Alessandro Muzzi1, Alessandro Brozzi2, Laura Serino3, Margherita Bodini4, Raquel Abad5, Dominique Caugant6, Maurizio Comanducci7, Ana Paula Lemos8, Maria Cecilia Gorla9, Pavla Křížová10, Claudia Mikula11, Robert Mulhall12, Michael Nissen13, Hanna Nohynek14, Maria João Simões15, Anna Skoczyńska16, Paola Stefanelli17, Muhamed-Kheir Taha18, Maija Toropainen19, Georgina Tzanakaki20, Kumaran Vadivelu-Pechai21, Philip Watson22, Julio A Vazquez23, Gowrisankar Rajam24, Rino Rappuoli25, Ray Borrow26, Duccio Medini27. 1. GSK, Siena, Italy. Electronic address: alessandro.x.muzzi@gsk.com. 2. GSK, Siena, Italy. Electronic address: alessandro.x.brozzi@gsk.com. 3. GSK, Siena, Italy. Electronic address: laura.x.serino@gsk.com. 4. GSK, Siena, Italy. Electronic address: margherita.x.bodini@gsk.com. 5. National Centre for Microbiology, Institute of Health Carlos III, Madrid, Spain. Electronic address: rabad@isciii.es. 6. Norwegian Institute of Public Health, Oslo, Norway. Electronic address: Dominique.Caugant@fhi.no. 7. GSK, Siena, Italy. 8. Instituto Adolfo Lutz, São Paulo, Brazil. Electronic address: ana.lemos@ial.sp.gov.br. 9. Instituto Adolfo Lutz, São Paulo, Brazil. Electronic address: maria.gorla@ial.sp.gov.br. 10. National Institute of Public Health, Prague, Czech Republic. Electronic address: pavla.krizova@szu.cz. 11. Austrian Agency for Health and Food Safety, Institute for Medical Microbiology and Hygiene, Graz, Austria. Electronic address: claudia.mikula@ages.at. 12. Irish Meningitis and Sepsis Reference Laboratory (IMSRL), Dublin, Ireland. Electronic address: Robert.Mulhall@cuh.ie. 13. Queensland Paediatric Infectious Diseases Laboratory, Children's Health Research Centre, University of Queensland, Lady Cilento Children's Hospital South Brisbane, Queensland, Australia. Electronic address: michael.d.nissen@gsk.com. 14. National Institute for Health and Welfare (THL), Helsinki, Finland. Electronic address: hanna.nohynek@thl.fi. 15. National Institute of Health Dr. Ricardo Jorge, Lisbon, Portugal. Electronic address: M.Joao.Simoes@insa.min-saude.pt. 16. National Medicines Institute, Warsaw, Poland. Electronic address: skoczek@cls.edu.pl. 17. Department of Infectious Parasitic and Immune-mediated Diseases, Istituto Superiore di Sanità, Rome, Italy. Electronic address: paola.stefanelli@iss.it. 18. Institut Pasteur, Paris, France. Electronic address: muhamed-kheir.taha@pasteur.fr. 19. National Institute for Health and Welfare (THL), Helsinki, Finland. Electronic address: maija.toropainen@thl.fi. 20. National Meningitis Reference Laboratory, National School of Public Health, Athens, Greece. Electronic address: gtzanakaki@esdy.edu.gr. 21. GSK, Rockville, USA. Electronic address: kumaran.k.vadivelu-pechai@gsk.com. 22. GSK, Rockville, USA. Electronic address: philip.s.watson@gsk.com. 23. National Centre for Microbiology, Institute of Health Carlos III, Madrid, Spain. Electronic address: jvazquez@isciii.es. 24. Centers for Disease Control and Prevention, Atlanta, GA, USA. 25. GSK, Siena, Italy. Electronic address: rino.r.rappuoli@gsk.com. 26. Meningococcal Reference Unit, Public Health England, Manchester Royal Infirmary, Manchester, UK. Electronic address: Ray.Borrow@phe.gov.uk. 27. GSK, Siena, Italy. Electronic address: duccio.x.medini@gsk.com.
Abstract
BACKGROUND: The Meningococcal Antigen Typing System (MATS) was developed to identify meningococcus group B strains with a high likelihood of being covered by the 4CMenB vaccine, but is limited by the requirement for viable isolates from culture-confirmed cases. We examined if antigen genotyping could complement MATS in predicting strain coverage by the 4CMenB vaccine. METHODS: From a panel of 3912 MATS-typed invasive meningococcal disease isolates collected in England and Wales in 2007-2008, 2014-2015 and 2015-2016, and in 16 other countries in 2000-2015, 3481 isolates were also characterized by antigen genotyping. Individual associations between antigen genotypes and MATS coverage for each 4CMenB component were used to define a genetic MATS (gMATS). gMATS estimates were compared with England and Wales human complement serum bactericidal assay (hSBA) data and vaccine effectiveness (VE) data from England. RESULTS: Overall, 81% of the strain panel had genetically predictable MATS coverage, with 92% accuracy and highly concordant results across national panels (Lin's accuracy coefficient, 0.98; root-mean-square deviation, 6%). England and Wales strain coverage estimates were 72-73% by genotyping (66-73% by MATS), underestimating hSBA values after four vaccine doses (88%) and VE after two doses (83%). The gMATS predicted strain coverage in other countries was 58-88%. CONCLUSIONS: gMATS can replace MATS in predicting 4CMenB strain coverage in four out of five cases, without requiring a cultivable isolate, and is open to further improvement. Both methods underestimated VE in England. Strain coverage predictions in other countries matched or exceeded England and Wales estimates.
BACKGROUND: The Meningococcal Antigen Typing System (MATS) was developed to identify meningococcus group B strains with a high likelihood of being covered by the 4CMenB vaccine, but is limited by the requirement for viable isolates from culture-confirmed cases. We examined if antigen genotyping could complement MATS in predicting strain coverage by the 4CMenB vaccine. METHODS: From a panel of 3912 MATS-typed invasive meningococcal disease isolates collected in England and Wales in 2007-2008, 2014-2015 and 2015-2016, and in 16 other countries in 2000-2015, 3481 isolates were also characterized by antigen genotyping. Individual associations between antigen genotypes and MATS coverage for each 4CMenB component were used to define a genetic MATS (gMATS). gMATS estimates were compared with England and Wales human complement serum bactericidal assay (hSBA) data and vaccine effectiveness (VE) data from England. RESULTS: Overall, 81% of the strain panel had genetically predictable MATS coverage, with 92% accuracy and highly concordant results across national panels (Lin's accuracy coefficient, 0.98; root-mean-square deviation, 6%). England and Wales strain coverage estimates were 72-73% by genotyping (66-73% by MATS), underestimating hSBA values after four vaccine doses (88%) and VE after two doses (83%). The gMATS predicted strain coverage in other countries was 58-88%. CONCLUSIONS: gMATS can replace MATS in predicting 4CMenB strain coverage in four out of five cases, without requiring a cultivable isolate, and is open to further improvement. Both methods underestimated VE in England. Strain coverage predictions in other countries matched or exceeded England and Wales estimates.
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