Urinary tract infections are common, especially in the elderly. The Escherichia coli bacterium is the main pathogen in urinary tract infections and also responsible for up to one-third of all cases of sepsis worldwide. Prevention of such invasive E. coli infections through vaccination could lead to significant health gains. However, no such vaccine is currently available. Therefore, in a large study, scientists are investigating whether a new vaccine could prevent sepsis.

For this study, UMC Utrecht is looking for people older than 60 who have had a urinary tract infection (UTI) in the past two years and are therefore are at increased risk of developing sepsis. Sepsis is a life-threatening form of organ failure caused by a dysregulated response to an infection. It is a common cause or complication of intensive care unit admission and causes high mortality and disease burden. Also, sepsis is often recognized late both outside and inside the hospital, resulting in a high impact on patients and healthcare.

Urinary tract infection

The E. coli bacteria is a harmless intestinal bacterium for most people, but in the elderly in particular, the bacteria can be dangerous. Because the immune system functions less well with aging, the elderly have an increased risk of infections and developing sepsis. The elderly are especially vulnerable to UTIs (e.g., cystitis) because as age increases, the bladder becomes weaker. As a result, more and more urine is retained in the bladder after urination. The longer and the more urine is retained in the bladder, the greater the risk of a UTI caused by E. coli.

E. coli is a major and increasing cause of sepsis worldwide, accounting for 17-37 percent of all cases of sepsis. In addition, the global increase in antibiotic resistance to E. coli is a major challenge for adequate treatment of E. coli infections. As a result, the effectiveness of treating UTIs with antibiotics is diminishing. It is therefore important to develop new ways to prevent serious infections caused by E. coli.

No vaccine yet exists that can prevent sepsis due to UTI caused by E. coli. In recent years, researchers have therefore developed a candidate vaccine against sepsis. They now want to investigate whether this new vaccine truly protects against sepsis.

18 Thousand participants

The E.mbrace study will assess the efficacy and safety of a candidate vaccine for the prevention of sepsis in 18,000 adults aged 60 years or older who have had a UTI in the past two years. UMC Utrecht is also participating in this international study and is seeking 800 participants in the Utrecht region. The study is placebo-controlled, meaning that half of the participants will receive the candidate vaccine and the other half will receive a placebo (fake vaccine). During the period after administration of the vaccine, the number of cases of sepsis due to E. coli infection with the candidate vaccine will be compared with the placebo.

People interested in participating in this study should meet the following conditions:

• Be 60 years of age or older at the time of study participation;
• Have been treated for a UTI within the past 2 years;
• Reside in the province of Utrecht.

In addition, participants must be willing to keep track of their health status in a special app via their cell phone.

More information about this study can be found at www.vaccinatiestudie.nl/onderzoeken/embrace