The purpose of this study is to determine the safety, tolerability, and immune response to the DNA HIV vaccine, PENNVAX-B alone, in combination with IL-12, or with 2 different doses of IL-15.
A vaccine that is effective against multiple strains of HIV remains the best option for preventing the spread of HIV. Plasmid DNA vaccines are inexpensive and easy to construct. When DNA vaccines are administered in combination with cytokines, such as IL-12 or IL-15, the immune response to the vaccine is increased. The purpose of this study is to determine the safety and tolerability of the DNA plasmid vaccine, PENNVAX-B when administered alone, or with IL-12 or IL-15 DNA adjuvants. The most effective and safe dose of IL-15 will also be determined during this study. This study will last approximately 12 months. Participants will be randomly assigned to one of four groups. Group 1 will receive an injection of PENNVAX-B combined with 0.8 mg IL-15 in each deltoid or placebo. Group 2 will receive an injection of PENNVAX-B alone or placebo. Group 3 will receive an injection of PENNVAX-B combined with IL-12 in each deltoid or placebo. Group 4 will receive PENNVAX-B combined with 2 mg IL-15 or placebo. Injections will occur at study entry, Months 1, 3, and 6. Additional study visits will occur on Days 14, 42, 98, 182, 273, and 364. At these visits a brief physical, blood collection, interview, and risk reduction counseling will occur. At some visits HIV testing, urine collection, and pregnancy tests will also occur. As of 05/30/08, participants will be enrolled into Groups 3 and 4 at a limited pace to allow for additional safety reviews for the first few participants in these groups. Additionally, safety data will be reviewed for Groups 1 and 2 to determine whether the remainder of participants in Groups 2, 3, and 4 will be enrolled.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
120
Alabama Vaccine CRS
Birmingham, Alabama, United States
San Francisco Vaccine and Prevention CRS
San Francisco, California, United States
Brigham and Women's Hosp. CRS
Boston, Massachusetts, United States
NY Blood Ctr./Union Square CRS
New York, New York, United States
Safety data including local and systemic reactogenicity sign and symptoms, laboratory measures of safety, and adverse and serious adverse events
Time frame: Throughout study
Safety data from Groups 1 and 4
Time frame: Throughout study
HIV-1 specific interferon gamma ELISpot and/or intracellular cytokine staining T cell response
Time frame: 2 weeks after 3rd and 4th vaccinations
HIV-1 specific neutralizing and binding antibody assays
Time frame: 2 weeks after 3rd and 4th vaccinations
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HIV Prevention & Treatment CRS
New York, New York, United States
NY Blood Ctr./Bronx CRS
The Bronx, New York, United States
3535 Market Street CRS
Philadelphia, Pennsylvania, United States
Vanderbilt Vaccine CRS
Nashville, Tennessee, United States