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DNA Promoters and Anthrax Vaccines

Posted Feb 04 2013 7:00pm

Description of Invention:
Currently, the only licensed vaccine against anthrax in the United States is AVA BioThrax®, which, although efficacious, suffers from several limitations. This vaccine requires six injectable doses over 18 months to stimulate protective immunity, requires a cold chain for storage, and in many cases has been associated with adverse effects.

This application claims a modified B. anthracis protective antigen (PA) gene for optimal expression and stability, linked it to an inducible promoter for maximal expression in the host, and fused to the secretion signal of the Escherichia coli alpha-hemolysin protein (HlyA) on a low-copy-number plasmid. This plasmid was introduced into the licensed typhoid vaccine strain, Salmonella enterica serovar Typhi strain Ty21a, and was found to be genetically stable. Immunization of mice with three vaccine doses elicited a strong PA-specific serum immunoglobulin G response with a geometric mean titer of 30,000 (range, 5,800 to 157,000) and lethal-toxin-neutralizing titers greater than 16,000. Vaccinated mice demonstrated 100% protection against a lethal intranasal challenge with aerosolized spores of B. anthracis 7702.

Anthrax vaccines, therapeutics and diagnostics.

  • Vector is well-characterized.
  • Simple manufacturing process.
  • Potential low-cost vaccine.
  • Oral vaccine – avoids needles and can be administered rapidly during emergencies.
  • Temperature-stable manufacturing allows for vaccine distribution without refrigeration.

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

Dennis J Kopecko (FDA)
Manuel A Osorio (FDA)
Chandrakan P Giri (FDA)
Milan Blake (FDA)
Siba Bhattacharyya (FDA)

Patent Status:
HHS, Reference No. E-344-2003/1
PCT, Application No. PCT/US2004/030616 filed 20 Sep 2004
US, , Patent No. 7,758,855, Issued 20 Jul 2010
US, , Patent No. 8,247,225, Issued 21 Aug 2012
US, Application No. 13/551,168 filed 17 Jul 2012

Relevant Publication:
  1. Osorio M, et al. [ PMID 19179420 ]

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 anthrax 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: 2526

Updated: 02/2013

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