A study to evaluate ExPEC9V vaccine for the prevention of Invasive E. coli Disease in adults aged 60 years and older with a history of urinary tract infection in the past two years.
- Conditions
- Invasive Extraintestinal Pathogenic Escherichia coli DiseaseMedDRA version: 21.1Level: PTClassification code 10052238Term: Escherichia urinary tract infectionSystem Organ Class: 10021881 - Infections and infestationsMedDRA version: 20.0Level: HLTClassification code 10015295Term: Escherichia infectionsSystem Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
- Registration Number
- EUCTR2020-005273-27-DK
- Lead Sponsor
- Janssen Vaccines & Prevention B.V
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 18556
-Participant must be =60 years of age on the day of signing the ICF and is expected to be available for the duration of the study, with no current intention of moving away from a study site area or travelling for periods longer than 30 consecutive days during the course of the study.
-Participant must have a history of UTI in the past 2 years for which evidence of diagnosis was verified by investigator. In case of a recent history of UTI or ABP (acute bacterial prostatitis), the condition must have resolved >14 days prior to randomization.
-Participant must be medically stable at the time of vaccination such that, according to the judgment of the investigator, hospitalization within the study period is not anticipated and the participant appears likely to be able to remain on study through the end of protocol-specified follow-up. A stable medical condition is defined as disease not requiring significant change in therapy during the 6 weeks before enrollment and when hospitalization for worsening of the disease is not anticipated. Participants will be included on the basis of physical examination, medical history, and vital signs performed between ICF signature and vaccination.
-Before randomization, participants who were born female must be either (as defined in Section 10.4, Appendix 4, Contraceptive Guidance and Collection of Pregnancy Information):
a. postmenopausal or permanently sterile, and
b. 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 and his/her designated caregiver (if applicable) must be able to read, understand, and complete questionnaires in the electronic clinical outcome assessment system (eCOA, ie, the electronic patient-reported outcomes [ePROs] and the eDiary). If the participant and caregiver are unable/unwilling to work with the eCOA system to complete the ePROs, participant or caregiver must agree to be available to be contacted by the site to complete all eCOA activities (ePROs) via site-assisted interview at the timepoints specified in the protocol. Participants in the Safety Subset must be willing and able to work with the eCOA system to complete the eDiary.
- Participant must have at least one additional risk factor for invasive extraintestinal pathogenic Escherichia coli disease (IED), beyond a history of urinary tract infection (UTI) in the past 2 years. Additional risk factors for IED are defined as one or more of the following:
a. a history of urosepsis and/or E. coli bacteremia at any time prior to randomization, and/or
b. a history of inpatient hospitalization (for a medical/surgical cause) in the two years prior to randomization, and/or
c. presence at baseline of at least one risk factor for complicated UTI of any toxicity grade.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 3712
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 14844
-Participant has a serious chronic disorder or significant cognitive impairment for which, in the opinion of the investigator, participation would not be in the best interest of the participant (eg, compromise well-being) or that could prevent, limit, or confound the protocol-specified assessments.
- Participant has end-stage renal disease for which dialysis is required.
- Participant has a history of malignancy within 5 years before screening that does not include the following categories:(a) Participants with curatively treated squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix may be enrolled at the discretion of the investigator; (b) Participants with a diagnosis of localized prostate cancer may be enrolled at the discretion of the investigator if they completed treatment, or, if they remain under observation or active surveillance; Participants who underwent radical prostatectomy or radiotherapy may be enrolled at the discretion of the investigator if treatment has been completed 6 months prior to the planned administration of the study vaccine (c) Participants with a history of other malignancy within 5 years, which is considered adequately treated with minimal risk of recurrence per the investigator’s judgment, may be enrolled.
- Participant has a known history of severe allergic reaction, anaphylaxis or other serious adverse reactions to vaccines or vaccines excipients (including specifically the excipients of the study vaccine; refer to IB).
- Abnormal function of the immune system resulting from:
a. Clinical conditions or their treatments expected to have an impact on the immune response elicited by the study vaccine.
b. Chronic or recurrent use of systemic corticosteroids within 3 months before administration of study vaccine and during the study. A substantially immunosuppressive steroid dose is considered to be =2 weeks of daily receipt of 20 mg or more of prednisone or equivalent.
c. Administration of antineoplastic and immunomodulating agents or radiotherapy expected to have an impact on the immune response elicited by the study vaccine within 6 months before administration of study vaccine and during the study.
- Participant has a history of acute polyneuropathy (eg, Guillain-Barré syndrome) or chronic inflammatory demyelinating polyneuropathy
- Participant has received any E. coli or ExPEC vaccine.
- Participant has received a hematopoietic stem cell transplant based on medical history, treatment with immunoglobulins within 2 months, apheresis therapies within 4 months, or blood products within 3 months prior to the planned administration of the study vaccine or has any plans to receive such treatment during the study.
- Participant has received or plans to receive: (a)licensed live attenuated vaccines - within 28 days before or after planned administration of the study vaccination; (b)other licensed (not live) vaccines - within 14 days before or after planned administration of the study vaccination; (c) vaccination with a vaccine authorized for Emergency Use Authorization, conditional Marketing Authorisation or a similar program is permitted when given at least 28 days before or after planned administration of the study vaccination.
- Participant has had major surgery (per the investigator’s judgment) within 4 weeks before dosing or will not have recovered from surgery per the investigator’s judgment at time of vaccination.
- Participant has chronic active hepatitis
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method