NCT05903339

Clinical Trial to Evaluate the Safety and Immunogenicity of Ferritin Nanoparticles Expressing Native-like HIV-1 Envelope Trimers Followed by Boost With mRNA Lipid Nanoparticles Encoding a Native-like HIV-1 Envelope Trimer in Adults Without HIV

A Phase 1 Clinical Trial to Evaluate the Safety and Immunogenicity of Ferritin Nanoparticles Expressing Native-like HIV-1 Envelope Trimers Followed by Boost With mRNA Lipid Nanoparticles Encoding a Native-like HIV-1 Envelope Trimer in Adults Without HIV

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) · NIH
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This first-in-human (FIH) phase 1 clinical trial will evaluate a prime-boost regimen of immunogens designed to induce HIV-1 Env V3-glycan-specific broadly neutralizing antibodies (V3G bNAbs). The priming immunogen (V3G CH848 Pr-NP1) consists of ferritin NPs expressing 8 copies of an Env trimer. This immunogen will be boosted with an mRNA LNP (V3G CH848 mRNA-Tr2), encoding a soluble Env trimer which does not utilize the ferritin NP design.

Conditions

• Hiv

Interventions

Type	Name	Description
DRUG	V3G CH848 Pr-NP1 60mcg	(60 mcg)
DRUG	3M-052-AF 5mcg	(5 mcg)
DRUG	Alum 500 mcg	(500 mcg)
DRUG	V3G CH848 mRNA-Tr2 50mcg	(50 mcg)
DRUG	ACU-026-001-1 2.0mg	(2.0 mg)
DRUG	V3G CH848 Pr-NP1 100mcg	(100 mcg)

Timeline

• Start date: 2023-08-29
• Primary completion: 2025-05-16
• Completion: 2026-10-30
• First posted: 2023-06-15
• Last updated: 2026-01-14

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated drug study