NCT06033209 is a Phase 1 clinical trial of N332-GT5 gp140 (IM, Bolus) in HIV, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

Who is sponsoring NCT06033209?

NCT06033209 is sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

What drugs are being tested in NCT06033209?

Interventions in NCT06033209: N332-GT5 gp140 (IM, Bolus), N332-GT5 gp140 (IM, Fractioned), N332-GT5 gp140 (SC, Bolus), N332-GT5 gp140 (SC, Fractioned), SMNP (IM, Bolus), SMNP (IM, Fractioned), SMNP (SC, Bolus), SMNP (SC, Fractioned).

Is NCT06033209 still recruiting?

NCT06033209 is currently completed. Last updated 27 March 2026.

Last reviewed 2026-03-27 · How we verify

NCT06033209

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Trial to Evaluate an HIV Envelope Trimer, N332-GT5 gp140, Adjuvanted With SMNP in Adult Participants Without HIV

Completed Phase 1 Last updated 27 March 2026

What this trial tests

Phase 1 trial testing N332-GT5 gp140 (IM, Bolus) in HIV in 57 participants. Completed in 13 March 2026.

Timeline

27 November 2023

Primary endpoint
10 December 2025

13 March 2026

Quick facts

Lead sponsor	National Institute of Allergy and Infectious Diseases (NIAID)
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	sequential
Masking	none
Primary purpose	prevention
Enrollment	57
Start date	27 November 2023
Primary completion	10 December 2025
Estimated completion	13 March 2026
Sites	8 locations across United States

Drugs / interventions tested

N332-GT5 gp140 (IM, Bolus) — full drug profile →
N332-GT5 gp140 (IM, Fractioned) — full drug profile →
N332-GT5 gp140 (SC, Bolus) — full drug profile →
N332-GT5 gp140 (SC, Fractioned)
SMNP (IM, Bolus)
SMNP (IM, Fractioned)
SMNP (SC, Bolus) — full drug profile →
SMNP (SC, Fractioned) — full drug profile →

Conditions studied

HIV — all drugs for HIV →

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Who can join

Adults 18 to 55, any sex, with HIV. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

mRNA-LNP HIV-1 trimer boosters elicit precursors to broad neutralizing antibodies.
Xie Z, Lin YC, Steichen JM, Ozorowski G, et al · · 2024 · cited 65× · PMID 38753770 · DOI 10.1126/science.adk0582
Vaccine priming of rare HIV broadly neutralizing antibody precursors in nonhuman primates.
Steichen JM, Phung I, Salcedo E, Ozorowski G, et al · · 2024 · cited 61× · PMID 38753769 · DOI 10.1126/science.adj8321
Diverse priming outcomes under conditions of very rare precursor B cells.
Madden PJ, Marina-Zárate E, Rodrigues KA, Steichen JM, et al · · 2025 · cited 12× · PMID 40168992 · DOI 10.1016/j.immuni.2025.03.003
Exploring synergies between B- and T-cell vaccine approaches to optimize immune responses against HIV-workshop report.
Maciel M, Amara RR, Bar KJ, Crotty S, et al · · 2024 · cited 12× · PMID 38383616 · DOI 10.1038/s41541-024-00818-y
Vaccination with nanoparticles displaying gH/gL from Epstein-Barr virus elicits limited cross-protection against rhesus lymphocryptovirus.
Edwards KR, Schmidt K, Homad LJ, Kher GM, et al · · 2024 · cited 9× · PMID 38781964 · DOI 10.1016/j.xcrm.2024.101587
Modulation of antigen delivery and lymph node activation in nonhuman primates by saponin adjuvant saponin/monophosphoryl lipid A nanoparticle.
Yousefpour P, Zhang YJ, Maiorino L, Melo MB, et al · · 2024 · cited 8× · PMID 39677368 · DOI 10.1093/pnasnexus/pgae529
The saponin monophosphoryl lipid A nanoparticle adjuvant induces dose-dependent HIV vaccine responses in nonhuman primates.
Ramezani-Rad P, Marina-Zárate E, Maiorino L, Myers A, et al · · 2025 · cited 7× · PMID 40036068 · DOI 10.1172/jci185292
Simultaneous priming of HIV broadly neutralizing antibody precursors to multiple epitopes by germline-targeting mRNA-LNP immunogens in mouse models.
Xie Z, Wang X, Yan Y, Steichen JM, et al · · 2025 · cited 5× · PMID 41105753 · DOI 10.1126/sciimmunol.adu7961

Verify or expand the search:

Other recruiting trials for HIV

Currently open trials in the same condition.

NCT06705478 — Pramipexole Versus Escitalopram to Treat Major Depressive Disorder (MDD) and Comorbid MDD With Mild Neurocognitive Disor · Phase 2 · recruiting
NCT07221214 — GLP-1 Receptor Agonists to Decrease Ethanol and CVD Risk in HIV · Phase 2 · recruiting
NCT07226128 — The Effects of Cognitive Behavioral Therapy on Insulin Resistance in People With HIV · NA · recruiting
NCT07390474 — Clinical Trial to Evaluate the Safety and Immunogenicity of the V2 Apex-Directed Immunogens DV201P-RNA and DV202B1-RNA i · Phase 1 · recruiting
NCT07390955 — A Study of Safety and Drug Levels of ePGT121v1-LS, PGDM1400LS, and VRC07-523LS in Adult Participants Without HIV-1 · Phase 1 · recruiting

Other National Institute of Allergy and Infectious Diseases (NIAID) trials

Trials by the same sponsor.

NCT07216794 — Small Trial of Alendronate Impact on the Reservoir of HIV · Phase 2 · not yet recruiting
NCT07215858 — BPL-1357 Against H1N1 Influenza Virus Challenge · Phase 2 · recruiting
NCT06987318 — A Study to Evaluate the Safety and Antiviral Activity of Two Human Monoclonal Antibodies (VRC07-523LS and PGT121.414.LS) · Phase 1 · not yet recruiting
NCT07124559 — A Study of Daily Rifapentine Combined With Isoniazid (1HP) for Tuberculosis Prevention in Children Less Than 13 Years of · Phase 1, PHASE2 · not yet recruiting
NCT07342491 — Dasatinib for HIV-1 Reservoir Reduction · Phase 1 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT06033209 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by National Institute of Allergy and Infectious Diseases (NIAID)
Last refreshed: 27 March 2026

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06033209.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing