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Cancer Vaccine

ExPEC9V Vaccine for E. coli Infections Prevention

Verified Trial
Phase 3
Recruiting
Research Sponsored by Janssen Research & Development, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Before randomization, participants who were born female must be either postmenopausal or permanently sterile, and not intending to conceive by any methods
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights

Study Summary

This trial will test a new vaccine for preventing disease caused by 9 different types of E. coli. The vaccine will be compared to a placebo to see if it is effective.

Who is the study for?
Adults aged 60+ with a history of UTI in the past 2 years can join this trial. They must be postmenopausal or sterile if born female, not planning to conceive, and able to use digital devices for communication. Excluded are those with bleeding disorders, certain neuropathies, previous E. coli vaccines, or needing dialysis.Check my eligibility
What is being tested?
The study tests whether a vaccine called ExPEC9V prevents invasive diseases caused by certain E. coli types better than a placebo in older adults who've had UTIs before.See study design
What are the potential side effects?
Potential side effects may include reactions at the injection site like pain and swelling, general symptoms such as fever or fatigue, and possibly allergic responses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am postmenopausal or permanently sterile and do not plan to get pregnant.
Select...
I had a urinary tract infection (UTI) in the last 2 years, but it was resolved more than 14 days ago.
Select...
I am postmenopausal, permanently sterile, or not planning to get pregnant.
Select...
I had a UTI in the last 2 years, confirmed by a doctor, and it was resolved more than 14 days ago.
Select...
I am either postmenopausal, permanently sterile, or not planning to get pregnant.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants with First IED Event with Microbiological Confirmation in Blood or Other Sterile Sites Caused by ExPEC9V O-serotypes
Number of Participants with First Invasive Extraintestinal Pathogenic E.coli Disease(IED) Event with Microbiological Confirmation in Blood, Other Sterile Sites, or Urine, Caused by 9-valent Extraintestinal Pathogenic E. coli Vaccine (ExPEC9V) O-serotypes
Secondary outcome measures
Antibody Titers to Genetically Detoxified Form of Exotoxin A Derived from Pseudomonas Aeruginosa (EPA) as Determined by Multiplex ECL-based Immunoassay
Antibody Titers to Vaccine O-serotype Antigens as Determined by Multiplex Electrochemiluminescent (ECL)-based Immunoassay
Serotyping
+25 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: ExPEC9VExperimental Treatment1 Intervention
Participants will receive a single intramuscular (IM) injection of 9-valent extraintestinal pathogenic Escherichia coli vaccine (ExPEC9V) on Day 1.
Group II: PlaceboPlacebo Group1 Intervention
Participants will receive a single IM injection of matching placebo on Day 1.

Find a Location

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor
975 Previous Clinical Trials
6,365,752 Total Patients Enrolled
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
745 Previous Clinical Trials
3,941,349 Total Patients Enrolled

Media Library

ExPEC9V (Cancer Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT04899336 — Phase 3
Extraintestinal Escherichia Coli Disease Prevention Research Study Groups: ExPEC9V, Placebo
Extraintestinal Escherichia Coli Disease Prevention Clinical Trial 2023: ExPEC9V Highlights & Side Effects. Trial Name: NCT04899336 — Phase 3
ExPEC9V (Cancer Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04899336 — Phase 3
Extraintestinal Escherichia Coli Disease Prevention Patient Testimony for trial: Trial Name: NCT04899336 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any known health risks associated with ExPEC9V?

"There is both pre-existing data to support the efficacy of ExPEC9V as well as evidence from Phase 3 clinical trials backing its safety--so our team gives it a 3."

Answered by AI

What goals does this research hope to achieve?

"The aim of this 3-year long clinical trial is to study the number of participants who develop invasive disease caused by 9-valent extraintestinal pathogenic E. coli bacteria, following vaccination with the ExPEC9V vaccine. Other objectives of the trial include measuring antibody response to the vaccine and assessing patient quality of life using the EQ-5D-5L questionnaire."

Answered by AI

How many subjects are included in this research project?

"That is correct. The trial, as listed on clinicaltrials.gov, appears to be recruiting patients at this time. 100 different centres are involved in the study and 18556 individuals are needed for completion."

Answered by AI

Are people currently being signed up for this experiment?

"This clinical trial is currently seeking patients. The original posting date was 6/30/2021 and the last edit was on 10/25/2022, as reported on clinicaltrials.gov."

Answered by AI

Could you inform me how many hospitals are conducting this research project?

"There are many places where this study is being conducted, but a few notable examples include IACT - Suffolk Multispecialty Research in Suffolk, Virginia and Medicor Research Inc. in Sudbury, Ontario."

Answered by AI

Who else is applying?

What state do they live in?
Florida
Nevada
California
Other
How old are they?
18 - 65
What site did they apply to?
Montefiore Medical Center
Indago Research & Health Center Inc
Be Well Clinical Studies
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1
3+
0

Why did patients apply to this trial?

To help with treatments. i contract uti's and would like to stop this. I have had UTI’s in the past and wound like to find a way to prevent them.
PatientReceived 2+ prior treatments
I'm a healthy volunteer and I hope this trials helps another people with this disease.
PatientReceived no prior treatments

What questions have other patients asked about this trial?

How long this trial will take? is this a paying clinical trial?
PatientReceived 1 prior treatment

How responsive is this trial?

Typically responds via
Phone Call
Email
Most responsive sites:
  1. SMS Clinical Research LLC: < 24 hours
  2. IACT - Suffolk Multispecialty Research: < 48 hours
Average response time
  • < 2 Days
Recent research and studies
clinicaltrials.govStudy
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
2021. "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". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04899336.
~4841 spots leftby May 2025
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