Experimental study of the protective effect of tuberculosis vaccines
Abstract
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.
About the Authors
D. T. Levy
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation
Chief expert of the Division for Expert Evaluation of Antibacterial MIBPs of the Centre for Evaluation and Control of MIBPs. Doctor of Medical Sciences, professor
Russian Federation
Chief expert of the Division for Expert Evaluation of Antibacterial MIBPs of the Centre for Evaluation and Control of MIBPs. Doctor of Medical Sciences, professor
N. V. Aleksandrova
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation
Chief expert of the Laboratory of Bacterial Vaccines of the Testing Centre for Evaluation of MIBPs’ Quality. Candidate of Medical Sciences
Russian Federation
Chief expert of the Laboratory of Bacterial Vaccines of the Testing Centre for Evaluation of MIBPs’ Quality. Candidate of Medical Sciences
E. V. Lebedinskaya
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation
Leading researcher associate of the Department for Editorial and Publishing Activities and Intellectual Property Protection of the Centre for Planning and Coordination of Scientific Activities. Candidate of Biological Sciences
Russian Federation
Leading researcher associate of the Department for Editorial and Publishing Activities and Intellectual Property Protection of the Centre for Planning and Coordination of Scientific Activities. Candidate of Biological Sciences
A. V. Nakonechnaya
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation
2nd professional category expert of the Laboratory of Bacterial Vaccines of the Testing Centre for Evaluation of MIBPs’ Quality
Russian Federation
2nd professional category expert of the Laboratory of Bacterial Vaccines of the Testing Centre for Evaluation of MIBPs’ Quality
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Review
For citations:
Levy D.T., Aleksandrova N.V., Lebedinskaya E.V., Nakonechnaya A.V. Experimental study of the protective effect of tuberculosis vaccines. BIOpreparations. Prevention, Diagnosis, Treatment. 2017;17(4):253-257. (In Russ.)
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