Collection and analysis of convalescent patient serum against E.coli

• Research type

  Research Study

• Full title

  Analysis of antibody responses to bacterial components in patients convalescing from bacteraemia/sepsis caused by pathogenic Escherichia coli

• IRAS ID

  166519

• Contact name

  Elizabeth Coates

• Sponsor organisation

  Public Health England

• Duration of Study in the UK

  2 years, 0 months, 1 days

• Research summary

  Extra-intestinal pathogenic Escherichia coli (ExPEC) strains are the leading cause of blood stream infections (bacteraemia) in the UK, with over 30000 cases reported in 2013. As a result of increasing incidence, the Department of Health has mandated reporting of E. coli bacteraemia cases from June 2011. The burden of disease has the potential to become much worse due to the growing prevalence of strains that are resistant to front-line antibiotics.

  Alternate treatment options or vaccines have the potential to reduce the reliance on antibiotics. Convalescent patient serum is an important tool for vaccine discovery programs as patients convalescing from ExPEC bacteraemia will have developed antibodies to a wide range of bacterial components. Such components will include lipopolysaccharide and various protein antigens, especially those on the bacterial cells surface and those that are secreted from the bacteria.

  The first objective of the study is to establish a collection of serum samples taken from immunocompetent patients who have developed ExPEC bacteraemia. These samples will be used to support an ongoing programme of work at Public Health England (PHE) to combat ExPEC bacteraemia. The rational for the first objective is that sera from individuals who have overcome ExPEC bacteraemia will possess antibodies which bind specific bacterial components thus helping to neutralise the infection. The identification of these key immunoreactive components using the sera would thus aid vaccine design.

  The second objective is to scrutinise the genetic differences between ExPEC bacteraemia strains isolated from immunocompetent versus severely immunocompromised individuals. Genetic analysis of the isolated ExPEC bacteraemia strains will allow for the potential mechanisms of ExPEC invasion to be better understood. An enhanced understanding of the molecular mechanisms responsible for E. coli invasion will guide future research into new therapeutics and vaccines.

• REC name

  North East - Tyne & Wear South Research Ethics Committee

• REC reference

  15/NE/0087

• Date of REC Opinion

  12 Mar 2015

• REC opinion

  Further Information Favourable Opinion