Evaluation of immunogenicity of the 2008-2009 seasonal influenza vaccines by microneutralization test.

Evaluation of immunogenicity of the 2008-2009 seasonal influenza vaccines by microneutralization test.
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DOI:
10.3345/kjp.2012.55.12.474
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发表时间:
2012-12
影响因子:
--
通讯作者:
Kim DH
Kim DH
中科院分区:
其他
文献类型:
--
作者:
Kim SY;Kim YK;Eun BW;Kim NH;Kang EK;Lee BS;Lim JS;Lee JA;Kim DH

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为了评价流感疫苗的免疫原性,与血凝抑制(HI)试验相比,微量中和(MN)试验具有更高的灵敏度和特异性。然而,MN测试更耗时,并且难以标准化。我们进行了MN试验,以确定其作为HI试验的替代或补充试验用于评价流感疫苗免疫原性的有效性。我们比较了MN测试与HI测试使用50配对样本从以前的临床研究(2008-2009年)在韩国儿童18岁以下。H3 N2、H1N1和B型流感病毒2种检测方法的线性相关系数分别为0.69、0.70和0.66。我们确定了两项测试之间的高一致性指数。对于流感疫苗,通过MN试验确定的接种后血清保护率和血清转换率对于H3 N2、H1N1和流感B分别为78.0%和96.0%、90%和42.0%以及42.0%和48.0%。H3 N2、H1N1和B型流感病毒的几何平均滴度倍数增加分别为2.89、5.04和4.29,高出2.5倍。我们在2008-2009年季节性流感疫苗的免疫原性评价中获得了良好结果。我们发现MN试验与HI试验一样有效。因此,我们建议MN试验可作为HI试验的替代或补充试验,用于评价流感疫苗的免疫原性。
For evaluating the immunogenicity of an influenza vaccine, the microneutralization (MN) test has a higher sensitivity and specificity as compared to the hemagglutination inhibition (HI) test. However, the MN test is more time consuming and is difficult to standardize. We performed the MN test to determine its usefulness as an alternative or complementary test to the HI test for evaluating the immunogenicity of influenza vaccines. We compared the MN test with the HI test using 50 paired samples taken from a previous clinical study (2008-2009) in Korean children under 18 years of age. The linear correlation coefficients of the 2 tests for H3N2, H1N1, and influenza B were 0.69, 0.70, and 0.66, respectively. We identified a high index of coincidence between the 2 tests. For an influenza vaccine, the postvaccination seroprotection rates and seroconversion rates determined by the MN test were 78.0% and 96.0%, 90% and 42.0%, and 42.0% and 48.0% for H3N2, H1N1, and influenza B, respectively. Geometric mean titer fold increases of H3N2, H1N1, and influenza B were 2.89, 5.04, and 4.29, respectively, and were 2.5-fold higher. We obtained good results in the evaluation of the immunogenicity of the 2008-2009 seasonal influenza vaccines. We found that the MN test was as effective as the HI test. Therefore, we suggest that the MN test can be used as an alternative or complementary test to the HI test for evaluating the immunogenicity of influenza vaccines.