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news.Sanofi Pasteur, the vaccines division of Sanofi-Aventis Group has announced that it is sponsoring a Phase II clinical study of a vaccine against Clostridium difficile, which is among the most common causes of hospital-acquired infection in Europe and North America.
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The trial currently conducted in the UK is investigating the safety and efficacy of Sanofi Pasteur’s Clostridium difficile (CDI) candidate vaccine. While the target indication for the vaccine is primary prevention CDI, this trial in infected patients aims at providing early proof of concept of the vaccine approach.
The Phase IIb trial involves about 600 participants with acute CDI at about 30 centers across the UK. Participants will be randomized to four study groups, where three groups will receive vaccine, while the fourth group will be given a placebo vaccine. All subjects will receive standard of care antibiotics.
Barry Cookson, lead investigator of the trial, said: “Treatment of C difficile infection includes the use of one of two antibiotics. Non-antibiotic approaches for managing C difficile infection are badly needed since the alteration of the gut flora associated with antibiotics triggers the infection in the first place.
“Vaccination has the potential to be a very effective strategy to combat gastrointestinal pathologies caused by C difficle along with better antibiotic stewardship and infection control practices.”