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CDVAX is an investigational oral vaccine designed to prevent Clostridium difficile infection (CDI). It consists of recombinant spores of Bacillus subtilis engineered to display a fragment of C. difficile toxin A (TcdA26-39) on their surface. The vaccine is administered orally and aims to induce both mucosal and systemic immune responses, providing protection against colonization by C. difficile as well as neutralizing its toxins. Preclinical studies demonstrated efficacy in animal models, protecting against primary infection and relapse with various virulent strains of C. difficile. The vaccine was developed through a European consortium led by Royal Holloway University of London, with contributions from several biotech SMEs for regulatory support, manufacturing, analytics, and clinical supervision[3].
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