Health
Vaccine study enrolling in Fairfield and Westchester Counties
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Feb 19, 2011 - 10:58 AM

Stamford Therapeutics Consortium announced recently that it is participating in a phase II clinical study of a vaccine for primary prevention of Clostridium difficile infection (CDI). The trial being held across the United States is focused on evaluating prevention of the first episode of CDI in at-risk individuals, which includes adults with imminent hospitalization or current or impending residence in a long-term care or rehabilitation facility.

The incidence of CDI has increased significantly in recent years in both North America and Europe. CDI-related treatments in these two regions of the world are estimated to be costing more than $7 billion a year. The recent emergence and spread of a hyper-virulent strain of C. difficile further highlights the importance of preventing CDI.

C. difficile is present worldwide and has become the most frequent hospital-acquired infection in the U.S., Europe, and Canada. Standard treatment of C. difficile infection involves the use of antibiotics. The trial in which Stamford Therapeutics is participating includes a CDI preventative vaccine being developed by Sanofi Pasteur.

“Sanofi Pasteur has chosen a well-established approach for this particular vaccine, according to David Radin, M.D.. “Toxoids have been used as the basis of a number of highly successful vaccines,” explains Dr. Radin, who added, “This candidate vaccine has already completed phase I clinical trials in more than 200 participants to evaluate its safety and immunogenicity.”

The U.S. Food and Drug Administration (FDA) recently granted fast-track designation to Sanofi Pasteur’s investigational Clostridium difficile vaccine candidate. The fast-track program of the FDA is designed to facilitate the development and expedite the review of new drugs and vaccines that are intended to treat or prevent serious or life-threatening conditions and demonstrate the potential to address unmet medical needs.

About C. difficile:

C. difficile is an anaerobic spore-forming bacterium, present asymptomatically in approximately 60 percent of infants and approximately three percent of healthy adults. It belongs to the Clostridium family of bacteria, which also includes C. tetani (tetanus) and C. botulinum (botulism). The C. difficile bacteria produce two potent toxins: A and B. When the natural microbial flora of the gut is disturbed, usually as a result of antibiotic treatment for other illnesses, and a patient is exposed to C. difficile spores, the bacteria can multiply and release the two toxins, which cause a broad range of gastrointestinal symptoms in humans known collectively as CDI.

Hospital-acquired infections caused by C. difficile are a considerable problem in many industrialized countries, including the U.S., Canada, and Europe. It is estimated that there are about 500,000 cases of CDI in the US alone1, with annual costs to the healthcare system of $3.2 billion2. In the EU, assuming a population of about 460 million people, the healthcare costs of CDI are estimated to be around $4.4 billion per year.3 Additional information is available at the US Centers for Disease Control and Prevention and UK Health Protection Agency C. difficile information pages1,4.

About Stamford Therapeutics Consortium:

Stamford Therapeutics Consortium (STC) is a privately owned and operated clinical research site specializing in phase II, III, and IV clinical trials for the pharmaceutical and biotechnology industries. Operating as an independent investigational site since its founding in 1994, the company’s sole mission is to conduct the highest quality clinical trials so that new, safe and effective medications can be developed, researched and approved for a variety of indications and diseases. With over 15 years of clinical trials operations, STC has conducted more than 350 national and multi-national clinical trials. For more information contact Judy at 203-325-8529.

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