Safety of and Immune Response to Two Different HIV Vaccines, Each Followed by a Adenoviral Vaccine Boost, in HIV Uninfected Adults
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the safety of and immune response to an adenoviral
      vector HIV vaccine or a DNA HIV vaccine, each followed by an adenoviral vector HIV vaccine
      boost, in HIV uninfected adults.
    

Detailed description: 
      Evaluating the immunogenicity of HIV vaccines is critical to improving vaccine design and
      development. The adenoviral vector HIV vaccine VRC-HIVADV014-00-VP has shown immunogenicity
      in early studies and appeared safe and well tolerated at three different doses in a prior
      dose-escalation vaccine trial in HIV uninfected adults. The DNA HIV vaccine
      VRC-HIVDNA009-00-VP has shown immunogenicity in multiple clinical trials; in one trial, the
      DNA vaccine demonstrated a nearly 100% CD4 T-cell response rate. The DNA plasmids in both
      vaccines code for proteins from HIV subtypes A, B, and C, which together represent 90% of new
      HIV infections. This study will determine the safety and immune response to the
      administration of an adenoviral vector HIV vaccine or a DNA HIV vaccine, each followed by an
      adenoviral vaccine boost, in HIV uninfected adults.

      This study will last 1 year. Participants will be randomly assigned to one of two groups.
      Within each group, participants will be randomly assigned to receive either vaccine or
      control injections. Group 1 participants will receive either placebo or the adenoviral HIV
      vaccine at study entry and Month 6. Group 2 participants will receive either placebo or the
      DNA HIV vaccine at study entry and Month 1 and the adenoviral HIV vaccine at Month 6.
      Participants will be asked to record their temperatures and other side effects in a symptom
      log on the day of each vaccination and for 3 days thereafter to report any side effects.

      Group 1 participants will have 16 study visits, and a physical exam and HIV and pregnancy
      prevention counseling will occur at each visit. Participants will also be asked about any
      side effects and medications they are taking. Blood collection will occur at most visits.
      Urine collection will occur at selected visits. Participants will be asked to complete a
      social impact assessment at Months 2, 6, and 12 and a testing and belief questionnaire at
      Months 6 and 12.
    

Intervention name(s): VRC-HIVADV014-00-VP; VRC-HIVDNA009-00-VP; FFB; PBS
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): HIV-1 recombinant adenoviral vector vaccine given as a 1 mL intramuscular injection in the deltoid; HIV-1 DNA plasmid vaccine given as a 1 mL intramuscular injection in the deltoid; Adenoviral vector FFB given as a 1 mL intramuscular injection in the deltoid; phosphate buffered saline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: HIV Seronegativity; Adenoviral Vector Vaccine; DNA Plasmid Vaccine