Phase 3 C. diff Vaccine Trial Launches at University of Washington to Protect High-Risk Older Adults
核心洞察
The University of Washington is enrolling volunteers in the BEETHOVEN study, a Phase 3 trial testing an investigational Clostridioides difficile (搜索) vaccine for adults 65 and older at increased risk of infection.
The multi-site trial involves 129 locations across the United States and other countries, with participants receiving two vaccine doses and being monitored for up to three and a half years.
C. diff is a leading cause of healthcare-acquired infections that can cause severe diarrhea (搜索), hospitalization, and life-threatening complications, particularly affecting older adults with recent antibiotic use or frequent healthcare exposure.
The University of Washington School of Medicine has launched enrollment for the BEETHOVEN study, a Phase 3 clinical trial testing an investigational vaccine (搜索) against Clostridioides difficile (搜索) (C. diff) in older adults at high risk for infection. Dr. Christine Johnston, professor of medicine and infectious diseases specialist at UW Medicine (搜索), serves as principal investigator for this international trial.
Trial Design and Scope
The BEETHOVEN study represents a major international effort involving 129 sites across the United States and other countries. Participants will receive two doses of either the investigational C. diff vaccine (搜索) or a placebo consisting of a saltwater injection. The trial will monitor participants for diarrhea (搜索) symptoms for up to three and a half years, requiring at least eight follow-up visits combining phone consultations and in-person assessments.
UW Medicine (搜索)'s Harborview Medical Center serves as one of the participating sites, with the vaccine test clinic located on the 11th floor of the Ninth and Jefferson Building in Seattle, operating Monday through Friday from 8 a.m. to 5 p.m.
Addressing a Critical Healthcare Challenge
C. diff stands as a leading cause of healthcare-acquired infections, presenting significant clinical challenges for both patients and healthcare systems. The bacterial gut pathogen can cause watery diarrhea (搜索), abdominal pain, and fever. In severe cases, infections can lead to hospitalization and become life-threatening.
"C. diff is a common infection that causes significant disruption to patients and healthcare systems," Johnston explained. "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 (搜索)."
While C. diff can affect anyone, the infection disproportionately impacts older adults who have been hospitalized, have frequent healthcare visits, or have recently received antibiotics (搜索).
Patient Eligibility and Exclusion Criteria
The trial targets adults 65 years of age or older who have at least one specific risk factor for C. diff infection (搜索). Eligible participants must have experienced one of the following within defined timeframes:
- Received antibiotics in the last three months
- Been hospitalized at least once or had two emergency room visits in the past year
- Had 10 or more healthcare visits in the last year
- Are scheduled for hospitalization or elective surgery
Several conditions exclude potential participants from the study. Individuals who have previously had C. diff infection (搜索) cannot participate, nor can those who have undergone surgery to remove part of their small or large intestine. The trial also excludes anyone with a history of serious allergic reactions to vaccines, as well as those with metastatic cancer, kidney failure, or other serious health conditions.
Study Compensation and Contact Information
Participants will receive compensation for their time and involvement in the trial. Those interested in participating can contact the UW Virology Research Clinic by email at vrc@uw.edu or by calling 206-520-4340. Additional study details are available on the UW Virology Research Clinic website.