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New vaccine aims to shield seniors from dangerous e. coli infections

NCT ID NCT03819049

Prevention Sponsor: Janssen Research & Development, LLC Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested an experimental vaccine (ExPEC10V) in 836 healthy adults aged 60 to 85 to see if it can prevent infections caused by a harmful type of E. coli. Participants received one of three vaccine doses or a placebo, and researchers monitored side effects and immune responses for about six months. The goal is to find the best dose for future larger studies, especially for people with a history of urinary tract infections.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

836 people

The number who actually took part.

Started

Jun 2019

Finished

Dec 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

60 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Must have a body mass index (BMI) of greater than (\>) 18.5 or less than 40 kilogram per meter square (kg/m\^2) * Before randomization, a woman must be: postmenopausal - A postmenopausal state is defined as no menses for 12 months without an alternative medical cause; or not intending to conceive by any methods * Must be healthy or medically stable * Must sign an informed consent form (ICF) indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study * Willing and able to adhere to the lifestyle restrictions specified in this protocol * Agrees not to donate blood until 12 weeks after receiving the study vaccine Exclusion Criteria: * Acute illness (this does not include minor illnesses such as diarrhea or mild upper respiratory tract infection) or temperature greater than equal to \>=38.0 degree Celsius (100.4 degree Fahrenheit) within 24 hours prior to the administration of study vaccine, or, applicable for Cohort 2 only, an ongoing or suspected symptomatic urinary tract infection (UTI); enrollment at a later date is permitted (provided the screening window of 28 days is respected) * History of malignancy within 5 years before screening (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy, which is considered cured with minimal risk of recurrence) * Known allergies, hypersensitivity, or intolerance to ExPEC10V or its excipients * Applicable for Cohort 1 only: known allergy or history of anaphylaxis or other serious adverse reactions to vaccines or vaccine products (including any of the constituents of the active control vaccines) * Contraindication to intramuscular (IM) injections and blood draws example, bleeding disorders * Abnormal function of the immune system * Has had major psychiatric illness and/or drug substance or alcohol abuse in the past 12 months

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Extraintestinal pathogenic escherichia coli prevention

Contacts and locations

Locations

  • APHP - Hopital Bichat - Claude Bernard

    Paris, 75018, France

  • ATC Pharma

    Liège, 4000, Belgium

  • Anima

    Alken, 3570, Belgium

  • CHRU Tours Hopital Bretonneau

    Tours, 37000, France

  • CHU Lyon Sud

    Pierre-Bénite, 69495, France

  • CHU Nantes

    Nantes, 44093, France

  • Chu Rennes Hopital Pontchaillou

    Rennes, 35000, France

  • Clinical Pharmacology Unit

    Merksem, 2170, Belgium

  • Coastal Carolina Research Center

    North Charleston, South Carolina, 29405, United States

  • EB Flevo Research

    Almere Stad, 1311 RL, Netherlands

  • Hopital Cochin

    Paris, 75014, France

  • Hosp Reina Sofia

    Córdoba, 14004, Spain

  • Hosp. Del Mar

    Barcelona, 08003, Spain

  • Hosp. Univ. La Paz

    Madrid, 28046, Spain

  • Hosp. Univ. Marques de Valdecilla

    Santander, 39008, Spain

  • Hosp. Univ. de La Princesa

    Madrid, 28006, Spain

  • Hosp. Virgen Macarena

    Seville, 41009, Spain

  • Johnson County Clin-Trials

    Lenexa, Kansas, 66219, United States

  • Optimal Research

    Melbourne, Florida, 32934, United States

  • Optimal Research 1

    Peoria, Illinois, 61614, United States

  • Optimal Research 2

    Huntsville, Alabama, 35802, United States

  • PRA Health Sciences

    Groningen, NZ 9728, Netherlands

  • Qps-Mra, Llc

    Miami, Florida, 33143, United States

  • Rochester Clinical Research, Inc

    Rochester, New York, 14609, United States

  • Synexus Clinical Research US Inc

    Columbus, Ohio, 43212, United States

  • Synexus Clinical Research US Inc 1

    Akron, Ohio, 44311, United States

  • Synexus Clinical Research US Inc 2

    Richfield, Minnesota, 55432, United States

  • Synexus Clinical Research US Inc 3

    Manhattan, New York, 10017, United States

  • Synexus Clinical Research US Inc 4

    Evansville, Indiana, 47714, United States