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.
Our team will contact you to verify your eligiblity and answer any questions you may have.