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 experimental single dose vaccine called ExPEC9V for the preventive 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 to receive the active study vaccine (ExPEC9V) or the placebo.
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 sample will be collected from participants experiencing UTIs (participants 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 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
The investigational vaccine (ExPEC9V or placebo) will be administered in a single injection after randomization. Participants will be randomly assigned to either the Investigational Vaccine Group or the Placebo Group 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 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). 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), and Day 1096 (Year 3). 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.
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.
