Jersey Shore hospital participates in clinical study of investigational vaccine for prevention of CDI

Mark Martens, M.D., chief of Obstetrics and Gynecology at Jersey Shore University Medical Center, announces that the hospital is participating in a clinical study 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. While most types of health care-associated infections (HAIs) are declining, C. diff is emerging as a leading cause of life-threatening, HAIs worldwide.

In 2010, the U.S. Food and Drug Administration (FDA) granted fast-track designation to the investigational C. diff vaccine candidate being developed by Sanofi Pasteur. The fast-track program of the FDA is designed to facilitate the development and expedite the review of new investigational drugs and vaccines that are intended to treat or prevent serious or life-threatening conditions and demonstrate the potential to address unmet medical needs.