The Secretary of State for Health

Health Protection Agency

Micropharm Limited

Secretary of State for Health and Social Care

April Roberts

Clifford Charles Shone

Michael Maynard-Smith

John Landon

Clifford Shone

Helen Ahern

The present invention relates to recombinantantigens based on a fusion protein that consists of or comprises a first amino acid sequence and a second amino acid sequence, wherein: a) the first amino acid sequence is provided by an amino acid sequence that has at least 80% sequence identity with an amino acid sequence consisting of residues 500-1850 of aToxin A sequence or residues 1500-1851 of aToxin B sequence; and b) the second amino acid sequence is provided by an amino acid sequence that has at least 80% sequence identity with an amino acid sequence consisting of a long repeat unit located within amino acid residues 1851-2710 of aToxin A sequence or within amino acid residues 1852-2366 of aToxin B sequence; though with the proviso that the fusion protein is not a polypeptide comprising amino acid residues 543-2710 of aToxin A and with the proviso that the fusion protein is not a polypeptide comprising amino acid residues 543-2366 of aToxin B. Also provided is the use of said antigens for the prevention/treatment/suppression ofinfection (CDI), together with methods for generating said antigens, methods for generating antibodies that bind to said antigens, and the use of said antibodies for the prevention/treatment/suppression of CDI.

antigens

The present invention relates to recombinantantigens based on a polypeptide, consisting of or comprising an amino acid sequence having at least 80% sequence identity with an amino acid sequence consisting of residues 1500-700 of aToxin A sequence or aToxin B sequence; though with the proviso that the polypeptide does not include one or more Repeat Unit (RU) located between amino acid residues 1851-2710 ofToxin A and/or residues 1853-2366 of aToxin B protein that consists of or comprises a first amino acid sequence and a second amino acid. Also provided is the use of said antigens for the prevention/treatment/suppression ofinfection (CDI), together with methods for generating said antigens, methods for generating antibodies that bind to said antigens, and the use of said antibodies for the prevention/treatment/suppression of CDI.

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The present invention provides an antibody composition comprising ovine antibodies, for use in the prevention or treatment ofinfection wherein the antibodies bind to atoxin, and wherein said prevention or treatment is by oral delivery of the antibody composition. Also provided is a pharmaceutical composition of ovine antibodies for oral delivery, which further comprises one or more means for protecting the antibodies from trypsin and/or chymotrypsin and/or stomach acid.

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Salisbury, United Kingdom

April Roberts