Summary

Eligibility
for people ages 60 years and up (full criteria)
Healthy Volunteers
healthy people welcome
Location
at UC Davis
Dates
study started
completion around

Description

Summary

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.

Official Title

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

Details

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.

Keywords

Invasive Extraintestinal Pathogenic Escherichia Coli Disease (IED) Prevention, Urinary Tract Infections, Escherichia coli Infections, ExPEC9V

Eligibility

You can join if…

Open to people ages 60 years and up

  • 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 CAN'T join 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

Locations

  • UC Davis Health System accepting new patients
    Sacramento California 92647 United States
  • Comprehensive Urology currently not accepting new patients, but might later
    Los Angeles California 90048 United States
  • Hoag Medical Group accepting new patients
    Newport Beach California 92663 United States
  • Medical Associates Research Group, Inc. completed
    San Diego California 92123 United States
  • Prestige Medical Group currently not accepting new patients, but might later
    Santa Ana California 92705 United States
  • Kaiser Permanente Los Angeles Medical Center accepting new patients
    Los Angeles California 90027 United States
  • Southern California Permanente Medical Group accepting new patients
    Los Angeles California 90027 United States
  • Marvel Clinical Research accepting new patients
    Huntington Beach California 92647 United States
  • American Institute of Research currently not accepting new patients, but might later
    Los Angeles California 90017 United States
  • San Diego Sports Medicine & Family Health Center currently not accepting new patients, but might later
    San Diego California 92120 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Janssen Research & Development, LLC
ID
NCT04899336
Phase
Phase 3 research study
Study Type
Interventional
Participants
Expecting 19800 study participants
Last Updated