Trial | NCT00849732  Report issue

Title

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

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    v520 ...

  • Study Participants

    360
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.
Study Started
Jun 30
2003
Primary Completion
Oct 31
2006
Study Completion
Feb 28
2011
Last Update
Feb 27
2015
Estimate

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

1 Experimental

V520 (1x10^9 vp/d)

2 Experimental

V520 (1x10^10 vp/d)

3 Placebo Comparator

Placebo to V520

Criteria 

Inclusion Criteria:

Subject is in good general health
Subject tests negative for Hepatitis B, Hepatitis C, and HIV
Subjects of reproductive potential agree to use an accepted method of birth control through the entire study

Exclusion Criteria:

Subject has a recent history of fever at time of vaccination
Subject has received immune globulin or blood product 3 months prior to injection
Subject has been vaccinated with live virus vaccine 30 days prior to receipt of first dose
Subject has been vaccinated with inactivated vaccine with 14 days prior to receipt of first dose
Subject has a chronic medical condition that is considered progressive
Subject has history of malignancy
Subject weighs less than 105 lb.
Female subject is pregnant or breast feeding, Male subject is planning to impregnate during the first year of study
Subject has contraindication to intramuscular injection
Subject is unlikely or unwilling to adhere to lower risk sex practices during the course of the study
Subject has a tattoo on the deltoid region of the arm or the injection of Depo-Provera
No Results Posted