• Manish Sadarangani, Tim Sell, Mildred A Iro, Matthew D Snape, Merryn Voysey, Adam Finn, Paul T Heath, Gianni Bona, Susanna Esposito, Javier Diez-Domingo, Roman Prymula, Adefowope Odueyungbo, Daniela Toneatto, Andrew J Pollard, and European MenB Vaccine Study Group.
• Oxford Vaccine Group, Department of Paediatrics (Sadarangani, Sell, Iro, Snape, Voysey, Pollard), University of Oxford, and the NIHR Oxford Biomedical Research Centre, Oxford, UK; Vaccine Evaluation Center (Sadarangani), BC Children's Hospital Research Institute, The University of British Columbia, Vancouver, BC; Nuffield Department of Primary Care Health Sciences (Voysey), University of Oxford, Oxford, UK; Bristol Children's Vaccine Centre (Finn), School of Clinical Sciences, University of Bristol, Bristol, UK; St. George's Vaccine Institute (Heath), University of London, London, UK; Azienda Ospedaliero-Universitaria Maggiore della Carità (Bona), Clinica Pediatrica, Novara, Italy; Pediatric Highly Intensive Care Unit (Esposito), Università degli Studi di Milano, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy; Vaccine Research Area (Diez-Domingo), Fundación para el Fomento de la Investigación Sanitaria y Biomédica (FISABIO), Valencia, Spain; Charles University Prague, School of Medicine, Department of Social Sciences (Prymula), Hradec Kralove, Czech Republic; Novartis Vaccines and Diagnostics Inc. (Odueyungbo), Cambridge, Mass.; Hoffmann-La Roche Limited (Odueyungbo), Mississauga, Ont.; GSK (Toneatto), Siena, Italy.
• CMAJ. 2017 Oct 16; 189 (41): E1276-E1285.

BackgroundOne schedule for the capsular group B meningococcal vaccine 4CMenB is 2 doses that are administered 2 months apart for children aged 12-23 months, with a booster dose 12-24 months later. Our objective was to provide data on persistence of human serum bactericidal antibody (hSBA) titres in children up to 4 years of age after initial doses at 12-24 months, and immunogenicity of a booster dose at 48 months of age compared with vaccine-naive children.MethodsChildren previously immunized, as part of a randomized controlled trial, with 2 doses of 4CMenB vaccine at 12-24 months of age received a booster at 4 years of age. Vaccine-naive age-matched toddlers received 2 doses of 4CMenB. Human serum bactericidal antibody titres against reference strains H44/76, 5/99, NZ98/254 and M10713 were evaluated before and after innoculation with 4CMenB vaccine in 4-year-old children.ResultsOf 332 children in the study, 123 had previously received 4CMenB and 209 were vaccine-naive controls. Before the booster, the proportions of participants (previously vaccinated groups compared with controls) with hSBA titres of 1:5 or more were as follows: 9%-11% v. 1% (H44/76), 84%-100% v. 4% (5/99), 0%-18% v. 0% (NZ98/254) and 59%-60% v. 60% (M10713). After 1 dose of 4CMenB in previously immunized children, the proportions of participants achieving hSBA titres of 1:5 or more were 100% (H44/76 and 5/99), 70%-100% (NZ98/254) and 90%-100% (M10713).InterpretationWe found that waning of hSBA titres by 4 years of age occurred after 2 doses of 4CMenB vaccine administered at 12-24 months, and doses at 12-24 months have a priming effect on the immune system. A booster may be necessary to maintain hSBA titres of 1:5 or more among those children with increased disease risk. Trial registration: ClinicalTrials.gov, no. NCT01717638.© 2017 Canadian Medical Association or its licensors.

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