Establishment of a new quality control and vaccine safety test for influenza vaccines and adjuvants using gene expression profiling.
Establishment of a new quality control and vaccine safety test for influenza vaccines and adjuvants using gene expression profiling.
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DOI：
10.1371/journal.pone.0124392
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发表时间：
2015
期刊：
影响因子：
3.7
通讯作者：
Hamaguchi I
中科院分区：
文献类型：
--
作者：
Momose H;Mizukami T;Kuramitsu M;Takizawa K;Masumi A;Araki K;Furuhata K;Yamaguchi K;Hamaguchi I
我们之前已经确定了17个被全病毒粒子流感疫苗上调的生物标记基因，并报道了这些生物标记基因的基因表达谱与常规动物安全测试（检查体重和白细胞计数）有很好的相关性。在这项研究中，我们已经表明，常规动物试验显示，在连续稀释的流感HA疫苗散装材料中，结果不同且无剂量依赖性。相比之下，剂量依赖性在生物标记基因的表达谱中被清楚地显示出来，表明基因表达分析比目前流感疫苗的动物安全性试验具有更高的敏感性。分支DNA并发表达分析的引入，可以简化多基因表达方法的复杂性，将检测周期从7天缩短到3天。此外，Zbp1、Mx2、Irf7、Lgals9、Ifi47、Tapbp、Timp1、Trafd1、Psmb9和Tap2等10个基因在病毒体佐剂疫苗治疗后出现上调，表明这些生物标志物可用于病毒体佐剂疫苗的安全性控制。总之，与传统方法相比，生物标志物基因表达谱分析是一种有用、快速、高灵敏度的动物安全性检测方法，可用于评价包括佐剂疫苗在内的各类流感疫苗的安全性。
We have previously identified 17 biomarker genes which were upregulated by whole virion influenza vaccines, and reported that gene expression profiles of these biomarker genes had a good correlation with conventional animal safety tests checking body weight and leukocyte counts. In this study, we have shown that conventional animal tests showed varied and no dose-dependent results in serially diluted bulk materials of influenza HA vaccines. In contrast, dose dependency was clearly shown in the expression profiles of biomarker genes, demonstrating higher sensitivity of gene expression analysis than the current animal safety tests of influenza vaccines. The introduction of branched DNA based-concurrent expression analysis could simplify the complexity of multiple gene expression approach, and could shorten the test period from 7 days to 3 days. Furthermore, upregulation of 10 genes, Zbp1, Mx2, Irf7, Lgals9, Ifi47, Tapbp, Timp1, Trafd1, Psmb9, and Tap2, was seen upon virosomal-adjuvanted vaccine treatment, indicating that these biomarkers could be useful for the safety control of virosomal-adjuvanted vaccines. In summary, profiling biomarker gene expression could be a useful, rapid, and highly sensitive method of animal safety testing compared with conventional methods, and could be used to evaluate the safety of various types of influenza vaccines, including adjuvanted vaccine.
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