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1. (WO2013112867) VACCINES AGAINST CLOSTRIDIUM DIFFICILE COMPRISING RECOMBINANT TOXINS

Pub. No.:    WO/2013/112867    International Application No.:    PCT/US2013/023189
Publication Date: Fri Aug 02 01:59:59 CEST 2013 International Filing Date: Sat Jan 26 00:59:59 CET 2013
IPC: C07K 14/33
Applicants: MERCK SHARP & DOHME CORP.
INTERVET INTERNATIONAL B.V.
HEINRICHS, Jon Henry
BODMER, Jean-Luc
SECORE, Susan Lynn
GOERKE, Aaron Rudy
CARO-AGUILAR, Ivette
GENTILE, Marie-Pierre
HORTON, Melanie, S.
MIEZEIEWSKI, Matthew Ryan
SKINNER, Julie, M.
SONDERMEIJER, Paulus Jacobus Antonius
SUBRAMANIAN, Shyamsundar
HEIJDEN-LIEFKENS, Karin Huberdina Antonia van der
WANG, Su
XIE, Jinfu
XOCONOSTLE, Rachel Flora
ZORMAN, Julie, K.
Inventors: HEINRICHS, Jon Henry
BODMER, Jean-Luc
SECORE, Susan Lynn
GOERKE, Aaron Rudy
CARO-AGUILAR, Ivette
GENTILE, Marie-Pierre
HORTON, Melanie, S.
MIEZEIEWSKI, Matthew Ryan
SKINNER, Julie, M.
SONDERMEIJER, Paulus Jacobus Antonius
SUBRAMANIAN, Shyamsundar
HEIJDEN-LIEFKENS, Karin Huberdina Antonia van der
WANG, Su
XIE, Jinfu
XOCONOSTLE, Rachel Flora
ZORMAN, Julie, K.
Title: VACCINES AGAINST CLOSTRIDIUM DIFFICILE COMPRISING RECOMBINANT TOXINS
Abstract:
The present invention relates to recombinant C. difficile toxin A (TcdA) and toxin B (TcdB) and binary toxin A (CDTa) proteins comprising specifically defined mutations relative to the native toxin sequence that substantially reduce or eliminate toxicity. The invention also relates to vaccines and immunogenic compositions comprising these recombinant toxins, as well as combinations of these toxins with binary toxin B (CDTb), which are capable of providing protection against C. difficile infection and/or the effects thereof. The invention also relates to methods of inducing an immune response to C. difficile comprising administering the vaccines and immunogenic compositions described herein to a patient. The invention also encompasses methods of expressing recombinant C. difficile toxin A and toxin B and CDTa mutants and CDTb in recombinant expression systems. In exemplary embodiments, TcdA, TcdB, and CDTa mutant toxins comprising sufficient mutations to substantially reduce or eliminate toxicity are expressed in the baculovirus/insect cell expression system.