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

  • End date
    May 31, 2027
  • participants needed
  • sponsor
    Janssen Research & Development, LLC
Updated on 7 October 2022
Accepts healthy volunteers


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.


Invasive extraintestinal pathogenic Escherichia coli (ExPEC) disease 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 will be conducted in 2 parts (Part 1 and Part 2) and incorporates an inferentially seamless group sequential design, where the enrollment will be staggered. This study consists of a Screening Phase (selected screening procedures may be performed up to 8 days prior to vaccination on Day 1), Vaccination Phase (Day 1) and Follow-up Phase (up to 3 years post-vaccination). The total study duration is up to 5 years and 11 months. Key safety assessments include serious adverse events (SAEs), solicited and unsolicited adverse events (AEs), physical examination, and vital signs.

Condition Invasive Extraintestinal Pathogenic Escherichia Coli Disease (IED) Prevention
Treatment Placebo, ExPEC9V
Clinical Study IdentifierNCT04899336
SponsorJanssen Research & Development, LLC
Last Modified on7 October 2022


Yes No Not Sure

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, 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
Participant or his/her designated caregiver must be able to work with smartphones/tablets/computers

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, bleeding disorders or difficulty to perform blood draws
Chronic systemic use of antibacterials (including antibiotics and urinary tract antiseptics). In case of prolonged antibacterial treatment (> 3 weeks) or chronic systemic use of antibacterials (including antibiotics and urinary tract antiseptics), the last dose must have been administered > 60 days prior to randomization
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
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