INTRODUCTION: Despite national guidelines and use of intrapartum antibiotic prophylaxis (IAP), Streptococcus agalactiae (group B streptococci (GBS)) is still a leading cause of morbidity and mortality in newborns in Europe and the United States. The European DEVANI (Design of a Vaccine Against Neonatal Infections) program assessed the neonatal GBS infection burden in Europe, the clinical characteristics of colonized women and microbiological data of GBS strains in colonized women and their infants with early-onset disease (EOD). METHODS: Overall, 1083 pregnant women with a GBS-positive culture result from eight European countries were included in the study. Clinical obstetrical information was collected by a standardized questionnaire. GBS strains were characterized by serological and molecular methods. RESULTS: Among GBS carriers included in this study after testing positive for GBS by vaginal or recto-vaginal sampling, 13.4% had at least one additional obstetrical risk factor for EOD. The five most common capsular types (i.e., Ia, Ib, II, III and V) comprised ~ 93% of GBS carried. Of the colonized women, 77.8% received any IAP, and in 49.5% the IAP was considered appropriate. In our cohort, nine neonates presented with GBS early-onset disease (EOD) with significant regional heterogeneity. CONCLUSIONS: Screening methods and IAP rates need to be harmonized across Europe in order to reduce the rates of EOD. The epidemiological data from eight different European countries provides important information for the development of a successful GBS vaccine.

Department of Biomedicine Health Aarhus University Aarhus Denmark

Department of Clinical Microbiology National Reference Center Streptococcus Agalactiae University Hospital Center of Liege Liege Belgium

Department of Infectious Diseases Istituto Superiore Di Sanità Rome Italy

Department of Obstetrics and Gynecology University Medical Center Medical Faculty University of Freiburg Freiburg Germany

Department of Pediatrics and Adolescent Medicine University Medical Center Medical Faculty University of Freiburg Freiburg Germany

Department of Pediatrics University Hospital Carl Gustav Carus Technische Universität Dresden Dresden Germany

GSK Vaccines Siena Italy

National Center of Infectious and Parasitic Diseases Sofia Bulgaria

National Institute of Public Health Prague Czech Republic

Servicio Andaluz de Salud Hospital Universitario Virgen de Las Nieves Granada Spain

UK Health Security Agency London UK

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