A phase 1/2a clinical trial to evaluate the safety and immunogenicity of ALVAC-HIV (vCP2438) and of MF59®- or AS01B-adjuvanted clade C Env protein, in healthy, HIV-uninfected adult participants
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Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regimen
Timeframe: Measured through 7 days after participants' last vaccination at Month 0,1,3, and 6
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen
Timeframe: Measured through 7 days after each vaccination at Month 0, 1, 3, and 6
Frequency of Adverse Events by Relationship to the Study Product
Timeframe: Measured through 30 days after each vaccination at Month 0, 1, 3 and 6.
Frequency of SAEs, AESIs, and New Chronic Conditions
Timeframe: Measured through Month 18.
Alkaline Phosphatase, AST, ALT in U/L
Timeframe: Measured at Month 0 (Screening) ,0.5(Day 14), 1.5 (Day 42) , 3.5 (Day 98) and 6.5 (Day 182)
Hemoglobin, Creatinine in g/dL
Timeframe: Measured at Month 0 (Screening) ,0.5(Day 14), 1.5 (Day 42) , 3.5 (Day 98) and 6.5 (Day 182)
WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm
Timeframe: Measured at Month 0 (Screening) ,0.5(Day 14), 1.5 (Day 42) , 3.5 (Day 98) and 6.5 (Day 182)
AEs or Reactro Leading to Early Participant Withdrawal or Early Discontinuation of Study Products Administration Throughout the Study.
Timeframe: Measured through month 12
Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine, After the Primary Vaccine Regimen. Measured by Flow Cytometry.
Timeframe: Measured at Month 6.5
Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine, After the Primary Vaccine Regimen. Measured by Flow Cytometry.
Timeframe: Measured at Month 6.5
Number of Participants With HIV-specific Total IgG Binding Antibody (Vaccine gp120 Panel) Response Magnitude as Assessed by Binding Antibody Multiplex Assay [Time Frame: Measured at Month 12.]
Timeframe: Measured at Month 12
Level of the HIV-specific Total IgG Binding Antibody (Vaccine gp120 Panel) Response Magnitude as Assessed by Binding Antibody Multiplex Assay [Time Frame: Measured at Month 12.]
Timeframe: Measured at Month 12