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NCT06033209 · ClinicalTrials.gov registry record · Phase 1
A Trial to Evaluate an HIV Envelope Trimer, N332-GT5 gp140, Adjuvanted With SMNP 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
- 57
- Enrollment target
- 8
- Study locations
NCT06033209 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 57 participants, below the 440-participant average among 303 other HIV trials with a reported enrollment target (87% lower). The trial reports 8 study locations across 6 states.
The verdict
NCT06033209, 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
- 57 participants
- Enrollment target
- 8
- Study locations
Study Summary
HVTN 144 is a phase 1 clinical trial to being conducted to evaluate the safety and immunogenicity of an HIV envelope trimer, N332-GT5 gp140, adjuvanted with saponin/MPLA nanoparticles (SMNP) in adult participants without HIV. The study aims to evaluate the safety and tolerability of N332-GT5 gp140 adjuvanted with SMNP in adult volunteers without HIV and in overall good health, including identifying a safe and tolerable dose, route, and schedule of administration of the novel adjuvant SMNP. The study also aims to evaluate the induction of BG18-class immunoglobulin G (IgG) B-cell responses in memory B cells by the study regimens and compare the responses between the different groups. HVTN 144 will be conducted in 2 parts with 84 volunteers without HIV and in overall good health, aged 18 to 55 years. The study duration is 22 months which includes 8 months for enrollment, planned safety holds, follow-up, and Adverse Event of Special Interest (AESI) health contact 1 year after last vaccination.
Conditions Studied
Interventions
- BIOLOGICAL N332-GT5 gp140 (IM, Bolus)
- BIOLOGICAL N332-GT5 gp140 (IM, Fractioned)
- BIOLOGICAL N332-GT5 gp140 (SC, Bolus)
- BIOLOGICAL N332-GT5 gp140 (SC, Fractioned)
- BIOLOGICAL SMNP (IM, Bolus)
Study Locations (8)
New York
- Columbia University Medical Center - New York
- New York Blood Center - New York
- University of Rochester Medical Center - Rochester
California
- Bridge HIV CRS - San Francisco
Georgia
- Atlanta - Hope Clinic - Decatur
Massachusetts
- Brigham & Women's Hospital - Boston
Pennsylvania
- Penn Prevention CRS [Site ID: 30310] - Philadelphia
Tennessee
- Vanderbilt Institute for Infection, Immunology and Inflammation - Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 57 participants |
| Start Date | 2023-11-27 |
| Est. Completion | 2026-07-21 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06033209
The ClinicalTrials.gov registry entry for NCT06033209 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 57 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 (87% 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 5 interventions - of which N332-GT5 gp140 (IM, Bolus) is the first listed.
NCT06033209 reports 8 study locations spanning 6 distinct geographic areas - top geographies include New York, California, Georgia.
Frequently Asked Questions
What is clinical trial NCT06033209 about?
NCT06033209 is a clinical study titled "A Trial to Evaluate an HIV Envelope Trimer, N332-GT5 gp140, Adjuvanted With SMNP in Adult Participants Without HIV". HVTN 144 is a phase 1 clinical trial to being conducted to evaluate the safety and immunogenicity of an HIV envelope trimer, N332-GT5 gp140, adjuvanted with saponin/MPLA nanoparticles (SMNP) in adult participants without HIV. The study aims to evaluate the safety and tolerability of N332-GT5 gp140 a...
What is the current status of trial NCT06033209?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 57 participants. The study started on 2023-11-27. Estimated completion is 2026-07-21.
What conditions does trial NCT06033209 study?
This clinical trial studies the following conditions: HIV.
What interventions are being tested in trial NCT06033209?
The interventions under investigation include: N332-GT5 gp140 (IM, Bolus) (BIOLOGICAL), N332-GT5 gp140 (IM, Fractioned) (BIOLOGICAL), N332-GT5 gp140 (SC, Bolus) (BIOLOGICAL), N332-GT5 gp140 (SC, Fractioned) (BIOLOGICAL), SMNP (IM, Bolus) (BIOLOGICAL).
Who is sponsoring clinical trial NCT06033209?
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 NCT06033209 being conducted?
This trial has 8 study locations across California, Georgia, Massachusetts, New York, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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