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NCT06919016 · ClinicalTrials.gov registry record · Phase 1
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
A Phase 1 study of HIV-1-infection, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Active
- Registry status
- Phase 1
- Development phase
- 45
- Enrollment target
- 8
- Study locations
NCT06919016: Active Phase 1 study of HIV-1-infection, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT06919016 is a Phase 1 study of HIV-1-infection that is active but no longer recruiting, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 45 participants, below the 351-participant average among 71 other HIV-1-infection trials with a reported enrollment target (87% lower). The trial reports 8 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06919016, a Phase 1 study of HIV-1-infection, is active but no longer recruiting, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 45 participants
- Enrollment target
- 8
- Study locations
Study 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.
Conditions Studied
Interventions
- BIOLOGICAL DV700P-RNA
- BIOLOGICAL DV701B1.1-RNA
Study Locations (8)
New York
- Columbia P&S CRS (Site ID: 30329) - New York
- University of Rochester Medical Center (Site ID: 31467) - Rochester
Alabama
- University of Alabama Medical Center (Site ID: 31788) - Birmingham
Georgia
- The Hope Clinic of the Emory Vaccine Center CRS (Site ID: 31440) - Decatur
Massachusetts
- Brigham and Women's Hospital (Site ID: 30007) - Boston
Pennsylvania
- University of Pittsburgh (Site ID: 1001) - Pittsburgh
Tennessee
- Vanderbilt University Medical Center (Site ID: 30352) - Nashville
Washington
- Seattle Vaccine and Prevention CRS (Site ID: 30331) - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2025-08-06 |
| Est. Completion | 2027-03-25 |
| Phase | Phase 1 |
What the registry record for NCT06919016 still lists
NCT06919016 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 45 participants, a relatively small participant target, below the 351-participant average among 71 other HIV-1-infection trials with a reported enrollment target (87% lower).
The record links to 1 condition, with HIV-1-infection appearing as the primary indexed condition, and to 2 interventions - of which DV700P-RNA is the first listed.
NCT06919016 lists 8 locations in 7 states (New York, Alabama, Georgia).
Frequently Asked Questions
What is clinical trial NCT06919016 about?
NCT06919016 is a clinical study titled "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". 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 unc...
What is the current status of trial NCT06919016?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 45 participants. The study started on 2025-08-06. Estimated completion is 2027-03-25.
What conditions does trial NCT06919016 study?
This clinical trial studies the following conditions: HIV-1-infection.
What interventions are being tested in trial NCT06919016?
The interventions under investigation include: DV700P-RNA (BIOLOGICAL), DV701B1.1-RNA (BIOLOGICAL).
Who is sponsoring clinical trial NCT06919016?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06919016 being conducted?
This trial has 8 study locations across Alabama, Georgia, Massachusetts, New York, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06919016's enrollment target sits among peer trials
45 52nd of 71 higher than 20 of 71 other HIV-1-infection trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other HIV-1-infection trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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