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NCT06665646 · ClinicalTrials.gov registry record · Phase 1
Clinical Trial to Evaluate the Safety and Immunogenicity of Hiltonol, Poly-ICLC-adjuvanted CD40.HIVRI.Env (VRIPRO) in Adult Participants Who Previously Participated in HVTN 706
A Phase 1 study of HIV Infections, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Recruiting
- Registry status
- Phase 1
- Development phase
- 40
- Enrollment target
- 7
- Study locations
NCT06665646: Recruiting Phase 1 study of HIV Infections, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT06665646 is a Phase 1 study of HIV Infections that is actively recruiting participants, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 40 participants, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (91% lower). The trial reports 7 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06665646, a Phase 1 study of HIV Infections, is actively recruiting participants, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 40 participants
- Enrollment target
- 7
- Study locations
Study Summary
The clinical schedule will consist of 3 injections of CD40.HIVRI.Env (VRIPRO) at weeks 0, 4, and 24.40 volunteers without HIV and in overall good health, aged 18 to 60 years, who previously participated in the HVTN 706 trial.
Primary Outcome
Local events at the injection site include pain/tenderness, induration and erythema. These will be graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1, July 2017 (exceptions apply)
Conditions Studied
Interventions
- BIOLOGICAL CD40.HIVRI.Env (VRIPRO)
- BIOLOGICAL Hiltonol Poly-ICLC-adjuvant
Study Locations (7)
California
- Bridge HIV CRS - San Francisco
Georgia
- The Hope Clinic of the Emory Vaccine Center CRS - Decatur
Massachusetts
- Brigham and Women's Hospital Vaccine CRS (BWH VCRS) - Boston
New York
- Columbia P&S CRS - New York
Pennsylvania
- Penn Prevention CRS (Site ID# 30310) - Philadelphia
Tennessee
- Vanderbilt Vaccine (VV) CRS - Nashville
Washington
- Seattle Vaccine and Prevention CRS - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2025-09-14 |
| Est. Completion | 2027-05-04 |
| Phase | Phase 1 |
What NCT06665646 shows while recruiting
NCT06665646 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (91% lower).
The record links to 1 condition, with HIV Infections appearing as the primary indexed condition, and to 2 interventions - of which CD40.HIVRI.Env (VRIPRO) is the first listed.
NCT06665646 lists 7 locations in 7 states (California, Georgia, Massachusetts).
Frequently Asked Questions
What is clinical trial NCT06665646 about?
NCT06665646 is a clinical study titled "Clinical Trial to Evaluate the Safety and Immunogenicity of Hiltonol, Poly-ICLC-adjuvanted CD40.HIVRI.Env (VRIPRO) in Adult Participants Who Previously Participated in HVTN 706". The clinical schedule will consist of 3 injections of CD40.HIVRI.Env (VRIPRO) at weeks 0, 4, and 24.40 volunteers without HIV and in overall good health, aged 18 to 60 years, who previously participated in the HVTN 706 trial.
What is the current status of trial NCT06665646?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 40 participants. The study started on 2025-09-14. Estimated completion is 2027-05-04.
What conditions does trial NCT06665646 study?
This clinical trial studies the following conditions: HIV Infections.
What interventions are being tested in trial NCT06665646?
The interventions under investigation include: CD40.HIVRI.Env (VRIPRO) (BIOLOGICAL), Hiltonol Poly-ICLC-adjuvant (BIOLOGICAL).
Who is sponsoring clinical trial NCT06665646?
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 NCT06665646 being conducted?
This trial has 7 study locations across California, 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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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06665646's enrollment target sits among peer trials
40 390th of 542 higher than 139 of 542 other HIV Infections trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other HIV Infections 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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