Sanofi Pasteur initiates Phase III study of investigational Clostridium difficile vaccine

Sanofi Pasteur, the vaccines division of Sanofi (EURONEXT: SAN and NYSE: SNY), announced today 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.1

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. For more information on the Cdiffense trial, please visit www.Cdiffense.org.

About C. diff

Clostridium difficile (C. diff) is a potentially life-threatening, spore-forming bacterium that causes intestinal disease. The risk of contracting CDI increases with age, antibiotic treatment and time spent in hospitals or nursing homes, where multiple cases can lead to outbreaks.1 A main source of C. diff is infected patients who release spores into the environment that can then infect other people. When antibiotics disrupt the gut’s normal flora and a person has ingested C. diff spores, the C. diff bacteria multiply and release potent toxins that can damage a person’s intestinal lining and cause C. diff disease.8

References

1. Centers for Disease Control and Prevention. Frequently Asked Questions about Clostridium difficile for Healthcare Providers. Centers for Disease Control and Prevention. http://www.cdc.gov/HAI/organisms/cdiff/Cdiff_faqs_HCP.html. Last Updated March 6, 2013. Accessed June 26, 2013.
2. Mitchell BG and Gardner A. (2012) Mortality and Clostridium difficile infection: a review. Aric journal.
3. Garey KW, et al. (2008). Meta-analysis to assess risk factors for recurrent Clostridium difficile infection. Journal Hospital Infection, 70, p. 298-304.
4. Dubberke ER and Olsen MA. Burden of Clostridium Difficile on the Healthcare System. Clinical Infectious Diseases 55, no. suppl 2 (2012): S88–S92. doi:10.1093/cid/cis335.
5. European CDC, Clostridium Difficile basic facts. Accessed June 26, 2013. http://www.ecdc.europa.eu/EN/HEALTHTOPICS/CLOSTRIDIUM_DIFFICILE_INFECTION/BASIC_FACTS/Pages/basic_facts.aspx
6. Centers for Disease Control and Prevention. Making Health Care Safer: Stopping C. difficile Infections. Centers for Disease Control and Prevention. http://www.cdc.gov/VitalSigns/HAI/index.html. Last Updated August 21, 2012. Accessed June 26, 2013.
7. Jones AM, Kuijper EJ and Wilcox MH. Clostridium difficile: A European perspective. Journal of Infection 2013; 66(2): 115-128. http://www.sciencedirect.com/science/article/pii/S0163445312003052. Accessed June 26, 2013.
8. Delmee M and Warny M. (1995). Clostridium difficile colitis: recent therapeutical and immunological considerations. Acta Gastroenterol Belg, 58 (3-4), p. 313-317.