A Study of Safety, Tolerability, and Immunogenicity of the MRKAd5 Gag/Pol/Nef Vaccine in Healthy Adults (V520-016)
HIV-1, HIV Infections
About this trial
This is an interventional prevention trial for HIV-1 focused on measuring HIV Seronegativity, Preventive Vaccine
Eligibility Criteria
Inclusion Criteria:
- 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 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 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Placebo Comparator
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Placebo
Monovalent MRKAd5 HIV-1 gag vaccine (1x10^9 vp/dose)
Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^6 vp/dose)
Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^7 vp/dose)
Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^8 vp/dose)
Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^9 vp/dose)
Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^10 vp/dose)
Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (1x10^11 vp/dose)
Participants receiving 1.0 ml of placebo to the MRKAd5 HIV-1 gag/pol/nef vaccine or the placebo to the MRKAd5 HIV-1 gag vaccine injected intramuscularly in a 3-dose regimen at Day 1, Week 4 and Week 26 or a 2-dose regimen at Day 1 and Week 26 or Day 1 and Week 4.
Participants receiving 1.0 ml of the Monovalent MRKAd5 HIV-1 gag vaccine (1x10^9 vp/dose) injected intramuscularly in a 3-dose regimen at Day 1, Week 4 and Week 26.
Participants receiving 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^6 vp/dose) injected intramuscularly in a 3-dose regimen at Day 1, Week 4 and Week 26.
Participants receiving 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^7 vp/dose) injected intramuscularly in a 3-dose regimen at Day 1, Week 4 and Week 26.
Participants receiving 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^8 vp/dose) injected intramuscularly in a 3-dose regimen at Day 1, Week 4 and Week 26.
Participants receiving 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^9 vp/dose) injected intramuscularly in a 3-dose regimen at Day 1, Week 4 and Week 26.
Participants receiving 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^10 vp/dose) injected intramuscularly in a 3-dose regimen at Day 1, Week 4 and Week 26, or in a 2-dose regimen at Day 1 and Week 4 (with no vaccine administered at Week 26) or Day 1 and Week 26 (with placebo to the MRKAd5 HIV-1 gag/pol/nef vaccine administered at Week 4)
Participants receiving 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (1x10^11 vp/dose) injected intramuscularly in a 3-dose regimen at Day 1, Week 4 and Week 26.