Evaluating the Safety of and Immune Response to HIV-MAG DNA Vaccine With or Without Plasmid IL-12 Adjuvant Delivered Intramuscularly Via Electroporation Followed by VSV-gag HIV Vaccine Boost in Healthy, HIV-Uninfected Adults

The effectiveness of a vaccine may be increased when combined with an adjuvant and/or when given with EP. The addition of an adjuvant or EP may increase a person's immune response to a vaccine. Furthermore, the immune response to HIV antigens may be improved by giving a DNA vaccine boosted with a live vector vaccine. The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of an HIV DNA vaccine (HIV-MAG) alone or in combination with an IL-12 pDNA adjuvant, delivered IM via EP followed by a Vesicular Stomatitis Virus (VSV) HIV gag vaccine boost given IM by needle and syringe in healthy, HIV-uninfected adults. Participants will be enrolled into the study in one of four groups. Each of the four groups will receive 3 mg of the HIV-MAG vaccine alone or combined with one of three different doses of the IL-12 pDNA adjuvant, followed by the VSV HIV gag vaccine boost. Within each of the four groups, participants will be randomly assigned to receive the study vaccines or placebo. At study entry (Day 0), all participants will undergo a physical examination and blood collection. Female participants will also take a pregnancy test. Participants will complete questionnaires and receive counseling on HIV risk reduction. They will also receive their first vaccination. Participants will remain in the clinic for 30 minutes after the vaccination for observation and monitoring. Additional vaccination study visits will occur at Months 1, 3, and 6. At Months 1 and 3, participants will receive the same vaccine or placebo they received at study entry; at Month 6, participants will receive the VSV HIV gag vaccine or placebo. For 3 days after the study entry and Months 1 and 3 vaccination visits, participants will record their symptoms in a diary. After the Month 6 vaccination visit, participants will record their symptoms for 7 days. Participants in Groups 1 and 3 will attend additional study visits on Days 1, 3, 14, 42, 91, 98, 169, 171, 175, 182, 273, and 364. Participants in Groups 2 and 4 will attend additional study visits on Days 14, 42, 98, 182, 273, and 364. Most study visits will include a physical examination, blood collection, oral mucosa examination, interviews and questionnaires, and oral mucosa examination. If participant has any oral sores, oral swabs may be collected. Saliva also may be collected. Select study visits will include a mini mental state exam, urine collection, HIV testing, and risk reduction counseling. Study researchers will contact participants at Months 15, 24, and 36 for follow-up health monitoring.