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NCT05903339 · ClinicalTrials.gov registry record · Phase 1
Clinical Trial to Evaluate the Safety and Immunogenicity of Ferritin Nanoparticles Expressing Native-like HIV-1 Envelope Trimers Followed by Boost With mRNA Lipid Nanoparticles Encoding a Native-like HIV-1 Envelope Trimer in Adults Without HIV
A Phase 1 study of HIV, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Active
- Registry status
- Phase 1
- Development phase
- 36
- Enrollment target
- 6
- Study locations
NCT05903339 is a Phase 1 study of HIV that is active but no longer recruiting, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 36 participants, below the 440-participant average among 303 other HIV trials with a reported enrollment target (92% lower). The trial reports 6 study locations across 5 states.
The verdict
NCT05903339, a Phase 1 study of HIV, 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
- 36 participants
- Enrollment target
- 6
- Study locations
Study Summary
This first-in-human (FIH) phase 1 clinical trial will evaluate a prime-boost regimen of immunogens designed to induce HIV-1 Env V3-glycan-specific broadly neutralizing antibodies (V3G bNAbs). The priming immunogen (V3G CH848 Pr-NP1) consists of ferritin NPs expressing 8 copies of an Env trimer. This immunogen will be boosted with an mRNA LNP (V3G CH848 mRNA-Tr2), encoding a soluble Env trimer which does not utilize the ferritin NP design.
Conditions Studied
Interventions
- DRUG V3G CH848 Pr-NP1 60mcg
- DRUG 3M-052-AF 5mcg
- DRUG Alum 500 mcg
- DRUG V3G CH848 mRNA-Tr2 50mcg
- DRUG ACU-026-001-1 2.0mg
Study Locations (6)
Massachusetts
- Brigham & Women's Hospital [Site ID: 30007] - Boston
- BIDMC VCRS [Site ID: 32077] - Boston
Alabama
- Alabama CRS [Site ID: 31788] - Birmingham
Georgia
- Emory University School of Medicine, The Ponce de Leon Center CRS [Site ID: 5802] - Atlanta
Tennessee
- Vanderbilt Vaccine (VV) CRS [Site ID: 30352] - Nashville
Washington
- Seattle Vaccine and Prevention CRS [Site ID: 30331] - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2023-08-29 |
| Est. Completion | 2026-10-30 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05903339
The ClinicalTrials.gov registry entry for NCT05903339 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 36 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 440-participant average among 303 other HIV trials with a reported enrollment target (92% lower). The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with HIV appearing as the primary indexed condition, and to 5 interventions - of which V3G CH848 Pr-NP1 60mcg is the first listed.
NCT05903339 reports 6 study locations spanning 5 distinct geographic areas - top geographies include Massachusetts, Alabama, Georgia.
Frequently Asked Questions
What is clinical trial NCT05903339 about?
NCT05903339 is a clinical study titled "Clinical Trial to Evaluate the Safety and Immunogenicity of Ferritin Nanoparticles Expressing Native-like HIV-1 Envelope Trimers Followed by Boost With mRNA Lipid Nanoparticles Encoding a Native-like HIV-1 Envelope Trimer in Adults Without HIV". This first-in-human (FIH) phase 1 clinical trial will evaluate a prime-boost regimen of immunogens designed to induce HIV-1 Env V3-glycan-specific broadly neutralizing antibodies (V3G bNAbs). The priming immunogen (V3G CH848 Pr-NP1) consists of ferritin NPs expressing 8 copies of an Env trimer. This...
What is the current status of trial NCT05903339?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 36 participants. The study started on 2023-08-29. Estimated completion is 2026-10-30.
What conditions does trial NCT05903339 study?
This clinical trial studies the following conditions: HIV.
What interventions are being tested in trial NCT05903339?
The interventions under investigation include: V3G CH848 Pr-NP1 60mcg (DRUG), 3M-052-AF 5mcg (DRUG), Alum 500 mcg (DRUG), V3G CH848 mRNA-Tr2 50mcg (DRUG), ACU-026-001-1 2.0mg (DRUG).
Who is sponsoring clinical trial NCT05903339?
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 NCT05903339 being conducted?
This trial has 6 study locations across Alabama, Georgia, Massachusetts, Tennessee, Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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