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Multicenter Study
. 2025 Feb;53(1):373-381.
doi: 10.1007/s15010-024-02380-0. Epub 2024 Sep 8.

Maternal Streptococcus agalactiae colonization in Europe: data from the multi-center DEVANI study

Florens Lohrmann  1 , Androulla Efstratiou  2 , Uffe B Skov Sørensen  3 , Roberta Creti  4 , Antoaneta Decheva  5 , Pavla Křížová  6 , Jana Kozáková  6 , Javier Rodriguez-Granger  7 , Manuel De La Rosa Fraile  7 , Immaculada Margarit  8 , Daniela Rinaudo  8 , Domenico Maione  8 , John Telford  8 , Graziella Orefici  4 , Mogens Kilian  3 , Baharak Afshar  2 , Pierrette Melin  9 , Reinhard Berner  10 , Markus Hufnagel  1 , Mirjam Kunze  11 ; DEVANI Study Group
Collaborators, Affiliations
Multicenter Study

Maternal Streptococcus agalactiae colonization in Europe: data from the multi-center DEVANI study

Florens Lohrmann et al. Infection. 2025 Feb.

Abstract

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.

Keywords: Streptococcus agalactiae; Early-onset disease; GBS vaccine; Group B streptococcus; Intrapartum prophylaxis; Maternal colonization; Neonatal sepsis; Vertical transmission.

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Conflict of interest statement

Declarations. Conflict of interest: Financial interests: Margarit I, Maione D and Rinaudo D are employees of the GSK group of companies and hold shares in the GSK group of companies. Margarit I, Maione D and Rinaudo D are listed as inventor on patents owned by the GSK group of companies. Uffe B. Skov Sørensen and Mogens Kilian received personal consultancy fees from Suzhou VACMICRO Biotech Co., Ltd. Non-financial interests: Markus Hufnagel has been invited by Novartis to an advisory board meeting on juvenile idiopathic arthritis. Pierrette Melin has provided one scientific consultation for GSK vaccines. All other authors have no financial or non-financial interests to disclose. Ethical approval: The study was approved by local ethics committees of each participating institution, and informed consent for study participation has been obtained from the legal caregivers. The study was performed in accordance with the ethical standards as laid down in the 1964 Declaration of Helsinki and its later amendments or comparable ethical standards.

Figures

Fig. 1
Fig. 1
Intrapartum antibiotic prophylaxis to colonized pregnant women and maternal risk factors for EOD. A Appropriate, inadequate or no IAP given to colonized pregnant women. Left, comparing mothers giving birth to infants without EOD (“no EOD”) or infants who developed EOD (“EOD”). P-value using Fisher’s exact test comparing appropriate versus inadequate or no IAP is 0.038. Right, comparing mothers with or without additional risk factors. P-value using Fisher’s exact test comparing appropriate versus inadequate or no IAP is < 0.001. B Maternal risk factors for giving birth to infants with EOD, stratified into mothers who gave birth to infants without (“no EOD”) or with EOD (“EOD”). P-values using Fisher’s exact test are 0.004 for PROM > 18 h; 0.01 for intrapartum fever; and 0.003 for any risk factor. EOD early onset disease. IAP intrapartum antibiotic prophylaxis. PROM premature rupture of membranes
Fig. 2
Fig. 2
Distribution of GBS capsular serotypes, clonal complexes and sequence types. A Distribution of capsular serotypes of 1083 GBS isolates from colonized pregnant women. Results from capsular serotyping are displayed, unless the isolate was untypeable (112 isolates), in that case the capsular genotype is used. All ten detected serotypes are displayed. B Distribution of multi-locus sequence types of 669 GBS isolates from colonized pregnant women. The ten most abundant sequence types are displayed, “others” contain 73 additional STs. C. Distribution of clonal complexes of 666 GBS isolates from colonized pregnant women. The ten most abundant clonal complexes are displayed, “others” contain three additional CCs. Nt not typable
Fig. 3
Fig. 3
Distribution of GBS pilus genotype and pilus expression. A Distribution of pilus genotypes of GBS isolates from colonized pregnant women. B Distribution of pilus expression of GBS isolates from colonized pregnant women. EOD early onset disease. Nt not typable
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