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NCT04899336

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

Last Updated: 2025-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

17935 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-30

Study Completion Date

2025-08-27

Brief Summary

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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.

Detailed Description

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Invasive extraintestinal pathogenic Escherichia coli disease (IED) is defined as an acute illness consistent with systemic bacterial infection, which is microbiologically confirmed either by the isolation and identification of Escherichia coli (E. coli) from blood or any other sterile body sites, or by the isolation and identification of E. coli from urine in a participant with urosepsis and no other identifiable source of infection. ExPEC9V (JNJ-78901563, primary compound number: VAC52416) is a 9-valent vaccine candidate in development for active immunization for the prevention of IED in adults 60 years of age and older. Although IED affects all ages, adults aged greater than or equal to (\>=) 60 years have an increased risk of developing IED, including bacteremia and sepsis, which can be community-acquired, hospital-acquired or healthcare associated. As the mechanism of action of conjugate vaccines in the prevention of invasive disease is not expected to be affected by antibiotic resistance mechanisms, that is, resistance mechanisms are not linked to O-polysaccharide structures, the sponsor has no reason to expect a difference in outcome of efficacy between antimicrobial-resistant and susceptible O-serotypes. This study incorporates an inferentially seamless group-sequential design. This study consists of a Screening Phase (selected screening procedures may be performed up to 8 days prior to vaccination on Day 1), Randomization, Vaccination Phase (Day 1) and Follow-up Phase (up to 4 years post-vaccination). The total study duration is approximately up to 6 years 9 months. Key safety assessments include serious adverse events (SAEs), solicited and unsolicited adverse events (AEs), physical examination, and vital signs.

Conditions

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Invasive Extraintestinal Pathogenic Escherichia Coli Disease (IED) Prevention

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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ExPEC9V

Participants will receive a single intramuscular (IM) injection of 9-valent extraintestinal pathogenic Escherichia coli vaccine (ExPEC9V) on Day 1.

Group Type EXPERIMENTAL

ExPEC9V

Intervention Type BIOLOGICAL

ExPEC9V will be administered as an IM injection.

Placebo

Participants will receive a single IM injection of matching placebo on Day 1.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Matching placebo will be administered as an IM injection.

Interventions

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ExPEC9V

ExPEC9V will be administered as an IM injection.

Intervention Type BIOLOGICAL

Placebo

Matching placebo will be administered as an IM injection.

Intervention Type OTHER

Other Intervention Names

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VAC52416, JNJ-78901563

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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

Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Janssen Research & Development, LLC Clinical Trial

Role: STUDY_DIRECTOR

Janssen Research & Development, LLC

Locations

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Lakeview Clinical Research

Guntersville, Alabama, United States

Site Status

Hope Research Institute

Phoenix, Arizona, United States

Site Status

Hope Research Institute

Phoenix, Arizona, United States

Site Status

Interspond-Clinical Research Institute of AZ

Sun City West, Arizona, United States

Site Status

Baptist Health Center For Clinical Research

Little Rock, Arkansas, United States

Site Status

Sun Urology - Buena Park Office

Buena Park, California, United States

Site Status

Hope clinical Research LLC

Canoga Park, California, United States

Site Status

Velocity Clinical Research, Inc.

Chula Vista, California, United States

Site Status

Marvel Clinical Research

Huntington Beach, California, United States

Site Status

California Adult Circumcision - Alvarado La Mesa Urology Center

La Mesa, California, United States

Site Status

Om Research LLC

Lancaster, California, United States

Site Status

Atlantic Urology Medical Group

Long Beach, California, United States

Site Status