NCT00849732

A Worldwide, Phase I, Dose-Escalating Study of a 3-Dose Regimen of the MRKAd5 (Clade B) Vaccine in Healthy Adults (V520-018)

A Worldwide, Phase I, Dose-Escalating Study of Safety, Tolerability, and Immunogenicity of a 3-Dose Regimen of the MRKAd5 HIV-1 Gag Vaccine in Healthy Adults

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 360 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

This three stage study will evaluate the safety and tolerability of MRKAd5 HIV-1 Gag Vaccine. In Stage I subjects will be randomized to receive the vaccine at 1x10\^9 viral particles/dose (vp/d) or placebo. In Stage II subjects will be randomized to receive the vaccine at 1x10\^10 vp/d or placebo. In Stage III subjects will be randomized to receive the vaccine at 1x10\^9 vp/d, at 1x10\^10 vp/d, or placebo. Immunogenicity of the single dose regimen of MRKAd5 HIV-1 Gag Vaccine will also be measured.

Conditions

• HIV-1
• HIV Infections

Interventions

Type	Name	Description
BIOLOGICAL	V520	Intentionally Blank
BIOLOGICAL	Comparator: V520 (1x10^9 vp/d)	1.0 mL intramuscular injection of MRKAd5 HIV-1 gag vaccine at 1x10\^9 vp/d given at Day 1, Week 4, and Week 26
BIOLOGICAL	Comparator: V520 (1x10^10 vp/d)	1.0 mL intramuscular injection of MRKAd5 HIV-1 gag vaccine at 1x10\^10 vp/d given at Day 1, Week 4, and Week 26
BIOLOGICAL	Comparator: Placebo	Placebo to MRKAd5 HIV-1 gag vaccine 1.0 mL intramuscular injection given at Day 1, Week 4, and Week 26

Timeline

• Start date: 2003-06-01
• Primary completion: 2006-10-01
• Completion: 2011-02-01
• First posted: 2009-02-24
• Last updated: 2015-02-27