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产气荚膜梭菌C型类毒素的研制、制备及安全性检测。II. 效价的实验室评估

Development, preparation and safety testing of a Clostridium welchii type C toxoid. II. Laboratory evaluation of potency.

作者信息

Knight P A, Lucken R N, Foster W, Walker P D

出版信息

J Biol Stand. 1979;7(4):373-81. doi: 10.1016/s0092-1157(79)80012-8.

DOI:10.1016/s0092-1157(79)80012-8
PMID:231607
Abstract

The results obtained with four laboratory tests on four candidate formulations of Clostridium welchii type C vaccine for use in man have been compared with clinical responses to the same vaccines. Quantal response assays in mice appeared to reflect the ranking of the four vaccines in human subjects better than did the guinea pig tests. They also enabled the potency of the vaccine preparations to be related to an existing International Reference Preparation. Mouse assays in which the animals received two spaced doses of vaccine prior to challenge yielded marginally more satisfactory results in terms of precision and reflection of human responses than did assays involving a single dose of vaccine.

摘要

对用于人类的4种C型魏氏梭菌疫苗候选配方进行了4项实验室检测,并将所得结果与相同疫苗的临床反应进行了比较。在小鼠身上进行的定量反应试验似乎比豚鼠试验能更好地反映这4种疫苗在人类受试者中的排名。这些试验还能将疫苗制剂的效力与现有的国际参考制剂相关联。与单剂量疫苗试验相比,在攻毒前给动物接种两剂间隔一定时间的疫苗的小鼠试验,在精度和反映人类反应方面产生的结果略好。

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