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

Janssen Vaccines & Prevention B.V.50 个研究点分布在 7 个国家目标入组 5,197 人开始时间: 2024年6月12日最近更新: 2025年5月22日

试验速览

阶段: 3 期
状态: 招募中
发起方: Janssen Vaccines & Prevention B.V.
入组人数: 5,197
试验地点: 50
主要终点: First IED event, with microbiological confirmation from blood or other sterile sites, excluding IED cases with microbiological confirmation from urine only, caused by ExPEC9V O-serotypes O1, O2, O4, O6, O15, O16, O18, O25, and O75

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

To demonstrate the efficacy of ExPEC9V compared to placebo in the prevention of the first IED event with microbiological confirmation from blood or other sterile sites caused by ExPEC9V O-serotypes O1, O2, O4, O6, O15, O16, O18, O25, and O75

研究设计

研究类型: Interventional
分配方式: Randomized
主要目的: Randomized, Double-Blind, Placebo-controlled, Multicenter Phase 3 Study
盲法: Double (Subject, Analyst, Monitor, Investigator, Carer)

入排标准

年龄范围: 18 years 至 65+ years（65+ Years, 18-64 Years）
接受健康志愿者: 否

入选标准

•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 the 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 and / or d. a history of pyelonephritis of any toxicity grade that has resolved > 14 days prior to randomization, and/or e. current or prior prostatic adenocarcinoma and/or tumors of the urinary tract of any toxicity grade

排除标准

•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 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 B or hepatitis C infection based on medical history. Note: participant may have stable HBV or HCV infection.
•Participant has evidence of HIV type 1 or type 2 infection by medical history. Note: participant may have stable/well-controlled HIV.
•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 vaccine 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.

结局指标

主要结局

First IED event, with microbiological confirmation from blood or other sterile sites, excluding IED cases with microbiological confirmation from urine only, caused by ExPEC9V O-serotypes O1, O2, O4, O6, O15, O16, O18, O25, and O75

次要结局

2. All IEDs (including multiple IEDs per participant) caused by ExPEC9V O serotypes
3. First hospitalized IED event caused by ExPEC9V O serotypes
4. First IED event meeting criteria for sepsis caused by ExPEC9V O serotypes
5. First bacteremic IED event caused by ExPEC9V O serotypes
6. First pyelonephritis event caused by ExPEC9V O serotypes
7. First UTI event caused by ExPEC9V O serotypes
8. All UTIs (including multiple UTIs per participant) caused by ExPEC9V O serotypes
9. First IED event caused by E. coli
10. First pyelonephritis event caused by E. coli
11. First UTI event caused by E. coli
12. Antibody titers to vaccine O-serotype antigens and EPA in the Immunogenicity Subset, as determined by multiplex ECL-based immunoassay and antibody titers to vaccine O-serotype antigens, as determined by multiplex opsonophagocytic killing assay (MOPA) on Day 1 (pre-vaccination), Day 30, Day 181, Year 1, Year 2, Year 3 and Year 4
13. Solicited local and systemic AEs (collected until 14 days postvaccination [from Day 1 to Day 15] in the Safety Subset)
14. Unsolicited AEs (collected until 29 days post-vaccination [from Day 1 to Day 30] in all participants)
15. Serious adverse events (SAEs) in all participants
16. SF-36 and EQ-5D-5L responses at scheduled timepoints
17. Frailty index as a measure of frailty at baseline, Year 1, Year 2, Year 3, Year 4 and at the time of an IED
18. Medical resource utilization for IED events caused by ExPEC9V O-serotypes
19. Medical resource utilization for UTI events (Immunogenicity Subset only) and ABP events (Immunogenicity Subset only) caused by ExPEC9V O-serotypes
20. Hospitalization and length of stay in the hospital, including intensive care unit (ICU) hospitalization and ICU length of stay, for IED, UTI or ABP events caused by ExPEC9V O-serotypes
21. IED-related and all-cause mortality
1. First IED event, with microbiological confirmation from blood, other sterile sites, or urine, caused by ExPEC9V O-serotypes

研究者

发起方

Janssen Vaccines & Prevention B.V.

申办方类型

Pharmaceutical company

责任方

Principal Investigator

主要研究者

CTIS point of Contact

Scientific

Janssen Vaccines & Prevention B.V.

研究点 (50)

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