The analysis of a long-term experience of studying inactivated cell-culture vaccines for preventing tick-borne encephalitis of domestic and foreign manufacture in terms of specific activity (immunogenicity)
The analysis of the use of the method for the evaluation of specific (immunogenic) activity of vaccines for preventing tick-borne encephalitis (TBE vaccines) against protective dilution (PD50) and the minimum immunizing dose (MID50) has been performed. The method was standardized and submitted to th...
| Main Authors: | , , , , , , , |
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| Format: | Article |
| Language: | Russian |
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Ministry of Health of the Russian Federation. Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products»
2018-02-01
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| Series: | Биопрепараты: Профилактика, диагностика, лечение |
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| Online Access: | https://www.biopreparations.ru/jour/article/view/26 |
| _version_ | 1797244560437411840 |
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| author | M. S. Vorobieva O. S. Afonina O. A. Barhaleva M. S. Shcherbinina K. A. Sarkisyan A. V. Rukavishnikov V. A. Shevtsov V. P. Bondarev |
| author_facet | M. S. Vorobieva O. S. Afonina O. A. Barhaleva M. S. Shcherbinina K. A. Sarkisyan A. V. Rukavishnikov V. A. Shevtsov V. P. Bondarev |
| author_sort | M. S. Vorobieva |
| collection | DOAJ |
| description | The analysis of the use of the method for the evaluation of specific (immunogenic) activity of vaccines for preventing tick-borne encephalitis (TBE vaccines) against protective dilution (PD50) and the minimum immunizing dose (MID50) has been performed. The method was standardized and submitted to the regulatory documents for TBE vaccines authorized in the Russian Federation. When analyzing the results of the study of specific (immunogenic) activity of TBE vaccines (107 TBE vaccine batches by different manufacturers have been studied) it was confirmed that the choice of real lethal dose (RLD50) indicator of TBE virus (test strain «Absettarov») in the range of 100-3000 LD50, the reasonability of using BALB /c cell-line mice, the effectiveness of the national method of determining immunogenicity in terms of MlD50 for TBE vaccines authorized in the Russian Federation. The reasonability of using immunogenicity reference standard for TBE-OSO 42-28-48 to assess the reproducibility of the experiments, and the homogeneity of laboratory animals in terms of quality. Methods for determining TBE vaccine immunogenicity («specific activity (immunogenicity)» in terms of PD50 and MID50 is applicable both for Russian commercial TBE vaccines and for FSME-Immun vaccine, manufactured by «Baxter Vaccine AG», Austria. |
| first_indexed | 2024-03-08T21:44:00Z |
| format | Article |
| id | doaj.art-4f60a4009a374763851059ba42d2ea6c |
| institution | Directory Open Access Journal |
| issn | 2221-996X 2619-1156 |
| language | Russian |
| last_indexed | 2024-04-24T19:12:57Z |
| publishDate | 2018-02-01 |
| publisher | Ministry of Health of the Russian Federation. Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» |
| record_format | Article |
| series | Биопрепараты: Профилактика, диагностика, лечение |
| spelling | doaj.art-4f60a4009a374763851059ba42d2ea6c2024-03-26T09:10:51ZrusMinistry of Health of the Russian Federation. Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products»Биопрепараты: Профилактика, диагностика, лечение2221-996X2619-11562018-02-010441026The analysis of a long-term experience of studying inactivated cell-culture vaccines for preventing tick-borne encephalitis of domestic and foreign manufacture in terms of specific activity (immunogenicity)M. S. Vorobieva0O. S. Afonina1O. A. Barhaleva2M. S. Shcherbinina3K. A. Sarkisyan4A. V. Rukavishnikov5V. A. Shevtsov6V. P. Bondarev7Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» of the Ministry of Health of the Russian FederationFederal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» of the Ministry of Health of the Russian FederationFederal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» of the Ministry of Health of the Russian FederationFederal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» of the Ministry of Health of the Russian FederationFederal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» of the Ministry of Health of the Russian FederationFederal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» of the Ministry of Health of the Russian FederationFederal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» of the Ministry of Health of the Russian FederationFederal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» of the Ministry of Health of the Russian FederationThe analysis of the use of the method for the evaluation of specific (immunogenic) activity of vaccines for preventing tick-borne encephalitis (TBE vaccines) against protective dilution (PD50) and the minimum immunizing dose (MID50) has been performed. The method was standardized and submitted to the regulatory documents for TBE vaccines authorized in the Russian Federation. When analyzing the results of the study of specific (immunogenic) activity of TBE vaccines (107 TBE vaccine batches by different manufacturers have been studied) it was confirmed that the choice of real lethal dose (RLD50) indicator of TBE virus (test strain «Absettarov») in the range of 100-3000 LD50, the reasonability of using BALB /c cell-line mice, the effectiveness of the national method of determining immunogenicity in terms of MlD50 for TBE vaccines authorized in the Russian Federation. The reasonability of using immunogenicity reference standard for TBE-OSO 42-28-48 to assess the reproducibility of the experiments, and the homogeneity of laboratory animals in terms of quality. Methods for determining TBE vaccine immunogenicity («specific activity (immunogenicity)» in terms of PD50 and MID50 is applicable both for Russian commercial TBE vaccines and for FSME-Immun vaccine, manufactured by «Baxter Vaccine AG», Austria.https://www.biopreparations.ru/jour/article/view/26клещевой энцефалитвакцинопрофилактикакачество вакцин клещевого энцефалитаиммуногенностьспецифическая активностьлабораторный контрольсертификациястандартизациялинейные мышиtick-borne encephalitisvaccinationtick-borne encephalitis vaccine qualityimmunogenicityspecific activitylaboratory testingcertificationstandardizationlinear mice |
| spellingShingle | M. S. Vorobieva O. S. Afonina O. A. Barhaleva M. S. Shcherbinina K. A. Sarkisyan A. V. Rukavishnikov V. A. Shevtsov V. P. Bondarev The analysis of a long-term experience of studying inactivated cell-culture vaccines for preventing tick-borne encephalitis of domestic and foreign manufacture in terms of specific activity (immunogenicity) Биопрепараты: Профилактика, диагностика, лечение клещевой энцефалит вакцинопрофилактика качество вакцин клещевого энцефалита иммуногенность специфическая активность лабораторный контроль сертификация стандартизация линейные мыши tick-borne encephalitis vaccination tick-borne encephalitis vaccine quality immunogenicity specific activity laboratory testing certification standardization linear mice |
| title | The analysis of a long-term experience of studying inactivated cell-culture vaccines for preventing tick-borne encephalitis of domestic and foreign manufacture in terms of specific activity (immunogenicity) |
| title_full | The analysis of a long-term experience of studying inactivated cell-culture vaccines for preventing tick-borne encephalitis of domestic and foreign manufacture in terms of specific activity (immunogenicity) |
| title_fullStr | The analysis of a long-term experience of studying inactivated cell-culture vaccines for preventing tick-borne encephalitis of domestic and foreign manufacture in terms of specific activity (immunogenicity) |
| title_full_unstemmed | The analysis of a long-term experience of studying inactivated cell-culture vaccines for preventing tick-borne encephalitis of domestic and foreign manufacture in terms of specific activity (immunogenicity) |
| title_short | The analysis of a long-term experience of studying inactivated cell-culture vaccines for preventing tick-borne encephalitis of domestic and foreign manufacture in terms of specific activity (immunogenicity) |
| title_sort | analysis of a long term experience of studying inactivated cell culture vaccines for preventing tick borne encephalitis of domestic and foreign manufacture in terms of specific activity immunogenicity |
| topic | клещевой энцефалит вакцинопрофилактика качество вакцин клещевого энцефалита иммуногенность специфическая активность лабораторный контроль сертификация стандартизация линейные мыши tick-borne encephalitis vaccination tick-borne encephalitis vaccine quality immunogenicity specific activity laboratory testing certification standardization linear mice |
| url | https://www.biopreparations.ru/jour/article/view/26 |
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