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 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 according to the presence of risk factors for complicated UTIs (cUTIs). The stratification will also ensure balance across arms of participants in the Immunogenicity subset and safety subset (or a combination of both).
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 investigational vaccine is given. If not possible, the samples are to be collected as soon as possible and no later than 48h after UTI/IED diagnosis.
Both men and women who experience urinary tract infection (UTI) may be eligible to participate in the E.mbrace Study if they:
- Are 60 years of age or older
- Have had at least 1 UTI in the past 2 years
- Feel comfortable, or have a caregiver who is comfortable, using an application on a smartphone
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.
- Participants in the study will be assigned to one of four Subsets: Investigational Vaccine No Subset, Investigational Vaccine Immunogenicity Subset, Investigational Vaccine Safety Subset, Investigational Vaccine Safety and Immunogenicity Subset
- The Investigational Vaccine Group will be enrolled in 2 parts. Part 1 will enroll 9,278 participants. When the first 200 vaccinated participants have completed the Day 30 visit, an immunogenicity interim analysis will be conducted. Once the first 500 participants have reached Day 30, an Independent Data Monitoring Committee (IDMC) will perform a safety review. By the time of this communication, the N=500 milestone has passed. Enrollment will pause during this review until the IDMC issues a recommendation regarding the continuation of the study. Part 2 will enroll an additional 9,278 participants if the interim analysis does not indicate futility.
The study will be conducted across multiple countries including in North America, South America, Europe and Asia Pacific, which, includes New Zealand and Australia.
What are the parts to the study?
Some Screening procedures may be performed up to 8 days prior to vaccination on study Day 1. If Screening procedures are split over different days, eligibility criteria must be rechecked on the day of vaccination. On Study Day 1, the study team will verify eligibility criteria and participants will review and sign the Informed Consent Form (ICF), if they haven’t had a Screening Visit already, before study participants 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). 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 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. After Year 1, visits will occur on Day 731 (Year 2), Day 1096 (Year 3) and Day 1462 (Year 4). During study visits participants will have any adverse events recorded for at least 6 months. Any related to the study vaccine will be recorded beyond this timeframe. All participants will have a study site visit on Day 30 where blood will be collected for immunogenicity and a physical examination will be performed.
Frequently asked questions
One of Canada's leading pharmaceutical research-based companies is responsible for conducting this clinical study.
No. 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.
