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Vaccine That Could Prevent C. difficile Infection Under Study at UH

Could your patient benefit from this important clinical trial?

UH Clinical Update - February 2018

In the last decade, the numbers, severity and deaths due to Clostridium difficile cases in hospitals and nursing homes, as well as from the community, have increased significantly. Key factors in this escalation include emergence of hypervirulent pathogenic strains (that disproportionately affect older individuals), increased use of antibiotics (sometimes inappropriately so), improved detection methods and increased exposure to spores in healthcare facilities.

To date, the only measures available to help prevent C. difficile infection (CDI) are behavioral ones, such as encouraging appropriate use of antimicrobials, use of contact precautions and cleaning and disinfection of equipment and the environment.

However, an investigational vaccine that could perhaps prevent CDI is under study at UH Cleveland Medical Center. The trial is a Phase 3, placebo-controlled, randomized, observer-blinded study to evaluate the efficacy, safety and tolerability of aluminum hydroxide (AlOH)-containing C difficile vaccine (200 ?g total toxoid) administered as a three-dose regimen at months 0, 1 and 6 in adults age 50 and older.

Robert Salata, MD, Physician-in-Chief at UH and Chairman of the Department of Medicine at UH Cleveland Medical Center, is leading this trial here. Currently, he and his team are seeking study volunteers who are age 60 or older and who:

• Have had at least two visits to the ED or had a hospitalization of at least two nights in the last 12 months
• Have a planned hospitalization that will require a stay of two or more nights
• Are a resident of a nursing facility
• Have had at least 10 outpatient visits in the last 12 months
• Have received systemic antibiotics at any time in the previous 12 weeks

Participation in this study may run from 18 to 42 months and will consist of at least five office visits and two phone calls. Eligible participants will receive study-related tests and procedures at no cost.

“Emerging information has detailed the importance of the immune system in controlling C. difficle infection and when there is an inadequate immune response to this infection, the rate of relapse/recurrence is high,” Dr. Salata says. “Previous studies have shown that the use of passive immunization with monoclonal antibodies directed against C. difficile is beneficial, but this approach is highly expensive and short-lived. This vaccine, which is an active approach to vaccine administration in older individuals, should theoretically be highly effective and long-lived.”


Please share this information with your patients who may benefit. If you have a patient who is interested in participating, please have them contact Study Coordinator Kieran McKibben, BSN, RN, at 216-286-0746 or