A retrospective global study of the prevalence of O-serotypes of invasive Escherichia coli disease in patients admitted to tertiary care hospitals.

Invasive Escherichia coli disease (IED) is associated with high hospitalization and mortality rates, particularly among adults aged ≥60 years. O-antigens are virulence factors required for E. coli survival. To inform EXPEC9V development, a novel glycoconjugate vaccine targeting E. coli O-antigens that is no longer in active clinical development, this retrospective observational study describes O-serotype prevalence among E. coli isolates from IED patients. Eligible patients were identified from medical record databases (9 January 2018-8 November 2019) across 17 tertiary care hospitals in Europe, North America, and Asia. To estimate vaccine serotype coverage of EXPEC9V, E. coli isolates were O-serotyped using whole-genome sequencing and agglutination. Antimicrobial susceptibility testing was also performed. Nine hundred and two patients were enrolled, of whom 690 (76.5%) were aged ≥60 years. Common serotypes were O25, O2, O6, O1, O15, O75, O16, O4, and O18, with O25 being the most reported (17.3%). In patients aged ≥60 years, 422/637 E. coli isolates were EXPEC9V O-serotypes. EXPEC9V O-serotype prevalence did not substantially differ when stratified according to sex, presence of a positive blood culture, sepsis, fatality, or multidrug resistance. Consistent with previous studies, serotype O25 was most prevalent and associated with ~20% of cases. An EXPEC9V vaccine serotype coverage of 66.2% was observed for IED patients aged ≥60 years.