首页> 外文OA文献 >Comparison and Correlation of Neisseria meningitidis Serogroup B Immunologic Assay Results and Human Antibody Responses following Three Doses of the Norwegian Meningococcal Outer Membrane Vesicle Vaccine MenBvac
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Comparison and Correlation of Neisseria meningitidis Serogroup B Immunologic Assay Results and Human Antibody Responses following Three Doses of the Norwegian Meningococcal Outer Membrane Vesicle Vaccine MenBvac

机译:三种脑膜炎球菌外膜囊泡疫苗MenBvac后脑膜炎奈瑟菌B血清群免疫测定结果与人抗体反应的比较及相关性

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摘要

The prediction of efficacy of Neisseria meningitidis serogroup B (MenB) vaccines is currently hindered due to the lack of an appropriate correlate of protection. For outer membrane vesicle (OMV) vaccines, immunogenicity has primarily been determined by the serum bactericidal antibody (SBA) assay and OMV enzyme-linked immunosorbent assay (ELISA). However, the opsonophagocytic assay (OPA), surface labeling assay, whole blood assay (WBA), and salivary antibody ELISA have been developed although correlation with protection is presently undetermined. Therefore, the aim of the study was to investigate further the usefulness of, and relationships between, MenB immunologic assays. A phase II trial of the OMV vaccine, MenBvac, with proven efficacy was initiated to compare immunologic assays incorporating the vaccine and six heterologous strains. Correlations were achieved between the SBA assay, OMV ELISA, and OPA using human polymorphonuclear leukocytes and human complement but not between an OPA using HL60 phagocytic cells and baby rabbit complement. Correlations between the surface labeling assay, the SBA assay, and the OMV ELISA were promising, although target strain dependent. Correlations between the salivary antibody ELISA and other assays were poor. Correlations to the WBA were prevented since many samples had results greater than the range of the assay. The study confirmed the immunogenicity and benefit of a third dose of MenBvac against the homologous vaccine strain using a variety of immunologic assays. These results emphasize the need for standardized methodologies that would allow a more robust comparison of assays between laboratories and promote their further evaluation as correlates of protection against MenB disease.
机译:由于缺乏适当的保护相关因素,目前对脑膜炎奈瑟氏球菌血清B型(MenB)疫苗功效的预测受到阻碍。对于外膜囊泡(OMV)疫苗,主要通过血清杀菌抗体(SBA)测定和OMV酶联免疫吸附测定(ELISA)确定免疫原性。然而,尽管目前尚不确定与保护的相关性,但已经开发了调理吞噬测定法(OPA),表面标记测定,全血测定(WBA)和唾液抗体ELISA。因此,该研究的目的是进一步研究MenB免疫测定的有用性以及它们之间的关系。已开始进行具有证实效力的OMV疫苗MenBvac的II期试验,以比较掺入该疫苗和6种异源菌株的免疫学检测方法。使用人多形核白细胞和人补体在SBA分析,OMV ELISA和OPA之间实现了相关性,但是在使用HL60吞噬细胞的OPA和幼兔补体之间未实现相关性。表面标记测定,SBA测定和OMV ELISA之间的相关性是有希望的,尽管依赖于靶菌株。唾液抗体ELISA与其他测定之间的相关性较差。由于许多样品的结果大于测定范围,因此避免了与WBA的相关性。该研究使用多种免疫学测定方法证实了第三剂MenBvac对同源疫苗株的免疫原性和益处。这些结果强调了对标准化方法学的需求,该方法应允许对实验室之间的测定法进行更稳健的比较,并促进其进一步的评估,作为针对MenB疾病的防护措施的相关性。

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