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Live Oral Shigella dysenteriae Vaccine

Posted Feb 15 2013 7:00pm

Description of Invention:
This application claims a Salmonella typhi Ty21a construct comprising a Shigella dysenteriae O-specific polysaccharide (O-Ps) inserted into the Salmonella typhi Ty21a chromosome, where heterologous Shigella dysenteriae serotype 1 O-antigen is stably expressed together with homologous Salmonella typhi O-antigen. The constructs of this invention elicit immune protection against virulent Shigella dysenteriae challenge, as well as Salmonella typhi challenge. Also claimed in this application are methods of making the constructs of this invention and methods for inducing an immune response.

Shigella cause millions of cases of dysentery every year, which result in about seven hundred thousand deaths worldwide. Shigella dysenteriae serotype 1, one of about forty serotypes of Shigella, causes a more severe disease with a much higher mortality rate than other serotypes. There are no licensed vaccines available for protection against Shigella. The fact that many isolates exhibit multiple antibiotic resistance complicates the management of dysentery infections.

  • One component of a multivalent anti-shigellosis vaccine under development.
  • Shigella vaccines, therapeutics and diagnostics.

  • Vector is well-characterized.
  • Simple manufacturing process.
  • Potential low-cost vaccine.
  • Oral vaccine – avoids need for needles.
  • Temperature-stable formulation allows for vaccine distribution without refrigeration.

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

Dennis J Kopecko (FDA)
De Qi Xu (FDA)

Patent Status:
HHS, Reference No. E-214-2004/0
PCT, Application No. PCT/US2005/018198 filed 24 May 2005
US, , Patent No. 8,071,113, Issued 06 Dec 2011
US, , Patent No. 8,337,831, Issued 25 Dec 2012
US, Application No. 13/687,797 filed 28 Nov 2012

Relevant Publication:
  1. Xu DQ, et al. [ PMID 17629369 ]

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 combination typhoid-shigellosis oral 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: 2527

Updated: 02/2013

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