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

NCT06033209 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 57

Last updated 2026-03-27

No results posted yet for this 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

Interventions

BIOLOGICAL

N332-GT5 gp140 (IM, Bolus)

IM in the deltoid

BIOLOGICAL

N332-GT5 gp140 (IM, Fractioned)

IM in the deltoid, Fractionated escalating dose for prime

BIOLOGICAL

N332-GT5 gp140 (SC, Bolus)

SC in the upper arm

BIOLOGICAL

N332-GT5 gp140 (SC, Fractioned)

SC in the upper arm, Fractionated escalating dose for prime

BIOLOGICAL

SMNP (IM, Bolus)

IM in the deltoid

BIOLOGICAL

SMNP (IM, Fractioned)

IM in the deltoid, Fractionated escalating dose for prime

BIOLOGICAL

SMNP (SC, Bolus)

SC in the upper arm

BIOLOGICAL

SMNP (SC, Fractioned)

SC in the upper arm, Fractionated escalating dose for prime

Sponsors & Collaborators

Principal Investigators

  • Lindsey Baden · Brigham and Women's Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-11-27
Primary Completion
2025-12-10
Completion
2026-03-13
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06033209 on ClinicalTrials.gov