HIV Infections
Conditions
Keywords
HIV vaccine, DNA vaccine, IL-12, Electroporation, p24, Gag, Adjuvant, Healthy
Brief summary
The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of two HIV-1 pDNA vaccines: p24CE1/2 pDNA and p55\^gag pDNA administered with IL-12 pDNA adjuvant, given by intramuscular (IM) injection with electroporation (EP), in healthy, HIV-uninfected adults.
Detailed description
This study will evaluate the safety, tolerability, and immunogenicity of two HIV-1 pDNA vaccines: p24CE1/2 pDNA and p55\^gag pDNA administered with IL-12 pDNA adjuvant, given by intramuscular (IM) injection with electroporation (EP), in healthy, HIV-uninfected adults. Participants will be randomly assigned to one of four groups: Group 1 Treatment, Group 1 Control, Group 2 Treatment, or Group 2 Control. Participants in Group 1 Treatment will receive p24CE1/2 pDNA and IL-12 pDNA at Day 0 and Month 1, then p24CE1/2 pDNA plus p55\^gag pDNA and IL-12 pDNA at Months 3 and 6. Participants in Group 1 Control will receive placebo (sodium chloride for injection) at Day 0 and Months 1, 3, and 6. Participants in Group 2 Treatment will receive p55\^gag pDNA and IL-12 pDNA at Day 0 and Months 1, 3, and 6. Participants in Group 2 Control will receive placebo (sodium chloride for injection) at Day 0 and Months 1, 3, and 6. Study visits will occur at Day 0, Week 2, and Months 1, 1.25, 1.5, 3, 3.5, 6, 6.25, 6.5, 9, and 12. Visits may include physical examinations and clinical assessments, blood and urine collection, optional stool collection, HIV testing, risk reduction counseling, and interviews/questionnaires. At Month 18, study staff will contact participants for follow-up health monitoring.
Interventions
BIOLOGICALp24CE1/2 pDNA Vaccine
Administered bilaterally using the Ichor Medical Systems Intramuscular TriGrid Delivery System (TDS-IM) electroporation (EP) device
BIOLOGICALp55^gag pDNA Vaccine
Administered bilaterally using the TDS-IM EP device
BIOLOGICALIL-12 pDNA Adjuvant
Administered bilaterally using the TDS-IM EP device
BIOLOGICALPlacebo
Administered bilaterally using the TDS-IM EP device
DEVICEIchor Medical Systems Intramuscular TriGrid Delivery System (TDS-IM) electroporation (EP) device
The TDS-IM EP device will be used to administer study product(s).
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 * Agrees not to enroll in another study of an investigational research agent prior to completion of last required protocol visit (excludes annual health contact visit) * Good general health as shown by medical history, physical exam, and screening laboratory tests HIV-Related Criteria: * Assessed by the clinic staff as being at low risk for HIV infection and committed to maintaining behavior consistent with low risk of HIV exposure through the last required protocol clinic visit. Laboratory Inclusion Values * 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 panel: alanine aminotransferase (ALT), aspartate aminotransferase (AST), and alkaline phosphatase less than 1.25 times the institutional upper limit of normal; creatine phosphokinase (CPK) less than or equal to 2.0 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: U.S. volunteers must have a negative 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 * Normal urine: * Negative urine glucose, and * Negative or trace urine protein, and * Negative or trace urine hemoglobin Reproductive Status * Reproductive status: A volunteer who was born female must: * Agree to consistently use effective contraception for sexual activity that could lead to pregnancy from at least 21 days prior to enrollment through the last required protocol clinic visit. * 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.
Exclusion criteria
General * Allergy to amide-type local anesthetics (bupivacaine \[Marcaine\], lidocaine \[Xylocaine\], mepivacaine \[Polocaine/Carbocaine\], etidocaine \[Duranest\], prilocaine \[Citanest, EMLA® cream\]) * 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 study * Pregnant or breastfeeding * Active duty and reserve U.S. 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 Protocol Safety Review Team (PSRT) will determine eligibility on a case-by-case basis. * Previous receipt of monoclonal antibodies (mAbs), whether licensed or investigational; the HVTN 119 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. Immune System * Immunosuppressive medications received within 168 days before first vaccination. * Serious adverse reactions to vaccines or to vaccine components * 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. * Any medical, psychiatric, occupational, or other condition that, in the judgment of the investigator, would interfere with, or serve as a contraindication to, protocol adherence, assessment of safety or reactogenicity, or a volunteer's ability to give informed consent * Psychiatric condition that precludes compliance with the protocol. Specifically excluded are persons with psychoses within the past 3 years, ongoing risk for suicide, or history of suicide attempt or gesture within the past 3 years. * Current anti-tuberculosis (TB) prophylaxis or therapy * Asthma
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Summary of T-Cell Epitope Mapping Breadth (Defined as the Number of Targeted CEs) Among All Participants by T-cell Subset (CD4+, CD8+), Visit, and Treatment Arm [Time Frame: Measured at M1.5 and M6.5] | M1.5 and M6.5 | For participants with a positive Fisher's Exact response to Gag CE Total and/or HBX2 p55Gag for either IFN-γ and/or IL2(CD4+ or CD8+) or for CD40L(CD4+)at month1.5and/or month 6.5, samples were further assayed against the seven individual CE peptide pools and the total number of positive responses was defined as the breadth. |
| Chemistry and Hematology Laboratory Measures - Hemoglobin in g/dL | Measured during screening, Days 14, 42, 98, 182 and 273 | For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population. |
| Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count in 1000*Cells/mm^3 | Measured during screening, Days 14, 42, 98, 175 and 273 | For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population. |
| Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000*Cells/mm^3 | Measured during screening, Days 14, 42, 98, 175 and 273 | For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population. |
| Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Measured during screening, Days 14, 42, 98, 182 and 273 for (ALP), (AST), (ALT), (CPK), creatinine. Measured during screening, Days 14, 42, 98, 175, 182 and 273 for Lymphocyte count, Neutrophil count Platelets, WBC, hemoglobin. | The number (percentage) of participants with Chemistry and Hematology Laboratory Measures - Counts of Lab Grade \> 1 for alkaline phosphate (ALP), aspartate aminotransferase (AST), alanine aminotransferase (ALT), creatine phosphokinase (CPK), creatinine, hemoglobin, lymphocyte count, neutrophil count, platelets, white blood cells (WBC) was summarized by treatment group and visit time |
| Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation | Measured through Month 18 | The number (percentage) of participants with early discontinuation of vaccinations and reason for discontinuation was summarized by arm |
| Magnitude of Local Injection/EP Site Pain as Measured by a Visual Analog Scale (Day 0, Day 28, Day 84, Day 168) | Measured during Day 0, 28, 84 and 168 | A visual analog scale is a horizontal line, 10 cm in length, anchored by word descriptors at each end (no pain and worst pain). The visual analog scale score is determined by measuring in centimeters from the left hand end of the line to the point that the patient marks, 0 cm being no pain and 10 cm being maximum pain.The pain assessment scores for each arm at each vaccination visit were summarized with visual analog scale (VAS) |
| Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Measured during Visit 3 (Day14), Visit 5 (Day 35), Visit 8 (Day 98), Visit 10 (Day 175) | Distribution of responses to questions regarding acceptability of study injection procedures \[ Visits 3, 5, 8, 10\] were summarized by category (Acceptable/Unacceptable/Don?t know/ Don?t Remember) |
| Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Measured through Month 0, 1, 3, 6 | Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1, July 2017. The maximum grade observed for each symptom ove |
| Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Measured through Month 0, 1, 3, 6 | Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1, July 2017. The maximum grade observed for each symptom ove |
| Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Measured through Month 0, 1, 3, 6 | Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1, July 2017. The maximum grade observed for each symptom ove |
| Chemistry and Hematology Laboratory Measures - Alkaline Phosphate (ALP), Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Creatine Phosphokinase (CPK) in U/L | Measured during screening, Days 14, 42, 98, 182 and 273 | For each local laboratory measure-alkaline phosphate (ALP), aspartate aminotransferase (AST), alanine aminotransferase (ALT), creatine phosphokinase (CPK) in U/L, summary statistics were presented by treatment group and timepoint for the overall population. |
| Chemistry and Hematology Laboratory Measures - Creatinine in g/dL | Measured during screening, Days 14, 42, 98, 182 and 273 | For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| CD4+ and CD8+ T Cell MIMOSA Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5] | M0, M1.5 and M6.5 | Flow cytometry was used to examine HIV-1 specific CD4+ and CD8+ T-cell responses using a validated ICS assay. Athe Mixture Models for Single-cell Assays (MIMOSA) statistical framework was applied to detective the positivity response. If at least one peptide pool for a specific HIV-1 protein was positive, then the overall response to the protein was considered positive. If any peptide pool was positive for a T-cellubset, then the overall response for that T-cell subset was considered positive. |
| Summary of CD4+ and CD8+ T Cell Response Magnitudes Among All Participants by Cytokine, T-Cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5] | M0, M1.5 and M6.5 | Flow cytometry was used to examine HIV-1 specific CD4+ and CD8+ T-cell responses using a validated ICS assay. Percentage of CD4+ T cells expressing CD40L+ was used as the magnititudes response for ICS assay. |
| CD4+ and CD8+ T Cell Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M1.5 and M6.5] | M0, M1.5 and M6.5 | Flow cytometry was used to examine HIV-1 specific CD4+ and CD8+ T-cell responses using a validated ICS assay. A one sided Fisher's exact test was applied to detective the positivity response. If at least one peptide pool for a specific HIV-1 protein was positive, then the overall response to the protein was considered positive. If any peptide pool was positive for a T-cellubset, then the overall response for that T-cell subset was considered positive. |
| Summary of CD4+ and CD8+ T Cell Response Magnitudes to Epitope Mapping Gag Among All Participants by by Cytokine, T-Cell Subset (CD4+, CD8+), Antigenand Treatment Group [Time Frame: Measured at M1.5 and M6.5] | M1.5 and M6.5 | For participants with a positive Fisher's Exact response to Gag CE Total and/or HBX2 p55Gag for either IFN-γ and/or IL2(CD4+ or CD8+) or for CD40L(CD4+)at month1.5and/or month 6.5, samples were further assayed against the seven individual CE peptide pools. Percentage of CD8+ T cells expressing IFN-gamma was used as the magnitude response. The background-substracted magnitude was summarized by treatment group. The negative reading of magnitude is due to background substracted. |
| Binding Antibody IgG Responses Rate by the HIV-1 Binding Antibody Multiplex Assay (BAMA) by Treatment Arm [Time Frame: M6.5] | M6.5 | The frequency of IgG binding antibody responses were measured by the HIV-1 binding antibody multiplex assay (BAMA).Samples from post-enrollment visits were declared to have positive responses if they met three conditions: (1) the MFI minus blank (MFI\*) values were ≥ antigen-specific cutoff at the 1:50 dilution level (based on the 95th percentile of baseline samples as calculated by SAS PROC UNIVARIATE default method, and at least 100 MFI minus blank), (2) the MFI minus blank values were greater than 3 times the baseline (day 0) MFI minus blank values, and (3) the MFI values were greater than 3 times the baseline MFI values. |
| Binding Antibody IgG Responses Magnitudes by the HIV-1 Binding Antibody Multiplex Assay (BAMA) by Treatment Arm [Time Frame: M6.5] | M6.5 | The magnitude of IgG binding antibody responses were measured by the HIV-1 binding antibody multiplex assay (BAMA). Serum HIV-1-specific IgG antibody responses are measured at the 1:50 dilution against the p24gag antigen on all available samples .The a background-subtracted mean fluorescent intensity (MFI) at the 1:50 dilution were used to summarize the magnitudes at a given time-point. MFI will be used to determine the positivity of samples. Samples from post-enrollment visits are declared to have positive responses if they meet three conditions: (1) the MFI\* values are greater than the antigen-specific cutoff (based on the 95th percentile of the baseline visit serum samples and at least 100 MFI), (2) the MFI\* values are greater than 3 times the baseline (day 0) MFI\* values, and (3) the MFI values are greater than 3 times the baseline MFI values. The values in Groups 1 and 2 are correct as currently reported. |
| CD4+ and CD8+ T Cell Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5] | M0, M1.5 and M6.5 | Flow cytometry was used to examine HIV-1 specific CD4+ and CD8+ T-cell responses using a validated ICS assay. A one sided Fisher's exact test was applied to detective the positivity response. If at least one peptide pool for a specific HIV-1 protein was positive, then the overall response to the protein was considered positive. If any peptide pool was positive for a T-cellubset, then the overall response for that T-cell subset was considered positive. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Group 1: Vaccine P24CE1/2(CE/CE) + gag vaccines | 25 |
| Group 2: Vaccine P55gag (gag/gag) vaccines | 25 |
| Group 3: Control 1 Placebo: Sodium Chloride, USP 0.9% | 3 |
| Group 4: Control 2 Placebo: Sodium Chloride, USP 0.9% | 3 |
| Total | 56 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 7 | 1 | 0 | 0 |
| Overall Study | Participant unable to adhere to visit | 0 | 1 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 1 | 1 | 0 |
Baseline characteristics
| Characteristic | Total | Group 1: Vaccine | Group 2: Vaccine | Group 3: Control 1 | Group 4: Control 2 |
|---|---|---|---|---|---|
| Age, Continuous | 29 years | 29 years | 31 years | 24 years | 30 years |
| Age, Customized 18 - 20 | 2 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants |
| Age, Customized 21 - 30 | 28 Participants | 13 Participants | 11 Participants | 2 Participants | 2 Participants |
| Age, Customized 31 - 40 | 13 Participants | 3 Participants | 9 Participants | 0 Participants | 1 Participants |
| Age, Customized 41 - 50 | 13 Participants | 8 Participants | 4 Participants | 1 Participants | 0 Participants |
| Age, Customized Less than 18 | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Customized Over 50 | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Customized Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants | 1 Participants | 3 Participants | 1 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 51 Participants | 24 Participants | 22 Participants | 2 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 0 Participants | 2 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 10 Participants | 4 Participants | 6 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 4 Participants | 2 Participants | 2 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 5 Participants | 2 Participants | 3 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 33 Participants | 16 Participants | 11 Participants | 3 Participants | 3 Participants |
| Region of Enrollment United States | 56 Participants | 25 Participants | 25 Participants | 3 Participants | 3 Participants |
| Sex: Female, Male Female | 33 Participants | 12 Participants | 15 Participants | 3 Participants | 3 Participants |
| Sex: Female, Male Male | 23 Participants | 13 Participants | 10 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 25 | 0 / 25 | 0 / 3 | 0 / 3 |
| other Total, other adverse events | 16 / 25 | 17 / 25 | 2 / 3 | 2 / 3 |
| serious Total, serious adverse events | 0 / 25 | 0 / 25 | 0 / 3 | 0 / 3 |
Outcome results
Primary
Chemistry and Hematology Laboratory Measures - Alkaline Phosphate (ALP), Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Creatine Phosphokinase (CPK) in U/L
For each local laboratory measure-alkaline phosphate (ALP), aspartate aminotransferase (AST), alanine aminotransferase (ALT), creatine phosphokinase (CPK) in U/L, summary statistics were presented by treatment group and timepoint for the overall population.
Time frame: Measured during screening, Days 14, 42, 98, 182 and 273
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 and Hematology Laboratory Measures - Alkaline Phosphate (ALP), Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Creatine Phosphokinase (CPK) in U/L | Alkaline Phosphatase (U/L)-Day 98 | 54 U/L |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Alkaline Phosphate (ALP), Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Creatine Phosphokinase (CPK) in U/L | creatine phosphokinase (U/L)-Day 98 | 110 U/L |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Alkaline Phosphate (ALP), Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Creatine Phosphokinase (CPK) in U/L | AST (U/L)- Screening | 17 U/L |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Alkaline Phosphate (ALP), Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Creatine Phosphokinase (CPK) in U/L | Alkaline Phosphatase (U/L)-Day 14 | 61 U/L |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Alkaline Phosphate (ALP), Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Creatine Phosphokinase (CPK) in U/L | ALT (SGPT) (U/L)-Day 14 | 14.5 U/L |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Alkaline Phosphate (ALP), Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Creatine Phosphokinase (CPK) in U/L | ALT (SGPT) (U/L)-Day 98 | 15 U/L |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Alkaline Phosphate (ALP), Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Creatine Phosphokinase (CPK) in U/L | AST (U/L)-Day 14 | 16 U/L |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Alkaline Phosphate (ALP), Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Creatine Phosphokinase (CPK) in U/L | Alkaline Phosphatase (U/L)-Day 42 | 55.5 U/L |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Alkaline Phosphate (ALP), Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Creatine Phosphokinase (CPK) in U/L | Alkaline Phosphatase (U/L)- Screening | 61 U/L |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Alkaline Phosphate (ALP), Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Creatine Phosphokinase (CPK) in U/L | creatine phosphokinase (U/L)-Day 42 | 118 U/L |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Alkaline Phosphate (ALP), Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Creatine Phosphokinase (CPK) in U/L | AST (U/L)-Day 42 | 16 U/L |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Alkaline Phosphate (ALP), Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Creatine Phosphokinase (CPK) in U/L | creatine phosphokinase (U/L)-Day 182 | 121 U/L |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Alkaline Phosphate (ALP), Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Creatine Phosphokinase (CPK) in U/L | ALT (SGPT) (U/L)- Screening | 17 U/L |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Alkaline Phosphate (ALP), Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Creatine Phosphokinase (CPK) in U/L | creatine phosphokinase (U/L)-Day 14 | 113.5 U/L |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Alkaline Phosphate (ALP), Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Creatine Phosphokinase (CPK) in U/L | AST (U/L)-Day 98 | 17 U/L |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Alkaline Phosphate (ALP), Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Creatine Phosphokinase (CPK) in U/L | ALT (SGPT) (U/L)-Day 182 | 16 U/L |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Alkaline Phosphate (ALP), Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Creatine Phosphokinase (CPK) in U/L | creatine phosphokinase (U/L)-Day 273 | 123 U/L |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Alkaline Phosphate (ALP), Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Creatine Phosphokinase (CPK) in U/L | Alkaline Phosphatase (U/L)-Day 273 | 57 U/L |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Alkaline Phosphate (ALP), Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Creatine Phosphokinase (CPK) in U/L | AST (U/L)-Day 182 | 18 U/L |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Alkaline Phosphate (ALP), Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Creatine Phosphokinase (CPK) in U/L | ALT (SGPT) (U/L)-Day 273 | 16 U/L |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Alkaline Phosphate (ALP), Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Creatine Phosphokinase (CPK) in U/L | ALT (SGPT) (U/L)-Day 42 | 14.5 U/L |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Alkaline Phosphate (ALP), Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Creatine Phosphokinase (CPK) in U/L | creatine phosphokinase (U/L)- Screening | 94 U/L |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Alkaline Phosphate (ALP), Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Creatine Phosphokinase (CPK) in U/L | AST (U/L)-Day 273 | 16 U/L |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Alkaline Phosphate (ALP), Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Creatine Phosphokinase (CPK) in U/L | Alkaline Phosphatase (U/L)-Day 182 | 59 U/L |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Alkaline Phosphate (ALP), Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Creatine Phosphokinase (CPK) in U/L | AST (U/L)-Day 273 | 18 U/L |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Alkaline Phosphate (ALP), Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Creatine Phosphokinase (CPK) in U/L | Alkaline Phosphatase (U/L)-Day 273 | 55 U/L |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Alkaline Phosphate (ALP), Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Creatine Phosphokinase (CPK) in U/L | Alkaline Phosphatase (U/L)- Screening | 61 U/L |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Alkaline Phosphate (ALP), Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Creatine Phosphokinase (CPK) in U/L | ALT (SGPT) (U/L)- Screening | 16 U/L |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Alkaline Phosphate (ALP), Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Creatine Phosphokinase (CPK) in U/L | Alkaline Phosphatase (U/L)-Day 14 | 57.5 U/L |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Alkaline Phosphate (ALP), Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Creatine Phosphokinase (CPK) in U/L | creatine phosphokinase (U/L)-Day 182 | 99 U/L |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Alkaline Phosphate (ALP), Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Creatine Phosphokinase (CPK) in U/L | Alkaline Phosphatase (U/L)-Day 182 | 56 U/L |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Alkaline Phosphate (ALP), Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Creatine Phosphokinase (CPK) in U/L | Alkaline Phosphatase (U/L)-Day 42 | 61 U/L |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Alkaline Phosphate (ALP), Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Creatine Phosphokinase (CPK) in U/L | ALT (SGPT) (U/L)-Day 182 | 17 U/L |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Alkaline Phosphate (ALP), Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Creatine Phosphokinase (CPK) in U/L | Alkaline Phosphatase (U/L)-Day 98 | 55 U/L |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Alkaline Phosphate (ALP), Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Creatine Phosphokinase (CPK) in U/L | ALT (SGPT) (U/L)-Day 98 | 13 U/L |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Alkaline Phosphate (ALP), Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Creatine Phosphokinase (CPK) in U/L | creatine phosphokinase (U/L)-Day 14 | 92.5 U/L |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Alkaline Phosphate (ALP), Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Creatine Phosphokinase (CPK) in U/L | creatine phosphokinase (U/L)-Day 98 | 102 U/L |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Alkaline Phosphate (ALP), Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Creatine Phosphokinase (CPK) in U/L | ALT (SGPT) (U/L)-Day 273 | 15.5 U/L |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Alkaline Phosphate (ALP), Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Creatine Phosphokinase (CPK) in U/L | creatine phosphokinase (U/L)-Day 273 | 98.5 U/L |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Alkaline Phosphate (ALP), Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Creatine Phosphokinase (CPK) in U/L | AST (U/L)- Screening | 17 U/L |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Alkaline Phosphate (ALP), Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Creatine Phosphokinase (CPK) in U/L | creatine phosphokinase (U/L)-Day 42 | 91 U/L |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Alkaline Phosphate (ALP), Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Creatine Phosphokinase (CPK) in U/L | AST (U/L)-Day 14 | 17 U/L |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Alkaline Phosphate (ALP), Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Creatine Phosphokinase (CPK) in U/L | ALT (SGPT) (U/L)-Day 14 | 16.5 U/L |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Alkaline Phosphate (ALP), Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Creatine Phosphokinase (CPK) in U/L | AST (U/L)-Day 42 | 16 U/L |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Alkaline Phosphate (ALP), Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Creatine Phosphokinase (CPK) in U/L | AST (U/L)-Day 98 | 16 U/L |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Alkaline Phosphate (ALP), Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Creatine Phosphokinase (CPK) in U/L | creatine phosphokinase (U/L)- Screening | 92 U/L |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Alkaline Phosphate (ALP), Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Creatine Phosphokinase (CPK) in U/L | AST (U/L)-Day 182 | 20 U/L |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Alkaline Phosphate (ALP), Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Creatine Phosphokinase (CPK) in U/L | ALT (SGPT) (U/L)-Day 42 | 15 U/L |
| Group 3: Control 1 | Chemistry and Hematology Laboratory Measures - Alkaline Phosphate (ALP), Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Creatine Phosphokinase (CPK) in U/L | Alkaline Phosphatase (U/L)-Day 42 | 51 U/L |
| Group 3: Control 1 | Chemistry and Hematology Laboratory Measures - Alkaline Phosphate (ALP), Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Creatine Phosphokinase (CPK) in U/L | ALT (SGPT) (U/L)-Day 182 | 13 U/L |
| Group 3: Control 1 | Chemistry and Hematology Laboratory Measures - Alkaline Phosphate (ALP), Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Creatine Phosphokinase (CPK) in U/L | creatine phosphokinase (U/L)-Day 14 | 58.5 U/L |
| Group 3: Control 1 | Chemistry and Hematology Laboratory Measures - Alkaline Phosphate (ALP), Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Creatine Phosphokinase (CPK) in U/L | ALT (SGPT) (U/L)- Screening | 12 U/L |
| Group 3: Control 1 | Chemistry and Hematology Laboratory Measures - Alkaline Phosphate (ALP), Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Creatine Phosphokinase (CPK) in U/L | ALT (SGPT) (U/L)-Day 14 | 9 U/L |
| Group 3: Control 1 | Chemistry and Hematology Laboratory Measures - Alkaline Phosphate (ALP), Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Creatine Phosphokinase (CPK) in U/L | ALT (SGPT) (U/L)-Day 42 | 12 U/L |
| Group 3: Control 1 | Chemistry and Hematology Laboratory Measures - Alkaline Phosphate (ALP), Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Creatine Phosphokinase (CPK) in U/L | ALT (SGPT) (U/L)-Day 98 | 11 U/L |
| Group 3: Control 1 | Chemistry and Hematology Laboratory Measures - Alkaline Phosphate (ALP), Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Creatine Phosphokinase (CPK) in U/L | ALT (SGPT) (U/L)-Day 273 | 11 U/L |
| Group 3: Control 1 | Chemistry and Hematology Laboratory Measures - Alkaline Phosphate (ALP), Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Creatine Phosphokinase (CPK) in U/L | AST (U/L)- Screening | 18 U/L |
| Group 3: Control 1 | Chemistry and Hematology Laboratory Measures - Alkaline Phosphate (ALP), Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Creatine Phosphokinase (CPK) in U/L | AST (U/L)-Day 14 | 13.5 U/L |
| Group 3: Control 1 | Chemistry and Hematology Laboratory Measures - Alkaline Phosphate (ALP), Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Creatine Phosphokinase (CPK) in U/L | AST (U/L)-Day 42 | 14 U/L |
| Group 3: Control 1 | Chemistry and Hematology Laboratory Measures - Alkaline Phosphate (ALP), Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Creatine Phosphokinase (CPK) in U/L | AST (U/L)-Day 98 | 15 U/L |
| Group 3: Control 1 | Chemistry and Hematology Laboratory Measures - Alkaline Phosphate (ALP), Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Creatine Phosphokinase (CPK) in U/L | AST (U/L)-Day 182 | 17 U/L |
| Group 3: Control 1 | Chemistry and Hematology Laboratory Measures - Alkaline Phosphate (ALP), Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Creatine Phosphokinase (CPK) in U/L | AST (U/L)-Day 273 | 15.5 U/L |
| Group 3: Control 1 | Chemistry and Hematology Laboratory Measures - Alkaline Phosphate (ALP), Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Creatine Phosphokinase (CPK) in U/L | Alkaline Phosphatase (U/L)- Screening | 52 U/L |
| Group 3: Control 1 | Chemistry and Hematology Laboratory Measures - Alkaline Phosphate (ALP), Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Creatine Phosphokinase (CPK) in U/L | Alkaline Phosphatase (U/L)-Day 14 | 52 U/L |
| Group 3: Control 1 | Chemistry and Hematology Laboratory Measures - Alkaline Phosphate (ALP), Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Creatine Phosphokinase (CPK) in U/L | Alkaline Phosphatase (U/L)-Day 98 | 51 U/L |
| Group 3: Control 1 | Chemistry and Hematology Laboratory Measures - Alkaline Phosphate (ALP), Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Creatine Phosphokinase (CPK) in U/L | Alkaline Phosphatase (U/L)-Day 182 | 55 U/L |
| Group 3: Control 1 | Chemistry and Hematology Laboratory Measures - Alkaline Phosphate (ALP), Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Creatine Phosphokinase (CPK) in U/L | Alkaline Phosphatase (U/L)-Day 273 | 53.5 U/L |
| Group 3: Control 1 | Chemistry and Hematology Laboratory Measures - Alkaline Phosphate (ALP), Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Creatine Phosphokinase (CPK) in U/L | creatine phosphokinase (U/L)- Screening | 88 U/L |
| Group 3: Control 1 | Chemistry and Hematology Laboratory Measures - Alkaline Phosphate (ALP), Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Creatine Phosphokinase (CPK) in U/L | creatine phosphokinase (U/L)-Day 42 | 77 U/L |
| Group 3: Control 1 | Chemistry and Hematology Laboratory Measures - Alkaline Phosphate (ALP), Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Creatine Phosphokinase (CPK) in U/L | creatine phosphokinase (U/L)-Day 98 | 63 U/L |
| Group 3: Control 1 | Chemistry and Hematology Laboratory Measures - Alkaline Phosphate (ALP), Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Creatine Phosphokinase (CPK) in U/L | creatine phosphokinase (U/L)-Day 182 | 79 U/L |
| Group 3: Control 1 | Chemistry and Hematology Laboratory Measures - Alkaline Phosphate (ALP), Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Creatine Phosphokinase (CPK) in U/L | creatine phosphokinase (U/L)-Day 273 | 54.5 U/L |
| Group 4: Control 2 | Chemistry and Hematology Laboratory Measures - Alkaline Phosphate (ALP), Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Creatine Phosphokinase (CPK) in U/L | creatine phosphokinase (U/L)-Day 273 | 111 U/L |
| Group 4: Control 2 | Chemistry and Hematology Laboratory Measures - Alkaline Phosphate (ALP), Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Creatine Phosphokinase (CPK) in U/L | Alkaline Phosphatase (U/L)-Day 273 | 51 U/L |
| Group 4: Control 2 | Chemistry and Hematology Laboratory Measures - Alkaline Phosphate (ALP), Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Creatine Phosphokinase (CPK) in U/L | AST (U/L)-Day 182 | 18 U/L |
| Group 4: Control 2 | Chemistry and Hematology Laboratory Measures - Alkaline Phosphate (ALP), Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Creatine Phosphokinase (CPK) in U/L | AST (U/L)-Day 98 | 18 U/L |
| Group 4: Control 2 | Chemistry and Hematology Laboratory Measures - Alkaline Phosphate (ALP), Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Creatine Phosphokinase (CPK) in U/L | creatine phosphokinase (U/L)-Day 182 | 133 U/L |
| Group 4: Control 2 | Chemistry and Hematology Laboratory Measures - Alkaline Phosphate (ALP), Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Creatine Phosphokinase (CPK) in U/L | creatine phosphokinase (U/L)- Screening | 88 U/L |
| Group 4: Control 2 | Chemistry and Hematology Laboratory Measures - Alkaline Phosphate (ALP), Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Creatine Phosphokinase (CPK) in U/L | AST (U/L)-Day 42 | 24 U/L |
| Group 4: Control 2 | Chemistry and Hematology Laboratory Measures - Alkaline Phosphate (ALP), Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Creatine Phosphokinase (CPK) in U/L | creatine phosphokinase (U/L)-Day 14 | 116 U/L |
| Group 4: Control 2 | Chemistry and Hematology Laboratory Measures - Alkaline Phosphate (ALP), Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Creatine Phosphokinase (CPK) in U/L | AST (U/L)-Day 14 | 13 U/L |
| Group 4: Control 2 | Chemistry and Hematology Laboratory Measures - Alkaline Phosphate (ALP), Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Creatine Phosphokinase (CPK) in U/L | AST (U/L)- Screening | 15 U/L |
| Group 4: Control 2 | Chemistry and Hematology Laboratory Measures - Alkaline Phosphate (ALP), Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Creatine Phosphokinase (CPK) in U/L | ALT (SGPT) (U/L)-Day 14 | 12 U/L |
| Group 4: Control 2 | Chemistry and Hematology Laboratory Measures - Alkaline Phosphate (ALP), Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Creatine Phosphokinase (CPK) in U/L | creatine phosphokinase (U/L)-Day 42 | 222 U/L |
| Group 4: Control 2 | Chemistry and Hematology Laboratory Measures - Alkaline Phosphate (ALP), Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Creatine Phosphokinase (CPK) in U/L | ALT (SGPT) (U/L)-Day 273 | 12 U/L |
| Group 4: Control 2 | Chemistry and Hematology Laboratory Measures - Alkaline Phosphate (ALP), Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Creatine Phosphokinase (CPK) in U/L | ALT (SGPT) (U/L)-Day 182 | 13.5 U/L |
| Group 4: Control 2 | Chemistry and Hematology Laboratory Measures - Alkaline Phosphate (ALP), Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Creatine Phosphokinase (CPK) in U/L | ALT (SGPT) (U/L)- Screening | 16 U/L |
| Group 4: Control 2 | Chemistry and Hematology Laboratory Measures - Alkaline Phosphate (ALP), Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Creatine Phosphokinase (CPK) in U/L | creatine phosphokinase (U/L)-Day 98 | 157 U/L |
| Group 4: Control 2 | Chemistry and Hematology Laboratory Measures - Alkaline Phosphate (ALP), Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Creatine Phosphokinase (CPK) in U/L | ALT (SGPT) (U/L)-Day 98 | 16 U/L |
| Group 4: Control 2 | Chemistry and Hematology Laboratory Measures - Alkaline Phosphate (ALP), Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Creatine Phosphokinase (CPK) in U/L | Alkaline Phosphatase (U/L)-Day 98 | 52 U/L |
| Group 4: Control 2 | Chemistry and Hematology Laboratory Measures - Alkaline Phosphate (ALP), Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Creatine Phosphokinase (CPK) in U/L | Alkaline Phosphatase (U/L)-Day 42 | 50 U/L |
| Group 4: Control 2 | Chemistry and Hematology Laboratory Measures - Alkaline Phosphate (ALP), Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Creatine Phosphokinase (CPK) in U/L | Alkaline Phosphatase (U/L)-Day 14 | 48 U/L |
| Group 4: Control 2 | Chemistry and Hematology Laboratory Measures - Alkaline Phosphate (ALP), Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Creatine Phosphokinase (CPK) in U/L | ALT (SGPT) (U/L)-Day 42 | 17 U/L |
| Group 4: Control 2 | Chemistry and Hematology Laboratory Measures - Alkaline Phosphate (ALP), Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Creatine Phosphokinase (CPK) in U/L | Alkaline Phosphatase (U/L)-Day 182 | 61.5 U/L |
| Group 4: Control 2 | Chemistry and Hematology Laboratory Measures - Alkaline Phosphate (ALP), Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Creatine Phosphokinase (CPK) in U/L | Alkaline Phosphatase (U/L)- Screening | 54 U/L |
| Group 4: Control 2 | Chemistry and Hematology Laboratory Measures - Alkaline Phosphate (ALP), Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Creatine Phosphokinase (CPK) in U/L | AST (U/L)-Day 273 | 15 U/L |
Primary
Chemistry and Hematology Laboratory Measures - Creatinine in g/dL
For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population
Time frame: Measured during screening, Days 14, 42, 98, 182 and 273
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 and Hematology Laboratory Measures - Creatinine in g/dL | Creatinine (g/dL)-Day 98 | 0.00085 g/dL |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Creatinine in g/dL | Creatinine (g/dL)-Day 273 | 0.00088 g/dL |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Creatinine in g/dL | Creatinine (g/dL)- Screening | 0.00084 g/dL |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Creatinine in g/dL | Creatinine (g/dL)-Day 182 | 0.00084 g/dL |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Creatinine in g/dL | Creatinine (g/dL)-Day 42 | 0.00083 g/dL |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Creatinine in g/dL | Creatinine (g/dL)-Day 14 | 0.00086 g/dL |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Creatinine in g/dL | Creatinine (g/dL)-Day 42 | 0.00085 g/dL |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Creatinine in g/dL | Creatinine (g/dL)-Day 98 | 0.00085 g/dL |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Creatinine in g/dL | Creatinine (g/dL)- Screening | 0.0008 g/dL |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Creatinine in g/dL | Creatinine (g/dL)-Day 14 | 0.00084 g/dL |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Creatinine in g/dL | Creatinine (g/dL)-Day 273 | 0.00083 g/dL |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Creatinine in g/dL | Creatinine (g/dL)-Day 182 | 0.00085 g/dL |
| Group 3: Control 1 | Chemistry and Hematology Laboratory Measures - Creatinine in g/dL | Creatinine (g/dL)-Day 14 | 0.000645 g/dL |
| Group 3: Control 1 | Chemistry and Hematology Laboratory Measures - Creatinine in g/dL | Creatinine (g/dL)-Day 273 | 0.00073 g/dL |
| Group 3: Control 1 | Chemistry and Hematology Laboratory Measures - Creatinine in g/dL | Creatinine (g/dL)- Screening | 0.00072 g/dL |
| Group 3: Control 1 | Chemistry and Hematology Laboratory Measures - Creatinine in g/dL | Creatinine (g/dL)-Day 182 | 0.00073 g/dL |
| Group 3: Control 1 | Chemistry and Hematology Laboratory Measures - Creatinine in g/dL | Creatinine (g/dL)-Day 42 | 0.00072 g/dL |
| Group 3: Control 1 | Chemistry and Hematology Laboratory Measures - Creatinine in g/dL | Creatinine (g/dL)-Day 98 | 0.00065 g/dL |
| Group 4: Control 2 | Chemistry and Hematology Laboratory Measures - Creatinine in g/dL | Creatinine (g/dL)-Day 273 | 0.00084 g/dL |
| Group 4: Control 2 | Chemistry and Hematology Laboratory Measures - Creatinine in g/dL | Creatinine (g/dL)- Screening | 0.00093 g/dL |
| Group 4: Control 2 | Chemistry and Hematology Laboratory Measures - Creatinine in g/dL | Creatinine (g/dL)-Day 42 | 0.00089 g/dL |
| Group 4: Control 2 | Chemistry and Hematology Laboratory Measures - Creatinine in g/dL | Creatinine (g/dL)-Day 98 | 0.00093 g/dL |
| Group 4: Control 2 | Chemistry and Hematology Laboratory Measures - Creatinine in g/dL | Creatinine (g/dL)-Day 182 | 0.00081 g/dL |
| Group 4: Control 2 | Chemistry and Hematology Laboratory Measures - Creatinine in g/dL | Creatinine (g/dL)-Day 14 | 0.00085 g/dL |
Primary
Chemistry and Hematology Laboratory Measures - Hemoglobin in g/dL
For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population.
Time frame: Measured during screening, Days 14, 42, 98, 182 and 273
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 and Hematology Laboratory Measures - Hemoglobin in g/dL | Hemoglobin (g/dL)-Day 98 | 14.25 g/dL |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Hemoglobin in g/dL | Hemoglobin (g/dL)-Day 14 | 13.8 g/dL |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Hemoglobin in g/dL | Hemoglobin (g/dL)-Day 182 | 12 g/dL |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Hemoglobin in g/dL | Hemoglobin (g/dL)-Day 42 | 14.05 g/dL |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Hemoglobin in g/dL | Hemoglobin (g/dL)- Screening | 14.2 g/dL |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Hemoglobin in g/dL | Hemoglobin (g/dL)-Day 273 | 14 g/dL |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Hemoglobin in g/dL | Hemoglobin (g/dL)-Day 175 | 13.95 g/dL |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Hemoglobin in g/dL | Hemoglobin (g/dL)-Day 175 | 13.45 g/dL |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Hemoglobin in g/dL | Hemoglobin (g/dL)-Day 273 | 14 g/dL |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Hemoglobin in g/dL | Hemoglobin (g/dL)- Screening | 14.4 g/dL |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Hemoglobin in g/dL | Hemoglobin (g/dL)-Day 14 | 13.95 g/dL |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Hemoglobin in g/dL | Hemoglobin (g/dL)-Day 42 | 14 g/dL |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Hemoglobin in g/dL | Hemoglobin (g/dL)-Day 98 | 13.95 g/dL |
| Group 3: Control 1 | Chemistry and Hematology Laboratory Measures - Hemoglobin in g/dL | Hemoglobin (g/dL)-Day 175 | 13.4 g/dL |
| Group 3: Control 1 | Chemistry and Hematology Laboratory Measures - Hemoglobin in g/dL | Hemoglobin (g/dL)-Day 42 | 12.7 g/dL |
| Group 3: Control 1 | Chemistry and Hematology Laboratory Measures - Hemoglobin in g/dL | Hemoglobin (g/dL)-Day 98 | 12 g/dL |
| Group 3: Control 1 | Chemistry and Hematology Laboratory Measures - Hemoglobin in g/dL | Hemoglobin (g/dL)- Screening | 12.6 g/dL |
| Group 3: Control 1 | Chemistry and Hematology Laboratory Measures - Hemoglobin in g/dL | Hemoglobin (g/dL)-Day 273 | 14 g/dL |
| Group 3: Control 1 | Chemistry and Hematology Laboratory Measures - Hemoglobin in g/dL | Hemoglobin (g/dL)-Day 14 | 13.35 g/dL |
| Group 4: Control 2 | Chemistry and Hematology Laboratory Measures - Hemoglobin in g/dL | Hemoglobin (g/dL)-Day 98 | 14.6 g/dL |
| Group 4: Control 2 | Chemistry and Hematology Laboratory Measures - Hemoglobin in g/dL | Hemoglobin (g/dL)-Day 14 | 13.9 g/dL |
| Group 4: Control 2 | Chemistry and Hematology Laboratory Measures - Hemoglobin in g/dL | Hemoglobin (g/dL)-Day 42 | 14.6 g/dL |
| Group 4: Control 2 | Chemistry and Hematology Laboratory Measures - Hemoglobin in g/dL | Hemoglobin (g/dL)- Screening | 14.7 g/dL |
| Group 4: Control 2 | Chemistry and Hematology Laboratory Measures - Hemoglobin in g/dL | Hemoglobin (g/dL)-Day 273 | 14.6 g/dL |
| Group 4: Control 2 | Chemistry and Hematology Laboratory Measures - Hemoglobin in g/dL | Hemoglobin (g/dL)-Day 175 | 13.5 g/dL |
Primary
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count in 1000*Cells/mm^3
For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population.
Time frame: Measured during screening, Days 14, 42, 98, 175 and 273
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 and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count in 1000*Cells/mm^3 | Neutrophils (1000*cells/mm^3)-Day 182 | 3.018 1000*cells/mm^3 |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count in 1000*Cells/mm^3 | Neutrophils (1000*cells/mm^3)-Day 42 | 3.348 1000*cells/mm^3 |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count in 1000*Cells/mm^3 | Lymphocytes (1000*cells/mm^3)-Day 98 | 1.8265 1000*cells/mm^3 |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count in 1000*Cells/mm^3 | Lymphocytes (1000*cells/mm^3)-Day 42 | 1.8925 1000*cells/mm^3 |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count in 1000*Cells/mm^3 | Lymphocytes (1000*cells/mm^3)-Day 273 | 1.717 1000*cells/mm^3 |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count in 1000*Cells/mm^3 | Lymphocytes (1000*cells/mm^3)-Day 14 | 1.907 1000*cells/mm^3 |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count in 1000*Cells/mm^3 | Neutrophils (1000*cells/mm^3)- Screening | 3.621 1000*cells/mm^3 |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count in 1000*Cells/mm^3 | Neutrophils (1000*cells/mm^3)-Day 98 | 2.9925 1000*cells/mm^3 |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count in 1000*Cells/mm^3 | Lymphocytes (1000*cells/mm^3)-Day 182 | 1.847 1000*cells/mm^3 |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count in 1000*Cells/mm^3 | Neutrophils (1000*cells/mm^3)-Day 14 | 3.5165 1000*cells/mm^3 |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count in 1000*Cells/mm^3 | Neutrophils (1000*cells/mm^3)-Day 175 | 2.773 1000*cells/mm^3 |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count in 1000*Cells/mm^3 | Lymphocytes (1000*cells/mm^3)-Day 175 | 1.8365 1000*cells/mm^3 |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count in 1000*Cells/mm^3 | Neutrophils (1000*cells/mm^3)-Day 273 | 3.279 1000*cells/mm^3 |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count in 1000*Cells/mm^3 | Lymphocytes (1000*cells/mm^3)- Screening | 1.916 1000*cells/mm^3 |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count in 1000*Cells/mm^3 | Lymphocytes (1000*cells/mm^3)-Day 98 | 1.668 1000*cells/mm^3 |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count in 1000*Cells/mm^3 | Lymphocytes (1000*cells/mm^3)-Day 175 | 1.846 1000*cells/mm^3 |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count in 1000*Cells/mm^3 | Lymphocytes (1000*cells/mm^3)- Screening | 1.765 1000*cells/mm^3 |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count in 1000*Cells/mm^3 | Lymphocytes (1000*cells/mm^3)-Day 14 | 1.873 1000*cells/mm^3 |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count in 1000*Cells/mm^3 | Lymphocytes (1000*cells/mm^3)-Day 273 | 1.701 1000*cells/mm^3 |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count in 1000*Cells/mm^3 | Neutrophils (1000*cells/mm^3)-Day 175 | 2.7645 1000*cells/mm^3 |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count in 1000*Cells/mm^3 | Neutrophils (1000*cells/mm^3)-Day 42 | 3.036 1000*cells/mm^3 |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count in 1000*Cells/mm^3 | Lymphocytes (1000*cells/mm^3)-Day 42 | 1.88 1000*cells/mm^3 |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count in 1000*Cells/mm^3 | Neutrophils (1000*cells/mm^3)-Day 98 | 3.0915 1000*cells/mm^3 |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count in 1000*Cells/mm^3 | Neutrophils (1000*cells/mm^3)-Day 14 | 3.1235 1000*cells/mm^3 |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count in 1000*Cells/mm^3 | Neutrophils (1000*cells/mm^3)-Day 273 | 3.011 1000*cells/mm^3 |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count in 1000*Cells/mm^3 | Neutrophils (1000*cells/mm^3)- Screening | 3.564 1000*cells/mm^3 |
| Group 3: Control 1 | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count in 1000*Cells/mm^3 | Lymphocytes (1000*cells/mm^3)-Day 175 | 1.42 1000*cells/mm^3 |
| Group 3: Control 1 | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count in 1000*Cells/mm^3 | Neutrophils (1000*cells/mm^3)-Day 14 | 5.1805 1000*cells/mm^3 |
| Group 3: Control 1 | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count in 1000*Cells/mm^3 | Neutrophils (1000*cells/mm^3)-Day 273 | 6.428 1000*cells/mm^3 |
| Group 3: Control 1 | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count in 1000*Cells/mm^3 | Lymphocytes (1000*cells/mm^3)- Screening | 1.84 1000*cells/mm^3 |
| Group 3: Control 1 | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count in 1000*Cells/mm^3 | Neutrophils (1000*cells/mm^3)- Screening | 3.16 1000*cells/mm^3 |
| Group 3: Control 1 | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count in 1000*Cells/mm^3 | Neutrophils (1000*cells/mm^3)-Day 42 | 2.292 1000*cells/mm^3 |
| Group 3: Control 1 | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count in 1000*Cells/mm^3 | Neutrophils (1000*cells/mm^3)-Day 98 | 2.961 1000*cells/mm^3 |
| Group 3: Control 1 | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count in 1000*Cells/mm^3 | Neutrophils (1000*cells/mm^3)-Day 175 | 2.902 1000*cells/mm^3 |
| Group 3: Control 1 | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count in 1000*Cells/mm^3 | Lymphocytes (1000*cells/mm^3)-Day 14 | 2.9485 1000*cells/mm^3 |
| Group 3: Control 1 | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count in 1000*Cells/mm^3 | Lymphocytes (1000*cells/mm^3)-Day 42 | 2.35 1000*cells/mm^3 |
| Group 3: Control 1 | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count in 1000*Cells/mm^3 | Lymphocytes (1000*cells/mm^3)-Day 98 | 2.13 1000*cells/mm^3 |
| Group 3: Control 1 | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count in 1000*Cells/mm^3 | Lymphocytes (1000*cells/mm^3)-Day 273 | 1.76 1000*cells/mm^3 |
| Group 4: Control 2 | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count in 1000*Cells/mm^3 | Neutrophils (1000*cells/mm^3)-Day 273 | 2.677 1000*cells/mm^3 |
| Group 4: Control 2 | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count in 1000*Cells/mm^3 | Lymphocytes (1000*cells/mm^3)-Day 273 | 2.328 1000*cells/mm^3 |
| Group 4: Control 2 | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count in 1000*Cells/mm^3 | Lymphocytes (1000*cells/mm^3)-Day 98 | 2.15 1000*cells/mm^3 |
| Group 4: Control 2 | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count in 1000*Cells/mm^3 | Neutrophils (1000*cells/mm^3)-Day 175 | 4.694 1000*cells/mm^3 |
| Group 4: Control 2 | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count in 1000*Cells/mm^3 | Neutrophils (1000*cells/mm^3)-Day 98 | 2.626 1000*cells/mm^3 |
| Group 4: Control 2 | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count in 1000*Cells/mm^3 | Neutrophils (1000*cells/mm^3)-Day 42 | 3.31 1000*cells/mm^3 |
| Group 4: Control 2 | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count in 1000*Cells/mm^3 | Lymphocytes (1000*cells/mm^3)-Day 175 | 1.855 1000*cells/mm^3 |
| Group 4: Control 2 | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count in 1000*Cells/mm^3 | Neutrophils (1000*cells/mm^3)- Screening | 3.306 1000*cells/mm^3 |
| Group 4: Control 2 | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count in 1000*Cells/mm^3 | Lymphocytes (1000*cells/mm^3)- Screening | 1.928 1000*cells/mm^3 |
| Group 4: Control 2 | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count in 1000*Cells/mm^3 | Neutrophils (1000*cells/mm^3)-Day 14 | 3.224 1000*cells/mm^3 |
| Group 4: Control 2 | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count in 1000*Cells/mm^3 | Lymphocytes (1000*cells/mm^3)-Day 42 | 2.037 1000*cells/mm^3 |
| Group 4: Control 2 | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count in 1000*Cells/mm^3 | Lymphocytes (1000*cells/mm^3)-Day 14 | 1.712 1000*cells/mm^3 |
Primary
Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000*Cells/mm^3
For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population.
Time frame: Measured during screening, Days 14, 42, 98, 175 and 273
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 and Hematology Laboratory Measures - Platelets, WBC in 1000*Cells/mm^3 | WBC (1000*cells/mm^3)-Day 14 | 6.25 1000*cells/mm^3 |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000*Cells/mm^3 | WBC (1000*cells/mm^3)-Day 273 | 5.9 1000*cells/mm^3 |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000*Cells/mm^3 | WBC (1000*cells/mm^3)-Day 182 | 5.45 1000*cells/mm^3 |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000*Cells/mm^3 | WBC (1000*cells/mm^3)-Day 98 | 5.75 1000*cells/mm^3 |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000*Cells/mm^3 | Platelets (1000*cells/mm^3)-Day 175 | 271 1000*cells/mm^3 |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000*Cells/mm^3 | WBC (1000*cells/mm^3)-Day 175 | 5.3 1000*cells/mm^3 |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000*Cells/mm^3 | Platelets (1000*cells/mm^3)-Day 98 | 275 1000*cells/mm^3 |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000*Cells/mm^3 | Platelets (1000*cells/mm^3)- Screening | 271 1000*cells/mm^3 |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000*Cells/mm^3 | Platelets (1000*cells/mm^3)-Day 273 | 284 1000*cells/mm^3 |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000*Cells/mm^3 | Platelets (1000*cells/mm^3)-Day 42 | 261.5 1000*cells/mm^3 |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000*Cells/mm^3 | Platelets (1000*cells/mm^3)-Day 182 | 255.5 1000*cells/mm^3 |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000*Cells/mm^3 | Platelets (1000*cells/mm^3)-Day 14 | 276.5 1000*cells/mm^3 |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000*Cells/mm^3 | WBC (1000*cells/mm^3)- Screening | 6.2 1000*cells/mm^3 |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000*Cells/mm^3 | WBC (1000*cells/mm^3)-Day 42 | 6 1000*cells/mm^3 |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000*Cells/mm^3 | WBC (1000*cells/mm^3)-Day 14 | 5.55 1000*cells/mm^3 |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000*Cells/mm^3 | WBC (1000*cells/mm^3)- Screening | 6.4 1000*cells/mm^3 |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000*Cells/mm^3 | Platelets (1000*cells/mm^3)- Screening | 244 1000*cells/mm^3 |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000*Cells/mm^3 | Platelets (1000*cells/mm^3)-Day 42 | 260 1000*cells/mm^3 |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000*Cells/mm^3 | WBC (1000*cells/mm^3)-Day 42 | 6 1000*cells/mm^3 |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000*Cells/mm^3 | WBC (1000*cells/mm^3)-Day 98 | 5.35 1000*cells/mm^3 |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000*Cells/mm^3 | WBC (1000*cells/mm^3)-Day 175 | 5.1 1000*cells/mm^3 |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000*Cells/mm^3 | WBC (1000*cells/mm^3)-Day 273 | 5.55 1000*cells/mm^3 |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000*Cells/mm^3 | Platelets (1000*cells/mm^3)-Day 14 | 269 1000*cells/mm^3 |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000*Cells/mm^3 | Platelets (1000*cells/mm^3)-Day 98 | 241 1000*cells/mm^3 |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000*Cells/mm^3 | Platelets (1000*cells/mm^3)-Day 175 | 241.5 1000*cells/mm^3 |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000*Cells/mm^3 | Platelets (1000*cells/mm^3)-Day 273 | 243.5 1000*cells/mm^3 |
| Group 3: Control 1 | Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000*Cells/mm^3 | Platelets (1000*cells/mm^3)-Day 14 | 335 1000*cells/mm^3 |
| Group 3: Control 1 | Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000*Cells/mm^3 | Platelets (1000*cells/mm^3)-Day 98 | 302 1000*cells/mm^3 |
| Group 3: Control 1 | Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000*Cells/mm^3 | WBC (1000*cells/mm^3)-Day 273 | 8.9 1000*cells/mm^3 |
| Group 3: Control 1 | Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000*Cells/mm^3 | WBC (1000*cells/mm^3)-Day 14 | 9.75 1000*cells/mm^3 |
| Group 3: Control 1 | Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000*Cells/mm^3 | Platelets (1000*cells/mm^3)-Day 273 | 229.5 1000*cells/mm^3 |
| Group 3: Control 1 | Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000*Cells/mm^3 | Platelets (1000*cells/mm^3)-Day 175 | 255 1000*cells/mm^3 |
| Group 3: Control 1 | Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000*Cells/mm^3 | Platelets (1000*cells/mm^3)-Day 42 | 265 1000*cells/mm^3 |
| Group 3: Control 1 | Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000*Cells/mm^3 | WBC (1000*cells/mm^3)-Day 98 | 7 1000*cells/mm^3 |
| Group 3: Control 1 | Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000*Cells/mm^3 | Platelets (1000*cells/mm^3)- Screening | 274 1000*cells/mm^3 |
| Group 3: Control 1 | Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000*Cells/mm^3 | WBC (1000*cells/mm^3)-Day 175 | 5.9 1000*cells/mm^3 |
| Group 3: Control 1 | Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000*Cells/mm^3 | WBC (1000*cells/mm^3)- Screening | 7.9 1000*cells/mm^3 |
| Group 3: Control 1 | Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000*Cells/mm^3 | WBC (1000*cells/mm^3)-Day 42 | 8.1 1000*cells/mm^3 |
| Group 4: Control 2 | Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000*Cells/mm^3 | WBC (1000*cells/mm^3)-Day 42 | 5.9 1000*cells/mm^3 |
| Group 4: Control 2 | Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000*Cells/mm^3 | WBC (1000*cells/mm^3)- Screening | 5.7 1000*cells/mm^3 |
| Group 4: Control 2 | Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000*Cells/mm^3 | WBC (1000*cells/mm^3)-Day 273 | 4.9 1000*cells/mm^3 |
| Group 4: Control 2 | Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000*Cells/mm^3 | Platelets (1000*cells/mm^3)- Screening | 264 1000*cells/mm^3 |
| Group 4: Control 2 | Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000*Cells/mm^3 | Platelets (1000*cells/mm^3)-Day 14 | 231 1000*cells/mm^3 |
| Group 4: Control 2 | Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000*Cells/mm^3 | Platelets (1000*cells/mm^3)-Day 42 | 226 1000*cells/mm^3 |
| Group 4: Control 2 | Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000*Cells/mm^3 | WBC (1000*cells/mm^3)-Day 14 | 5.4 1000*cells/mm^3 |
| Group 4: Control 2 | Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000*Cells/mm^3 | Platelets (1000*cells/mm^3)-Day 273 | 232 1000*cells/mm^3 |
| Group 4: Control 2 | Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000*Cells/mm^3 | Platelets (1000*cells/mm^3)-Day 98 | 262 1000*cells/mm^3 |
| Group 4: Control 2 | Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000*Cells/mm^3 | WBC (1000*cells/mm^3)-Day 98 | 6.2 1000*cells/mm^3 |
| Group 4: Control 2 | Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000*Cells/mm^3 | Platelets (1000*cells/mm^3)-Day 175 | 256 1000*cells/mm^3 |
| Group 4: Control 2 | Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000*Cells/mm^3 | WBC (1000*cells/mm^3)-Day 175 | 7.2 1000*cells/mm^3 |
Primary
Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10]
Distribution of responses to questions regarding acceptability of study injection procedures \[ Visits 3, 5, 8, 10\] were summarized by category (Acceptable/Unacceptable/Don?t know/ Don?t Remember)
Time frame: Measured during Visit 3 (Day14), Visit 5 (Day 35), Visit 8 (Day 98), Visit 10 (Day 175)
Population: One participant in Group 1 had VASOVAGAL REACTION AND SEIZURE on enrollment. One participant in Group 2 had an interim visit done as the visit was done prior to the visit 3.0 window opening. Data Manager instructed site to complete the interim visit and then following w/ a missed visit. These two cases were missed in the enrollment visit.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1: Vaccine | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-1- Acceptable- Day 175 | 16 Participants |
| Group 1: Vaccine | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-2- Acceptable- Day 14 | 22 Participants |
| Group 1: Vaccine | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-2- Unacceptable- Day 35 | 1 Participants |
| Group 1: Vaccine | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-2- Acceptable- Day 35 | 22 Participants |
| Group 1: Vaccine | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-1- Unacceptable- Day 175 | 2 Participants |
| Group 1: Vaccine | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-1- Don't Know/Don't Remember- Day 175 | 0 Participants |
| Group 1: Vaccine | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-5- No Other Side Effects- Day 98 | 20 Participants |
| Group 1: Vaccine | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-2- Don't Know/Don't Remember- Day 175 | 0 Participants |
| Group 1: Vaccine | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-2- Unacceptable- Day 175 | 1 Participants |
| Group 1: Vaccine | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-1- Acceptable- Day 35 | 20 Participants |
| Group 1: Vaccine | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-4- Don't Know/Don't Remember- Day 98 | 0 Participants |
| Group 1: Vaccine | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-2- Acceptable- Day 175 | 17 Participants |
| Group 1: Vaccine | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-2- Don't Know/Don't Remember- Day 14 | 0 Participants |
| Group 1: Vaccine | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-1- Unacceptable- Day 35 | 3 Participants |
| Group 1: Vaccine | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-4- Unacceptable- Day 98 | 0 Participants |
| Group 1: Vaccine | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-2- Unacceptable- Day 14 | 2 Participants |
| Group 1: Vaccine | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-1- Don't Know/Don't Remember- Day 98 | 0 Participants |
| Group 1: Vaccine | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-1- Don't Know/Don't Remember- Day 35 | 0 Participants |
| Group 1: Vaccine | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-4- Don't Know/Don't Remember- Day 175 | 0 Participants |
| Group 1: Vaccine | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-1- Unacceptable- Day 98 | 3 Participants |
| Group 1: Vaccine | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-1- Acceptable- Day 98 | 19 Participants |
| Group 1: Vaccine | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-4- Acceptable- Day 35 | 23 Participants |
| Group 1: Vaccine | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-4- Acceptable- Day 98 | 22 Participants |
| Group 1: Vaccine | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-4- Don't Know/Don't Remember- Day 35 | 0 Participants |
| Group 1: Vaccine | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-5- Acceptable- Day 14 | 4 Participants |
| Group 1: Vaccine | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-5- Don't Know/Don't Remember- Day 35 | 0 Participants |
| Group 1: Vaccine | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-4- Unacceptable- Day 35 | 0 Participants |
| Group 1: Vaccine | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-4- Unacceptable- Day 175 | 0 Participants |
| Group 1: Vaccine | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-4- Acceptable- Day 175 | 18 Participants |
| Group 1: Vaccine | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-5- Acceptable- Day 175 | 2 Participants |
| Group 1: Vaccine | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-5- Acceptable- Day 35 | 4 Participants |
| Group 1: Vaccine | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-4- Don't Know/Don't Remember- Day 14 | 0 Participants |
| Group 1: Vaccine | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-5- Don't Know/Don't Remember- Day 98 | 1 Participants |
| Group 1: Vaccine | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-4- Unacceptable- Day 14 | 0 Participants |
| Group 1: Vaccine | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-4- Acceptable- Day 14 | 24 Participants |
| Group 1: Vaccine | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-5- Don't Know/Don't Remember- Day 175 | 0 Participants |
| Group 1: Vaccine | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-3- Don't Know/Don't Remember- Day 98 | 0 Participants |
| Group 1: Vaccine | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-5- No Other Side Effects- Day 175 | 15 Participants |
| Group 1: Vaccine | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-5- Unacceptable- Day 175 | 1 Participants |
| Group 1: Vaccine | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-3- Unacceptable- Day 98 | 2 Participants |
| Group 1: Vaccine | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-3- Acceptable- Day 98 | 20 Participants |
| Group 1: Vaccine | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-5- Unacceptable- Day 35 | 0 Participants |
| Group 1: Vaccine | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-5- No Other Side Effects- Day 14 | 20 Participants |
| Group 1: Vaccine | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-3- Don't Know/Don't Remember- Day 35 | 0 Participants |
| Group 1: Vaccine | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-3- Unacceptable- Day 35 | 5 Participants |
| Group 1: Vaccine | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-3- Acceptable- Day 35 | 18 Participants |
| Group 1: Vaccine | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-5- Acceptable- Day 98 | 1 Participants |
| Group 1: Vaccine | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-3- Unacceptable- Day 14 | 4 Participants |
| Group 1: Vaccine | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-3- Don't Know/Don't Remember- Day 175 | 0 Participants |
| Group 1: Vaccine | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-3- Unacceptable- Day 175 | 3 Participants |
| Group 1: Vaccine | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-5- Unacceptable- Day 98 | 0 Participants |
| Group 1: Vaccine | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-5- No Other Side Effects- Day 35 | 19 Participants |
| Group 1: Vaccine | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-1- Acceptable- Day 14 | 17 Participants |
| Group 1: Vaccine | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-5- Don't Know/Don't Remember- Day 14 | 0 Participants |
| Group 1: Vaccine | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-3- Acceptable- Day 175 | 15 Participants |
| Group 1: Vaccine | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-3- Acceptable- Day 14 | 19 Participants |
| Group 1: Vaccine | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-1- Unacceptable- Day 14 | 7 Participants |
| Group 1: Vaccine | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-5- Unacceptable- Day 14 | 0 Participants |
| Group 1: Vaccine | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-2- Don't Know/Don't Remember- Day 98 | 0 Participants |
| Group 1: Vaccine | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-2- Unacceptable- Day 98 | 2 Participants |
| Group 1: Vaccine | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-1- Don't Know/Don't Remember- Day 14 | 0 Participants |
| Group 1: Vaccine | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-3- Don't Know/Don't Remember- Day 14 | 1 Participants |
| Group 1: Vaccine | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-2- Acceptable- Day 98 | 20 Participants |
| Group 1: Vaccine | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-2- Don't Know/Don't Remember- Day 35 | 0 Participants |
| Group 2: Vaccine | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-5- Unacceptable- Day 175 | 0 Participants |
| Group 2: Vaccine | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-2- Acceptable- Day 14 | 23 Participants |
| Group 2: Vaccine | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-3- Acceptable- Day 14 | 21 Participants |
| Group 2: Vaccine | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-3- Unacceptable- Day 14 | 2 Participants |
| Group 2: Vaccine | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-3- Don't Know/Don't Remember- Day 14 | 1 Participants |
| Group 2: Vaccine | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-4- Unacceptable- Day 175 | 1 Participants |
| Group 2: Vaccine | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-5- Unacceptable- Day 14 | 0 Participants |
| Group 2: Vaccine | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-5- Acceptable- Day 175 | 1 Participants |
| Group 2: Vaccine | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-1- Unacceptable- Day 175 | 2 Participants |
| Group 2: Vaccine | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-5- Acceptable- Day 35 | 5 Participants |
| Group 2: Vaccine | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-5- Unacceptable- Day 35 | 2 Participants |
| Group 2: Vaccine | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-5- Acceptable- Day 98 | 4 Participants |
| Group 2: Vaccine | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-5- Unacceptable- Day 98 | 1 Participants |
| Group 2: Vaccine | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-1- Acceptable- Day 14 | 20 Participants |
| Group 2: Vaccine | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-1- Unacceptable- Day 14 | 2 Participants |
| Group 2: Vaccine | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-1- Don't Know/Don't Remember- Day 14 | 2 Participants |
| Group 2: Vaccine | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-1- Acceptable- Day 175 | 19 Participants |
| Group 2: Vaccine | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-1- Don't Know/Don't Remember- Day 175 | 0 Participants |
| Group 2: Vaccine | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-1- Acceptable- Day 35 | 20 Participants |
| Group 2: Vaccine | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-1- Unacceptable- Day 35 | 2 Participants |
| Group 2: Vaccine | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-1- Don't Know/Don't Remember- Day 35 | 0 Participants |
| Group 2: Vaccine | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-1- Acceptable- Day 98 | 18 Participants |
| Group 2: Vaccine | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-1- Unacceptable- Day 98 | 3 Participants |
| Group 2: Vaccine | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-1- Don't Know/Don't Remember- Day 98 | 1 Participants |
| Group 2: Vaccine | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-2- Unacceptable- Day 14 | 0 Participants |
| Group 2: Vaccine | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-2- Don't Know/Don't Remember- Day 14 | 1 Participants |
| Group 2: Vaccine | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-2- Acceptable- Day 175 | 21 Participants |
| Group 2: Vaccine | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-2- Unacceptable- Day 175 | 0 Participants |
| Group 2: Vaccine | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-2- Don't Know/Don't Remember- Day 175 | 0 Participants |
| Group 2: Vaccine | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-2- Acceptable- Day 35 | 20 Participants |
| Group 2: Vaccine | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-2- Unacceptable- Day 35 | 2 Participants |
| Group 2: Vaccine | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-2- Don't Know/Don't Remember- Day 35 | 0 Participants |
| Group 2: Vaccine | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-2- Acceptable- Day 98 | 21 Participants |
| Group 2: Vaccine | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-2- Unacceptable- Day 98 | 0 Participants |
| Group 2: Vaccine | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-2- Don't Know/Don't Remember- Day 98 | 1 Participants |
| Group 2: Vaccine | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-3- Acceptable- Day 175 | 18 Participants |
| Group 2: Vaccine | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-3- Unacceptable- Day 175 | 3 Participants |
| Group 2: Vaccine | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-3- Don't Know/Don't Remember- Day 175 | 0 Participants |
| Group 2: Vaccine | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-3- Acceptable- Day 35 | 19 Participants |
| Group 2: Vaccine | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-3- Unacceptable- Day 35 | 3 Participants |
| Group 2: Vaccine | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-3- Don't Know/Don't Remember- Day 35 | 0 Participants |
| Group 2: Vaccine | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-3- Acceptable- Day 98 | 19 Participants |
| Group 2: Vaccine | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-3- Unacceptable- Day 98 | 3 Participants |
| Group 2: Vaccine | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-3- Don't Know/Don't Remember- Day 98 | 0 Participants |
| Group 2: Vaccine | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-4- Acceptable- Day 14 | 24 Participants |
| Group 2: Vaccine | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-4- Unacceptable- Day 14 | 0 Participants |
| Group 2: Vaccine | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-4- Don't Know/Don't Remember- Day 14 | 0 Participants |
| Group 2: Vaccine | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-4- Acceptable- Day 175 | 20 Participants |
| Group 2: Vaccine | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-4- Don't Know/Don't Remember- Day 175 | 0 Participants |
| Group 2: Vaccine | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-4- Acceptable- Day 35 | 20 Participants |
| Group 2: Vaccine | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-4- Unacceptable- Day 35 | 2 Participants |
| Group 2: Vaccine | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-4- Don't Know/Don't Remember- Day 35 | 0 Participants |
| Group 2: Vaccine | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-4- Acceptable- Day 98 | 21 Participants |
| Group 2: Vaccine | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-4- Unacceptable- Day 98 | 0 Participants |
| Group 2: Vaccine | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-4- Don't Know/Don't Remember- Day 98 | 1 Participants |
| Group 2: Vaccine | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-5- Acceptable- Day 14 | 8 Participants |
| Group 2: Vaccine | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-5- Don't Know/Don't Remember- Day 14 | 1 Participants |
| Group 2: Vaccine | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-5- No Other Side Effects- Day 14 | 15 Participants |
| Group 2: Vaccine | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-5- Don't Know/Don't Remember- Day 175 | 0 Participants |
| Group 2: Vaccine | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-5- No Other Side Effects- Day 175 | 20 Participants |
| Group 2: Vaccine | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-5- Don't Know/Don't Remember- Day 35 | 0 Participants |
| Group 2: Vaccine | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-5- No Other Side Effects- Day 35 | 15 Participants |
| Group 2: Vaccine | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-5- Don't Know/Don't Remember- Day 98 | 1 Participants |
| Group 2: Vaccine | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-5- No Other Side Effects- Day 98 | 16 Participants |
| Group 3: Control 1 | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-2- Don't Know/Don't Remember- Day 35 | 0 Participants |
| Group 3: Control 1 | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-1- Don't Know/Don't Remember- Day 14 | 0 Participants |
| Group 3: Control 1 | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-2- Acceptable- Day 98 | 3 Participants |
| Group 3: Control 1 | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-3- Unacceptable- Day 14 | 1 Participants |
| Group 3: Control 1 | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-1- Unacceptable- Day 14 | 0 Participants |
| Group 3: Control 1 | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-2- Don't Know/Don't Remember- Day 98 | 0 Participants |
| Group 3: Control 1 | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-3- Don't Know/Don't Remember- Day 14 | 0 Participants |
| Group 3: Control 1 | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-1- Acceptable- Day 14 | 3 Participants |
| Group 3: Control 1 | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-5- Don't Know/Don't Remember- Day 14 | 1 Participants |
| Group 3: Control 1 | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-3- Acceptable- Day 175 | 1 Participants |
| Group 3: Control 1 | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-3- Unacceptable- Day 175 | 0 Participants |
| Group 3: Control 1 | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-5- Acceptable- Day 98 | 0 Participants |
| Group 3: Control 1 | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-3- Don't Know/Don't Remember- Day 175 | 2 Participants |
| Group 3: Control 1 | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-5- No Other Side Effects- Day 98 | 3 Participants |
| Group 3: Control 1 | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-3- Acceptable- Day 35 | 3 Participants |
| Group 3: Control 1 | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-5- No Other Side Effects- Day 35 | 2 Participants |
| Group 3: Control 1 | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-3- Unacceptable- Day 35 | 0 Participants |
| Group 3: Control 1 | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-5- Unacceptable- Day 35 | 0 Participants |
| Group 3: Control 1 | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-3- Acceptable- Day 14 | 2 Participants |
| Group 3: Control 1 | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-3- Don't Know/Don't Remember- Day 35 | 0 Participants |
| Group 3: Control 1 | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-5- Don't Know/Don't Remember- Day 98 | 0 Participants |
| Group 3: Control 1 | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-3- Acceptable- Day 98 | 2 Participants |
| Group 3: Control 1 | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-5- Acceptable- Day 35 | 1 Participants |
| Group 3: Control 1 | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-5- Don't Know/Don't Remember- Day 175 | 0 Participants |
| Group 3: Control 1 | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-3- Unacceptable- Day 98 | 1 Participants |
| Group 3: Control 1 | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-3- Don't Know/Don't Remember- Day 98 | 0 Participants |
| Group 3: Control 1 | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-5- No Other Side Effects- Day 175 | 3 Participants |
| Group 3: Control 1 | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-4- Acceptable- Day 14 | 3 Participants |
| Group 3: Control 1 | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-5- Unacceptable- Day 175 | 0 Participants |
| Group 3: Control 1 | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-4- Unacceptable- Day 14 | 0 Participants |
| Group 3: Control 1 | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-5- Acceptable- Day 175 | 0 Participants |
| Group 3: Control 1 | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-4- Don't Know/Don't Remember- Day 14 | 0 Participants |
| Group 3: Control 1 | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-4- Acceptable- Day 175 | 3 Participants |
| Group 3: Control 1 | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-5- No Other Side Effects- Day 14 | 2 Participants |
| Group 3: Control 1 | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-2- Unacceptable- Day 98 | 0 Participants |
| Group 3: Control 1 | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-4- Don't Know/Don't Remember- Day 175 | 0 Participants |
| Group 3: Control 1 | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-1- Unacceptable- Day 175 | 0 Participants |
| Group 3: Control 1 | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-4- Acceptable- Day 35 | 2 Participants |
| Group 3: Control 1 | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-5- Unacceptable- Day 14 | 0 Participants |
| Group 3: Control 1 | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-5- Don't Know/Don't Remember- Day 35 | 0 Participants |
| Group 3: Control 1 | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-4- Unacceptable- Day 35 | 1 Participants |
| Group 3: Control 1 | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-4- Don't Know/Don't Remember- Day 35 | 0 Participants |
| Group 3: Control 1 | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-4- Don't Know/Don't Remember- Day 98 | 0 Participants |
| Group 3: Control 1 | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-4- Acceptable- Day 98 | 3 Participants |
| Group 3: Control 1 | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-1- Acceptable- Day 98 | 3 Participants |
| Group 3: Control 1 | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-1- Don't Know/Don't Remember- Day 35 | 0 Participants |
| Group 3: Control 1 | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-1- Unacceptable- Day 98 | 0 Participants |
| Group 3: Control 1 | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-1- Don't Know/Don't Remember- Day 98 | 0 Participants |
| Group 3: Control 1 | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-2- Acceptable- Day 14 | 3 Participants |
| Group 3: Control 1 | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-1- Unacceptable- Day 35 | 0 Participants |
| Group 3: Control 1 | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-4- Unacceptable- Day 98 | 0 Participants |
| Group 3: Control 1 | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-2- Unacceptable- Day 14 | 0 Participants |
| Group 3: Control 1 | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-2- Don't Know/Don't Remember- Day 14 | 0 Participants |
| Group 3: Control 1 | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-1- Acceptable- Day 35 | 3 Participants |
| Group 3: Control 1 | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-4- Unacceptable- Day 175 | 0 Participants |
| Group 3: Control 1 | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-2- Acceptable- Day 175 | 3 Participants |
| Group 3: Control 1 | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-5- Unacceptable- Day 98 | 0 Participants |
| Group 3: Control 1 | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-2- Unacceptable- Day 175 | 0 Participants |
| Group 3: Control 1 | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-1- Don't Know/Don't Remember- Day 175 | 0 Participants |
| Group 3: Control 1 | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-2- Don't Know/Don't Remember- Day 175 | 0 Participants |
| Group 3: Control 1 | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-5- Acceptable- Day 14 | 0 Participants |
| Group 3: Control 1 | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-2- Acceptable- Day 35 | 3 Participants |
| Group 3: Control 1 | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-1- Acceptable- Day 175 | 3 Participants |
| Group 3: Control 1 | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-2- Unacceptable- Day 35 | 0 Participants |
| Group 4: Control 2 | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-5- Unacceptable- Day 35 | 0 Participants |
| Group 4: Control 2 | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-2- Don't Know/Don't Remember- Day 35 | 0 Participants |
| Group 4: Control 2 | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-2- Acceptable- Day 35 | 2 Participants |
| Group 4: Control 2 | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-5- Unacceptable- Day 14 | 0 Participants |
| Group 4: Control 2 | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-4- Acceptable- Day 175 | 2 Participants |
| Group 4: Control 2 | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-2- Acceptable- Day 98 | 2 Participants |
| Group 4: Control 2 | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-1- Unacceptable- Day 14 | 1 Participants |
| Group 4: Control 2 | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-2- Acceptable- Day 14 | 3 Participants |
| Group 4: Control 2 | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-2- Unacceptable- Day 175 | 0 Participants |
| Group 4: Control 2 | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-1- Unacceptable- Day 175 | 0 Participants |
| Group 4: Control 2 | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-1- Don't Know/Don't Remember- Day 14 | 0 Participants |
| Group 4: Control 2 | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-2- Don't Know/Don't Remember- Day 98 | 0 Participants |
| Group 4: Control 2 | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-1- Acceptable- Day 14 | 2 Participants |
| Group 4: Control 2 | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-4- Don't Know/Don't Remember- Day 175 | 0 Participants |
| Group 4: Control 2 | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-3- Don't Know/Don't Remember- Day 14 | 0 Participants |
| Group 4: Control 2 | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-5- Unacceptable- Day 98 | 0 Participants |
| Group 4: Control 2 | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-2- Unacceptable- Day 14 | 0 Participants |
| Group 4: Control 2 | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-4- Acceptable- Day 35 | 2 Participants |
| Group 4: Control 2 | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-3- Acceptable- Day 175 | 2 Participants |
| Group 4: Control 2 | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-5- Acceptable- Day 98 | 0 Participants |
| Group 4: Control 2 | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-5- Don't Know/Don't Remember- Day 14 | 0 Participants |
| Group 4: Control 2 | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-1- Acceptable- Day 35 | 2 Participants |
| Group 4: Control 2 | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-3- Unacceptable- Day 175 | 0 Participants |
| Group 4: Control 2 | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-4- Unacceptable- Day 98 | 0 Participants |
| Group 4: Control 2 | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-3- Acceptable- Day 14 | 3 Participants |
| Group 4: Control 2 | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-5- Acceptable- Day 14 | 0 Participants |
| Group 4: Control 2 | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-3- Don't Know/Don't Remember- Day 175 | 0 Participants |
| Group 4: Control 2 | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-5- No Other Side Effects- Day 35 | 2 Participants |
| Group 4: Control 2 | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-4- Unacceptable- Day 35 | 0 Participants |
| Group 4: Control 2 | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-4- Don't Know/Don't Remember- Day 98 | 0 Participants |
| Group 4: Control 2 | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-3- Acceptable- Day 35 | 2 Participants |
| Group 4: Control 2 | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-5- Don't Know/Don't Remember- Day 35 | 0 Participants |
| Group 4: Control 2 | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-5- Acceptable- Day 175 | 1 Participants |
| Group 4: Control 2 | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-2- Don't Know/Don't Remember- Day 14 | 0 Participants |
| Group 4: Control 2 | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-3- Unacceptable- Day 35 | 0 Participants |
| Group 4: Control 2 | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-4- Don't Know/Don't Remember- Day 35 | 0 Participants |
| Group 4: Control 2 | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-2- Don't Know/Don't Remember- Day 175 | 0 Participants |
| Group 4: Control 2 | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-1- Don't Know/Don't Remember- Day 98 | 0 Participants |
| Group 4: Control 2 | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-3- Don't Know/Don't Remember- Day 35 | 0 Participants |
| Group 4: Control 2 | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-5- Acceptable- Day 35 | 0 Participants |
| Group 4: Control 2 | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-1- Acceptable- Day 175 | 2 Participants |
| Group 4: Control 2 | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-1- Don't Know/Don't Remember- Day 35 | 0 Participants |
| Group 4: Control 2 | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-3- Acceptable- Day 98 | 2 Participants |
| Group 4: Control 2 | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-4- Acceptable- Day 98 | 2 Participants |
| Group 4: Control 2 | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-3- Unacceptable- Day 14 | 0 Participants |
| Group 4: Control 2 | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-1- Acceptable- Day 98 | 2 Participants |
| Group 4: Control 2 | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-3- Unacceptable- Day 98 | 0 Participants |
| Group 4: Control 2 | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-5- Don't Know/Don't Remember- Day 175 | 0 Participants |
| Group 4: Control 2 | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-5- Don't Know/Don't Remember- Day 98 | 0 Participants |
| Group 4: Control 2 | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-2- Acceptable- Day 175 | 2 Participants |
| Group 4: Control 2 | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-3- Don't Know/Don't Remember- Day 98 | 0 Participants |
| Group 4: Control 2 | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-5- Unacceptable- Day 175 | 0 Participants |
| Group 4: Control 2 | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-4- Unacceptable- Day 175 | 0 Participants |
| Group 4: Control 2 | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-1- Don't Know/Don't Remember- Day 175 | 0 Participants |
| Group 4: Control 2 | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-4- Acceptable- Day 14 | 3 Participants |
| Group 4: Control 2 | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-1- Unacceptable- Day 98 | 0 Participants |
| Group 4: Control 2 | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-5- No Other Side Effects- Day 175 | 1 Participants |
| Group 4: Control 2 | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-1- Unacceptable- Day 35 | 0 Participants |
| Group 4: Control 2 | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-4- Unacceptable- Day 14 | 0 Participants |
| Group 4: Control 2 | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-5- No Other Side Effects- Day 98 | 2 Participants |
| Group 4: Control 2 | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-2- Unacceptable- Day 98 | 0 Participants |
| Group 4: Control 2 | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-2- Unacceptable- Day 35 | 0 Participants |
| Group 4: Control 2 | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-4- Don't Know/Don't Remember- Day 14 | 0 Participants |
| Group 4: Control 2 | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Question-5- No Other Side Effects- Day 14 | 3 Participants |
Primary
Magnitude of Local Injection/EP Site Pain as Measured by a Visual Analog Scale (Day 0, Day 28, Day 84, Day 168)
A visual analog scale is a horizontal line, 10 cm in length, anchored by word descriptors at each end (no pain and worst pain). The visual analog scale score is determined by measuring in centimeters from the left hand end of the line to the point that the patient marks, 0 cm being no pain and 10 cm being maximum pain.The pain assessment scores for each arm at each vaccination visit were summarized with visual analog scale (VAS)
Time frame: Measured during Day 0, 28, 84 and 168
Population: One participant in Group 1 had VASOVAGAL REACTION AND SEIZURE on enrollment visit. One participant in Group 2 experienced EP device difficulty on enrollment visit. These two participants had no Visual Analog Scale - Pain Assessment Scores.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Group 1: Vaccine | Magnitude of Local Injection/EP Site Pain as Measured by a Visual Analog Scale (Day 0, Day 28, Day 84, Day 168) | 0 - V9.0 - Day 168 | 5.1 Score |
| Group 1: Vaccine | Magnitude of Local Injection/EP Site Pain as Measured by a Visual Analog Scale (Day 0, Day 28, Day 84, Day 168) | 5-7 - V2.0 - Day 0 | 0.8 Score |
| Group 1: Vaccine | Magnitude of Local Injection/EP Site Pain as Measured by a Visual Analog Scale (Day 0, Day 28, Day 84, Day 168) | 5-7 - V7.0 - Day 84 | 1.1 Score |
| Group 1: Vaccine | Magnitude of Local Injection/EP Site Pain as Measured by a Visual Analog Scale (Day 0, Day 28, Day 84, Day 168) | 25_60 - V7.0 - Day 84 | 0.55 Score |
| Group 1: Vaccine | Magnitude of Local Injection/EP Site Pain as Measured by a Visual Analog Scale (Day 0, Day 28, Day 84, Day 168) | 0 - V2.0 - Day 0 | 4.65 Score |
| Group 1: Vaccine | Magnitude of Local Injection/EP Site Pain as Measured by a Visual Analog Scale (Day 0, Day 28, Day 84, Day 168) | 25_60 - V2.0 - Day 0 | 0.45 Score |
| Group 1: Vaccine | Magnitude of Local Injection/EP Site Pain as Measured by a Visual Analog Scale (Day 0, Day 28, Day 84, Day 168) | 0 - V4.0 - Day 28 | 4.3 Score |
| Group 1: Vaccine | Magnitude of Local Injection/EP Site Pain as Measured by a Visual Analog Scale (Day 0, Day 28, Day 84, Day 168) | 5-7 - V9.0 - Day 168 | 0.8 Score |
| Group 1: Vaccine | Magnitude of Local Injection/EP Site Pain as Measured by a Visual Analog Scale (Day 0, Day 28, Day 84, Day 168) | 5-7 - V4.0 - Day 28 | 1.6 Score |
| Group 1: Vaccine | Magnitude of Local Injection/EP Site Pain as Measured by a Visual Analog Scale (Day 0, Day 28, Day 84, Day 168) | 25_60 - V4.0 - Day 28 | 0.5 Score |
| Group 1: Vaccine | Magnitude of Local Injection/EP Site Pain as Measured by a Visual Analog Scale (Day 0, Day 28, Day 84, Day 168) | 25_60 - V9.0 - Day 168 | 0.2 Score |
| Group 1: Vaccine | Magnitude of Local Injection/EP Site Pain as Measured by a Visual Analog Scale (Day 0, Day 28, Day 84, Day 168) | 0 - V7.0 - Day 84 | 3.95 Score |
| Group 2: Vaccine | Magnitude of Local Injection/EP Site Pain as Measured by a Visual Analog Scale (Day 0, Day 28, Day 84, Day 168) | 25_60 - V9.0 - Day 168 | 0.3 Score |
| Group 2: Vaccine | Magnitude of Local Injection/EP Site Pain as Measured by a Visual Analog Scale (Day 0, Day 28, Day 84, Day 168) | 0 - V7.0 - Day 84 | 3.6 Score |
| Group 2: Vaccine | Magnitude of Local Injection/EP Site Pain as Measured by a Visual Analog Scale (Day 0, Day 28, Day 84, Day 168) | 0 - V4.0 - Day 28 | 3.65 Score |
| Group 2: Vaccine | Magnitude of Local Injection/EP Site Pain as Measured by a Visual Analog Scale (Day 0, Day 28, Day 84, Day 168) | 25_60 - V7.0 - Day 84 | 0.3 Score |
| Group 2: Vaccine | Magnitude of Local Injection/EP Site Pain as Measured by a Visual Analog Scale (Day 0, Day 28, Day 84, Day 168) | 0 - V2.0 - Day 0 | 4.75 Score |
| Group 2: Vaccine | Magnitude of Local Injection/EP Site Pain as Measured by a Visual Analog Scale (Day 0, Day 28, Day 84, Day 168) | 5-7 - V7.0 - Day 84 | 0.8 Score |
| Group 2: Vaccine | Magnitude of Local Injection/EP Site Pain as Measured by a Visual Analog Scale (Day 0, Day 28, Day 84, Day 168) | 5-7 - V2.0 - Day 0 | 0.85 Score |
| Group 2: Vaccine | Magnitude of Local Injection/EP Site Pain as Measured by a Visual Analog Scale (Day 0, Day 28, Day 84, Day 168) | 0 - V9.0 - Day 168 | 3.95 Score |
| Group 2: Vaccine | Magnitude of Local Injection/EP Site Pain as Measured by a Visual Analog Scale (Day 0, Day 28, Day 84, Day 168) | 25_60 - V4.0 - Day 28 | 0.5 Score |
| Group 2: Vaccine | Magnitude of Local Injection/EP Site Pain as Measured by a Visual Analog Scale (Day 0, Day 28, Day 84, Day 168) | 5-7 - V9.0 - Day 168 | 0.6 Score |
| Group 2: Vaccine | Magnitude of Local Injection/EP Site Pain as Measured by a Visual Analog Scale (Day 0, Day 28, Day 84, Day 168) | 5-7 - V4.0 - Day 28 | 0.7 Score |
| Group 2: Vaccine | Magnitude of Local Injection/EP Site Pain as Measured by a Visual Analog Scale (Day 0, Day 28, Day 84, Day 168) | 25_60 - V2.0 - Day 0 | 0.7 Score |
| Group 3: Control 1 | Magnitude of Local Injection/EP Site Pain as Measured by a Visual Analog Scale (Day 0, Day 28, Day 84, Day 168) | 5-7 - V7.0 - Day 84 | 1.7 Score |
| Group 3: Control 1 | Magnitude of Local Injection/EP Site Pain as Measured by a Visual Analog Scale (Day 0, Day 28, Day 84, Day 168) | 0 - V2.0 - Day 0 | 6.9 Score |
| Group 3: Control 1 | Magnitude of Local Injection/EP Site Pain as Measured by a Visual Analog Scale (Day 0, Day 28, Day 84, Day 168) | 5-7 - V2.0 - Day 0 | 2.2 Score |
| Group 3: Control 1 | Magnitude of Local Injection/EP Site Pain as Measured by a Visual Analog Scale (Day 0, Day 28, Day 84, Day 168) | 0 - V4.0 - Day 28 | 5.5 Score |
| Group 3: Control 1 | Magnitude of Local Injection/EP Site Pain as Measured by a Visual Analog Scale (Day 0, Day 28, Day 84, Day 168) | 5-7 - V4.0 - Day 28 | 2.4 Score |
| Group 3: Control 1 | Magnitude of Local Injection/EP Site Pain as Measured by a Visual Analog Scale (Day 0, Day 28, Day 84, Day 168) | 25_60 - V4.0 - Day 28 | 1.8 Score |
| Group 3: Control 1 | Magnitude of Local Injection/EP Site Pain as Measured by a Visual Analog Scale (Day 0, Day 28, Day 84, Day 168) | 0 - V7.0 - Day 84 | 6.85 Score |
| Group 3: Control 1 | Magnitude of Local Injection/EP Site Pain as Measured by a Visual Analog Scale (Day 0, Day 28, Day 84, Day 168) | 25_60 - V2.0 - Day 0 | 1.7 Score |
| Group 3: Control 1 | Magnitude of Local Injection/EP Site Pain as Measured by a Visual Analog Scale (Day 0, Day 28, Day 84, Day 168) | 25_60 - V7.0 - Day 84 | 1.1 Score |
| Group 3: Control 1 | Magnitude of Local Injection/EP Site Pain as Measured by a Visual Analog Scale (Day 0, Day 28, Day 84, Day 168) | 0 - V9.0 - Day 168 | 3.4 Score |
| Group 3: Control 1 | Magnitude of Local Injection/EP Site Pain as Measured by a Visual Analog Scale (Day 0, Day 28, Day 84, Day 168) | 5-7 - V9.0 - Day 168 | 2.4 Score |
| Group 3: Control 1 | Magnitude of Local Injection/EP Site Pain as Measured by a Visual Analog Scale (Day 0, Day 28, Day 84, Day 168) | 25_60 - V9.0 - Day 168 | 0.8 Score |
| Group 4: Control 2 | Magnitude of Local Injection/EP Site Pain as Measured by a Visual Analog Scale (Day 0, Day 28, Day 84, Day 168) | 25_60 - V4.0 - Day 28 | 0.65 Score |
| Group 4: Control 2 | Magnitude of Local Injection/EP Site Pain as Measured by a Visual Analog Scale (Day 0, Day 28, Day 84, Day 168) | 5-7 - V4.0 - Day 28 | 1.05 Score |
| Group 4: Control 2 | Magnitude of Local Injection/EP Site Pain as Measured by a Visual Analog Scale (Day 0, Day 28, Day 84, Day 168) | 25_60 - V2.0 - Day 0 | 0.7 Score |
| Group 4: Control 2 | Magnitude of Local Injection/EP Site Pain as Measured by a Visual Analog Scale (Day 0, Day 28, Day 84, Day 168) | 0 - V9.0 - Day 168 | 2.6 Score |
| Group 4: Control 2 | Magnitude of Local Injection/EP Site Pain as Measured by a Visual Analog Scale (Day 0, Day 28, Day 84, Day 168) | 0 - V4.0 - Day 28 | 3.3 Score |
| Group 4: Control 2 | Magnitude of Local Injection/EP Site Pain as Measured by a Visual Analog Scale (Day 0, Day 28, Day 84, Day 168) | 5-7 - V2.0 - Day 0 | 1.7 Score |
| Group 4: Control 2 | Magnitude of Local Injection/EP Site Pain as Measured by a Visual Analog Scale (Day 0, Day 28, Day 84, Day 168) | 25_60 - V9.0 - Day 168 | 0.3 Score |
| Group 4: Control 2 | Magnitude of Local Injection/EP Site Pain as Measured by a Visual Analog Scale (Day 0, Day 28, Day 84, Day 168) | 5-7 - V9.0 - Day 168 | 0.75 Score |
| Group 4: Control 2 | Magnitude of Local Injection/EP Site Pain as Measured by a Visual Analog Scale (Day 0, Day 28, Day 84, Day 168) | 5-7 - V7.0 - Day 84 | 2.15 Score |
| Group 4: Control 2 | Magnitude of Local Injection/EP Site Pain as Measured by a Visual Analog Scale (Day 0, Day 28, Day 84, Day 168) | 0 - V7.0 - Day 84 | 5 Score |
| Group 4: Control 2 | Magnitude of Local Injection/EP Site Pain as Measured by a Visual Analog Scale (Day 0, Day 28, Day 84, Day 168) | 0 - V2.0 - Day 0 | 4.9 Score |
| Group 4: Control 2 | Magnitude of Local Injection/EP Site Pain as Measured by a Visual Analog Scale (Day 0, Day 28, Day 84, Day 168) | 25_60 - V7.0 - Day 84 | 1.9 Score |
Primary
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1, July 2017. The maximum grade observed for each symptom ove
Time frame: Measured through Month 0, 1, 3, 6
| 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/Redness | None | 23 Participants |
| Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Moderate | 1 Participants |
| Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | None | 22 Participants |
| Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Severe | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Potentially Life-threatening | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Potentially Life-threatening | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Severe | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Mild | 2 Participants |
| Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Moderate | 1 Participants |
| Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Moderate | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Severe | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Potentially Life-threatening | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | None | 23 Participants |
| Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Mild | 2 Participants |
| Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Mild | 1 Participants |
| Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | None | 22 Participants |
| Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Moderate | 1 Participants |
| Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Moderate | 1 Participants |
| Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | None | 21 Participants |
| Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Severe | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Severe | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Severe | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Potentially Life-threatening | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Potentially Life-threatening | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Mild | 4 Participants |
| Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Mild | 2 Participants |
| Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Potentially Life-threatening | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Mild | 3 Participants |
| Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Moderate | 1 Participants |
| Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | None | 20 Participants |
| Group 3: Control 1 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | None | 2 Participants |
| Group 3: Control 1 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Potentially Life-threatening | 0 Participants |
| Group 3: Control 1 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Moderate | 0 Participants |
| Group 3: Control 1 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | None | 2 Participants |
| Group 3: Control 1 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Mild | 1 Participants |
| Group 3: Control 1 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Severe | 0 Participants |
| Group 3: Control 1 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | None | 3 Participants |
| Group 3: Control 1 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Mild | 0 Participants |
| Group 3: Control 1 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Moderate | 0 Participants |
| Group 3: Control 1 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Severe | 0 Participants |
| Group 3: Control 1 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Potentially Life-threatening | 0 Participants |
| Group 3: Control 1 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Moderate | 0 Participants |
| Group 3: Control 1 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Mild | 1 Participants |
| Group 3: Control 1 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Severe | 0 Participants |
| Group 3: Control 1 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Potentially Life-threatening | 0 Participants |
| Group 4: Control 2 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Potentially Life-threatening | 0 Participants |
| Group 4: Control 2 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | None | 2 Participants |
| Group 4: Control 2 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | None | 3 Participants |
| Group 4: Control 2 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Severe | 0 Participants |
| Group 4: Control 2 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Moderate | 0 Participants |
| Group 4: Control 2 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Mild | 1 Participants |
| Group 4: Control 2 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Mild | 1 Participants |
| Group 4: Control 2 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | None | 2 Participants |
| Group 4: Control 2 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Moderate | 0 Participants |
| Group 4: Control 2 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Potentially Life-threatening | 0 Participants |
| Group 4: Control 2 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Severe | 0 Participants |
| Group 4: Control 2 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Severe | 0 Participants |
| Group 4: Control 2 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Potentially Life-threatening | 0 Participants |
| Group 4: Control 2 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Moderate | 0 Participants |
| Group 4: Control 2 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Mild | 0 Participants |
Primary
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness
Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1, July 2017. The maximum grade observed for each symptom ove
Time frame: Measured through Month 0, 1, 3, 6
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Tenderness | Potentially Life-threatening | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Pain | Severe | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Pain and/or Tenderness | Moderate | 10 Participants |
| Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Tenderness | Severe | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Tenderness | Moderate | 8 Participants |
| Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Pain | Potentially Life-threatening | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Pain | Mild | 13 Participants |
| Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Tenderness | None | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Pain | None | 4 Participants |
| Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Pain and/or Tenderness | Potentially Life-threatening | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Tenderness | Mild | 17 Participants |
| Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Pain and/or Tenderness | Mild | 15 Participants |
| Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Pain | Moderate | 8 Participants |
| Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Pain and/or Tenderness | Severe | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Pain and/or Tenderness | None | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Pain and/or Tenderness | Mild | 18 Participants |
| Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Tenderness | Mild | 18 Participants |
| Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Pain | None | 1 Participants |
| Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Tenderness | Moderate | 7 Participants |
| Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Pain | Mild | 21 Participants |
| Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Pain | Moderate | 3 Participants |
| Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Pain | Severe | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Pain | Potentially Life-threatening | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Tenderness | None | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Tenderness | Severe | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Tenderness | Potentially Life-threatening | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Pain and/or Tenderness | None | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Pain and/or Tenderness | Moderate | 7 Participants |
| Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Pain and/or Tenderness | Severe | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Pain and/or Tenderness | Potentially Life-threatening | 0 Participants |
| Group 3: Control 1 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Tenderness | Moderate | 2 Participants |
| Group 3: Control 1 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Pain | Severe | 0 Participants |
| Group 3: Control 1 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Pain and/or Tenderness | Severe | 0 Participants |
| Group 3: Control 1 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Tenderness | Severe | 0 Participants |
| Group 3: Control 1 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Tenderness | Potentially Life-threatening | 0 Participants |
| Group 3: Control 1 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Pain | Moderate | 1 Participants |
| Group 3: Control 1 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Tenderness | Mild | 1 Participants |
| Group 3: Control 1 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Pain and/or Tenderness | None | 0 Participants |
| Group 3: Control 1 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Pain | Mild | 2 Participants |
| Group 3: Control 1 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Pain and/or Tenderness | Mild | 1 Participants |
| Group 3: Control 1 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Pain and/or Tenderness | Moderate | 2 Participants |
| Group 3: Control 1 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Pain | None | 0 Participants |
| Group 3: Control 1 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Pain | Potentially Life-threatening | 0 Participants |
| Group 3: Control 1 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Pain and/or Tenderness | Potentially Life-threatening | 0 Participants |
| Group 3: Control 1 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Tenderness | None | 0 Participants |
| Group 4: Control 2 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Pain | Potentially Life-threatening | 0 Participants |
| Group 4: Control 2 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Tenderness | Moderate | 1 Participants |
| Group 4: Control 2 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Tenderness | None | 0 Participants |
| Group 4: Control 2 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Pain and/or Tenderness | Mild | 2 Participants |
| Group 4: Control 2 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Pain | None | 0 Participants |
| Group 4: Control 2 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Tenderness | Severe | 0 Participants |
| Group 4: Control 2 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Pain | Moderate | 0 Participants |
| Group 4: Control 2 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Pain and/or Tenderness | Severe | 0 Participants |
| Group 4: Control 2 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Pain and/or Tenderness | Potentially Life-threatening | 0 Participants |
| Group 4: Control 2 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Tenderness | Potentially Life-threatening | 0 Participants |
| Group 4: Control 2 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Tenderness | Mild | 2 Participants |
| Group 4: Control 2 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Pain and/or Tenderness | Moderate | 1 Participants |
| Group 4: Control 2 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Pain | Severe | 0 Participants |
| Group 4: Control 2 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Pain and/or Tenderness | None | 0 Participants |
| Group 4: Control 2 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Pain | Mild | 3 Participants |
Primary
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1, July 2017. The maximum grade observed for each symptom ove
Time frame: Measured through Month 0, 1, 3, 6
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Mild | 2 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Mild | 11 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 | Arthralgia | Potentially Life-threatening | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | None | 4 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Mild | 14 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Moderate | 6 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Moderate | 3 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Severe | 1 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Potentially Life-threatening | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | None | 23 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Severe | 1 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 | Temperature | Potentially Life-threatening | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Moderate | 1 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Potentially Life-threatening | 0 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 | Myalgia | None | 13 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Mild | 9 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Moderate | 3 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 | Chills | Potentially Life-threatening | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Potentially Life-threatening | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | None | 14 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | None | 19 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Mild | 9 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Moderate | 2 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Moderate | 1 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 | Headache | Potentially Life-threatening | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | None | 18 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Mild | 6 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 | Nausea | Potentially Life-threatening | 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 | Vomiting | Moderate | 0 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 | Temperature | Moderate | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Vomiting | Potentially Life-threatening | 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 | Vomiting | None | 25 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 | None | 10 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 | Arthralgia | Mild | 5 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | None | 15 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Potentially Life-threatening | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Potentially Life-threatening | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Mild | 5 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Severe | 1 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Potentially Life-threatening | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Mild | 14 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 | Arthralgia | Potentially Life-threatening | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | None | 11 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Severe | 1 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Vomiting | Potentially Life-threatening | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | None | 3 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Mild | 6 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Moderate | 1 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | None | 21 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Moderate | 1 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Moderate | 9 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Moderate | 7 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Severe | 1 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 | Max. Systemic Symptoms | Severe | 1 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 | Malaise and/or fatigue | Moderate | 4 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Mild | 12 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Potentially Life-threatening | 0 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 | Headache | Severe | 1 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Mild | 1 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | None | 25 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | None | 6 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Moderate | 1 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Mild | 2 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 | Chills | None | 22 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Potentially Life-threatening | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Severe | 1 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Vomiting | None | 24 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 | Myalgia | Severe | 1 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Mild | 8 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | None | 18 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Potentially Life-threatening | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Vomiting | Severe | 1 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Potentially Life-threatening | 0 Participants |
| Group 3: Control 1 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Moderate | 0 Participants |
| Group 3: Control 1 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Potentially Life-threatening | 0 Participants |
| Group 3: Control 1 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | None | 2 Participants |
| Group 3: Control 1 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | None | 0 Participants |
| Group 3: Control 1 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Vomiting | Moderate | 0 Participants |
| Group 3: Control 1 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Mild | 3 Participants |
| Group 3: Control 1 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Moderate | 0 Participants |
| Group 3: Control 1 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Potentially Life-threatening | 0 Participants |
| Group 3: Control 1 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Moderate | 0 Participants |
| Group 3: Control 1 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Severe | 0 Participants |
| Group 3: Control 1 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Vomiting | Severe | 0 Participants |
| Group 3: Control 1 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Potentially Life-threatening | 0 Participants |
| Group 3: Control 1 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Mild | 1 Participants |
| Group 3: Control 1 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Vomiting | Potentially Life-threatening | 0 Participants |
| Group 3: Control 1 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Moderate | 0 Participants |
| Group 3: Control 1 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Severe | 0 Participants |
| Group 3: Control 1 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Severe | 0 Participants |
| Group 3: Control 1 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Potentially Life-threatening | 0 Participants |
| Group 3: Control 1 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | None | 3 Participants |
| Group 3: Control 1 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | None | 3 Participants |
| Group 3: Control 1 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | None | 2 Participants |
| Group 3: Control 1 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Mild | 1 Participants |
| Group 3: Control 1 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Potentially Life-threatening | 0 Participants |
| Group 3: Control 1 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Severe | 0 Participants |
| Group 3: Control 1 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Mild | 0 Participants |
| Group 3: Control 1 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Potentially Life-threatening | 0 Participants |
| Group 3: Control 1 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Mild | 1 Participants |
| Group 3: Control 1 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Mild | 0 Participants |
| Group 3: Control 1 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | None | 0 Participants |
| Group 3: Control 1 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Vomiting | Mild | 0 Participants |
| Group 3: Control 1 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Moderate | 0 Participants |
| Group 3: Control 1 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | None | 2 Participants |
| Group 3: Control 1 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Moderate | 0 Participants |
| Group 3: Control 1 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Severe | 0 Participants |
| Group 3: Control 1 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Severe | 0 Participants |
| Group 3: Control 1 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Potentially Life-threatening | 0 Participants |
| Group 3: Control 1 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Moderate | 0 Participants |
| Group 3: Control 1 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | None | 3 Participants |
| Group 3: Control 1 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Mild | 3 Participants |
| Group 3: Control 1 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Mild | 0 Participants |
| Group 3: Control 1 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Moderate | 0 Participants |
| Group 3: Control 1 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Severe | 0 Participants |
| Group 3: Control 1 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Severe | 0 Participants |
| Group 3: Control 1 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Vomiting | None | 3 Participants |
| Group 3: Control 1 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Potentially Life-threatening | 0 Participants |
| Group 4: Control 2 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | None | 2 Participants |
| Group 4: Control 2 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Potentially Life-threatening | 0 Participants |
| Group 4: Control 2 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Vomiting | Mild | 0 Participants |
| Group 4: Control 2 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Severe | 0 Participants |
| Group 4: Control 2 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Moderate | 1 Participants |
| Group 4: Control 2 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Mild | 1 Participants |
| Group 4: Control 2 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Mild | 0 Participants |
| Group 4: Control 2 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Moderate | 2 Participants |
| Group 4: Control 2 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | None | 0 Participants |
| Group 4: Control 2 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Mild | 1 Participants |
| Group 4: Control 2 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Severe | 0 Participants |
| Group 4: Control 2 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Potentially Life-threatening | 0 Participants |
| Group 4: Control 2 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | None | 0 Participants |
| Group 4: Control 2 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Mild | 2 Participants |
| Group 4: Control 2 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Moderate | 1 Participants |
| Group 4: Control 2 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Severe | 0 Participants |
| Group 4: Control 2 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Potentially Life-threatening | 0 Participants |
| Group 4: Control 2 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | None | 1 Participants |
| Group 4: Control 2 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Mild | 1 Participants |
| Group 4: Control 2 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Moderate | 1 Participants |
| Group 4: Control 2 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Severe | 0 Participants |
| Group 4: Control 2 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Mild | 1 Participants |
| Group 4: Control 2 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Moderate | 0 Participants |
| Group 4: Control 2 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Severe | 0 Participants |
| Group 4: Control 2 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Potentially Life-threatening | 0 Participants |
| Group 4: Control 2 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Vomiting | None | 3 Participants |
| Group 4: Control 2 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Vomiting | Moderate | 0 Participants |
| Group 4: Control 2 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Vomiting | Severe | 0 Participants |
| Group 4: Control 2 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Vomiting | Potentially Life-threatening | 0 Participants |
| Group 4: Control 2 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | None | 1 Participants |
| Group 4: Control 2 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Mild | 0 Participants |
| Group 4: Control 2 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Moderate | 2 Participants |
| Group 4: Control 2 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Potentially Life-threatening | 0 Participants |
| Group 4: Control 2 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | None | 1 Participants |
| Group 4: Control 2 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Mild | 1 Participants |
| Group 4: Control 2 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Severe | 0 Participants |
| Group 4: Control 2 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Potentially Life-threatening | 0 Participants |
| Group 4: Control 2 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | None | 0 Participants |
| Group 4: Control 2 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Moderate | 2 Participants |
| Group 4: Control 2 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Severe | 0 Participants |
| Group 4: Control 2 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Potentially Life-threatening | 0 Participants |
| Group 4: Control 2 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | None | 3 Participants |
| Group 4: Control 2 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Moderate | 0 Participants |
| Group 4: Control 2 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Severe | 0 Participants |
| Group 4: Control 2 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Potentially Life-threatening | 0 Participants |
Primary
Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1
The number (percentage) of participants with Chemistry and Hematology Laboratory Measures - Counts of Lab Grade \> 1 for alkaline phosphate (ALP), aspartate aminotransferase (AST), alanine aminotransferase (ALT), creatine phosphokinase (CPK), creatinine, hemoglobin, lymphocyte count, neutrophil count, platelets, white blood cells (WBC) was summarized by treatment group and visit time
Time frame: Measured during screening, Days 14, 42, 98, 182 and 273 for (ALP), (AST), (ALT), (CPK), creatinine. Measured during screening, Days 14, 42, 98, 175, 182 and 273 for Lymphocyte count, Neutrophil count Platelets, WBC, hemoglobin.
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. Visit schedule is not the same for each laboratory measures. For visits not on the schedule, number analyzed is 0 or applicable participants number.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | WBC (1000*Cells/mm^3)-Day 98 | 0 Participants |
| Group 1: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Platelets (1000*Cells/mm^3)-Day 175 | 0 Participants |
| Group 1: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Platelets (1000*Cells/mm^3)-Day 98 | 0 Participants |
| Group 1: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Hemoglobin (g/dL)-Day 14 | 0 Participants |
| Group 1: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | creatine phosphokinase (U/L)-Day 273 | 0 Participants |
| Group 1: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Platelets (1000*Cells/mm^3)-Day 42 | 0 Participants |
| Group 1: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Platelets (1000*Cells/mm^3)-Day 14 | 0 Participants |
| Group 1: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Hemoglobin (g/dL)-Day 42 | 0 Participants |
| Group 1: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Creatinine (g/dL)-Day 175 | 0 Participants |
| Group 1: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Platelets (1000*Cells/mm^3)- Screening | 0 Participants |
| Group 1: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Lymphocytes (1000*Cells/mm^3)-Day 273 | 0 Participants |
| Group 1: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Hemoglobin (g/dL)-Day 98 | 0 Participants |
| Group 1: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Creatinine (g/dL)-Day 98 | 0 Participants |
| Group 1: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Lymphocytes (1000*Cells/mm^3)-Day 182 | 0 Participants |
| Group 1: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Lymphocytes (1000*Cells/mm^3)-Day 175 | 0 Participants |
| Group 1: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Hemoglobin (g/dL)-Day 175 | 0 Participants |
| Group 1: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Creatinine (g/dL)-Day 182 | 0 Participants |
| Group 1: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Lymphocytes (1000*Cells/mm^3)-Day 98 | 0 Participants |
| Group 1: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Lymphocytes (1000*Cells/mm^3)-Day 14 | 0 Participants |
| Group 1: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Hemoglobin (g/dL)-Day 182 | 0 Participants |
| Group 1: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | creatine phosphokinase (U/L)-Day 182 | 0 Participants |
| Group 1: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Lymphocytes (1000*Cells/mm^3)- Screening | 0 Participants |
| Group 1: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | WBC (1000*Cells/mm^3)-Day 175 | 0 Participants |
| Group 1: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Creatinine (g/dL)-Day 42 | 0 Participants |
| Group 1: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Creatinine (g/dL)-Day 14 | 0 Participants |
| Group 1: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | WBC (1000*Cells/mm^3)-Day 14 | 0 Participants |
| Group 1: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | creatine phosphokinase (U/L)-Day 175 | 0 Participants |
| Group 1: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Creatinine (g/dL)- Screening | 0 Participants |
| Group 1: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | WBC (1000*Cells/mm^3)-Day 42 | 0 Participants |
| Group 1: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | creatine phosphokinase (U/L)-Day 98 | 0 Participants |
| Group 1: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Alkaline Phosphatase (U/L)-Day 273 | 0 Participants |
| Group 1: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Neutrophils (1000*Cells/mm^3)-Day 98 | 0 Participants |
| Group 1: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Alkaline Phosphatase (U/L)-Day 182 | 0 Participants |
| Group 1: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Alkaline Phosphatase (U/L)-Day 175 | 0 Participants |
| Group 1: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | WBC (1000*Cells/mm^3)- Screening | 0 Participants |
| Group 1: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Alkaline Phosphatase (U/L)-Day 98 | 0 Participants |
| Group 1: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Alkaline Phosphatase (U/L)-Day 42 | 0 Participants |
| Group 1: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | WBC (1000*Cells/mm^3)-Day 182 | 0 Participants |
| Group 1: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Hemoglobin (g/dL)-Day 273 | 1 Participants |
| Group 1: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Alkaline Phosphatase (U/L)-Day 14 | 0 Participants |
| Group 1: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | WBC (1000*Cells/mm^3)-Day 273 | 0 Participants |
| Group 1: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | creatine phosphokinase (U/L)-Day 42 | 0 Participants |
| Group 1: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Alkaline Phosphatase (U/L)- Screening | 0 Participants |
| Group 1: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Neutrophils (1000*Cells/mm^3)- Screening | 0 Participants |
| Group 1: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Lymphocytes (1000*Cells/mm^3)-Day 42 | 0 Participants |
| Group 1: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | AST (U/L)-Day 273 | 0 Participants |
| Group 1: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | AST (U/L)-Day 182 | 0 Participants |
| Group 1: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Neutrophils (1000*Cells/mm^3)-Day 14 | 0 Participants |
| Group 1: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | creatine phosphokinase (U/L)-Day 14 | 0 Participants |
| Group 1: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | AST (U/L)-Day 175 | 0 Participants |
| Group 1: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | AST (U/L)-Day 98 | 0 Participants |
| Group 1: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Neutrophils (1000*Cells/mm^3)-Day 42 | 0 Participants |
| Group 1: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | creatine phosphokinase (U/L)- Screening | 0 Participants |
| Group 1: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | AST (U/L)-Day 42 | 0 Participants |
| Group 1: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | AST (U/L)- Screening | 0 Participants |
| Group 1: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | ALT (SGPT) (U/L)-Day 273 | 0 Participants |
| Group 1: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | ALT (SGPT) (U/L)-Day 182 | 0 Participants |
| Group 1: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Neutrophils (1000*Cells/mm^3)-Day 175 | 0 Participants |
| Group 1: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | ALT (SGPT) (U/L)-Day 42 | 0 Participants |
| Group 1: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | ALT (SGPT) (U/L)-Day 175 | 0 Participants |
| Group 1: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | ALT (SGPT) (U/L)-Day 98 | 0 Participants |
| Group 1: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Neutrophils (1000*Cells/mm^3)-Day 182 | 0 Participants |
| Group 1: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Creatinine (g/dL)-Day 273 | 0 Participants |
| Group 1: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | ALT (SGPT) (U/L)-Day 14 | 0 Participants |
| Group 1: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | ALT (SGPT) (U/L)- Screening | 0 Participants |
| Group 1: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Neutrophils (1000*Cells/mm^3)-Day 273 | 0 Participants |
| Group 1: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | AST (U/L)-Day 14 | 0 Participants |
| Group 1: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Platelets (1000*Cells/mm^3)-Day 273 | 0 Participants |
| Group 1: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Platelets (1000*Cells/mm^3)-Day 182 | 0 Participants |
| Group 1: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Hemoglobin (g/dL)- Screening | 0 Participants |
| Group 2: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Hemoglobin (g/dL)- Screening | 0 Participants |
| Group 2: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Neutrophils (1000*Cells/mm^3)-Day 98 | 0 Participants |
| Group 2: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Alkaline Phosphatase (U/L)-Day 175 | 0 Participants |
| Group 2: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Creatinine (g/dL)-Day 182 | 0 Participants |
| Group 2: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | WBC (1000*Cells/mm^3)- Screening | 0 Participants |
| Group 2: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | WBC (1000*Cells/mm^3)-Day 14 | 0 Participants |
| Group 2: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | WBC (1000*Cells/mm^3)-Day 42 | 0 Participants |
| Group 2: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | WBC (1000*Cells/mm^3)-Day 98 | 0 Participants |
| Group 2: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | WBC (1000*Cells/mm^3)-Day 175 | 0 Participants |
| Group 2: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | WBC (1000*Cells/mm^3)-Day 182 | 0 Participants |
| Group 2: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | WBC (1000*Cells/mm^3)-Day 273 | 0 Participants |
| Group 2: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Neutrophils (1000*Cells/mm^3)- Screening | 0 Participants |
| Group 2: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Neutrophils (1000*Cells/mm^3)-Day 14 | 0 Participants |
| Group 2: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Neutrophils (1000*Cells/mm^3)-Day 42 | 0 Participants |
| Group 2: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Neutrophils (1000*Cells/mm^3)-Day 175 | 0 Participants |
| Group 2: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Neutrophils (1000*Cells/mm^3)-Day 182 | 0 Participants |
| Group 2: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Neutrophils (1000*Cells/mm^3)-Day 273 | 0 Participants |
| Group 2: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Hemoglobin (g/dL)-Day 14 | 0 Participants |
| Group 2: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Hemoglobin (g/dL)-Day 42 | 0 Participants |
| Group 2: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Hemoglobin (g/dL)-Day 98 | 0 Participants |
| Group 2: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Hemoglobin (g/dL)-Day 175 | 0 Participants |
| Group 2: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Hemoglobin (g/dL)-Day 182 | 0 Participants |
| Group 2: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Hemoglobin (g/dL)-Day 273 | 0 Participants |
| Group 2: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Lymphocytes (1000*Cells/mm^3)- Screening | 0 Participants |
| Group 2: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Lymphocytes (1000*Cells/mm^3)-Day 14 | 0 Participants |
| Group 2: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Lymphocytes (1000*Cells/mm^3)-Day 42 | 0 Participants |
| Group 2: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Lymphocytes (1000*Cells/mm^3)-Day 98 | 0 Participants |
| Group 2: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Lymphocytes (1000*Cells/mm^3)-Day 175 | 0 Participants |
| Group 2: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Lymphocytes (1000*Cells/mm^3)-Day 182 | 0 Participants |
| Group 2: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Lymphocytes (1000*Cells/mm^3)-Day 273 | 0 Participants |
| Group 2: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Platelets (1000*Cells/mm^3)- Screening | 0 Participants |
| Group 2: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Platelets (1000*Cells/mm^3)-Day 14 | 0 Participants |
| Group 2: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Platelets (1000*Cells/mm^3)-Day 42 | 0 Participants |
| Group 2: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Platelets (1000*Cells/mm^3)-Day 98 | 0 Participants |
| Group 2: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Platelets (1000*Cells/mm^3)-Day 175 | 0 Participants |
| Group 2: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Platelets (1000*Cells/mm^3)-Day 182 | 0 Participants |
| Group 2: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Platelets (1000*Cells/mm^3)-Day 273 | 0 Participants |
| Group 2: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | ALT (SGPT) (U/L)- Screening | 0 Participants |
| Group 2: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | ALT (SGPT) (U/L)-Day 14 | 0 Participants |
| Group 2: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | ALT (SGPT) (U/L)-Day 42 | 0 Participants |
| Group 2: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | ALT (SGPT) (U/L)-Day 98 | 0 Participants |
| Group 2: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | ALT (SGPT) (U/L)-Day 175 | 0 Participants |
| Group 2: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | ALT (SGPT) (U/L)-Day 182 | 0 Participants |
| Group 2: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | ALT (SGPT) (U/L)-Day 273 | 0 Participants |
| Group 2: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | AST (U/L)- Screening | 0 Participants |
| Group 2: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | AST (U/L)-Day 14 | 0 Participants |
| Group 2: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | AST (U/L)-Day 42 | 0 Participants |
| Group 2: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | AST (U/L)-Day 98 | 0 Participants |
| Group 2: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | AST (U/L)-Day 175 | 0 Participants |
| Group 2: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | AST (U/L)-Day 182 | 0 Participants |
| Group 2: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | AST (U/L)-Day 273 | 0 Participants |
| Group 2: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Alkaline Phosphatase (U/L)- Screening | 0 Participants |
| Group 2: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Alkaline Phosphatase (U/L)-Day 14 | 0 Participants |
| Group 2: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Alkaline Phosphatase (U/L)-Day 42 | 0 Participants |
| Group 2: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Alkaline Phosphatase (U/L)-Day 98 | 0 Participants |
| Group 2: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Alkaline Phosphatase (U/L)-Day 182 | 0 Participants |
| Group 2: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Alkaline Phosphatase (U/L)-Day 273 | 0 Participants |
| Group 2: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Creatinine (g/dL)- Screening | 0 Participants |
| Group 2: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Creatinine (g/dL)-Day 14 | 0 Participants |
| Group 2: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Creatinine (g/dL)-Day 42 | 0 Participants |
| Group 2: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Creatinine (g/dL)-Day 98 | 0 Participants |
| Group 2: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Creatinine (g/dL)-Day 175 | 0 Participants |
| Group 2: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Creatinine (g/dL)-Day 273 | 1 Participants |
| Group 2: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | creatine phosphokinase (U/L)- Screening | 0 Participants |
| Group 2: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | creatine phosphokinase (U/L)-Day 14 | 0 Participants |
| Group 2: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | creatine phosphokinase (U/L)-Day 42 | 0 Participants |
| Group 2: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | creatine phosphokinase (U/L)-Day 98 | 0 Participants |
| Group 2: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | creatine phosphokinase (U/L)-Day 175 | 0 Participants |
| Group 2: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | creatine phosphokinase (U/L)-Day 182 | 0 Participants |
| Group 2: Vaccine | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | creatine phosphokinase (U/L)-Day 273 | 2 Participants |
| Group 3: Control 1 | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | creatine phosphokinase (U/L)- Screening | 0 Participants |
| Group 3: Control 1 | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Alkaline Phosphatase (U/L)-Day 42 | 0 Participants |
| Group 3: Control 1 | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | AST (U/L)- Screening | 0 Participants |
| Group 3: Control 1 | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | WBC (1000*Cells/mm^3)-Day 175 | 0 Participants |
| Group 3: Control 1 | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | WBC (1000*Cells/mm^3)-Day 273 | 0 Participants |
| Group 3: Control 1 | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Alkaline Phosphatase (U/L)-Day 98 | 0 Participants |
| Group 3: Control 1 | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Platelets (1000*Cells/mm^3)-Day 273 | 0 Participants |
| Group 3: Control 1 | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | AST (U/L)-Day 14 | 0 Participants |
| Group 3: Control 1 | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Alkaline Phosphatase (U/L)-Day 175 | 0 Participants |
| Group 3: Control 1 | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Creatinine (g/dL)-Day 273 | 0 Participants |
| Group 3: Control 1 | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | WBC (1000*Cells/mm^3)-Day 98 | 0 Participants |
| Group 3: Control 1 | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | WBC (1000*Cells/mm^3)-Day 14 | 0 Participants |
| Group 3: Control 1 | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Alkaline Phosphatase (U/L)-Day 182 | 0 Participants |
| Group 3: Control 1 | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Neutrophils (1000*Cells/mm^3)-Day 42 | 0 Participants |
| Group 3: Control 1 | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | WBC (1000*Cells/mm^3)-Day 42 | 0 Participants |
| Group 3: Control 1 | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | creatine phosphokinase (U/L)-Day 98 | 0 Participants |
| Group 3: Control 1 | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Alkaline Phosphatase (U/L)-Day 273 | 0 Participants |
| Group 3: Control 1 | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Lymphocytes (1000*Cells/mm^3)-Day 98 | 0 Participants |
| Group 3: Control 1 | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | AST (U/L)-Day 42 | 0 Participants |
| Group 3: Control 1 | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Creatinine (g/dL)- Screening | 0 Participants |
| Group 3: Control 1 | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | ALT (SGPT) (U/L)-Day 98 | 0 Participants |
| Group 3: Control 1 | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Neutrophils (1000*Cells/mm^3)-Day 182 | 0 Participants |
| Group 3: Control 1 | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | creatine phosphokinase (U/L)-Day 182 | 0 Participants |
| Group 3: Control 1 | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | WBC (1000*Cells/mm^3)-Day 182 | 0 Participants |
| Group 3: Control 1 | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Hemoglobin (g/dL)-Day 273 | 0 Participants |
| Group 3: Control 1 | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | AST (U/L)-Day 98 | 0 Participants |
| Group 3: Control 1 | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Hemoglobin (g/dL)-Day 182 | 0 Participants |
| Group 3: Control 1 | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Creatinine (g/dL)-Day 14 | 0 Participants |
| Group 3: Control 1 | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Lymphocytes (1000*Cells/mm^3)- Screening | 0 Participants |
| Group 3: Control 1 | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Neutrophils (1000*Cells/mm^3)-Day 175 | 0 Participants |
| Group 3: Control 1 | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Neutrophils (1000*Cells/mm^3)-Day 14 | 0 Participants |
| Group 3: Control 1 | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | creatine phosphokinase (U/L)-Day 14 | 0 Participants |
| Group 3: Control 1 | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Lymphocytes (1000*Cells/mm^3)-Day 14 | 0 Participants |
| Group 3: Control 1 | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | WBC (1000*Cells/mm^3)- Screening | 0 Participants |
| Group 3: Control 1 | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Lymphocytes (1000*Cells/mm^3)-Day 42 | 0 Participants |
| Group 3: Control 1 | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | AST (U/L)-Day 175 | 0 Participants |
| Group 3: Control 1 | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Hemoglobin (g/dL)-Day 175 | 0 Participants |
| Group 3: Control 1 | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Platelets (1000*Cells/mm^3)-Day 182 | 0 Participants |
| Group 3: Control 1 | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | ALT (SGPT) (U/L)-Day 175 | 0 Participants |
| Group 3: Control 1 | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | ALT (SGPT) (U/L)-Day 14 | 0 Participants |
| Group 3: Control 1 | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Creatinine (g/dL)-Day 42 | 0 Participants |
| Group 3: Control 1 | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Lymphocytes (1000*Cells/mm^3)-Day 175 | 0 Participants |
| Group 3: Control 1 | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | AST (U/L)-Day 182 | 0 Participants |
| Group 3: Control 1 | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Hemoglobin (g/dL)-Day 98 | 0 Participants |
| Group 3: Control 1 | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Neutrophils (1000*Cells/mm^3)-Day 273 | 0 Participants |
| Group 3: Control 1 | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Neutrophils (1000*Cells/mm^3)- Screening | 0 Participants |
| Group 3: Control 1 | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Lymphocytes (1000*Cells/mm^3)-Day 182 | 0 Participants |
| Group 3: Control 1 | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | AST (U/L)-Day 273 | 0 Participants |
| Group 3: Control 1 | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Lymphocytes (1000*Cells/mm^3)-Day 273 | 0 Participants |
| Group 3: Control 1 | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | ALT (SGPT) (U/L)-Day 182 | 0 Participants |
| Group 3: Control 1 | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Hemoglobin (g/dL)-Day 42 | 0 Participants |
| Group 3: Control 1 | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | creatine phosphokinase (U/L)-Day 175 | 0 Participants |
| Group 3: Control 1 | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Platelets (1000*Cells/mm^3)- Screening | 0 Participants |
| Group 3: Control 1 | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Creatinine (g/dL)-Day 182 | 0 Participants |
| Group 3: Control 1 | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Neutrophils (1000*Cells/mm^3)-Day 98 | 0 Participants |
| Group 3: Control 1 | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Creatinine (g/dL)-Day 98 | 0 Participants |
| Group 3: Control 1 | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Platelets (1000*Cells/mm^3)-Day 14 | 0 Participants |
| Group 3: Control 1 | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Alkaline Phosphatase (U/L)- Screening | 0 Participants |
| Group 3: Control 1 | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Hemoglobin (g/dL)-Day 14 | 0 Participants |
| Group 3: Control 1 | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | creatine phosphokinase (U/L)-Day 273 | 0 Participants |
| Group 3: Control 1 | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Platelets (1000*Cells/mm^3)-Day 42 | 0 Participants |
| Group 3: Control 1 | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | ALT (SGPT) (U/L)-Day 273 | 0 Participants |
| Group 3: Control 1 | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | creatine phosphokinase (U/L)-Day 42 | 0 Participants |
| Group 3: Control 1 | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Alkaline Phosphatase (U/L)-Day 14 | 0 Participants |
| Group 3: Control 1 | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Platelets (1000*Cells/mm^3)-Day 98 | 0 Participants |
| Group 3: Control 1 | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | ALT (SGPT) (U/L)-Day 42 | 0 Participants |
| Group 3: Control 1 | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Hemoglobin (g/dL)- Screening | 0 Participants |
| Group 3: Control 1 | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Creatinine (g/dL)-Day 175 | 0 Participants |
| Group 3: Control 1 | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Platelets (1000*Cells/mm^3)-Day 175 | 0 Participants |
| Group 3: Control 1 | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | ALT (SGPT) (U/L)- Screening | 0 Participants |
| Group 4: Control 2 | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Platelets (1000*Cells/mm^3)-Day 175 | 0 Participants |
| Group 4: Control 2 | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Creatinine (g/dL)-Day 175 | 0 Participants |
| Group 4: Control 2 | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Platelets (1000*Cells/mm^3)-Day 182 | 0 Participants |
| Group 4: Control 2 | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Platelets (1000*Cells/mm^3)-Day 273 | 0 Participants |
| Group 4: Control 2 | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Neutrophils (1000*Cells/mm^3)-Day 182 | 0 Participants |
| Group 4: Control 2 | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Creatinine (g/dL)-Day 182 | 0 Participants |
| Group 4: Control 2 | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | ALT (SGPT) (U/L)- Screening | 0 Participants |
| Group 4: Control 2 | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | AST (U/L)- Screening | 0 Participants |
| Group 4: Control 2 | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | ALT (SGPT) (U/L)-Day 14 | 0 Participants |
| Group 4: Control 2 | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | WBC (1000*Cells/mm^3)-Day 42 | 0 Participants |
| Group 4: Control 2 | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | ALT (SGPT) (U/L)-Day 42 | 0 Participants |
| Group 4: Control 2 | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Neutrophils (1000*Cells/mm^3)-Day 175 | 0 Participants |
| Group 4: Control 2 | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | ALT (SGPT) (U/L)-Day 98 | 0 Participants |
| Group 4: Control 2 | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Creatinine (g/dL)-Day 273 | 0 Participants |
| Group 4: Control 2 | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | ALT (SGPT) (U/L)-Day 175 | 0 Participants |
| Group 4: Control 2 | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Neutrophils (1000*Cells/mm^3)-Day 98 | 0 Participants |
| Group 4: Control 2 | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | ALT (SGPT) (U/L)-Day 182 | 0 Participants |
| Group 4: Control 2 | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | ALT (SGPT) (U/L)-Day 273 | 0 Participants |
| Group 4: Control 2 | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Neutrophils (1000*Cells/mm^3)-Day 42 | 0 Participants |
| Group 4: Control 2 | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | creatine phosphokinase (U/L)- Screening | 0 Participants |
| Group 4: Control 2 | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | AST (U/L)-Day 14 | 0 Participants |
| Group 4: Control 2 | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | AST (U/L)-Day 42 | 0 Participants |
| Group 4: Control 2 | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Neutrophils (1000*Cells/mm^3)-Day 14 | 0 Participants |
| Group 4: Control 2 | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | AST (U/L)-Day 98 | 0 Participants |
| Group 4: Control 2 | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | AST (U/L)-Day 175 | 0 Participants |
| Group 4: Control 2 | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Neutrophils (1000*Cells/mm^3)- Screening | 0 Participants |
| Group 4: Control 2 | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | creatine phosphokinase (U/L)-Day 14 | 0 Participants |
| Group 4: Control 2 | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | AST (U/L)-Day 182 | 0 Participants |
| Group 4: Control 2 | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Lymphocytes (1000*Cells/mm^3)-Day 14 | 0 Participants |
| Group 4: Control 2 | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | AST (U/L)-Day 273 | 0 Participants |
| Group 4: Control 2 | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | WBC (1000*Cells/mm^3)-Day 273 | 0 Participants |
| Group 4: Control 2 | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | creatine phosphokinase (U/L)-Day 182 | 0 Participants |
| Group 4: Control 2 | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Alkaline Phosphatase (U/L)- Screening | 0 Participants |
| Group 4: Control 2 | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | WBC (1000*Cells/mm^3)-Day 182 | 0 Participants |
| Group 4: Control 2 | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Alkaline Phosphatase (U/L)-Day 14 | 0 Participants |
| Group 4: Control 2 | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | WBC (1000*Cells/mm^3)-Day 175 | 0 Participants |
| Group 4: Control 2 | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | creatine phosphokinase (U/L)-Day 42 | 1 Participants |
| Group 4: Control 2 | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Alkaline Phosphatase (U/L)-Day 42 | 0 Participants |
| Group 4: Control 2 | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Alkaline Phosphatase (U/L)-Day 98 | 0 Participants |
| Group 4: Control 2 | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | WBC (1000*Cells/mm^3)-Day 98 | 0 Participants |
| Group 4: Control 2 | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Alkaline Phosphatase (U/L)-Day 175 | 0 Participants |
| Group 4: Control 2 | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Alkaline Phosphatase (U/L)-Day 182 | 0 Participants |
| Group 4: Control 2 | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | WBC (1000*Cells/mm^3)-Day 14 | 0 Participants |
| Group 4: Control 2 | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | creatine phosphokinase (U/L)-Day 98 | 0 Participants |
| Group 4: Control 2 | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Creatinine (g/dL)- Screening | 0 Participants |
| Group 4: Control 2 | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | WBC (1000*Cells/mm^3)- Screening | 0 Participants |
| Group 4: Control 2 | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Hemoglobin (g/dL)-Day 182 | 0 Participants |
| Group 4: Control 2 | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Hemoglobin (g/dL)-Day 273 | 0 Participants |
| Group 4: Control 2 | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Lymphocytes (1000*Cells/mm^3)- Screening | 0 Participants |
| Group 4: Control 2 | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Hemoglobin (g/dL)-Day 175 | 0 Participants |
| Group 4: Control 2 | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Creatinine (g/dL)-Day 14 | 0 Participants |
| Group 4: Control 2 | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Lymphocytes (1000*Cells/mm^3)-Day 42 | 0 Participants |
| Group 4: Control 2 | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | creatine phosphokinase (U/L)-Day 273 | 0 Participants |
| Group 4: Control 2 | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Lymphocytes (1000*Cells/mm^3)-Day 98 | 0 Participants |
| Group 4: Control 2 | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Hemoglobin (g/dL)-Day 98 | 0 Participants |
| Group 4: Control 2 | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Lymphocytes (1000*Cells/mm^3)-Day 175 | 0 Participants |
| Group 4: Control 2 | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Creatinine (g/dL)-Day 42 | 0 Participants |
| Group 4: Control 2 | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Lymphocytes (1000*Cells/mm^3)-Day 182 | 0 Participants |
| Group 4: Control 2 | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Hemoglobin (g/dL)-Day 42 | 0 Participants |
| Group 4: Control 2 | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Creatinine (g/dL)-Day 98 | 0 Participants |
| Group 4: Control 2 | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Lymphocytes (1000*Cells/mm^3)-Day 273 | 0 Participants |
| Group 4: Control 2 | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Platelets (1000*Cells/mm^3)- Screening | 0 Participants |
| Group 4: Control 2 | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Hemoglobin (g/dL)-Day 14 | 0 Participants |
| Group 4: Control 2 | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Platelets (1000*Cells/mm^3)-Day 14 | 0 Participants |
| Group 4: Control 2 | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Alkaline Phosphatase (U/L)-Day 273 | 0 Participants |
| Group 4: Control 2 | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Platelets (1000*Cells/mm^3)-Day 42 | 0 Participants |
| Group 4: Control 2 | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Hemoglobin (g/dL)- Screening | 0 Participants |
| Group 4: Control 2 | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | creatine phosphokinase (U/L)-Day 175 | 0 Participants |
| Group 4: Control 2 | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Platelets (1000*Cells/mm^3)-Day 98 | 0 Participants |
| Group 4: Control 2 | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | Neutrophils (1000*Cells/mm^3)-Day 273 | 0 Participants |
Primary
Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation
The number (percentage) of participants with early discontinuation of vaccinations and reason for discontinuation was summarized by arm
Time frame: Measured through Month 18
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1: Vaccine | Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation | Refused study product administration | 3 Participants |
| Group 1: Vaccine | Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation | Clinical event (not reacto, HIV, death) | 1 Participants |
| Group 1: Vaccine | Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation | Investigator decision | 1 Participants |
| Group 1: Vaccine | Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation | EP device difficulty | 0 Participants |
| Group 1: Vaccine | Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation | Participant Relocated | 0 Participants |
| Group 1: Vaccine | Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation | Did not discontinue SPA | 20 Participants |
| Group 2: Vaccine | Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation | Did not discontinue SPA | 21 Participants |
| Group 2: Vaccine | Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation | EP device difficulty | 1 Participants |
| Group 2: Vaccine | Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation | Refused study product administration | 1 Participants |
| Group 2: Vaccine | Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation | Investigator decision | 0 Participants |
| Group 2: Vaccine | Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation | Clinical event (not reacto, HIV, death) | 1 Participants |
| Group 2: Vaccine | Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation | Participant Relocated | 1 Participants |
| Group 3: Control 1 | Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation | Clinical event (not reacto, HIV, death) | 0 Participants |
| Group 3: Control 1 | Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation | Investigator decision | 0 Participants |
| Group 3: Control 1 | Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation | EP device difficulty | 0 Participants |
| Group 3: Control 1 | Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation | Did not discontinue SPA | 3 Participants |
| Group 3: Control 1 | Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation | Participant Relocated | 0 Participants |
| Group 3: Control 1 | Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation | Refused study product administration | 0 Participants |
| Group 4: Control 2 | Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation | Participant Relocated | 0 Participants |
| Group 4: Control 2 | Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation | Did not discontinue SPA | 2 Participants |
| Group 4: Control 2 | Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation | Clinical event (not reacto, HIV, death) | 0 Participants |
| Group 4: Control 2 | Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation | EP device difficulty | 0 Participants |
| Group 4: Control 2 | Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation | Refused study product administration | 1 Participants |
| Group 4: Control 2 | Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation | Investigator decision | 0 Participants |
Primary
Summary of T-Cell Epitope Mapping Breadth (Defined as the Number of Targeted CEs) Among All Participants by T-cell Subset (CD4+, CD8+), Visit, and Treatment Arm [Time Frame: Measured at M1.5 and M6.5]
For participants with a positive Fisher's Exact response to Gag CE Total and/or HBX2 p55Gag for either IFN-γ and/or IL2(CD4+ or CD8+) or for CD40L(CD4+)at month1.5and/or month 6.5, samples were further assayed against the seven individual CE peptide pools and the total number of positive responses was defined as the breadth.
Time frame: M1.5 and M6.5
Population: Immunogenicity Population. Group 3 and Group 4 are control groups. Control groups were excluded in this analysis because that no peptide responses were expected in control groups. This is pre-specified in Study Analysis Plan.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Group 1: Vaccine | Summary of T-Cell Epitope Mapping Breadth (Defined as the Number of Targeted CEs) Among All Participants by T-cell Subset (CD4+, CD8+), Visit, and Treatment Arm [Time Frame: Measured at M1.5 and M6.5] | IFNg+ - CD4+ - M1.5 | 0.261 Number of targeted CEs |
| Group 1: Vaccine | Summary of T-Cell Epitope Mapping Breadth (Defined as the Number of Targeted CEs) Among All Participants by T-cell Subset (CD4+, CD8+), Visit, and Treatment Arm [Time Frame: Measured at M1.5 and M6.5] | IFNg+ - CD8+ - M6.5 | 0.455 Number of targeted CEs |
| Group 1: Vaccine | Summary of T-Cell Epitope Mapping Breadth (Defined as the Number of Targeted CEs) Among All Participants by T-cell Subset (CD4+, CD8+), Visit, and Treatment Arm [Time Frame: Measured at M1.5 and M6.5] | IFNg+ - CD4+ - M6.5 | 0.682 Number of targeted CEs |
| Group 1: Vaccine | Summary of T-Cell Epitope Mapping Breadth (Defined as the Number of Targeted CEs) Among All Participants by T-cell Subset (CD4+, CD8+), Visit, and Treatment Arm [Time Frame: Measured at M1.5 and M6.5] | IFNg+ - Overall - M1.5 | 0.304 Number of targeted CEs |
| Group 1: Vaccine | Summary of T-Cell Epitope Mapping Breadth (Defined as the Number of Targeted CEs) Among All Participants by T-cell Subset (CD4+, CD8+), Visit, and Treatment Arm [Time Frame: Measured at M1.5 and M6.5] | IFNg+ - Overall - M6.5 | 1.136 Number of targeted CEs |
| Group 1: Vaccine | Summary of T-Cell Epitope Mapping Breadth (Defined as the Number of Targeted CEs) Among All Participants by T-cell Subset (CD4+, CD8+), Visit, and Treatment Arm [Time Frame: Measured at M1.5 and M6.5] | IFNg+ - CD8+ - M1.5 | 0.042 Number of targeted CEs |
| Group 2: Vaccine | Summary of T-Cell Epitope Mapping Breadth (Defined as the Number of Targeted CEs) Among All Participants by T-cell Subset (CD4+, CD8+), Visit, and Treatment Arm [Time Frame: Measured at M1.5 and M6.5] | IFNg+ - Overall - M6.5 | 0.522 Number of targeted CEs |
| Group 2: Vaccine | Summary of T-Cell Epitope Mapping Breadth (Defined as the Number of Targeted CEs) Among All Participants by T-cell Subset (CD4+, CD8+), Visit, and Treatment Arm [Time Frame: Measured at M1.5 and M6.5] | IFNg+ - CD4+ - M6.5 | 0.217 Number of targeted CEs |
| Group 2: Vaccine | Summary of T-Cell Epitope Mapping Breadth (Defined as the Number of Targeted CEs) Among All Participants by T-cell Subset (CD4+, CD8+), Visit, and Treatment Arm [Time Frame: Measured at M1.5 and M6.5] | IFNg+ - Overall - M1.5 | 0.583 Number of targeted CEs |
| Group 2: Vaccine | Summary of T-Cell Epitope Mapping Breadth (Defined as the Number of Targeted CEs) Among All Participants by T-cell Subset (CD4+, CD8+), Visit, and Treatment Arm [Time Frame: Measured at M1.5 and M6.5] | IFNg+ - CD8+ - M1.5 | 0.25 Number of targeted CEs |
| Group 2: Vaccine | Summary of T-Cell Epitope Mapping Breadth (Defined as the Number of Targeted CEs) Among All Participants by T-cell Subset (CD4+, CD8+), Visit, and Treatment Arm [Time Frame: Measured at M1.5 and M6.5] | IFNg+ - CD8+ - M6.5 | 0.304 Number of targeted CEs |
| Group 2: Vaccine | Summary of T-Cell Epitope Mapping Breadth (Defined as the Number of Targeted CEs) Among All Participants by T-cell Subset (CD4+, CD8+), Visit, and Treatment Arm [Time Frame: Measured at M1.5 and M6.5] | IFNg+ - CD4+ - M1.5 | 0.333 Number of targeted CEs |
Secondary
Binding Antibody IgG Responses Magnitudes by the HIV-1 Binding Antibody Multiplex Assay (BAMA) by Treatment Arm [Time Frame: M6.5]
The magnitude of IgG binding antibody responses were measured by the HIV-1 binding antibody multiplex assay (BAMA). Serum HIV-1-specific IgG antibody responses are measured at the 1:50 dilution against the p24gag antigen on all available samples .The a background-subtracted mean fluorescent intensity (MFI) at the 1:50 dilution were used to summarize the magnitudes at a given time-point. MFI will be used to determine the positivity of samples. Samples from post-enrollment visits are declared to have positive responses if they meet three conditions: (1) the MFI\* values are greater than the antigen-specific cutoff (based on the 95th percentile of the baseline visit serum samples and at least 100 MFI), (2) the MFI\* values are greater than 3 times the baseline (day 0) MFI\* values, and (3) the MFI values are greater than 3 times the baseline MFI values. The values in Groups 1 and 2 are correct as currently reported.
Time frame: M6.5
Population: Immunogenicity Population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Group 1: Vaccine | Binding Antibody IgG Responses Magnitudes by the HIV-1 Binding Antibody Multiplex Assay (BAMA) by Treatment Arm [Time Frame: M6.5] | 22000 adjusted Mean fluorescent intensity (MFI |
| Group 2: Vaccine | Binding Antibody IgG Responses Magnitudes by the HIV-1 Binding Antibody Multiplex Assay (BAMA) by Treatment Arm [Time Frame: M6.5] | 22000 adjusted Mean fluorescent intensity (MFI |
| Group 3: Control 1 | Binding Antibody IgG Responses Magnitudes by the HIV-1 Binding Antibody Multiplex Assay (BAMA) by Treatment Arm [Time Frame: M6.5] | 1042.1 adjusted Mean fluorescent intensity (MFI |
Secondary
Binding Antibody IgG Responses Rate by the HIV-1 Binding Antibody Multiplex Assay (BAMA) by Treatment Arm [Time Frame: M6.5]
The frequency of IgG binding antibody responses were measured by the HIV-1 binding antibody multiplex assay (BAMA).Samples from post-enrollment visits were declared to have positive responses if they met three conditions: (1) the MFI minus blank (MFI\*) values were ≥ antigen-specific cutoff at the 1:50 dilution level (based on the 95th percentile of baseline samples as calculated by SAS PROC UNIVARIATE default method, and at least 100 MFI minus blank), (2) the MFI minus blank values were greater than 3 times the baseline (day 0) MFI minus blank values, and (3) the MFI values were greater than 3 times the baseline MFI values.
Time frame: M6.5
Population: Immunogenicity Population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1: Vaccine | Binding Antibody IgG Responses Rate by the HIV-1 Binding Antibody Multiplex Assay (BAMA) by Treatment Arm [Time Frame: M6.5] | 20 Participants |
| Group 2: Vaccine | Binding Antibody IgG Responses Rate by the HIV-1 Binding Antibody Multiplex Assay (BAMA) by Treatment Arm [Time Frame: M6.5] | 16 Participants |
| Group 3: Control 1 | Binding Antibody IgG Responses Rate by the HIV-1 Binding Antibody Multiplex Assay (BAMA) by Treatment Arm [Time Frame: M6.5] | 0 Participants |
Secondary
CD4+ and CD8+ T Cell MIMOSA Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5]
Flow cytometry was used to examine HIV-1 specific CD4+ and CD8+ T-cell responses using a validated ICS assay. Athe Mixture Models for Single-cell Assays (MIMOSA) statistical framework was applied to detective the positivity response. If at least one peptide pool for a specific HIV-1 protein was positive, then the overall response to the protein was considered positive. If any peptide pool was positive for a T-cellubset, then the overall response for that T-cell subset was considered positive.
Time frame: M0, M1.5 and M6.5
Population: Immunogenicity Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1: Vaccine | CD4+ and CD8+ T Cell MIMOSA Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5] | CD40L+ - CD4+ - HBX2 p55 Gag - at Month 1.5 | 9 Participants |
| Group 1: Vaccine | CD4+ and CD8+ T Cell MIMOSA Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5] | CD40L+ - CD4+ - Gag CE Total - at Month 1.5 | 8 Participants |
| Group 1: Vaccine | CD4+ and CD8+ T Cell MIMOSA Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5] | CD40L+ - CD4+ - Gag CE Total - at Month 6.5 | 16 Participants |
| Group 1: Vaccine | CD4+ and CD8+ T Cell MIMOSA Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5] | CD40L+ - CD4+ - HBX2 p55 Gag - at Month 0 | 0 Participants |
| Group 1: Vaccine | CD4+ and CD8+ T Cell MIMOSA Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5] | CD40L+ - CD4+ - Gag CE Total - at Month 0 | 0 Participants |
| Group 1: Vaccine | CD4+ and CD8+ T Cell MIMOSA Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5] | CD40L+ - CD4+ - HBX2 p55 Gag - at Month 6.5 | 20 Participants |
| Group 1: Vaccine | CD4+ and CD8+ T Cell MIMOSA Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5] | IFNg/IL2 - CD4+ - Gag CE Total - at Month 0 | 0 Participants |
| Group 1: Vaccine | CD4+ and CD8+ T Cell MIMOSA Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5] | IFNg/IL2 - CD4+ - Gag CE Total - at Month 1.5 | 7 Participants |
| Group 1: Vaccine | CD4+ and CD8+ T Cell MIMOSA Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5] | IFNg/IL2 - CD4+ - Gag CE Total - at Month 6.5 | 14 Participants |
| Group 1: Vaccine | CD4+ and CD8+ T Cell MIMOSA Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5] | IFNg/IL2 - CD4+ - HBX2 p55 Gag - at Month 0 | 0 Participants |
| Group 1: Vaccine | CD4+ and CD8+ T Cell MIMOSA Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5] | IFNg/IL2 - CD4+ - HBX2 p55 Gag - at Month 1.5 | 8 Participants |
| Group 1: Vaccine | CD4+ and CD8+ T Cell MIMOSA Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5] | IFNg/IL2 - CD4+ - HBX2 p55 Gag - at Month 6.5 | 20 Participants |
| Group 1: Vaccine | CD4+ and CD8+ T Cell MIMOSA Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5] | IFNg/IL2 - CD8+ - Gag CE Total - at Month 0 | 0 Participants |
| Group 1: Vaccine | CD4+ and CD8+ T Cell MIMOSA Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5] | IFNg/IL2 - CD8+ - Gag CE Total - at Month 1.5 | 1 Participants |
| Group 1: Vaccine | CD4+ and CD8+ T Cell MIMOSA Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5] | IFNg/IL2 - CD8+ - Gag CE Total - at Month 6.5 | 9 Participants |
| Group 1: Vaccine | CD4+ and CD8+ T Cell MIMOSA Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5] | IFNg/IL2 - CD8+ - HBX2 p55 Gag - at Month 0 | 0 Participants |
| Group 1: Vaccine | CD4+ and CD8+ T Cell MIMOSA Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5] | IFNg/IL2 - CD8+ - HBX2 p55 Gag - at Month 1.5 | 1 Participants |
| Group 1: Vaccine | CD4+ and CD8+ T Cell MIMOSA Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5] | IFNg/IL2 - CD8+ - HBX2 p55 Gag - at Month 6.5 | 5 Participants |
| Group 2: Vaccine | CD4+ and CD8+ T Cell MIMOSA Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5] | IFNg/IL2 - CD8+ - HBX2 p55 Gag - at Month 6.5 | 18 Participants |
| Group 2: Vaccine | CD4+ and CD8+ T Cell MIMOSA Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5] | CD40L+ - CD4+ - Gag CE Total - at Month 0 | 0 Participants |
| Group 2: Vaccine | CD4+ and CD8+ T Cell MIMOSA Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5] | IFNg/IL2 - CD4+ - HBX2 p55 Gag - at Month 0 | 0 Participants |
| Group 2: Vaccine | CD4+ and CD8+ T Cell MIMOSA Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5] | IFNg/IL2 - CD8+ - Gag CE Total - at Month 0 | 0 Participants |
| Group 2: Vaccine | CD4+ and CD8+ T Cell MIMOSA Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5] | CD40L+ - CD4+ - Gag CE Total - at Month 1.5 | 8 Participants |
| Group 2: Vaccine | CD4+ and CD8+ T Cell MIMOSA Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5] | IFNg/IL2 - CD8+ - Gag CE Total - at Month 6.5 | 5 Participants |
| Group 2: Vaccine | CD4+ and CD8+ T Cell MIMOSA Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5] | IFNg/IL2 - CD8+ - HBX2 p55 Gag - at Month 0 | 0 Participants |
| Group 2: Vaccine | CD4+ and CD8+ T Cell MIMOSA Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5] | CD40L+ - CD4+ - Gag CE Total - at Month 6.5 | 11 Participants |
| Group 2: Vaccine | CD4+ and CD8+ T Cell MIMOSA Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5] | IFNg/IL2 - CD4+ - HBX2 p55 Gag - at Month 1.5 | 22 Participants |
| Group 2: Vaccine | CD4+ and CD8+ T Cell MIMOSA Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5] | IFNg/IL2 - CD8+ - HBX2 p55 Gag - at Month 1.5 | 10 Participants |
| Group 2: Vaccine | CD4+ and CD8+ T Cell MIMOSA Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5] | CD40L+ - CD4+ - HBX2 p55 Gag - at Month 0 | 0 Participants |
| Group 2: Vaccine | CD4+ and CD8+ T Cell MIMOSA Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5] | IFNg/IL2 - CD4+ - Gag CE Total - at Month 6.5 | 9 Participants |
| Group 2: Vaccine | CD4+ and CD8+ T Cell MIMOSA Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5] | IFNg/IL2 - CD8+ - Gag CE Total - at Month 1.5 | 5 Participants |
| Group 2: Vaccine | CD4+ and CD8+ T Cell MIMOSA Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5] | CD40L+ - CD4+ - HBX2 p55 Gag - at Month 1.5 | 22 Participants |
| Group 2: Vaccine | CD4+ and CD8+ T Cell MIMOSA Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5] | IFNg/IL2 - CD4+ - Gag CE Total - at Month 1.5 | 8 Participants |
| Group 2: Vaccine | CD4+ and CD8+ T Cell MIMOSA Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5] | IFNg/IL2 - CD4+ - HBX2 p55 Gag - at Month 6.5 | 19 Participants |
| Group 2: Vaccine | CD4+ and CD8+ T Cell MIMOSA Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5] | CD40L+ - CD4+ - HBX2 p55 Gag - at Month 6.5 | 22 Participants |
| Group 2: Vaccine | CD4+ and CD8+ T Cell MIMOSA Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5] | IFNg/IL2 - CD4+ - Gag CE Total - at Month 0 | 0 Participants |
| Group 3: Control 1 | CD4+ and CD8+ T Cell MIMOSA Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5] | CD40L+ - CD4+ - HBX2 p55 Gag - at Month 6.5 | 0 Participants |
| Group 3: Control 1 | CD4+ and CD8+ T Cell MIMOSA Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5] | IFNg/IL2 - CD4+ - Gag CE Total - at Month 0 | 0 Participants |
| Group 3: Control 1 | CD4+ and CD8+ T Cell MIMOSA Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5] | IFNg/IL2 - CD4+ - Gag CE Total - at Month 1.5 | 0 Participants |
| Group 3: Control 1 | CD4+ and CD8+ T Cell MIMOSA Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5] | IFNg/IL2 - CD8+ - Gag CE Total - at Month 6.5 | 0 Participants |
| Group 3: Control 1 | CD4+ and CD8+ T Cell MIMOSA Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5] | IFNg/IL2 - CD4+ - Gag CE Total - at Month 6.5 | 0 Participants |
| Group 3: Control 1 | CD4+ and CD8+ T Cell MIMOSA Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5] | IFNg/IL2 - CD8+ - HBX2 p55 Gag - at Month 6.5 | 0 Participants |
| Group 3: Control 1 | CD4+ and CD8+ T Cell MIMOSA Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5] | IFNg/IL2 - CD4+ - HBX2 p55 Gag - at Month 0 | 0 Participants |
| Group 3: Control 1 | CD4+ and CD8+ T Cell MIMOSA Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5] | IFNg/IL2 - CD4+ - HBX2 p55 Gag - at Month 1.5 | 0 Participants |
| Group 3: Control 1 | CD4+ and CD8+ T Cell MIMOSA Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5] | IFNg/IL2 - CD8+ - HBX2 p55 Gag - at Month 0 | 0 Participants |
| Group 3: Control 1 | CD4+ and CD8+ T Cell MIMOSA Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5] | IFNg/IL2 - CD4+ - HBX2 p55 Gag - at Month 6.5 | 0 Participants |
| Group 3: Control 1 | CD4+ and CD8+ T Cell MIMOSA Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5] | CD40L+ - CD4+ - Gag CE Total - at Month 0 | 0 Participants |
| Group 3: Control 1 | CD4+ and CD8+ T Cell MIMOSA Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5] | CD40L+ - CD4+ - Gag CE Total - at Month 1.5 | 0 Participants |
| Group 3: Control 1 | CD4+ and CD8+ T Cell MIMOSA Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5] | IFNg/IL2 - CD8+ - Gag CE Total - at Month 0 | 0 Participants |
| Group 3: Control 1 | CD4+ and CD8+ T Cell MIMOSA Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5] | CD40L+ - CD4+ - Gag CE Total - at Month 6.5 | 0 Participants |
| Group 3: Control 1 | CD4+ and CD8+ T Cell MIMOSA Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5] | CD40L+ - CD4+ - HBX2 p55 Gag - at Month 0 | 0 Participants |
| Group 3: Control 1 | CD4+ and CD8+ T Cell MIMOSA Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5] | CD40L+ - CD4+ - HBX2 p55 Gag - at Month 1.5 | 0 Participants |
| Group 3: Control 1 | CD4+ and CD8+ T Cell MIMOSA Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5] | IFNg/IL2 - CD8+ - Gag CE Total - at Month 1.5 | 0 Participants |
| Group 3: Control 1 | CD4+ and CD8+ T Cell MIMOSA Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5] | IFNg/IL2 - CD8+ - HBX2 p55 Gag - at Month 1.5 | 0 Participants |
Secondary
CD4+ and CD8+ T Cell Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5]
Flow cytometry was used to examine HIV-1 specific CD4+ and CD8+ T-cell responses using a validated ICS assay. A one sided Fisher's exact test was applied to detective the positivity response. If at least one peptide pool for a specific HIV-1 protein was positive, then the overall response to the protein was considered positive. If any peptide pool was positive for a T-cellubset, then the overall response for that T-cell subset was considered positive.
Time frame: M0, M1.5 and M6.5
Population: Immunogenicity Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1: Vaccine | CD4+ and CD8+ T Cell Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5] | IFNg/IL2 - CD8+ - Gag CE Total - at Month 0 | 0 Participants |
| Group 1: Vaccine | CD4+ and CD8+ T Cell Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5] | CD40L+ - CD4+ - Gag CE Total - at Month 6.5 | 15 Participants |
| Group 1: Vaccine | CD4+ and CD8+ T Cell Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5] | IFNg/IL2 - CD4+ - HBX2 p55 Gag - at Month 6.5 | 20 Participants |
| Group 1: Vaccine | CD4+ and CD8+ T Cell Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5] | CD40L+ - CD4+ - HBX2 p55 Gag - at Month 1.5 | 9 Participants |
| Group 1: Vaccine | CD4+ and CD8+ T Cell Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5] | IFNg/IL2 - CD8+ - HBX2 p55 Gag - at Month 1.5 | 1 Participants |
| Group 1: Vaccine | CD4+ and CD8+ T Cell Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5] | IFNg/IL2 - CD4+ - HBX2 p55 Gag - at Month 1.5 | 7 Participants |
| Group 1: Vaccine | CD4+ and CD8+ T Cell Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5] | IFNg/IL2 - CD4+ - Gag CE Total - at Month 0 | 0 Participants |
| Group 1: Vaccine | CD4+ and CD8+ T Cell Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5] | CD40L+ - CD4+ - HBX2 p55 Gag - at Month 6.5 | 20 Participants |
| Group 1: Vaccine | CD4+ and CD8+ T Cell Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5] | IFNg/IL2 - CD4+ - HBX2 p55 Gag - at Month 0 | 0 Participants |
| Group 1: Vaccine | CD4+ and CD8+ T Cell Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5] | IFNg/IL2 - CD8+ - HBX2 p55 Gag - at Month 6.5 | 5 Participants |
| Group 1: Vaccine | CD4+ and CD8+ T Cell Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5] | IFNg/IL2 - CD8+ - HBX2 p55 Gag - at Month 0 | 0 Participants |
| Group 1: Vaccine | CD4+ and CD8+ T Cell Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5] | IFNg/IL2 - CD4+ - Gag CE Total - at Month 1.5 | 7 Participants |
| Group 1: Vaccine | CD4+ and CD8+ T Cell Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5] | CD40L+ - CD4+ - Gag CE Total - at Month 1.5 | 8 Participants |
| Group 1: Vaccine | CD4+ and CD8+ T Cell Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5] | IFNg/IL2 - CD8+ - Gag CE Total - at Month 6.5 | 9 Participants |
| Group 1: Vaccine | CD4+ and CD8+ T Cell Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5] | IFNg/IL2 - CD4+ - Gag CE Total - at Month 6.5 | 14 Participants |
| Group 1: Vaccine | CD4+ and CD8+ T Cell Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5] | CD40L+ - CD4+ - Gag CE Total - at Month 0 | 0 Participants |
| Group 1: Vaccine | CD4+ and CD8+ T Cell Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5] | CD40L+ - CD4+ - HBX2 p55 Gag - at Month 0 | 0 Participants |
| Group 1: Vaccine | CD4+ and CD8+ T Cell Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5] | IFNg/IL2 - CD8+ - Gag CE Total - at Month 1.5 | 1 Participants |
| Group 2: Vaccine | CD4+ and CD8+ T Cell Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5] | IFNg/IL2 - CD4+ - Gag CE Total - at Month 1.5 | 8 Participants |
| Group 2: Vaccine | CD4+ and CD8+ T Cell Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5] | CD40L+ - CD4+ - Gag CE Total - at Month 1.5 | 7 Participants |
| Group 2: Vaccine | CD4+ and CD8+ T Cell Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5] | CD40L+ - CD4+ - Gag CE Total - at Month 6.5 | 9 Participants |
| Group 2: Vaccine | CD4+ and CD8+ T Cell Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5] | CD40L+ - CD4+ - HBX2 p55 Gag - at Month 0 | 0 Participants |
| Group 2: Vaccine | CD4+ and CD8+ T Cell Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5] | CD40L+ - CD4+ - HBX2 p55 Gag - at Month 1.5 | 22 Participants |
| Group 2: Vaccine | CD4+ and CD8+ T Cell Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5] | IFNg/IL2 - CD4+ - Gag CE Total - at Month 0 | 0 Participants |
| Group 2: Vaccine | CD4+ and CD8+ T Cell Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5] | CD40L+ - CD4+ - Gag CE Total - at Month 0 | 0 Participants |
| Group 2: Vaccine | CD4+ and CD8+ T Cell Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5] | CD40L+ - CD4+ - HBX2 p55 Gag - at Month 6.5 | 21 Participants |
| Group 2: Vaccine | CD4+ and CD8+ T Cell Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5] | IFNg/IL2 - CD4+ - Gag CE Total - at Month 6.5 | 8 Participants |
| Group 2: Vaccine | CD4+ and CD8+ T Cell Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5] | IFNg/IL2 - CD4+ - HBX2 p55 Gag - at Month 0 | 0 Participants |
| Group 2: Vaccine | CD4+ and CD8+ T Cell Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5] | IFNg/IL2 - CD4+ - HBX2 p55 Gag - at Month 1.5 | 22 Participants |
| Group 2: Vaccine | CD4+ and CD8+ T Cell Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5] | IFNg/IL2 - CD4+ - HBX2 p55 Gag - at Month 6.5 | 19 Participants |
| Group 2: Vaccine | CD4+ and CD8+ T Cell Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5] | IFNg/IL2 - CD8+ - Gag CE Total - at Month 0 | 0 Participants |
| Group 2: Vaccine | CD4+ and CD8+ T Cell Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5] | IFNg/IL2 - CD8+ - Gag CE Total - at Month 1.5 | 5 Participants |
| Group 2: Vaccine | CD4+ and CD8+ T Cell Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5] | IFNg/IL2 - CD8+ - Gag CE Total - at Month 6.5 | 5 Participants |
| Group 2: Vaccine | CD4+ and CD8+ T Cell Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5] | IFNg/IL2 - CD8+ - HBX2 p55 Gag - at Month 0 | 0 Participants |
| Group 2: Vaccine | CD4+ and CD8+ T Cell Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5] | IFNg/IL2 - CD8+ - HBX2 p55 Gag - at Month 1.5 | 9 Participants |
| Group 2: Vaccine | CD4+ and CD8+ T Cell Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5] | IFNg/IL2 - CD8+ - HBX2 p55 Gag - at Month 6.5 | 16 Participants |
| Group 3: Control 1 | CD4+ and CD8+ T Cell Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5] | CD40L+ - CD4+ - Gag CE Total - at Month 1.5 | 0 Participants |
| Group 3: Control 1 | CD4+ and CD8+ T Cell Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5] | CD40L+ - CD4+ - HBX2 p55 Gag - at Month 1.5 | 0 Participants |
| Group 3: Control 1 | CD4+ and CD8+ T Cell Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5] | IFNg/IL2 - CD8+ - Gag CE Total - at Month 0 | 0 Participants |
| Group 3: Control 1 | CD4+ and CD8+ T Cell Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5] | CD40L+ - CD4+ - Gag CE Total - at Month 0 | 0 Participants |
| Group 3: Control 1 | CD4+ and CD8+ T Cell Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5] | IFNg/IL2 - CD8+ - HBX2 p55 Gag - at Month 6.5 | 0 Participants |
| Group 3: Control 1 | CD4+ and CD8+ T Cell Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5] | IFNg/IL2 - CD8+ - Gag CE Total - at Month 1.5 | 0 Participants |
| Group 3: Control 1 | CD4+ and CD8+ T Cell Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5] | IFNg/IL2 - CD4+ - Gag CE Total - at Month 1.5 | 0 Participants |
| Group 3: Control 1 | CD4+ and CD8+ T Cell Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5] | IFNg/IL2 - CD8+ - HBX2 p55 Gag - at Month 1.5 | 0 Participants |
| Group 3: Control 1 | CD4+ and CD8+ T Cell Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5] | IFNg/IL2 - CD8+ - Gag CE Total - at Month 6.5 | 0 Participants |
| Group 3: Control 1 | CD4+ and CD8+ T Cell Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5] | IFNg/IL2 - CD4+ - Gag CE Total - at Month 6.5 | 0 Participants |
| Group 3: Control 1 | CD4+ and CD8+ T Cell Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5] | IFNg/IL2 - CD4+ - Gag CE Total - at Month 0 | 0 Participants |
| Group 3: Control 1 | CD4+ and CD8+ T Cell Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5] | IFNg/IL2 - CD4+ - HBX2 p55 Gag - at Month 0 | 0 Participants |
| Group 3: Control 1 | CD4+ and CD8+ T Cell Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5] | CD40L+ - CD4+ - HBX2 p55 Gag - at Month 6.5 | 0 Participants |
| Group 3: Control 1 | CD4+ and CD8+ T Cell Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5] | CD40L+ - CD4+ - HBX2 p55 Gag - at Month 0 | 0 Participants |
| Group 3: Control 1 | CD4+ and CD8+ T Cell Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5] | IFNg/IL2 - CD4+ - HBX2 p55 Gag - at Month 1.5 | 0 Participants |
| Group 3: Control 1 | CD4+ and CD8+ T Cell Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5] | CD40L+ - CD4+ - Gag CE Total - at Month 6.5 | 0 Participants |
| Group 3: Control 1 | CD4+ and CD8+ T Cell Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5] | IFNg/IL2 - CD8+ - HBX2 p55 Gag - at Month 0 | 0 Participants |
| Group 3: Control 1 | CD4+ and CD8+ T Cell Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5] | IFNg/IL2 - CD4+ - HBX2 p55 Gag - at Month 6.5 | 0 Participants |
Secondary
CD4+ and CD8+ T Cell Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M1.5 and M6.5]
Flow cytometry was used to examine HIV-1 specific CD4+ and CD8+ T-cell responses using a validated ICS assay. A one sided Fisher's exact test was applied to detective the positivity response. If at least one peptide pool for a specific HIV-1 protein was positive, then the overall response to the protein was considered positive. If any peptide pool was positive for a T-cellubset, then the overall response for that T-cell subset was considered positive.
Time frame: M0, M1.5 and M6.5
Population: Immunogenicity Population. Group 3 and Group 4 are control groups. Control groups were excluded in this analysis because that no peptide responses were expected in control groups. This is pre-specified in Study Analysis Plan.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1: Vaccine | CD4+ and CD8+ T Cell Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M1.5 and M6.5] | IFNg+ - CD4+ - Gag CE 4 - M1.5 | 0 Participants |
| Group 1: Vaccine | CD4+ and CD8+ T Cell Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M1.5 and M6.5] | IFNg+ - CD4+ - Gag p17 - M6.5 | 6 Participants |
| Group 1: Vaccine | CD4+ and CD8+ T Cell Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M1.5 and M6.5] | IFNg+ - CD4+ - Gag CE 1 - M6.5 | 1 Participants |
| Group 1: Vaccine | CD4+ and CD8+ T Cell Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M1.5 and M6.5] | IFNg+ - CD4+ - Gag p24 - M1.5 | 6 Participants |
| Group 1: Vaccine | CD4+ and CD8+ T Cell Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M1.5 and M6.5] | IFNg+ - CD4+ - Gag CE 4 - M6.5 | 0 Participants |
| Group 1: Vaccine | CD4+ and CD8+ T Cell Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M1.5 and M6.5] | IFNg+ - CD4+ - Gag p24 - M6.5 | 17 Participants |
| Group 1: Vaccine | CD4+ and CD8+ T Cell Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M1.5 and M6.5] | IFNg+ - CD8+ - Gag CE 6 - M6.5 | 2 Participants |
| Group 1: Vaccine | CD4+ and CD8+ T Cell Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M1.5 and M6.5] | IFNg+ - CD8+ - Gag CE 1 - M1.5 | 0 Participants |
| Group 1: Vaccine | CD4+ and CD8+ T Cell Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M1.5 and M6.5] | IFNg+ - CD4+ - Gag CE 5 - M1.5 | 3 Participants |
| Group 1: Vaccine | CD4+ and CD8+ T Cell Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M1.5 and M6.5] | IFNg+ - CD4+ - Gag CE 2 - M1.5 | 0 Participants |
| Group 1: Vaccine | CD4+ and CD8+ T Cell Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M1.5 and M6.5] | IFNg+ - CD8+ - Gag CE 2 - M1.5 | 0 Participants |
| Group 1: Vaccine | CD4+ and CD8+ T Cell Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M1.5 and M6.5] | IFNg+ - CD4+ - Gag CE 5 - M6.5 | 6 Participants |
| Group 1: Vaccine | CD4+ and CD8+ T Cell Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M1.5 and M6.5] | IFNg+ - CD8+ - Gag CE 2 - M6.5 | 1 Participants |
| Group 1: Vaccine | CD4+ and CD8+ T Cell Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M1.5 and M6.5] | IFNg+ - CD8+ - Gag CE 3 - M1.5 | 0 Participants |
| Group 1: Vaccine | CD4+ and CD8+ T Cell Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M1.5 and M6.5] | IFNg+ - CD4+ - Gag CE 6 - M1.5 | 2 Participants |
| Group 1: Vaccine | CD4+ and CD8+ T Cell Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M1.5 and M6.5] | IFNg+ - CD8+ - Gag CE 3 - M6.5 | 1 Participants |
| Group 1: Vaccine | CD4+ and CD8+ T Cell Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M1.5 and M6.5] | IFNg+ - CD8+ - Gag CE 4 - M1.5 | 1 Participants |
| Group 1: Vaccine | CD4+ and CD8+ T Cell Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M1.5 and M6.5] | IFNg+ - CD4+ - Gag CE 2 - M6.5 | 1 Participants |
| Group 1: Vaccine | CD4+ and CD8+ T Cell Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M1.5 and M6.5] | IFNg+ - CD8+ - Gag CE 4 - M6.5 | 3 Participants |
| Group 1: Vaccine | CD4+ and CD8+ T Cell Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M1.5 and M6.5] | IFNg+ - CD4+ - Gag CE 6 - M6.5 | 6 Participants |
| Group 1: Vaccine | CD4+ and CD8+ T Cell Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M1.5 and M6.5] | IFNg+ - CD8+ - Gag CE 5 - M1.5 | 0 Participants |
| Group 1: Vaccine | CD4+ and CD8+ T Cell Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M1.5 and M6.5] | IFNg+ - CD8+ - Gag p17 - M6.5 | 0 Participants |
| Group 1: Vaccine | CD4+ and CD8+ T Cell Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M1.5 and M6.5] | IFNg+ - CD4+ - Gag CE 7 - M1.5 | 0 Participants |
| Group 1: Vaccine | CD4+ and CD8+ T Cell Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M1.5 and M6.5] | IFNg+ - CD8+ - Gag CE 6 - M1.5 | 0 Participants |
| Group 1: Vaccine | CD4+ and CD8+ T Cell Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M1.5 and M6.5] | IFNg+ - CD4+ - Gag CE 3 - M1.5 | 1 Participants |
| Group 1: Vaccine | CD4+ and CD8+ T Cell Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M1.5 and M6.5] | IFNg+ - CD4+ - Gag CE 7 - M6.5 | 0 Participants |
| Group 1: Vaccine | CD4+ and CD8+ T Cell Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M1.5 and M6.5] | IFNg+ - CD8+ - Gag CE 7 - M1.5 | 0 Participants |
| Group 1: Vaccine | CD4+ and CD8+ T Cell Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M1.5 and M6.5] | IFNg+ - CD4+ - Gag CE 1 - M1.5 | 0 Participants |
| Group 1: Vaccine | CD4+ and CD8+ T Cell Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M1.5 and M6.5] | IFNg+ - CD8+ - Gag CE 7 - M6.5 | 0 Participants |
| Group 1: Vaccine | CD4+ and CD8+ T Cell Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M1.5 and M6.5] | IFNg+ - CD4+ - Gag p15 - M1.5 | 0 Participants |
| Group 1: Vaccine | CD4+ and CD8+ T Cell Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M1.5 and M6.5] | IFNg+ - CD8+ - Gag p15 - M1.5 | 0 Participants |
| Group 1: Vaccine | CD4+ and CD8+ T Cell Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M1.5 and M6.5] | IFNg+ - CD4+ - Gag CE 3 - M6.5 | 1 Participants |
| Group 1: Vaccine | CD4+ and CD8+ T Cell Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M1.5 and M6.5] | IFNg+ - CD8+ - Gag p15 - M6.5 | 0 Participants |
| Group 1: Vaccine | CD4+ and CD8+ T Cell Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M1.5 and M6.5] | IFNg+ - CD4+ - Gag p15 - M6.5 | 3 Participants |
| Group 1: Vaccine | CD4+ and CD8+ T Cell Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M1.5 and M6.5] | IFNg+ - CD8+ - Gag p17 - M1.5 | 0 Participants |
| Group 1: Vaccine | CD4+ and CD8+ T Cell Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M1.5 and M6.5] | IFNg+ - CD8+ - Gag CE 5 - M6.5 | 1 Participants |
| Group 1: Vaccine | CD4+ and CD8+ T Cell Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M1.5 and M6.5] | IFNg+ - CD8+ - Gag p24 - M1.5 | 1 Participants |
| Group 1: Vaccine | CD4+ and CD8+ T Cell Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M1.5 and M6.5] | IFNg+ - CD4+ - Gag p17 - M1.5 | 0 Participants |
| Group 1: Vaccine | CD4+ and CD8+ T Cell Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M1.5 and M6.5] | IFNg+ - CD8+ - Gag p24 - M6.5 | 7 Participants |
| Group 1: Vaccine | CD4+ and CD8+ T Cell Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M1.5 and M6.5] | IFNg+ - CD8+ - Gag CE 1 - M6.5 | 2 Participants |
| Group 2: Vaccine | CD4+ and CD8+ T Cell Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M1.5 and M6.5] | IFNg+ - CD8+ - Gag p24 - M6.5 | 7 Participants |
| Group 2: Vaccine | CD4+ and CD8+ T Cell Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M1.5 and M6.5] | IFNg+ - CD8+ - Gag CE 3 - M6.5 | 2 Participants |
| Group 2: Vaccine | CD4+ and CD8+ T Cell Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M1.5 and M6.5] | IFNg+ - CD8+ - Gag p17 - M1.5 | 2 Participants |
| Group 2: Vaccine | CD4+ and CD8+ T Cell Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M1.5 and M6.5] | IFNg+ - CD4+ - Gag CE 1 - M1.5 | 4 Participants |
| Group 2: Vaccine | CD4+ and CD8+ T Cell Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M1.5 and M6.5] | IFNg+ - CD4+ - Gag CE 1 - M6.5 | 2 Participants |
| Group 2: Vaccine | CD4+ and CD8+ T Cell Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M1.5 and M6.5] | IFNg+ - CD4+ - Gag CE 2 - M1.5 | 0 Participants |
| Group 2: Vaccine | CD4+ and CD8+ T Cell Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M1.5 and M6.5] | IFNg+ - CD4+ - Gag CE 2 - M6.5 | 0 Participants |
| Group 2: Vaccine | CD4+ and CD8+ T Cell Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M1.5 and M6.5] | IFNg+ - CD4+ - Gag CE 3 - M1.5 | 0 Participants |
| Group 2: Vaccine | CD4+ and CD8+ T Cell Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M1.5 and M6.5] | IFNg+ - CD4+ - Gag CE 3 - M6.5 | 0 Participants |
| Group 2: Vaccine | CD4+ and CD8+ T Cell Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M1.5 and M6.5] | IFNg+ - CD4+ - Gag CE 4 - M1.5 | 0 Participants |
| Group 2: Vaccine | CD4+ and CD8+ T Cell Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M1.5 and M6.5] | IFNg+ - CD4+ - Gag CE 4 - M6.5 | 0 Participants |
| Group 2: Vaccine | CD4+ and CD8+ T Cell Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M1.5 and M6.5] | IFNg+ - CD4+ - Gag CE 5 - M1.5 | 1 Participants |
| Group 2: Vaccine | CD4+ and CD8+ T Cell Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M1.5 and M6.5] | IFNg+ - CD4+ - Gag CE 5 - M6.5 | 0 Participants |
| Group 2: Vaccine | CD4+ and CD8+ T Cell Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M1.5 and M6.5] | IFNg+ - CD4+ - Gag CE 6 - M1.5 | 3 Participants |
| Group 2: Vaccine | CD4+ and CD8+ T Cell Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M1.5 and M6.5] | IFNg+ - CD4+ - Gag CE 6 - M6.5 | 3 Participants |
| Group 2: Vaccine | CD4+ and CD8+ T Cell Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M1.5 and M6.5] | IFNg+ - CD4+ - Gag CE 7 - M1.5 | 0 Participants |
| Group 2: Vaccine | CD4+ and CD8+ T Cell Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M1.5 and M6.5] | IFNg+ - CD4+ - Gag CE 7 - M6.5 | 0 Participants |
| Group 2: Vaccine | CD4+ and CD8+ T Cell Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M1.5 and M6.5] | IFNg+ - CD4+ - Gag p15 - M1.5 | 9 Participants |
| Group 2: Vaccine | CD4+ and CD8+ T Cell Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M1.5 and M6.5] | IFNg+ - CD4+ - Gag p15 - M6.5 | 9 Participants |
| Group 2: Vaccine | CD4+ and CD8+ T Cell Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M1.5 and M6.5] | IFNg+ - CD4+ - Gag p17 - M1.5 | 18 Participants |
| Group 2: Vaccine | CD4+ and CD8+ T Cell Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M1.5 and M6.5] | IFNg+ - CD4+ - Gag p17 - M6.5 | 14 Participants |
| Group 2: Vaccine | CD4+ and CD8+ T Cell Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M1.5 and M6.5] | IFNg+ - CD4+ - Gag p24 - M1.5 | 18 Participants |
| Group 2: Vaccine | CD4+ and CD8+ T Cell Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M1.5 and M6.5] | IFNg+ - CD4+ - Gag p24 - M6.5 | 14 Participants |
| Group 2: Vaccine | CD4+ and CD8+ T Cell Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M1.5 and M6.5] | IFNg+ - CD8+ - Gag CE 1 - M1.5 | 0 Participants |
| Group 2: Vaccine | CD4+ and CD8+ T Cell Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M1.5 and M6.5] | IFNg+ - CD8+ - Gag CE 1 - M6.5 | 0 Participants |
| Group 2: Vaccine | CD4+ and CD8+ T Cell Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M1.5 and M6.5] | IFNg+ - CD8+ - Gag CE 2 - M1.5 | 1 Participants |
| Group 2: Vaccine | CD4+ and CD8+ T Cell Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M1.5 and M6.5] | IFNg+ - CD8+ - Gag CE 2 - M6.5 | 0 Participants |
| Group 2: Vaccine | CD4+ and CD8+ T Cell Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M1.5 and M6.5] | IFNg+ - CD8+ - Gag CE 3 - M1.5 | 3 Participants |
| Group 2: Vaccine | CD4+ and CD8+ T Cell Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M1.5 and M6.5] | IFNg+ - CD8+ - Gag CE 4 - M1.5 | 2 Participants |
| Group 2: Vaccine | CD4+ and CD8+ T Cell Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M1.5 and M6.5] | IFNg+ - CD8+ - Gag CE 4 - M6.5 | 3 Participants |
| Group 2: Vaccine | CD4+ and CD8+ T Cell Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M1.5 and M6.5] | IFNg+ - CD8+ - Gag CE 5 - M1.5 | 1 Participants |
| Group 2: Vaccine | CD4+ and CD8+ T Cell Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M1.5 and M6.5] | IFNg+ - CD8+ - Gag CE 5 - M6.5 | 1 Participants |
| Group 2: Vaccine | CD4+ and CD8+ T Cell Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M1.5 and M6.5] | IFNg+ - CD8+ - Gag CE 6 - M1.5 | 1 Participants |
| Group 2: Vaccine | CD4+ and CD8+ T Cell Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M1.5 and M6.5] | IFNg+ - CD8+ - Gag CE 6 - M6.5 | 1 Participants |
| Group 2: Vaccine | CD4+ and CD8+ T Cell Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M1.5 and M6.5] | IFNg+ - CD8+ - Gag CE 7 - M1.5 | 0 Participants |
| Group 2: Vaccine | CD4+ and CD8+ T Cell Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M1.5 and M6.5] | IFNg+ - CD8+ - Gag CE 7 - M6.5 | 0 Participants |
| Group 2: Vaccine | CD4+ and CD8+ T Cell Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M1.5 and M6.5] | IFNg+ - CD8+ - Gag p15 - M1.5 | 3 Participants |
| Group 2: Vaccine | CD4+ and CD8+ T Cell Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M1.5 and M6.5] | IFNg+ - CD8+ - Gag p15 - M6.5 | 3 Participants |
| Group 2: Vaccine | CD4+ and CD8+ T Cell Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M1.5 and M6.5] | IFNg+ - CD8+ - Gag p17 - M6.5 | 3 Participants |
| Group 2: Vaccine | CD4+ and CD8+ T Cell Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M1.5 and M6.5] | IFNg+ - CD8+ - Gag p24 - M1.5 | 4 Participants |
Secondary
Summary of CD4+ and CD8+ T Cell Response Magnitudes Among All Participants by Cytokine, T-Cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5]
Flow cytometry was used to examine HIV-1 specific CD4+ and CD8+ T-cell responses using a validated ICS assay. Percentage of CD4+ T cells expressing CD40L+ was used as the magnititudes response for ICS assay.
Time frame: M0, M1.5 and M6.5
Population: Immunogenicity Population
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Group 1: Vaccine | Summary of CD4+ and CD8+ T Cell Response Magnitudes Among All Participants by Cytokine, T-Cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5] | CD40L+ - CD4+ - HBX2 p55 Gag - at Month 1.5 | 0 percentage |
| Group 1: Vaccine | Summary of CD4+ and CD8+ T Cell Response Magnitudes Among All Participants by Cytokine, T-Cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5] | CD40L+ - CD4+ - Gag CE Total - at Month 1.5 | 0 percentage |
| Group 1: Vaccine | Summary of CD4+ and CD8+ T Cell Response Magnitudes Among All Participants by Cytokine, T-Cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5] | CD40L+ - CD4+ - Gag CE Total - at Month 6.5 | 0.1 percentage |
| Group 1: Vaccine | Summary of CD4+ and CD8+ T Cell Response Magnitudes Among All Participants by Cytokine, T-Cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5] | CD40L+ - CD4+ - HBX2 p55 Gag - at Month 0 | 0 percentage |
| Group 1: Vaccine | Summary of CD4+ and CD8+ T Cell Response Magnitudes Among All Participants by Cytokine, T-Cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5] | CD40L+ - CD4+ - Gag CE Total - at Month 0 | 0 percentage |
| Group 1: Vaccine | Summary of CD4+ and CD8+ T Cell Response Magnitudes Among All Participants by Cytokine, T-Cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5] | CD40L+ - CD4+ - HBX2 p55 Gag - at Month 6.5 | 0.2 percentage |
| Group 1: Vaccine | Summary of CD4+ and CD8+ T Cell Response Magnitudes Among All Participants by Cytokine, T-Cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5] | IFNg/IL2 - CD4+ - Gag CE Total - at Month 0 | 0 percentage |
| Group 1: Vaccine | Summary of CD4+ and CD8+ T Cell Response Magnitudes Among All Participants by Cytokine, T-Cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5] | IFNg/IL2 - CD4+ - Gag CE Total - at Month 1.5 | 0 percentage |
| Group 1: Vaccine | Summary of CD4+ and CD8+ T Cell Response Magnitudes Among All Participants by Cytokine, T-Cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5] | IFNg/IL2 - CD4+ - Gag CE Total - at Month 6.5 | 0.1 percentage |
| Group 1: Vaccine | Summary of CD4+ and CD8+ T Cell Response Magnitudes Among All Participants by Cytokine, T-Cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5] | IFNg/IL2 - CD4+ - HBX2 p55 Gag - at Month 0 | 0 percentage |
| Group 1: Vaccine | Summary of CD4+ and CD8+ T Cell Response Magnitudes Among All Participants by Cytokine, T-Cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5] | IFNg/IL2 - CD4+ - HBX2 p55 Gag - at Month 1.5 | 0 percentage |
| Group 1: Vaccine | Summary of CD4+ and CD8+ T Cell Response Magnitudes Among All Participants by Cytokine, T-Cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5] | IFNg/IL2 - CD4+ - HBX2 p55 Gag - at Month 6.5 | 0.2 percentage |
| Group 1: Vaccine | Summary of CD4+ and CD8+ T Cell Response Magnitudes Among All Participants by Cytokine, T-Cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5] | IFNg/IL2 - CD8+ - Gag CE Total - at Month 0 | 0 percentage |
| Group 1: Vaccine | Summary of CD4+ and CD8+ T Cell Response Magnitudes Among All Participants by Cytokine, T-Cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5] | IFNg/IL2 - CD8+ - Gag CE Total - at Month 1.5 | 0 percentage |
| Group 1: Vaccine | Summary of CD4+ and CD8+ T Cell Response Magnitudes Among All Participants by Cytokine, T-Cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5] | IFNg/IL2 - CD8+ - Gag CE Total - at Month 6.5 | 0 percentage |
| Group 1: Vaccine | Summary of CD4+ and CD8+ T Cell Response Magnitudes Among All Participants by Cytokine, T-Cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5] | IFNg/IL2 - CD8+ - HBX2 p55 Gag - at Month 0 | 0 percentage |
| Group 1: Vaccine | Summary of CD4+ and CD8+ T Cell Response Magnitudes Among All Participants by Cytokine, T-Cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5] | IFNg/IL2 - CD8+ - HBX2 p55 Gag - at Month 1.5 | 0 percentage |
| Group 1: Vaccine | Summary of CD4+ and CD8+ T Cell Response Magnitudes Among All Participants by Cytokine, T-Cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5] | IFNg/IL2 - CD8+ - HBX2 p55 Gag - at Month 6.5 | 0 percentage |
| Group 2: Vaccine | Summary of CD4+ and CD8+ T Cell Response Magnitudes Among All Participants by Cytokine, T-Cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5] | IFNg/IL2 - CD8+ - HBX2 p55 Gag - at Month 6.5 | 0.1 percentage |
| Group 2: Vaccine | Summary of CD4+ and CD8+ T Cell Response Magnitudes Among All Participants by Cytokine, T-Cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5] | CD40L+ - CD4+ - Gag CE Total - at Month 0 | 0 percentage |
| Group 2: Vaccine | Summary of CD4+ and CD8+ T Cell Response Magnitudes Among All Participants by Cytokine, T-Cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5] | IFNg/IL2 - CD4+ - HBX2 p55 Gag - at Month 0 | 0 percentage |
| Group 2: Vaccine | Summary of CD4+ and CD8+ T Cell Response Magnitudes Among All Participants by Cytokine, T-Cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5] | IFNg/IL2 - CD8+ - Gag CE Total - at Month 0 | 0 percentage |
| Group 2: Vaccine | Summary of CD4+ and CD8+ T Cell Response Magnitudes Among All Participants by Cytokine, T-Cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5] | CD40L+ - CD4+ - Gag CE Total - at Month 1.5 | 0 percentage |
| Group 2: Vaccine | Summary of CD4+ and CD8+ T Cell Response Magnitudes Among All Participants by Cytokine, T-Cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5] | IFNg/IL2 - CD8+ - Gag CE Total - at Month 6.5 | 0 percentage |
| Group 2: Vaccine | Summary of CD4+ and CD8+ T Cell Response Magnitudes Among All Participants by Cytokine, T-Cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5] | IFNg/IL2 - CD8+ - HBX2 p55 Gag - at Month 0 | 0 percentage |
| Group 2: Vaccine | Summary of CD4+ and CD8+ T Cell Response Magnitudes Among All Participants by Cytokine, T-Cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5] | CD40L+ - CD4+ - Gag CE Total - at Month 6.5 | 0 percentage |
| Group 2: Vaccine | Summary of CD4+ and CD8+ T Cell Response Magnitudes Among All Participants by Cytokine, T-Cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5] | IFNg/IL2 - CD4+ - HBX2 p55 Gag - at Month 1.5 | 0.3 percentage |
| Group 2: Vaccine | Summary of CD4+ and CD8+ T Cell Response Magnitudes Among All Participants by Cytokine, T-Cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5] | IFNg/IL2 - CD8+ - HBX2 p55 Gag - at Month 1.5 | 0.1 percentage |
| Group 2: Vaccine | Summary of CD4+ and CD8+ T Cell Response Magnitudes Among All Participants by Cytokine, T-Cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5] | CD40L+ - CD4+ - HBX2 p55 Gag - at Month 0 | 0 percentage |
| Group 2: Vaccine | Summary of CD4+ and CD8+ T Cell Response Magnitudes Among All Participants by Cytokine, T-Cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5] | IFNg/IL2 - CD4+ - Gag CE Total - at Month 6.5 | 0 percentage |
| Group 2: Vaccine | Summary of CD4+ and CD8+ T Cell Response Magnitudes Among All Participants by Cytokine, T-Cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5] | IFNg/IL2 - CD8+ - Gag CE Total - at Month 1.5 | 0 percentage |
| Group 2: Vaccine | Summary of CD4+ and CD8+ T Cell Response Magnitudes Among All Participants by Cytokine, T-Cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5] | CD40L+ - CD4+ - HBX2 p55 Gag - at Month 1.5 | 0.3 percentage |
| Group 2: Vaccine | Summary of CD4+ and CD8+ T Cell Response Magnitudes Among All Participants by Cytokine, T-Cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5] | IFNg/IL2 - CD4+ - Gag CE Total - at Month 1.5 | 0 percentage |
| Group 2: Vaccine | Summary of CD4+ and CD8+ T Cell Response Magnitudes Among All Participants by Cytokine, T-Cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5] | IFNg/IL2 - CD4+ - HBX2 p55 Gag - at Month 6.5 | 0.3 percentage |
| Group 2: Vaccine | Summary of CD4+ and CD8+ T Cell Response Magnitudes Among All Participants by Cytokine, T-Cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5] | CD40L+ - CD4+ - HBX2 p55 Gag - at Month 6.5 | 0.3 percentage |
| Group 2: Vaccine | Summary of CD4+ and CD8+ T Cell Response Magnitudes Among All Participants by Cytokine, T-Cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5] | IFNg/IL2 - CD4+ - Gag CE Total - at Month 0 | 0 percentage |
| Group 3: Control 1 | Summary of CD4+ and CD8+ T Cell Response Magnitudes Among All Participants by Cytokine, T-Cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5] | CD40L+ - CD4+ - HBX2 p55 Gag - at Month 6.5 | 0 percentage |
| Group 3: Control 1 | Summary of CD4+ and CD8+ T Cell Response Magnitudes Among All Participants by Cytokine, T-Cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5] | IFNg/IL2 - CD4+ - Gag CE Total - at Month 0 | 0 percentage |
| Group 3: Control 1 | Summary of CD4+ and CD8+ T Cell Response Magnitudes Among All Participants by Cytokine, T-Cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5] | IFNg/IL2 - CD4+ - Gag CE Total - at Month 1.5 | 0 percentage |
| Group 3: Control 1 | Summary of CD4+ and CD8+ T Cell Response Magnitudes Among All Participants by Cytokine, T-Cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5] | IFNg/IL2 - CD8+ - Gag CE Total - at Month 6.5 | 0 percentage |
| Group 3: Control 1 | Summary of CD4+ and CD8+ T Cell Response Magnitudes Among All Participants by Cytokine, T-Cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5] | IFNg/IL2 - CD4+ - Gag CE Total - at Month 6.5 | 0 percentage |
| Group 3: Control 1 | Summary of CD4+ and CD8+ T Cell Response Magnitudes Among All Participants by Cytokine, T-Cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5] | IFNg/IL2 - CD8+ - HBX2 p55 Gag - at Month 6.5 | 0 percentage |
| Group 3: Control 1 | Summary of CD4+ and CD8+ T Cell Response Magnitudes Among All Participants by Cytokine, T-Cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5] | IFNg/IL2 - CD4+ - HBX2 p55 Gag - at Month 0 | 0 percentage |
| Group 3: Control 1 | Summary of CD4+ and CD8+ T Cell Response Magnitudes Among All Participants by Cytokine, T-Cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5] | IFNg/IL2 - CD4+ - HBX2 p55 Gag - at Month 1.5 | 0 percentage |
| Group 3: Control 1 | Summary of CD4+ and CD8+ T Cell Response Magnitudes Among All Participants by Cytokine, T-Cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5] | IFNg/IL2 - CD8+ - HBX2 p55 Gag - at Month 0 | 0 percentage |
| Group 3: Control 1 | Summary of CD4+ and CD8+ T Cell Response Magnitudes Among All Participants by Cytokine, T-Cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5] | IFNg/IL2 - CD4+ - HBX2 p55 Gag - at Month 6.5 | 0 percentage |
| Group 3: Control 1 | Summary of CD4+ and CD8+ T Cell Response Magnitudes Among All Participants by Cytokine, T-Cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5] | CD40L+ - CD4+ - Gag CE Total - at Month 0 | 0 percentage |
| Group 3: Control 1 | Summary of CD4+ and CD8+ T Cell Response Magnitudes Among All Participants by Cytokine, T-Cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5] | CD40L+ - CD4+ - Gag CE Total - at Month 1.5 | 0 percentage |
| Group 3: Control 1 | Summary of CD4+ and CD8+ T Cell Response Magnitudes Among All Participants by Cytokine, T-Cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5] | IFNg/IL2 - CD8+ - Gag CE Total - at Month 0 | 0 percentage |
| Group 3: Control 1 | Summary of CD4+ and CD8+ T Cell Response Magnitudes Among All Participants by Cytokine, T-Cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5] | CD40L+ - CD4+ - Gag CE Total - at Month 6.5 | 0 percentage |
| Group 3: Control 1 | Summary of CD4+ and CD8+ T Cell Response Magnitudes Among All Participants by Cytokine, T-Cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5] | CD40L+ - CD4+ - HBX2 p55 Gag - at Month 0 | 0 percentage |
| Group 3: Control 1 | Summary of CD4+ and CD8+ T Cell Response Magnitudes Among All Participants by Cytokine, T-Cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5] | CD40L+ - CD4+ - HBX2 p55 Gag - at Month 1.5 | 0 percentage |
| Group 3: Control 1 | Summary of CD4+ and CD8+ T Cell Response Magnitudes Among All Participants by Cytokine, T-Cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5] | IFNg/IL2 - CD8+ - Gag CE Total - at Month 1.5 | 0 percentage |
| Group 3: Control 1 | Summary of CD4+ and CD8+ T Cell Response Magnitudes Among All Participants by Cytokine, T-Cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5] | IFNg/IL2 - CD8+ - HBX2 p55 Gag - at Month 1.5 | 0 percentage |
Secondary
Summary of CD4+ and CD8+ T Cell Response Magnitudes to Epitope Mapping Gag Among All Participants by by Cytokine, T-Cell Subset (CD4+, CD8+), Antigenand Treatment Group [Time Frame: Measured at M1.5 and M6.5]
For participants with a positive Fisher's Exact response to Gag CE Total and/or HBX2 p55Gag for either IFN-γ and/or IL2(CD4+ or CD8+) or for CD40L(CD4+)at month1.5and/or month 6.5, samples were further assayed against the seven individual CE peptide pools. Percentage of CD8+ T cells expressing IFN-gamma was used as the magnitude response. The background-substracted magnitude was summarized by treatment group. The negative reading of magnitude is due to background substracted.
Time frame: M1.5 and M6.5
Population: Immunogenicity Population. Group 3 and Group 4 are control groups. Control groups were excluded in this analysis because that no peptide responses were expected in control groups. This is pre-specified in Study Analysis Plan.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Group 1: Vaccine | Summary of CD4+ and CD8+ T Cell Response Magnitudes to Epitope Mapping Gag Among All Participants by by Cytokine, T-Cell Subset (CD4+, CD8+), Antigenand Treatment Group [Time Frame: Measured at M1.5 and M6.5] | IFNg+ - CD4+ - Gag p17 - M1.5 | 0 percentage |
| Group 1: Vaccine | Summary of CD4+ and CD8+ T Cell Response Magnitudes to Epitope Mapping Gag Among All Participants by by Cytokine, T-Cell Subset (CD4+, CD8+), Antigenand Treatment Group [Time Frame: Measured at M1.5 and M6.5] | IFNg+ - CD8+ - Gag CE 2 - M6.5 | -0.003 percentage |
| Group 1: Vaccine | Summary of CD4+ and CD8+ T Cell Response Magnitudes to Epitope Mapping Gag Among All Participants by by Cytokine, T-Cell Subset (CD4+, CD8+), Antigenand Treatment Group [Time Frame: Measured at M1.5 and M6.5] | IFNg+ - CD4+ - Gag p24 - M1.5 | 0.055 percentage |
| Group 1: Vaccine | Summary of CD4+ and CD8+ T Cell Response Magnitudes to Epitope Mapping Gag Among All Participants by by Cytokine, T-Cell Subset (CD4+, CD8+), Antigenand Treatment Group [Time Frame: Measured at M1.5 and M6.5] | IFNg+ - CD4+ - Gag p24 - M6.5 | 0.08 percentage |
| Group 1: Vaccine | Summary of CD4+ and CD8+ T Cell Response Magnitudes to Epitope Mapping Gag Among All Participants by by Cytokine, T-Cell Subset (CD4+, CD8+), Antigenand Treatment Group [Time Frame: Measured at M1.5 and M6.5] | IFNg+ - CD4+ - Gag CE 4 - M1.5 | 0.001 percentage |
| Group 1: Vaccine | Summary of CD4+ and CD8+ T Cell Response Magnitudes to Epitope Mapping Gag Among All Participants by by Cytokine, T-Cell Subset (CD4+, CD8+), Antigenand Treatment Group [Time Frame: Measured at M1.5 and M6.5] | IFNg+ - CD8+ - Gag CE 1 - M1.5 | 0 percentage |
| Group 1: Vaccine | Summary of CD4+ and CD8+ T Cell Response Magnitudes to Epitope Mapping Gag Among All Participants by by Cytokine, T-Cell Subset (CD4+, CD8+), Antigenand Treatment Group [Time Frame: Measured at M1.5 and M6.5] | IFNg+ - CD8+ - Gag CE 4 - M1.5 | 0 percentage |
| Group 1: Vaccine | Summary of CD4+ and CD8+ T Cell Response Magnitudes to Epitope Mapping Gag Among All Participants by by Cytokine, T-Cell Subset (CD4+, CD8+), Antigenand Treatment Group [Time Frame: Measured at M1.5 and M6.5] | IFNg+ - CD8+ - Gag CE 1 - M6.5 | -0.002 percentage |
| Group 1: Vaccine | Summary of CD4+ and CD8+ T Cell Response Magnitudes to Epitope Mapping Gag Among All Participants by by Cytokine, T-Cell Subset (CD4+, CD8+), Antigenand Treatment Group [Time Frame: Measured at M1.5 and M6.5] | IFNg+ - CD4+ - Gag CE 4 - M6.5 | 0.002 percentage |
| Group 1: Vaccine | Summary of CD4+ and CD8+ T Cell Response Magnitudes to Epitope Mapping Gag Among All Participants by by Cytokine, T-Cell Subset (CD4+, CD8+), Antigenand Treatment Group [Time Frame: Measured at M1.5 and M6.5] | IFNg+ - CD8+ - Gag CE 2 - M1.5 | 0 percentage |
| Group 1: Vaccine | Summary of CD4+ and CD8+ T Cell Response Magnitudes to Epitope Mapping Gag Among All Participants by by Cytokine, T-Cell Subset (CD4+, CD8+), Antigenand Treatment Group [Time Frame: Measured at M1.5 and M6.5] | IFNg+ - CD4+ - Gag p15 - M1.5 | -0.002 percentage |
| Group 1: Vaccine | Summary of CD4+ and CD8+ T Cell Response Magnitudes to Epitope Mapping Gag Among All Participants by by Cytokine, T-Cell Subset (CD4+, CD8+), Antigenand Treatment Group [Time Frame: Measured at M1.5 and M6.5] | IFNg+ - CD4+ - Gag CE 5 - M1.5 | 0.034 percentage |
| Group 1: Vaccine | Summary of CD4+ and CD8+ T Cell Response Magnitudes to Epitope Mapping Gag Among All Participants by by Cytokine, T-Cell Subset (CD4+, CD8+), Antigenand Treatment Group [Time Frame: Measured at M1.5 and M6.5] | IFNg+ - CD8+ - Gag CE 3 - M1.5 | 0 percentage |
| Group 1: Vaccine | Summary of CD4+ and CD8+ T Cell Response Magnitudes to Epitope Mapping Gag Among All Participants by by Cytokine, T-Cell Subset (CD4+, CD8+), Antigenand Treatment Group [Time Frame: Measured at M1.5 and M6.5] | IFNg+ - CD8+ - Gag CE 5 - M1.5 | 0 percentage |
| Group 1: Vaccine | Summary of CD4+ and CD8+ T Cell Response Magnitudes to Epitope Mapping Gag Among All Participants by by Cytokine, T-Cell Subset (CD4+, CD8+), Antigenand Treatment Group [Time Frame: Measured at M1.5 and M6.5] | IFNg+ - CD8+ - Gag CE 3 - M6.5 | 0 percentage |
| Group 1: Vaccine | Summary of CD4+ and CD8+ T Cell Response Magnitudes to Epitope Mapping Gag Among All Participants by by Cytokine, T-Cell Subset (CD4+, CD8+), Antigenand Treatment Group [Time Frame: Measured at M1.5 and M6.5] | IFNg+ - CD4+ - Gag CE 5 - M6.5 | 0.022 percentage |
| Group 1: Vaccine | Summary of CD4+ and CD8+ T Cell Response Magnitudes to Epitope Mapping Gag Among All Participants by by Cytokine, T-Cell Subset (CD4+, CD8+), Antigenand Treatment Group [Time Frame: Measured at M1.5 and M6.5] | IFNg+ - CD4+ - Gag CE 2 - M1.5 | 0 percentage |
| Group 1: Vaccine | Summary of CD4+ and CD8+ T Cell Response Magnitudes to Epitope Mapping Gag Among All Participants by by Cytokine, T-Cell Subset (CD4+, CD8+), Antigenand Treatment Group [Time Frame: Measured at M1.5 and M6.5] | IFNg+ - CD8+ - Gag CE 4 - M6.5 | 0 percentage |
| Group 1: Vaccine | Summary of CD4+ and CD8+ T Cell Response Magnitudes to Epitope Mapping Gag Among All Participants by by Cytokine, T-Cell Subset (CD4+, CD8+), Antigenand Treatment Group [Time Frame: Measured at M1.5 and M6.5] | IFNg+ - CD4+ - Gag CE 6 - M1.5 | 0.008 percentage |
| Group 1: Vaccine | Summary of CD4+ and CD8+ T Cell Response Magnitudes to Epitope Mapping Gag Among All Participants by by Cytokine, T-Cell Subset (CD4+, CD8+), Antigenand Treatment Group [Time Frame: Measured at M1.5 and M6.5] | IFNg+ - CD8+ - Gag CE 5 - M6.5 | 0 percentage |
| Group 1: Vaccine | Summary of CD4+ and CD8+ T Cell Response Magnitudes to Epitope Mapping Gag Among All Participants by by Cytokine, T-Cell Subset (CD4+, CD8+), Antigenand Treatment Group [Time Frame: Measured at M1.5 and M6.5] | IFNg+ - CD4+ - Gag CE 1 - M1.5 | -0.003 percentage |
| Group 1: Vaccine | Summary of CD4+ and CD8+ T Cell Response Magnitudes to Epitope Mapping Gag Among All Participants by by Cytokine, T-Cell Subset (CD4+, CD8+), Antigenand Treatment Group [Time Frame: Measured at M1.5 and M6.5] | IFNg+ - CD8+ - Gag CE 6 - M1.5 | 0 percentage |
| Group 1: Vaccine | Summary of CD4+ and CD8+ T Cell Response Magnitudes to Epitope Mapping Gag Among All Participants by by Cytokine, T-Cell Subset (CD4+, CD8+), Antigenand Treatment Group [Time Frame: Measured at M1.5 and M6.5] | IFNg+ - CD4+ - Gag CE 6 - M6.5 | 0.02 percentage |
| Group 1: Vaccine | Summary of CD4+ and CD8+ T Cell Response Magnitudes to Epitope Mapping Gag Among All Participants by by Cytokine, T-Cell Subset (CD4+, CD8+), Antigenand Treatment Group [Time Frame: Measured at M1.5 and M6.5] | IFNg+ - CD8+ - Gag CE 6 - M6.5 | 0.001 percentage |
| Group 1: Vaccine | Summary of CD4+ and CD8+ T Cell Response Magnitudes to Epitope Mapping Gag Among All Participants by by Cytokine, T-Cell Subset (CD4+, CD8+), Antigenand Treatment Group [Time Frame: Measured at M1.5 and M6.5] | IFNg+ - CD4+ - Gag p17 - M6.5 | 0.03 percentage |
| Group 1: Vaccine | Summary of CD4+ and CD8+ T Cell Response Magnitudes to Epitope Mapping Gag Among All Participants by by Cytokine, T-Cell Subset (CD4+, CD8+), Antigenand Treatment Group [Time Frame: Measured at M1.5 and M6.5] | IFNg+ - CD8+ - Gag CE 7 - M1.5 | -0.002 percentage |
| Group 1: Vaccine | Summary of CD4+ and CD8+ T Cell Response Magnitudes to Epitope Mapping Gag Among All Participants by by Cytokine, T-Cell Subset (CD4+, CD8+), Antigenand Treatment Group [Time Frame: Measured at M1.5 and M6.5] | IFNg+ - CD4+ - Gag CE 7 - M1.5 | -0.001 percentage |
| Group 1: Vaccine | Summary of CD4+ and CD8+ T Cell Response Magnitudes to Epitope Mapping Gag Among All Participants by by Cytokine, T-Cell Subset (CD4+, CD8+), Antigenand Treatment Group [Time Frame: Measured at M1.5 and M6.5] | IFNg+ - CD8+ - Gag CE 7 - M6.5 | -0.003 percentage |
| Group 1: Vaccine | Summary of CD4+ and CD8+ T Cell Response Magnitudes to Epitope Mapping Gag Among All Participants by by Cytokine, T-Cell Subset (CD4+, CD8+), Antigenand Treatment Group [Time Frame: Measured at M1.5 and M6.5] | IFNg+ - CD4+ - Gag CE 1 - M6.5 | -0.002 percentage |
| Group 1: Vaccine | Summary of CD4+ and CD8+ T Cell Response Magnitudes to Epitope Mapping Gag Among All Participants by by Cytokine, T-Cell Subset (CD4+, CD8+), Antigenand Treatment Group [Time Frame: Measured at M1.5 and M6.5] | IFNg+ - CD8+ - Gag p15 - M1.5 | 0 percentage |
| Group 1: Vaccine | Summary of CD4+ and CD8+ T Cell Response Magnitudes to Epitope Mapping Gag Among All Participants by by Cytokine, T-Cell Subset (CD4+, CD8+), Antigenand Treatment Group [Time Frame: Measured at M1.5 and M6.5] | IFNg+ - CD4+ - Gag CE 7 - M6.5 | 0.001 percentage |
| Group 1: Vaccine | Summary of CD4+ and CD8+ T Cell Response Magnitudes to Epitope Mapping Gag Among All Participants by by Cytokine, T-Cell Subset (CD4+, CD8+), Antigenand Treatment Group [Time Frame: Measured at M1.5 and M6.5] | IFNg+ - CD8+ - Gag p15 - M6.5 | -0.001 percentage |
| Group 1: Vaccine | Summary of CD4+ and CD8+ T Cell Response Magnitudes to Epitope Mapping Gag Among All Participants by by Cytokine, T-Cell Subset (CD4+, CD8+), Antigenand Treatment Group [Time Frame: Measured at M1.5 and M6.5] | IFNg+ - CD4+ - Gag CE 2 - M6.5 | -0.001 percentage |
| Group 1: Vaccine | Summary of CD4+ and CD8+ T Cell Response Magnitudes to Epitope Mapping Gag Among All Participants by by Cytokine, T-Cell Subset (CD4+, CD8+), Antigenand Treatment Group [Time Frame: Measured at M1.5 and M6.5] | IFNg+ - CD8+ - Gag p17 - M1.5 | 0 percentage |
| Group 1: Vaccine | Summary of CD4+ and CD8+ T Cell Response Magnitudes to Epitope Mapping Gag Among All Participants by by Cytokine, T-Cell Subset (CD4+, CD8+), Antigenand Treatment Group [Time Frame: Measured at M1.5 and M6.5] | IFNg+ - CD4+ - Gag CE 3 - M1.5 | 0 percentage |
| Group 1: Vaccine | Summary of CD4+ and CD8+ T Cell Response Magnitudes to Epitope Mapping Gag Among All Participants by by Cytokine, T-Cell Subset (CD4+, CD8+), Antigenand Treatment Group [Time Frame: Measured at M1.5 and M6.5] | IFNg+ - CD8+ - Gag p17 - M6.5 | 0 percentage |
| Group 1: Vaccine | Summary of CD4+ and CD8+ T Cell Response Magnitudes to Epitope Mapping Gag Among All Participants by by Cytokine, T-Cell Subset (CD4+, CD8+), Antigenand Treatment Group [Time Frame: Measured at M1.5 and M6.5] | IFNg+ - CD8+ - Gag p24 - M1.5 | 0.007 percentage |
| Group 1: Vaccine | Summary of CD4+ and CD8+ T Cell Response Magnitudes to Epitope Mapping Gag Among All Participants by by Cytokine, T-Cell Subset (CD4+, CD8+), Antigenand Treatment Group [Time Frame: Measured at M1.5 and M6.5] | IFNg+ - CD4+ - Gag p15 - M6.5 | 0.013 percentage |
| Group 1: Vaccine | Summary of CD4+ and CD8+ T Cell Response Magnitudes to Epitope Mapping Gag Among All Participants by by Cytokine, T-Cell Subset (CD4+, CD8+), Antigenand Treatment Group [Time Frame: Measured at M1.5 and M6.5] | IFNg+ - CD8+ - Gag p24 - M6.5 | 0.005 percentage |
| Group 1: Vaccine | Summary of CD4+ and CD8+ T Cell Response Magnitudes to Epitope Mapping Gag Among All Participants by by Cytokine, T-Cell Subset (CD4+, CD8+), Antigenand Treatment Group [Time Frame: Measured at M1.5 and M6.5] | IFNg+ - CD4+ - Gag CE 3 - M6.5 | -0.001 percentage |
| Group 2: Vaccine | Summary of CD4+ and CD8+ T Cell Response Magnitudes to Epitope Mapping Gag Among All Participants by by Cytokine, T-Cell Subset (CD4+, CD8+), Antigenand Treatment Group [Time Frame: Measured at M1.5 and M6.5] | IFNg+ - CD8+ - Gag CE 2 - M1.5 | 0 percentage |
| Group 2: Vaccine | Summary of CD4+ and CD8+ T Cell Response Magnitudes to Epitope Mapping Gag Among All Participants by by Cytokine, T-Cell Subset (CD4+, CD8+), Antigenand Treatment Group [Time Frame: Measured at M1.5 and M6.5] | IFNg+ - CD4+ - Gag CE 2 - M6.5 | 0.002 percentage |
| Group 2: Vaccine | Summary of CD4+ and CD8+ T Cell Response Magnitudes to Epitope Mapping Gag Among All Participants by by Cytokine, T-Cell Subset (CD4+, CD8+), Antigenand Treatment Group [Time Frame: Measured at M1.5 and M6.5] | IFNg+ - CD4+ - Gag CE 3 - M1.5 | 0 percentage |
| Group 2: Vaccine | Summary of CD4+ and CD8+ T Cell Response Magnitudes to Epitope Mapping Gag Among All Participants by by Cytokine, T-Cell Subset (CD4+, CD8+), Antigenand Treatment Group [Time Frame: Measured at M1.5 and M6.5] | IFNg+ - CD4+ - Gag p17 - M1.5 | 0.07 percentage |
| Group 2: Vaccine | Summary of CD4+ and CD8+ T Cell Response Magnitudes to Epitope Mapping Gag Among All Participants by by Cytokine, T-Cell Subset (CD4+, CD8+), Antigenand Treatment Group [Time Frame: Measured at M1.5 and M6.5] | IFNg+ - CD4+ - Gag p24 - M1.5 | 0.054 percentage |
| Group 2: Vaccine | Summary of CD4+ and CD8+ T Cell Response Magnitudes to Epitope Mapping Gag Among All Participants by by Cytokine, T-Cell Subset (CD4+, CD8+), Antigenand Treatment Group [Time Frame: Measured at M1.5 and M6.5] | IFNg+ - CD8+ - Gag CE 4 - M6.5 | 0 percentage |
| Group 2: Vaccine | Summary of CD4+ and CD8+ T Cell Response Magnitudes to Epitope Mapping Gag Among All Participants by by Cytokine, T-Cell Subset (CD4+, CD8+), Antigenand Treatment Group [Time Frame: Measured at M1.5 and M6.5] | IFNg+ - CD8+ - Gag p17 - M6.5 | 0.007 percentage |
| Group 2: Vaccine | Summary of CD4+ and CD8+ T Cell Response Magnitudes to Epitope Mapping Gag Among All Participants by by Cytokine, T-Cell Subset (CD4+, CD8+), Antigenand Treatment Group [Time Frame: Measured at M1.5 and M6.5] | IFNg+ - CD4+ - Gag CE 1 - M1.5 | 0.002 percentage |
| Group 2: Vaccine | Summary of CD4+ and CD8+ T Cell Response Magnitudes to Epitope Mapping Gag Among All Participants by by Cytokine, T-Cell Subset (CD4+, CD8+), Antigenand Treatment Group [Time Frame: Measured at M1.5 and M6.5] | IFNg+ - CD4+ - Gag CE 2 - M1.5 | 0.001 percentage |
| Group 2: Vaccine | Summary of CD4+ and CD8+ T Cell Response Magnitudes to Epitope Mapping Gag Among All Participants by by Cytokine, T-Cell Subset (CD4+, CD8+), Antigenand Treatment Group [Time Frame: Measured at M1.5 and M6.5] | IFNg+ - CD4+ - Gag CE 3 - M6.5 | -0.001 percentage |
| Group 2: Vaccine | Summary of CD4+ and CD8+ T Cell Response Magnitudes to Epitope Mapping Gag Among All Participants by by Cytokine, T-Cell Subset (CD4+, CD8+), Antigenand Treatment Group [Time Frame: Measured at M1.5 and M6.5] | IFNg+ - CD4+ - Gag CE 4 - M1.5 | 0.002 percentage |
| Group 2: Vaccine | Summary of CD4+ and CD8+ T Cell Response Magnitudes to Epitope Mapping Gag Among All Participants by by Cytokine, T-Cell Subset (CD4+, CD8+), Antigenand Treatment Group [Time Frame: Measured at M1.5 and M6.5] | IFNg+ - CD4+ - Gag CE 4 - M6.5 | 0.001 percentage |
| Group 2: Vaccine | Summary of CD4+ and CD8+ T Cell Response Magnitudes to Epitope Mapping Gag Among All Participants by by Cytokine, T-Cell Subset (CD4+, CD8+), Antigenand Treatment Group [Time Frame: Measured at M1.5 and M6.5] | IFNg+ - CD4+ - Gag CE 5 - M1.5 | 0.005 percentage |
| Group 2: Vaccine | Summary of CD4+ and CD8+ T Cell Response Magnitudes to Epitope Mapping Gag Among All Participants by by Cytokine, T-Cell Subset (CD4+, CD8+), Antigenand Treatment Group [Time Frame: Measured at M1.5 and M6.5] | IFNg+ - CD4+ - Gag CE 5 - M6.5 | 0.002 percentage |
| Group 2: Vaccine | Summary of CD4+ and CD8+ T Cell Response Magnitudes to Epitope Mapping Gag Among All Participants by by Cytokine, T-Cell Subset (CD4+, CD8+), Antigenand Treatment Group [Time Frame: Measured at M1.5 and M6.5] | IFNg+ - CD4+ - Gag CE 6 - M1.5 | 0.012 percentage |
| Group 2: Vaccine | Summary of CD4+ and CD8+ T Cell Response Magnitudes to Epitope Mapping Gag Among All Participants by by Cytokine, T-Cell Subset (CD4+, CD8+), Antigenand Treatment Group [Time Frame: Measured at M1.5 and M6.5] | IFNg+ - CD4+ - Gag CE 6 - M6.5 | 0.004 percentage |
| Group 2: Vaccine | Summary of CD4+ and CD8+ T Cell Response Magnitudes to Epitope Mapping Gag Among All Participants by by Cytokine, T-Cell Subset (CD4+, CD8+), Antigenand Treatment Group [Time Frame: Measured at M1.5 and M6.5] | IFNg+ - CD4+ - Gag CE 7 - M1.5 | -0.001 percentage |
| Group 2: Vaccine | Summary of CD4+ and CD8+ T Cell Response Magnitudes to Epitope Mapping Gag Among All Participants by by Cytokine, T-Cell Subset (CD4+, CD8+), Antigenand Treatment Group [Time Frame: Measured at M1.5 and M6.5] | IFNg+ - CD4+ - Gag CE 7 - M6.5 | -0.003 percentage |
| Group 2: Vaccine | Summary of CD4+ and CD8+ T Cell Response Magnitudes to Epitope Mapping Gag Among All Participants by by Cytokine, T-Cell Subset (CD4+, CD8+), Antigenand Treatment Group [Time Frame: Measured at M1.5 and M6.5] | IFNg+ - CD4+ - Gag p15 - M1.5 | 0.028 percentage |
| Group 2: Vaccine | Summary of CD4+ and CD8+ T Cell Response Magnitudes to Epitope Mapping Gag Among All Participants by by Cytokine, T-Cell Subset (CD4+, CD8+), Antigenand Treatment Group [Time Frame: Measured at M1.5 and M6.5] | IFNg+ - CD4+ - Gag p15 - M6.5 | 0.026 percentage |
| Group 2: Vaccine | Summary of CD4+ and CD8+ T Cell Response Magnitudes to Epitope Mapping Gag Among All Participants by by Cytokine, T-Cell Subset (CD4+, CD8+), Antigenand Treatment Group [Time Frame: Measured at M1.5 and M6.5] | IFNg+ - CD4+ - Gag p17 - M6.5 | 0.066 percentage |
| Group 2: Vaccine | Summary of CD4+ and CD8+ T Cell Response Magnitudes to Epitope Mapping Gag Among All Participants by by Cytokine, T-Cell Subset (CD4+, CD8+), Antigenand Treatment Group [Time Frame: Measured at M1.5 and M6.5] | IFNg+ - CD4+ - Gag p24 - M6.5 | 0.053 percentage |
| Group 2: Vaccine | Summary of CD4+ and CD8+ T Cell Response Magnitudes to Epitope Mapping Gag Among All Participants by by Cytokine, T-Cell Subset (CD4+, CD8+), Antigenand Treatment Group [Time Frame: Measured at M1.5 and M6.5] | IFNg+ - CD8+ - Gag CE 1 - M1.5 | 0 percentage |
| Group 2: Vaccine | Summary of CD4+ and CD8+ T Cell Response Magnitudes to Epitope Mapping Gag Among All Participants by by Cytokine, T-Cell Subset (CD4+, CD8+), Antigenand Treatment Group [Time Frame: Measured at M1.5 and M6.5] | IFNg+ - CD8+ - Gag CE 1 - M6.5 | -0.001 percentage |
| Group 2: Vaccine | Summary of CD4+ and CD8+ T Cell Response Magnitudes to Epitope Mapping Gag Among All Participants by by Cytokine, T-Cell Subset (CD4+, CD8+), Antigenand Treatment Group [Time Frame: Measured at M1.5 and M6.5] | IFNg+ - CD4+ - Gag CE 1 - M6.5 | 0.003 percentage |
| Group 2: Vaccine | Summary of CD4+ and CD8+ T Cell Response Magnitudes to Epitope Mapping Gag Among All Participants by by Cytokine, T-Cell Subset (CD4+, CD8+), Antigenand Treatment Group [Time Frame: Measured at M1.5 and M6.5] | IFNg+ - CD8+ - Gag CE 2 - M6.5 | 0 percentage |
| Group 2: Vaccine | Summary of CD4+ and CD8+ T Cell Response Magnitudes to Epitope Mapping Gag Among All Participants by by Cytokine, T-Cell Subset (CD4+, CD8+), Antigenand Treatment Group [Time Frame: Measured at M1.5 and M6.5] | IFNg+ - CD8+ - Gag CE 3 - M1.5 | 0 percentage |
| Group 2: Vaccine | Summary of CD4+ and CD8+ T Cell Response Magnitudes to Epitope Mapping Gag Among All Participants by by Cytokine, T-Cell Subset (CD4+, CD8+), Antigenand Treatment Group [Time Frame: Measured at M1.5 and M6.5] | IFNg+ - CD8+ - Gag CE 3 - M6.5 | 0 percentage |
| Group 2: Vaccine | Summary of CD4+ and CD8+ T Cell Response Magnitudes to Epitope Mapping Gag Among All Participants by by Cytokine, T-Cell Subset (CD4+, CD8+), Antigenand Treatment Group [Time Frame: Measured at M1.5 and M6.5] | IFNg+ - CD8+ - Gag CE 4 - M1.5 | 0 percentage |
| Group 2: Vaccine | Summary of CD4+ and CD8+ T Cell Response Magnitudes to Epitope Mapping Gag Among All Participants by by Cytokine, T-Cell Subset (CD4+, CD8+), Antigenand Treatment Group [Time Frame: Measured at M1.5 and M6.5] | IFNg+ - CD8+ - Gag CE 5 - M1.5 | 0 percentage |
| Group 2: Vaccine | Summary of CD4+ and CD8+ T Cell Response Magnitudes to Epitope Mapping Gag Among All Participants by by Cytokine, T-Cell Subset (CD4+, CD8+), Antigenand Treatment Group [Time Frame: Measured at M1.5 and M6.5] | IFNg+ - CD8+ - Gag CE 5 - M6.5 | 0.002 percentage |
| Group 2: Vaccine | Summary of CD4+ and CD8+ T Cell Response Magnitudes to Epitope Mapping Gag Among All Participants by by Cytokine, T-Cell Subset (CD4+, CD8+), Antigenand Treatment Group [Time Frame: Measured at M1.5 and M6.5] | IFNg+ - CD8+ - Gag CE 6 - M1.5 | 0 percentage |
| Group 2: Vaccine | Summary of CD4+ and CD8+ T Cell Response Magnitudes to Epitope Mapping Gag Among All Participants by by Cytokine, T-Cell Subset (CD4+, CD8+), Antigenand Treatment Group [Time Frame: Measured at M1.5 and M6.5] | IFNg+ - CD8+ - Gag CE 6 - M6.5 | 0 percentage |
| Group 2: Vaccine | Summary of CD4+ and CD8+ T Cell Response Magnitudes to Epitope Mapping Gag Among All Participants by by Cytokine, T-Cell Subset (CD4+, CD8+), Antigenand Treatment Group [Time Frame: Measured at M1.5 and M6.5] | IFNg+ - CD8+ - Gag CE 7 - M1.5 | 0 percentage |
| Group 2: Vaccine | Summary of CD4+ and CD8+ T Cell Response Magnitudes to Epitope Mapping Gag Among All Participants by by Cytokine, T-Cell Subset (CD4+, CD8+), Antigenand Treatment Group [Time Frame: Measured at M1.5 and M6.5] | IFNg+ - CD8+ - Gag CE 7 - M6.5 | 0 percentage |
| Group 2: Vaccine | Summary of CD4+ and CD8+ T Cell Response Magnitudes to Epitope Mapping Gag Among All Participants by by Cytokine, T-Cell Subset (CD4+, CD8+), Antigenand Treatment Group [Time Frame: Measured at M1.5 and M6.5] | IFNg+ - CD8+ - Gag p15 - M1.5 | 0 percentage |
| Group 2: Vaccine | Summary of CD4+ and CD8+ T Cell Response Magnitudes to Epitope Mapping Gag Among All Participants by by Cytokine, T-Cell Subset (CD4+, CD8+), Antigenand Treatment Group [Time Frame: Measured at M1.5 and M6.5] | IFNg+ - CD8+ - Gag p15 - M6.5 | 0.002 percentage |
| Group 2: Vaccine | Summary of CD4+ and CD8+ T Cell Response Magnitudes to Epitope Mapping Gag Among All Participants by by Cytokine, T-Cell Subset (CD4+, CD8+), Antigenand Treatment Group [Time Frame: Measured at M1.5 and M6.5] | IFNg+ - CD8+ - Gag p17 - M1.5 | 0.007 percentage |
| Group 2: Vaccine | Summary of CD4+ and CD8+ T Cell Response Magnitudes to Epitope Mapping Gag Among All Participants by by Cytokine, T-Cell Subset (CD4+, CD8+), Antigenand Treatment Group [Time Frame: Measured at M1.5 and M6.5] | IFNg+ - CD8+ - Gag p24 - M1.5 | 0.01 percentage |
| Group 2: Vaccine | Summary of CD4+ and CD8+ T Cell Response Magnitudes to Epitope Mapping Gag Among All Participants by by Cytokine, T-Cell Subset (CD4+, CD8+), Antigenand Treatment Group [Time Frame: Measured at M1.5 and M6.5] | IFNg+ - CD8+ - Gag p24 - M6.5 | 0.016 percentage |