Sanofi Pasteur starts Phase III clinical program for C. difficile vaccine

Sanofi Pasteur announced on Monday that it has begun the Cdiffense program, a Phase III clinical program to investigate the safety and efficacy of an investigational vaccine.

The investigation vaccine is for the prevention of primary symptomatic Clostridium difficile infection. The Phase III clinical program has begun recruiting volunteers in Canada. The program will include up to 15,000 adults at 200 sites across 17 countries.

C. difficile is potentially life-threatening bacterium that is formed by spores. It causes intestinal disease and the risk of contracting the disease is increased with age, antibiotic treatment and time spent in hospitals. The risk of death is around 15 percent.

"With the emergence of difficult-to-manage strains of C. difficile, CDI has become more frequent, more severe and more difficult to treat in recent years, raising concerns about how to control it and prevent transmission," John Shiver, the senior vice president of Research and Development at Sanofi Pasteur, said. "Vaccination could be an efficacious, cost-effective and important public-health measure to protect individuals from C. difficile."

People who are interested in taking part in the study should be over the age of 50, be planning an upcoming hospitalization or have had at least two hospital stays and have already received systemic antibiotics.