Clinical trials on a possible vaccine for Clostridium difficile have been underway for at least a year, and everyone in the long-term care (LTC) industry is watching closely. The clinical trial efforts for the “Cdiffense” vaccine program, initiated by Sanofi Pasteur, have now moved to Phase 3 in the clinical trials process, a stage that is garnering the attention of clinicians and LTC infection control specialists.
So far, the clinical trial has determined that the risk of acquiring a C. diff infection increases with age, previous antibiotic treatment and/or with time spent in hospitals, among other factors. Phase 3 will recruit volunteers at 100 U.S. locations to join a total pool of 15,000 study volunteers across 17 countries. The ideal study volunteer, Sanofi researchers say, will be at least 50 years old and will have been hospitalized in the past year or be planning a hospital stay. Seniors who has received systemic antibiotics during the past year are also encouraged to volunteer.
The idea is that one day we might have a vaccine that can stop C. diff at the door: protecting the residents who are already in place, and protecting residents who will enter skilled nursing spaces later. Being able to bolster the immune systems of older LTC residents also may reduce infection recurrence rates and thwart the development of resistant strains of the bacteria.
Finding a way to control or prevent the C. diff bacteria is a formidable and ongoing challenge for all LTC facilities. The toxins can produce inflammation and extreme disturbances in a person’s gut-bacteria balance, which usually results in massive and long-term uncontrollable diarrhea and discomfort. The infection kills 14,000 people each year, according to the Centers for Disease Control and Prevention, and other studies estimate that C. diff costs U.S. healthcare $4.8 billion annually.
The Food and Drug Administration fast-tracked the Sanofi investigational vaccine research in 2010.