ExPEC9V Vaccine for E. coli Infections Prevention
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a vaccine to protect older adults from serious E. coli infections. The vaccine trains the immune system to recognize and fight off nine types of harmful E. coli bacteria. In earlier studies, a similar vaccine caused fever and/or diarrhea in some participants and provided limited protection against illness.
Do I need to stop my current medications for the ExPEC9V vaccine trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
How is the ExPEC9V vaccine different from other treatments for E. coli infections?
What data supports the effectiveness of the ExPEC9V treatment for preventing E. coli infections?
Who Is on the Research Team?
Janssen Research & Development, LLC Clinical Trial
Principal Investigator
Janssen Research & Development, LLC
Are You a Good Fit for This Trial?
Adults aged 60+ with a history of UTI in the past 2 years can join this trial. They must be postmenopausal or sterile if born female, not planning to conceive, and able to use digital devices for communication. Excluded are those with bleeding disorders, certain neuropathies, previous E. coli vaccines, or needing dialysis.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Vaccination
Participants receive a single intramuscular injection of either the ExPEC9V vaccine or placebo
Follow-up
Participants are monitored for safety and effectiveness after vaccination
Long-term Follow-up
Participants continue to be monitored for long-term safety and efficacy outcomes
What Are the Treatments Tested in This Trial?
Interventions
- ExPEC9V
- Placebo
Find a Clinic Near You
Who Is Running the Clinical Trial?
Janssen Research & Development, LLC
Lead Sponsor
Joaquin Duato
Janssen Research & Development, LLC
Chief Executive Officer since 2022
MBA from ESADE, Master of International Management from Thunderbird School of Global Management
Dr. Jijo James, MD
Janssen Research & Development, LLC
Chief Medical Officer since 2014
MD from St. Johns Medical College, MPH from Columbia University