Safety of and Immune Response to a DNA HIV Vaccine Followed By Boosting With One of Two Serotypes of Adenoviral Vector HIV Vaccine in Healthy Adults
Condition: HIV Infections
MeSH terms: Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the safety of and immune response to an
      experimental DNA HIV vaccine followed by boosting with either an experimental adenoviral
      vector HIV vaccine of serotype 5 or 35 in HIV uninfected adults. This study will also
      determine the safety of and immune response to an adenoviral vector HIV vaccine of serotype 5
      followed by a booster of an adenoviral vector of serotype 35, or vice versa, in HIV
      uninfected adults.
    

Detailed description: 
      The worldwide HIV/AIDS epidemic may only be controlled through development and utilization of
      a safe and effective vaccine that will prevent HIV infection. Vaccines using a DNA plasmid to
      prime the response to an adenoviral vector boost are currently being developed. Due to high
      prevalence of pre-existing immunity to adenovirus serotype Ad5 in the developing world, this
      study will evaluate boosting with a different serotype, Ad35, as compared to boosting with
      the Ad5 serotype. This study will also test the effect of the order of administration of
      recombinant adenoviral vector HIV vaccines when administered without the DNA plasmid vaccine.
      Two arms of this study will evaluate the safety and immunogenicity of the experimental
      multiclade, multigene HIV DNA vaccine VRC-HIVDNA044-00-VP, followed by a similarly structured
      adenovirus vector vaccine boost (either VRC-HIVADV027-00-VP or VRC-HIVADV038-00-VP), in HIV
      uninfected adults. To determine the effect of pre-existing Ad5 or Ad35 immunity, the other
      two arms will test the safety and immunogenicity of receiving either VRC-HIVADV027-00-VP
      followed by VRC-HIVADV038-00-VP, or vice versa.

      Each volunteer will participate in the study for at least 6 months. Participants will be
      randomly assigned to one of four groups and will receive either an experimental vaccine or
      placebo at each vaccination visit. Group 1 participants will receive an injection of the
      adenoviral vector vaccine VRC-HIVADV027-00-VP at study entry and an injection of
      VRC-HIVADV038-00-VP at Month 3. Group 2 participants will receive an injection of the
      adenoviral vector vaccine VRC-HIVADV038-00-VP at study entry and an injection of
      VRC-HIVADV027-00-VP at Month 3. Group 3 participants will receive an injection of the
      VRC-HIVDNA044-00-VP vaccine at study entry and Months 1 and 2, followed by an injection of
      VRC-HIVADV027-00-VP at Month 6. Group 4 participants will receive an injection of the DNA HIV
      vaccine at study entry and Months 1 and 2, followed by an injection of VRC-HIVADV038-00-VP at
      Month 6.

      For Groups 1 and 2, there will be 9 study visits. For Groups 3 and 4, there will be 13 study
      visits. Medication history, assessment of intercurrent illness and adverse effects, and HIV
      and pregnancy prevention counseling will occur at all visits. A medical history, a physical
      exam, HIV testing and counseling and blood and urine collection will occur at selected
      visits. Participants will also be asked to complete social impact and HIV testing and history
      questionnaires at selected visits.

      As of 11/19/07 enrollment and vaccinations have been discontinued. Participants who have
      already been enrolled have been told which vaccinations they received and will be followed
      for a total of 5 years.
    

Intervention name(s): VRC-HIVADV027-00-VP; VRC-HIVADV038-00-VP; VRC-HIVDNA044-00-VP
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Adenoviral vector booster vaccine; Adenovirus vector booster vaccine; Experimental, multiclade, multigene HIV DNA vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Prevention
Keywords: HIV Seronegativity; HIV Preventive Vaccine; Adenovirus