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A Phase I Trial to Evaluate the Safety and Immunogenicity of rMVA-HIV (rMVA-HIV Env/Gag + rMVA-HIV Tat/Rev/Nef-RT) and rFPV-HIV (rFPV-HIV Env/Gag + rFPV-HIV Tat/Rev/Nef-RT) Vaccines, Alone or in Combination, in Healthy, Vaccinia Naive HIV-1 Negative Participants
The purpose of this study is to evaluate the safety of and immune response to two HIV vaccine formulations, rMVA-HIV and rFPV-HIV, alone and in combination, in HIV uninfected adults.
Details
| Lead sponsor | National Institute of Allergy and Infectious Diseases (NIAID) |
|---|---|
| Phase | Phase 1 |
| Status | COMPLETED |
| Enrolment | 150 |
| Start date | 2004-09 |
| Completion | 2007-08 |
Conditions
- HIV Infections
Interventions
- rMVA-HIV (rMVA-HIV env/gag + rMVA-HIV tat/rev/nef-RT)
- rFPV-HIV (rFPV-HIV env/gag + rFPV-HIV tat/rev/nef-RT)
- Empty TBC-FPV
- rMVA-HIV (rMVA-HIV env/gag + rMVA-HIV tat/rev/nef-RT)
- rMVA-HIV (rMVA-HIV env/gag + rMVA-HIV tat/rev/nef-RT)
- TBC-MVA and TBC-FPV
- TBC-MVA and TBC-FPV
- TBC-MVA and TBC-FPV
Primary outcomes
- Safety and tolerability, as judged by local and systemic reactogenicity signs and symptoms, laboratory measures, and adverse events — After each injection and 12 months after the first injection
- Immunogenicity, as judged by qualitative HIV-1-specific T-cell responses — At Days 98 and 210
Countries
United States, Brazil