Phase III Program Evaluates Clostridium difficile Vaccine
Subjects recruited for large international trial (August 5)
A phase III clinical program called Cdiffense has been initiated to evaluate the safety, immunogenicity, and efficacy of an investigational vaccine for the prevention of primary symptomatic Clostridium difficile infection (CDI) (Sanofi Pasteur).
C. difficile is a potentially life-threatening, spore-forming bacterium that causes intestinal disease, which can lead to death in approximately 8% to 15% of infected people. The risk of CDI increases with age, antibiotic treatment, and the time spent in hospitals or nursing homes, where multiple cases can lead to outbreaks. Since 20% to 30% of patients experience recurrences of CDI, rehospitalizations and longer hospital stays remain common.
The investigational vaccine is designed to help protect at-risk individuals from C. difficile, which is emerging as a leading cause of life-threatening, healthcare-associated infections (HAIs) worldwide. The vaccine produces an immune response that targets the toxins generated by C. difficile bacteria, which can cause inflammation of the gut and lead to diarrhea.
The Cdiffense phase III clinical program has started recruiting subjects for a randomized, observer-blinded, placebo-controlled trial that will include up to 15,000 adults at 200 sites in 17 countries.
Source: Sanofi Pasteur; August 5, 2013.