This phase 1 study will evaluate the safety, tolerability, and immune responses of two experimental mRNA HIV vaccines in adults living with HIV who are in overall good health. The study will enroll about 42 participants at multiple study sites. Researchers will assess whether these vaccines can start or strengthen antibody responses against HIV. The study will also evaluate how a closely monitored planned pause in antiretroviral therapy affects these immune responses.
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Local reactogenicity following study product administration
Timeframe: 14 days following each vaccination
Systemic reactogenicity following study product administration
Timeframe: 14 days following each vaccination
Number and description of serious adverse events (SAEs)
Timeframe: Through study completion, expected to be up to 88 weeks
Number and description of medically attended adverse events (MAAEs)
Timeframe: Through study completion, expected to be up to 88 weeks
Number and description of adverse events of special interest (AESIs)
Timeframe: Through study completion, expected to be up to 88 weeks
Number and description of adverse events leading to study product discontinuation or participant withdrawal
Timeframe: Through study completion, expected to be up to 88 weeks
Number and description of adverse events (AEs) following study product administration
Timeframe: 30 days following each vaccination
Response rate of differential serum neutralizing antibody responses to precursor detection viruses
Timeframe: At Baseline (Week 0) and 2 weeks after last vaccination
Magnitude of differential serum neutralizing antibody responses to precursor detection viruses
Timeframe: At Baseline (Week 0) and 2 weeks after last vaccination
Response rate of differential serum neutralizing antibody responses to precursor detection viruses after last vaccination and after ART restart
Timeframe: 6 weeks after last vaccination and 8 weeks after ART restart
Magnitude of differential serum neutralizing antibody responses to precursor detection viruses after last vaccination and after ART restart
Timeframe: 6 weeks after last vaccination and 8 weeks after ART restart