Volunteers Wanted for Vaccine Trial

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Healthcare professionals are encouraged to identify patients who may be eligible to be part of a trial to evaluate vaccine against a leading cause of life-threatening healthcare-associated infections worldwide.

Sanofi Pasteur has launched its phase three study of investigational Clostridium Difficile(Cdiffence) vaccine in Australia to evaluate the safety, immunogenicity and efficacy of a n 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 can cause inflammation of the gut, leading to diarrhea and intestinal disease. The risk of CDI increases with age, antibiotic treatment and duration of hospitalisation or length of stay in nursing homes, where multiple cases can lead to outbreaks. C. diff is a leading cause of life-threatening, healthcare -associated infections worldwide.1

Sanofi Pasteur’s 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 and more serious complications. The phase III clinical trial is designed to determine if the investigational vaccine can effectively help to 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 how to prevent transmission in healthcare settings”, 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 at-risk individuals from C. diff infection,” says  Shiver.

The CDiffense Phase III clinical program is recruiting volunteers in Australia. There will be six sites in Australia, Sydney, Melbourne, Brisbane, Cairns, Adelaide and Perth, and 150 volunteers from will be involved in the extensive global trial. CDiffense is a randomised, observer-blind, placebocontrolled, multi-centre trial that will include up to 15,000 adults at 200 sites across 17 countries.

Volunteers for the study should be 50 years or older and planning an upcoming hospitalisation, or have had at least two hospital stays and have received systemic antibiotics in the past year.

For more information visit www.Cdiffense.org or email vaccinehelp@sanofi.com