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Randomized, Double-blind, Placebo-controlled, Multicenter Phase 3 Study to Assess the Efficacy, Safety And Immunogenicity of Vaccination with 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

Urinary tract infections
All genders
person-wave 60+
Recruiting now


Principal Investigator: Yoav Golan, MD

This clinical research study to look at the effectiveness and safety of an investigational vaccine that is being developed by Janssen Pharmaceuticals. This study is looking at whether the investigational vaccine can help prevent a bloodstream infection caused by E. coli bacteria, which is commonly found in the gastrointestinal tract, and can spread to the urinary tract and blood stream.

Study details

Inclusion Criteria
  • 1. Male or female >/= 60 years old
  • 2. Must have a documented medical history of Urinary Tract Infection (UTI) in the past 2 years,
  • 3. Must have access to the internet and be able to reasonable navigate basic internet applications
Exclusion Criteria
  • 1. Diagnosed with End-Stage Renal Disease
  • 2. Diagnosed with any other chronic disorder or significant cognitive impairment
  • 3. Abnormal function of the immune system
Study Requirements

This study will take place over the course of 3 years from the time of enrollment. It will include 2 in-person visits to Tufts Medical Center and 6 phone calls. Participants may also be asked to fill out electronic questionnaires using an app throughout the study. Participants will receive 1 injection of either the ExPEC9V study vaccine or a placebo, this will be decided randomly and will occur at the first study visit. These are some other activities that could occur at some or all of the study visits and phone calls: (a) Reviewing health and medical history (b) Blood draws (about 1.5 tablespoons of blood total will be drawn throughout the study) (c) Tests to asses mobility and balance

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