This study will evaluate the safety, tolerability, and immune response to five different combinations of three HIV vaccines-a DNA vaccine (DNA-HIV-PT123), a NYVAC vaccine (NYVAC-HIV-PT1 and NYVAC-HIV-PT4 injections), and the AIDSVAX® B/E vaccine-in healthy, HIV-uninfected adult participants.~The study will enroll 180 healthy, HIV-uninfected participants aged 18 to 50 years. The participants will be randomly assigned to one of five groups. All participants will receive injections according to their assigned group schedule at study entry (Month 0) and Months 1, 3, and 6. The immune response of different prime and boost vaccine strategies will be tested in Groups 1 through 4, and the immune response of the co-administration of the DNA and AIDSVAX® B/E vaccine will be tested in Group 5. Group 1 participants will receive AIDSVAX® B/E as a prime followed by NYVAC as a boost; Group 2 participants will receive NYVAC as a prime followed by an AIDSVAX® B/E boost; Group 3 participants will receive AIDSVAX® B/E as a prime followed by a DNA boost; Group 4 participants will receive a DNA prime followed by an AIDSVAX® B/E boost; and Group 5 participants will receive both the DNA and AIDSVAX® B/E vaccines at each of the 4 vaccination visits.~Total study duration will be approximately 42 months and will involve 12 months of scheduled clinic visits at screening, study entry [Month 0], and Months 0.5, 1, 1.5, 3, 3.5, 6, 6.5, 9, and 12) followed by annual health contacts via e-mail or phone to a total of 3 years following initial study injection.~All study visits will include a physical exam, HIV risk reduction counseling, and an interview and/or questionnaire. Select study visits will include blood collection, urine collection, an electrocardiogram (ECG), and a pregnancy test for participants who were born female. For participants in Groups 1 and 2, select study visits will also include an assessment of cardiac symptoms. Participants will remain in the clinic for 30 minutes after receiving the vaccines for observation and monitoring. For 7 days after receiving the vaccines, participants will record their symptoms and report them to study researchers.
This study will evaluate the safety and immune response to five different combinations of three HIV vaccines in healthy, HIV-uninfected adults.