Evaluating the Immune Response to a rAd5 HIV Vaccine Administered in Three Different Ways in Healthy, HIV-Uninfected Adults
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the immune response to the Vaccine Research Center
      (VRC) rAd5 HIV vaccine when the vaccine components are administered in three different ways,
      in healthy, HIV-uninfected adults.
    

Detailed description: 
      The VRC rAd5 HIV vaccine contains four different components. In this study, researchers will
      examine how the immune system responds to the vaccine when the four components are
      administered in three different ways:

        1. The vaccine dose containing all four components is given as a single injection in one
           arm, and placebo injections are given in the other arm and both legs.

        2. The vaccine dose containing all four components is divided into fourths, and one-fourth
           of the full dose is given in each arm and leg.

        3. The four vaccine components are separated, and a different component is given in each
           arm and leg.

      This study will enroll healthy, HIV-uninfected adults. Participants will be randomly assigned
      to one of three groups. Group 1 will receive the entire dose of vaccine in their right arm
      and placebo vaccine in the other arm and both legs. Group 2 will receive all four different
      components of the vaccine, given separately as a different component per each arm and leg.
      Group 3 will receive the entire vaccine dose divided into fourths, with one fourth of the
      full dose given in each arm and leg.

      At a baseline study visit, participants will undergo a physical examination and a medical and
      medication history review. Female participants will also take a pregnancy test. Participants
      will complete questionnaires and receive counseling on HIV risk reduction and pregnancy
      prevention. All participants will then receive vaccine given as four injections-one each in
      their right arm, left arm, right thigh, and left thigh (except for Group 1, placebo
      injections are given in left arm and both legs). After receiving the vaccine, participants
      will remain in the clinic for at least 30 minutes for observation and monitoring of side
      effects. For 7 days after the vaccination, participants will record any side effects in a
      symptom log; for the first 3 days after the vaccination, study staff will call participants
      to ensure they are completing the symptom log. Follow-up visits will occur at Months 1, 4,
      and 7. These visits will include the baseline study procedures and a blood collection.
      Participants will be contacted by study researchers once a year for 5 years for follow-up
      health monitoring. Blood collected during study visits will be saved for future testing.
    

Intervention name(s): VRC rAd5 vaccine (rAd5 gag-pol/env A/B/C); rAd5 env A; rAd5 env B; rAd5 env C; rAd5 gag-pol; Placebo Vaccine
Intervention type(s): Biological; Biological; Biological; Biological; Biological; Biological
Intervention description(s): Given intramuscularly; Given intramuscularly; Given intramuscularly; Given intramuscularly; Given intramuscularly; Given intramuscularly
Other intervention name(s): VRC-HIVADV014-00-VP; VRC-HIVADV038-00-VP; VRC-HIVADV052-00-VP; VRC-HIVADV053-00-VP; VRC-HIVADV054-00-VP; VRC-DILUENT013-DIL-VP
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention