Japan Joins The Phase III Cdiffense Trial Of Investigational Clostridium difficile Vaccine



Cdiffense trial to evaluate vaccine against a leading cause of life-threatening

The Following is a Press Released Produced By Sanofi Pasteur

January 7, 2016:  Tokyo, Japan – Sanofi K.K. Headquarters; Shinjuku-ku, Tokyo: President: Fabrice Baschiera announced on January 7th, 2016 that Sanofi Pasteur; the vaccines division of Sanofi, started the initiation of its Phase III clinical program in Japan called Cdiffense to evaluate the safety, immunogenicity and efficacy of an investigational vaccine for the prevention of symptomatic Clostridium difficile infection (CDI).  Clostridium difficile (C. diff. ) is a potentially life-threatening, spore-forming bacterium that causes intestinal disease.

The risk of CDI 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 CDI, which is emerging as a leading cause of life-threatening ,  healthcare-associated infections (HAI’s) worldwide.

Since 20 to 30 percent of patients experience recurrances of CDI, re-hospitalizations and longer hospital stays remain common (2)  Although relatively few studies on C. difficile have been performed in Asia, what work has been done demonstrates that CDI is a significant cause of nosocomial disease in Asian countries. (3).

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.  The phase III clinical trial is designed to determine if the investigational vaccine will help prevent a future infection from occurring.

“With an increased focus on surveillance, we are learning more about the frequency, severity, and cost of C. diff. infections in Japan.  Prevention and control through vaccination represents an opportunity to protect patients and reduce healthcare costs associated with C. diff.” explained Michael Mullette, Corporate Office, at Sanofi Pasteur.

The Cdiffense Phase III clinical program has just started recruiting volunteers in Japan for a randomized, obsserver-blind, placebo-controlled, multi-center, multi-national trial that will include up to 15,000 adults at 200 sites across 20+ countries.  Volunteers for the study should be age 50 or older and are planning an upcoming hospitalization, or have been in the hospital and received systemic antibiotics in the past year.  For more information on the Cdiffense trial, please visit http://www.Cdiffense.org


About C. diff.

Clostridium difficile (C. diff. ) is a potentially life-threatening, spore-forming bacterium that causes intestinal disease (infection).  A main source of C. diff. is infected patients who release spores into the environment that can then infect other people (hand to mouth route *)

When antibiotics disrupt the gut’s normal flora and a person ingests C. diff. spores, the C. diff. bacteria multiply and proliferate into the colon* and then release potent toxins that cause the C. difficile symptoms and damage a person’s intestinal lining.

*Mode of transmission of CDI can be either directly or indirectly, hospital acquired (nosocomial) or community – acquired; Ingesting C Diff spores transmitted from others and patients by hands, or altered normal intestinal flora by antibiotic therapy allowing proliferation of C Diff in the colon.  Coming in contact with surfaces, devices, or material with Clostridium difficile spores can easily be transferred to individuals by hands that have touched a contaminated surface or item. Examples of surfaces, devices, and materials contaminated with C Diff spores in hospital and community/outpatient settings: commodes, bath tubs, showers, hand rails, bed rails, counter tops, handles, clothing, medical equipment. *

About Sanofi Pasteur:

Sanofi, a global healthcare leader, discovers, develops, and distributes therapeutic solutions focused on patients’ needs.  Sanofi has core strengths in diabetes solutions, human vaccines, innovative drugs, consumer healthcare, emerging markets, animal health and Genzyme.  Sanofi is listed in Paris (EURONEXT:SAN) and in New York (NYSE:SNY).

Sanofi Pasteur; the vaccines division of Sanofi, provides more than 1 billion doses of vaccine each year, making it possible to immunize more than 500 million people across the globe.  A world leader in the vaccine industry, Sanofi Pasteur offers a broad range of vaccines protecting against 20 infectious diseases.  the company’s heritage to create vaccines that protect life, dates back more than a century.  Sanofi Pasteur is the largest company entirely dedicated to vaccines.  Every day, the company invests more than EUR 1 million in research and development.  For more information please visit http://www.sanofipasteur.com

or http://www.sanofipasteur.ip


1 Center of Disease Control and Prevention, Frequently Asked Questions about Clostridium difficile for Healthcare Providers, Centers for Disease Control and Prevention  http://www.cdc.gov/HAI/organism/cdiff/Cdiff_faqs_HCP.html

2  Garey KW, et al (2006) Mete-analysis to assess risk factors for recurrent Clostridium difficile infection, Journal Hospital Infection, 70 p , 206-304

3.  Collins et al. Antimicrobial Resistance and Infection Control 2013, 2-21; http://www.aricjournal.com/content2/1/21

* Clostridium difficile (CDI) Infections thttp://www.cdc.gov/hai/pdfs/toolkits/CDItoolkitwhite_clearance_edits.pdf


*Please note – The C Diff Foundation does not endorse this product or any product and this posting is strictly for informational purposes only.