Experimental study of the protective effect of tuberculosis vaccines

The article presents the results of a retrospective analysis of experimental data on the protective properties of the three seed lots of tuberculosis vaccines which have been used in the production of BCG and BCG-M vaccines since 1984. It was shown that these seed lots have comparable characteristic...

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Main Authors: D. T. Levy, N. V. Aleksandrova, E. V. Lebedinskaya, A. V. Nakonechnaya
Format: Article
Language:Russian
Published: Ministry of Health of the Russian Federation. Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» 2018-02-01
Series:Биопрепараты: Профилактика, диагностика, лечение
Subjects:
Online Access:https://www.biopreparations.ru/jour/article/view/113
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author D. T. Levy
N. V. Aleksandrova
E. V. Lebedinskaya
A. V. Nakonechnaya
author_facet D. T. Levy
N. V. Aleksandrova
E. V. Lebedinskaya
A. V. Nakonechnaya
author_sort D. T. Levy
collection DOAJ
description The article presents the results of a retrospective analysis of experimental data on the protective properties of the three seed lots of tuberculosis vaccines which have been used in the production of BCG and BCG-M vaccines since 1984. It was shown that these seed lots have comparable characteristics of viability, which accounts for their equivalent immunogenicity. An additional study of the protective properties of the preparations was carried out in guinea pigs vaccinated with production batches of tuberculosis vaccines containing a different amount of viable BCG cells in the vaccine dose. Exposure of animals to a virulent strain of M. tuberculosis 2.5 months after the vaccination demonstrated high immunogenicity of the tuberculosis vaccines. It was established that a fivefold reduction in the dose of a vaccine with a high content of viable BCG cells only slightly reduces the degree of protection of the animals from disseminated tuberculosis. Thus, the data obtained confirmed that the 30 % reduction of the upper limit of the viability (viable BCG) of the BCG and BCG-M tuberculosis vaccines aimed at reducing their reactogenicity does not affect the protective properties of the preparation. It is important to note that previous post-marketing surveillance of such improved vaccines has shown a significant reduction in the number of post-vaccination complications in children.
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publisher Ministry of Health of the Russian Federation. Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products»
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spelling doaj.art-9d3f2c682d20417ba73c66dc192efd022025-03-02T10:49:19ZrusMinistry of Health of the Russian Federation. Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products»Биопрепараты: Профилактика, диагностика, лечение2221-996X2619-11562018-02-01174253257113Experimental study of the protective effect of tuberculosis vaccinesD. T. Levy0N. V. Aleksandrova1E. V. Lebedinskaya2A. V. Nakonechnaya3Scientific Centre for Expert Evaluation of Medicinal ProductsScientific Centre for Expert Evaluation of Medicinal ProductsScientific Centre for Expert Evaluation of Medicinal ProductsScientific Centre for Expert Evaluation of Medicinal ProductsThe article presents the results of a retrospective analysis of experimental data on the protective properties of the three seed lots of tuberculosis vaccines which have been used in the production of BCG and BCG-M vaccines since 1984. It was shown that these seed lots have comparable characteristics of viability, which accounts for their equivalent immunogenicity. An additional study of the protective properties of the preparations was carried out in guinea pigs vaccinated with production batches of tuberculosis vaccines containing a different amount of viable BCG cells in the vaccine dose. Exposure of animals to a virulent strain of M. tuberculosis 2.5 months after the vaccination demonstrated high immunogenicity of the tuberculosis vaccines. It was established that a fivefold reduction in the dose of a vaccine with a high content of viable BCG cells only slightly reduces the degree of protection of the animals from disseminated tuberculosis. Thus, the data obtained confirmed that the 30 % reduction of the upper limit of the viability (viable BCG) of the BCG and BCG-M tuberculosis vaccines aimed at reducing their reactogenicity does not affect the protective properties of the preparation. It is important to note that previous post-marketing surveillance of such improved vaccines has shown a significant reduction in the number of post-vaccination complications in children.https://www.biopreparations.ru/jour/article/view/113вакцина бцжосложненияпоказатель жизнеспособностииммуногенностьтуберкулезbcg vaccinecomplicationsviabilityimmunogenicitytuberculosis
spellingShingle D. T. Levy
N. V. Aleksandrova
E. V. Lebedinskaya
A. V. Nakonechnaya
Experimental study of the protective effect of tuberculosis vaccines
Биопрепараты: Профилактика, диагностика, лечение
вакцина бцж
осложнения
показатель жизнеспособности
иммуногенность
туберкулез
bcg vaccine
complications
viability
immunogenicity
tuberculosis
title Experimental study of the protective effect of tuberculosis vaccines
title_full Experimental study of the protective effect of tuberculosis vaccines
title_fullStr Experimental study of the protective effect of tuberculosis vaccines
title_full_unstemmed Experimental study of the protective effect of tuberculosis vaccines
title_short Experimental study of the protective effect of tuberculosis vaccines
title_sort experimental study of the protective effect of tuberculosis vaccines
topic вакцина бцж
осложнения
показатель жизнеспособности
иммуногенность
туберкулез
bcg vaccine
complications
viability
immunogenicity
tuberculosis
url https://www.biopreparations.ru/jour/article/view/113
work_keys_str_mv AT dtlevy experimentalstudyoftheprotectiveeffectoftuberculosisvaccines
AT nvaleksandrova experimentalstudyoftheprotectiveeffectoftuberculosisvaccines
AT evlebedinskaya experimentalstudyoftheprotectiveeffectoftuberculosisvaccines
AT avnakonechnaya experimentalstudyoftheprotectiveeffectoftuberculosisvaccines