A Study of Vaccination With 9-valent Extraintestinal Pathogenic Escherichia Coli Vaccine (ExPEC9V) in the Prevention of Invasive Extraintestinal Pathogenic Escherichia Coli Disease in Adults Aged 60 Years And Older With a History of Urinary Tract Infection in the Past 2 Years

Completed · Phase 3 · Has a placebo group

Conditions studied: Invasive Extraintestinal Pathogenic Escherichia Coli Disease (IED) Prevention

In brief

The purpose of this study is to demonstrate the efficacy of 9-valent extraintestinal pathogenic Escherichia coli vaccine (ExPEC9V) compared to placebo in the prevention of the first invasive extraintestinal pathogenic Escherichia coli disease (IED) event caused by ExPEC9V O-serotypes.

Key facts

Study ID

NCT04899336

Run by

Janssen Research & Development, LLC

People needed

17797

Starts

2021-06-30

Expected to finish

2025-08-27

Last updated by the study team

2026-07-06

Who can join

Age: 60 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Participant must be willing to share relevant medical information pertaining to medical history and to share medical records relevant to the medical events identified as suspected cases of invasive extraintestinal pathogenic Escherichia coli disease (IED), urinary tract infections (UTI), or acute bacterial prostatitis (ABP) occurring during the study observation period
• Participant must have a history of UTI in the past 2 years for which evidence of diagnosis was verified by the investigator. In case of a recent history of UTI or ABP, the condition must have resolved greater than (>)14 days prior to randomization
• Before randomization, participants who were born female must be either postmenopausal or permanently sterile, and not intending to conceive by any methods
• Participant must be willing to provide verifiable identification, has means to be contacted and to contact the investigator during the study

You may not qualify if…

• Participant has end-stage renal disease for which dialysis is required
• Participant has a contraindication to intramuscular (IM) injections and blood draws example, due to bleeding disorders or a history of difficult blood draws
• Participant has a history of acute polyneuropathy (for example, Guillain-Barre syndrome) or chronic inflammatory demyelinating polyneuropathy
• Participant has received any Escherichia coli (E. coli) or extraintestinal pathogenic Escherichia coli (ExPEC) vaccine

Where it is running

• Hope Research Institute — Phoenix, Arizona, United States
• Hope Research Institute — Phoenix, Arizona, United States
• Interspond-Clinical Research Institute of AZ — Sun City West, Arizona, United States
• Baptist Health Center For Clinical Research — Little Rock, Arkansas, United States
• Sun Urology - Buena Park Office — Buena Park, California, United States
• Hope clinical Research LLC — Canoga Park, California, United States
• Velocity Clinical Research, Inc. — Chula Vista, California, United States
• Marvel Clinical Research — Huntington Beach, California, United States
• California Adult Circumcision - Alvarado La Mesa Urology Center — La Mesa, California, United States
• Om Research LLC — Lancaster, California, United States
• Atlantic Urology Medical Group — Long Beach, California, United States
• Long Beach Clinical Trials, LLC — Long Beach, California, United States
• American Institute of Research — Los Angeles, California, United States
• Kaiser Permanente Los Angeles Medical Center — Los Angeles, California, United States
• Southern California Permanente Medical Group — Los Angeles, California, United States
• Comprehensive Urology — Los Angeles, California, United States
• Veterans Affairs Greater Los Angeles HCS — Los Angeles, California, United States
• VA Sacramento Medical Center — Mather, California, United States
• Hoag Medical Group — Newport Beach, California, United States
• Kaiser Permanente Vaccine Study Center — Oakland, California, United States
• Empire Clinical Research, LLC — Pomona, California, United States
• Inland Urology Medical Group — Pomona, California, United States
• UC Davis Health System — Sacramento, California, United States
• Northern California Research — Sacramento, California, United States
• Lakeview Clinical Research — Guntersville, Alabama, United States

Full record on ClinicalTrials.gov

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