Safety of and Immune Response to an HIV Vaccine (VRC-HIVDNA009-00-VP) Administered With Interleukin-2/Immunoglobulin (IL-2/Ig) DNA Adjuvant in Uninfected Adults
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will test the safety of and immune system response to a new HIV vaccine. The
      vaccine in this study is made from HIV DNA produced in a laboratory. Only part of the virus's
      DNA is used in the vaccine and the vaccine itself cannot cause HIV infection or AIDS. In
      addition to HIV DNA, the vaccine contains interleukin-2 (IL-2) DNA fused to a portion of
      immunoglobulin (Ig) DNA. IL-2 is a chemical that stimulates the immune system and may improve
      response to the vaccine.

      Study hypothesis: The IL-2/Ig plasmid will be very well tolerated in humans.
    

Detailed description: 
      Over 90% of the 40 million people infected with HIV live in developing countries and have
      little or no access to antiretroviral medications. The worldwide HIV/AIDS epidemic will only
      be controlled through development of a safe and effective vaccine that will prevent HIV
      infection. DNA vaccines are inexpensive to construct, readily produced in large quantities,
      and stable for long periods of time. The DNA vaccine in this study, VRC-HIVDNA009-00-VP
      (Gag-Pol-Nef-multiclade Env), uses multiple gene products to increase the breadth of the
      immune response across different HIV subtypes. The DNA plasmids in VRC-HIVDNA009-00-VP code
      for proteins from HIV subtypes A, B, and C, which together represent 90% of new HIV
      infections in the world.

      The study vaccine is administered with an adjuvant. The adjuvant is a DNA plasmid encoding
      interleukin 2 (IL-2) fused to the Fc portion of IgG for enhanced stability. This IL-2/Ig
      adjuvant may augment the immune system's response to the vaccine.

      Participants in this study will be randomly assigned to receive either the vaccine and
      adjuvant, the vaccine and placebo, the adjuvant and placebo, or placebo alone. All injections
      will be administered by needle-free injection in the upper arm. Participants will receive
      four does of vaccine: one at their first study visit and then at Months 1, 2, and 6.
      Participants will have a follow-up visit 2 days after each injection. Some participants may
      receive another injection at this follow-up visit. All study participants will be followed
      for 18 months and will have 16 to 20 study visits. Study visits will last 1/2 to 2 hours and
      will include blood and urine tests and a physical exam. Participants will also have six HIV
      tests over the course of the study.
    

Intervention name(s): VRC-HIVDNA009-00-VP (Gag-Pol-Nef-multiclade-Env) with adjuvant VRC-ADJDNA004-IL2-VP
Intervention type(s): Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Prevention
Keywords: HIV Seronegativity; HIV Preventive Vaccine; HIV-1; AIDS Vaccines; Vaccines, DNA; Dose-Response Relationship, Immunologic; Cytokines; Plasmids; Adjuvants, Immunologic; Drug Administration Schedule; Interleukin; IL2; Ig; IL@/Ig