Current State of the Vaccine Prophylaxis of Particularly Dangerous Infections
https://doi.org/10.21055/0370-1069-2016-2-107-110
Abstract
Considered are the problems of handling of the vaccine strains Yersinia pestis EV NIIEG, Bacillus anthracis STI-1, Francisella tularensis 15 NIIEG, and Brucella abortus 19 BA, utilized for manufacturing of live vaccines against particularly dangerous infections, in connection with absence of normative legal document, specifying the algorithm for storage and handling of strains after production stage throughout the shelf-life (10 years). It is indicated that under current conditions the system of handling and record keeping on the transfer of strains of vaccines against particularly dangerous infections is compromised. It has led to disruption of interdepartmental cooperation in the transfer, testing, maintenance, and storage of the latest manufactured batches.
Keywords
вакцинные штаммы Yersinia pestis EV НИИЭГ,
Bacillus anthracis СТИ-1,
Francisella tularensis 15 НИИЭГ и Brucella abortus 19 BА,
нормативно-правовая база,
vaccine strains Yersinia pestis EV NIIEG,
Bacillus anthracis STI-1,
Francisella tularensis 15 NIIEG,
and Brucella abortus 19 BA,
legal and regulatory framework
About the Authors
L. V. Sayapina
Scientific Center on Expertise of Medical Application Products
Russian Federation
Russian Federation
V. P. Bondarev
Scientific Center on Expertise of Medical Application Products
Russian Federation
Russian Federation
Yu. V. Olefir
Scientific Center on Expertise of Medical Application Products
Russian Federation
Russian Federation
References
1. Byvalov A.A., Kutyrev V.V. [The experience of application of Yersinia pestis antigens for plague chemical vaccine development]. Probl. Osobo Opasn. Infek. 2010; 4:47–50.
2. Olsuf’ev N.G., Emel’yanova O.S., Uglovoy G.P., Saltykov R.A., Sirotyuk L.V., Sil’chenko V.S., Kaptsyn M.S., Levacheva Z.A., Kochurkova S.A., Bobylkova T.V., Baranchikov V.D., Vedeneeva E.V., Egorova L.S., Ivanov V.S., Baranova N.K., Denisova V.D., Shel’mover R.S., Khomutova N.V., Kutseryb G.G., Panysheva M.D., Pelekhova K.I., Krasitskaya Z.I., Nazarova M.G., Krasnikova E.I., Shtuchnaya A.A., Vladimirova A.I., Korzheva V.S. [Comparative tests of the vaccine tularemia strain 15 NIIEG in humans]. Zh. Mikrobiol. Epidemiol. Immunobiol. 1971; 5:55–7.
3. Onishchenko G.G., Kozhukhov V.V., Vasil’ev N.T., Bondarev V.P., Borisevich I.V., Darmov I.V., Gorin O.V., Vorob’ev A.A., Pyatkov V.A., Shevtsov A.N., Seroglazov V.V., Kryuchkov A.V., Lub M.Yu. [Anthrax: Topical Issues of Development and Introduction of Medical Protectors: Guidelines for Medical Officers]. M.: Meditsina; 2010.
4. [Essential requirements to vaccine strains of anthrax agent for immunization of humans]. MR 3.3.1.1112-02. M.: RF Ministry of Health; 2002. P. 47.
5. [Essential requirements to vaccine strains of tularemia microbe]. MR 3.3.1.2161-07. M.: RF Ministry of Health; 2007. P. 51.
6. [Essential requirements to vaccine strains of plague microbe]. MR 3.3.1.1113-02. M.: RF Ministry of Health; 2002. P. 65.
7. Sayapina L.V., Solov’ev E.A., Goryaev A.A., Bondarev V.P. [Studies of immunobiological properties in Francisella tularensis vaccine strain 15 NIIEG under extended storage conditions]. Probl. Osobo Opasn. Infek. 2015; 2:87–91.
8. Solov’ev E.A., Sayapina L.V., Osina N.A., Davydov D.S., Bondarev V.P. [Characteristics of phenotypic and genetic properties of Francisella tularensis 15 NIIEG vaccine strain with an extended storage period]. Probl. Osobo Opasn. Infek. 2015; 4:91–5.
9. Supotnitsky M.V., Borisevich I.V., Klimov V.I., Shevtsov A.N., Lub M.Yu., Tumanov A.S. [The role of the Russian and Soviet researches in the development of anthrax vaccines]. Biopreparaty. 2015; 2(54):46–52.
10. Mann B.J., Ark N.M. Rationally designed tularemia vaccines. Expert Rev Vaccines. 2009; 8(7):877–85. DOI: 10.1586/erv.09.51.
11. Hall J.D., Woolard M.D., Gunn B.M., Craven R.R., Taft-Benz S., Frelinger J.A., Kawula T.H. Infected-host-cell repertoire and cellular response in the lung following inhalation of Francisella tularensis Schu S4, LVS, or U112. Infect. Immun. 2008; 76:5843–52. DOI: 10.1128/IAI.01176-08.
12. Thomas R.M., Titball R.W., Oyston P.C., Griffin K., Waters E., Hitchen P.G., Michell S.L., Grice I.D., Wilson J.C., Prior J.L. The immunologically distinct O antigens from Francisella tularensis subspecies tularensis and Francisella novicida are both virulence determinants and protective antigens. Infect. Immun. 2007;75:371–8. DOI: 10.1128/IAI.01241-06.
Review
For citations:
Sayapina L.V., Bondarev V.P., Olefir Yu.V. Current State of the Vaccine Prophylaxis of Particularly Dangerous Infections. Problems of Particularly Dangerous Infections. 2016;(2):107-110. (In Russ.) https://doi.org/10.21055/0370-1069-2016-2-107-110
Views:
1023
Email this article 