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NOT YET RECRUITING
NCT07569029
PHASE1

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)

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

42

Start Date

2026-06-02

Completion Date

2027-08-31

Last Updated

2026-05-06

Healthy Volunteers

No

Conditions

Interventions

BIOLOGICAL

DV700P-RNA 100 mcg

Intramuscular injection

BIOLOGICAL

DV701B1.1-RNA 100 mcg

Intramuscular injection

Locations (9)

Alabama CRS (Site ID: 31788)

Birmingham, Alabama, United States

The Ponce de Leon Center CRS (Site ID: 5802)

Atlanta, Georgia, United States

Beth Israel Deaconess Medical Center / BIDMC VCRS (Site ID: 32077)

Boston, Massachusetts, United States

Seattle Vaccine and Prevention CRS (Site ID: 30331)

Seattle, Washington, United States

Fundacion Huesped CRS (Site ID: 31957)

Buenos Aires, Argentina

Centro de Investigaciones Tecnológicas, Biomédicas y Medioambientales CRS (CITBM) - Unidad de Ensayos Clínicos (UNIDEC) (Site ID: 31970)

Bellavista, Provincia Constitucional del Callao, Peru

Via Libre CRS (Site ID: 31909)

Lima, Peru

Barranco CRS (Site ID: 11301)

Lima, Peru

San Miguel CRS (Site ID: 11302)

Lima, Peru