RecruitingPhase 1NCT07569029

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

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


Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Enrollment

42 participants

Start Date

Sep 15, 2026

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a biological treatment called DV700P-RNA 100 mcg and a biological treatment called DV701B1.1-RNA 100 mcg for people with hiv. The study is currently recruiting participants at 19 locations. People eligible for this study include aged 18 Years to 60 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALDV700P-RNA 100 mcg

Intramuscular injection

BIOLOGICALDV701B1.1-RNA 100 mcg

Intramuscular injection


Locations(16)

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

View Full Details on ClinicalTrials.gov

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NCT07569029


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