A Study of Safety, Tolerability, and Immunogenicity of the MRKAd5 Gag/Pol/Nef Vaccine in Healthy Adults (V520-016)
Condition: HIV-1; HIV Infections
MeSH terms: HIV Infections
Intervention: Comparator: Placebo to the MRKAd5 HIV-1 gag/pol/nef vaccine; 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); Comparator: Placebo to MRKAd5 HIV-1 gag vaccine
Intervention description: Placebo to the MRKAd5 HIV-1 gag/pol/nef vaccine.; 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); Placebo to the MRKAd5 HIV-1 gag vaccine.
Intervention MeSH terms: Vaccines
Phase: Phase 1
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 317.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: HIV Seronegativity; Preventive Vaccine

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 healthy human volunteers compared to placebo.
      The study will also evaluate a number of dose levels and the necessity for and timing of
      booster injections.
    

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