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Oral Shigellosis Vaccine

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Technology Summary

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.

FDA Researchers developed 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.

Potential Commercial Applications Competitive Advantages
  • A component of a multivalent oral Shigellosis vaccine candidate
  • Oral vaccine - no needles required
  • Lower cost of production
  • Low cost vaccine
  • Temperature-stable manufacturing process - avoids need for refrigeration during vaccine distribution

Inventors: Madushini Dharmasena, Dennis Kopecko

“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 Apr;303(3):105-13. PMID: 23474241

Intellectual Property:
United States Patent: US 9,750,793 B2, issued 09.05.2017
China patent application: 201380059559.5, filed 05.14.2015
European patent application: 13836396.5, filed 03.18.2015
Israel patent application: 237339, filed 02.22.2015
Japan patent application: 2015-532125, filed 03.17.2015
Korea patent application: 10-2015-7010066, filed 04.17.2015

Product Area: vaccines, diagnostics, therapeutics

FDA Reference No: E-2012-016

Licensing Contact:
Ken Millburne, J.D.
FDA Technology Transfer Program
Email: FDAInventionlicensing@fda.hhs.gov 
Phone: 240-402-4315

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