Prevention of E. coli Disease in Adults Age 60 and Older with a History of UTI
The purpose of this clinical research study is to assess the efficacy and safety of an investigational vaccine in the prevention of a blood infection caused by E. coli bacteria. Currently there is no approved vaccine to prevent blood infections caused by E. coli bacteria.
We are doing a clinical research study to see if an investigational vaccine can help protect adults, 60 years of age and older, against these blood infections. These blood infections can lead to serious complications such as dangerously low blood pressure or shock.
What we learn in this study may be helpful for infection prevention of these types of serious infections in the future. These infections are more common in older people who have had urinary tract infections.
If you qualify and choose to join the study and sign the Informed Consent Form, you will be asked to attend a screening visit with the study team. At this visit, you will undergo tests and procedures to determine if you are a good match for being in the study.
If eligible, you will be in the study for approximately 3 years. You will complete a minimum of 8 study visits, some in person and some remote via telephone.
You will be randomly assigned to one of the two study groups. This means you may receive either a placebo (contains no active medicine) or the investigational vaccine. Neither you nor the study team will know which study group you are in.
The investigational vaccine or placebo will be given via a single injection on Day 1 of the 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 your daily health care routine.
You may be eligible if you:
- Are age 60 or older
- Have been treated for a UTI (urinary tract infection) in the past 2 years
- Are not currently taking antibiotics
Additional eligibility criteria will be assessed by the study team during the screening process prior to being enrolled in the study and receiving any investigational vaccine. Not all individuals may qualify to participate in the research.
View study on ClinicalTrials.gov