Researchers begin trial of C. diff vaccine

KPWHRI is inviting Kaiser Permanente Washington members age 65 and older to take part

Kaiser Permanente Washington Health Research Institute (KPWHRI) is looking for volunteers to join a study testing a vaccine against the bacteria Clostridioides difficile, or C. diff for short.

Infection with C. diff can cause severe diarrhea. It usually occurs during or after antibiotic use. Older adults tend to be more susceptible, especially if they have been in the hospital or had frequent medical visits. Although most people recover within a couple weeks, some develop serious complications, such as repeat infections, severe dehydration, and damage to the colon. These problems are more likely for older patients and those with weakened immune systems.

“C. diff is easily spread, particularly in hospitals and other settings where antibiotic use is common,” said KPWHRI Senior Investigator Lisa Jackson, MD, who is overseeing the research at the institute. “Prevention is key, especially for those at risk of more severe infection and complications.”

There currently isn’t a C. diff vaccine approved by the Food and Drug Administration to protect against the infection. KPWHRI is one of many research sites worldwide testing an investigational vaccine developed by Pfizer Inc. The study, called BEETHOVEN, will look at how effective, safe, and well tolerated the vaccine is for decreasing C. diff infections among older adults.

Who can participate?

KPWHRI is enrolling Kaiser Permanente Washington members age 65 or older who have never had C. diff and meet at least one of the following criteria:

• They have been hospitalized at least once in the last year or are scheduled to be hospitalized or have surgery.
• They have had frequent medical visits over the past year.
• They have taken antibiotics in the last 3 months.
• They have had 2 or more emergency room visits in the past year.

What to expect?

• Up to 5 study visits at KPWHRI’s downtown Seattle research clinic over a span of up to 3 1/2 years
• 2 injections of either the investigational vaccine or a placebo (salt water), 6 months apart
• Participants will receive $150 for each in-person study visit and additional payments for other study activities. They will also receive free parking in the research clinic's garage or free bus tickets.

To learn more about this trial, please visit C. difficile Vaccine Study or call 206-287-2061.

By Sophie Ramsey​​​​