National Institute of Allergy and Infectious Diseases (NIAID)
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.
Inclusion Criteria: * Able and willing to provide informed consent. * Age 18 to 60 years. * Documented HIV infection. * Lowest (nadir) CD4+ count between 250 and 450 cells/mm³. * On stable combination antiretroviral therapy (ART) for at least 48 weeks prior to screening. * Plasma HIV RNA \<50 copies/mL for at least 48 weeks prior to enrollment, allowing limited transient increases. * CD4+ count \>450 cells/mm³ and CD4+ percentage ≥15%. * Willing and able to comply with study visits and procedures. * Agrees not to participate in another investigational study during participation unless approve…
Intramuscular injection
Intramuscular injection