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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.
NCT06332339 · View on ClinicalTrials.gov ↗
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 |
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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. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 45 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 1,295 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06332339 reports 6 study locations spanning 5 distinct geographic areas — top geographies include New York, Alabama, Georgia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06332339?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 1,295 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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