Status:
COMPLETED
A Study of Safety, Tolerability, and Immunogenicity of the MRKAd5 Gag/Pol/Nef Vaccine in Healthy Adults (V520-016)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
HIV-1
HIV Infections
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief 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 healt...
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)...
Eligibility Criteria
Inclusion
- Subjects 18 Years to 45 Years in Stages I-III and 18 Years to 50 Years in Stage IV.
- Subject is in good general health
- Subjects of reproductive potential agree to use acceptable method of birth control through study
- Subject tests negative for Hepatitis B, Hepatitis C, and HIV
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 has a tattoo on the deltoid region of the arm or the injection of Depo-Provera
- Subject is unlikely or unwilling to adhere to lower risk sex practices during the course of the study
Key Trial Info
Start Date :
April 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2010
Estimated Enrollment :
317 Patients enrolled
Trial Details
Trial ID
NCT00849680
Start Date
April 1 2003
End Date
February 1 2010
Last Update
February 2 2015
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