Japan BCG Laboratory, Japan.
Vaccine. 2012 Feb 14;30(8):1460-4. doi: 10.1016/j.vaccine.2011.12.101. Epub 2012 Jan 5.
Many genetic differences have been found among currently available BCG vaccines. To avoid continued accumulation of phenotypic or genotypic changes in the strains, WHO and most national regulatory authorities request that the vaccine should not be prepared by more than 12 passages from the master seed lot. However, it has recently been reported that genetic changes occur even during the passage for vaccine production. In this study, the genetic stability of Japanese BCG vaccine production using currently available PCR methods and protective efficacy using a guinea-pig model during the passages were examined. The results showed that there were no significant differences between the seed lot, the product manufactured by normal procedures, and the 20th passage product. These results indicate that the maximum number of passages as currently required by WHO for BCG vaccine production is adequate for the Japanese vaccine, and that new genetic tools may help to examine the quality control of the BCG vaccine.
目前可用的卡介苗疫苗之间存在许多遗传差异。为了避免菌株中表型或基因型的持续变化，世界卫生组织和大多数国家监管机构要求疫苗不应超过从主种子批传代 12 代来制备。然而，最近有报道称，即使在疫苗生产过程中也会发生遗传变化。在这项研究中，使用目前可用的 PCR 方法检查了日本卡介苗疫苗生产的遗传稳定性，以及在传代过程中使用豚鼠模型的保护效力。结果表明，种子批、按正常程序生产的产品和第 20 代产品之间没有显著差异。这些结果表明，目前世界卫生组织要求的卡介苗疫苗生产的最大传代数对于日本疫苗是足够的，并且新的遗传工具可能有助于检查卡介苗疫苗的质量控制。
