Problematic Aspects of the Evaluation of the Epidemiological Effectiveness of Vaccination against Tick-BORNE Encephalitis

This review analyzes the methodological reasons for the heterogeneity of the results of the evaluation of the epidemiological effectiveness of vaccine prophylaxis of tick-borne encephalitis (TBE) using indicators such as the efficiency coefficient (COEF) and the efficiency index (IEF), and their discrepancy with similar indicators of the immunological effectiveness of vaccines. It is shown that the calculation of COEF and IEF according to official statistical reporting is illegal in connection with the emergence of systematic errors of selection due to the impossibility of retrospective formation of compared groups of vaccinated and unvaccinated, comparable in risk of infection and disease. In addition, COEF and IEF do not allow to compare the efficiency of vaccination in different areas in physical and monetary units.

Based on the analysis of the literature data on immunogenicity of modern vaccines against TBE, protective titer of antibodies and results of field tests of vaccine efficacy in the conditions of total coverage of the population with vaccinations, the authors conclude that the third generation vaccines against TBE protect against disease 95–98% of persons attacked by ticks. Algorithm for calculating the number of preventable cases of TBE diseases is proposed for a comparative evaluation of the effectiveness of vaccination as an anti-epidemic measure in different areas.

1. Brico N. I., Lobzin Y. V., Baranov A. A., Namazova-Baranova L. S., Ilyina S. V., Koroleva I. S. et al. Vaccination effectiveness analysis: main approaches and controversial issues. Pediatricheskaya farmakologiya [Pediatric pharmacology]. 2014; 11 (4): 8–15 (in Russian).

2. Brico N. I., Pokrovsky V. I. Epidemiology: textbook. M.: GEOTAR-Media, 2015: 368 (in Russian).

3. Romanenko V. V., Kilyachina A. S., Esjunina M. S., Ankudinova A. V., Pimenova T. A. The effectiveness of the TBE mass immunization program. Biopreparaty [Biopreparation]. 2008; 2: 9–14 (in Russian).

4. Esjunina M. S. Modern trends in the incidence of tick-borne viral encephalitis in a variety tactics of immunization and improving epidemiological surveillance and control: Doctorat of med.sci.. Ekaterinburg; 2015: 153 (in Russian).

5. Luchinina S. V. Particularity of immunity to tick-borne encephalitis virus in the population in the natural focus in the Southern Urals: Avtoreferat Doctorat of med.sci. diss. Chelyabinsk; 2016: 24 (in Russian).

6. Efimova A. R. Epidemiological characteristics of tick-borne infections in the Kemerovo region and improvement of measures for their prevention: Avtoreferat Doctorat of med.sci.diss. Omsk; 2017: 21(in Russian).

7. Fletcher R., Fletcher S., Wagner E. Clinical epidemiology: the essentials: translation from English. M. : Media Sphere; 1998: 352 (in Russian).

8. Gorbunov M. A. Principles and system of organization of field tests of epidemiological efficiency of vaccines. Vakcinaciya [Vaccination]. 2000; 11: 6–7 (in Russian).

9. Volkova L. I. Tick-borne encephalitis in the Middle Urals: clinical and epidemiological analysis of acute and chronic forms, ways to optimize the provision of specialized medical care in the endemic focus : Avtoreferat PhD of med.sci.diss. Ekaterinburg; 2009: 45 (in Russian).

10. Romanenko V. V., Prokhorova O. G., Zlobin V. I. New strategy of specific prevention of tick-borne encephalitis: experience of mass vaccination of the population of Sverdlovsk region. Epidemiologiya i vakcinoprofilaktika [Epidemiology and vaccinal prevention]. 2005; 3: 24–27 (in Russian).

11. Penyevskaya N. A. Evaluation of the effectiveness of etiotropic prevention of infections transmitted by ticks: problems of theory and practice. Omsk: IC Omskij nauchny`j vestnik. [Omsk scientific Bulletin]; 2010: 232 (in Russian).

12. Prevention of tick-borne viral encephalitis: Sanitary and epidemiological rules and regulations SP 3.1.3.2352-08. Moscow. 2008. Available at: www.consultant.ru (in Russian).

13. Leonova G. N. Vaccinal prevention of tick-borne encephalitis in the past, present and future. Byulleten` SO RAMN [Bulletin SB RAMS]. 2011; 31 (4): 79–85 (in Russian).

14. Shcherbinina M. S., Skrynnik S. M., Levina L. S., Gerasimov S. G., Bochkova N. G., Lisenkov A. N., Ishmyhametov A. A., Pogodina V. V. The condition of post-vaccination immunity to the tick-borne encephalitis virus in the population highly endemic area with Siberian subtype domination. Epidemiologiya i vakcinoprofilaktika [Epidemiology and vaccinal prevention]. 2018; 99 (2): 27–36 (in Russian).

15. Verigina E. V. Optimization of information and analytical support of surveillance of infections transmitted by ticks in the territory of the Russian Federation. Avtoreferat Doctorat of med.sci.diss; 2016: 24 (in Russian).

16. Luchinina S. V., Semenov A. I., Stepanova O. N., Pogodina V. V., Gerasimov S. G., Shcherbinina M. S. et al. Vaccinal prevention of tick-borne encephalitis in Chelyabinsk region: dynamics of vaccination, population immunity, analysis of TBE cases in vaccinated persons. Epidemiologiya i vakcinoprofilaktika [Epidemiology and vaccinal prevention]. 2016; 86 (1): 67–76 (in Russian).

17. Vorobjeva M. S., Ladizhenskaja I. P., Barhaleva O. A., Stavickaja N. X., Soljanik R. G., Shkuratova O. V. Immune response during rapid immunization against tickborne encephalitis vaccines Encevir (Russia) and FSME-Immun (Austria). Epidemiologiya i vakcinoprofilaktika [Epidemiology and vaccinal prevention]. 2009; 48 (5): 61–65(in Russian).

18. Bilalova G. P. Issues of practical using of Encevir vaccine. Sibirskij medicinskij zhurnal (g.Tomsk) [Siberian medical journal (Tomsk)]. 2009; 2: 86–91 (in Russian).

19. Vorovitch M. F., Maikova G. B., Chernokhaeva L. L., Romanenko V. V., Ankudinova A. V., Khapchaev Y. H. et al. Immunogenicity and safety of adult TBE vaccine «Tick-eVAC». Voprosy virusologii [Virology issues]. 2017; 62 (2): 73–80 (in Russian).

20. Shoutova N. A. Shkouratova O. V., Rouzavina Ye. V., Vlasova N. M., Stavitskaya N. Kh., Vorobyova M. S. et al. Studying immunologic activity and reactogeneity of Encevir vaccine during immunization using express-scheme. Sibirskij medicinskij zhurnal (g.Tomsk) [Siberian medical journal (Tomsk)]. 2009; 24 (2–2): 30–33 (in Russian).

21. Ankudinova A. V. The tactic of routine immunization and preventive efficacy of children’s vaccines against tick-borne encephalitis: Doctorat of med.sci. Ekaterinburg; 2015: 137 (in Russian).

22. Terekhina L. L., Vorovitch M. F., Maikova G. B., Rogova Y. V., Kiktenko A.V., Romanenko V. V. et al. The ELISA and neutralization test use to assess the protection of the population against TBE. Medicinskaya virusologiya [Medical Virology]. 2013; XXVII (1): 81 (in Russian).

23. Loew-Baselli A, Poellabauer EM, Pavlova BG, Fritsch S, Firth C, Petermann R, et al. Prevention of Tick-Borne Encephalitis by FSME-IMMUN® Vaccines: Review of a Clinical Development Programme. Vaccine. 2011; 29(43): 7307–19

24. Paulke-Korinek M., Kundi M., Laaber B., Brodtraeger N., Seidl-Friedrich C., Wiedermann U., Kollaritsch H. Factors associated with seroimmunity against tick-borne encephalitis virus 10 years after booster vaccination. Vaccine. 2013; 31 (9): 1293–1297.

25. Schosser R., Reichert A, Mansmann U, Unger B, Heininger U, Kaiser R. Irregular tick-borne encephalitis vaccination schedules: The effect of a single catch-up vaccination with FSME-IMMUN. A prospective non-interventional study. Vaccine. 2014; 32 (20): 2375–2381.

26. Pogodina V. V., Skrynnik S. M., Sagajdak O. A., Gerasimov S. G., Shcherbinina M. S., Rumjanceva Z. N. The structure of post-vaccination immunity to tick-borne encephalitis virus in the population in the early and late period. Molekulyarnaya diagnostika [Molecular diagnostics]. Moscow. 2014; 1: 501 –502 (in Russian).

27. Topychkanova N. G., Kuvshinova I. N., Ofitserov V. I. About of revaccination time against tick-borne encephalitis. Novosti «Vektor-best» [News “Vector-Best”]. 2015; 76 (2): 3–6 (in Russian).

28. Shchuchinova L. D., Shchuchinov L. V., Zlobin V. I. The analysis of factors determining efficiency of vaccination against tick-borne encephalitis. Epidemiologiya i vakcinoprofilaktika [Epidemiology and vaccinal prevention]. 2016; 87 (2): 72–76 (in Russian).

29. Leonova G. N., Pavlenko E. V., Krylova N.V. Vaccinal prevention of tick-borne encephalitis. Vladivostok: JSC «Primorskiy poligrafkombinat»; 2006: 100 (in Russian).

30. Chernokhaeva L. L., Maikova G. B., Rogova Y. V., Romanenko V. V., Ankudinova A. V., Kilyachina A.S. et al. Comparison of results obtained by ELISA and neutralization test in assessing the protection of population from tick-borne encephalitis. Voprosy Virusologii [Virology issues]. 2018; 63 (1): 36–40 (in Russian).

31. Pogodina V. V., Shcherbinina M. S., Levina L. S., Gerasimov S. G., Kolyasnikova N. M. Modern problems of tick-borne encephalitis specific prevention. Communication II: peculiarity of immunity in area with Siberian subtype domination. Epidemiologiya i vakcinoprofilaktika [Epidemiology and vaccinal prevention]. 2015; 85 (6): 65–73 (in Russian).

32. Korenberg E. I. Current characteristics of natural nidality of tick-borne encephalitis: new or well forgotten? Medicinskaya parazitologiya i parazitarny`e bolezni [Medical Parasitology and parasitic diseases]. 2008; 3: 3 –8 (in Russian).

33. Korotkov Y. S., Shelanova G. N., Bogdanova N. G. Dynamics of tick-borne encephalitis incidence in Udmurtia during half a century (1957-2007). Trudy` Instituta poliomielita i virusny`x e`ncefalitov im. M.P. Chumakova [Proceedings of the Institute of PVE M. P. Chumakov]. 2008; 25: 80–90 (in Russian).

34. Naumov R. L., Gutova V. P., Fonareva K. S. Degree of coincidence of long-term extrapolation expert prognosis with real incidence of tick-borne encephalitis in the USSR. Medicinskaya parazitologiya i parazitarny`e bolezni [Medical Parasitology and parasitic diseases]. 1990; 5: 40–43 (in Russian).

35. Naumov R. L. Tick-borne encephalitis and Lyme disease: epidemiological parallels and monitoring. Medicinskaya parazitologiya i parazitarny`e bolezni [Medical Parasitology and parasitic diseases]. 1999; 2: 20–26 (in Russian).

36. Zlobin V. I., Rudakov N. V., Malov I. V. Tick-borne transmissive infections. Novosibirsk: Nauka [Science]; 2015: 224 (in Russian).

37. Medunitsyn N. Y., Mironov A. N. Vaccine. New approaches for the enhancement of vaccination efficiency and safety. Voprosy Virusologii [Virology issues]. 2012. Annex 1: 43–51(in Russian).

38. Penyevskaya N. A. Rudakov N. V. Efficiency of use of immunoglobulin preparations for the postexposure prevention of tick-borne encephalitis in Russia (a review of semi-centennial experience). Medicinskaya parazitologiya i parazitarny`e bolezni [Medical Parasitology and parasitic diseases]. 2010; 1: 53–59 (in Russian).

39. Korenberg E. I., Pomelova V. G., Osin N. S. Infections with natural focality transmitted by Ixodes ticks. In: Tick-borne encephalitis. Moscow; 2013: 61–173 (in Russian).

40. Leonova G. N., Lubova V. A., Kalinin A. V. The value of the effect of the level of specific antibodies on elimination different tick-borne encephalitis virus strains. Epidemiologiya i vakcinoprofilaktika [Epidemiology and vaccinal prevention]. 2017; 2 (93): 50–55 (in Russian)

41. Afonina O. S., Burkhalev O.A., Sarkisyan K.A., Vorobieva M.S., Movsesyants A. A., Olefir Yu.V., Pirozhkov A. P., Piscov M. N., Saharov M. N., Kutaev D. A. The study of protective properties of vaccines against virulent strains of the virus tick-borne encephalitis three genotypes: European, Far Eastern and Siberian (experimental research). Epidemiologiya i vakcinoprofilaktika [Epidemiology and vaccinal prevention]. 2017; 92 (1): 62–68 (in Russian).

42. Heifets L. B. Theoretical and methodical bases of an assessment of efficiency of specific prevention. M.: Medicine; 1968: 355 (in Russian).

43. Heinz F., Holtzmann H., Essl A., Kundt M. Analysis of the efficiency of tick-borne encephalitis vaccination in the population in the natural foci of Austria. Voprosy Virusologii [Virology issues]. 2008; 53 (2): 19–27 (in Russian).