Sadarangani Manish, Sell Tim, Iro Mildred A, Snape Matthew D, Voysey Merryn, Finn Adam, Heath Paul T, Bona Gianni, Esposito Susanna, Diez-Domingo Javier, Prymula Roman, Odueyungbo Adefowope, Toneatto Daniela, Pollard Andrew J
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.
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. doi: 10.1503/cmaj.161288.
One 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.
Children 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.
Of 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).
We 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. : ClinicalTrials.gov, no. NCT01717638.
B群脑膜炎球菌结合疫苗4CMenB的一种接种程序是，针对12至23个月大的儿童，间隔2个月接种2剂，12至24个月后接种加强剂。我们的目标是提供12至24个月龄首次接种疫苗后4岁以下儿童的人血清杀菌抗体（hSBA）滴度持久性数据，以及与未接种疫苗儿童相比48个月龄加强剂的免疫原性数据。
作为一项随机对照试验的一部分，先前在12至24个月龄时接种过2剂4CMenB疫苗的儿童在4岁时接种加强剂。年龄匹配的未接种疫苗的幼儿接种2剂4CMenB。在4岁儿童接种4CMenB疫苗前后，评估针对参考菌株H44/76、5/99、NZ98/254和M10713的人血清杀菌抗体滴度。
在该研究的332名儿童中，123名先前接种过4CMenB，209名是未接种疫苗的对照。在加强剂接种前，hSBA滴度为1:5或更高的参与者比例（先前接种组与对照组相比）如下：9%-11%对1%（H44/76），84%-100%对4%（5/99），0%-18%对0%（NZ98/254），59%-60%对60%（M10713）。在先前接种过疫苗的儿童接种1剂4CMenB后，hSBA滴度达到1:5或更高的参与者比例为100%（H44/76和5/99）,70%-100%（NZ98/254），90%-100%（M10713）。
我们发现，在12至24个月龄接种2剂4CMenB疫苗后，4岁时hSBA滴度会下降，且12至24个月龄的剂量对免疫系统有启动作用。对于疾病风险增加的儿童，可能需要接种加强剂以维持hSBA滴度在1:5或更高。：ClinicalTrials.gov，编号NCT01717638。
