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NCT06546709 · ClinicalTrials.gov registry record · Phase 1
DMID 23-0015; Lassa Fever CVD 1000
A Phase 1 study of Lassa Fever, sponsored by Wilbur Chen, MD, MS.
- Active
- Registry status
- Phase 1
- Development phase
- 55
- Enrollment target
- 1
- Study location
NCT06546709: Active Phase 1 study of Lassa Fever, sponsored by Wilbur Chen, MD, MS.
NCT06546709 is a Phase 1 study of Lassa Fever that is active but no longer recruiting, run by Wilbur Chen, MD, MS. The registered enrollment target is 55 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06546709, a Phase 1 study of Lassa Fever, is active but no longer recruiting, sponsored by Wilbur Chen, MD, MS.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 55 participants
- Enrollment target
- 1
- Study location
Study Summary
This study proposes the evaluation of a novel, first-in-human Lassa fever vaccine based on the complete Lassa glycoprotein complex (GPC) antigen. The antigen will be presented on a genetically modified and attenuated rabies vector expressing both the rabies glycoprotein (GP) antigen and the Lassa GPC. The inactivated chimeric virus is delivered with a toll-like receptor (TLR-4)-activating oil-in-water emulsion adjuvant. Studies using this vaccine administered as a prime-boost series in mice and non-human primates, and then challenged with Lassa virus demonstrated significant protection against Lassa fever. Given that the vaccine backbone is an attenuated and inactivated rabies virus expressing rabies GP, this vaccine will also be evaluated for immunogenicity against rabies virus.
Conditions Studied
Interventions
- BIOLOGICAL LASSARAB+ aPHAD-SEat 700rU
- BIOLOGICAL HDCV Comparator
- OTHER Normal Saline Placebo
- BIOLOGICAL LASSARAB+ aPHAD-SEat 1400rU
Study Locations (1)
Maryland
- University of Maryland, Baltimore, University of Maryland School of Medicine, Center for Vaccine Development and Global Health - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 55 participants |
| Start Date | 2025-01-13 |
| Est. Completion | 2026-03 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06546709
The ClinicalTrials.gov registry entry for NCT06546709 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 55 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. The listed sponsor is Wilbur Chen, MD, MS, which has 1 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Lassa Fever appearing as the primary indexed condition, and to 4 interventions - of which LASSARAB+ aPHAD-SEat 700rU is the first listed.
NCT06546709 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT06546709 about?
NCT06546709 is a clinical study titled "DMID 23-0015; Lassa Fever CVD 1000". This study proposes the evaluation of a novel, first-in-human Lassa fever vaccine based on the complete Lassa glycoprotein complex (GPC) antigen. The antigen will be presented on a genetically modified and attenuated rabies vector expressing both the rabies glycoprotein (GP) antigen and the Lassa GP...
What is the current status of trial NCT06546709?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 55 participants. The study started on 2025-01-13. Estimated completion is 2026-03.
What conditions does trial NCT06546709 study?
This clinical trial studies the following conditions: Lassa Fever.
What interventions are being tested in trial NCT06546709?
The interventions under investigation include: LASSARAB+ aPHAD-SEat 700rU (BIOLOGICAL), HDCV Comparator (BIOLOGICAL), Normal Saline Placebo (OTHER), LASSARAB+ aPHAD-SEat 1400rU (BIOLOGICAL).
Who is sponsoring clinical trial NCT06546709?
This trial is sponsored by Wilbur Chen, MD, MS, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06546709 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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