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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: Active Phase 1 study of HIV, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

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. According to ClinicalTrials.gov, the official US trial registry.

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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

HIV

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

FieldValue
Enrollment Target 57 participants
Start Date 2023-11-27
Est. Completion 2026-07-21
Phase Phase 1
National Institute of Allergy and Infectious Diseases (NIAID)

2,006 total trials

What the registry record for NCT06033209 still lists

NCT06033209 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 57 participants, a relatively small participant target, below the 440-participant average among 303 other HIV trials with a reported enrollment target (87% lower).

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 lists 8 locations in 6 states (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.

Learn More About Clinical Trials

Similar trials for HIV

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 NCT06033209's enrollment target sits among peer trials

57 206th of 303 higher than 98 of 303 other HIV trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other HIV 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.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT06033209, the US trial registry maintained by the National Library of Medicine. NCT06033209 (small enrollment · multi site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.