HIV Infections Clinical Trial
Official title:
A Phase 1 Clinical Trial to Evaluate the Immunogenicity of AIDSVAX B/E Bivalent gp120 Vaccine and MVA/HIV62B in Healthy, HIV-1-Uninfected Adult Participants Who Previously Received MVA/HIV62B in DNA/MVA or MVA/MVA Regimens in HVTN 205
The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of the AIDSVAX B/E vaccine and the MVA/HIV62B vaccine in healthy, HIV-1-uninfected adults who previously received MVA/HIV62B in DNA/MVA or MVA/MVA vaccine regimens in the HVTN 205 study.
This study will evaluate the safety, tolerability, and immunogenicity of the AIDSVAX B/E vaccine and the MVA/HIV62B vaccine in healthy, HIV-1-uninfected adults who previously received MVA/HIV62B in DNA/MVA or MVA/MVA vaccine regimens as part of the HVTN 205 study. Participants in this study will be assigned to one of five groups based on their previous vaccine regimen received in HVTN 205. Depending on their group, participants will receive the MVA/HIV62B vaccine, the AIDSVAX B/E vaccine, or both the MVA/HIV62B vaccine and the AIDSVAX B/E vaccine. All participants will receive their assigned vaccines at study entry (Day 0) and Month 4. Participants will attend several study visits through Month 10. Visits will include physical examinations, blood collection, HIV testing and risk reduction counseling, and interviews and questionnaires. Optional procedures at some visits include collection of rectal fluids, cervical fluids, and semen. Study staff will contact participants 2 years following the initial study injection for follow-up health monitoring. ;
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