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Filovirus Vaccines and Diagnostics Based on Glycoprotein-Fc Fusion Proteins

Download the Kaplan Abstract E-2010-018 (PDF - 239KB)

Technology Summary

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.

Potential Commercial Applications: Competitive Advantages:
  • Vaccines for protection against infections by Ebola Virus and other Filoviruses.
  • Diagnostic tests for cellular and humoral immunity based on FiloGP-Fc and rVSV-FiloGP to evaluate anti-Filovirus immune responses in vaccinated and infected animals and individuals.
  • Ideal substrates to evaluate immune responses in animals and vaccinees.
  • Although Filovirus vaccine candidates based on virus-like particles and virus vectors are currently under development by others, efficacious subunit vaccines have not yet been developed.
  • The FiloGP-Fc fusion protein resembles the native glycoprotein expressed at the surface of cells and viral particles.

Development Stage: preclinical animal studies

Inventors: Gerardo Kaplan, Krishnamurthy Konduru, Sina Bavari, David Bradfute

Publications:
”Ebola virus glycoprotein Fc fusion protein confers protection against lethal challenge in vaccinated mice” Vaccine 2011 Apr. 5;29(16):2968-77 PMID: 21329775

Intellectual Property:
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

Product Areas
biologics

FDA Reference No: E-2010-018

Licensing Contact:
Bill Ronnenberg, MS, JD/MIP
FDA Technology Transfer Program
Email: FDAInventionlicensing@fda.hhs.gov
Phone: 240-402-4561