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DMID 23-0015; Lassa Fever CVD 1000
Sponsor: Wilbur Chen, MD, MS
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.
Official title: A Phase 1, Randomized, Recipient- and Observer-Blinded, Dose-Escalation Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of Two Doses of Rabies-Vectored Monovalent Lassa Fever Vaccine (LASSARAB) Administered With 3D-(6-Acyl) PHAD-SE (aPHAD-SE) Adjuvant in Healthy Adults
Key Details
Gender
All
Age Range
18 Years - 50 Years
Study Type
INTERVENTIONAL
Enrollment
55
Start Date
2025-01-13
Completion Date
2026-05
Last Updated
2026-04-08
Healthy Volunteers
Yes
Conditions
Interventions
LASSARAB+ aPHAD-SEat 700rU
Rabies-Vectored Monovalent Lassa Fever Vaccine (LASSARAB) with 3D-(6- acyl) Phosphorylated Hexaacyl Disaccharides (PHAD)-Stable squalene oil-in-water nanoemulsion (aPHAD-SE) adjuvant administered by IM injection
HDCV Comparator
Sterile, stable, freeze-dried suspension of rabies virus prepared from strain PM-1503-3M
Normal Saline Placebo
Sterile 0.9% sodium chloride for injection, USP, or normal saline, is a sterile, nonpyrogenic, isotonic solution; each mL contains sodium chloride 9 mg
LASSARAB+ aPHAD-SEat 1400rU
Rabies-Vectored Monovalent Lassa Fever Vaccine (LASSARAB) with 3D-(6- acyl) Phosphorylated Hexaacyl Disaccharides (PHAD)-Stable squalene oil-in-water nanoemulsion (aPHAD-SE) adjuvant administered by IM injection
Locations (1)
University of Maryland, Baltimore, University of Maryland School of Medicine, Center for Vaccine Development and Global Health
Baltimore, Maryland, United States