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ACTIVE NOT RECRUITING
NCT06919016
PHASE1

A Study to Evaluate the Safety and Immunogenicity of the V3-region Directed Immunogens DV700P-RNA Followed by DV701B1.1-RNA in Adults Without HIV

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

View on ClinicalTrials.gov

Summary

This is a phase 1, first-in-human (FIH) trial for two vaccines, DV700P-RNA and DV701B1.1-RNA. This means it is the first time these study products are being tested in people. The purpose of this study is to see if the study products are safe, if people are able to take them without becoming too uncomfortable, and how a person's immune system responds to them (a person's immune system protects them from infections and disease). Forty-five volunteers without HIV and in overall good health, aged 18 to 55 years, will be enrolled and be in this study for about 16 months (about 12 visits), Study procedures will include blood draws, injections, and the collection of white blood cells and cells from their lymph nodes.

Official title: A Phase 1 Clinical Trial to Evaluate the Safety and Immunogenicity of the V3-region Directed Immunogens DV700P-RNA (Prime) Followed by DV701B1.1-RNA (Boost) in Adult Participants Without HIV

Key Details

Gender

All

Age Range

18 Years - 55 Years

Study Type

INTERVENTIONAL

Enrollment

45

Start Date

2025-08-06

Completion Date

2027-03-25

Last Updated

2025-12-16

Healthy Volunteers

Yes

Conditions

Interventions

BIOLOGICAL

DV700P-RNA

Intramuscular (IM) injection

BIOLOGICAL

DV701B1.1-RNA

IM injection

Locations (8)

University of Alabama Medical Center (Site ID: 31788)

Birmingham, Alabama, United States

The Hope Clinic of the Emory Vaccine Center CRS (Site ID: 31440)

Decatur, Georgia, United States

Brigham and Women's Hospital (Site ID: 30007)

Boston, Massachusetts, United States

Columbia P&S CRS (Site ID: 30329)

New York, New York, United States

University of Rochester Medical Center (Site ID: 31467)

Rochester, New York, United States

University of Pittsburgh (Site ID: 1001)

Pittsburgh, Pennsylvania, United States

Vanderbilt University Medical Center (Site ID: 30352)

Nashville, Tennessee, United States

Seattle Vaccine and Prevention CRS (Site ID: 30331)

Seattle, Washington, United States