Safety of an HIV DNA Vaccine Given to HIV Uninfected Adults
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to see if the experimental HIV vaccine pGA2/JS2 is safe and is
      well tolerated at two different doses. Another important purpose of this study is to observe
      how the immune system responds to the vaccine at different dose levels.

      Vaccines are given to people to help their bodies fight infection. The vaccine being tested
      in this study is a DNA vaccine. The pGA2/JS2 plasmid DNA vaccine instructs the body to make
      some HIV proteins. These HIV proteins may trigger an immune response. Because only a few of
      the many proteins HIV needs are made through DNA vaccination, there is no risk of getting HIV
      from the vaccination. This and other similar DNA vaccines have been tested for safety in
      mice, rabbits, and monkeys. The vaccine has been well tolerated at doses to be used in this
      study.
    

Detailed description: 
      DNA vaccination has induced immune responses in animals to a number of viral, bacterial, and
      parasite derived antigens. Early clinical experiences with HIV DNA vaccines in humans
      indicate: 1) the tolerability and short-term safety of DNA at doses up to 5000 mcg in humans
      are excellent; and 2) there is potential for immunogenicity.

      The pGA2/JS2 DNA vaccine is part of a planned prime/boost regimen of a DNA vaccine prime
      followed by a modified vaccinia Ankara (MVA) vaccine boost. In studies in monkeys, a
      combination of a DNA vaccine and an MVA vaccine protected the monkeys against disease caused
      by a monkey virus similar to HIV. The current study is an initial investigation of the safety
      and immunogenicity of the DNA vaccine given alone. The pGA2/JS2 DNA vaccine expresses gag,
      protease, reverse transcriptase, env, tat, vpu, and rev.

      Participants are randomized to 1 of 2 groups. People in Group A receive either 2 injections
      of a lower dose (300 mcg) of the DNA plasmid vaccine or the placebo control. People in Group
      B receive either 2 injections of a higher dose (3000 mcg) of the DNA plasmid vaccine or the
      control. Group B will be enrolled only if the vaccine is found to be safe and well-tolerated
      during the initial 2-week evaluation of all participants in Group A. Participants receive
      vaccinations administered at Months 0 and 2. All vaccinations are administered by
      intramuscular (IM) injection in an outpatient setting. Participants have about 10 clinic
      visits during this study, including the screening and injection visits. Participants give
      blood and urine samples at study visits. They are tested for HIV before entering the study
      and 4 more times during the study. Women who can become pregnant may undergo up to 3
      pregnancy tests during the study period.
    

Intervention name(s): pGA2/JS2 Plasmid DNA Vaccine
Intervention type(s): Biological
Masking: Double
Primary purpose: Prevention
Keywords: Injections, Intramuscular; HIV Seronegativity; Plasmids; Vaccines, DNA; HIV Preventive Vaccine