Ebola virus is a member of the Filoviridae, a family of viruses classified as “Category A” bioterrorism agents that cause severe hemorrhagic fever in humans and nonhuman primates with high morbidity and mortality rates up to 90%.
Researchers at FDA developed an efficacious Filovirus subunit vaccine based on a recombinant protein consisting of the extracellular domain of the Filovirus glycoprotein fused to an Fc Fragment of human immunoglobulin (FiloGP-Fc). Vaccination with FiloGP-Fc elicited humoral and cellular immunity against Filoviruses. The FiloGP-Fc vaccine induced antibodies that bound and neutralized replication-competent recombinant G-deleted Vesicular Stomatitis Virus containing the Filovirus GP (rVSV-FiloGP), and protected animals against Filovirus lethal challenge. Also available are cellular and humoral immunity tests, as well as rVSV-FiloGP neutralization tests to evaluate anti-Filovirus immune responses in individuals.
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Development Stage: preclinical animal studies
Inventors: Gerardo Kaplan, Krishnamurthy Konduru, Sina Bavari, David Bradfute
”Ebola virus glycoprotein Fc fusion protein confers protection against lethal challenge in vaccinated mice” Vaccine 2011 Apr. 5;29(16):2968-77 PMID: 21329775
United States patent: US 9,347,951 B2, issued 05.24.2016
China patent: ZL201180063188.9, issued 09.07.2016
Germany, France, United Kingdom patent application: pending-allowed
India patent application: 3983/CHENP/2013, filed 10.28.2011
FDA Reference No: E-2010-018
Bill Ronnenberg, MS, JD/MIP
FDA Technology Transfer Program