This study will evaluate the safety, tolerability, and immunogenicity of env (A,B,C,A/E)/gag (C) DNA and gp120 (A,B,C,A/E) protein/GLA-SE HIV-1 vaccines (PDPHV-201401) as a prime-boost regimen or co-administered in repeated doses, in healthy, HIV-1-uninfected adults.~The study will be conducted in two parts (Part A and Part B).~Participants in Part A will be randomly assigned to either Group 1 (Treatment) or Group 1 (Control). Participants in Group 1 (Treatment) will receive the gp120 (A,B,C,A/E) protein vaccine admixed with GLA-SE adjuvant on Day 0 and Month 2. Participants in Group 1 (Control) will receive placebo on Day 0 and Month 2.~Researchers will evaluate study data from Part A before enrolling participants in Part B.~Participants in Part B will be enrolled in either Groups 2 or 3. Within Group 2, participants will be randomly assigned to either Group 2 (Treatment) or Group 2 (Control). Participants in Group 2 (Treatment) will receive the env (A,B,C,A/E)/gag (C) DNA vaccine and placebo on Day 0 and Months 1 and 3. At Months 6 and 8, participants will receive the gp120 (A,B,C,A/E) protein vaccine admixed with GLA-SE adjuvant and a placebo vaccine. Participants in Group 2 (Control) will receive placebo on Day 0 and Months 1, 3, 6, and 8.~Participants in Group 3 will be randomly assigned to either Group 3 (Treatment) or Group 3 (Control). Participants in Group 3 (Treatment) will receive the env (A,B,C,A/E)/gag (C) DNA vaccine and the gp120 (A,B,C,A/E) protein vaccine admixed with GLA-SE adjuvant on Day 0 and Months 1, 3, 6, and 8. Participants in Group 3 (Control) will receive placebo on Day 0 and Months 1, 3, 6, and 8.~Study visits for participants in Part A will occur on Day 0, Week 2, and Months 2, 2.5, 5, and 8. Study visits for participants in Part B will occur on Day 0, Week 2, and Months 1, 1.5, 3, 3.5, 6, 6.5, 8, 8 + 1 Week, 8.5, 11, and 14. Visits may include physical examinations, blood and urine collection, HIV testing, risk reduction counseling, and questionnaires. Participants in Part B may also have optional saliva, semen, cervical fluid, rectal fluid, and stool sample collection.~Study staff will contact all participants 12 months after the last vaccination for follow-up health monitoring.
The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of env (A,B,C,A/E)/gag (C) DNA and gp120 (A,B,C,A/E) protein/GLA-SE HIV-1 vaccines (PDPHV-201401) as a prime-boost regimen or co-administered in repeated doses, in healthy, HIV-1-uninfected adults.