Sanofi's vaccines division Sanofi Pasteur has launched  phase III clinical trials programme of Cdiffense to assess the safety, immunogenicity and efficacy of a candidate vaccine for the prevention of symptomatic primary infection with Clostridium difficile (ICD).

The Clostridium difficile (C. difficile) is a potentially lethal spore-forming bacterium that causes intestinal ailments. The risk of contracting C.difficile increases with age, antibiotic treatment and length of stay in hospital or nursing homes, where the number of cases may cause epidemics. The candidate vaccine is designed to help protect at-risk individuals against C.difficile, which appears as a major cause of life-threatening infections associated with care in the world.

The toxins of C. difficile cause gastro-intestinal diseases that can cause death in approximately 8% to 15% of infected persons.  In European countries, for hospitalized patients with ICD complications, infection causes a significant increase in length of hospital stay.  Data from the European Union (EU) show that health systems spend more than €3 billion per year for acute care to treat CDI.  In Globally, an increase in the incidence and severity of CDI in the countries of North America, it was reported [ 5] 's Europe and Asia, probably due to the emergence of virulent strains. Vaccine candidate against C. difficile is designed to trigger an immune response that targets the toxins produced by the bacterium C. difficile can cause inflammation of the intestinal wall and cause diarrhoea. Ultimately, the vaccine could help prevent future infections with C. difficile.

"With the ' emergence of strains of C. difficile more difficult to control in recent years, ICD has become more frequent, more severe and  complicated  to deal with, which raises concerns about the methods of control and prevention transmission  , "said Sabine Vitale , director of global clinical operations at Sanofi Pasteur. "  By providing an efficient and effective to protect individuals against C. difficile, vaccination could be an important step in the service of public health . "

Cdiffense , clinical programme phase III study has just begun recruiting in France to participate in the multicenter international clinical trial randomized single-blind placebo-controlled trial included 15,000 adult volunteers. This test will be conducted at 200 sites in 17 countries. For this study, volunteers must be aged 50 and over, enjoy a planned or have been hospitalized at least twice in the last year and treated with systemic antibiotics hospitalization.

The Clostridium difficile (C. difficile) is a potentially lethal spore-forming bacterium that causes intestinal ailments. Risk of infection with C. difficile (ICD) increases with age, antibiotic treatment and length of stay in hospital or nursing homes, where multiple cases can lead to an epidemic.  Indeed, one of the main CDI is causes the proximity of patients infected with that release spores into the environment may infect others. When antibiotics disrupt normal intestinal flora of a person that has been contaminated with spores of C. difficile, bacteria C. difficile multiply and release potent toxins that can damage the intestinal wall and cause infection with C. difficile.

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