High stability of yellow fever 17D-204 vaccine:: A 12-year restrospective analysis of large-scale production
High stability of yellow fever 17D-204 vaccine:: A 12-year restrospective analysis of large-scale production
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DOI：
10.1016/j.vaccine.2006.06.082
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发表时间：
2007-04-12
期刊：
影响因子：
5.5
通讯作者：
Lang, J.
中科院分区：
文献类型：
--
作者：
Barban, V.;Girerd, Y.;Lang, J.
我们回顾性地分析了1990年至2002年期间生产的12批黄热病疫苗Stamaril (TM)，这些疫苗是由1990年以来连续使用的同一批种子制备的。所有批次的疫苗显示相同的基因组序列。与先前发表的序列相比，仅观察到四个核苷酸取代，在氨基酸水平上没有发生率。对病毒斑块大小分布的精细分析被用作遗传稳定性的额外标记，并证明了病毒种群的显著同质性。通过qRT-PCR测量的总病毒载量也是均匀的，这表明疫苗生产过程具有可重复性。不同体积体脑内接种小鼠的平均存活时间相似，批间体外效价与小鼠LD50滴度之比保持不变。综上所述，这些数据证明了该毒株在12年的大规模生产水平上的遗传稳定性，并加强了基于yf17d的疫苗的安全性这一普遍认可的观点。(c) 2006 Elsevier Ltd.版权所有。
We have retrospectively analyzed 12 bulk lots of yellow fever vaccine Stamaril (TM), produced between 1990 and 2002 and prepared from the same seed lot that has been in continuous Use since 1990. All vaccine batches displayed identical genome sequence. Only four nucleotide substitutions were observed, compared to previously published sequence, with no incidence at amino-acid level. Fine analysis of viral plaque size distribution was used as an additional marker for genetic stability and demonstrated a remarkable homogeneity of the viral population. The total virus load, measured by qRT-PCR, was also homogeneous pointing out reproducibility of the vaccine production process. Mice inoculated intracerebrally with the different bulks exhibited a similar average survival time, and ratio between in vitro potency and mouse LD50 titers remained constant from batch-to-batch. Taken together, these data demonstrate the genetic stability of the strain at mass production level over a period of 12 years and reinforce the generally admitted idea of the safety of YF17D-based vaccines. (c) 2006 Elsevier Ltd. All rights reserved.