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A Phase 1 Randomized, Double-Blind, Placebo Controlled Clinical Trial to Evaluate the Safety, Mucosal Immunogenicity and Innate Immune Responses of Recombinant Adenovirus Serotype 26 HIV-1 Vaccine (Ad26.ENVA.01) in Healthy, HIV-1 Uninfected Adults (Ad26.ENVA.01 (rAd26) HIV-1 Mucosal/IPCAVD-003 Vaccine Study)
The purpose of this study is to evaluate the safety and immune response of an adenovirus-based HIV vaccine in HIV-uninfected adults.
Details
| Lead sponsor | National Institute of Allergy and Infectious Diseases (NIAID) |
|---|---|
| Phase | Phase 1 |
| Status | COMPLETED |
| Enrolment | 24 |
| Start date | 2010-07 |
| Completion | 2016-05 |
Conditions
- HIV Infections
Interventions
- Ad26.ENVA.01 (rAd26)
- Placebo Vaccine
Primary outcomes
- Local and systemic reactions to vaccine — Measured through the 18-month follow-up visit
- Adverse and serious adverse experiences — Measured through the 18-month follow-up visit
Countries
United States