Evaluating the Safety and Immune Response to Different Combinations of the DNA-HIV-PT123 and AIDSVAX® B/E Vaccines in Healthy, HIV-Uninfected Adults

This study will evaluate the safety, tolerability, and immune response to different combinations of two experimental HIV vaccines-the DNA-HIV-PT123 vaccine and the AIDSVAX® B/E vaccine-in healthy adults who are not infected with HIV.

The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of the combination of two different experimental HIV vaccines-the DNA-HIV-PT123 vaccine and the AIDSVAX® B/E vaccine-administered in different sequences or simultaneously, in healthy adults who are not infected with HIV. Participants will be randomly assigned to four groups. Depending on which group participants are in, they will receive different combinations of the DNA-HIV-PT123 vaccine, the AIDSVAX® B/E vaccine, a placebo for DNA-HIV-PT123 vaccine, and/or a placebo for AIDSVAX® B/E vaccine. Study visits will occur at study entry, Week 2, and Months 1, 1.5, 3, 3.5, 6, 6.5, 9, and 12. All participants will receive their assigned combinations of vaccines at study entry and Months 1, 3, and 6. At each vaccination visit, participants will receive one injection in each upper arm. Following each vaccination, participants will remain in the clinic for 30 minutes for monitoring. All study visits will include a physical examination, HIV risk reduction counseling, and questionnaires and assessments. Select study visits will also include a urine collection, a blood collection, a pregnancy test for participants who were born female, and HIV testing and counseling.