NCT06267872

A Clinical Trial in Adult Participants Without HIV and in Overall Good Health to Evaluate the Safety and Immunogenicity of CD4BS CH505M5 Pr-NP1 Followed by CH505 TF chTrimer Boost Both Adjuvanted With Either Lipid Nanoparticles (LNPs) or 3M-052-AF + Alum

A Phase 1 Clinical Trial in Adult Participants Without HIV and in Overall Good Health to Evaluate the Safety and Immunogenicity of CD4BS CH505M5 Pr-NP1 Followed by CH505 TF chTrimer Boost Both Adjuvanted With Either Lipid Nanoparticles (LNPs) or 3M-052-AF + Alum

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) · NIH
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This is a multicenter, open-label, phase 1 clinical trial to test two human immunodeficiency virus (HIV) vaccines with two adjuvants. An adjuvant is an ingredient used with some vaccines that may help people make an immune response. HIV is the virus that causes acquired immunodeficiency syndrome (AIDS). About 42 people will take part in the HVTN 309 clinical trial. This clinical trial will take place at multiple sites in the US and South Africa and the clinical trial is divided into 3 parts: Part A, Part B and Part C. About 3 people will participate in Part A of this study. After results from Part A are reviewed, it will be determined whether or not Part B and Part C of the clinical trial will proceed.

Conditions

• HIV

Interventions

Type	Name	Description
BIOLOGICAL	CD4BS CH505M5 Pr-NP1	A ferritin NP expressing 8 copies of an HIV-1 Env protein trimer. To be administered intramuscularly (IM).
BIOLOGICAL	CH505TF chTrimer	A stabilized chimeric SOSIP Env trimer protein with the N-terminal sequence of CH505 TF gp120 Env transplanted into the BG505 SOSIP sequence. To be administered IM.
BIOLOGICAL	3M-052-AF (labeled as AP 60-702)	An aqueous formulation (AF) of the small molecule imidazoquinoline immune response modifier (IRM) 3M-052; toll-like receptor (TLR)7/8 agonist.
BIOLOGICAL	Aluminum Hydroxide Suspension (Alum)	Alum to be administered IM as 500 mcg (aluminum content) admixed with 3M-052-AF (5 mcg) along with CD4BS CH505M5 Pr-NP1 and CH505 TF chTrimer.
BIOLOGICAL	ACU-026-001-1 (labeled as empty LNP)	An AF consisting of 4 lipid components.

Timeline

• Start date: 2024-10-07
• Primary completion: 2025-12-30
• Completion: 2026-09-12
• First posted: 2024-02-20
• Last updated: 2025-03-26

Locations

6 sites across 2 countries: United States, South Africa

Regulatory

• FDA-regulated drug study