NCT06557785

A Clinical Trial to Evaluate the Safety and Immunogenicity of CH505M5 N197D mRNA-gp160 Followed by CH505 TF mRNA-gp160 in Adults in Overall Good Health Without HIV

A Phase 1 Clinical Trial to Evaluate the Safety and Immunogenicity of CH505M5 N197D mRNA-gp160 Followed by CH505 TF mRNA-gp160 in Adults in Overall Good Health Without HIV

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 53 (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, non-randomized, dose escalation, first-in-human (FIH) trial to evaluate the safety and immunogenicity of CH505M5 N197D mRNA-gp160 and CH505 TF mRNA-gp160. Both products are mRNA encapsulated in lipid nanoparticles (LNPs) (subsequently referred to as mRNA-LNPs). The primary hypotheses are: 1. the CH505M5 N197D mRNA-gp160 will expand CH235-like B cell precursors, 2. the CH505 TF mRNA-gp160 will boost CH235-like bnAb B cell precursors to acquire more functional mutations needed for broadly neutralizing antibody (bnAb) development, and 3. these mRNA-LNPs will be safe and well tolerated among individuals living without HIV.

Conditions

• HIV Infections

Interventions

Type	Name	Description
BIOLOGICAL	CH505M5 N197D mRNA-gp160	To be administered intramuscularly as a split dose
BIOLOGICAL	CH505 TF mRNA-gp160	To be administered intramuscularly as a split dose

Timeline

• Start date: 2024-11-25
• Primary completion: 2027-03-09
• Completion: 2027-03-09
• First posted: 2024-08-16
• Last updated: 2026-01-14

Locations

7 sites across 2 countries: United States, Thailand

Regulatory

• FDA-regulated drug study