Safety of and Immune Response to a Combination HIV Vaccine Regimen in HIV Uninfected Adults
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      To prevent HIV infection, a vaccine that produces strong HIV-specific humoral (B-cell) and
      cellular (T-cell) immune system responses is desirable. The purpose of this study is to test
      the safety of and immune response to a novel combination HIV vaccine in HIV uninfected
      adults. This study will also test the safety of and immune response to a protein vaccine
      given alone.
    

Detailed description: 
      The development of a vaccine eliciting HIV-specific humoral and cellular immune responses is
      desirable for the prevention of HIV infection. This study will investigate a combination
      vaccine regimen consisting of priming with DNA followed by boosting with a recombinant
      envelope glycoprotein adjuvanted in MF59.

      All participants will be followed for 15 months. Participants enrolled in Groups 1, 2, 3, and
      4 will receive either the vaccine or placebo. Study visits will be completed at initial
      entry; five visits every 14 days for the first 2.5 months; and visits at Months 4, 4.5, 6,
      6.5, 9, 9.5, 12, and 15. All participants will undergo physical exams, urine collection, and
      blood tests to assess safety, HIV infection, and immune responses to injections. Risk
      reduction/pregnancy prevention counseling will be given at every study visit. Participants
      will also be asked to complete questionnaires about outside testing and beliefs at certain
      visits.

      There are two parts to this study. In Part A, participants will be sequentially assigned to
      one of three groups. Each group will receive injections of different amounts of either DNA
      vaccine or placebo at entry, Month 1, and Month 2. This is followed by identical injections
      of glycoprotein/adjuvant or placebo at Months 6 and 9. Group 1 will receive 250 mcg each of
      the gag and env DNA plasmid with microparticle vaccine; Group 2 will receive 500 mcg of each
      vaccine; Group 3 will receive 1000 mcg of each vaccine. Participants will be enrolled
      sequentially from low to high dose beginning with Group 1.

      In Part B, Group 4 will begin the second part of the study simultaneously after safety review
      of all participants in Part A. Group 4 participants will receive identical injections of
      either DNA vaccine or placebo at entry and at Months 1, 2, 6, and 9.

      Group 5 will begin enrollment after enrollment is completed for Groups 1, 2, 3, and 4. Group
      5 participants will receive identical injections of either glycoprotein/adjuvant or placebo
      at study entry and at Months 3 and 9. There will be 11 study visits for Group 5 participants;
      they will occur at screening, study entry, and Months 0.5, 2, 3, 3.5, 6, 9, 9.5, 12, and 15.
      A physical exam and risk reduction/pregnancy prevention counseling will occur at all visits;
      participants will be asked at every visit about any adverse events they may have experienced.
      Blood and urine collection will occur at selected visits. Participants will be also asked to
      complete questionnaires about outside testing and beliefs at certain visits.
    

Intervention name(s): Clade B gag DNA/PLG and env DNA/PLG Microparticles; Clade B Recombinant, Oligomeric gp140/MF59 Adjuvant
Intervention type(s): Biological; Biological
Allocation: Randomized
Intervention model: Factorial Assignment
Primary purpose: Prevention
Keywords: HIV Seronegativity; HIV Preventive Vaccine