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 (NCT06557785)
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
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Beth Israel Deaconess Medical Center (Site ID: 32077) — Boston, Massachusetts
Age range: 18 Years to 55 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (7 Sites)
- Beth Israel Deaconess Medical Center (Site ID: 32077) — Boston, Massachusetts
- Columbia P&S (Site ID: 30329) — New York, New York
- New York Blood Center (Site ID: 31801) — New York, New York
- Penn Prevention (Site ID: 30310) — Philadelphia, Pennsylvania
- University of Pittsburgh (Site ID: 1001) — Pittsburgh, Pennsylvania
- Seattle Vaccine and Prevention (Site ID: 30331) — Seattle, Washington
- Vaccine Trial Centre, Mahidol University CRS (Site ID: 32021) — Bangkok, Ratchathewi
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.