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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
360
Intentionally Blank
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
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
Placebo to MRKAd5 HIV-1 gag vaccine 1.0 mL intramuscular injection given at Day 1, Week 4, and Week 26
Safety and tolerability of 3 dose prime-boost regimen of MRKAd5 HIV-1 gag vaccine
Time frame: 4 weeks after third vaccination
breadth of immune response measured by several assays
Time frame: 4 weeks after third vaccination
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