Validation of alternative potency assays for influenza vaccines requires clinical studies.
Validation of alternative potency assays for influenza vaccines requires clinical studies.
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流感疫苗替代效力测定的验证需要临床研究。
DOI：
10.1016/j.vaccine.2015.07.060
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发表时间：
2015
期刊：
影响因子：
5.5
通讯作者：
Rowlen,Kathy
中科院分区：
文献类型：
--
作者：
Rowlen,Kathy
本期《疫苗》特刊的读者可能都渴望增强疫苗功效和提高疫苗生产效率。对于流感疫苗来说，实现这些目标面临的挑战有很多，从改进监测到简化生产平台和更可靠的性能验证。具体来说，对替代疫苗效力测定的需求正在增长。假设替代效价测定被认为是有希望的，那么一个问题将是：如何判断它是否准确？人们普遍认为，SRID 的任何潜在替代品都必须表现出与 SRID 良好的相关性，并产生 SRID 测定效价 ±20% 以内的值。在我看来，SRID 本身有足够的局限性，判断相对于该特定标准的替代方案并不能确保整个行业过渡到改进的方法。事实上，它可能会让我们忽视一种最终可能提供更好的疫苗功效（或免疫原性）预测指标的检测方法。只有一种方法可以验证测量的效力与测量的免疫原性相关并预测免疫原性——在临床研究中测试这种关系。
Readers of this Special Issue ofVaccineare likely unified by a desire to enhance vaccine efficacy and improve vaccine manufacturing efficiency. For influenza vaccines, challenges to achieving those goals are many, and range from improved surveillance to less cumbersome production platforms and more reliable performance verification. Specifically, demand is growing for an alternative vaccine potency assay. Assuming that a replacement potency assay is found to be promising, one question will be:how will it be judged to be accurate?It is generally agreed that any potential replacement for SRID will have to exhibit good correlation with SRID and yield a value within ±20% of the SRID determined potency. In my opinion, SRID itself has enough limitations that judging alternatives relative to that particular standard will not ensure that the industry as a whole transitions to an improved method. In fact, it could blind us to an assay that may ultimately provide a better predictive measure of vaccine efficacy (or immunogenicity). There is only one way to verify that measured potency is correlated with, and predictive of, measured immunogenicity – test the relationship in clinical studies.