Safety of and Immune Response to an Adenoviral HIV-1 Vaccine in Healthy Adults
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      Successful control of the HIV epidemic will require a safe and effective vaccine to be
      developed. A successful vaccine will need to stimulate a widespread immune response. The
      purpose of this study is to determine the safety of and immune response to an adenovirus
      serotype HIV vaccine in HIV uninfected adults.
    

Detailed description: 
      HIV infection continues to spread at pandemic levels throughout the world. Control of this
      pandemic can only be achieved with the development of a safe and effective preventive HIV
      vaccine. A vaccine that will prevent HIV infection will elicit a strong immune response from
      both CD4 and CD8 cells. Recombinant adenovirus serotype vectors have been shown to elicit
      just such a response. The purpose of this study is to determine the safety and immunogenicity
      of the recombinant adenovirus serotype 26 preventive HIV-1 vaccine.

      This study will last 12 months. Participants will be randomly assigned to one of four arms
      that will receive different doses of the vaccine or placebo administered via intermuscular
      injection. Participants in Arms 1, 2, and 3 will all receive 3 injections. Each injection
      will contain the same dose of vaccine. Arm 4 will receive 2 injections of a dose of vaccine
      that will be determined by the safety data from Arms 1, 2, and 3. Participants will be
      enrolled sequentially, from lowest to highest dose of vaccine, into Arms 1, 2, and 3. Arms
      will begin enrollment only following review of safety data from the previous group. After the
      Day 42 safety data from Arms 1, 2, and 3 have been reviewed, the dose for Arm 4 will be
      determined, and enrollment into that arm will begin.

      There will be 10 study visits in this study, occurring at baseline and after 0.5, 1, 1.5, 2,
      6, 6.5, 7, and 12 months. Participants in Arms 1, 2, and 3 will receive injections on Days 0,
      28, and 168. Participants in Arm 4 will receive injections on Days 0 and 168. Participants
      will be asked to record their temperature and other side effects in a symptom log for 7 days
      after each injection. Risk reduction/pregnancy prevention counseling will occur at visits 1
      through 9, and physical exams and assessments of illness or adverse events will occur at all
      visits. At most visits, blood, urine, and oral swab collection will occur. At some visits,
      HIV testing and pregnancy testing will occur.

      Once a year for 5 years following study entry, participants will attend a study visit or will
      be contacted by study staff by telephone or e-mail for follow-up safety and health
      monitoring. Some participants will also undergo a blood collection at these visits.
    

Intervention name(s): Ad26.ENVA.01 HIV-1 vaccine
Intervention type(s): Biological
Intervention description(s): Recombinant adenovirus serotype 26 HIV-1 vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Prevention
Keywords: HIV Seronegativity; HIV Preventative Vaccine