This study will evaluate the preventive vaccine efficacy, safety, and tolerability of ALVAC-HIV (vCP2438) + Bivalent Subtype C gp120/MF59 in HIV-seronegative South African adults over 24 months and potentially up to 36 months from enrollment.
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Incidence Rate of HIV-1 Infection Diagnosed After Enrollment (Concurrent With First Vaccination) Through 24 Months After Enrollment
Timeframe: Measured through 24 months after first vaccination
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness
Timeframe: Measured through 3 full days following each vaccination
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Timeframe: Measured through 3 full days following each vaccination
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Timeframe: Measured through 3 full days following each vaccination
Number of Participants Reporting Adverse Events (AEs), by Relationship to Study Product
Timeframe: Measured through 30 days after each vaccination
Number of Participants Reporting Adverse Events (AEs), by Severity Grade
Timeframe: Measured through 30 days after each vaccination
Number of Participants Reporting Serious Adverse Events (SAEs)
Timeframe: Measured through 12 months after last vaccination
Number of Participants Reporting Adverse Events of Special Interest (AESIs)
Timeframe: Measured through 12 months after last vaccination
Number of Participants Reporting New Chronic Medical Conditions
Timeframe: Measured through 12 months after last vaccination
Number of Participants With Early Study Termination Associated With an AE or Reactogenicity
Timeframe: Measured through study completion (through 6 months after confirmation of HIV-1 diagnosis for participants who acquired HIV and through 12 months after last vaccination for the rest)
Number of Participants With Study Product Discontinuation Associated With an AE or Reactogenicity
Timeframe: Measured through study completion (through 6 months after confirmation of HIV-1 diagnosis for participants who acquired HIV and through 12 months after last vaccination for the rest)
Incidence Rate of HIV-1 Infections Diagnosed Following Enrollment and Throughout All Participant Follow-Up
Timeframe: Measured through 36 months after first vaccination