Stopped: The HVTN 303 IND was placed on clinical hold, and recruitment did not resume.
This is an open-label, dose-escalation study to examine the safety, tolerability, and immunogenicity of adjuvanted Fusion Peptide Vaccine alone or in prime-boost regimens with adjuvanted Trimer 4571 and Trimer 6931 vaccines in healthy adults. The hypothesis is that the vaccines will be safe, and well tolerated when administered alone, and when co-administered with HIV-1 Trimer 4571, in prime-boost regimens, and will induce detectable immune response.
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Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness
Timeframe: Measured through 7 days after each vaccine dose (7 days after the first dose at Week 0 in all Groups, and 7 days after the second dose at Week 4 in Groups 7 and 8 for participants who received the second dose).
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Timeframe: Measured through 7 days after each vaccine dose (7 days after the first dose at Week 0 in all Groups, and 7 days after the second dose at Week 4 in Groups 7 and 8 for participants who received the second dose).
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Timeframe: Measured through 7 days after each vaccine dose (7 days after the first dose at Week 0 in all Groups, and 7 days after the second dose at Week 4 in Groups 7 and 8 for participants who received the second dose).
Number (Percentage) of Participants With Local Laboratory Values Recorded as Meeting Grade 1 AE Criteria or Above as Specified in the Division of AIDS Table.
Timeframe: T1-T5: Screening, Days 0,7,14,28; T6: Screening, Days 0,7,14,84,91,98,168,175,182,252,259; T7: Screening, Days 0,7,14,28,35,42,56,63,70,84,91,98,168,175,252,259; T8: Screening, Days 0,7,14,28,35,42,56,63,70,140,147,154,231,238,252
Number of Participants Reporting Adverse Events (AEs), by Severity Grade
Timeframe: 28 days after each vaccine dose (28 days after the first dose at Week 0 in all Groups, and 28 days after the second dose at Week 4 in Groups 7 and 8 for participants who received the second dose).
Number of Participants Reporting Adverse Events (AEs), by Relationship to Study Product
Timeframe: 28 days after each vaccine dose (28 days after the first dose at Week 0 in all Groups, and 28 days after the second dose at Week 4 in Groups 7 and 8 for participants who received the second dose).
Number of Participants Reporting Serious Adverse Events (SAEs)
Timeframe: 12 months after each vaccine dose (12 months after the first dose at Week 0 in all Groups, and 12 months after the second dose at Week 4 in Groups 7 and 8 for participants who received the second dose).
Number of Participants Reporting Medically Attended Adverse Events (MAAEs)
Timeframe: 12 months after each vaccine dose (12 months after the first dose at Week 0 in all Groups, and 12 months after the second dose at Week 4 in Groups 7 and 8 for participants who received the second dose).
Number of Participants Reporting Adverse Events of Special Interest (AESIs)
Timeframe: 12 months after each vaccine dose (12 months after the first dose at Week 0 in all Groups, and 12 months after the second dose at Week 4 in Groups 7 and 8 for participants who received the second dose).
Number of Participants With Study Product Discontinuation Associated With an AE or Reactogenicity
Timeframe: 12 months after each vaccine dose (12 months after the first dose at Week 0 in all Groups, and 12 months after the second dose at Week 4 in Groups 7 and 8 for participants who received the second dose).
Number of Participants With Early Study Termination Associated With an AE or Reactogenicity
Timeframe: 12 months after each vaccine dose (12 months after the first dose at Week 0 in all Groups, and 12 months after the second dose at Week 4 in Groups 7 and 8 for participants who received the second dose).
Response Rate of Serum Antibody Binding of FP and Envelope Trimer Antigens as Measured by the MSD Assay 2 Weeks After the Last Vaccination.
Timeframe: Measured at week 2, 2 weeks after the 1st vaccination, for Groups T5+T6, T7, and T8 and week 6, 2 weeks after the 2nd vaccination for Groups T7 and T8.
Magnitude of Serum Antibody Binding of FP and Envelope Trimer Antigens as Measured by the MSD Assay 2 Weeks After the Last Vaccination.
Timeframe: Measured at week 2, 2 weeks after the 1st vaccination, for Groups T5+T6, T7, and T8 and week 6, 2 weeks after the 2nd vaccination for Groups T7 and T8.