Sanofi launches PhII study of C. diff vaccine
Sanofi Pasteur has launched an ambitious mid-stage clinical trial for an experimental new vaccine that will attempt to thwart the rising risk of hospital-acquired Clostridium difficile infection. Targeting middle-aged and older patients bound for hospitals or rehab and long-term care facilities, investigators plan to recruit 650 people at 30 centers in the U.S. to see if this new toxoid vaccine can help guard them against C. diff.
C. diff is already responsible for some $7 billion in added annual health care costs in the U.S. and Europe. With the emergence of a virulent strain of C. diff, the need for a new vaccine increased significantly, says Sanofi. And the FDA recently granted fast-track status to Sanofi's vaccine.
"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, 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."
- check out this Sanofi release