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Antibody persistence 5 years after vaccination at 2 to 10 years of age with Quadrivalent MenACWY-CRM conjugate vaccine,and responses to a booster vaccination
Affiliation:1. Kentucky Pediatric and Adult Research, Bardstown, KY, USA;2. J. Lewis Research Inc., Salt Lake City, UT, USA;3. Novartis Vaccines and Diagnostics, Inc., Cambridge, MA, USA;4. Novartis Pharma BV, Amsterdam, The Netherlands;1. Public Health England, Public Health Laboratory, Manchester, Manchester Medical Microbiology Partnership, PO Box 209, Clinical Sciences Building II, Manchester Royal Infirmary, Manchester M13 9WZ, UK;2. Immunisation Department, Health Protection Services, Public Health England, Colindale, London NW9 5EQ, UK;3. University of Manchester, Inflammation Sciences Research Group, School of Translational Medicine, Stopford Building, Manchester M13 9PL, UK;1. Vaccine and Immunisation Research Group (VIRGo), Murdoch Childrens Research Institute and Melbourne School of Population and Global Health, The University of Melbourne, Melbourne, Australia;2. School of Paediatrics and Child Health, University of Western Australia, Wesfarmers Centre of Vaccines and Infectious Diseases, Telethon Kids Institute, Princess Margaret Hospital for Children, Perth, Australia;3. Vaccinology and Immunology Research Trials Unit (VIRTU), Women''s and Children''s Hospital, School of Paediatrics and Reproductive Health and Robinson Research Institute, The University of Adelaide, Adelaide, Australia;4. Queensland Paediatric Infectious Diseases Laboratory (Qpid), Queensland Children''s Medical Research Institute, Royal Children''s Hospital, University of Queensland, Brisbane, Australia;5. Novartis Vaccines and Diagnostics Inc., Cambridge, MA, USA;6. Novartis Vaccines and Diagnostics S.r.l., Siena, Italy;1. Kentucky Pediatric and Adult Research, Bardstown, KY, USA;2. Department of Pediatric Infectious Diseases, Wroclaw Medical University, Wroclaw, Poland;3. Bluegrass Clinical Research Inc, Louisville, KY, USA;4. Department of Pediatrics, Medical Center of Postgraduate Education, Warsaw, Poland;5. Novartis Pharma BV, Amsterdam, Netherlands;6. Novartis Vaccines and Diagnostics, Inc., Cambridge, MA, USA;1. Instituto de Atención Pediatrica, Apdo 607–1150 La Uruca, San Jose, Costa Rica;2. Wee Care Pediatrics, 2084N 1700W Suite A, Layton, UT, United States;3. Guanchipelin, San Rafael, Escazu, Heredia, Costa Rica;4. Centro de Investigaciones en Pediatría, Guatemala City, Guatemala;5. Department of Pediatrics, Mackay Memorial Hospital, 92, Sec. 2, Zhongshan N. Rd., Zhongshan District, Taipei City 104, Taiwan;6. Department of Pediatrics, Chang Gung Children''s Hospital, Chang Gung University College of Medicine, No.199, Tunghwa Rd., Taipei, Taiwan;7. Instituto de Investigación Nutricional, Av. La Molina 1885, Lima 12, Peru;8. Hospital Materno Infantil José Domingo de Obaldía, Ciudad de David, Chiriqui, Panama;9. Novartis Vaccines and Diagnostics, Inc., 350 Massachusetts Avenue, Cambridge, MA 02139, United States;1. Immunization Safety Office, Division of Healthcare Quality Promotion, Centers for Disease Control and Prevention, 1600 Clifton Road NE, Atlanta, GA 30333, USA;2. Rollins School of Public Health, Emory University, 1518 Clifton Road, Atlanta, GA 30322, USA;1. Academic Unit of Clinical Experimental Sciences and NIHR Southampton Respiratory Biomedical Research Unit, Faculty of Medicine and Institute for Life Sciences, University of Southampton, Southampton, UK;2. Faculty of Medical and Human Sciences, University of Manchester, Manchester, UK;3. The James Cook University Hospital, Middlesborough, UK;4. Southampton NIHR Wellcome Trust Clinical Research Facility, University Hospital Southampton NHS Foundation Trust, Southampton, UK;5. Schools of Clinical Science and Cellular and Molecular Medicine, University of Bristol, Bristol, UK;6. Department of Clinical Sciences, Liverpool School of Tropical Medicine, Liverpool, UK;7. Division of Clinical Sciences, St George''s, University of London, London, UK;8. Surrey Clinical Research Centre, University of Surrey, Guildford, UK;9. Oxford Vaccine Group, Department of Paediatrics, University of Oxford and the NIHR Oxford Biomedical Centre, Oxford, UK;10. Centre for Biomolecular Sciences, University of Nottingham, Nottingham, UK;11. Department of Infection and Immunity, University of Sheffield, Sheffield, UK;12. NIHR Wellcome Trust Clinical Research Facility, Manchester Royal Infirmary, Manchester, UK;13. Public Health England, Manchester Royal Infirmary, Manchester, UK;14. Department of Zoology, University of Oxford, Oxford, UK;15. Novartis Vaccines and Diagnostics, Cambridge, MA, USA
Abstract:
BackgroundIn a multi-center extension study, children 2–10 years of age, initially vaccinated with one or two doses (2–5 year-olds) or one dose (6–10 year-olds) of quadrivalent meningococcal CRM197-conjugate vaccine (MenACWY-CRM), were assessed five years later for antibody persistence and booster response using serum bactericidal assay with human complement (hSBA).MethodsChildren 7–10 and 11–15 years of age, who received MenACWY-CRM in the original study, and age-matched vaccine-naïve children, were enrolled in this extension study. After an initial blood draw, children received one dose of MenACWY-CRM as booster or primary dose, with a second blood draw 28 days later.ResultshSBA titers decreased five years after primary vaccination, but were higher than in non-vaccinated controls against serogroups C, W and Y, with substantial proportions having titers ≥8: 7–22% for A, 32–57% for C, 74–83% for W, and 48–54% for Y. Previously-vaccinated children demonstrated booster responses to revaccination against all four serogroups. Responses to primary vaccination in vaccine-naïve controls were lower and similar to primary responses observed in the original study. All vaccinations were generally well tolerated, with no safety concern raised.ConclusionsApproximately half the children vaccinated as 2–10 year-olds maintained protective antibodies against serogroups C, W and Y five years later, but fewer did against serogroup A. Declining titers five years after vaccination and robust booster responses suggest that five years may be an appropriate interval to revaccinate children, subject to epidemiology and delivery considerations.
Keywords:Meningococcal vaccine  Childhood vaccination  Antibody persistence  Booster vaccination  hSBA"  },{"  #name"  :"  keyword"  ,"  $"  :{"  id"  :"  kw0035"  },"  $$"  :[{"  #name"  :"  text"  ,"  _"  :"  serum bactericidal assay using human complement  non-toxic mutant of diphtheria toxin  IMD"  },{"  #name"  :"  keyword"  ,"  $"  :{"  id"  :"  kw0055"  },"  $$"  :[{"  #name"  :"  text"  ,"  _"  :"  invasive meningococcal disease  GMT"  },{"  #name"  :"  keyword"  ,"  $"  :{"  id"  :"  kw0065"  },"  $$"  :[{"  #name"  :"  text"  ,"  _"  :"  geometric mean titer
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