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首页> 外文OA文献 >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
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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

机译：挪威MenBvac外膜囊泡疫苗接种前后，通过使用人补体对抗B型脑膜炎球菌血清B组，实验室间杀菌活性的实验室间标准化。

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There is currently no standardized serum bactericidal antibody (SBA) assay for evaluating immune responses to meningococcal outer membrane vesicle or protein vaccines. Four laboratories, Manchester Health Protection Agency (MC HPA), New Zealand Institute of Environmental Science and Research Limited (NZ ESR), Norwegian Institute of Public Health (NIPH), and Chiron Vaccines (Chiron), measured SBA titers in the same panel of human sera (n = 76) from laboratory staff (n = 21) vaccinated with MenBvac. Blood samples were collected prevaccination, prior to each of the three doses of MenBvac given at 6-week intervals, and 6 weeks following the third dose. Initial results showed a number of discrepancies in results between the four participating laboratories. The greatest effect on titers appeared to be due to differences among laboratories in the maintenance of the meningococcal serogroup B test strain, 44/76-SL. A repeat study was conducted using the same frozen isolate (meningococcal serogroup B test strain 44/76-SL), freshly distributed to all four laboratories. Using SBA titers from the tilt method for all samples, and using MC HPA as the comparator, the results were as follows for NZ ESR, NIPH, and Chiron, respectively, using log10 titers: correlation coefficients (r) were 0.966, 0.967, and 0.936; intercepts were 0.08, 0.15, and 0.17; and slopes were 0.930, 0.851, and 0.891. In both prevaccination and postvaccination samples from 15 subjects assayed by all four laboratories, similar increases in SBA (fourfold or greater) were observed (for 11, 11, 9, and 9 subjects for MC HPA, NZ ESR, NIPH, and Chiron, respectively), and similar percentages of subjects with SBA titers of ≥4 prevaccination and 6 weeks following each dose were found. The SBA assay has been harmonized between the four different laboratories with good agreement on seroconversion rates, n-fold changes in titers, and percentages of subjects with SBA titers of ≥4.
机译：当前，尚无用于评估对脑膜炎球菌外膜囊泡或蛋白疫苗的免疫反应的标准化血清杀菌抗体（SBA）分析。曼彻斯特健康保护局（MC HPA），新西兰环境科学研究所（NZ ESR），挪威公共卫生研究所（NIPH）和凯龙疫苗（Chiron）这四个实验室在同一小组中对SBA效价进行了测量接种MenBvac的实验室工作人员（n = 21）的人血清（n = 76）。在三剂MenBvac之前，以6周的间隔以及在第三剂的6周后，在接种疫苗前采集血样。初步结果显示，四个参与实验室之间的结果存在许多差异。对滴度的最大影响似乎是由于实验室之间在维持B型脑膜炎球菌血清测试菌株44 / 76-SL中的差异所致。使用相同的冷冻分离株（B型脑膜炎球菌血清测试菌株44 / 76-SL）进行了重复研究，该分离株新鲜分布到所有四个实验室。使用所有样品的倾斜法SBA滴度，并使用MC HPA作为比较器，使用log10滴度分别得出NZ ESR，NIPH和Chiron的结果：相关系数（r）为0.966、0.967和0.936；截距分别为0.08、0.15和0.17；斜率分别为0.930、0.851和0.891。在由所有四个实验室测定的15位受试者的疫苗接种前和疫苗接种后样品中，均观察到SBA的相似增加（四倍或更多）（分别针对MC HPA，NZ ESR，NIPH和Chiron的11、11、9和9位受试者） ），并且在每次给药后6周前接种SBA滴度≥4的受试者的百分比相似。 SBA测定法已在四个不同实验室之间进行了协调，在血清转化率，滴度n倍变化以及SBA滴度≥4的受试者百分比方面具有良好的一致性。

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