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Typhoid-Plague Bivalent Vaccine

Posted Jan 10 2013 7:00pm

Description of Invention:
Yersinia pestis (Y. pestis) bacteria is the causative agent of plague, typically transmitted from animals to humans by the bite of an infected flea. Y. pestis infection of the lungs leads to pneumonic plague, which is highly contagious and generally fatal. Y. pestis is a potential bioterrorist threat agent for which no vaccine yet exists.

This invention claims the generation and development of a candidate oral vaccine against plague. The vaccine consists of a synthetic gene construct that expresses a Y. pestis F1-V fusion antigen linked to a secretion signal, resulting in the production of large amounts of the F1-V antigen. The F1-V synthetic gene fusion is housed within Ty21a, an attenuated typhoid fever strain that is licensed for human use as a live oral bacterial vaccine. Ty21a serves as a carrier to deliver the F1-V fusion antigens of the plague bacteria; the combined F1-V fusion in the Ty21a carrier has been shown to stimulate a robust immune response in mice. The possibility of combining the oral plague vaccine of this invention with FDA’s candidate oral anthrax vaccine exists and would result in an easy-to-administer oral delivery system to streamline administration of the vaccine to large numbers of recipients in emergency situations.

Plague vaccines, therapeutics and diagnostics.

  • Vector is well-characterized.
  • Simple manufacturing process.
  • Potential low-cost vaccine.

Development Status:
  • Pre-clinical
  • In vitro data available
  • In vivo data available (animal)

Dennis J Kopecko (FDA)
Manuel A Osorio (FDA)
Monica R Foote (FDA)

Patent Status:
HHS, Reference No. E-105-2011/0
US, Application No. 61/650,676 filed 23 May 2012

Related Technologies:
US, Patent No. 7,758,855, Issued 20 Jul 2010, Reference No. E-344-2003/1
US, Patent No. 8,247,225, Issued 21 Aug 2012, Reference No. E-344-2003/1
US, Application No. 13/551,168 filed 17 Jul 2012, Reference No. E-344-2003/1

Collaborative Research Opportunity:
The FDA Center for Biologics Evaluation and Research, Lab of Enteric and Sexually Transmitted Diseases, is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate or commercialize oral plague vaccine. For collaboration opportunities, please contact Dennis Kopecko at .

For Licensing Information Please Contact:
Peter Soukas J.D.
NIH Office of Technology Transfer
6011 Executive Blvd. Suite 325 Room 14,
Rockville, MD 20852-3804
United States
Phone: 301-435-4646
Fax: 301-402-0220

Ref No: 2509

Updated: 01/2013

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