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ACTIVE NOT RECRUITING Phase 1

DMID 23-0015; Lassa Fever CVD 1000

NCT06546709 · View on ClinicalTrials.gov ↗

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

FieldValue
Enrollment Target 55 participants
Start Date 2025-01-13
Est. Completion 2026-03
Phase Phase 1

Sponsor

Wilbur Chen, MD, MS

1 total trials

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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. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 55 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Wilbur Chen, MD, MS, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06546709 reports 1 study location spanning 1 distinct geographic area — top geographies include Maryland. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

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. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial