Trials / Completed
CompletedNCT00849680
A Study of Safety, Tolerability, and Immunogenicity of the MRKAd5 Gag/Pol/Nef Vaccine in Healthy Adults (V520-016)
A Phase I Dose-Ranging Study of the Safety, Tolerability, and Immunogenicity of the Merck Trivalent Adenovirus Serotype 5 HIV-1 Gag/Pol/Nef Vaccine (MRKAd5 HIV-1 Gag/Pol/Nef) in a Prime-Boost Regimen in Healthy Adults
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 317 (actual)
- Sponsor
- Merck Sharp & Dohme LLC · Industry
- Sex
- All
- Age
- 18 Years – 45 Years
- Healthy volunteers
- Accepted
Summary
The goal of this study is to understand the safety, tolerability and immunogenicity of the Merck Trivalent Adenovirus Serotype 5 HIV-1 gag/pol/nef Vaccine (MRKAd 5 HIV-1 gag/pol/nef) vaccine in healthy human volunteers compared to placebo. The study will also evaluate a number of dose levels and the necessity for and timing of booster injections.
Detailed description
The study will proceed in four stages. Following stages I, II and III, all subjects will have the Postdose 1 (PD1) clinical and laboratory safety data reviewed by the Safety Evaluation Committee (SEC). If these data are acceptable, the next stage will be initiated. * In Stage I, participants will be randomized to receive 3 doses of the 3x10\^9vp/dose level Trivalent vaccine or placebo. * In Stage II, participants will be randomized to receive 2 or 3 doses of the 3x10\^10vp/dose level Trivalent vaccine or placebo. * In Stage III, participants will be randomized to receive 3 doses of the Trivalent vaccine with titers of 1x10\^11vp/dose, 3x10\^6vp/dose, 3x10\^7vp/dose, or 3x10\^8vp/dose or placebo. * In Stage IV, participants will be randomized to all treatment groups. In addition, some participants will be randomized to an MRKAd 5 HIV-1 gag Monovalent vaccine. In this stage, participants will be pre-stratified by baseline Ad5 titers (=\<200, and \>200), to ensure an even distribution of participants with high and low Ad5 titers across the various treatment groups.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Comparator: Placebo to the MRKAd5 HIV-1 gag/pol/nef vaccine | Placebo to the MRKAd5 HIV-1 gag/pol/nef vaccine. |
| BIOLOGICAL | Monovalent MRKAd5 HIV-1 gag vaccine (1x10^9 vp/dose) | Monovalent MRKAd5 HIV-1 gag vaccine (1x10\^9 vp/dose) |
| BIOLOGICAL | Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^6 vp/dose) | Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10\^6 vp/dose) |
| BIOLOGICAL | Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^7 vp/dose) | Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10\^7 vp/dose) |
| BIOLOGICAL | Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^8 vp/dose) | Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10\^8 vp/dose) |
| BIOLOGICAL | Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^9 vp/dose) | Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10\^9 vp/dose) |
| BIOLOGICAL | Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^10 vp/dose) | Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10\^10 vp/dose) |
| BIOLOGICAL | Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (1x10^11 vp/dose) | Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (1x10\^11 vp/dose) |
| BIOLOGICAL | Comparator: Placebo to MRKAd5 HIV-1 gag vaccine | Placebo to the MRKAd5 HIV-1 gag vaccine. |
Timeline
- Start date
- 2003-04-01
- Primary completion
- 2005-03-01
- Completion
- 2010-02-01
- First posted
- 2009-02-24
- Last updated
- 2015-02-02
- Results posted
- 2011-07-07
Source: ClinicalTrials.gov record NCT00849680. Inclusion in this directory is not an endorsement.