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Live Oral Shigella dysenteriae Vaccine

Live Oral Shigella dysenteriae Vaccine

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.

Potential Commercial Applications:

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

Competitive Advantages:

  • 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.

Dennis Kopecko
De Qi Xu

Intellectual Property:
U.S. Pat: 8,071,113 issued 2011-12-06
U.S. Pat: 8,337,831 issued 2012-12-25
U.S. Pat: 8,790,635 issued 2014-07-29
U.S. Pat: 8,968,719 issued 2015-03-03
US Application No. 14/585,721
PCT Application No. PCT/US2005/018198
Various international patent applications pending

Xu DQ, et al. PMID 17629369

Licensing Contact:
Bill Ronnenberg, JD-MIP, MS
FDA Technology Transfer Program
10903 New Hampshire Ave.
Building WO1, Rm 4214
Silver Spring, MD 20993
Email: FDAInventionlicensing@fda.hhs.gov
Phone: 240-402-4561

OTT Reference No: E-214-2004/0
Updated: August 4, 2015