A Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of a Multiclade HIV-1 DNA Plasmid Vaccine, VRC-HIVDNA009-00-VP, in Uninfected Adult Volunteers in Uganda

Brief Summary

Detailed Description

The global HIV/AIDS epidemic continues to increase at unacceptably high levels, and there is not yet an effective prevention method for HIV infection. This study will test the safety and immune responses of a preventive HIV vaccine, VRC-HIVDNA009-00-VP, which is a multiclade HIV-1 DNA plasmid vaccine. This study will seek to enroll 30 participants, randomly assigning 15 participants each to the study vaccine arm and the placebo vaccine arm. Three doses of the vaccine will be given by intramuscular (IM) injection using the Biojector 2000 needle-free injection management system: the first dose at Day 0 (entry), second dose at Day 28 (within 7 days before or after Day 28), and third dose at Day 56 (within 7 days before or after Day 56). Participants will attend two screening visits and visits at Days 0 (entry), 2, 14, 28, 30, 42, 56, 58, 70, 84, 168, 252, and 336. At most visits, participants will give a medical history and undergo a physical exam, blood draw, and urine collection. For women, a pregnancy test will be given at each study injection visit. Participants also will be instructed to maintain a diary of local and systemic reactions for 7 days after each injection. They also will be provided with a ruler to measure erythema, induration, or other observable reactions and a thermometer to record temperature on a daily basis.

Primary Outcomes

Secondary Outcomes

• Lymphoproliferative responses(Measured through Week 48 visit)
• Cytotoxic T lymphocyte (CTL) measured by chromium release assays(Measured through Week 48 visit)
• Antibody immune responses as measured by enzyme-linked immunosorbent assay (ELISA)(Measured through Week 48 visit)
• Neutralizing antibody assays(Measured through Day 70)