Sanofi Pasteur Initiates Phase III Study Investigational Clostridium Difficile Vaccine

Sanofi Pasteur announced the initiation of its Phase III clinical program called Cdiffense to evaluate the safety, immunogenicity and efficacy of an investigational vaccine for the prevention of primary symptomatic Clostridium difficile infection (CDI). Clostridium difficile (C. diff) is a potentially life-threatening, spore-forming bacterium that causes intestinal disease. The risk of C. diff increases with age, antibiotic treatment and time spent in hospitals or nursing homes, where multiple cases can lead to outbreaks. The investigational vaccine is designed to help protect at-risk individuals from C. diff, which is emerging as a leading cause of life-threatening, healthcare-associated infections (HAIs) worldwide.

C. diff toxins cause gastrointestinal disease that can lead to death in approximately eight to 15 percent of infected people.2 Since 20 to 30 percent of patients experience recurrences of CDI, re-hospitalizations and longer hospital stays remain common.3 Combined data from the United States (U.S.) and European Union (EU) indicate that healthcare systems spend more than $7 billion annually on CDI acute care.4,5 Globally, there has been an increase in the incidence and severity of CDI reported in North American,6 European and Asian countries, possibly due to the emergence of hyper-virulent strains.7 The investigational C. diff vaccine is designed to produce an immune response that targets the toxins generated by C. diff bacteria, which can cause inflammation of the gut and lead to diarrhea. It ultimately may help prevent a future infection from occurring.

“With the emergence of difficult-to-manage strains of C. diff, 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”, explained John Shiver PhD, Senior Vice President for Research & Development at Sanofi Pasteur. “Vaccination could be an efficacious, cost-effective and important public-health measure to protect individuals from C. diff.”

The Cdiffense Phase III clinical program has just started recruiting volunteers for a randomized, observer-blind, placebo-controlled, multi-center, multi-national trial that will include up to 15,000 adults at 200 sites across 17 countries. Volunteers for the study should be age 50 or older and planning an upcoming hospitalization or have had at least two hospital stays and have received systemic antibiotics in the past year.