Quantification of two variant strains contained in freeze-dried Japanese BCG vaccine preparation by real-time PCR
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 percenta...
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| Veröffentlicht in: | Biologicals 2007-04, Vol.35 (2), p.139-143 |
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| creator | Shibayama, Keigo Mochida, Keiko Yagi, Tetsuya Mori, Shigetaro Arakawa, Yoshichika Yamamoto, Saburo |
| description | 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. |
| doi_str_mv | 10.1016/j.biologicals.2006.07.005 |
| format | Article |
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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. 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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.</description><subject>Bacillus Calmette–Guerin</subject><subject>Base Sequence</subject><subject>BCG Vaccine - genetics</subject><subject>Freeze Drying</subject><subject>Genetic Variation</subject><subject>Japan</subject><subject>Molecular Sequence Data</subject><subject>Mycobacterium bovis - genetics</subject><subject>Nucleic Acid Probes - chemistry</subject><subject>Polymerase Chain Reaction</subject><subject>Quality Control</subject><subject>Quantification</subject><subject>Real-time PCR</subject><subject>Sequence Homology, Nucleic Acid</subject><subject>Variant strain</subject><issn>1045-1056</issn><issn>1095-8320</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2007</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqNkcuO1DAQRS0EYoaBX0Bmwy6hnPi5hAgG0Eg8BGvLccrIrXScsdODhq_HrW4JdrByuXTurVJdQl4waBkw-WrXjjHN6Uf0bi5tByBbUC2AeEAuGRjR6L6Dh8eai4aBkBfkSSk7AMa44o_JBVOguABzSW6_HNyyxVCttpgWmgLdfiZ653KsfVq27OJSqE_LVgucaFxoyIi_sJlyrP-PbnULFqRvhusq875SdM24unxyHO9pRjc3W9wj_Tx8fUoehbo2Pju_V-T7u7ffhvfNzafrD8Prm8Zz1W2N63Xgk9Zceuk4V8rz0U1KdF2YtJc9BI5aiykooQ0yPQZvRuUNGCnGgLK_Ii9PvmtOtwcsm93H4nGe67rpUKyCvh4B1D9BZnTfc2kqaE6gz6mUjMGuOe5dvrcM7DEYu7N_BWOPwVhQtgZTtc_PQw7jHqc_ynMSFRhOANab3EXMtviIi8cpZvSbnVL8jzG_AcsFpl4</recordid><startdate>20070401</startdate><enddate>20070401</enddate><creator>Shibayama, Keigo</creator><creator>Mochida, Keiko</creator><creator>Yagi, Tetsuya</creator><creator>Mori, Shigetaro</creator><creator>Arakawa, Yoshichika</creator><creator>Yamamoto, Saburo</creator><general>Elsevier Ltd</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7QL</scope><scope>7T7</scope><scope>7U9</scope><scope>8FD</scope><scope>C1K</scope><scope>FR3</scope><scope>H94</scope><scope>P64</scope><scope>7X8</scope></search><sort><creationdate>20070401</creationdate><title>Quantification of two variant strains contained in freeze-dried Japanese BCG vaccine preparation by real-time PCR</title><author>Shibayama, Keigo ; Mochida, Keiko ; Yagi, Tetsuya ; Mori, Shigetaro ; Arakawa, Yoshichika ; Yamamoto, Saburo</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c472t-a38f4d8846c6a4477c4bad7522fd8c630f4e885df7589e18bfc9b7c90965bfe63</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2007</creationdate><topic>Bacillus Calmette–Guerin</topic><topic>Base Sequence</topic><topic>BCG Vaccine - genetics</topic><topic>Freeze Drying</topic><topic>Genetic Variation</topic><topic>Japan</topic><topic>Molecular Sequence Data</topic><topic>Mycobacterium bovis - genetics</topic><topic>Nucleic Acid Probes - chemistry</topic><topic>Polymerase Chain Reaction</topic><topic>Quality Control</topic><topic>Quantification</topic><topic>Real-time PCR</topic><topic>Sequence Homology, Nucleic Acid</topic><topic>Variant strain</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Shibayama, Keigo</creatorcontrib><creatorcontrib>Mochida, Keiko</creatorcontrib><creatorcontrib>Yagi, Tetsuya</creatorcontrib><creatorcontrib>Mori, Shigetaro</creatorcontrib><creatorcontrib>Arakawa, Yoshichika</creatorcontrib><creatorcontrib>Yamamoto, Saburo</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Bacteriology Abstracts (Microbiology B)</collection><collection>Industrial and Applied Microbiology Abstracts (Microbiology A)</collection><collection>Virology and AIDS Abstracts</collection><collection>Technology Research Database</collection><collection>Environmental Sciences and Pollution Management</collection><collection>Engineering Research Database</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>Biotechnology and BioEngineering Abstracts</collection><collection>MEDLINE - Academic</collection><jtitle>Biologicals</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Shibayama, Keigo</au><au>Mochida, Keiko</au><au>Yagi, Tetsuya</au><au>Mori, Shigetaro</au><au>Arakawa, Yoshichika</au><au>Yamamoto, Saburo</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Quantification of two variant strains contained in freeze-dried Japanese BCG vaccine preparation by real-time PCR</atitle><jtitle>Biologicals</jtitle><addtitle>Biologicals</addtitle><date>2007-04-01</date><risdate>2007</risdate><volume>35</volume><issue>2</issue><spage>139</spage><epage>143</epage><pages>139-143</pages><issn>1045-1056</issn><eissn>1095-8320</eissn><abstract>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. 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| ispartof | Biologicals, 2007-04, Vol.35 (2), p.139-143 |
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| source | MEDLINE; Elsevier ScienceDirect Journals |
| subjects | Bacillus Calmette–Guerin Base Sequence BCG Vaccine - genetics Freeze Drying Genetic Variation Japan Molecular Sequence Data Mycobacterium bovis - genetics Nucleic Acid Probes - chemistry Polymerase Chain Reaction Quality Control Quantification Real-time PCR Sequence Homology, Nucleic Acid Variant strain |
| title | Quantification of two variant strains contained in freeze-dried Japanese BCG vaccine preparation by real-time PCR |
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