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.
Potential Commercial Applications:
- Multivalent meningitis vaccine
- Research tool
- Higher vaccine yield
- More efficient conjugation method
- Lower cost vaccines
Che-Hung Robert Lee
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 email@example.com or 301-451-5934.
Bill Ronnenberg, JD-MIP, MS
FDA Technology Transfer Program
10903 New Hampshire Ave.
Building WO1, Rm 4214
Silver Spring, MD 20993
OTT Reference No: E-082-2012/0
Updated: August 5, 2015