E.mbrace Study

People aged 60 years or older with a history of urinary tract infection (UTI) are at an increased risk of developing a bloodstream infection caused by an E. coli bacteria. Currently there is no approved vaccine to prevent blood infections caused by E.coli bacteria, so the purpose of this clinical trial is to evaluate the safety and effectiveness of an investigational vaccine in the prevention of bloodstream infections they can cause.

This is a randomised, double-blind placebo-controlled clinical trial, which means that participants will be randomly (by chance) assigned 50/50 to one of two vaccination groups in this study – 50% of participants will receive the active vaccine and 50 % will receive the placebo (contains no active medicine). Neither the study team, nor the participants themselves, will know which vaccination group people have been assigned to. The investigational vaccine or placebo will be given via a single intramuscular injection on Day 1 of the study.

Recruitment for this study ends in December 2023.

Eligbility

How to participate

Potential participants will be pre-screened initially by the study research nurse over the phone to assess if this study is suitable for them, then if suitable they will be invited into UQCCR for a Screening Visit with the Study Doctor to further assess eligibility.
The Study Doctor will explain all the details of the trial, including potential risks and benefits of participation and answer any questions people may have. Participants will be asked to sign an Informed Consent Form and undergo tests and procedures to determine if they are a good match for being in the study.
If all eligibility criteria are met, participants will be enrolled into the study and vaccinated (with either the active or placebo vaccines) at the same initial visit at UQCCR.
Participation involves 8 study visits over a 3-year period - 2 visits take place face-to-face at the University of Queensland Centre for Clinical Research (UQCCR) and the remaining 6 visits are all conducted over the phone.

E.mbrace Study

Eligbility

How to participate

Reimbursement

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