Now enrolling adults 60 years of age or older who may be at risk for developing a bloodstream infection caused by E. coli
The E.mbrace Study is a clinical research study to evaluate an investigational single dose vaccine called ExPEC9V for the prevention of invasive E.coli disease (IED) in adults 60 years of age or older who have had a urinary tract infection (UTI) in the past 2 years.
There are two vaccination groups in this study and all participants will be randomly assigned into either the active (receive ExPEC9V) or placebo vaccine group.
Participants will be stratified according to their age and the presence of risk factors for complicated UTIs (cUTIs). The stratification will also ensure a balanced distribution across groups of participants. Blood immunogenicity samples will be collected from all participants at Day 1 (pre-vaccination) and Day 30.
Blood immunogenicity samples will be collected from participants experiencing UTIs (subjects in the immunogenicity subset only) and IEDs (all participants), ideally before any antibiotic treatment is given. If not possible, the samples are to be collected as soon as possible and no later than 48h after pyelonephritis/IED diagnosis.
Both men and women who experience UTIs may be eligible to participate in the E.mbrace Study if they:
- Are 60 years of age or older
- Have had at least one UTI in the past 2 years
- Have one of the following additional risk factors for IED:
- A history of urosepsis and/or E. coli bacteremia.
- A history of inpatient hospitalization in the past 2 years.
- At least one risk factor for complicated UTI.
While there may be no health disparity in ExPEC Disease (IED), the inclusion of more diverse participants can help determine how well a vaccine might work in certain populations or whether it might pose an additional risk to a particular population. The FDA encourages all of us, both Sponsors and investigative sites, to proactively seek to enroll participants that reflect the population that may use the investigational vaccine if ultimately approved by the FDA.
The investigational vaccine (ExPEC9V or placebo) will be administered in a single injection after randomization. Participants will be randomly assigned to receive either the investigational vaccine or the placebo at a 1:1 ratio.
The study will be conducted across multiple markets, including North America, South America, Europe, and Asia Pacific, which includes New Zealand and Australia.
What are the parts of the study?
Screening and vaccination may take place at the same visit on Study Day 1. However, some Screening procedures may be performed up to 8 days prior to vaccination on Study Day 1, the study team will verify eligibility criteria and participants will review and sign the Informed Consent Form (ICF) before they are randomized and the investigational vaccine (ExPEC9V) or placebo is administered.
During the Day 1 visit, participants will also have a pre-vaccination physical examination including height and body weight measurements. Their vital signs will be recorded, and they will complete a survey on their health status and their health-related quality of life (ePRO instruments) and undergo a multimorbidity checklist and Short Physical Performance Battery (SPPB). Participants who are unable or unwilling to use a digital system to complete ePROs may complete the questionnaires via interviews with the site staff. It is recommended that participants use one data collection method throughout the study. Prior to vaccination each participant will undergo blood sampling for immunogenicity. Post-vaccination, participants will have a 30-minute post-vaccination observation period and members of the Safety Subset will be issued an eDiary.
At the conclusion of the Screening and Study Vaccination Visit, study participants will enter the Follow-up Period. Study visits in the form of telephone contact or in-person visits will occur on Day 15, Day 30, Day 61, Day 181, and Day 366 during Year 1 of the study. At the Day 30 Visit, all participants will have blood collected for immunogenicity. After Year 1, visits will occur on Day 731 (Year 2), Day 1096 (Year 3) and and Day 1461 (Year 4). Participants who leave the study early will attend an Early Exit Visit. During study visits participants will have any serious adverse events recorded for at least 6 months. Any related to the study vaccine will be recorded beyond this timeframe.
Frequently asked questions
Janssen Research & Development is responsible for conducting this clinical study.
Qualified participants may receive the investigational vaccine or placebo and some study-required medical care at no cost. The study will not pay for other medical care or current medication(s) needed to support their daily health care routine.
