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NCT06796686 · ClinicalTrials.gov registry record · Phase 1
Clinical Trial to Evaluate the Safety and Immunogenicity of a Priming Regimen of 426c.Mod.Core-C4b Followed by HxB2.WT.Core-C4b Boosts, Both Adjuvanted With 3M-052 AF + Alum, in Adult Participants Without HIV and in Overall Good Health
A Phase 1 study of HIV, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Recruiting
- Registry status
- Phase 1
- Development phase
- 42
- Enrollment target
- 6
- Study locations
NCT06796686: Recruiting Phase 1 study of HIV, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT06796686 is a Phase 1 study of HIV that is actively recruiting participants, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 42 participants, below the 440-participant average among 303 other HIV trials with a reported enrollment target (90% lower). The trial reports 6 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06796686, a Phase 1 study of HIV, is actively recruiting participants, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 42 participants
- Enrollment target
- 6
- Study locations
Study Summary
This is a partially randomized, open-label phase 1 study to evaluate the safety and immunogenicity of a priming regimen of 426c.Mod.Core-C4b adjuvanted with 3M-052 AF + Alum followed by boosts with HxB2.WT.Core-C4b adjuvanted with 3M-052 AF + Alum. The primary hypothesis is that the boosting with HxB2.WT.Core-C4b adjuvanted with 3M-052 AF + Alum will further mature broadly neutralizing antibody (bnAb)-precursor B-cell lineages elicited by 426c.Mod.Core-C4b adjuvanted with 3M-052 AF + Alum. 426c.Mod.Core-C4b adjuvanted with 3M-052 AF + Alum has been tested in HVTN 301 previously, whereas the HxB2.WT.Core-C4b will be first-in-human (FIH).
Conditions Studied
Interventions
- BIOLOGICAL 426c.Mod.Core-C4b
- BIOLOGICAL HxB2.WT.Core-C4b
- BIOLOGICAL 3M-052-AF adjuvant
- OTHER Aluminum hydroxide suspension (Alum) adjuvant
- OTHER Diluent
Study Locations (6)
Georgia
- Ponce de Leon Center CRS - Atlanta
- The Hope Clinic of the Emory Vaccine Research Center; Emory University - Decatur
New York
- Columbia Physicians & Surgeons - New York
- NY Blood Center CRS - New York
California
- Bridge HIV, San Francisco Department of Public Health - San Francisco
Massachusetts
- Brigham and Women's Hospital Vaccine CRS (BWH VCRS) - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 42 participants |
| Start Date | 2025-03-17 |
| Est. Completion | 2027-01-15 |
| Phase | Phase 1 |
What NCT06796686 shows while recruiting
NCT06796686 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 42 participants, a relatively small participant target, below the 440-participant average among 303 other HIV trials with a reported enrollment target (90% lower).
The record links to 1 condition, with HIV appearing as the primary indexed condition, and to 5 interventions - of which 426c.Mod.Core-C4b is the first listed.
NCT06796686 lists 6 locations in 4 states (Georgia, New York, California).
Frequently Asked Questions
What is clinical trial NCT06796686 about?
NCT06796686 is a clinical study titled "Clinical Trial to Evaluate the Safety and Immunogenicity of a Priming Regimen of 426c.Mod.Core-C4b Followed by HxB2.WT.Core-C4b Boosts, Both Adjuvanted With 3M-052 AF + Alum, in Adult Participants Without HIV and in Overall Good Health". This is a partially randomized, open-label phase 1 study to evaluate the safety and immunogenicity of a priming regimen of 426c.Mod.Core-C4b adjuvanted with 3M-052 AF + Alum followed by boosts with HxB2.WT.Core-C4b adjuvanted with 3M-052 AF + Alum. The primary hypothesis is that the boosting with H...
What is the current status of trial NCT06796686?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 42 participants. The study started on 2025-03-17. Estimated completion is 2027-01-15.
What conditions does trial NCT06796686 study?
This clinical trial studies the following conditions: HIV.
What interventions are being tested in trial NCT06796686?
The interventions under investigation include: 426c.Mod.Core-C4b (BIOLOGICAL), HxB2.WT.Core-C4b (BIOLOGICAL), 3M-052-AF adjuvant (BIOLOGICAL), Aluminum hydroxide suspension (Alum) adjuvant (OTHER), Diluent (OTHER).
Who is sponsoring clinical trial NCT06796686?
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 NCT06796686 being conducted?
This trial has 6 study locations across California, Georgia, Massachusetts, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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42 241st of 303 higher than 62 of 303 other HIV trials
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