Study of an HIV Preventive Vaccine Given With or Without an Adjuvant 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 evaluate the safety and tolerability of an experimental HIV
      vaccine. The vaccine will be given with or without IL-12 DNA adjuvant (at three escalating
      doses of 100, 500, and 1,500 mcg respectively), a substance that helps the body respond to a
      vaccine. This study will also determine the safety and tolerability of an experimental HIV
      vaccine boosted with two adjuvants.
    

Detailed description: 
      The HIV epidemic is a major global health challenge, causing tremendous human suffering and
      economic loss throughout the world. The need for a safe, effective, and affordable HIV
      preventive vaccine is critical. This study will determine the safety and immunogenicity of an
      experimental HIV vaccine, HIV-1 gag DNA, given with or without an IL-12 adjuvant and boosted
      HIV-1 gag DNA with or without IL-12 DNA adjuvant.

      This study will comprise two parts (Parts A and B). Part A will last 9 months and Part B, 15
      months. Part A will consist of 48 participants enrolled in 4 groups. Group 1 participants
      will be randomly assigned to receive the gag DNA vaccine or placebo. Participants in Groups
      2, 3, and 4 will be randomly assigned to receive the gag DNA vaccine and either 100 mcg, 500
      mcg, or 1,500 mcg IL-12 DNA or placebo. Vaccinations for Groups 1 through 4 will be given
      intramuscularly and will occur at study entry and at Months 1 and 3.

      Part B will consist of 96 participants, enrolled in 3 groups. Participants in Part B will
      receive their first vaccination 2 weeks after Part A participants receive their second
      vaccination. Group 5 participants will receive either the HIV-1 gag DNA vaccine or placebo.
      Group 6 participants will receive either the HIV-1 gag DNA vaccine plus IL-12 DNA or placebo.
      Vaccinations for Groups 5 and 6 will occur at study entry and at Months 1, 3, 6, and 9. Group
      7 participants will receive either the gag DNA vaccine plus IL-12 DNA or placebo at study
      entry and at Months 1 and 3. Throughout the study, blood and urine collections will occur,
      physical exams will be conducted, HIV testing and counseling will be offered, and interviews
      and questionnaires will be completed.
    

Intervention name(s): HIV-1 gag DNA; HIV-1 gag DNA plus IL-12 DNA adjuvant; CTL MEP/RC529-SE/GM-CSF (CTL MEP vaccine); Sodium chloride injection (0.9%)
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): A 0.75 mL intramuscular injection of HIV gag DNA vaccine into the deltoid; Injection IL-12 DNA adjuvant intramuscularly into the deltoid; A 1 mL intramuscular injection in the deltoid; All placebo groups will receive an intramuscular injection of sodium chloride (0.9%) in the deltoid.
Group 1 will receive a 0.75 mL injection on Days 0, 28, and 84. Group 2 will receive a 0.8 mL injection on Days 0, 28, and 84. Group 3 will receive a 1.0 mL injection on Days 0, 28, and 84. Group 4 will receive a 1.5 mL injection on Days 0, 28, and 84. Group 5 will receive a 0.75 mL injection on Days 0, 28, 84, 168, and 273. Group 6 will receive a 1.5 mL injection on Days 0, 28, 84, 168, and 273. Group 7 will receive a 1.5 mL injection on Days 0, 28, and 84 and a 1 mL injection into the deltoid on Days 168 and 273.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: AIDS Vaccines; HIV Vaccines; HIV Preventive Vaccine; HIV Seronegativity