NCT06033209

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 57 (actual)
• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) · NIH
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Detailed description

This study will evaluate the safety and immunogenicity of combining 2 FIH products: N332-GT5 gp140 HIV trimer protein adjuvanted with SMNP, co-administered as 2 bolus immunizations (week 0 and 8) or fractionated escalating dose prime (6 immunizations over 3 weeks) followed by bolus immunization boost (week 10), via either subcutaneous (SC) route in the upper arm or intramuscular (IM) route to the deltoid. N332-GT5 gp140 is based on the BG505 MD39 native-like trimer (NLT). The dose escalation study (Part A) will determine the maximum safe dose, within our schema, of N332-GT5 gp140 and SMNP for 4 vaccination modalities: IM/bolus, IM/fractionated escalating dose prime, SC/bolus, and SC/fractionated escalating dose prime. A primary endpoint will be safety and tolerability. The trial will evaluate: (1) the concept of generalized germline targeting for HCDR3-dominant bnAb precursors; (2) germline targeting for V3-glycan (V3G)-specific BG18-class bnAbs; (3) establishing a safe and effective dose of SMNP in humans; (4) immunogenicity of an HIV Env trimer adjuvanted with SMNP; and (5) ranking of HIV trimer immune response magnitude and quality for bolus/IM, bolus/SC, and fractionated escalating dose with one of either IM or SC.

Conditions

• HIV

Interventions

Type	Name	Description
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

Timeline

• Start date: 2023-11-27
• Primary completion: 2025-12-10
• Completion: 2026-03-13
• First posted: 2023-09-13
• Last updated: 2026-03-27

Locations

8 sites across 1 country: United States

Regulatory

• FDA-regulated drug study