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CpG-adjuvanted Clostridioides difficile toxoid vaccine (PF-07831694) is an investigational bivalent protein subunit vaccine developed by Pfizer for the prevention of Clostridioides difficile infection (CDI). It is a second-generation, updated formulation of Pfizer's previous C. difficile vaccine candidate, PF-06425090, which failed to meet its primary endpoint in the Phase 3 CLOVER trial despite showing efficacy in reducing disease severity and duration. PF-07831694 consists of genetically and chemically inactivated C. difficile toxoids A and B (TcdA and TcdB) adjuvanted with CpG 24555, a synthetic B-class CpG oligodeoxynucleotide (ODN) that acts as a Toll-like receptor 9 (TLR9) agonist. The addition of the CpG adjuvant is designed to enhance the vaccine's immunogenicity, particularly in older adults, and enable a more potent and durable immune response using a 2-dose regimen. The vaccine is currently in Phase 3 clinical development (BEETHOVEN trial, NCT07282665) for the prevention of primary CDI in adults aged 65 years and older.
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