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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
Must not have
Participant has end-stage renal disease for which dialysis is required
Participant has a history of acute polyneuropathy (for example, Guillain-Barre syndrome) or chronic inflammatory demyelinating polyneuropathy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights
Summary
This trial tests a vaccine to protect older adults from serious E. coli infections. The vaccine trains the immune system to recognize and fight off nine types of harmful E. coli bacteria. In earlier studies, a similar vaccine caused fever and/or diarrhea in some participants and provided limited protection against illness.
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.
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.
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 belowSelect...
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.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I require dialysis for my end-stage kidney disease.
Select...
I have had Guillain-Barre syndrome or a similar nerve condition.
Select...
I have been vaccinated against E. coli or ExPEC.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
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 study objectives
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 moreTrial 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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ExPEC9V
2023
Completed Phase 3
~960
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The ExPEC9V vaccine works by stimulating the immune system to produce antibodies against specific O-serotypes of Extraintestinal Pathogenic Escherichia coli (ExPEC), thereby preventing infection. This targeted approach is crucial for patients as it provides protection against the most common and virulent strains of ExPEC, significantly reducing the risk of invasive disease.
Other preventive measures include good hygiene practices and the use of probiotics to maintain a healthy gut microbiota, which can help prevent colonization by pathogenic bacteria.
Find a Location
Who is running the clinical trial?
Janssen Research & Development, LLCLead Sponsor
988 Previous Clinical Trials
6,367,401 Total Patients Enrolled
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
754 Previous Clinical Trials
3,943,169 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can provide ID and stay in touch with the study team.I had a urinary tract infection (UTI) in the last 2 years, but it was resolved more than 14 days ago.I can provide ID and stay in touch with the study team.I require dialysis for my end-stage kidney disease.I had a urinary tract infection (UTI) in the last 2 years, but it was resolved more than 14 days ago.I had a UTI in the last 2 years, confirmed by a doctor, and it was resolved more than 14 days ago.I am either postmenopausal, permanently sterile, or not planning to get pregnant.You must be able to work with smartphones/tablets/computers.I am postmenopausal or permanently sterile and do not plan to get pregnant.I have had Guillain-Barre syndrome or a similar nerve condition.I can provide ID and stay in touch with the study team.I have been vaccinated against E. coli or ExPEC.I am postmenopausal, permanently sterile, or not planning to get pregnant.
Research Study Groups:
This trial has the following groups:- Group 1: ExPEC9V
- Group 2: Placebo
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Extraintestinal Escherichia Coli Disease Prevention Patient Testimony for trial: Trial Name: NCT04899336 — Phase 3
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