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Treatment ofClostridium difficile is a major problem as a hospital-associated infection which can cause severe, recurrent diarrhea. The currently available antibiotics are not effective in all cases and alternative treatments are required. In the present study, an ovine antibody-based platform for passive immunotherapy ofC. difficile infection is described. Antibodies with high toxin-neutralizing titers were generated againstC. difficile toxins A and B and were shown to neutralize three sequence variants of these toxins (toxinotypes) which are prevalent in humanC. difficile infection. Passive immunization of hamsters with a mixture of toxin A and B antibodies protected them from a challenge withC. difficile spores in a dose-dependent manner. Antibodies to both toxins A and B were required for protection. The administration of toxin A and B antibodies up to 24 h postchallenge was found to reduce significantly the onset ofC. difficile infection compared to nonimmunized controls. Protection from infection was also demonstrated with key disease isolates (ribotypes 027 and 078), which are members of the hypervirulentC. difficile clade. The ribotype 027 and 078 strains also have the capacity to produce an active binary toxin and these data suggest that neutralization of this toxin is unnecessary for the management of infection induced by these strains. In summary, the data suggest that ovine toxin A and B antibodies may be effective in the treatment ofC. difficile infection; their potential use for the management of severe, fulminant cases is discussed.

Development and Evaluation of an Ovine Antibody-Based Platform for Treatment of Clostridium difficile Infection