Special thanks to Irena L. Kenneley, PhD, APRN-BC, CIC and Carol McLay, RN, MPH, DrPH, CIC, both members of the Association for Professionals in Infection Control and Epidemiology (APIC) Communications Committee, for this guest blog on the promise of a Clostridium difficile vaccine.
Clostridium difficile (C. diff) is a potentially life-threatening bacterium that causes diarrhea and more serious intestinal conditions. It is frequently associated with previous antibiotic use and is commonly contracted by the elderly and those with recent exposure to hospitals, nursing homes, and other healthcare institutions. Infections with this deadly bacterium are rapidly increasing due to a highly virulent strain which is causing disease in long-term care facilities and hospitals across the United States, Canada, and Europe.
In March 2012, the Centers for Disease Control and Prevention (CDC) issued a Vital Signs report, sounding the alarm that C. difficile infections (CDI) were at an all-time high. An August 2012 USA TODAY investigation reported that CDI is far more prevalent in the US than federal reports suggest – affecting some 500,000 individuals and leading to more than 30,000 deaths each year, almost as high as the 32,000 who die in the US each year in traffic accidents.
An APIC prevalence study published in 2008 made similar headlines showing that 13 of every 1,000 inpatients were either infected or colonized with C. diff. More recently, a 2013 CDI ‘Pace of Progress’ survey among APIC’s 14,000 members who lead infection prevention and control programs revealed that prevention efforts in US healthcare facilities are not yielding significant improvements: 70 percent of respondents have adopted additional interventions to address the problem since March 2010, yet only 42 percent have seen a decline in their infection rates during that time period.
Fortunately, an exciting new prospect for a CDI vaccine is on the horizon. A CDI vaccine study, which is in phase II of clinical trials, has been granted fast-track designation by the US Food and Drug Administration (FDA). The vaccine is reported to be well-tolerated and able to generate an immune response with the ability to resolve recurrence of the disease.
The impact of this vaccine would be striking, resulting in a substantial decline in cases of C. difficile hospitalizations, deaths, and healthcare costs associated with the disease. If successful, this would be the first vaccine capable of preventing a healthcare-associated infection.
It is clear that a new approach to the prevention and management of CDI is needed. The promise of this vaccine candidate will continue to be carefully monitored to determine the exact role of vaccine therapy in managing this deadly and preventable disease.