The purpose of this study is to evaluate the safety, tolerability, and immune response of the DNA-HIV-PT123 vaccine when used in combination with one of two protein vaccines: Bivalent Subtype C gp120/MF59 (Protein/MF59) or Bivalent Subtype C gp120/AS01B (Protein/AS01B). These protein vaccines may boost the immune response to the DNA vaccine.~The study will enroll healthy, HIV-uninfected adults. Participants will be randomly assigned to one of eight groups, and each group will receive a different sequence of vaccines during the study. Groups 1 and 4 will receive the DNA-HIV-PT123 vaccine, the Protein/MF59 vaccine, and placebo. Groups 2, 3, 5, 6, and 7 will receive the DNA-HIV-PT123 vaccine, the Protein/AS01B vaccine, and placebo. Group 8 will only receive placebo.~All participants will receive their assigned vaccines at Months 0, 1, 3, and 6. Each of these visits will include three injections. Follow-up visits will occur at Week 2 and Months 1.5, 3.5, 6.25, 6.5, 9, and 12.~Study visits will include a physical examination, an interview and/or questionnaire, HIV testing and HIV risk reduction counseling, and urine and blood collection. Participants may optionally choose to provide stool, rectal fluid, cervical fluid, or semen samples. Participants will be contacted 6 months after the last scheduled visit by phone, text message, or e-mail for information about their health.
This study will evaluate the safety and immune response to the DNA-HIV-PT123 vaccine used in combination with one of two protein vaccines (Bivalent Subtype C gp120/MF59 or Bivalent Subtype C gp120/AS01B) in healthy, HIV-uninfected adults.