Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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.
Primary Outcome
Number of participants experiencing solicited local and systemic reactogenicity Adverse Events (AEs)
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 |
What the registry record for NCT06546709 still lists
NCT06546709 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 55 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Lassa Fever
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06546709's enrollment target sits among peer trials
55 918th of 2000 higher than 1,070 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT01638676 · 55 participants · Phase 1
A Phase I/II Trial of Vemurafenib and Metformin to Melanoma Patients
- NCT01906385 · 55 participants · Phase 1
Maximum Tolerated Dose, Safety, and Efficacy of Rhenium Nanoliposomes in Recurrent Glioma (ReSPECT)
- NCT03007030 · 55 participants · Phase 2
Brentuximab Vedotin in Treating Patients With CD30+ Malignant Mesothelioma That Cannot Be Removed by Surgery
- NCT03152058 · 55 participants · Phase 2
IMPACT Study: IMProve Pregnancy in APS With Certolizumab Therapy
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI