Status:
COMPLETED
A Worldwide, Phase I, Dose-Escalating Study of a 3-Dose Regimen of the MRKAd5 (Clade B) Vaccine in Healthy Adults (V520-018)
Lead Sponsor:
Merck Sharp & Dohme LLC
Collaborating Sponsors:
HIV Vaccine Trials Network
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
HIV-1
HIV Infections
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
Brief 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 pl...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2011
Estimated Enrollment :
360 Patients enrolled
Trial Details
Trial ID
NCT00849732
Start Date
June 1 2003
End Date
February 1 2011
Last Update
February 27 2015
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.