RecruitingPhase 1NCT07390474

Clinical Trial to Evaluate the Safety and Immunogenicity of the V2 Apex-Directed Immunogens DV201P-RNA and DV202B1-RNA in Adult Participants Without HIV

A Phase 1 Clinical Trial to Evaluate the Safety and Immunogenicity of the V2 Apex-Directed Immunogens DV201P-RNA and DV202B1-RNA in Adult Participants Without HIV


Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Enrollment

40 participants

Start Date

Mar 25, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

This is a phase 1, multicenter, open-label, dose escalation, first-in-human (FIH) trial to evaluate the safety and immunogenicity of DV201P-RNA and DV202B1-RNA, immunogens designed to induce HIV-1 envelope (Env) V2 apex-specific broadly neutralizing antibodies (V2 apex bnAbs). Both vaccines consist of a modified mRNA encapsulated in lipid nanoparticles (LNP) that when translated in cells produces HIV-1 Env gp150 transmembrane trimers. The trial will enroll adult volunteers without HIV and in overall good health.


Eligibility

Min Age: 18 YearsMax Age: 55 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a biological treatment called DV201P-RNA and a biological treatment called DV202B1-RNA for people with hiv. The study is currently recruiting participants at 7 locations. People eligible for this study include aged 18 Years to 55 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

BIOLOGICALDV201P-RNA

To be administered intramuscularly as a split dose.

BIOLOGICALDV202B1-RNA

To be administered intramuscularly as a split dose.


Locations(7)

The Ponce de Leon Center CRS

Atlanta, Georgia, United States

The Hope Clinic of the Emory Vaccine Research Center; Emory University

Decatur, Georgia, United States

Beth Israel Deaconess Medical Center VCRS (BIDMC VCRS Site # 32077)

Boston, Massachusetts, United States

Columbia P&S CRS (Site ID: 30329)

New York, New York, United States

University of Rochester Vaccines to Prevent HIV Infection CRS

Rochester, New York, United States

Penn Prevention CRS

Philadelphia, Pennsylvania, United States

University of Pittsburgh CRS

Pittsburgh, Pennsylvania, United States

View Full Details on ClinicalTrials.gov

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NCT07390474


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