Safety of and Immune Response to a DNA HIV Vaccine (pGA2/JS7) Boosted With a Modified Vaccinia HIV Vaccine (MVA/HIV62) in Healthy Adults
Condition: HIV Infections
MeSH terms: Vaccinia
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the safety of and immune response to a DNA HIV
      vaccine, pGA2/JS7, followed by a modified vaccinia (smallpox) HIV vaccine, MVA/HIV62, in HIV
      uninfected adults.
    

Detailed description: 
      The worldwide HIV/AIDS epidemic may only be controlled through a safe and effective vaccine
      that will prevent HIV infection. DNA vaccines are inexpensive to construct, easily produced
      in large quantities, and stable for long periods of time. Recombinant modified vaccinia
      Ankara vaccines have been shown to be safe in humans, and immunogenicity after administration
      of both vaccines has been encouraging. When used together, a more robust immunologic response
      was associated with DNA HIV vaccine administration followed by modified vaccinia vaccine
      administration, compared to using either DNA or vaccinia vaccine alone. This study will
      evaluate the safety and immunogenicity of an experimental DNA HIV vaccine prime, pGA/JS7,
      followed by a similarly structured modified vaccinia boost, MVA/HIV62, in HIV uninfected
      adults. Participants in this study will be recruited only in the United States.

      This study will be divided into 2 parts. Each participant will be involved with their part of
      study for 1 year. Participants in Part 1 will be randomly assigned to one of two different
      vaccination groups. Group 1A participants will be randomly assigned to receive either placebo
      or 2 lower doses of the DNA HIV vaccine (DNA) at study entry and Month 2, followed by 2 lower
      doses of the modified vaccinia vaccine (MVA) at Months 4 and 6. Group 1B will not enroll
      until safety and immunogenicity data from Group 1A have been evaluated. Group 1B participants
      will receive either placebo or two higher doses of DNA at study entry and Month 2, followed
      by two higher doses of MVA at Months 4 and 6.

      Enrollment into Part 2 will begin only after safety data from Part 1 are reviewed. In Part 2,
      participants will be randomly assigned to one of two different vaccination groups. Within
      each group, participants will be randomly assigned to receive some series of vaccines or
      placebo. Group 2A participants will receive either placebo or the maximum tolerated dose
      (MTD) from Part 1 of DNA at study entry and MTD of MVA at Months 2 and 6. Group 2B
      participants will receive MTD of MVA at study entry and Months 2 and 6.

      There will be 12 study visits over 12 months for Groups 1 and 2. There will be 11 study
      visits over 12 months for Groups 3 and 4. Medication history, a physical exam, an interview,
      HIV and pregnancy prevention counseling, and adverse events reporting will occur at all
      visits. Blood and urine collection and an electrocardiogram (ECG) will occur at selected
      visits.
    

Intervention name(s): pGA2/JS7 DNA; Modified vaccinia Ankara/HIV62
Intervention type(s): Biological; Biological
Intervention description(s): DNA Vaccine; Recombinant Modified Ankara Vaccine
Other intervention name(s): MVA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: HIV Seronegativity; HIV Preventive Vaccine; HIV DNA Vaccine; Modified Vaccinia Ankara Vaccine