through All Vaccinations | ALT (SGPT) (U/L)-Day 273 | 0 Participants |
| Group 3: Placebo | Chemistry and Hematology Laboratory Results With Grade 1 or Higher, Through All Vaccinations | Creatinine (g/dL)-Screening | 0 Participants |
| Group 3: Placebo | Chemistry and Hematology Laboratory Results With Grade 1 or Higher, Through All Vaccinations | Creatinine (g/dL)-Day 14 | 0 Participants |
| Group 3: Placebo | Chemistry and Hematology Laboratory Results With Grade 1 or Higher, Through All Vaccinations | Creatinine (g/dL)-Day 70 | 0 Participants |
| Group 3: Placebo | Chemistry and Hematology Laboratory Results With Grade 1 or Higher, Through All Vaccinations | Creatinine (g/dL)-Day 273 | 0 Participants |
| Group 3: Placebo | Chemistry and Hematology Laboratory Results With Grade 1 or Higher, Through All Vaccinations | WBC (1000/cubic mm)-Day 70 | 0 Participants |
| Group 3: Placebo | Chemistry and Hematology Laboratory Results With Grade 1 or Higher, Through All Vaccinations | WBC (1000/cubic mm)-Day 182 | 0 Participants |
| Group 3: Placebo | Chemistry and Hematology Laboratory Results With Grade 1 or Higher, Through All Vaccinations | WBC (1000/cubic mm)-Day 273 | 0 Participants |
| Group 3: Placebo | Chemistry and Hematology Laboratory Results With Grade 1 or Higher, Through All Vaccinations | Neutrophils (1000/cubic mm)-Screening | 0 Participants |
| Group 3: Placebo | Chemistry and Hematology Laboratory Results With Grade 1 or Higher, Through All Vaccinations | Neutrophils (1000/cubic mm)-Day 70 | 0 Participants |
| Group 3: Placebo | Chemistry and Hematology Laboratory Results With Grade 1 or Higher, Through All Vaccinations | Neutrophils (1000/cubic mm)-Day 182 | 0 Participants |
| Group 3: Placebo | Chemistry and Hematology Laboratory Results With Grade 1 or Higher, Through All Vaccinations | Neutrophils (1000/cubic mm)-Day 273 | 0 Participants |
| Group 3: Placebo | Chemistry and Hematology Laboratory Results With Grade 1 or Higher, Through All Vaccinations | Hemoglobin (g/dL)-Screening | 0 Participants |
| Group 3: Placebo | Chemistry and Hematology Laboratory Results With Grade 1 or Higher, Through All Vaccinations | Hemoglobin (g/dL)-Day 14 | 0 Participants |
| Group 3: Placebo | Chemistry and Hematology Laboratory Results With Grade 1 or Higher, Through All Vaccinations | Hemoglobin (g/dL)-Day 70 | 0 Participants |
| Group 3: Placebo | Chemistry and Hematology Laboratory Results With Grade 1 or Higher, Through All Vaccinations | Hemoglobin (g/dL)-Day 182 | 0 Participants |
| Group 3: Placebo | Chemistry and Hematology Laboratory Results With Grade 1 or Higher, Through All Vaccinations | WBC (1000/cubic mm)-Screening | 0 Participants |
| Group 3: Placebo | Chemistry and Hematology Laboratory Results With Grade 1 or Higher, Through All Vaccinations | Lymphocytes (1000/cubic mm)-Day 70 | 0 Participants |
| Group 3: Placebo | Chemistry and Hematology Laboratory Results With Grade 1 or Higher, Through All Vaccinations | Lymphocytes (1000/cubic mm)-Day 182 | 0 Participants |
| Group 3: Placebo | Chemistry and Hematology Laboratory Results With Grade 1 or Higher, Through All Vaccinations | Lymphocytes (1000/cubic mm)-Day 273 | 0 Participants |
| Group 3: Placebo | Chemistry and Hematology Laboratory Results With Grade 1 or Higher, Through All Vaccinations | Platelets (1000/cubic mm)-Screening | 0 Participants |
| Group 3: Placebo | Chemistry and Hematology Laboratory Results With Grade 1 or Higher, Through All Vaccinations | Platelets (1000/cubic mm)-Day 70 | 0 Participants |
Secondary
Chemistry Laboratory Measures: ALT, Through All Vaccinations
For each chemistry laboratory measure, summary statistics were presented by analyte and treatment group for the overall population.
Time frame: Measured during Screening, Month 0.5, 2.5, 6.5 and 9
Population: The overall number of participants analyzed represents participants enrolled and eligible for laboratory assessment. Participants do not have laboratory assessments if they attended the visit but laboratory specimens were not collected, or they missed the scheduled visit, or they terminated participation in the study prior to the scheduled visit.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Group 1: Vaccine | Chemistry Laboratory Measures: ALT, Through All Vaccinations | ALT (SGPT) (U/L)-Screening | 13 U/L |
| Group 1: Vaccine | Chemistry Laboratory Measures: ALT, Through All Vaccinations | ALT (SGPT) (U/L)-Day 14 | 14 U/L |
| Group 1: Vaccine | Chemistry Laboratory Measures: ALT, Through All Vaccinations | ALT (SGPT) (U/L)-Day 70 | 12 U/L |
| Group 1: Vaccine | Chemistry Laboratory Measures: ALT, Through All Vaccinations | ALT (SGPT) (U/L)-Day 182 | 13 U/L |
| Group 1: Vaccine | Chemistry Laboratory Measures: ALT, Through All Vaccinations | ALT (SGPT) (U/L)-Day 273 | 13 U/L |
| Group 2: Vaccine | Chemistry Laboratory Measures: ALT, Through All Vaccinations | ALT (SGPT) (U/L)-Day 14 | 15 U/L |
| Group 2: Vaccine | Chemistry Laboratory Measures: ALT, Through All Vaccinations | ALT (SGPT) (U/L)-Screening | 14 U/L |
| Group 2: Vaccine | Chemistry Laboratory Measures: ALT, Through All Vaccinations | ALT (SGPT) (U/L)-Day 182 | 15 U/L |
| Group 2: Vaccine | Chemistry Laboratory Measures: ALT, Through All Vaccinations | ALT (SGPT) (U/L)-Day 273 | 15 U/L |
| Group 2: Vaccine | Chemistry Laboratory Measures: ALT, Through All Vaccinations | ALT (SGPT) (U/L)-Day 70 | 16 U/L |
| Group 3: Placebo | Chemistry Laboratory Measures: ALT, Through All Vaccinations | ALT (SGPT) (U/L)-Day 273 | 15 U/L |
| Group 3: Placebo | Chemistry Laboratory Measures: ALT, Through All Vaccinations | ALT (SGPT) (U/L)-Day 14 | 14 U/L |
| Group 3: Placebo | Chemistry Laboratory Measures: ALT, Through All Vaccinations | ALT (SGPT) (U/L)-Day 70 | 12 U/L |
| Group 3: Placebo | Chemistry Laboratory Measures: ALT, Through All Vaccinations | ALT (SGPT) (U/L)-Screening | 15 U/L |
| Group 3: Placebo | Chemistry Laboratory Measures: ALT, Through All Vaccinations | ALT (SGPT) (U/L)-Day 182 | 14 U/L |
Secondary
Chemistry Laboratory Measures: Hemoglobin, Creatinine, Through All Vaccinations
For each chemistry laboratory measure, summary statistics were presented by analyte and treatment group for the overall population.
Time frame: Measured during Screening, Month 0.5, 2.5, 6.5 and 9
Population: The overall number of participants analyzed represents participants enrolled and eligible for laboratory assessment. Participants do not have laboratory assessments if they attended the visit but laboratory specimens were not collected, or they missed the scheduled visit, or they terminated participation in the study prior to the scheduled visit.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Group 1: Vaccine | Chemistry Laboratory Measures: Hemoglobin, Creatinine, Through All Vaccinations | Hemoglobin (g/dL)-Day 70 | 13.40 g/dL |
| Group 1: Vaccine | Chemistry Laboratory Measures: Hemoglobin, Creatinine, Through All Vaccinations | Creatinine (g/dL)-Day 70 | .00084 g/dL |
| Group 1: Vaccine | Chemistry Laboratory Measures: Hemoglobin, Creatinine, Through All Vaccinations | Hemoglobin (g/dL)-Day 273 | 13.60 g/dL |
| Group 1: Vaccine | Chemistry Laboratory Measures: Hemoglobin, Creatinine, Through All Vaccinations | Creatinine (g/dL)-Day 273 | .00087 g/dL |
| Group 1: Vaccine | Chemistry Laboratory Measures: Hemoglobin, Creatinine, Through All Vaccinations | Creatinine (g/dL)-Day 182 | .00086 g/dL |
| Group 1: Vaccine | Chemistry Laboratory Measures: Hemoglobin, Creatinine, Through All Vaccinations | Hemoglobin (g/dL)-Screening | 14.20 g/dL |
| Group 1: Vaccine | Chemistry Laboratory Measures: Hemoglobin, Creatinine, Through All Vaccinations | Hemoglobin (g/dL)-Day 182 | 13.55 g/dL |
| Group 1: Vaccine | Chemistry Laboratory Measures: Hemoglobin, Creatinine, Through All Vaccinations | Hemoglobin (g/dL)-Day 14 | 13.50 g/dL |
| Group 1: Vaccine | Chemistry Laboratory Measures: Hemoglobin, Creatinine, Through All Vaccinations | Creatinine (g/dL)-Day 14 | .00086 g/dL |
| Group 1: Vaccine | Chemistry Laboratory Measures: Hemoglobin, Creatinine, Through All Vaccinations | Creatinine (g/dL)-Screening | .00082 g/dL |
| Group 2: Vaccine | Chemistry Laboratory Measures: Hemoglobin, Creatinine, Through All Vaccinations | Creatinine (g/dL)-Day 182 | .00079 g/dL |
| Group 2: Vaccine | Chemistry Laboratory Measures: Hemoglobin, Creatinine, Through All Vaccinations | Hemoglobin (g/dL)-Screening | 13.60 g/dL |
| Group 2: Vaccine | Chemistry Laboratory Measures: Hemoglobin, Creatinine, Through All Vaccinations | Hemoglobin (g/dL)-Day 14 | 12.75 g/dL |
| Group 2: Vaccine | Chemistry Laboratory Measures: Hemoglobin, Creatinine, Through All Vaccinations | Hemoglobin (g/dL)-Day 182 | 13.30 g/dL |
| Group 2: Vaccine | Chemistry Laboratory Measures: Hemoglobin, Creatinine, Through All Vaccinations | Creatinine (g/dL)-Day 14 | .00087 g/dL |
| Group 2: Vaccine | Chemistry Laboratory Measures: Hemoglobin, Creatinine, Through All Vaccinations | Creatinine (g/dL)-Day 70 | .00081 g/dL |
| Group 2: Vaccine | Chemistry Laboratory Measures: Hemoglobin, Creatinine, Through All Vaccinations | Creatinine (g/dL)-Day 273 | .00080 g/dL |
| Group 2: Vaccine | Chemistry Laboratory Measures: Hemoglobin, Creatinine, Through All Vaccinations | Hemoglobin (g/dL)-Day 70 | 13.90 g/dL |
| Group 2: Vaccine | Chemistry Laboratory Measures: Hemoglobin, Creatinine, Through All Vaccinations | Hemoglobin (g/dL)-Day 273 | 13.45 g/dL |
| Group 2: Vaccine | Chemistry Laboratory Measures: Hemoglobin, Creatinine, Through All Vaccinations | Creatinine (g/dL)-Screening | .00084 g/dL |
| Group 3: Placebo | Chemistry Laboratory Measures: Hemoglobin, Creatinine, Through All Vaccinations | Creatinine (g/dL)-Day 14 | .00076 g/dL |
| Group 3: Placebo | Chemistry Laboratory Measures: Hemoglobin, Creatinine, Through All Vaccinations | Hemoglobin (g/dL)-Screening | 14.20 g/dL |
| Group 3: Placebo | Chemistry Laboratory Measures: Hemoglobin, Creatinine, Through All Vaccinations | Hemoglobin (g/dL)-Day 70 | 13.30 g/dL |
| Group 3: Placebo | Chemistry Laboratory Measures: Hemoglobin, Creatinine, Through All Vaccinations | Hemoglobin (g/dL)-Day 182 | 13.40 g/dL |
| Group 3: Placebo | Chemistry Laboratory Measures: Hemoglobin, Creatinine, Through All Vaccinations | Hemoglobin (g/dL)-Day 14 | 12.90 g/dL |
| Group 3: Placebo | Chemistry Laboratory Measures: Hemoglobin, Creatinine, Through All Vaccinations | Creatinine (g/dL)-Screening | .00078 g/dL |
| Group 3: Placebo | Chemistry Laboratory Measures: Hemoglobin, Creatinine, Through All Vaccinations | Creatinine (g/dL)-Day 182 | .00083 g/dL |
| Group 3: Placebo | Chemistry Laboratory Measures: Hemoglobin, Creatinine, Through All Vaccinations | Creatinine (g/dL)-Day 70 | .00079 g/dL |
| Group 3: Placebo | Chemistry Laboratory Measures: Hemoglobin, Creatinine, Through All Vaccinations | Hemoglobin (g/dL)-Day 273 | 13.80 g/dL |
| Group 3: Placebo | Chemistry Laboratory Measures: Hemoglobin, Creatinine, Through All Vaccinations | Creatinine (g/dL)-Day 273 | .00084 g/dL |
Secondary
Frequency of 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 12
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1: Vaccine | Frequency of Serious Adverse Events (SAEs) | Non-SAE | 14 Participants |
| Group 1: Vaccine | Frequency of Serious Adverse Events (SAEs) | SAE | 1 Participants |
| Group 1: Vaccine | Frequency of Serious Adverse Events (SAEs) | No Adverse Event Reported | 10 Participants |
| Group 2: Vaccine | Frequency of Serious Adverse Events (SAEs) | Non-SAE | 8 Participants |
| Group 2: Vaccine | Frequency of Serious Adverse Events (SAEs) | SAE | 0 Participants |
| Group 2: Vaccine | Frequency of Serious Adverse Events (SAEs) | No Adverse Event Reported | 7 Participants |
| Group 3: Placebo | Frequency of Serious Adverse Events (SAEs) | SAE | 0 Participants |
| Group 3: Placebo | Frequency of Serious Adverse Events (SAEs) | No Adverse Event Reported | 1 Participants |
| Group 3: Placebo | Frequency of Serious Adverse Events (SAEs) | Non-SAE | 4 Participants |
Secondary
Hematology Laboratory Measures: WBC, Platelets, Lymphocytes, Neutrophils , Through All Vaccinations
For each chemistry laboratory measure, summary statistics were presented by analyte and treatment group for the overall population.
Time frame: Measured during Screening, Month 0.5, 2.5, 6.5 and 9
Population: The overall number of participants analyzed represents participants enrolled and eligible for laboratory assessment. Participants do not have laboratory assessments if they attended the visit but laboratory specimens were not collected, or they missed the scheduled visit, or they terminated participation in the study prior to the scheduled visit.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Group 1: Vaccine | Hematology Laboratory Measures: WBC, Platelets, Lymphocytes, Neutrophils , Through All Vaccinations | WBC (1000/cubic mm)-Day 273 | 6.75 thousand cells/cubic mm |
| Group 1: Vaccine | Hematology Laboratory Measures: WBC, Platelets, Lymphocytes, Neutrophils , Through All Vaccinations | Platelets (1000/cubic mm)-Day 14 | 262.0 thousand cells/cubic mm |
| Group 1: Vaccine | Hematology Laboratory Measures: WBC, Platelets, Lymphocytes, Neutrophils , Through All Vaccinations | Neutrophils (1000/cubic mm)-Day 273 | 4.061 thousand cells/cubic mm |
| Group 1: Vaccine | Hematology Laboratory Measures: WBC, Platelets, Lymphocytes, Neutrophils , Through All Vaccinations | WBC (1000/cubic mm)-Day 70 | 6.00 thousand cells/cubic mm |
| Group 1: Vaccine | Hematology Laboratory Measures: WBC, Platelets, Lymphocytes, Neutrophils , Through All Vaccinations | Platelets (1000/cubic mm)-Screening | 256.0 thousand cells/cubic mm |
| Group 1: Vaccine | Hematology Laboratory Measures: WBC, Platelets, Lymphocytes, Neutrophils , Through All Vaccinations | Lymphocytes (1000/cubic mm)-Screening | 1.670 thousand cells/cubic mm |
| Group 1: Vaccine | Hematology Laboratory Measures: WBC, Platelets, Lymphocytes, Neutrophils , Through All Vaccinations | Lymphocytes (1000/cubic mm)-Day 182 | 1.818 thousand cells/cubic mm |
| Group 1: Vaccine | Hematology Laboratory Measures: WBC, Platelets, Lymphocytes, Neutrophils , Through All Vaccinations | Lymphocytes (1000/cubic mm)-Day 273 | 2.166 thousand cells/cubic mm |
| Group 1: Vaccine | Hematology Laboratory Measures: WBC, Platelets, Lymphocytes, Neutrophils , Through All Vaccinations | Lymphocytes (1000/cubic mm)-Day 14 | 1.750 thousand cells/cubic mm |
| Group 1: Vaccine | Hematology Laboratory Measures: WBC, Platelets, Lymphocytes, Neutrophils , Through All Vaccinations | Neutrophils (1000/cubic mm)-Screening | 3.910 thousand cells/cubic mm |
| Group 1: Vaccine | Hematology Laboratory Measures: WBC, Platelets, Lymphocytes, Neutrophils , Through All Vaccinations | Lymphocytes (1000/cubic mm)-Day 70 | 1.825 thousand cells/cubic mm |
| Group 1: Vaccine | Hematology Laboratory Measures: WBC, Platelets, Lymphocytes, Neutrophils , Through All Vaccinations | Platelets (1000/cubic mm)-Day 182 | 272.5 thousand cells/cubic mm |
| Group 1: Vaccine | Hematology Laboratory Measures: WBC, Platelets, Lymphocytes, Neutrophils , Through All Vaccinations | WBC (1000/cubic mm)-Day 14 | 6.10 thousand cells/cubic mm |
| Group 1: Vaccine | Hematology Laboratory Measures: WBC, Platelets, Lymphocytes, Neutrophils , Through All Vaccinations | Neutrophils (1000/cubic mm)-Day 14 | 3.802 thousand cells/cubic mm |
| Group 1: Vaccine | Hematology Laboratory Measures: WBC, Platelets, Lymphocytes, Neutrophils , Through All Vaccinations | Platelets (1000/cubic mm)-Day 70 | 262.0 thousand cells/cubic mm |
| Group 1: Vaccine | Hematology Laboratory Measures: WBC, Platelets, Lymphocytes, Neutrophils , Through All Vaccinations | WBC (1000/cubic mm)-Screening | 6.20 thousand cells/cubic mm |
| Group 1: Vaccine | Hematology Laboratory Measures: WBC, Platelets, Lymphocytes, Neutrophils , Through All Vaccinations | Neutrophils (1000/cubic mm)-Day 70 | 3.715 thousand cells/cubic mm |
| Group 1: Vaccine | Hematology Laboratory Measures: WBC, Platelets, Lymphocytes, Neutrophils , Through All Vaccinations | WBC (1000/cubic mm)-Day 182 | 5.90 thousand cells/cubic mm |
| Group 1: Vaccine | Hematology Laboratory Measures: WBC, Platelets, Lymphocytes, Neutrophils , Through All Vaccinations | Platelets (1000/cubic mm)-Day 273 | 261.5 thousand cells/cubic mm |
| Group 1: Vaccine | Hematology Laboratory Measures: WBC, Platelets, Lymphocytes, Neutrophils , Through All Vaccinations | Neutrophils (1000/cubic mm)-Day 182 | 3.307 thousand cells/cubic mm |
| Group 2: Vaccine | Hematology Laboratory Measures: WBC, Platelets, Lymphocytes, Neutrophils , Through All Vaccinations | WBC (1000/cubic mm)-Screening | 6.45 thousand cells/cubic mm |
| Group 2: Vaccine | Hematology Laboratory Measures: WBC, Platelets, Lymphocytes, Neutrophils , Through All Vaccinations | WBC (1000/cubic mm)-Day 14 | 5.95 thousand cells/cubic mm |
| Group 2: Vaccine | Hematology Laboratory Measures: WBC, Platelets, Lymphocytes, Neutrophils , Through All Vaccinations | WBC (1000/cubic mm)-Day 70 | 7.19 thousand cells/cubic mm |
| Group 2: Vaccine | Hematology Laboratory Measures: WBC, Platelets, Lymphocytes, Neutrophils , Through All Vaccinations | WBC (1000/cubic mm)-Day 273 | 6.85 thousand cells/cubic mm |
| Group 2: Vaccine | Hematology Laboratory Measures: WBC, Platelets, Lymphocytes, Neutrophils , Through All Vaccinations | Neutrophils (1000/cubic mm)-Screening | 4.180 thousand cells/cubic mm |
| Group 2: Vaccine | Hematology Laboratory Measures: WBC, Platelets, Lymphocytes, Neutrophils , Through All Vaccinations | Neutrophils (1000/cubic mm)-Day 14 | 3.523 thousand cells/cubic mm |
| Group 2: Vaccine | Hematology Laboratory Measures: WBC, Platelets, Lymphocytes, Neutrophils , Through All Vaccinations | Neutrophils (1000/cubic mm)-Day 70 | 4.480 thousand cells/cubic mm |
| Group 2: Vaccine | Hematology Laboratory Measures: WBC, Platelets, Lymphocytes, Neutrophils , Through All Vaccinations | Neutrophils (1000/cubic mm)-Day 182 | 3.930 thousand cells/cubic mm |
| Group 2: Vaccine | Hematology Laboratory Measures: WBC, Platelets, Lymphocytes, Neutrophils , Through All Vaccinations | Neutrophils (1000/cubic mm)-Day 273 | 3.998 thousand cells/cubic mm |
| Group 2: Vaccine | Hematology Laboratory Measures: WBC, Platelets, Lymphocytes, Neutrophils , Through All Vaccinations | Lymphocytes (1000/cubic mm)-Screening | 1.970 thousand cells/cubic mm |
| Group 2: Vaccine | Hematology Laboratory Measures: WBC, Platelets, Lymphocytes, Neutrophils , Through All Vaccinations | Lymphocytes (1000/cubic mm)-Day 14 | 1.483 thousand cells/cubic mm |
| Group 2: Vaccine | Hematology Laboratory Measures: WBC, Platelets, Lymphocytes, Neutrophils , Through All Vaccinations | Lymphocytes (1000/cubic mm)-Day 70 | 1.975 thousand cells/cubic mm |
| Group 2: Vaccine | Hematology Laboratory Measures: WBC, Platelets, Lymphocytes, Neutrophils , Through All Vaccinations | Lymphocytes (1000/cubic mm)-Day 273 | 2.184 thousand cells/cubic mm |
| Group 2: Vaccine | Hematology Laboratory Measures: WBC, Platelets, Lymphocytes, Neutrophils , Through All Vaccinations | Platelets (1000/cubic mm)-Screening | 242.0 thousand cells/cubic mm |
| Group 2: Vaccine | Hematology Laboratory Measures: WBC, Platelets, Lymphocytes, Neutrophils , Through All Vaccinations | Platelets (1000/cubic mm)-Day 273 | 250.0 thousand cells/cubic mm |
| Group 2: Vaccine | Hematology Laboratory Measures: WBC, Platelets, Lymphocytes, Neutrophils , Through All Vaccinations | WBC (1000/cubic mm)-Day 182 | 7.15 thousand cells/cubic mm |
| Group 2: Vaccine | Hematology Laboratory Measures: WBC, Platelets, Lymphocytes, Neutrophils , Through All Vaccinations | Lymphocytes (1000/cubic mm)-Day 182 | 1.814 thousand cells/cubic mm |
| Group 2: Vaccine | Hematology Laboratory Measures: WBC, Platelets, Lymphocytes, Neutrophils , Through All Vaccinations | Platelets (1000/cubic mm)-Day 14 | 245.5 thousand cells/cubic mm |
| Group 2: Vaccine | Hematology Laboratory Measures: WBC, Platelets, Lymphocytes, Neutrophils , Through All Vaccinations | Platelets (1000/cubic mm)-Day 70 | 239.0 thousand cells/cubic mm |
| Group 2: Vaccine | Hematology Laboratory Measures: WBC, Platelets, Lymphocytes, Neutrophils , Through All Vaccinations | Platelets (1000/cubic mm)-Day 182 | 254.0 thousand cells/cubic mm |
| Group 3: Placebo | Hematology Laboratory Measures: WBC, Platelets, Lymphocytes, Neutrophils , Through All Vaccinations | Neutrophils (1000/cubic mm)-Day 182 | 3.995 thousand cells/cubic mm |
| Group 3: Placebo | Hematology Laboratory Measures: WBC, Platelets, Lymphocytes, Neutrophils , Through All Vaccinations | Neutrophils (1000/cubic mm)-Day 70 | 4.040 thousand cells/cubic mm |
| Group 3: Placebo | Hematology Laboratory Measures: WBC, Platelets, Lymphocytes, Neutrophils , Through All Vaccinations | WBC (1000/cubic mm)-Day 70 | 7.00 thousand cells/cubic mm |
| Group 3: Placebo | Hematology Laboratory Measures: WBC, Platelets, Lymphocytes, Neutrophils , Through All Vaccinations | Platelets (1000/cubic mm)-Day 273 | 340.0 thousand cells/cubic mm |
| Group 3: Placebo | Hematology Laboratory Measures: WBC, Platelets, Lymphocytes, Neutrophils , Through All Vaccinations | Neutrophils (1000/cubic mm)-Day 14 | 4.114 thousand cells/cubic mm |
| Group 3: Placebo | Hematology Laboratory Measures: WBC, Platelets, Lymphocytes, Neutrophils , Through All Vaccinations | Neutrophils (1000/cubic mm)-Screening | 3.860 thousand cells/cubic mm |
| Group 3: Placebo | Hematology Laboratory Measures: WBC, Platelets, Lymphocytes, Neutrophils , Through All Vaccinations | WBC (1000/cubic mm)-Screening | 6.38 thousand cells/cubic mm |
| Group 3: Placebo | Hematology Laboratory Measures: WBC, Platelets, Lymphocytes, Neutrophils , Through All Vaccinations | Platelets (1000/cubic mm)-Day 182 | 342.5 thousand cells/cubic mm |
| Group 3: Placebo | Hematology Laboratory Measures: WBC, Platelets, Lymphocytes, Neutrophils , Through All Vaccinations | WBC (1000/cubic mm)-Day 182 | 7.00 thousand cells/cubic mm |
| Group 3: Placebo | Hematology Laboratory Measures: WBC, Platelets, Lymphocytes, Neutrophils , Through All Vaccinations | Lymphocytes (1000/cubic mm)-Day 70 | 1.888 thousand cells/cubic mm |
| Group 3: Placebo | Hematology Laboratory Measures: WBC, Platelets, Lymphocytes, Neutrophils , Through All Vaccinations | WBC (1000/cubic mm)-Day 273 | 6.80 thousand cells/cubic mm |
| Group 3: Placebo | Hematology Laboratory Measures: WBC, Platelets, Lymphocytes, Neutrophils , Through All Vaccinations | Lymphocytes (1000/cubic mm)-Day 14 | 1.780 thousand cells/cubic mm |
| Group 3: Placebo | Hematology Laboratory Measures: WBC, Platelets, Lymphocytes, Neutrophils , Through All Vaccinations | Platelets (1000/cubic mm)-Day 70 | 318.0 thousand cells/cubic mm |
| Group 3: Placebo | Hematology Laboratory Measures: WBC, Platelets, Lymphocytes, Neutrophils , Through All Vaccinations | Lymphocytes (1000/cubic mm)-Day 182 | 2.164 thousand cells/cubic mm |
| Group 3: Placebo | Hematology Laboratory Measures: WBC, Platelets, Lymphocytes, Neutrophils , Through All Vaccinations | Lymphocytes (1000/cubic mm)-Screening | 1.872 thousand cells/cubic mm |
| Group 3: Placebo | Hematology Laboratory Measures: WBC, Platelets, Lymphocytes, Neutrophils , Through All Vaccinations | WBC (1000/cubic mm)-Day 14 | 6.80 thousand cells/cubic mm |
| Group 3: Placebo | Hematology Laboratory Measures: WBC, Platelets, Lymphocytes, Neutrophils , Through All Vaccinations | Lymphocytes (1000/cubic mm)-Day 273 | 2.014 thousand cells/cubic mm |
| Group 3: Placebo | Hematology Laboratory Measures: WBC, Platelets, Lymphocytes, Neutrophils , Through All Vaccinations | Neutrophils (1000/cubic mm)-Day 273 | 4.112 thousand cells/cubic mm |
| Group 3: Placebo | Hematology Laboratory Measures: WBC, Platelets, Lymphocytes, Neutrophils , Through All Vaccinations | Platelets (1000/cubic mm)-Day 14 | 326.0 thousand cells/cubic mm |
| Group 3: Placebo | Hematology Laboratory Measures: WBC, Platelets, Lymphocytes, Neutrophils , Through All Vaccinations | Platelets (1000/cubic mm)-Screening | 334.0 thousand cells/cubic mm |
Secondary
Level of Neutralizing Antibody Responses Against HIV-1 Isolates
Assessed by multiplex assay. Response to a virus/isolate in the TZM-bl assay is considered positive if the neutralization titer is above a pre-specified cutoff (one-half the lowest dilution tested). A titer is defined as the serum dilution that reduces relative luminescence units (RLUs) by 50% relative to the RLUs in virus control wells (cells + virus only) after subtraction of background RLU (cells only). The pre-specified cutoff is 10 for TZM-bl cells. Titers below the limit of detection (\<10) were set to 5.
Time frame: Measured at 2 weeks after the third vaccination
Population: Overall Number of Participants Analyzed includes those with samples collected at the month 6.5 immunogenicity timepoint, who were HIV-uninfected. Number Analyzed shows the number of participants with available data after filtering for assay-specific quality control criteria. Tier 2 isolates data were collected for a subset of participants (9 for group 1, 5 for Group 2, 1 for Group 3).
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Group 1: Vaccine | Level of Neutralizing Antibody Responses Against HIV-1 Isolates | Tier 2: Ce1176_A3 | 5 Titer |
| Group 1: Vaccine | Level of Neutralizing Antibody Responses Against HIV-1 Isolates | Vaccine Strains - 6980.v0.c22 | 5 Titer |
| Group 1: Vaccine | Level of Neutralizing Antibody Responses Against HIV-1 Isolates | Tier 1: MW965.26 | 91 Titer |
| Group 1: Vaccine | Level of Neutralizing Antibody Responses Against HIV-1 Isolates | Tier 2: 246-F3_C10_2 | 5 Titer |
| Group 1: Vaccine | Level of Neutralizing Antibody Responses Against HIV-1 Isolates | Tier 2: 25710-2.43 | 5 Titer |
| Group 1: Vaccine | Level of Neutralizing Antibody Responses Against HIV-1 Isolates | Tier 2: BJOX002000.03.2 | 5 Titer |
| Group 1: Vaccine | Level of Neutralizing Antibody Responses Against HIV-1 Isolates | Tier 2: CH119.10 | 5 Titer |
| Group 1: Vaccine | Level of Neutralizing Antibody Responses Against HIV-1 Isolates | Tier 2: CNE55 | 5 Titer |
| Group 1: Vaccine | Level of Neutralizing Antibody Responses Against HIV-1 Isolates | Tier 2: Ce703010217_B6 | 5 Titer |
| Group 1: Vaccine | Level of Neutralizing Antibody Responses Against HIV-1 Isolates | Tier 2: TRO.11 | 5 Titer |
| Group 1: Vaccine | Level of Neutralizing Antibody Responses Against HIV-1 Isolates | Tier 2: X1632-S2-B10 | 5 Titer |
| Group 2: Vaccine | Level of Neutralizing Antibody Responses Against HIV-1 Isolates | Tier 2: 25710-2.43 | 5 Titer |
| Group 2: Vaccine | Level of Neutralizing Antibody Responses Against HIV-1 Isolates | Tier 2: X1632-S2-B10 | 5 Titer |
| Group 2: Vaccine | Level of Neutralizing Antibody Responses Against HIV-1 Isolates | Tier 2: BJOX002000.03.2 | 5 Titer |
| Group 2: Vaccine | Level of Neutralizing Antibody Responses Against HIV-1 Isolates | Tier 2: TRO.11 | 5 Titer |
| Group 2: Vaccine | Level of Neutralizing Antibody Responses Against HIV-1 Isolates | Tier 2: CH119.10 | 5 Titer |
| Group 2: Vaccine | Level of Neutralizing Antibody Responses Against HIV-1 Isolates | Tier 2: CNE55 | 5 Titer |
| Group 2: Vaccine | Level of Neutralizing Antibody Responses Against HIV-1 Isolates | Tier 2: Ce1176_A3 | 5 Titer |
| Group 2: Vaccine | Level of Neutralizing Antibody Responses Against HIV-1 Isolates | Vaccine Strains - 6980.v0.c22 | 5 Titer |
| Group 2: Vaccine | Level of Neutralizing Antibody Responses Against HIV-1 Isolates | Tier 1: MW965.26 | 30 Titer |
| Group 2: Vaccine | Level of Neutralizing Antibody Responses Against HIV-1 Isolates | Tier 2: Ce703010217_B6 | 5 Titer |
| Group 2: Vaccine | Level of Neutralizing Antibody Responses Against HIV-1 Isolates | Tier 2: 246-F3_C10_2 | 5 Titer |
| Group 3: Placebo | Level of Neutralizing Antibody Responses Against HIV-1 Isolates | Tier 1: MW965.26 | 10 Titer |
| Group 3: Placebo | Level of Neutralizing Antibody Responses Against HIV-1 Isolates | Tier 2: 25710-2.43 | 5 Titer |
| Group 3: Placebo | Level of Neutralizing Antibody Responses Against HIV-1 Isolates | Tier 2: Ce1176_A3 | 5 Titer |
| Group 3: Placebo | Level of Neutralizing Antibody Responses Against HIV-1 Isolates | Tier 2: 246-F3_C10_2 | 5 Titer |
| Group 3: Placebo | Level of Neutralizing Antibody Responses Against HIV-1 Isolates | Tier 2: BJOX002000.03.2 | 5 Titer |
| Group 3: Placebo | Level of Neutralizing Antibody Responses Against HIV-1 Isolates | Vaccine Strains - 6980.v0.c22 | 5 Titer |
| Group 3: Placebo | Level of Neutralizing Antibody Responses Against HIV-1 Isolates | Tier 2: X1632-S2-B10 | 5 Titer |
| Group 3: Placebo | Level of Neutralizing Antibody Responses Against HIV-1 Isolates | Tier 2: CH119.10 | 5 Titer |
| Group 3: Placebo | Level of Neutralizing Antibody Responses Against HIV-1 Isolates | Tier 2: TRO.11 | 5 Titer |
| Group 3: Placebo | Level of Neutralizing Antibody Responses Against HIV-1 Isolates | Tier 2: Ce703010217_B6 | 5 Titer |
| Group 3: Placebo | Level of Neutralizing Antibody Responses Against HIV-1 Isolates | Tier 2: CNE55 | 5 Titer |
Secondary
Level of Vaccine-induced Binding Antibodies to HIV Proteins Measured by the Binding Antibody Multiplex Assay (BAMA)
Serum HIV-1-specific IgG responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay. The readout is background-subtracted mean fluorescent intensity (MFI), with background adjustment for an antigen-specific plate level control. For each sample, response magnitude is net MFI, defined as experimental antigen MFI minus reference antigen MFI. Net MFI less than 1 is set to 1. Samples from post-enrollment visits have positive responses if they meet three conditions: (1) net MFI greater than or equal to an antigen-specific response threshold (defined as the maximum of 100 and the 95th percentile of pre-vaccination net MFI), (2) net MFI values are greater than 3 times pre-vaccination net MFI, and (3) experimental antigen MFI values are greater than 3 times pre-vaccination MFI. Data are excluded if the blood draw date was outside the allowable window, a participant was HIV-infected, or the reference antigen exceeds 5000 MFI.
Time frame: Measured at 2 weeks after the third vaccination
Population: Overall Number of Participants Analyzed includes those with samples collected at month 6.5, who were HIV-uninfected. Number Analyzed counts participants with available data after filtering for assay-specific quality control criteria.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Group 1: Vaccine | Level of Vaccine-induced Binding Antibodies to HIV Proteins Measured by the Binding Antibody Multiplex Assay (BAMA) | gp145 Ref. Std | 30210.0 mean fluorescent intensity (MFI) |
| Group 1: Vaccine | Level of Vaccine-induced Binding Antibodies to HIV Proteins Measured by the Binding Antibody Multiplex Assay (BAMA) | Con S gp140 CFI | 30999.8 mean fluorescent intensity (MFI) |
| Group 1: Vaccine | Level of Vaccine-induced Binding Antibodies to HIV Proteins Measured by the Binding Antibody Multiplex Assay (BAMA) | 1086C_D7gp120.avi/293 | 12189.8 mean fluorescent intensity (MFI) |
| Group 1: Vaccine | Level of Vaccine-induced Binding Antibodies to HIV Proteins Measured by the Binding Antibody Multiplex Assay (BAMA) | C.1086C_V1_V2 Tags | 20.2 mean fluorescent intensity (MFI) |
| Group 1: Vaccine | Level of Vaccine-induced Binding Antibodies to HIV Proteins Measured by the Binding Antibody Multiplex Assay (BAMA) | gp41 | 30111.0 mean fluorescent intensity (MFI) |
| Group 2: Vaccine | Level of Vaccine-induced Binding Antibodies to HIV Proteins Measured by the Binding Antibody Multiplex Assay (BAMA) | Con S gp140 CFI | 22801.4 mean fluorescent intensity (MFI) |
| Group 2: Vaccine | Level of Vaccine-induced Binding Antibodies to HIV Proteins Measured by the Binding Antibody Multiplex Assay (BAMA) | 1086C_D7gp120.avi/293 | 7134.2 mean fluorescent intensity (MFI) |
| Group 2: Vaccine | Level of Vaccine-induced Binding Antibodies to HIV Proteins Measured by the Binding Antibody Multiplex Assay (BAMA) | C.1086C_V1_V2 Tags | 20.1 mean fluorescent intensity (MFI) |
| Group 2: Vaccine | Level of Vaccine-induced Binding Antibodies to HIV Proteins Measured by the Binding Antibody Multiplex Assay (BAMA) | gp145 Ref. Std | 24435.8 mean fluorescent intensity (MFI) |
| Group 2: Vaccine | Level of Vaccine-induced Binding Antibodies to HIV Proteins Measured by the Binding Antibody Multiplex Assay (BAMA) | gp41 | 20853.0 mean fluorescent intensity (MFI) |
| Group 3: Placebo | Level of Vaccine-induced Binding Antibodies to HIV Proteins Measured by the Binding Antibody Multiplex Assay (BAMA) | gp41 | 137.8 mean fluorescent intensity (MFI) |
| Group 3: Placebo | Level of Vaccine-induced Binding Antibodies to HIV Proteins Measured by the Binding Antibody Multiplex Assay (BAMA) | gp145 Ref. Std | 1.0 mean fluorescent intensity (MFI) |
| Group 3: Placebo | Level of Vaccine-induced Binding Antibodies to HIV Proteins Measured by the Binding Antibody Multiplex Assay (BAMA) | 1086C_D7gp120.avi/293 | 1.0 mean fluorescent intensity (MFI) |
| Group 3: Placebo | Level of Vaccine-induced Binding Antibodies to HIV Proteins Measured by the Binding Antibody Multiplex Assay (BAMA) | Con S gp140 CFI | 1.0 mean fluorescent intensity (MFI) |
| Group 3: Placebo | Level of Vaccine-induced Binding Antibodies to HIV Proteins Measured by the Binding Antibody Multiplex Assay (BAMA) | C.1086C_V1_V2 Tags | 2.4 mean fluorescent intensity (MFI) |
Secondary
Level of Vaccine-induced Binding Antibodies to HIV Proteins Measured by the Binding Antibody Multiplex Assay (BAMA)
Serum HIV-1-specific IgG responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay. The readout is background-subtracted mean fluorescent intensity (MFI), with background adjustment for an antigen-specific plate level control. For each sample, response magnitude is net MFI, defined as experimental antigen MFI minus reference antigen MFI. Net MFI less than 1 is set to 1. Samples from post-enrollment visits have positive responses if they meet three conditions: (1) net MFI greater than or equal to an antigen-specific response threshold (defined as the maximum of 100 and the 95th percentile of pre-vaccination net MFI), (2) net MFI values are greater than 3 times pre-vaccination net MFI, and (3) experimental antigen MFI values are greater than 3 times pre-vaccination MFI. Data are excluded if the blood draw date was outside the allowable window, a participant was HIV-infected, or the reference antigen exceeds 5000 MFI.
Time frame: Measured at 2 weeks after the first vaccination
Population: Overall Number of Participants Analyzed includes those with samples collected at week 2, who were HIV-uninfected and received the first vaccination. Number Analyzed counts participants with available data after filtering for assay-specific quality control criteria.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Group 1: Vaccine | Level of Vaccine-induced Binding Antibodies to HIV Proteins Measured by the Binding Antibody Multiplex Assay (BAMA) | 1086C_D7gp120.avi/293F | 1.0 mean fluorescent intensity (MFI) |
| Group 1: Vaccine | Level of Vaccine-induced Binding Antibodies to HIV Proteins Measured by the Binding Antibody Multiplex Assay (BAMA) | C.1086C_V1_V2 Tags | 1.0 mean fluorescent intensity (MFI) |
| Group 1: Vaccine | Level of Vaccine-induced Binding Antibodies to HIV Proteins Measured by the Binding Antibody Multiplex Assay (BAMA) | gp145 Ref. Std. | 1.0 mean fluorescent intensity (MFI) |
| Group 1: Vaccine | Level of Vaccine-induced Binding Antibodies to HIV Proteins Measured by the Binding Antibody Multiplex Assay (BAMA) | gp41 | 357.2 mean fluorescent intensity (MFI) |
| Group 1: Vaccine | Level of Vaccine-induced Binding Antibodies to HIV Proteins Measured by the Binding Antibody Multiplex Assay (BAMA) | Con S gp140 CFI | 1.0 mean fluorescent intensity (MFI) |
| Group 2: Vaccine | Level of Vaccine-induced Binding Antibodies to HIV Proteins Measured by the Binding Antibody Multiplex Assay (BAMA) | Con S gp140 CFI | 1.0 mean fluorescent intensity (MFI) |
| Group 2: Vaccine | Level of Vaccine-induced Binding Antibodies to HIV Proteins Measured by the Binding Antibody Multiplex Assay (BAMA) | 1086C_D7gp120.avi/293F | 1.0 mean fluorescent intensity (MFI) |
| Group 2: Vaccine | Level of Vaccine-induced Binding Antibodies to HIV Proteins Measured by the Binding Antibody Multiplex Assay (BAMA) | gp41 | 561.8 mean fluorescent intensity (MFI) |
| Group 2: Vaccine | Level of Vaccine-induced Binding Antibodies to HIV Proteins Measured by the Binding Antibody Multiplex Assay (BAMA) | gp145 Ref. Std. | 1.0 mean fluorescent intensity (MFI) |
| Group 2: Vaccine | Level of Vaccine-induced Binding Antibodies to HIV Proteins Measured by the Binding Antibody Multiplex Assay (BAMA) | C.1086C_V1_V2 Tags | 4.8 mean fluorescent intensity (MFI) |
| Group 3: Placebo | Level of Vaccine-induced Binding Antibodies to HIV Proteins Measured by the Binding Antibody Multiplex Assay (BAMA) | gp145 Ref. Std. | 1.0 mean fluorescent intensity (MFI) |
| Group 3: Placebo | Level of Vaccine-induced Binding Antibodies to HIV Proteins Measured by the Binding Antibody Multiplex Assay (BAMA) | Con S gp140 CFI | 1.0 mean fluorescent intensity (MFI) |
| Group 3: Placebo | Level of Vaccine-induced Binding Antibodies to HIV Proteins Measured by the Binding Antibody Multiplex Assay (BAMA) | C.1086C_V1_V2 Tags | 2.0 mean fluorescent intensity (MFI) |
| Group 3: Placebo | Level of Vaccine-induced Binding Antibodies to HIV Proteins Measured by the Binding Antibody Multiplex Assay (BAMA) | 1086C_D7gp120.avi/293F | 2.5 mean fluorescent intensity (MFI) |
| Group 3: Placebo | Level of Vaccine-induced Binding Antibodies to HIV Proteins Measured by the Binding Antibody Multiplex Assay (BAMA) | gp41 | 128.5 mean fluorescent intensity (MFI) |
Secondary
Levels of CD4+ and CD8+ T Cells Responses to the HIV Proteins Included in the Vaccine. Measured by Flow Cytometry.
PBMC samples are stimulated with synthetic peptide pools or left unstimulated as a negative control. For each sample, T-cell subset, and peptide pool, response magnitude is % cells expressing markers after peptide stimulation minus % cells expressing markers after no stimulation. A contingency table is constructed to assess response: stimulation (peptide/none) vs. marker expression (yes/no). A one-sided Fisher's exact test is applied, testing if the number of cells positive for the marker is equal in the stimulated vs. unstimulated cells. A discrete Bonferroni adjustment is made over the peptide pools. Response is positive if p\<=0.00001. Data are excluded if the blood draw date was outside the visit window, the participant was HIV-infected, PBMC viability or T-cell count were low, or negative control was high.
Time frame: Measured at 2 weeks after the third vaccination
Population: Overall Number of Participants Analyzed includes those with samples collected at the month 6.5 immunogenicity timepoint, who were HIV-uninfected. Number Analyzed shows the number of participants with available data after filtering for assay-specific quality control criteria.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Group 1: Vaccine | Levels of CD4+ and CD8+ T Cells Responses to the HIV Proteins Included in the Vaccine. Measured by Flow Cytometry. | CD4+: ENV-2-PTEG-SEQ | .041 % of T-cell |
| Group 1: Vaccine | Levels of CD4+ and CD8+ T Cells Responses to the HIV Proteins Included in the Vaccine. Measured by Flow Cytometry. | CD4+: ANY ENV PTEG | .109 % of T-cell |
| Group 1: Vaccine | Levels of CD4+ and CD8+ T Cells Responses to the HIV Proteins Included in the Vaccine. Measured by Flow Cytometry. | CD4+: ENV-1-PTEG-SEQ | .035 % of T-cell |
| Group 1: Vaccine | Levels of CD4+ and CD8+ T Cells Responses to the HIV Proteins Included in the Vaccine. Measured by Flow Cytometry. | CD4+: ENV-3A-PTEG-SEQ | .006 % of T-cell |
| Group 1: Vaccine | Levels of CD4+ and CD8+ T Cells Responses to the HIV Proteins Included in the Vaccine. Measured by Flow Cytometry. | CD4+: ENV-3B-PTEG-SEQ | .001 % of T-cell |
| Group 1: Vaccine | Levels of CD4+ and CD8+ T Cells Responses to the HIV Proteins Included in the Vaccine. Measured by Flow Cytometry. | CD8+: ANY ENV PTEG | -.004 % of T-cell |
| Group 1: Vaccine | Levels of CD4+ and CD8+ T Cells Responses to the HIV Proteins Included in the Vaccine. Measured by Flow Cytometry. | CD8+: ENV-1-PTEG-SEQ | 0 % of T-cell |
| Group 1: Vaccine | Levels of CD4+ and CD8+ T Cells Responses to the HIV Proteins Included in the Vaccine. Measured by Flow Cytometry. | CD8+: ENV-2-PTEG-SEQ | -.001 % of T-cell |
| Group 1: Vaccine | Levels of CD4+ and CD8+ T Cells Responses to the HIV Proteins Included in the Vaccine. Measured by Flow Cytometry. | CD8+: ENV-3A-PTEG-SEQ | -.003 % of T-cell |
| Group 1: Vaccine | Levels of CD4+ and CD8+ T Cells Responses to the HIV Proteins Included in the Vaccine. Measured by Flow Cytometry. | CD8+: ENV-3B-PTEG-SEQ | -.001 % of T-cell |
| Group 2: Vaccine | Levels of CD4+ and CD8+ T Cells Responses to the HIV Proteins Included in the Vaccine. Measured by Flow Cytometry. | CD4+: ENV-2-PTEG-SEQ | .050 % of T-cell |
| Group 2: Vaccine | Levels of CD4+ and CD8+ T Cells Responses to the HIV Proteins Included in the Vaccine. Measured by Flow Cytometry. | CD8+: ENV-2-PTEG-SEQ | -.003 % of T-cell |
| Group 2: Vaccine | Levels of CD4+ and CD8+ T Cells Responses to the HIV Proteins Included in the Vaccine. Measured by Flow Cytometry. | CD4+: ENV-3A-PTEG-SEQ | .007 % of T-cell |
| Group 2: Vaccine | Levels of CD4+ and CD8+ T Cells Responses to the HIV Proteins Included in the Vaccine. Measured by Flow Cytometry. | CD4+: ENV-3B-PTEG-SEQ | .001 % of T-cell |
| Group 2: Vaccine | Levels of CD4+ and CD8+ T Cells Responses to the HIV Proteins Included in the Vaccine. Measured by Flow Cytometry. | CD8+: ANY ENV PTEG | -.005 % of T-cell |
| Group 2: Vaccine | Levels of CD4+ and CD8+ T Cells Responses to the HIV Proteins Included in the Vaccine. Measured by Flow Cytometry. | CD8+: ENV-3A-PTEG-SEQ | -.002 % of T-cell |
| Group 2: Vaccine | Levels of CD4+ and CD8+ T Cells Responses to the HIV Proteins Included in the Vaccine. Measured by Flow Cytometry. | CD8+: ENV-3B-PTEG-SEQ | -.001 % of T-cell |
| Group 2: Vaccine | Levels of CD4+ and CD8+ T Cells Responses to the HIV Proteins Included in the Vaccine. Measured by Flow Cytometry. | CD8+: ENV-1-PTEG-SEQ | 0 % of T-cell |
| Group 2: Vaccine | Levels of CD4+ and CD8+ T Cells Responses to the HIV Proteins Included in the Vaccine. Measured by Flow Cytometry. | CD4+: ANY ENV PTEG | .117 % of T-cell |
| Group 2: Vaccine | Levels of CD4+ and CD8+ T Cells Responses to the HIV Proteins Included in the Vaccine. Measured by Flow Cytometry. | CD4+: ENV-1-PTEG-SEQ | .038 % of T-cell |
| Group 3: Placebo | Levels of CD4+ and CD8+ T Cells Responses to the HIV Proteins Included in the Vaccine. Measured by Flow Cytometry. | CD4+: ENV-1-PTEG-SEQ | -.002 % of T-cell |
| Group 3: Placebo | Levels of CD4+ and CD8+ T Cells Responses to the HIV Proteins Included in the Vaccine. Measured by Flow Cytometry. | CD4+: ENV-2-PTEG-SEQ | .001 % of T-cell |
| Group 3: Placebo | Levels of CD4+ and CD8+ T Cells Responses to the HIV Proteins Included in the Vaccine. Measured by Flow Cytometry. | CD8+: ANY ENV PTEG | .008 % of T-cell |
| Group 3: Placebo | Levels of CD4+ and CD8+ T Cells Responses to the HIV Proteins Included in the Vaccine. Measured by Flow Cytometry. | CD8+: ENV-1-PTEG-SEQ | 0 % of T-cell |
| Group 3: Placebo | Levels of CD4+ and CD8+ T Cells Responses to the HIV Proteins Included in the Vaccine. Measured by Flow Cytometry. | CD4+: ENV-3A-PTEG-SEQ | .009 % of T-cell |
| Group 3: Placebo | Levels of CD4+ and CD8+ T Cells Responses to the HIV Proteins Included in the Vaccine. Measured by Flow Cytometry. | CD8+: ENV-2-PTEG-SEQ | .005 % of T-cell |
| Group 3: Placebo | Levels of CD4+ and CD8+ T Cells Responses to the HIV Proteins Included in the Vaccine. Measured by Flow Cytometry. | CD4+: ANY ENV PTEG | .008 % of T-cell |
| Group 3: Placebo | Levels of CD4+ and CD8+ T Cells Responses to the HIV Proteins Included in the Vaccine. Measured by Flow Cytometry. | CD4+: ENV-3B-PTEG-SEQ | .001 % of T-cell |
| Group 3: Placebo | Levels of CD4+ and CD8+ T Cells Responses to the HIV Proteins Included in the Vaccine. Measured by Flow Cytometry. | CD8+: ENV-3B-PTEG-SEQ | 0 % of T-cell |
| Group 3: Placebo | Levels of CD4+ and CD8+ T Cells Responses to the HIV Proteins Included in the Vaccine. Measured by Flow Cytometry. | CD8+: ENV-3A-PTEG-SEQ | .002 % of T-cell |
Secondary
Number of Participants Reporting Adverse Events (AEs), by Relationship to Study Product
Severity definitions are found in The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Corrected Version 2.1, dated July 2017); For participants reporting multiple AEs over the time frame, the maximum severity grade is counted.
Time frame: Measured through Month 7
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1: Vaccine | Number of Participants Reporting Adverse Events (AEs), by Relationship to Study Product | No AE Reported | 10 Participants |
| Group 1: Vaccine | Number of Participants Reporting Adverse Events (AEs), by Relationship to Study Product | Not Related | 14 Participants |
| Group 1: Vaccine | Number of Participants Reporting Adverse Events (AEs), by Relationship to Study Product | Related | 1 Participants |
| Group 2: Vaccine | Number of Participants Reporting Adverse Events (AEs), by Relationship to Study Product | No AE Reported | 7 Participants |
| Group 2: Vaccine | Number of Participants Reporting Adverse Events (AEs), by Relationship to Study Product | Related | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Adverse Events (AEs), by Relationship to Study Product | Not Related | 8 Participants |
| Group 3: Placebo | Number of Participants Reporting Adverse Events (AEs), by Relationship to Study Product | No AE Reported | 1 Participants |
| Group 3: Placebo | Number of Participants Reporting Adverse Events (AEs), by Relationship to Study Product | Not Related | 4 Participants |
| Group 3: Placebo | Number of Participants Reporting Adverse Events (AEs), by Relationship to Study Product | Related | 0 Participants |
Secondary
Number of Participants Reporting Adverse Events (AEs), by Severity Grade
Severity definitions are found in The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Corrected Version 2.1, dated July 2017); for participants reporting multiple AEs over the time frame, the maximum severity grade is counted.
Time frame: Measured through Month 7
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1: Vaccine | Number of Participants Reporting Adverse Events (AEs), by Severity Grade | Mild | 5 Participants |
| Group 1: Vaccine | Number of Participants Reporting Adverse Events (AEs), by Severity Grade | Severe | 1 Participants |
| Group 1: Vaccine | Number of Participants Reporting Adverse Events (AEs), by Severity Grade | Potentially Life-Threatening | 1 Participants |
| Group 1: Vaccine | Number of Participants Reporting Adverse Events (AEs), by Severity Grade | Moderate | 8 Participants |
| Group 1: Vaccine | Number of Participants Reporting Adverse Events (AEs), by Severity Grade | No AE Reported | 10 Participants |
| Group 2: Vaccine | Number of Participants Reporting Adverse Events (AEs), by Severity Grade | No AE Reported | 7 Participants |
| Group 2: Vaccine | Number of Participants Reporting Adverse Events (AEs), by Severity Grade | Moderate | 3 Participants |
| Group 2: Vaccine | Number of Participants Reporting Adverse Events (AEs), by Severity Grade | Potentially Life-Threatening | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Adverse Events (AEs), by Severity Grade | Severe | 1 Participants |
| Group 2: Vaccine | Number of Participants Reporting Adverse Events (AEs), by Severity Grade | Mild | 4 Participants |
| Group 3: Placebo | Number of Participants Reporting Adverse Events (AEs), by Severity Grade | Potentially Life-Threatening | 0 Participants |
| Group 3: Placebo | Number of Participants Reporting Adverse Events (AEs), by Severity Grade | Mild | 0 Participants |
| Group 3: Placebo | Number of Participants Reporting Adverse Events (AEs), by Severity Grade | Severe | 0 Participants |
| Group 3: Placebo | Number of Participants Reporting Adverse Events (AEs), by Severity Grade | Moderate | 4 Participants |
| Group 3: Placebo | Number of Participants Reporting Adverse Events (AEs), by Severity Grade | No AE Reported | 1 Participants |
Secondary
Number of Participants Reporting Local Reactogenicity Signs and Symptoms：Erythema and/or Induration
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events. Corrected Version 2.1, dated July 2017. The maximum grade observed for each symptom over the time frame is presented.
Time frame: Measured through Month 6.5
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms：Erythema and/or Induration | Erythema | Grade 2: Between 25 to 100 cm sq area | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms：Erythema and/or Induration | Erythema and/or Induration | Not Gradable | 3 Participants |
| Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms：Erythema and/or Induration | Erythema and/or Induration | Grade 1: Between 6.25 to 25 cm sq area | 1 Participants |
| Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms：Erythema and/or Induration | Induration | Grade 3: Greater or equal to 100 cm sq | 1 Participants |
| Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms：Erythema and/or Induration | Erythema | Grade 1: Less than 5 cm diameter | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms：Erythema and/or Induration | Erythema | Grade 2: Between 5 to 10 cm diameter | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms：Erythema and/or Induration | Erythema | Not Gradable | 4 Participants |
| Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms：Erythema and/or Induration | Erythema and/or Induration | Grade 2: Between 5 to 10 cm diameter | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms：Erythema and/or Induration | Induration | Grade 3: Greater or equal to 10 cm | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms：Erythema and/or Induration | Erythema and/or Induration | Grade 4: complications | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms：Erythema and/or Induration | Erythema and/or Induration | Grade 2: Between 25 to 100 cm sq area | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms：Erythema and/or Induration | Erythema and/or Induration | Grade 3: complications | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms：Erythema and/or Induration | Erythema and/or Induration | Grade 3: Greater or equal to 100 cm sq | 1 Participants |
| Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms：Erythema and/or Induration | Erythema and/or Induration | Grade 3: Greater or equal to 10 cm | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms：Erythema and/or Induration | Induration | Grade 2: Between 5 to 10 cm diameter | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms：Erythema and/or Induration | Erythema | Grade 3: complications | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms：Erythema and/or Induration | Induration | Grade 4: complications | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms：Erythema and/or Induration | Induration | Grade 1: Between 6.25 to 25 cm sq area | 1 Participants |
| Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms：Erythema and/or Induration | Erythema | Grade 4: complications | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms：Erythema and/or Induration | Erythema | None | 20 Participants |
| Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms：Erythema and/or Induration | Induration | Grade 1: Less than 5 cm diameter | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms：Erythema and/or Induration | Induration | None | 23 Participants |
| Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms：Erythema and/or Induration | Induration | Not Gradable | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms：Erythema and/or Induration | Erythema | Grade 3: Greater or equal to 100 cm sq | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms：Erythema and/or Induration | Erythema and/or Induration | Grade 1: Less than 5 cm diameter | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms：Erythema and/or Induration | Induration | Grade 2: Between 25 to 100 cm sq area | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms：Erythema and/or Induration | Induration | Grade 3: complications | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms：Erythema and/or Induration | Erythema | Grade 3: Greater or equal to 10 cm | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms：Erythema and/or Induration | Erythema and/or Induration | None | 20 Participants |
| Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms：Erythema and/or Induration | Erythema | Grade 1: Between 6.25 to 25 cm sq area | 1 Participants |
| Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms：Erythema and/or Induration | Induration | Grade 1: Less than 5 cm diameter | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms：Erythema and/or Induration | Erythema | None | 14 Participants |
| Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms：Erythema and/or Induration | Erythema | Grade 1: Between 6.25 to 25 cm sq area | 1 Participants |
| Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms：Erythema and/or Induration | Erythema | Grade 3: Greater or equal to 10 cm | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms：Erythema and/or Induration | Erythema | Grade 3: complications | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms：Erythema and/or Induration | Erythema | Grade 4: complications | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms：Erythema and/or Induration | Induration | Grade 1: Between 6.25 to 25 cm sq area | 1 Participants |
| Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms：Erythema and/or Induration | Induration | Grade 2: Between 25 to 100 cm sq area | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms：Erythema and/or Induration | Erythema and/or Induration | None | 14 Participants |
| Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms：Erythema and/or Induration | Erythema and/or Induration | Not Gradable | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms：Erythema and/or Induration | Erythema and/or Induration | Grade 1: Less than 5 cm diameter | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms：Erythema and/or Induration | Erythema and/or Induration | Grade 1: Between 6.25 to 25 cm sq area | 1 Participants |
| Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms：Erythema and/or Induration | Erythema and/or Induration | Grade 2: Between 5 to 10 cm diameter | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms：Erythema and/or Induration | Erythema and/or Induration | Grade 2: Between 25 to 100 cm sq area | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms：Erythema and/or Induration | Erythema and/or Induration | Grade 3: Greater or equal to 10 cm | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms：Erythema and/or Induration | Erythema and/or Induration | Grade 3: Greater or equal to 100 cm sq | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms：Erythema and/or Induration | Erythema and/or Induration | Grade 3: complications | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms：Erythema and/or Induration | Erythema and/or Induration | Grade 4: complications | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms：Erythema and/or Induration | Erythema | Not Gradable | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms：Erythema and/or Induration | Erythema | Grade 1: Less than 5 cm diameter | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms：Erythema and/or Induration | Erythema | Grade 2: Between 5 to 10 cm diameter | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms：Erythema and/or Induration | Erythema | Grade 2: Between 25 to 100 cm sq area | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms：Erythema and/or Induration | Erythema | Grade 3: Greater or equal to 100 cm sq | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms：Erythema and/or Induration | Induration | None | 14 Participants |
| Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms：Erythema and/or Induration | Induration | Not Gradable | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms：Erythema and/or Induration | Induration | Grade 2: Between 5 to 10 cm diameter | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms：Erythema and/or Induration | Induration | Grade 3: Greater or equal to 10 cm | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms：Erythema and/or Induration | Induration | Grade 3: Greater or equal to 100 cm sq | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms：Erythema and/or Induration | Induration | Grade 3: complications | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms：Erythema and/or Induration | Induration | Grade 4: complications | 0 Participants |
| Group 3: Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms：Erythema and/or Induration | Erythema and/or Induration | None | 4 Participants |
| Group 3: Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms：Erythema and/or Induration | Induration | Grade 3: Greater or equal to 10 cm | 0 Participants |
| Group 3: Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms：Erythema and/or Induration | Erythema | Grade 2: Between 25 to 100 cm sq area | 0 Participants |
| Group 3: Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms：Erythema and/or Induration | Induration | Grade 4: complications | 0 Participants |
| Group 3: Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms：Erythema and/or Induration | Erythema | Grade 3: Greater or equal to 10 cm | 0 Participants |
| Group 3: Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms：Erythema and/or Induration | Induration | Grade 1: Less than 5 cm diameter | 0 Participants |
| Group 3: Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms：Erythema and/or Induration | Erythema | Grade 1: Between 6.25 to 25 cm sq area | 0 Participants |
| Group 3: Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms：Erythema and/or Induration | Induration | Grade 3: complications | 0 Participants |
| Group 3: Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms：Erythema and/or Induration | Induration | None | 5 Participants |
| Group 3: Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms：Erythema and/or Induration | Erythema and/or Induration | Not Gradable | 1 Participants |
| Group 3: Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms：Erythema and/or Induration | Induration | Grade 3: Greater or equal to 100 cm sq | 0 Participants |
| Group 3: Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms：Erythema and/or Induration | Induration | Not Gradable | 0 Participants |
| Group 3: Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms：Erythema and/or Induration | Erythema | Grade 4: complications | 0 Participants |
| Group 3: Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms：Erythema and/or Induration | Erythema | Grade 3: complications | 0 Participants |
| Group 3: Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms：Erythema and/or Induration | Induration | Grade 1: Between 6.25 to 25 cm sq area | 0 Participants |
| Group 3: Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms：Erythema and/or Induration | Erythema and/or Induration | Grade 3: Greater or equal to 10 cm | 0 Participants |
| Group 3: Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms：Erythema and/or Induration | Erythema and/or Induration | Grade 2: Between 25 to 100 cm sq area | 0 Participants |
| Group 3: Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms：Erythema and/or Induration | Erythema | Grade 3: Greater or equal to 100 cm sq | 0 Participants |
| Group 3: Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms：Erythema and/or Induration | Erythema and/or Induration | Grade 3: Greater or equal to 100 cm sq | 0 Participants |
| Group 3: Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms：Erythema and/or Induration | Erythema | None | 4 Participants |
| Group 3: Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms：Erythema and/or Induration | Erythema and/or Induration | Grade 3: complications | 0 Participants |
| Group 3: Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms：Erythema and/or Induration | Erythema and/or Induration | Grade 2: Between 5 to 10 cm diameter | 0 Participants |
| Group 3: Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms：Erythema and/or Induration | Induration | Grade 2: Between 5 to 10 cm diameter | 0 Participants |
| Group 3: Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms：Erythema and/or Induration | Erythema and/or Induration | Grade 1: Between 6.25 to 25 cm sq area | 0 Participants |
| Group 3: Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms：Erythema and/or Induration | Induration | Grade 2: Between 25 to 100 cm sq area | 0 Participants |
| Group 3: Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms：Erythema and/or Induration | Erythema | Not Gradable | 1 Participants |
| Group 3: Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms：Erythema and/or Induration | Erythema and/or Induration | Grade 1: Less than 5 cm diameter | 0 Participants |
| Group 3: Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms：Erythema and/or Induration | Erythema | Grade 2: Between 5 to 10 cm diameter | 0 Participants |
| Group 3: Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms：Erythema and/or Induration | Erythema | Grade 1: Less than 5 cm diameter | 0 Participants |
| Group 3: Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms：Erythema and/or Induration | Erythema and/or Induration | Grade 4: complications | 0 Participants |
Secondary
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events. Corrected Version 2.1, dated July 2017. The maximum grade observed for each symptom over the time frame is presented.
Time frame: Measured through Month 6.5
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Severe | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Life Threatening | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | None | 6 Participants |
| Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Mild | 14 Participants |
| Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Moderate | 5 Participants |
| Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Moderate | 1 Participants |
| Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Severe | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Mild | 10 Participants |
| Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Life Threatening | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | None | 4 Participants |
| Group 3: Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Life Threatening | 0 Participants |
| Group 3: Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Moderate | 0 Participants |
| Group 3: Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Severe | 0 Participants |
| Group 3: Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | None | 4 Participants |
| Group 3: Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Mild | 1 Participants |
Secondary
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events. Corrected Version 2.1, dated July 2017. The following symptoms are considered as systemic reactogenicity if the onset date was within the periods of assessment specified in the protocol: malaise and/or fatigue, myalgia, headache, nausea, vomiting, chills, arthralgia, and body temperature. The item Max. Systemic Reaction is the maximum of the individual systemic variables for a participant. It does not include temperature.
Time frame: Measured through Month 6.5
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Mild | 2 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Moderate | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Moderate | 2 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Moderate | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | None | 24 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | None | 14 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Severe | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Mild | 8 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Life Threatening | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Life Threatening | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Severe | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Severe | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | None | 22 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Life Threatening | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Moderate | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Mild | 3 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Vomiting | None | 25 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Life Threatening | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Moderate | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | None | 16 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Severe | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Severe | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Mild | 9 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Mild | 11 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Life Threatening | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Life Threatening | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | None | 11 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Moderate | 3 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Life Threatening | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | None | 24 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Severe | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Vomiting | Mild | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Moderate | 1 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Moderate | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Vomiting | Moderate | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Life Threatening | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Mild | 4 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Vomiting | Severe | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Mild | 1 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | None | 21 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Vomiting | Life Threatening | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Mild | 1 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | None | 23 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Severe | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Severe | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Severe | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Mild | 8 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Severe | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Life Threatening | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | None | 11 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Life Threatening | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Moderate | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Life Threatening | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | None | 13 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Mild | 1 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Moderate | 1 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Severe | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Life Threatening | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Vomiting | None | 15 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Vomiting | Mild | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Vomiting | Moderate | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Vomiting | Severe | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Vomiting | Life Threatening | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | None | 12 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Mild | 3 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Moderate | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Severe | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Life Threatening | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | None | 14 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Mild | 1 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Moderate | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Life Threatening | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | None | 5 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Moderate | 2 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Severe | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Life Threatening | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | None | 14 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Moderate | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Severe | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Life Threatening | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | None | 5 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Moderate | 2 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Mild | 4 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Moderate | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Severe | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | None | 10 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Mild | 5 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Severe | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Mild | 8 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Mild | 1 Participants |
| Group 3: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Life Threatening | 0 Participants |
| Group 3: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Severe | 0 Participants |
| Group 3: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Severe | 0 Participants |
| Group 3: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Severe | 0 Participants |
| Group 3: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Moderate | 0 Participants |
| Group 3: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | None | 4 Participants |
| Group 3: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | None | 4 Participants |
| Group 3: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Mild | 0 Participants |
| Group 3: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Mild | 0 Participants |
| Group 3: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Vomiting | Life Threatening | 0 Participants |
| Group 3: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Moderate | 1 Participants |
| Group 3: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | None | 5 Participants |
| Group 3: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Severe | 0 Participants |
| Group 3: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Life Threatening | 0 Participants |
| Group 3: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Vomiting | Severe | 0 Participants |
| Group 3: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Vomiting | Moderate | 0 Participants |
| Group 3: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Moderate | 0 Participants |
| Group 3: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Mild | 1 Participants |
| Group 3: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Vomiting | Mild | 0 Participants |
| Group 3: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Mild | 3 Participants |
| Group 3: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Moderate | 0 Participants |
| Group 3: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Vomiting | None | 5 Participants |
| Group 3: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Life Threatening | 0 Participants |
| Group 3: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Severe | 0 Participants |
| Group 3: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Life Threatening | 0 Participants |
| Group 3: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Life Threatening | 0 Participants |
| Group 3: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Severe | 0 Participants |
| Group 3: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Life Threatening | 0 Participants |
| Group 3: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Moderate | 0 Participants |
| Group 3: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | None | 1 Participants |
| Group 3: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Severe | 0 Participants |
| Group 3: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | None | 3 Participants |
| Group 3: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Moderate | 1 Participants |
| Group 3: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Moderate | 0 Participants |
| Group 3: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Moderate | 0 Participants |
| Group 3: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Severe | 0 Participants |
| Group 3: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Mild | 0 Participants |
| Group 3: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | None | 4 Participants |
| Group 3: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Life Threatening | 0 Participants |
| Group 3: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Mild | 2 Participants |
| Group 3: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | None | 5 Participants |
| Group 3: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Mild | 0 Participants |
| Group 3: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | None | 5 Participants |
| Group 3: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Mild | 1 Participants |
| Group 3: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Life Threatening | 0 Participants |
Secondary
Occurrence of HIV-specific CD4+ and CD8+ T-cell Responses to the HIV Proteins Included in the Vaccine. Measured by Flow Cytometry.
PBMC samples are stimulated with synthetic peptide pools or left unstimulated as a negative control. For each sample, T-cell subset, and peptide pool, response magnitude is % cells expressing markers after peptide stimulation minus % cells expressing markers after no stimulation. A contingency table is constructed to assess response: stimulation (peptide/none) vs. marker expression (yes/no). A one-sided Fisher's exact test is applied, testing if the number of cells positive for the marker is equal in the stimulated vs. unstimulated cells. A discrete Bonferroni adjustment is made over the peptide pools. Response is positive if p\<=0.00001. Data are excluded if the blood draw date was outside the visit window, the participant was HIV-infected, PBMC viability or T-cell count were low, or negative control was high.
Time frame: Measured at 2 weeks after the third vaccination
Population: Overall Number of Participants Analyzed includes those with samples collected at the month 6.5 immunogenicity timepoint, who were HIV-uninfected. Number Analyzed counts participants with available data after filtering for assay-specific quality control criteria.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1: Vaccine | Occurrence of HIV-specific CD4+ and CD8+ T-cell Responses to the HIV Proteins Included in the Vaccine. Measured by Flow Cytometry. | CD8+: ENV-1-PTEG-SEQ | 0 Participants |
| Group 1: Vaccine | Occurrence of HIV-specific CD4+ and CD8+ T-cell Responses to the HIV Proteins Included in the Vaccine. Measured by Flow Cytometry. | CD4+: ENV-2-PTEG-SEQ | 7 Participants |
| Group 1: Vaccine | Occurrence of HIV-specific CD4+ and CD8+ T-cell Responses to the HIV Proteins Included in the Vaccine. Measured by Flow Cytometry. | CD8+: ENV-2-PTEG-SEQ | 0 Participants |
| Group 1: Vaccine | Occurrence of HIV-specific CD4+ and CD8+ T-cell Responses to the HIV Proteins Included in the Vaccine. Measured by Flow Cytometry. | CD8+: ENV-3A-PTEG-SEQ | 0 Participants |
| Group 1: Vaccine | Occurrence of HIV-specific CD4+ and CD8+ T-cell Responses to the HIV Proteins Included in the Vaccine. Measured by Flow Cytometry. | CD4+: ANY ENV PTEG | 7 Participants |
| Group 1: Vaccine | Occurrence of HIV-specific CD4+ and CD8+ T-cell Responses to the HIV Proteins Included in the Vaccine. Measured by Flow Cytometry. | CD8+: ENV-3B-PTEG-SEQ | 0 Participants |
| Group 1: Vaccine | Occurrence of HIV-specific CD4+ and CD8+ T-cell Responses to the HIV Proteins Included in the Vaccine. Measured by Flow Cytometry. | CD4+: ENV-3A-PTEG-SEQ | 0 Participants |
| Group 1: Vaccine | Occurrence of HIV-specific CD4+ and CD8+ T-cell Responses to the HIV Proteins Included in the Vaccine. Measured by Flow Cytometry. | CD4+: ENV-1-PTEG-SEQ | 5 Participants |
| Group 1: Vaccine | Occurrence of HIV-specific CD4+ and CD8+ T-cell Responses to the HIV Proteins Included in the Vaccine. Measured by Flow Cytometry. | CD4+: ENV-3B-PTEG-SEQ | 0 Participants |
| Group 1: Vaccine | Occurrence of HIV-specific CD4+ and CD8+ T-cell Responses to the HIV Proteins Included in the Vaccine. Measured by Flow Cytometry. | CD8+: ANY ENV PTEG | 0 Participants |
| Group 2: Vaccine | Occurrence of HIV-specific CD4+ and CD8+ T-cell Responses to the HIV Proteins Included in the Vaccine. Measured by Flow Cytometry. | CD8+: ENV-1-PTEG-SEQ | 0 Participants |
| Group 2: Vaccine | Occurrence of HIV-specific CD4+ and CD8+ T-cell Responses to the HIV Proteins Included in the Vaccine. Measured by Flow Cytometry. | CD4+: ENV-3A-PTEG-SEQ | 0 Participants |
| Group 2: Vaccine | Occurrence of HIV-specific CD4+ and CD8+ T-cell Responses to the HIV Proteins Included in the Vaccine. Measured by Flow Cytometry. | CD8+: ANY ENV PTEG | 0 Participants |
| Group 2: Vaccine | Occurrence of HIV-specific CD4+ and CD8+ T-cell Responses to the HIV Proteins Included in the Vaccine. Measured by Flow Cytometry. | CD4+: ENV-2-PTEG-SEQ | 5 Participants |
| Group 2: Vaccine | Occurrence of HIV-specific CD4+ and CD8+ T-cell Responses to the HIV Proteins Included in the Vaccine. Measured by Flow Cytometry. | CD4+: ANY ENV PTEG | 5 Participants |
| Group 2: Vaccine | Occurrence of HIV-specific CD4+ and CD8+ T-cell Responses to the HIV Proteins Included in the Vaccine. Measured by Flow Cytometry. | CD8+: ENV-3A-PTEG-SEQ | 0 Participants |
| Group 2: Vaccine | Occurrence of HIV-specific CD4+ and CD8+ T-cell Responses to the HIV Proteins Included in the Vaccine. Measured by Flow Cytometry. | CD4+: ENV-3B-PTEG-SEQ | 0 Participants |
| Group 2: Vaccine | Occurrence of HIV-specific CD4+ and CD8+ T-cell Responses to the HIV Proteins Included in the Vaccine. Measured by Flow Cytometry. | CD4+: ENV-1-PTEG-SEQ | 3 Participants |
| Group 2: Vaccine | Occurrence of HIV-specific CD4+ and CD8+ T-cell Responses to the HIV Proteins Included in the Vaccine. Measured by Flow Cytometry. | CD8+: ENV-3B-PTEG-SEQ | 0 Participants |
| Group 2: Vaccine | Occurrence of HIV-specific CD4+ and CD8+ T-cell Responses to the HIV Proteins Included in the Vaccine. Measured by Flow Cytometry. | CD8+: ENV-2-PTEG-SEQ | 0 Participants |
| Group 3: Placebo | Occurrence of HIV-specific CD4+ and CD8+ T-cell Responses to the HIV Proteins Included in the Vaccine. Measured by Flow Cytometry. | CD8+: ENV-3B-PTEG-SEQ | 0 Participants |
| Group 3: Placebo | Occurrence of HIV-specific CD4+ and CD8+ T-cell Responses to the HIV Proteins Included in the Vaccine. Measured by Flow Cytometry. | CD4+: ANY ENV PTEG | 0 Participants |
| Group 3: Placebo | Occurrence of HIV-specific CD4+ and CD8+ T-cell Responses to the HIV Proteins Included in the Vaccine. Measured by Flow Cytometry. | CD4+: ENV-1-PTEG-SEQ | 0 Participants |
| Group 3: Placebo | Occurrence of HIV-specific CD4+ and CD8+ T-cell Responses to the HIV Proteins Included in the Vaccine. Measured by Flow Cytometry. | CD4+: ENV-2-PTEG-SEQ | 0 Participants |
| Group 3: Placebo | Occurrence of HIV-specific CD4+ and CD8+ T-cell Responses to the HIV Proteins Included in the Vaccine. Measured by Flow Cytometry. | CD4+: ENV-3A-PTEG-SEQ | 0 Participants |
| Group 3: Placebo | Occurrence of HIV-specific CD4+ and CD8+ T-cell Responses to the HIV Proteins Included in the Vaccine. Measured by Flow Cytometry. | CD4+: ENV-3B-PTEG-SEQ | 0 Participants |
| Group 3: Placebo | Occurrence of HIV-specific CD4+ and CD8+ T-cell Responses to the HIV Proteins Included in the Vaccine. Measured by Flow Cytometry. | CD8+: ANY ENV PTEG | 1 Participants |
| Group 3: Placebo | Occurrence of HIV-specific CD4+ and CD8+ T-cell Responses to the HIV Proteins Included in the Vaccine. Measured by Flow Cytometry. | CD8+: ENV-1-PTEG-SEQ | 0 Participants |
| Group 3: Placebo | Occurrence of HIV-specific CD4+ and CD8+ T-cell Responses to the HIV Proteins Included in the Vaccine. Measured by Flow Cytometry. | CD8+: ENV-2-PTEG-SEQ | 1 Participants |
| Group 3: Placebo | Occurrence of HIV-specific CD4+ and CD8+ T-cell Responses to the HIV Proteins Included in the Vaccine. Measured by Flow Cytometry. | CD8+: ENV-3A-PTEG-SEQ | 0 Participants |
Secondary
Occurrence of Neutralizing Antibody Responses Against HIV-1 Isolates
Assessed by multiplex assay. Response to a virus/isolate in the TZM-bl assay is considered positive if the neutralization titer is above a pre-specified cutoff (one-half the lowest dilution tested). A titer is defined as the serum dilution that reduces relative luminescence units (RLUs) by 50% relative to the RLUs in virus control wells (cells + virus only) after subtraction of background RLU (cells only). The pre-specified cutoff is 10 for TZM-bl cells.
Time frame: Measured at 2 weeks after the third vaccination
Population: Overall Number of Participants Analyzed includes those with samples collected at the month 6.5 immunogenicity timepoint, who were HIV-uninfected. Number Analyzed shows the number of participants with available data after filtering for assay-specific quality control criteria. Tier 2 isolates data were collected for a subset of participants (9 for group 1, 5 for Group 2, 1 for Group 3).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1: Vaccine | Occurrence of Neutralizing Antibody Responses Against HIV-1 Isolates | Tier 2: Ce1176_A3 | 0 Participants |
| Group 1: Vaccine | Occurrence of Neutralizing Antibody Responses Against HIV-1 Isolates | Tier 2: 246-F3_C10_2 | 0 Participants |
| Group 1: Vaccine | Occurrence of Neutralizing Antibody Responses Against HIV-1 Isolates | Tier 2: Ce703010217_B6 | 0 Participants |
| Group 1: Vaccine | Occurrence of Neutralizing Antibody Responses Against HIV-1 Isolates | Tier 2: TRO.11 | 0 Participants |
| Group 1: Vaccine | Occurrence of Neutralizing Antibody Responses Against HIV-1 Isolates | Tier 2: X1632-S2-B10 | 0 Participants |
| Group 1: Vaccine | Occurrence of Neutralizing Antibody Responses Against HIV-1 Isolates | Vaccine Strains - 6980.v0.c22 | 0 Participants |
| Group 1: Vaccine | Occurrence of Neutralizing Antibody Responses Against HIV-1 Isolates | Tier 2: 25710-2.43 | 0 Participants |
| Group 1: Vaccine | Occurrence of Neutralizing Antibody Responses Against HIV-1 Isolates | Tier 2: BJOX002000.03.2 | 0 Participants |
| Group 1: Vaccine | Occurrence of Neutralizing Antibody Responses Against HIV-1 Isolates | Tier 2: CH119.10 | 0 Participants |
| Group 1: Vaccine | Occurrence of Neutralizing Antibody Responses Against HIV-1 Isolates | Tier 1: MW965.26 | 18 Participants |
| Group 1: Vaccine | Occurrence of Neutralizing Antibody Responses Against HIV-1 Isolates | Tier 2: CNE55 | 0 Participants |
| Group 2: Vaccine | Occurrence of Neutralizing Antibody Responses Against HIV-1 Isolates | Tier 2: Ce1176_A3 | 0 Participants |
| Group 2: Vaccine | Occurrence of Neutralizing Antibody Responses Against HIV-1 Isolates | Tier 2: 25710-2.43 | 0 Participants |
| Group 2: Vaccine | Occurrence of Neutralizing Antibody Responses Against HIV-1 Isolates | Vaccine Strains - 6980.v0.c22 | 0 Participants |
| Group 2: Vaccine | Occurrence of Neutralizing Antibody Responses Against HIV-1 Isolates | Tier 2: Ce703010217_B6 | 0 Participants |
| Group 2: Vaccine | Occurrence of Neutralizing Antibody Responses Against HIV-1 Isolates | Tier 2: 246-F3_C10_2 | 0 Participants |
| Group 2: Vaccine | Occurrence of Neutralizing Antibody Responses Against HIV-1 Isolates | Tier 2: CH119.10 | 0 Participants |
| Group 2: Vaccine | Occurrence of Neutralizing Antibody Responses Against HIV-1 Isolates | Tier 2: TRO.11 | 0 Participants |
| Group 2: Vaccine | Occurrence of Neutralizing Antibody Responses Against HIV-1 Isolates | Tier 2: CNE55 | 0 Participants |
| Group 2: Vaccine | Occurrence of Neutralizing Antibody Responses Against HIV-1 Isolates | Tier 2: BJOX002000.03.2 | 0 Participants |
| Group 2: Vaccine | Occurrence of Neutralizing Antibody Responses Against HIV-1 Isolates | Tier 2: X1632-S2-B10 | 0 Participants |
| Group 2: Vaccine | Occurrence of Neutralizing Antibody Responses Against HIV-1 Isolates | Tier 1: MW965.26 | 8 Participants |
| Group 3: Placebo | Occurrence of Neutralizing Antibody Responses Against HIV-1 Isolates | Tier 2: X1632-S2-B10 | 0 Participants |
| Group 3: Placebo | Occurrence of Neutralizing Antibody Responses Against HIV-1 Isolates | Vaccine Strains - 6980.v0.c22 | 0 Participants |
| Group 3: Placebo | Occurrence of Neutralizing Antibody Responses Against HIV-1 Isolates | Tier 2: CNE55 | 0 Participants |
| Group 3: Placebo | Occurrence of Neutralizing Antibody Responses Against HIV-1 Isolates | Tier 1: MW965.26 | 0 Participants |
| Group 3: Placebo | Occurrence of Neutralizing Antibody Responses Against HIV-1 Isolates | Tier 2: 246-F3_C10_2 | 0 Participants |
| Group 3: Placebo | Occurrence of Neutralizing Antibody Responses Against HIV-1 Isolates | Tier 2: 25710-2.43 | 0 Participants |
| Group 3: Placebo | Occurrence of Neutralizing Antibody Responses Against HIV-1 Isolates | Tier 2: BJOX002000.03.2 | 0 Participants |
| Group 3: Placebo | Occurrence of Neutralizing Antibody Responses Against HIV-1 Isolates | Tier 2: CH119.10 | 0 Participants |
| Group 3: Placebo | Occurrence of Neutralizing Antibody Responses Against HIV-1 Isolates | Tier 2: Ce1176_A3 | 0 Participants |
| Group 3: Placebo | Occurrence of Neutralizing Antibody Responses Against HIV-1 Isolates | Tier 2: Ce703010217_B6 | 0 Participants |
| Group 3: Placebo | Occurrence of Neutralizing Antibody Responses Against HIV-1 Isolates | Tier 2: TRO.11 | 0 Participants |
Secondary
Occurrence of Vaccine-induced Binding Antibodies to HIV Proteins Measured by the Binding Antibody Multiplex Assay (BAMA)
Serum HIV-1-specific IgG responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay. The readout is background-subtracted mean fluorescent intensity (MFI), with background adjustment for an antigen-specific plate level control. For each sample, response magnitude is net MFI, defined as experimental antigen MFI minus reference antigen MFI. Net MFI less than 1 is set to 1. Samples from post-enrollment visits have positive responses if they meet three conditions: (1) net MFI greater than or equal to an antigen-specific response threshold (defined as the maximum of 100 and the 95th percentile of pre-vaccination net MFI), (2) net MFI values are greater than 3 times pre-vaccination net MFI, and (3) experimental antigen MFI values are greater than 3 times pre-vaccination MFI. Data are excluded if the blood draw date was outside the allowable window, a participant was HIV-infected, or the reference antigen exceeds 5000 MFI.
Time frame: Measured at 2 weeks after the third vaccination
Population: Overall Number of Participants Analyzed includes those with samples collected at month 6.5, who were HIV-uninfected. Number Analyzed counts participants with available data after filtering for assay-specific quality control criteria.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1: Vaccine | Occurrence of Vaccine-induced Binding Antibodies to HIV Proteins Measured by the Binding Antibody Multiplex Assay (BAMA) | gp145 Ref. Std | 17 Participants |
| Group 1: Vaccine | Occurrence of Vaccine-induced Binding Antibodies to HIV Proteins Measured by the Binding Antibody Multiplex Assay (BAMA) | Con S gp140 CFI | 17 Participants |
| Group 1: Vaccine | Occurrence of Vaccine-induced Binding Antibodies to HIV Proteins Measured by the Binding Antibody Multiplex Assay (BAMA) | 1086C_D7gp120.avi/293F | 17 Participants |
| Group 1: Vaccine | Occurrence of Vaccine-induced Binding Antibodies to HIV Proteins Measured by the Binding Antibody Multiplex Assay (BAMA) | C.1086C_V1_V2 Tags | 0 Participants |
| Group 1: Vaccine | Occurrence of Vaccine-induced Binding Antibodies to HIV Proteins Measured by the Binding Antibody Multiplex Assay (BAMA) | gp41 | 17 Participants |
| Group 2: Vaccine | Occurrence of Vaccine-induced Binding Antibodies to HIV Proteins Measured by the Binding Antibody Multiplex Assay (BAMA) | Con S gp140 CFI | 12 Participants |
| Group 2: Vaccine | Occurrence of Vaccine-induced Binding Antibodies to HIV Proteins Measured by the Binding Antibody Multiplex Assay (BAMA) | 1086C_D7gp120.avi/293F | 11 Participants |
| Group 2: Vaccine | Occurrence of Vaccine-induced Binding Antibodies to HIV Proteins Measured by the Binding Antibody Multiplex Assay (BAMA) | C.1086C_V1_V2 Tags | 0 Participants |
| Group 2: Vaccine | Occurrence of Vaccine-induced Binding Antibodies to HIV Proteins Measured by the Binding Antibody Multiplex Assay (BAMA) | gp145 Ref. Std | 12 Participants |
| Group 2: Vaccine | Occurrence of Vaccine-induced Binding Antibodies to HIV Proteins Measured by the Binding Antibody Multiplex Assay (BAMA) | gp41 | 12 Participants |
| Group 3: Placebo | Occurrence of Vaccine-induced Binding Antibodies to HIV Proteins Measured by the Binding Antibody Multiplex Assay (BAMA) | gp41 | 0 Participants |
| Group 3: Placebo | Occurrence of Vaccine-induced Binding Antibodies to HIV Proteins Measured by the Binding Antibody Multiplex Assay (BAMA) | gp145 Ref. Std | 0 Participants |
| Group 3: Placebo | Occurrence of Vaccine-induced Binding Antibodies to HIV Proteins Measured by the Binding Antibody Multiplex Assay (BAMA) | 1086C_D7gp120.avi/293F | 0 Participants |
| Group 3: Placebo | Occurrence of Vaccine-induced Binding Antibodies to HIV Proteins Measured by the Binding Antibody Multiplex Assay (BAMA) | Con S gp140 CFI | 0 Participants |
| Group 3: Placebo | Occurrence of Vaccine-induced Binding Antibodies to HIV Proteins Measured by the Binding Antibody Multiplex Assay (BAMA) | C.1086C_V1_V2 Tags | 0 Participants |
Secondary
Occurrence of Vaccine-induced Binding Antibodies to HIV Proteins Measured by the Binding Antibody Multiplex Assay (BAMA)
Serum HIV-1-specific IgG responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay. The readout is background-subtracted mean fluorescent intensity (MFI), with background adjustment for an antigen-specific plate level control. For each sample, response magnitude is net MFI, defined as experimental antigen MFI minus reference antigen MFI. Net MFI less than 1 is set to 1. Samples from post-enrollment visits have positive responses if they meet three conditions: (1) net MFI greater than or equal to an antigen-specific response threshold (defined as the maximum of 100 and the 95th percentile of pre-vaccination net MFI), (2) net MFI values are greater than 3 times pre-vaccination net MFI, and (3) experimental antigen MFI values are greater than 3 times pre-vaccination MFI. Data are excluded if the blood draw date was outside the allowable window, a participant was HIV-infected, or the reference antigen exceeds 5000 MFI.
Time frame: Measured at 2 weeks after the first vaccination
Population: Overall Number of Participants Analyzed includes those with samples collected at week 2, who were HIV-uninfected and received the first vaccination. Number Analyzed counts participants with available data after filtering for assay-specific quality control criteria.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1: Vaccine | Occurrence of Vaccine-induced Binding Antibodies to HIV Proteins Measured by the Binding Antibody Multiplex Assay (BAMA) | gp41 | 0 Participants |
| Group 1: Vaccine | Occurrence of Vaccine-induced Binding Antibodies to HIV Proteins Measured by the Binding Antibody Multiplex Assay (BAMA) | Con S gp140 CFI | 2 Participants |
| Group 1: Vaccine | Occurrence of Vaccine-induced Binding Antibodies to HIV Proteins Measured by the Binding Antibody Multiplex Assay (BAMA) | C.1086C_V1_V2 Tags | 0 Participants |
| Group 1: Vaccine | Occurrence of Vaccine-induced Binding Antibodies to HIV Proteins Measured by the Binding Antibody Multiplex Assay (BAMA) | gp145 Ref. Std. | 1 Participants |
| Group 1: Vaccine | Occurrence of Vaccine-induced Binding Antibodies to HIV Proteins Measured by the Binding Antibody Multiplex Assay (BAMA) | 1086C_D7gp120.avi/293F | 0 Participants |
| Group 2: Vaccine | Occurrence of Vaccine-induced Binding Antibodies to HIV Proteins Measured by the Binding Antibody Multiplex Assay (BAMA) | gp41 | 0 Participants |
| Group 2: Vaccine | Occurrence of Vaccine-induced Binding Antibodies to HIV Proteins Measured by the Binding Antibody Multiplex Assay (BAMA) | 1086C_D7gp120.avi/293F | 1 Participants |
| Group 2: Vaccine | Occurrence of Vaccine-induced Binding Antibodies to HIV Proteins Measured by the Binding Antibody Multiplex Assay (BAMA) | C.1086C_V1_V2 Tags | 0 Participants |
| Group 2: Vaccine | Occurrence of Vaccine-induced Binding Antibodies to HIV Proteins Measured by the Binding Antibody Multiplex Assay (BAMA) | Con S gp140 CFI | 0 Participants |
| Group 2: Vaccine | Occurrence of Vaccine-induced Binding Antibodies to HIV Proteins Measured by the Binding Antibody Multiplex Assay (BAMA) | gp145 Ref. Std. | 0 Participants |
| Group 3: Placebo | Occurrence of Vaccine-induced Binding Antibodies to HIV Proteins Measured by the Binding Antibody Multiplex Assay (BAMA) | 1086C_D7gp120.avi/293F | 0 Participants |
| Group 3: Placebo | Occurrence of Vaccine-induced Binding Antibodies to HIV Proteins Measured by the Binding Antibody Multiplex Assay (BAMA) | C.1086C_V1_V2 Tags | 0 Participants |
| Group 3: Placebo | Occurrence of Vaccine-induced Binding Antibodies to HIV Proteins Measured by the Binding Antibody Multiplex Assay (BAMA) | gp41 | 0 Participants |
| Group 3: Placebo | Occurrence of Vaccine-induced Binding Antibodies to HIV Proteins Measured by the Binding Antibody Multiplex Assay (BAMA) | gp145 Ref. Std. | 0 Participants |
| Group 3: Placebo | Occurrence of Vaccine-induced Binding Antibodies to HIV Proteins Measured by the Binding Antibody Multiplex Assay (BAMA) | Con S gp140 CFI | 0 Participants |