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.
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.
Current use of ART that includes non-nucleoside reverse transcriptase inhibitors (NNRTIs).
Use of long-acting ART within 3 months prior to enrollment.
Known resistance to any component of the current ART regimen (excluding M184V/I mutation).
Resistance to one or more drugs in two or more ART classes (excluding M184V/I mutation).
National Institute of Allergy and Infectious Diseases (NIAID)
Lead sponsor
Department of Health and Human Services
Collaborator
Duke University
Collaborator