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Antibody persistence and booster response in adolescents and young adults 4 and 7.5 years after immunization with 4CMenB vaccine.

  • Nolan, Terry1
  • Santolaya, Maria Elena2
  • de Looze, Ferdinandus3
  • Marshall, Helen4
  • Richmond, Peter5
  • Henein, Sam6
  • Rheault, Paul7
  • Heaton, Ken7
  • Perrett, Kirsten P8
  • Garfield, Hartley9
  • Gupta, Anil9
  • Ferguson, Murdo10
  • D'Agostino, Diego11
  • Toneatto, Daniela12
  • O'Ryan, Miguel13
  • 1 Vaccine and Immunisation Research Group (VIRGo) at the University of Melbourne School of Population and Global Health and Murdoch Children's Research Institute, Melbourne, Victoria, Australia. , (Australia)
  • 2 Department of Pediatrics, Hospital Dr Luis Calvo Mackenna, Faculty of Medicine, Universidad de Chile, Santiago, Chile. , (Chile)
  • 3 School of Medicine, University of Queensland and AusTrials Pty Ltd, Brisbane, Australia. , (Austria)
  • 4 Adelaide Medical School and Robinson Research Institute, The University of Adelaide and Vaccinology and Immunology Research Trials Unit, Women's and Children's Health Network, Adelaide, South Australia, Australia. , (Australia)
  • 5 Division of Paediatrics and Centre for Child Health Research, University of Western Australia, Wesfarmers Centre of Vaccines and Infectious Diseases, Telethon Kids Institute, Princess Margaret Hospital for Children, Perth, Australia. , (Australia)
  • 6 University of Toronto, Toronto, Ontario, Canada. , (Canada)
  • 7 Medicor Research Inc, Sudbury, Ontario, Canada. , (Canada)
  • 8 Murdoch Children's Research Institute and Melbourne School of Population and Global Health, University of Melbourne and Royal Children's Hospital, Melbourne, VIC, Australia. , (Australia)
  • 9 University of Toronto, Department of Medicine, Queen's University and The Hospital for Sick Children, Toronto, Ontario, Canada. , (Canada)
  • 10 Colchester Research Group, Truro, Nova Scotia, Canada. , (Canada)
  • 11 GSK, Amsterdam, the Netherlands. , (Netherlands)
  • 12 GSK, Siena, Italy. , (Italy)
  • 13 Microbiology and Mycology Program, Institute of Biomedical Sciences, and Millennium Institute of Immunology and Immunotherapy, Faculty of Medicine, Universidad de Chile, Santiago, Chile. Electronic address: [email protected] , (Chile)
Published Article
Publication Date
Feb 21, 2019
DOI: 10.1016/j.vaccine.2018.12.059
PMID: 30691980


Data on duration of protection against invasive meningococcal disease post-vaccination with the recombinant, 4-component, meningococcal serogroup B vaccine (4CMenB) are limited. We evaluated bactericidal activity persistence in adolescents/young adults up to 7.5 years post-primary vaccination with 4CMenB, and response to a booster dose compared with vaccine-naïve controls. This open-label, multicenter study (NCT02446743) enrolled 15-24 year-old-previously vaccinated participants from Canada, Australia (group Primed_4y) 4 years post-priming with 4CMenB (2 doses; 0,1-month schedule), and Chile (Primed_7.5y) 7.5 years after priming with 4CMenB (2 doses; 0,1/0,2/0,6-month schedule) and vaccine-naïve participants of similar age (Naïve_4y and Naïve_7.5y groups). Primed participants received a booster dose; vaccine-naïve participants received 2 catch-up doses of 4CMenB, 1 month apart. We evaluated antibody persistence and immune responses using hSBA in terms of geometric mean titers and percentages of participants with hSBA titers ≥4, the kinetics of bactericidal activity post-booster (previously vaccinated) or post-2 doses (vaccine-naïve), and safety. Antibody levels declined at 4 (Primed_4y) and 7.5 (Primed_7.5y) years post-primary vaccination, but remained higher than in vaccine-naïve participants at baseline (≤44% vs ≤ 13% [fHbp]; ≤84% vs ≤ 24% [NadA]; ≤29% vs ≤ 14% [PorA]) for all vaccine antigens except NHBA (≤81% vs ≤ 79%). One month post-booster and post-second dose, 93-100% of primed and 79-100% of vaccine-naïve participants had hSBA titers ≥4 for all antigens. Kinetics of the antibody response were similar across groups with an early robust response observed 7 days post-booster/second dose. No vaccine-related serious adverse event was reported. For all antigens except NHBA, a higher proportion of primed participants had hSBA titers ≥4, at 4 and 7.5 years post-vaccination, compared with vaccine-naïve participants. A more robust immune response after booster compared to a first dose in vaccine-naïve individuals, showed effective priming in an adolescent/young adult population. No safety or new reactogenicity issues were identified. Copyright © 2019 GlaxoSmithKline Biologicals SA. Published by Elsevier Ltd.. All rights reserved.

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