Clinical Research Directory
Browse clinical research sites, groups, and studies.
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)
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
DV700P-RNA
Intramuscular (IM) injection
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