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Sanofi Pasteur Starts a Phase II Study of a Vaccine Against Clostridium Difficile
Date:2/17/2009

ese two regions of the world are estimated to be costing more than $7bn a year. The emergence of a hyper-virulent strain of C. difficile in 2002 further highlighted the importance of tackling CDI.

About the Clinical Trial

The phase IIb trial involves about 600 participants with acute CDI at about 30 centers across the United Kingdom. Participants will be randomized to 4 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.

About C. difficile

C. difficile is an anaerobic spore-forming bacterium, present asymptomatically in approximately 60% of infants but only about 3% of healthy adults. It belongs to the Clostridium family of bacteria, which also includes C. tetani (tetanus) and C. botulinum (botulism). The C. difficile bacteria produce two potent toxins: A and B. When the natural microbial flora of the gut is disturbed, usually as a result of antibiotic treatment, and a patient ingests C. difficile spores, the bacteria can multiply and release the two toxins, which cause gastrointestinal pathologies in humans known collectively as CDI.

Hospital-acquired infections caused by C. difficile bacteria are a considerable problem in many industrialized countries, including the U.S., Canada, and Europe. It is estimated that C. difficile causes about 500,000 cases in the US alone (1) with annual costs to the healthcare system of $3.2bn.(2) In the EU, assuming a population of about 460 million people, the healthcare costs of CDI are estimated to be around $4.4bn per year.(3) Additional information is available at the UK Health Protection Agency C. difficile information page (4) and at http://www.sanofipasteur.com/cdiff

About sanofi-aventis

Sanofi-aventis, a leading global pharmaceutica
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