Sanofi Pasteur, the vaccines division of sanofi-aventis Group, announced today that it has started its phase II clinical study of a vaccine for primary prevention of Clostridium difficile infection (CDI). The trial starting in 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 Sanofi Pasteur trial is investigating the safety and immunogenicity of different formulations of a Clostridium difficile toxoid vaccine administered in adults aged 40 to 75 years who are at risk of C. difficile infection.
"Sanofi Pasteur has chosen a well established approach for this particular vaccine Toxoids have been used as the basis of a number of highly successful vaccines," explained Michel DeWilde, PhD, Senior Vice President for R&D at Sanofi Pasteur."This candidate vaccine has 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.
The phase II trial hopes to recruit approximately 650 participants at some 30 health-care centers across the U.S.