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Multivalent Meningiococcal Conjugates and Methods for Preparing Conjugates

Posted Jan 22 2013 7:00pm

Description of Invention:
Among 13 isolated meningococcal serogroups, A, B, C, W-135 and Y are the most prevalent. There are three FDA-approved capsular polysaccharide (PS)-based vaccines, one tetravalent PS vaccine, and two tetravalent conjugate vaccines for protection against meningococcal disease caused by groups A, C, W-135 and Y Neisseria meningitidis. Group B capsular PS is similar to the PS structure expressed in certain human tissues, thus making it a poor immunogen. Furthermore, if used as a vaccine, the possibility exists of it inducing an autoimmune response. Thus, a need remains to develop additional meningococcal vaccines, particularly for group B and group X meningococcal serogroups.

This application claims immunogenic conjugates including at least one polysaccharide conjugated to a group B factor H binding protein (fHbp). Also claimed are immunogenic conjugates including at least one polysaccharide conjugated to a Neisserial surface protein A (NspA). Additionally, improved methods for preparing conjugates are claimed.

Applications:
  • Multivalent meningitis vaccine
  • Research tool


Advantages:
  • Higher vaccine yield
  • More efficient conjugation method
  • Lower cost vaccines


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


Inventors:
Che-Hung Robert Lee (FDA)
Vavlerian Pinto (Walter Reed Army Institute of Research)
Elizabeth E Moran (Walter Reed Army Institute of Research)
Robert E Burden (Walter Reed Army Institute of Research)


Patent Status:
HHS, Reference No. E-082-2012/0
US, Application No. 61/651,382 filed 24 May 2012


Related Technologies:
US, Patent No. 8,048,432, Issued 01 Nov 2011, Reference No. E-301-2003/0
US, Application No. 13/243,480 filed 06 Aug 2004, Reference No. E-301-2003/0
US, Patent No. 8,173,135, Issued 08 May 2012, Reference No. E-085-2005/0
US, Application No. 13/440,856 filed 05 Apr 2012, Reference No. E-085-2005/0
US, Application No. 60/493,389 filed 06 Aug 2003, Reference No. E-301-2003/0
US, Application No. 60/783,490 filed 17 Mar 2006, Reference No. E-085-2005/0
PCT, Application No. PCT/US2007/006627 filed 16 Mar 2007, Reference No. E-085-2005/0


Collaborative Research Opportunity:
The FDA/CBER is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate or commercialize Multivalent Meningiococcal Conjugates and Methods for Preparing Conjugates. For collaboration opportunities, please contact Che-Hung Robert Lee at robert.lee@fda.hhs.gov or 301-451-5934.


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
Email: soukasp@mail.nih.gov
Phone: 301-435-4646
Fax: 301-402-0220


Ref No: 2516

Updated: 01/2013

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