[en] [en] 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.
Disciplines :
Reproductive medicine (gynecology, andrology, obstetrics) Immunology & infectious disease Pediatrics Public health, health care sciences & services Laboratory medicine & medical technology
Author, co-author :
Lohrmann, Florens ✱; Department of Pediatrics and Adolescent Medicine, University Medical Center, Medical Faculty, University of Freiburg, Freiburg, Germany
Efstratiou, Androulla; UK Health Security Agency, London, UK
Sørensen, Uffe B Skov; Department of Biomedicine, Health, Aarhus University, Aarhus, Denmark
Creti, Roberta; Department of Infectious Diseases, Istituto Superiore Di Sanità, Rome, Italy
Decheva, Antoaneta; National Center of Infectious and Parasitic Diseases, Sofia, Bulgaria
Křížová, Pavla; National Institute of Public Health, Prague, Czech Republic
Kozáková, Jana; National Institute of Public Health, Prague, Czech Republic
Rodriguez-Granger, Javier; Servicio Andaluz de Salud, Hospital Universitario Virgen de Las Nieves, Granada, Spain
De La Rosa Fraile, Manuel; Servicio Andaluz de Salud, Hospital Universitario Virgen de Las Nieves, Granada, Spain
Margarit, Immaculada; GSK Vaccines, Siena, Italy
Rinaudo, Daniela; GSK Vaccines, Siena, Italy
Maione, Domenico; GSK Vaccines, Siena, Italy
Telford, John; GSK Vaccines, Siena, Italy
Orefici, Graziella; Department of Infectious Diseases, Istituto Superiore Di Sanità, Rome, Italy
Kilian, Mogens; Department of Biomedicine, Health, Aarhus University, Aarhus, Denmark
Afshar, Baharak; UK Health Security Agency, London, UK
Melin, Pierrette ; Université de Liège - ULiège > Département des sciences biomédicales et précliniques
Berner, Reinhard; Department of Pediatrics, University Hospital Carl Gustav Carus, Technische Universität Dresden, Dresden, Germany
Hufnagel, Markus; Department of Pediatrics and Adolescent Medicine, University Medical Center, Medical Faculty, University of Freiburg, Freiburg, Germany
Kunze, Mirjam ✱; Department of Obstetrics and Gynecology, University Medical Center, Medical Faculty, University of Freiburg, Freiburg, Germany. mirjam.kunze@uniklinik-freiburg.de
FP7 - 200481 - DEVANI - Design of a vaccine to immunize neonates against GBS infections through a durable maternal immune response
Name of the research project :
DEVANI
Funders :
EU - European Union GSK - GlaxoSmithKline Universitätsklinikum Freiburg
Funding text :
Open Access funding enabled and organized by Projekt DEAL. This work was supported by the European Commission Seventh Framework (Grant agreement number 200481) and by Novartis Vaccines Division and GlaxoSmithKline Biologicals SA (Novartis\u2019 non-influenza vaccines business was acquired by the GSK group of companies on 2 March 2015) as part of the DEVANI program.
P. Melin A. Efstratiou Group B streptococcal epidemiology and vaccine needs in developed countries Vaccine 2013 31 D31 42 10.1016/j.vaccine.2013.05.012 23973345
S.J. Schrag S. Zywicki M.M. Farley A.L. Reingold L.H. Harrison L.B. Lefkowitz J.L. Hadler R. Danila P.R. Cieslak A. Schuchat Group B streptococcal disease in the era of intrapartum antibiotic prophylaxis N Engl J Med 2000 342 15 20 1:STN:280:DC%2BD3c%2FnsVWitg%3D%3D 10.1056/NEJM200001063420103 10620644
K.M. Edmond C. Kortsalioudaki S. Scott S.J. Schrag A.K.M. Zaidi S. Cousens P.T. Heath Group B streptococcal disease in infants aged younger than 3 months: systematic review and meta-analysis Lancet 2012 379 547 556 10.1016/S0140-6736(11)61651-6 22226047
K.M. Puopolo R. Lynfield J.J. Cummings I. Hand I. Adams-Chapman B. Poindexter D.L. Stewart S.W. Aucott J.P. Goldsmith M. Mowitz K. Watterberg Y.A. Maldonado T.E. Zaoutis R. Banerjee E.D. Barnett J.D. Campbell J.S. Gerber A.P. Kourtis F.M. Munoz D. Nolt A.C. Nyquist S.T. O’Leary M.H. Sawyer W.J. Steinbach K. Zangwill Committee on fetus and newborn, Committee on infectious diseases Management of infants at risk for group B Streptococcal disease Pediatrics 2019 144 e20191881 10.1542/peds.2019-1881 31285392
F. Lohrmann M. Hufnagel M. Kunze B. Afshar R. Creti A. Detcheva J. Kozakova J. Rodriguez-Granger U.B.S. Sørensen I. Margarit D. Maione D. Rinaudo G. Orefici J. Telford F.M. de la Rosa M. Kilian A. Efstratiou R. Berner P. Melin Neonatal invasive disease caused by Streptococcus agalactiae in Europe: the DEVANI multi-center study Infection 2023 51 981 991 1:CAS:528:DC%2BB3sXit1Gmuw%3D%3D 10.1007/s15010-022-01965-x 36547864
S.J. Schrag J. Verani Intrapartum antibiotic prophylaxis for the prevention of perinatal group B streptococcal disease: experience in the United States and implications for a potential group B streptococcal vaccine Vaccine 2013 10.1016/j.vaccine.2012.11.056 23973347
ACOG (American Congress of Obstetricians and Gynecologists) Committee on Obstetric Practice ACOG committee opinion no 485: prevention of early-onset group B streptococcal disease in newborns Obstet Gynecol 2011 117 1019 1027 10.1097/AOG.0b013e318219229b
Verani JR, L McGee, Schrag, S.J. (2010) Division of bacterial diseases, national center for immunization and respiratory diseases, centers for disease control and prevention (CDC. Prevention of perinatal group B streptococcal disease–revised guidelines from CDC 59:1–36
S. Schrag R. Gorwitz K. Fultz-Butts A. Schuchat Prevention of perinatal group B streptococcal disease Revis Guidel CDC Morb Mort Wkly Rep Recomm Rep 2002 51 1 22
R.G. Hughes P. Brocklehurst P.J. Steer P. Heath Stenson BM on behalf of the royal college of obstetricians and gynaecologists prevention of early-onset neonatal group B streptococcal disease Green-top Guidel 2017 10.1111/1471-0528.14821
M. Kunze A. Ziegler K. Fluegge R. Hentschel H. Proempeler R. Berner Colonization, serotypes and transmission rates of group B streptococci in pregnant women and their infants born at a single university center in Germany J Perinat Med 2011 39 417 422 10.1515/jpm.2011.037 21557677
J. Rodriguez-Granger J.C. Alvargonzalez A. Berardi R. Berner M. Kunze M. Hufnagel P. Melin A. Decheva G. Orefici C. Poyart J. Telford A. Efstratiou M. Killian P. Krizova L. Baldassarri B. Spellerberg A. Puertas M. Rosa-Fraile Prevention of group B streptococcal neonatal disease revisited. The DEVANI European project Eur J Clin Microbiol Infect Dis 2012 31 2097 2104 1:STN:280:DC%2BC38vitlertw%3D%3D 10.1007/s10096-012-1559-0 22314410
V. Bekker M.W. Bijlsma D. van de Beek T.W. Kuijpers A. van der Ende Incidence of invasive group B streptococcal disease and pathogen genotype distribution in newborn babies in the Netherlands over 25 years: a nationwide surveillance study Lancet Infect Dis 2014 14 1083 1089 10.1016/S1473-3099(14)70919-3 25444407
N.J. Russell A.C. Seale C. O’Sullivan K. Le Doare P.T. Heath J.E. Lawn L. Bartlett C. Cutland M. Gravett M. Ip S.A. Madhi C.E. Rubens S.K. Saha S. Schrag A. Sobanjo-Ter Meulen J. Vekemans C.J. Baker Risk of early-onset neonatal group b streptococcal disease with maternal colonization worldwide systematic review meta-analyses Clin Infect Dis 2017 65 S152 S159 10.1093/cid/cix655 29117325 5850448
J. Rodriguez-Granger J.C. Alvargonzalez A. Berardi R. Berner M. Kunze M. Hufnagel P. Melin A. Decheva G. Orefici C. Poyart J. Telford A. Efstratiou M. Killian P. Krizova L. Baldassarri B. Spellerberg A. Puertas M. Rosa-Fraile Prevention of group B streptococcal neonatal disease revisited DEVANI European project Eur J Clin Microbiol Infect Dis 2012 31 2097 2104 1:STN:280:DC%2BC38vitlertw%3D%3D 10.1007/s10096-012-1559-0 22314410
M. Fabbrini F. Rigat C.D. Rinaudo I. Passalaqua S. Khacheh R. Creti L. Baldassarri F. Carboni G. Anderloni R. Rosini D. Maione G. Grandi J.L. Telford I. Margarit The protective value of maternal group B Streptococcus antibodies: quantitative and functional analysis of naturally acquired responses to capsular polysaccharides and pilus proteins in European maternal sera Clin Infect Dis 2016 63 746 753 1:CAS:528:DC%2BC1cXitFSit74%3D 10.1093/cid/ciw377 27402816
B. Afshar K. Broughton R. Creti A. Decheva M. Hufnagel P. Kriz L. Lambertsen M. Lovgren P. Melin G. Orefici C. Poyart A. Radtke J. Rodriguez-Granger U.B.S. Sørensen J. Telford L. Valinsky L. Zachariadou A. Efstratiou Members of the DEVANI Study Group International external quality assurance for laboratory identification and typing of Streptococcus agalactiae (group B streptococci) J Clin Microbiol 2011 49 1475 1482 1:CAS:528:DC%2BC3MXhtFKrt7fM 10.1128/JCM.02365-10 21325542 3122801
K. Yao K. Poulsen D. Maione C.D. Rinaudo L. Baldassarri J.L. Telford U.B.S. Sørensen M. Kilian Members of the DEVANI Study Group Capsular gene typing of Streptococcus agalactiae compared to serotyping by latex agglutination J Clin Microbiol 2013 51 503 507 1:CAS:528:DC%2BC3sXlvVektLo%3D 10.1128/JCM.02417-12 23196363 3553911
R. Rosini E. Campisi M. De Chiara H. Tettelin D. Rinaudo C. Toniolo M. Metruccio S. Guidotti U.B.S. Sørensen M. Kilian M. Ramirez R. Janulczyk C. Donati G. Grandi I. Margarit DEVANI Consortium Genomic analysis reveals the molecular basis for capsule loss in the group B Streptococcus population PLoS ONE 2015 10 e0125985 1:CAS:528:DC%2BC2MXhslaisrrP 10.1371/journal.pone.0125985 25946017 4422693
F. Lohrmann A. Berg E. Wicker A. Imm G. Krause K. Zürn R. Berner M. Hufnagel F. Lander Prevalence of capsular serotype, Pilus Island distribution, and antibiotic resistance in pediatric and adult invasive Group B Streptococcus isolates: data from a nationwide prospective surveillance study in Germany Pediatr Infect Dis J 2021 40 76 82 10.1097/INF.0000000000002943 33201062
R. Creti M. Imperi A. Berardi M. Pataracchia S. Recchia G. Alfarone L. Baldassarri Italian Neonatal GBS Infections Working Group Neonatal group B streptococcus infections: prevention strategies, clinical and microbiologic characteristics in 7 years of surveillance Pediatr Infect Dis J 2017 36 256 262 10.1097/INF.0000000000001414 27870810
J. Absalon N. Segall S.L. Block K.J. Center I.L. Scully P.C. Giardina J. Peterson W.J. Watson W.C. Gruber K.U. Jansen Y. Peng S. Munson D. Pavliakova D.A. Scott A.S. Anderson Safety and immunogenicity of a novel hexavalent group B streptococcus conjugate vaccine in healthy, non-pregnant adults: a phase 1/2, randomised, placebo-controlled, observer-blinded, dose-escalation trial Lancet Infect Dis 2021 21 263 274 1:CAS:528:DC%2BB3cXhsl2kt7%2FP 10.1016/S1473-3099(20)30478-3 32891191
C.J. Baker M.A. Rench P. McInnes Immunization of pregnant women with group B streptococcal type III capsular polysaccharide-tetanus toxoid conjugate vaccine Vaccine 2003 21 3468 3472 1:CAS:528:DC%2BD3sXlt1eisbk%3D 10.1016/s0264-410x(03)00353-0 12850362
G.K. Swamy T.D. Metz K.M. Edwards D.E. Soper R.H. Beigi J.D. Campbell L. Grassano G. Buffi A. Dreisbach I. Margarit A. Karsten O. Henry M. Lattanzi Z. Bebia Safety and immunogenicity of an investigational maternal trivalent group B streptococcus vaccine in pregnant women and their infants: results from a randomized placebo-controlled phase II trial Vaccine 2020 38 6930 6940 1:CAS:528:DC%2BB3cXhslWjurfM 10.1016/j.vaccine.2020.08.056 32883555
S.A. Madhi A.S. Anderson J. Absalon D. Radley R. Simon B. Jongihlati R. Strehlau A.M. van Niekerk A. Izu N. Naidoo G. Kwatra Y. Ramsamy M. Said S. Jones L. Jose L. Fairlie S.L. Barnabas R. Newton S. Munson Z. Jefferies D. Pavliakova N.C. Silmon de Monerri E. Gomme J.L. Perez D.A. Scott W.C. Gruber K.U. Jansen Potential for maternally administered vaccine for infant group B streptococcus N Engl J Med 2023 389 215 227 1:CAS:528:DC%2BB3sXhs1Kgt7zK 10.1056/NEJMoa2116045 37467497
M. Imperi M. Pataracchia G. Alfarone L. Baldassarri G. Orefici R. Creti A multiplex PCR assay for the direct identification of the capsular type (Ia to IX) of Streptococcus agalactiae J Microbiol Methods 2010 80 212 214 1:CAS:528:DC%2BC3cXhtVGls7g%3D 10.1016/j.mimet.2009.11.010 19958797
Prevention of group B streptococcal early-onset disease in newborns: ACOG committee opinion summary, Number 797. Obstet Gynecol. 2020;135(2):489–492. https://doi.org/10.1097/AOG.0000000000003669.
L. Madrid A.C. Seale M. Kohli-Lynch K.M. Edmond J.E. Lawn P.T. Heath S.A. Madhi C.J. Baker L. Bartlett C. Cutland M.G. Gravett M. Ip K. Le Doare C.E. Rubens S.K. Saha A. Sobanjo-Ter Meulen J. Vekemans S. Schrag Infant GBS Disease Investigator Group Infant group B streptococcal disease incidence and serotypes worldwide: systematic review and meta-analyses Clin Infect Dis 2017 65 S172 10.1093/cid/cix656
R Core Team (2024) R: A Language and Environment for Statistical Computing. R Foundation for Statistical Computing, Vienna, Austria
L.L. Vieira A.V. Perez M.M. Machado M.L. Kayser D.V. Vettori A.P. Alegretti C.F. Ferreira J. Vettorazzi E.G. Valério Group B Streptococcus detection in pregnant women: comparison of qPCR assay, culture, and the Xpert GBS rapid test BMC Pregnancy Childbirth 2019 19 532 10.1186/s12884-019-2681-0 31888631 6937909
S.M. Hansen N. Uldbjerg M. Kilian U.B.S. Sørensen Dynamics of Streptococcus agalactiae colonization in women during and after pregnancy and in their infants J Clin Microbiol 2004 42 83 89 10.1128/JCM.42.1.83-89.2004 14715736 321715
M. Kunze K. Zumstein F. Markfeld-Erol R. Elling F. Lander H. Prömpeler R. Berner M. Hufnagel Comparison of pre- and intrapartum screening of group B streptococci and adherence to screening guidelines: a cohort study Eur J Pediatr 2015 174 827 835 10.1007/s00431-015-2548-y 25922140
K.H. Kjerulff L.B. Attanasio J. Vanderlaan K.K. Sznajder Timing of hospital admission at first childbirth: A prospective cohort study PLoS ONE 2023 18 e0281707 1:CAS:528:DC%2BB3sXjvFymt7s%3D 10.1371/journal.pone.0281707 36795737 9934383
M. Williams E. Zantow M. Turrentine Cost effectiveness of latest recommendations for group B streptococci screening in the United States Obstet Gynecol 2020 135 789 798 10.1097/AOG.0000000000003649 32168204
WHO Group B Streptococcus (GBS). https://www.who.int/teams/immunization-vaccines-and-biologicals/diseases/group-b-streptococcus-(gbs). Accessed 11 Jul 2024
