Investigation of V520 in an HIV Vaccine Proof-of-Concept Study (V520-023)
Condition: AIDS; HIV Infections
MeSH terms: Infections
Intervention: Trivalent MRKAd5 HIV-1 gag/pol/nef (1.5x10^10 ad-vg/dose); Comparator: placebo
Intervention description: Trivalent MRKAd5 HIV-1 gag/pol/nef (1.5x10^10 adenovirus genomes [ad-vg]/dose).
This dose is equivalent to 3x10^10 vp/dose used in study V520-016.; Placebo to Trivalent MRKAd5 HIV-1 gag/pol/nef in three 1 mL doses at Day 1, Week 4, and Week 26 administered intramuscularly.
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 3000.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study will test the safety and efficacy of an investigational Human Immunodeficiency
      Virus (HIV) vaccine. Efficacy will be measured by either prevention of HIV infection or
      control of HIV viral load in subjects who become HIV infected.

      On September 18, 2007 the Protocol V520-023 DSMB (Data & Safety Monitoring Board) reviewed
      data from a planned interim analysis. These data demonstrated that the investigational
      vaccine candidate was not effective, and all vaccinations in the study were halted.

      Participants were encouraged to continue to come to the clinic for scheduled visits and
      ongoing risk reduction counseling since the vaccine was not effective.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy, HIV seronegative adults at high risk of acquiring HIV infection

          -  Cannot have previously received an investigational vaccine

        Exclusion Criteria:

          -  In a monogamous relationship with an HIV-1 seronegative partner for > 1 year

          -  History of anaphylaxis and/or allergy to vaccine components, including Tris buffer,
             MgCl2, and polysorbate 80 (TWEEN)

          -  Received an immune globulin or blood derived products 3 months before injection with
             the first dose of vaccine/placebo or scheduled within 14 days after injection

          -  Previously vaccinated with a live virus vaccine within 30 days before injection with
             the first dose of vaccine or scheduled within 14 days after injection

          -  Previously vaccinated with an inactivated vaccine within 5 days before injection with
             the first dose of vaccine or scheduled within 14 days after injection

          -  Known history of immunodeficiency

          -  History of malignancy (with some exceptions)

          -  Contraindication to intramuscular (IM) injection such as anticoagulant therapy or
             thrombocytopenia

          -  Female subject who is pregnant or breast feeding, or expecting to conceive or donate
             eggs through Week 30 of the study

          -  Male subject who is planning to impregnate or provide sperm donation through Week 30
             of the study

          -  Previously received an investigational HIV vaccine

          -  Has active drug or alcohol abuse or dependence that would interfere with adherence to
             study requirements, or endanger the subject's health while on the study

          -  Has a condition that might endanger the subject's health or interfere with the
             evaluation of the study objectives