Drug intelligence / Profile preview

Clostridium difficile vaccine

Development stage
Phase 3
Lead developer
Pfizer
Modality
mRNA Therapeutics → RNA Therapeutics → Nucleic Acid Therapeutics, Vaccines & Immunotherapeutics
Administration
Intramuscular
01

Overview

A *Clostridium difficile* vaccine is an investigational immunization designed to prevent infection by the bacterium *Clostridioides* (formerly *Clostridium*) *difficile*, a major cause of antibiotic-associated diarrhea and colitis. Several candidates have been developed targeting the primary virulence factors of *C. difficile*—namely toxins A (TcdA) and B (TcdB)—using various platforms such as genetically detoxified toxoid vaccines and mRNA-lipid nanoparticle vaccines. The most advanced candidate, PF-06425090 from Pfizer, is a recombinant toxoid-based vaccine that induces neutralizing antibodies against toxins A and B but did not meet its primary efficacy endpoint in phase 3 trials for prevention of *C. difficile* infection in at-risk adults[3][5][6]. Other approaches include multivalent mRNA-LNP vaccines targeting both toxins and additional virulence factors; these have shown robust immune responses and protection in animal models[8]. No *C. difficile* vaccine has been approved as of April 2025[1].

Brand names
CDIFFENSE
Other names
C. difficile vaccineClostridioides difficile vaccine
02

Targets

TcdA (Clostridioides difficile toxin A)SlpA (Surface layer protein A)TcdB (Clostridioides difficile large clostridial toxin family)

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