{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,3]],"date-time":"2026-06-03T22:05:08Z","timestamp":1780524308034,"version":"3.54.1"},"reference-count":96,"publisher":"American Society for Microbiology","issue":"4","license":[{"start":{"date-parts":[[2025,4,29]],"date-time":"2025-04-29T00:00:00Z","timestamp":1745884800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"},{"start":{"date-parts":[[2025,4,29]],"date-time":"2025-04-29T00:00:00Z","timestamp":1745884800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.asm.org\/non-commercial-tdm-license"}],"content-domain":{"domain":["journals.asm.org"],"crossmark-restriction":true},"short-container-title":["mSphere"],"published-print":{"date-parts":[[2025,4,29]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n          <jats:sec>\n            <jats:title\/>\n            <jats:p>Meningococcal serogroup B (MenB) vaccine licensure was based on the assessment of vaccine-induced immune responses by human serum bactericidal antibody (hSBA) assay against a small number of antigen-specific strains complemented by strain coverage predictions. However, the evaluation of vaccine strain coverage is challenging because of genotypic and phenotypic diversity in surface-exposed MenB strain antigens. This narrative review considers the principal methods applied to assess the performance of a multicomponent MenB vaccine at different stages of its development. Traditional hSBA assay against a limited panel of strains is useful at all stages, while predicted strain coverage methods, such as the meningococcal antigen typing system, are used independent of clinical trials. A new method, the endogenous complement hSBA assay, has been developed to evaluate a vaccine\u2019s ability to induce a bactericidal immune response in clinical trials, in conditions that approximate real-world settings through the use of each vaccinee\u2019s serum as a source of complement and by testing against a panel of 110 epidemiologically representative MenB strains. Each assay, therefore, has a different scope during the vaccine\u2019s development and all complement each other, enabling comprehensive evaluation of the performance of multicomponent MenB vaccines, in advance of real-world evidence of vaccine effectiveness and vaccine impact.<\/jats:p>\n          <\/jats:sec>","DOI":"10.1128\/msphere.00898-24","type":"journal-article","created":{"date-parts":[[2025,4,8]],"date-time":"2025-04-08T13:00:41Z","timestamp":1744117241000},"update-policy":"https:\/\/doi.org\/10.1128\/asmj-crossmark-policy-page","source":"Crossref","is-referenced-by-count":4,"title":["Methods to evaluate the performance of a multicomponent meningococcal serogroup B vaccine"],"prefix":"10.1128","volume":"10","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-0691-6568","authenticated-orcid":false,"given":"Ray","family":"Borrow","sequence":"first","affiliation":[{"name":"Meningococcal Reference Unit, UK Health Security Agency, Manchester Royal Infirmary","place":["Manchester, United Kingdom"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0005-1027-2960","authenticated-orcid":true,"given":"Laura","family":"Tomasi Cont","sequence":"additional","affiliation":[{"name":"GSK","place":["Siena, Italy"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7661-4370","authenticated-orcid":true,"given":"Daniela","family":"Toneatto","sequence":"additional","affiliation":[{"name":"GSK","place":["Siena, Italy"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0005-4115-9442","authenticated-orcid":false,"given":"Stefania","family":"Bambini","sequence":"additional","affiliation":[{"name":"GSK","place":["Siena, Italy"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0006-9480-5521","authenticated-orcid":false,"given":"Shravani","family":"Bobde","sequence":"additional","affiliation":[{"name":"GSK","place":["Rockville, USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4034-4735","authenticated-orcid":false,"given":"Woo-Yun","family":"Sohn","sequence":"additional","affiliation":[{"name":"GSK","place":["Rockville, USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5104-5522","authenticated-orcid":false,"given":"Alessia","family":"Biolchi","sequence":"additional","affiliation":[{"name":"GSK","place":["Siena, Italy"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0004-2415-1521","authenticated-orcid":false,"given":"Vega","family":"Masignani","sequence":"additional","affiliation":[{"name":"GSK","place":["Siena, Italy"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5734-083X","authenticated-orcid":true,"given":"Peter T.","family":"Beernink","sequence":"additional","affiliation":[{"name":"University of California","place":["San Francisco, USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3457-426X","authenticated-orcid":false,"given":"Maria","family":"Lattanzi","sequence":"additional","affiliation":[{"name":"GSK","place":["Siena, Italy"]}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"235","reference":[{"key":"e_1_3_4_2_2","doi-asserted-by":"publisher","DOI":"10.1186\/s12889-022-13342-2"},{"key":"e_1_3_4_3_2","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(07)61016-2"},{"key":"e_1_3_4_4_2","doi-asserted-by":"publisher","DOI":"10.1007\/s40121-018-0213-2"},{"key":"e_1_3_4_5_2","unstructured":"US Food and Drug Administration. 2019. 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