Evaluating the Safety of and Immune Response to the VSV-Indiana HIV Vaccine 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 safety and immune response to an HIV vaccine in
      HIV-uninfected adults. Study researchers will also determine the maximum dose of the vaccine
      that participants can safely receive.
    

Detailed description: 
      Many HIV vaccines that are in development use a virus vector to deliver the vaccine into the
      body's cells in order to elicit an immune response. Vesicular stomatitis virus (VSV) is a
      vector that has been studied in animals. As an HIV vaccine vector, it has been shown to
      prevent disease progression in monkeys infected with simian/human immunodeficiency virus
      (SHIV). This study will evaluate the safety and immune response to the VSV-Indiana (one type
      of VSV vector) HIV gag vaccine in healthy, HIV-uninfected adults. In addition, study
      researchers will determine the maximum dose of the vaccine that can be safely tolerated.

      This study will enroll healthy, HIV-uninfected adults. Five groups of participants will be
      enrolled, with each subsequent group receiving a slightly higher dose of the vaccine. Within
      each group, participants will be randomly assigned to receive the study vaccine or a placebo
      vaccine. Study researchers will examine safety data and how participants react to the study
      vaccine before enrolling the next group of participants. At baseline and Week 8, participants
      will receive two injections of the study vaccine or placebo vaccine-one in each upper arm at
      each time point. At the baseline study visit, all participants will undergo a physical
      examination; mouth examination; a medical and medication history review; and saliva, blood,
      and urine collection. Female participants will also take a pregnancy test. Participants will
      complete questionnaires to assess mental status and receive counseling on HIV risk reduction
      and pregnancy prevention. 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.

      Participants will attend study visits 3 days and 1 and 2 weeks after the baseline study
      visit, at Week 8 for the second vaccination, 3 days and 1 and 2 weeks after the Week 8 visit,
      and at Months 5 and 8. Follow-up study visits will include select baseline study procedures.
      Participants will be contacted annually for 3 years for follow-up health monitoring.
    

Intervention name(s): VSV-Indiana HIV gag vaccine; Placebo injection (normal saline)
Intervention type(s): Biological; Biological
Intervention description(s): Administered IM in both deltoids at baseline and Week 8. Dose will vary depending on which group the participant is enrolled in.; Administered IM in both deltoids at baseline and Week 8.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention