A 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
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) • ClinicalTrials.gov ID: NCT07569029
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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.
Interventions
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DV700P-RNA 100 mcg
(Biological)
Intramuscular injection
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DV701B1.1-RNA 100 mcg
(Biological)
Intramuscular injection
Eligibility criteria
Conditions
Locations
- Alabama CRS (Site ID: 31788) — Birmingham, Alabama, United States
- The Ponce de Leon Center CRS (Site ID: 5802) — Atlanta, Georgia, United States
- The Hope Clinic of the Emory Vaccine Center CRS (Site #: 31440) — Decatur, Georgia, United States
- Beth Israel Deaconess Medical Center / BIDMC VCRS (Site ID: 32077) — Boston, Massachusetts, United States
- Columbia P&S CRS (Site#: 30329) — New York, New York, United States
- University of Rochester Vaccines to Prevent HIV Infection CRS (Site#: 31467) — Rochester, New York, United States
- Penn Prevention CRS (Site#: 30310) — Philadelphia, Pennsylvania, United States
- Houston Advancing Research Team CRS (Site # 31473) — Houston, Texas, United States
- Seattle Vaccine and Prevention CRS (Site ID: 30331) — Seattle, Washington, United States
- Fundacion Huesped CRS (Site ID: 31957) — Buenos Aires, Buenos Aires, Argentina
- Via Libre CRS (Site ID: 31909) — Lima, Lima Province, Peru
- Barranco CRS (Site ID: 11301) — Lima, Lima Province, Peru
- San Miguel CRS (Site ID: 11302) — Lima, Lima Province, Peru
- Centro de Investigaciones Tecnológicas, Biomédicas y Medioambientales CRS (CITBM) - Unidad de Ensayos Clínicos (UNIDEC) (Site ID: 31970) — Bellavista, Provincia Constitucional del Callao, Peru
- Seke South CRS/30294 University of Zimbabwe -Clinical Trials Research Centre (UZ-CTRC) — Harare, Zimbabwe
- Spilhaus CRS/30314 University of Zimbabwe -Clinical Trials Research Centre (UZ-CTRC) — Harare, Zimbabwe
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Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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