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Oral Shigellosis Vaccine

Posted Feb 04 2013 7:00pm

Description of Invention:
This application claims a Salmonella typhi Ty21a construct comprising a Shigella sonnei O-antigen biosynthetic gene region inserted into the Salmonella typhi Ty21a chromosome, where heterologous Shigella sonnei form 1 O-antigen is stably expressed together with homologous Salmonella typhi O-antigen. The constructs of this invention elicit immune protection against virulent Shigella sonnei challenge, as well as Salmonella Typhi challenge. Also claimed in this application are methods of recombineering a large antigenic gene region into a bacterial chromosome.

Bacillary dysentery and enteric fevers continue to be important causes of morbidity in both developed and developing nations. Shigella cause greater than one hundred and fifty million cases of dysentery and enteric fever occurs in greater than twenty-seven million people annually. Currently, there is no licensed vaccine to prevent the occurrence of shigellosis. Increasing multiple resistance in Shigella commonly thwarts local therapies.

  • One component of a multivalent Shigellosis vaccine under development
  • Research tool

  • Low cost production
  • Lower cost vaccine
  • Oral vaccine – no needles required
  • Temperature-stable manufacturing process - avoids need for refrigeration during vaccine distribution

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

Madushini N Dharmasena (FDA)
Dennis J Kopecko (FDA)

Patent Status:
HHS, Reference No. E-168-2012/0
US, Application No. 61/701,939 filed 17 Sep 2012

Relevant Publication:
  1. Dharmasena MN, et al. Stable Expression of Shigella sonnei Form I O-Polysaccharide Genes Recombineered into the Chromosome of Live Salmonella Oral Vaccine Vector Ty21a. Int J Med Microbiol. 2013 (accepted).

Collaborative Research Opportunity:
The FDA Center for Biologics Evaluation and Research is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate or commercialize oral Shigellosis vaccine. For collaboration opportunities, please contact Dr. Dennis J. Kopecko at or 301-661-8839.

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: 2528

Updated: 02/2013

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