A Trial to Evaluate an HIV Envelope Trimer, N332-GT5 gp140, Adjuvanted With SMNP in Adult Participants Without HIV
Public ClinicalTrials.gov record NCT06033209. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 1 Clinical Trial to Evaluate the Safety and Immunogenicity of an HIV Envelope Trimer, N332-GT5 gp140, Adjuvanted With SMNP in Adult Participants Without HIV
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT06033209
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 57 participants
Conditions and interventions
Conditions
Interventions
- 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
- SMNP (IM, Fractioned) Biological
- SMNP (SC, Bolus) Biological
- SMNP (SC, Fractioned) Biological
Biological
Eligibility (public fields only)
- Age range
- 18 Years to 55 Years
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 27, 2023 (Actual)
- Primary completion
- Dec 10, 2025 (Actual)
- Completion
- Mar 13, 2026 (Actual)
- Last update posted
- Jul 14, 2026
2023 – 2026
United States locations
- U.S. sites
- 8
- U.S. states
- 6
- U.S. cities
- 7
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Bridge HIV CRS | San Francisco | California | 94102 | — |
| Atlanta - Hope Clinic | Decatur | Georgia | 30030 | — |
| Brigham & Women's Hospital | Boston | Massachusetts | 02115 | — |
| Columbia University Medical Center | New York | New York | 100032 | — |
| New York Blood Center | New York | New York | 10065 | — |
| University of Rochester Medical Center | Rochester | New York | 14642 | — |
| Penn Prevention CRS [Site ID: 30310] | Philadelphia | Pennsylvania | 19104 | — |
| Vanderbilt Institute for Infection, Immunology and Inflammation | Nashville | Tennessee | 37232-2582 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06033209, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 14, 2026 · Synced Oct 15, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT06033209 live on ClinicalTrials.gov.