Investigation of V520 in a HIV Vaccine Dose Refinement Study (V520-027)(TERMINATED)
Phase 2
Terminated
- Conditions
- HIV Infections
- Interventions
- Biological: MRKAd5 HIV-1 gag/pol/nef 1.5 x 10^10 Ad5 vg/dose (V520)Biological: MRKAd5 HIV-1 gag/pol/nef 4 x 10^9 Ad5 vg/dose (V520)Biological: MRKAd5 HIV-1 gag/pol/nef 8 x 10^9 Ad5 vg/dose (V520)
- Registration Number
- NCT00350623
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief Summary
This study will test the safety and immunogenicity of an investigational Human Immunodeficiency Virus (HIV) vaccine. Immunogenicity will be measured by evaluating the immune response to several different dose levels.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 210
Inclusion Criteria
- Demonstrates good general health
- Human Immunodeficiency Virus (HIV), Hepatitis B surface Antigen (HBsAg), and Hepatitis C (HCV) seronegative
- Low risk of acquiring HIV infection
- ALT lab value within normal range
Exclusion Criteria
- Previously received an investigational HIV vaccine
- Has a known or suspected impairment of immunologic function
- Has a clinically significant chronic medical condition that is considered progressive
- Has a major psychiatric illness
- Has any history of malignancy, with the exception of basal cell or squamous cell skin cancer
- Weighs less than 105 lbs.
- Has a recent (within two years) history of chronic alcohol abuse
- Has a contraindication to intramuscular (IM) injection, such as anticoagulant therapy or thrombocytopenia
- Female is pregnant or breast feeding, or expecting to conceive or donate eggs during the study
- Male subject is planning to impregnate or provide sperm donation during the study
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description MRKAd5 HIV-1 gag/pol/nef 1.5 x 10^10 Ad5 vg/dose MRKAd5 HIV-1 gag/pol/nef 1.5 x 10^10 Ad5 vg/dose (V520) MRKAd5 HIV-1 gag/pol/nef 1.5 x 10\^10 Ad5 vg/dose, 3 doses administered at Day 1, Week 4, and Week 26. MRKAd5 HIV-1 gag/pol/nef 4 x 10^9 Ad5 vg/dose MRKAd5 HIV-1 gag/pol/nef 4 x 10^9 Ad5 vg/dose (V520) MRKAd5 HIV-1 gag/pol/nef 4 x 10\^9 Ad5 vg/dose, 3 doses administered at Day 1, Week 4, and Week 26. MRKAd5 HIV-1 gag/pol/nef 8 x 10^9 Ad5 vg/dose MRKAd5 HIV-1 gag/pol/nef 8 x 10^9 Ad5 vg/dose (V520) MRKAd5 HIV-1 gag/pol/nef 8 x 10\^9 Ad5 vg/dose, 3 doses administered at Day 1, Week 4, and Week 26.
- Primary Outcome Measures
Name Time Method Number of Enzyme-linked Immunosorbent Spot (ELISPOT) Responders at 30 Weeks 30 weeks
- Secondary Outcome Measures
Name Time Method