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NCT06332339 · ClinicalTrials.gov registry record · Phase 1
Clinical Trial to Evaluate the Safety, Tolerability, and Immunogenicity of 16055 NFL Delta Gly4 Env Protein Trimer and Trimer 4571 Combined With 3M-052-AF + Alum Adjuvant and Ad4-Env145NFL Viral Particles as Heterologous Prime-boost Regimens in Adult Participants Without HIV.
A Phase 1 study of HIV, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Active
- Registry status
- Phase 1
- Development phase
- 45
- Enrollment target
- 6
- Study locations
NCT06332339 is a Phase 1 study of HIV 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 440-participant average among 303 other HIV trials with a reported enrollment target (90% lower). The trial reports 6 study locations across 5 states.
The verdict
NCT06332339, a Phase 1 study of HIV, 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
- 6
- Study locations
Study Summary
The goal of this clinical trial is to test 16055 NFL delta Gly4 Env protein trimer and Trimer 4571 combined with 3M-052-AF + Alum adjuvant and Ad4-Env145NFL viral particles as heterologous prime-boost regimens in adult participants without HIV. The main question\[s\] it aims to answer are: * Are these vaccine regimens safe and well tolerated? * Are the prime-boost vaccine regimens that include Ad4-Env145NFL and Trimer 4571 as heterologous boosts going contribute to the development of B-cell and antibody responses? Participants will attend scheduled study visits to receive their vaccine and will record symptoms on a daily eDiary.
Conditions Studied
Interventions
- BIOLOGICAL 16055 NFL delta Gly4 trimer
- BIOLOGICAL Trimer 4571
- BIOLOGICAL Ad4-Env145NFL, 5 x 108 viral particles (vp)
Study Locations (6)
New York
- Columbia P&S CRS - New York
- University of Rochester HIV/AIDS CTU - Rochester
Alabama
- Alabama CRS - Birmingham
Georgia
- The Hope Clinic of the Emory Vaccine Center CRS Site# 31440 - Decatur
Massachusetts
- Brigham and Women's Hospital Vaccine CRS (BWH VCRS) - Boston
Pennsylvania
- University of Pennsylvania HIV Therapeutics and Prevention Clinical Trials Unit - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2024-03-15 |
| Est. Completion | 2026-11-11 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06332339
The ClinicalTrials.gov registry entry for NCT06332339 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 45 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 440-participant average among 303 other HIV trials with a reported enrollment target (90% lower). The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with HIV appearing as the primary indexed condition, and to 3 interventions - of which 16055 NFL delta Gly4 trimer is the first listed.
NCT06332339 reports 6 study locations spanning 5 distinct geographic areas - top geographies include New York, Alabama, Georgia.
Frequently Asked Questions
What is clinical trial NCT06332339 about?
NCT06332339 is a clinical study titled "Clinical Trial to Evaluate the Safety, Tolerability, and Immunogenicity of 16055 NFL Delta Gly4 Env Protein Trimer and Trimer 4571 Combined With 3M-052-AF + Alum Adjuvant and Ad4-Env145NFL Viral Particles as Heterologous Prime-boost Regimens in Adult Participants Without HIV.". The goal of this clinical trial is to test 16055 NFL delta Gly4 Env protein trimer and Trimer 4571 combined with 3M-052-AF + Alum adjuvant and Ad4-Env145NFL viral particles as heterologous prime-boost regimens in adult participants without HIV. The main question\[s\] it aims to answer are: * Are t...
What is the current status of trial NCT06332339?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 45 participants. The study started on 2024-03-15. Estimated completion is 2026-11-11.
What conditions does trial NCT06332339 study?
This clinical trial studies the following conditions: HIV.
What interventions are being tested in trial NCT06332339?
The interventions under investigation include: 16055 NFL delta Gly4 trimer (BIOLOGICAL), Trimer 4571 (BIOLOGICAL), Ad4-Env145NFL, 5 x 108 viral particles (vp) (BIOLOGICAL).
Who is sponsoring clinical trial NCT06332339?
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 NCT06332339 being conducted?
This trial has 6 study locations across Alabama, Georgia, Massachusetts, New York, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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