New vaccine trial targets C. diff

Dr. Christine Johnston, professor (Allergy and Infectious Diseases) is principal investigator on the BEETHOVEN study, an investigational Phase 3 Clostridioides difficile vaccine trial, which is currently enrolling volunteers.

This bacterial gut pathogen, also known as C. diff, is a leading cause of health care-acquired infection. It can cause watery diarrhea, abdominal pain, and fever. In severe cases, the infection can lead to hospitalization and be life-threatening. While anyone can get C. diff, it is most common among older adults who have been hospitalized, have frequent healthcare visits, or have recently received antibiotics.

The study will help researchers learn whether an investigational vaccine is safe and can help prevent C. diff infection in people 65 years of age or older who are at increased risk of C. diff. UW Medicine’s Harborview Medical Center is one of 129 sites in the United States and other countries involved in this vaccine trial.

Trial participants will receive two doses of the investigational C. diff vaccine or placebo, which will be a saltwater injection with no vaccine. They will be checked for symptoms of diarrhea for up to three and a half years and need to be available for at least eight follow-up study visits (a combination of phone and in-person).  

 “C. diff is a common infection that causes significant disruption to patients and healthcare systems. A tool to prevent this infection, especially among older people at increased risk, will help patients avoid this dreaded complication of hospital stays or antibiotics,” said Johnston.

Eligibility

To be eligible for this trial, participants must be 65 years of age or older and have at least one of these risk factors: 

• Have received antibiotics in the last three months  
• Have been hospitalized at least once or had two emergency room visits in the past year  
• Have had 10 or more healthcare visits in the last year  
• Are scheduled to be hospitalized or have elective surgery  

Conditions that would prevent participation:  

• Anyone who has had C. diff infection before 
• Anyone who has had surgery to remove part of their small or large intestine  
• Anyone who has had a serious allergic reaction to a vaccine. Anyone with cancer that has spread, kidney failure, or another serious health problem 
• Other requirements that the study team will discuss with you 

Participants will be compensated for their time. The vaccine test clinic is located on the 11th floor of the Ninth and Jefferson Building at Harborview Medical Center in Seattle. It is open from 8 a.m. to 5 p.m. Monday through Friday.  More details on this study are available on the website of the UW Virology Research Clinic.  

People interested in participating should contact the UW Virology Research Clinic: Email vrc@uw.edu or call 206-520-4340. 

For more information about the trial, visit its identifier page (NCT07282665) at ClinicalTrials.gov. The study is sponsored and funded by Pfizer.