Quantification of two variant strains contained in freeze-dried Japanese BCG vaccine preparation by real-time PCR

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• 作者：Keigo Shibayama ; Keiko Mochida ; Tetsuya Yagi ; Shigetaro Mori ; Yoshichika Arakawa ; Saburo Yamamoto
• 关键词：Bacillus Calmette– ; Guerin ; Variant strain ; Quantification ; Real-time PCR
• 刊名：Biologicals
• 出版年：2007
• 出版时间：April 2007
• 年：2007
• 卷：35
• 期：2
• 页码：139-143
• 全文大小：178 K

文摘

Japanese bacillus Calmette–Guerin (BCG) vaccine preparation contains two types of variant strains, Type I, which has a 22-base-pair deletion in the RD16 region, and Type II, which has an identical sequence to those of other BCG strains. In this study, we established a method to quantify the percentage of variant strain Type II contained in freeze-dried BCG product with real-time PCR. With this method we examined the master seed lot Tokyo 172, two secondary seed lots, Tokyo 172-1 and Tokyo 172-2, which were produced from Tokyo 172, and four commercial lots produced form Tokyo 172-1. Tokyo 172, Tokyo 172-1, and Tokyo 172-2 contained 55.1 % , 19.5 % , and 3.6 % of Type II variant strain, respectively. Commercial lots contained 1.5 % , 4.5 % , 7.4 % , and 4.3 % of Type II variant strain, respectively. These results indicated that the two variant strains contained in the master seed lot continued to coexist in subsequently produced lots with a decrease in population of variant strain Type II. This method would be useful for quality control of commercial Japanese BCG vaccine preparations.