← Back to Search

Virus Therapy

ExPEC10V Vaccine for Urinary Tract Infections

Phase 1 & 2
Waitlist Available
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, a woman must be: postmenopausal - A postmenopausal state is defined as no menses for 12 months without an alternative medical cause; or not intending to conceive by any methods
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up on days 30, 181, 366, 731, 1096, 1461, and 1826
Awards & highlights

Study Summary

This trial is looking at the safety and effectiveness of a new vaccine for urinary tract infections. The first part of the trial will test different doses of the vaccine to see which is the most effective. The second part of the trial will test the safety and long-term effectiveness of the most effective dose.

Who is the study for?
Adults aged 60-85 in stable health or with controlled medical conditions can join. They must understand the study, agree not to donate blood for 12 weeks post-vaccine, and women must be postmenopausal or not planning pregnancy. Participants need a BMI of >18.5 but <40 kg/m^2. Exclusions include acute illness, temperature >=38°C before vaccine administration, immune system issues, severe allergies to vaccines or their ingredients.Check my eligibility
What is being tested?
The trial is testing three doses of a vaccine called ExPEC10V against E.coli infections in older adults. It aims to find the best dose and check its safety and effectiveness (Cohort 1). A second group (Cohort 2) will further evaluate this optimal dose's long-term safety and effectiveness in those who've had UTIs.See study design
What are the potential side effects?
Possible side effects may include reactions at the injection site like pain or swelling, general feelings of discomfort such as fatigue or headache, muscle pain, feverishness after vaccination; more serious allergic reactions are rare.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am a woman who has not had a period for 12 months or I do not plan to get pregnant.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~on days 30, 181, 366, 731, 1096, 1461, and 1826
This trial's timeline: 3 weeks for screening, Varies for treatment, and on days 30, 181, 366, 731, 1096, 1461, and 1826 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Cohort 1 and Cohort 2: Number of Participants with Serious Adverse Events (SAE's) from the Administration of the Study Vaccine until Day 181
Cohort 1 and Cohort 2: Number of Participants with Solicited Local and Systemic Adverse Events (AEs) Collected for 14 days post-Vaccination
Vaccines
+4 more
Secondary outcome measures
Cohort 1 and Cohort 2: Number of Participants with Serious Adverse Events Related to the Study Intervention or Study Procedures From Day 182 Until the end of the Study
Cohort 1: Antibody Titers for ExPEC10V as Determined by MOPA on Days 30, 181, 366, 731, 1096, 1461, and 1826
Cohort 1: Antibody Titers for ExPEC10V as Determined by Multiplex ECL-based Immunoassay and MOPA to find Correlation Between Multiplex ECL-based Immunoassay and MOPA
+4 more

Trial Design

7Treatment groups
Experimental Treatment
Placebo Group
Group I: Cohort 2: ExPEC10VExperimental Treatment1 Intervention
Participants will be randomized to receive a single IM injection of selected dose of ExPEC10V on Day 1. The ExPEC10V dose used in Cohort 2 will be based on the primary analysis (Day 30) results of Cohort 1.
Group II: Cohort 1: Prevnar 13Experimental Treatment1 Intervention
Participants will be randomized to receive a single IM injection of Prevnar 13 on Day 1.
Group III: Cohort 1: ExPEC4VExperimental Treatment1 Intervention
Participants will be randomized to receive a single IM injection of ExPEC4V on Day 1.
Group IV: Cohort 1: ExPEC10V (Medium dose)Experimental Treatment1 Intervention
Participants will be randomized to receive a single IM injection of medium dose ExPEC10V on Day 1.
Group V: Cohort 1: ExPEC10V (Low Dose)Experimental Treatment1 Intervention
Participants will be randomized to receive a single intramuscular (IM) injection of low dose ExPEC10V on Day 1.
Group VI: Cohort 1: ExPEC10V (High dose)Experimental Treatment1 Intervention
Participants will be randomized to receive a single IM injection of high dose ExPEC10V on Day 1.
Group VII: Cohort 2: PlaceboPlacebo Group1 Intervention
Participants will be randomized to receive a single IM injection of matching placebo on Day 1.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ExPEC10V
2020
Completed Phase 1
~30
ExPEC4V
2016
Completed Phase 2
~150
Prevnar 13
2012
Completed Phase 4
~13260

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor
975 Previous Clinical Trials
6,383,472 Total Patients Enrolled
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
745 Previous Clinical Trials
3,959,069 Total Patients Enrolled

Media Library

ExPEC10V (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03819049 — Phase 1 & 2
Extraintestinal Escherichia Coli Prevention Research Study Groups: Cohort 2: Placebo, Cohort 1: ExPEC4V, Cohort 1: ExPEC10V (Medium dose), Cohort 1: ExPEC10V (Low Dose), Cohort 1: Prevnar 13, Cohort 1: ExPEC10V (High dose), Cohort 2: ExPEC10V
Extraintestinal Escherichia Coli Prevention Clinical Trial 2023: ExPEC10V Highlights & Side Effects. Trial Name: NCT03819049 — Phase 1 & 2
ExPEC10V (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03819049 — Phase 1 & 2

Frequently Asked Questions

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

How many individuals are eligible to partake in this experiment?

"This investigation is no longer recruiting patients as of November 22nd 2022. Initially posted June 6th 2019, this trial has been superseded by 10 studies actively searching for escherichia coli infections and 21 medical trials targeting ExPEC10V."

Answered by AI

What is the main purpose of ExPEC10V?

"The ExPEC10V drug regimen is recommended for the treatment of tetanus, trauma-related injuries, and pneumococcal infections."

Answered by AI

Are there any openings left to join this experiment?

"As of today, clinicaltrials.gov states that patient recruitment is no longer ongoing for this trial which was first announced on June 6th 2019 and last updated on November 22nd 2022. Fortunately, there are 31 other studies actively seeking participants at the moment."

Answered by AI

How many sites are hosting this research endeavor?

"This medical research project is taking place in Optimal Research (Akron, Ohio), Johnson County Clin-Trials (Columbus, Minnesota) and Coastal Carolina Research Center (Richfield, Florida), plus an additional 13 sites."

Answered by AI

What other empirical investigations have been done on ExPEC10V?

"Initially studied in 2007 at Memorial Sloan-Kettering Cancer Center 1275 York Avenue, ExPEC10V has generated a wealth of data from 18510 completed trials. Currently, 21 active clinical studies are recruiting patients with many located in Akron, Ohio."

Answered by AI

What is the main objective of this clinical experiment?

"Per Janssen Research & Development, LLC - the trial's sponsor - its primary parameter of evaluation is Cohort 1 and 2’s number of participants with solicited local and systemic adverse events collected for 14 days post-vaccination. Secondary objectives include analyzing antibody titers for ExPEC10V via multiplex ECL-based immunoassay on Days 15, 181, 366, 731 and 1096; quantifying correlation between MOPA (macrophage polarization assay) to determine antibody titer response in Cohort 2; as well as determining the concentration of antibodies against ExPEC10V within Cohort"

Answered by AI

Who else is applying?

What state do they live in?
Missouri
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
A Study of Three Different Doses of VAC52416 (ExPEC10V) in Adults Aged 60 to 85 Years in Stable Health
2019. "A Study of Three Different Doses of VAC52416 (ExPEC10V) in Adults Aged 60 to 85 Years in Stable Health". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03819049.
~143 spots leftby Apr 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top