{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,7]],"date-time":"2026-05-07T11:24:36Z","timestamp":1778153076184,"version":"3.51.4"},"reference-count":19,"publisher":"Oxford University Press (OUP)","issue":"5","license":[{"start":{"date-parts":[[2020,4,29]],"date-time":"2020-04-29T00:00:00Z","timestamp":1588118400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/www.nationalarchives.gov.uk\/doc\/open-government-licence\/version\/2\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2020,5,1]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Background<\/jats:title>\n                  <jats:p>The 4-component capsular group B meningococcal vaccine (4CMenB) was licensed as a 4-dose infant schedule but introduced into the United Kingdom as 3 doses at 2, 4, and 12 months of age. We describe the immunogenicity and reactogenicity of the 2 + 1 schedule in infants.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>Infants were randomized to receive 4CMenB with routine immunizations (test group) at 2, 4, and 12 months or 4CMenB alone at 6, 8, and 13 months of age (control group). Serum bactericidal antibody (SBA) assay against a serogroup B meningococcal reference strain (44\/76-SL), memory B-cell responses to factor H binding protein, Neisseria adhesion protein A, Neisseria heparin binding antigen, Porin A (PorA), and reactogenicity was measured.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>One hundred eighty-seven infants were randomized (test group: 94; control group: 93). In the test group, 4CMenB induced SBA titers above the putative protective threshold (1:4) after primary and booster doses in 97% of participants. Postbooster, the SBA GMT (72.1; 95% confidence interval [CI], 51.7\u2013100.4) was numerically higher than the serum bactericidal antibody geometric mean titre (SBA GMT) determined post\u2013primary vaccination (48.6; 95% CI, 37.2\u201363.4).<\/jats:p>\n                  <jats:p>After primary immunizations, memory B-cell responses did not change when compared with baseline controls, but frequencies significantly increased after booster. Higher frequency of local and systemic adverse reactions was associated with 4CMenB.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusions<\/jats:title>\n                  <jats:p>A reduced schedule of 4CMenB was immunogenic and established immunological memory after booster.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1093\/ofid\/ofaa143","type":"journal-article","created":{"date-parts":[[2020,4,29]],"date-time":"2020-04-29T16:25:55Z","timestamp":1588177555000},"source":"Crossref","is-referenced-by-count":7,"title":["Immunogenicity and Reactogenicity of a Reduced Schedule of a 4-component Capsular Group B Meningococcal Vaccine: A Randomized Controlled Trial in Infants"],"prefix":"10.1093","volume":"7","author":[{"given":"Marta","family":"Valente Pinto","sequence":"first","affiliation":[{"name":"Oxford Vaccine Group, Department of Paediatrics, Centre for Clinical Vaccinology and Tropical Medicine, University of Oxford and the NIHR Oxford Biomedical Research Centre, Oxford, United Kingdom"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Daniel","family":"O\u2019Connor","sequence":"first","affiliation":[{"name":"Oxford Vaccine Group, Department of Paediatrics, Centre for Clinical Vaccinology and Tropical Medicine, University of Oxford and the NIHR Oxford Biomedical Research Centre, Oxford, United Kingdom"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ushma","family":"Galal","sequence":"first","affiliation":[{"name":"Nuffield Department of Primary Care Health Sciences, Clinical Trials Unit, University of Oxford, Oxford, United Kingdom"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Elizabeth A","family":"Clutterbuck","sequence":"first","affiliation":[{"name":"Oxford Vaccine Group, Department of Paediatrics, Centre for Clinical Vaccinology and Tropical Medicine, University of Oxford and the NIHR Oxford Biomedical Research Centre, Oxford, United Kingdom"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hannah","family":"Robinson","sequence":"first","affiliation":[{"name":"Oxford Vaccine Group, Department of Paediatrics, Centre for Clinical Vaccinology and Tropical Medicine, University of Oxford and the NIHR Oxford Biomedical Research Centre, Oxford, United Kingdom"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Emma","family":"Plested","sequence":"first","affiliation":[{"name":"Oxford Vaccine Group, Department of Paediatrics, Centre for Clinical Vaccinology and Tropical Medicine, University of Oxford and the NIHR Oxford Biomedical Research Centre, Oxford, United Kingdom"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sagida","family":"Bibi","sequence":"first","affiliation":[{"name":"Oxford Vaccine Group, Department of Paediatrics, Centre for Clinical Vaccinology and Tropical Medicine, University of Oxford and the NIHR Oxford Biomedical Research Centre, Oxford, United Kingdom"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Susana","family":"Camara Pellisso","sequence":"first","affiliation":[{"name":"Oxford Vaccine Group, Department of Paediatrics, Centre for Clinical Vaccinology and Tropical Medicine, University of Oxford and the NIHR Oxford Biomedical Research Centre, Oxford, United Kingdom"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Harri","family":"Hughes","sequence":"first","affiliation":[{"name":"Oxford Vaccine Group, Department of Paediatrics, Centre for Clinical Vaccinology and Tropical Medicine, University of Oxford and the NIHR Oxford Biomedical Research Centre, Oxford, United Kingdom"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Simon","family":"Kerridge","sequence":"first","affiliation":[{"name":"Oxford Vaccine Group, Department of Paediatrics, Centre for Clinical Vaccinology and Tropical Medicine, University of Oxford and the NIHR Oxford Biomedical Research Centre, Oxford, United Kingdom"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yama F","family":"Mujadidi","sequence":"first","affiliation":[{"name":"Oxford Vaccine Group, Department of Paediatrics, Centre for Clinical Vaccinology and Tropical Medicine, University of Oxford and the NIHR Oxford Biomedical Research Centre, Oxford, United Kingdom"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Helen","family":"Findlow","sequence":"first","affiliation":[{"name":"Vaccine Evaluation Unit, Public Health England, Manchester Royal Infirmary, Manchester, United Kingdom"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ray","family":"Borrow","sequence":"first","affiliation":[{"name":"Vaccine Evaluation Unit, Public Health England, Manchester Royal Infirmary, Manchester, United Kingdom"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Matthew D","family":"Snape","sequence":"first","affiliation":[{"name":"Oxford Vaccine Group, Department of Paediatrics, Centre for Clinical Vaccinology and Tropical Medicine, University of Oxford and the NIHR Oxford Biomedical Research Centre, Oxford, United Kingdom"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Andrew J","family":"Pollard","sequence":"first","affiliation":[{"name":"Oxford Vaccine Group, Department of Paediatrics, Centre for Clinical Vaccinology and Tropical Medicine, University of Oxford and the NIHR Oxford Biomedical Research Centre, Oxford, United Kingdom"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"286","published-online":{"date-parts":[[2020,4,29]]},"reference":[{"key":"2020070713241086300_CIT0001","volume-title":"Invasive Meningococcal Disease","author":"European Centre for Disease Preventation and Control","year":"2019"},{"key":"2020070713241086300_CIT0002","doi-asserted-by":"crossref","first-page":"53","DOI":"10.1016\/S2049-0801(13)70037-2","article-title":"The long road to an effective vaccine for meningococcus group B (MenB)","volume":"2","author":"Shea","year":"2013","journal-title":"Ann Med Surg (Lond)"},{"key":"2020070713241086300_CIT0003","doi-asserted-by":"crossref","first-page":"825","DOI":"10.1016\/S0140-6736(12)61961-8","article-title":"Immunogenicity and safety of an investigational multicomponent, recombinant, meningococcal serogroup B vaccine (4CMenB) administered concomitantly with routine infant and child vaccinations: results of two randomised trials","volume":"381","author":"Vesikari","year":"2013","journal-title":"Lancet"},{"key":"2020070713241086300_CIT0004","author":"European Medicines Agency"},{"key":"2020070713241086300_CIT0005","doi-asserted-by":"crossref","first-page":"573","DOI":"10.1001\/jama.2012.85","article-title":"Immunogenicity and tolerability of recombinant serogroup B meningococcal vaccine administered with or without routine infant vaccinations according to different immunization schedules: a randomized controlled trial","volume":"307","author":"Gossger","year":"2012","journal-title":"JAMA"},{"key":"2020070713241086300_CIT0006","doi-asserted-by":"crossref","first-page":"611","DOI":"10.1016\/j.jinf.2015.09.035","article-title":"The introduction of the meningococcal B (MenB) vaccine (Bexsero\u00ae) into the national infant immunisation programme\u2014new challenges for public health","volume":"71","author":"Ladhani","year":"2015","journal-title":"J Infect"},{"key":"2020070713241086300_CIT0007","doi-asserted-by":"crossref","first-page":"2775","DOI":"10.1016\/S0140-6736(16)31921-3","article-title":"Effectiveness and impact of a reduced infant schedule of 4CMenB vaccine against group B meningococcal disease in England: a national observational cohort study","volume":"388","author":"Parikh","year":"2016","journal-title":"Lancet"},{"key":"2020070713241086300_CIT0008","doi-asserted-by":"crossref","first-page":"970","DOI":"10.1128\/CDLI.12.8.970-976.2005","article-title":"Interlaboratory standardization of the measurement of serum bactericidal activity by using human complement against meningococcal serogroup b, strain 44\/76-SL, before and after vaccination with the Norwegian MenBvac outer membrane vesicle vaccine","volume":"12","author":"Borrow","year":"2005","journal-title":"Clin Diagn Lab Immunol"},{"key":"2020070713241086300_CIT0009","doi-asserted-by":"crossref","first-page":"e130","DOI":"10.1097\/INF.0000000000001497","article-title":"Divergent Memory B cell responses in a mixed infant pneumococcal conjugate vaccine schedule","volume":"36","author":"Tr\u00fcck","year":"2017","journal-title":"Pediatr Infect Dis J"},{"key":"2020070713241086300_CIT0010","doi-asserted-by":"crossref","first-page":"551","DOI":"10.1016\/j.vaccine.2003.09.007","article-title":"Fever as an adverse event following immunization: case definition and guidelines of data collection, analysis, and presentation","volume":"22","author":"Marcy","year":"2004","journal-title":"Vaccine"},{"key":"2020070713241086300_CIT0011","doi-asserted-by":"crossref","first-page":"3548","DOI":"10.1016\/j.vaccine.2017.05.023","article-title":"Reduced schedules of 4CMenB vaccine in infants and catch-up series in children: immunogenicity and safety results from a randomised open-label phase 3b trial","volume":"35","author":"Martin\u00f3n-Torres","year":"2017","journal-title":"Vaccine"},{"key":"2020070713241086300_CIT0012","doi-asserted-by":"crossref","first-page":"e0197186","DOI":"10.1371\/journal.pone.0197186","article-title":"Clustered intergenic region sequences as predictors of factor H binding protein expression patterns and for assessing Neisseria meningitidis strain coverage by meningococcal vaccines","volume":"13","author":"Cayrou","year":"2018","journal-title":"PLoS One"},{"key":"2020070713241086300_CIT0013","doi-asserted-by":"crossref","first-page":"271","DOI":"10.1111\/j.1365-2249.2010.04206.x","article-title":"Reference values for B cell subpopulations from infancy to adulthood","volume":"162","author":"Morbach","year":"2010","journal-title":"Clin Exp Immunol"},{"key":"2020070713241086300_CIT0014","doi-asserted-by":"crossref","first-page":"134","DOI":"10.1111\/j.1365-2567.2008.02934.x","article-title":"Plasma and memory B-cell kinetics in infants following a primary schedule of CRM 197-conjugated serogroup C meningococcal polysaccharide vaccine","volume":"127","author":"Kelly","year":"2009","journal-title":"Immunology"},{"key":"2020070713241086300_CIT0015","doi-asserted-by":"crossref","first-page":"1","DOI":"10.1186\/s13073-017-0400-x","article-title":"High-dimensional assessment of B-cell responses to quadrivalent meningococcal conjugate and plain polysaccharide vaccine","volume":"9","author":"O\u2019Connor","year":"2017","journal-title":"Genome Med"},{"key":"2020070713241086300_CIT0016","doi-asserted-by":"crossref","first-page":"760","DOI":"10.1097\/INF.0000000000000327","article-title":"Persistence of bactericidal antibodies to 5 years of age after immunization with serogroup B meningococcal vaccines at 6, 8, 12 and 40 months of age","volume":"33","author":"McQuaid","year":"2014","journal-title":"Pediatr Infect Dis J"},{"key":"2020070713241086300_CIT0017","doi-asserted-by":"crossref","first-page":"E215","DOI":"10.1503\/cmaj.141200","article-title":"Persistence of specific bactericidal antibodies at 5 years of age after vaccination against serogroup B meningococcus in infancy and at 40 months","volume":"187","author":"McQuaid","year":"2015","journal-title":"CMAJ"},{"key":"2020070713241086300_CIT0018","doi-asserted-by":"crossref","first-page":"395","DOI":"10.1016\/j.vaccine.2016.11.009","article-title":"Persistence of bactericidal antibodies following booster vaccination with 4CMenB at 12, 18 or 24 months and immunogenicity of a fifth dose administered at 4 years of age\u2014a phase 3 extension to a randomised controlled trial","volume":"35","author":"Iro","year":"2017","journal-title":"Vaccine"},{"key":"2020070713241086300_CIT0019","doi-asserted-by":"crossref","first-page":"2673","DOI":"10.4049\/jimmunol.1200451","article-title":"B cell memory to a serogroup C meningococcal conjugate vaccine in childhood and response to booster: little association with serum IgG antibody","volume":"189","author":"Perrett","year":"2012","journal-title":"J Immunol"}],"container-title":["Open Forum Infectious Diseases"],"original-title":[],"language":"en","link":[{"URL":"http:\/\/academic.oup.com\/ofid\/advance-article-pdf\/doi\/10.1093\/ofid\/ofaa143\/33145409\/ofaa143.pdf","content-type":"application\/pdf","content-version":"am","intended-application":"syndication"},{"URL":"http:\/\/academic.oup.com\/ofid\/article-pdf\/7\/5\/ofaa143\/33471997\/ofaa143.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"syndication"},{"URL":"http:\/\/academic.oup.com\/ofid\/article-pdf\/7\/5\/ofaa143\/33471997\/ofaa143.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2020,7,7]],"date-time":"2020-07-07T17:26:02Z","timestamp":1594142762000},"score":1,"resource":{"primary":{"URL":"https:\/\/academic.oup.com\/ofid\/article\/doi\/10.1093\/ofid\/ofaa143\/5826915"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2020,4,29]]},"references-count":19,"journal-issue":{"issue":"5","published-print":{"date-parts":[[2020,5,1]]}},"URL":"https:\/\/doi.org\/10.1093\/ofid\/ofaa143","relation":{},"ISSN":["2328-8957"],"issn-type":[{"value":"2328-8957","type":"electronic"}],"subject":[],"published-other":{"date-parts":[[2020,5]]},"published":{"date-parts":[[2020,4,29]]},"article-number":"ofaa143"}}