A Nonrandomized Phase 1 Clinical Trial to Evaluate the Safety and Tolerability of DV700P-RNA and DV701B1.1-RNA Immunization in Combination With Antiretroviral Analytical Treatment Interruption (ATI) in People Living With HIV for Elicitation of V3-glycan Antibodies
National Institute of Allergy and Infectious Diseases (NIAID)
Summary
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.
Eligibility
- Age range
- 18–60 years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- BiologicalDV700P-RNA 100 mcg
Intramuscular injection
- BiologicalDV701B1.1-RNA 100 mcg
Intramuscular injection
Locations (9)
- Alabama CRS (Site ID: 31788)Birmingham, Alabama
- The Ponce de Leon Center CRS (Site ID: 5802)Atlanta, Georgia
- Beth Israel Deaconess Medical Center / BIDMC VCRS (Site ID: 32077)Boston, Massachusetts
- Seattle Vaccine and Prevention CRS (Site ID: 30331)Seattle, Washington
- Fundacion Huesped CRS (Site ID: 31957)Buenos Aires
- Centro de Investigaciones Tecnológicas, Biomédicas y Medioambientales CRS (CITBM) - Unidad de Ensayos Clínicos (UNIDEC) (Site ID: 31970)Bellavista, Provincia Constitucional del Callao