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NCT06557785 · ClinicalTrials.gov registry record · Phase 1
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 study of HIV Infections, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Active
- Registry status
- Phase 1
- Development phase
- 53
- Enrollment target
- 7
- Study locations
NCT06557785: Active Phase 1 study of HIV Infections, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT06557785 is a Phase 1 study of HIV Infections that is active but no longer recruiting, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 53 participants, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (88% lower). The trial reports 7 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06557785, a Phase 1 study of HIV Infections, is active but no longer recruiting, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 53 participants
- Enrollment target
- 7
- Study locations
Study 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 Studied
Interventions
- BIOLOGICAL CH505M5 N197D mRNA-gp160
- BIOLOGICAL CH505 TF mRNA-gp160
Study Locations (7)
New York
- Columbia P&S (Site ID: 30329) - New York
- New York Blood Center (Site ID: 31801) - New York
Pennsylvania
- Penn Prevention (Site ID: 30310) - Philadelphia
- University of Pittsburgh (Site ID: 1001) - Pittsburgh
Massachusetts
- Beth Israel Deaconess Medical Center (Site ID: 32077) - Boston
Washington
- Seattle Vaccine and Prevention (Site ID: 30331) - Seattle
Ratchathewi
- Vaccine Trial Centre, Mahidol University CRS (Site ID: 32021) - Bangkok
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 53 participants |
| Start Date | 2024-11-25 |
| Est. Completion | 2027-03-09 |
| Phase | Phase 1 |
What the registry record for NCT06557785 still lists
NCT06557785 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 53 participants, a relatively small participant target, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (88% lower).
The record links to 1 condition, with HIV Infections appearing as the primary indexed condition, and to 2 interventions - of which CH505M5 N197D mRNA-gp160 is the first listed.
NCT06557785 lists 7 locations in 5 states (New York, Pennsylvania, Massachusetts).
Frequently Asked Questions
What is clinical trial NCT06557785 about?
NCT06557785 is a clinical study titled "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". 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...
What is the current status of trial NCT06557785?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 53 participants. The study started on 2024-11-25. Estimated completion is 2027-03-09.
What conditions does trial NCT06557785 study?
This clinical trial studies the following conditions: HIV Infections.
What interventions are being tested in trial NCT06557785?
The interventions under investigation include: CH505M5 N197D mRNA-gp160 (BIOLOGICAL), CH505 TF mRNA-gp160 (BIOLOGICAL).
Who is sponsoring clinical trial NCT06557785?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06557785 being conducted?
This trial has 7 study locations across Massachusetts, New York, Pennsylvania, Washington, Ratchathewi. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06557785's enrollment target sits among peer trials
53 349th of 542 higher than 193 of 542 other HIV Infections trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other HIV Infections trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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