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

This study has been completed.
Sponsor:
Collaborators:
HIV Vaccine Trials Network
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00849732
First received: February 20, 2009
Last updated: March 13, 2014
Last verified: March 2014

February 20, 2009
March 13, 2014
June 2003
October 2006   (final data collection date for primary outcome measure)
Safety and tolerability of 3 dose prime-boost regimen of MRKAd5 HIV-1 gag vaccine [ Time Frame: 4 weeks after third vaccination ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00849732 on ClinicalTrials.gov Archive Site
breadth of immune response measured by several assays [ Time Frame: 4 weeks after third vaccination ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
  • HIV-1
  • HIV Infections
  • 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
  • Experimental: 1
    V520 (1x10^9 vp/d)
    Interventions:
    • Biological: V520
    • Biological: Comparator: V520 (1x10^9 vp/d)
  • Experimental: 2
    V520 (1x10^10 vp/d)
    Intervention: Biological: Comparator: V520 (1x10^10 vp/d)
  • Placebo Comparator: 3
    Placebo to V520
    Intervention: Biological: Comparator: Placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
360
February 2011
October 2006   (final data collection date for primary outcome measure)

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
Both
18 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00849732
V520-018, 2009_549
No
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
  • HIV Vaccine Trials Network
  • National Institute of Allergy and Infectious Diseases (NIAID)
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP