Last updated on February 2018

Pivotal Phase 2b/3 ALVAC/Bivalent gp120/MF59 HIV Vaccine Prevention Safety and Efficacy Study in South Africa


Brief description of study

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.

Detailed Study Description

This study will evaluate the preventive vaccine efficacy, safety, and tolerability of the ALVAC-HIV vaccine + Bivalent Subtype C gp120 protein adjuvanted with MF59 in HIV-seronegative South African adults over 24 months from enrollment.

Participants will be randomized to receive ALVAC-HIV (vCP2438), or placebo, by intramuscular injection at weeks 0 and 4; they will receive ALVAC-HIV (vCP2438) + Bivalent Subtype C gp120/MF59, or placebo, by IM injection at weeks 12, 24, and 52.

In addition to the vaccination visits, participants will attend study visits at weeks 26, 39, 54, 65, 78, 91, 104, 117, 130, 142, and 156. All study visits, including vaccination visits, will include HIV risk reduction counseling, a physical exam, and an interview/questionnaire. and pregnancy testing for participants capable of becoming pregnant. Select study visits will include a medical history review, physical exam, blood collection, urine collection, HIV testing, and pregnancy testing for participants capable of becoming pregnant.

Clinical Study Identifier: NCT02968849

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Emavundleni CRS

Cape Town, South Africa
8.32miles
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Recruitment Status: Open


Brief Description Eligibility Contact Research Team


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