Department of Research & Evaluation News

Kaiser Permanente Southern California is participating in a clinical trial of a novel vaccine against invasive E. coli infections in older adults.

William Towner, MD, the principal investigator for Kaiser Permanente Southern California, said, “I’m enthusiastic about this cutting-edge research because it has the potential, if successful, to reduce morbidity and mortality from a very common form of sepsis in the elderly.”

The study is the first Phase 3 trial of an E. coli vaccine candidate and will enroll around 18,000 patients at almost 130 sites in 10 countries over the next 3 years. The clinical trial will recruit patients 60 years of age and older who have had an E. coli urinary tract infection (UTI) in the 2 years prior to enrollment. Subjects will be randomized to 1:1 to receive either the vaccine or placebo, and then followed for 3 years to identify any cases of invasive E. coli infections.

The database team from the Department of Research & Evaluation will monitor if a patient is treated or hospitalized at a Kaiser Permanente facility for an E. coli infection. “This integration of information from our electronic health record is one of the reasons research sponsors really like to collaborate with us,” Dr. Towner said.   

UTIs caused by E. coli are very common in the elderly, and can lead to sepsis, complications, and death. “Many providers have treated an elderly patient with urinary sepsis caused by E. coli at some point in their careers,” said Dr. Towner. “Having a vaccine that could prevent or reduce the severity of these infections would be hugely helpful.”

Kaiser Permanente’s participation in several COVID-19 vaccination trials recently has distinguished the organization for its vaccine research. “A lot of what Kaiser Permanente has done in the COVID-19 vaccine trials paved the way for participation in this study. Kaiser Permanente Southern California has a strong track record of well-done vaccine research, which makes us very attractive to sponsors for exciting and cutting-edge research such as this study,” according to Dr. Towner.

Dr. Towner’s team is now enrolling patients 60 and older who have a history of an E. coli UTI in the past 2 years. The team will reach out to Kaiser Permanente Southern California members who meet these criteria, however, providers can also direct interested patients to call the study hotline at 323-783-5673, or email REClinicalTrialsVaccine@KP.org.

Participants will visit the Kaiser Permanente Los Angeles Medical Center twice: once to get vaccinated, and 30 days later for a blood draw. All subsequent visits will be remote.

The study team is also collaborating with Kaiser Permanente’s Regional Reference Laboratories in North Hollywood and Chino Hills for analysis of microbiology specimens.

“Vaccine research is an expanding portfolio we’ll definitely continue to pursue in the future,” Dr. Towner said, “as it fits well into Kaiser Permanente’s emphasis on preventive health.”