Preview

Biological Products. Prevention, Diagnosis, Treatment

Advanced search

Analysis of Efficacy and Safety of Tick-Borne Encephalitis Vaccines

https://doi.org/10.30895/2221-996X-2018-18-1-33-41

Abstract

This article provides a review on efficacy and safety of tick-borne encephalitis vaccines licensed in the Russian Federation. It highlights  that both Russian and imported tick-borne encephalitis vaccines  demonstrate high immunogenicity, safety and epidemiological  effectiveness in regions with high vaccine coverage. All licensed tick- borne encephalitis vaccines meet interchangeability criteria in terms of  indications for use (with due regard to age limits), medical  contraindications, vaccination schedules, vaccine composition, as well as safety, immunological activity and efficacy parameters. Timely and  specific prophylaxis help reduce the incidence of tick-borne encephalitis  in endemic regions.

About the Authors

T. Yu. Kozlova
Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» of the Ministry of Health of the Russian Federation
Russian Federation

1st Professional Category Expert of the Division for Evaluation  of Antiviral Medicinal Immunobiological Products of the Centre  for Evaluation and Control of Medicinal Immunobiological Products

8/2 Petrovsky boulevard, Moscow 127051, Russian Federation



L. M. Khantimirova
Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» of the Ministry of Health of the Russian Federation
Russian Federation

Analyst of the Division for Evaluation of Antiviral Medicinal  Immunobiological Products of the Centre for Evaluation and  Control of Medicinal Immunobiological Products

8/2 Petrovsky boulevard, Moscow 127051, Russian Federation



A. V. Rukavishnikov
Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» of the Ministry of Health of the Russian Federation
Russian Federation

Deputy Head of the Division for Evaluation of Antiviral  Medicinal Immunobiological Products of the Centre for  Evaluation and Control of Medicinal Immunobiological Products. Candidate of Biological Sciences

8/2 Petrovsky boulevard, Moscow 127051, Russian Federation



V. A. Shevtsov
Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» of the Ministry of Health of the Russian Federation
Russian Federation

Head of the Division for Evaluation of Antiviral Medicinal  Immunobiological Products of the Centre for Evaluation and  Control of Medicinal Immunobiological Products. Candidate of Medicinal Sciences

8/2 Petrovsky boulevard, Moscow 127051, Russian Federation



References

1. Konjkova-Reidman АB, Zlobin VI. Clinical and Epidemiologic Al Characteristics of Tick-Borne Encephalitis in the Southern Urals. Sibirskij Medicinskij Zurnal 2011; 103(4): 92–5 (In Russ.)

2. WHO. Vaccines against Tick-Borne Encephalitis: WHO Position Paper. WER 2011; 86(24): 241–256. Available from: http://www.who.int/wer/2011/wer8624.pdf?ua=1

3. Demina TV, Dzhioev YP, Verkhozina MM, Kozlova IV, Tkachev SE, Plyusnin A, et al. Genotyping and Characterization of the Geographical Distribution of Tick-Borne Encephalitis Virus Variants with a Set of Molecular Probes. J Med Virol. 2010; 82(6): 965–76.

4. ECDC Technical Report. Epidemiological Situation of Tick-Borne Encephalitis in the European Union and European Free Trade Association Countries. Stockholm; 2012. Available from: https://ecdc.europa.eu/sites/portal/files/media/en/publications/Publications/TBE-in-EU-EFTA.pdf

5. Pogodina VV, Levina LS, Skrynnik SM, Travina NS, Karan LS, Kolyasnikova NM, et al. Tick- Borne Encephalitis with Fulminant Course and Lethal Outcome in Patients After Plural Vaccination. Vopr Virusol. 2013; 58(2): 33–7 (In Russ.)

6. Amicizia D, Domnich A, Panatto D, Lai PL, Cristina ML, Avio U, et al. Epidemiology of Tickborne Encephalitis (TBE) in Europe and Its Prevention by Available Vaccines. Hum Vaccin Immunother. 2013; 9(5): 1163–71.

7. Zueva LP, Yafaev VV, Dudareva VV. General Aspects of Immunoprophylaxis. Epidemiology&Vaccinal Prevention. 2002; 2: 6–7 (In Russ.)

8. Kollaritsch H, Krasilnikov V, Holzmann H, Karganova G, Barrett A, Süss J, et al. Background Document on Vaccines and Vaccination against Tick-Borne Encephalitis. Geneva; 2011. Available from: http://www.who.int/immunization/sage/6_TBE_backgr_18_Mar_net_apr_2011.pdf

9. Votyakov VI, Zlobin VI, Mishaeva NP. Tick-Borne Encephalitis of Eurasia. Issues of Ecology, Molecular Epidemiology, Nosology, Evolution. Novosibirsk: Nauka; 2002 (In Russ.)

10. WHO. Tick-Borne Encephalitis. 2014. Available from: http://www.who.int/immunization/diseases/tick_encephalitis/en/

11. Gritsun TS, Lashkevich VA, Gould EA. Tick–Borne Encephalitis. Antiviral Res. 2003; 57(1–2): 129–46.

12. State Report «About Sanitary and Epidemiologic Wellbeing of the Population in the Russian Federation in 2016» (In Russ.)] Available from: http://www.rospotrebnadzor.ru/upload/iblock/0b3/gosudarstvennyy-doklad-2016.pdf

13. Sanitary-Epidemiological Rules SP 3.1.3.2352-08 «Prevention of Tick-Borne Encephalitis» (In Russ.) Available from: http://docs.cntd.ru/document/902094567

14. About Epidemiological Situation of Tick-Borne Infections in the Russian Federation in 2015 and the Forecast for 2016 (In Russ.) Available from: http://rospotrebnadzor.ru/upload/iblock/a02/ob-epid.-situatsii-po-infek.-pered.- kleshchami-v-2015-g.-na-terr.-rf.pdf

15. Vorobieva MS, Merkulov VA, Ladyzhenskaya IP, Rukavishnikov AV, Shevtsov VA. The History and Quality Evaluation of Tick-Borne Encephalitis Vaccine. The Bulletin of the Scientific for Expert Evaluation of Medicinal Products 2013; (3): 40–4 (In Russ.)

16. Aitov KA, Malov IV, Zlobin VI, Burdanova TM. Characteristic of Tick-Borne Encephalitis in the Irkutsk Region. National Priorities of Russia 2014; 3(13): 18–20 (In Russ.)

17. Vorob’eva MS, Rashсhepkina MN, Pavlova LI, Bystritsky LD, Stavitskaya NH, Iltchenko TE, et al. The Present Vaccinoprophilaxis of Tick- Borne Encephalitis and Vaccines for Its Provision. Bulletin of Siberian Medicine 2006; 5(S1): 63–72 (In Russ.)

18. Konjkova-Reidman АB, Zlobin VI. Clinical and Epidemiologic Al Characteristics of Tick-Borne Encephalitis in the Southern Urals. Sibirskij Medicinskij Zurnal 2011; 103(4): 92–5 (In Russ.)

19. Monograph 3.3.1.0031.15. The Cultured Purified Concentrated Inactivated Liquid Sorbed or Dry Tick-Borne Encephalitis Vaccine, Complete with an Aluminum Hydroxide Solvent. State Pharmacopoeia of the Russian Federation. 13th ed. V. 3, Moscow; 2015 (In Russ.) Available from: http://www.femb.ru/feml

20. Demina TV, Dzhioev YP, Verkhozina MM, Kozlova IV, Tkachev SE, Plyusnin A, et al. Genotyping and Characterization of the Geographical Distribution of Tick-Borne Encephalitis Virus Variants with a Set of Molecular Probes. J Med Virol. 2010; 82(6): 965–76.

21. Chernokhaeva LL, Rogova YuV, Vorovitch MF, Romanova LIu, Kozlovskaya LI, Maikova GB, et al. Protective Immunity Spectrum Induced by Immunization with a Vaccine from the TBEV Strain Sofjin. Vaccine. 2016; 34(20): 2354–61.

22. Pogodina VV, Levina LS, Skrynnik SM, Travina NS, Karan LS, Kolyasnikova NM, et al. Tick- Borne Encephalitis with Fulminant Course and Lethal Outcome in Patients After Plural Vaccination. Vopr Virusol. 2013; 58(2): 33–7 (In Russ.)

23. Vorob’jova MS, Rasshhepkina MN. The History of the Development and Production of a Tick-Borne Encephalitis Vaccine in Russia and Abroad. Dal’nevostochnyj Zhurnal Infekcionnoj Patologii 2007; 11: 21–6 (In Russ.)

24. Zueva LP, Yafaev VV, Dudareva VV. General Aspects of Immunoprophylaxis. Epidemiology&Vaccinal Prevention. 2002; 2: 6–7 (In Russ.)

25. Mironov AN, ed. Guideline on Conduct of Clinical Trials of Medicines (Immunobiological Drugs). Part Two. Moscow: Grif and K; 2012 (In Russ.)

26. Votyakov VI, Zlobin VI, Mishaeva NP. Tick-Borne Encephalitis of Eurasia. Issues of Ecology, Molecular Epidemiology, Nosology, Evolution. Novosibirsk: Nauka; 2002 (In Russ.)

27. Leonova GN, Krylova NV, Pavlenko YeV, Maystrovskaya OS. Influence of the Reactogenity of the Tick-Borne Encephalitis Vaccines on the Immune Response in Vaccinated People. Bulletin of Siberian Medicine 2006; 5(S1): 72–8 (In Russ.)

28. Gritsun TS, Lashkevich VA, Gould EA. Tick–Borne Encephalitis. Antiviral Res. 2003; 57(1–2): 129–46.

29. Domnich A, Panatto D, Arbuzova EK, Signori A, Avio U, Gasparini R, et al. Immunogenicity against Far Eastern and Siberian Subtypes of Tick-Borne Encephalitis (TBE) Virus Elicited by the Currently Available Vaccines Based on the European Subtype: Systematic Review and Meta-Analysis. Hum Vaccin Immunother. 2014; 10(10): 2819–33.

30. Sanitary-Epidemiological Rules SP 3.1.3.2352-08 «Prevention of Tick-Borne Encephalitis» (In Russ.) Available from: http://docs.cntd.ru/document/902094567

31. Krasilnikov IV, Mischenko IA, Sharova OI, Bilalova GP, Atavitskaya HC, Vorob’eva MS, et al. Vaccine «EnceVir»: Development in Implementaiton in Practical Use. BIOpreparations. Prevention, Diagnosis, Treatment 2004; 2(14): 21–4 (In Russ.)

32. Vorobieva MS, Merkulov VA, Ladyzhenskaya IP, Rukavishnikov AV, Shevtsov VA. The History and Quality Evaluation of Tick-Borne Encephalitis Vaccine. The Bulletin of the Scientific for Expert Evaluation of Medicinal Products 2013; (3): 40–4 (In Russ.)

33. Shoutova NA, Shkouratova OV, Rouzavina YeV, Vlasova NM, Stavitskaya NKh, Vorobyova MS, et al. Studying Immunologic Activity and Reactogeneity of «Encevir» Vaccine During Immunization Using Express-Scheme. Sibirskij Medicinskij Zurnal 2009; 24(2–2): 30–3 (In Russ.)

34. Vorob’eva MS, Rashсhepkina MN, Pavlova LI, Bystritsky LD, Stavitskaya NH, Iltchenko TE, et al. The Present Vaccinoprophilaxis of Tick- Borne Encephalitis and Vaccines for Its Provision. Bulletin of Siberian Medicine 2006; 5(S1): 63–72 (In Russ.)

35. Vorovitch MF, Maikova GB, Chernokhaeva LL, Romanenko VV, Ankudinova AV, Khapchaev YuKh, et al. Immunogenicity and Safety of the Adult the Vaccine «Tick-EVac ». Vopr Virusol. 2017; 62(2): 73–80 (In Russ.)

36. Monograph 3.3.1.0031.15. The Cultured Purified Concentrated Inactivated Liquid Sorbed or Dry Tick-Borne Encephalitis Vaccine, Complete with an Aluminum Hydroxide Solvent. State Pharmacopoeia of the Russian Federation. 13th ed. V. 3, Moscow; 2015 (In Russ.) Available from: http://www.femb.ru/feml

37. 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.

38. Chernokhaeva LL, Rogova YuV, Vorovitch MF, Romanova LIu, Kozlovskaya LI, Maikova GB, et al. Protective Immunity Spectrum Induced by Immunization with a Vaccine from the TBEV Strain Sofjin. Vaccine. 2016; 34(20): 2354–61.

39. Wittermann C, Schöndorf I, Gniel D. Antibody Response Following Administration of Two Paediatric Tick-Borne Encephalitis Vaccines Using Two Different Vaccination Schedules. Vaccine. 2009; 27(10): 1661–6.

40. Vorob’jova MS, Rasshhepkina MN. The History of the Development and Production of a Tick-Borne Encephalitis Vaccine in Russia and Abroad. Dal’nevostochnyj Zhurnal Infekcionnoj Patologii 2007; 11: 21–6 (In Russ.)

41. Pavlova BG, Stavitskaya IV, Gorbunov MA, Shtukaturova OV, Pomogayeva AP, Stronin OV, et al. Immunization of Children and Adolescents with Inactivated Vaccines against Tick- Borne Encephalitis. BIOpreparations. Prevention, Diagnosis, Treatment 2003; (1): 24–8 (In Russ.)

42. Mironov AN, ed. Guideline on Conduct of Clinical Trials of Medicines (Immunobiological Drugs). Part Two. Moscow: Grif and K; 2012 (In Russ.)

43. Kollaritsch H, Paulke-Korinek M, Holzmann H, Hombach J, Bjorvatn B, Barrett A. Vaccines and Vaccination against Tick-Borne Encephalitis. Expert Rev Vaccines. 2012; 11(9): 1103–19.

44. Leonova GN, Krylova NV, Pavlenko YeV, Maystrovskaya OS. Influence of the Reactogenity of the Tick-Borne Encephalitis Vaccines on the Immune Response in Vaccinated People. Bulletin of Siberian Medicine 2006; 5(S1): 72–8 (In Russ.)

45. Kharit SM, Ruleva AA, Fridman IV, Nacharova EP, Alekseeva LA, Vasil’eva GA, et al. The Results of an Open, Randomized Comparative Clinical Study to Assess the Reactogenicity, Safety and Immunogenicity of the Vaccine EntseVir in Children Aged 3 to 17 Years. Epidemiology&Vaccinal Prevention. 2015; 14(2): 66–72 (In Russ.)

46. Domnich A, Panatto D, Arbuzova EK, Signori A, Avio U, Gasparini R, et al. Immunogenicity against Far Eastern and Siberian Subtypes of Tick-Borne Encephalitis (TBE) Virus Elicited by the Currently Available Vaccines Based on the European Subtype: Systematic Review and Meta-Analysis. Hum Vaccin Immunother. 2014; 10(10): 2819–33.

47. Ankudinova AV, Romanenko VV, Vorovich MF, Kovtun OP, Esyunina MS, Kiktenko AV, et al. Results of a Clinical Immunogenicity and Safety Trial of Tick-E-Vac 0.25 ml Vaccine (Pediatric Dosage). The Vestnik Uralskoi Meditsinskoi Akademicheskoi Nauki 2014; 5(51): 64–9 (In Russ.)

48. Krasilnikov IV, Mischenko IA, Sharova OI, Bilalova GP, Atavitskaya HC, Vorob’eva MS, et al. Vaccine «EnceVir»: Development in Implementaiton in Practical Use. BIOpreparations. Prevention, Diagnosis, Treatment 2004; 2(14): 21–4 (In Russ.)

49. Leonova GN, Ternovoi VA, Pavlenko EV, Maistrovskaya OS, Protopopova EV, Loktev VB. Evaluation of Vaccine Encepur Adult for Induction of Human Neutralizing Antibodies against Recent Far Eastern Subtype Strains of Tick-Borne Encephalitis Virus. Vaccine. 2007; 25(5): 895–901.

50. Shoutova NA, Shkouratova OV, Rouzavina YeV, Vlasova NM, Stavitskaya NKh, Vorobyova MS, et al. Studying Immunologic Activity and Reactogeneity of «Encevir» Vaccine During Immunization Using Express-Scheme. Sibirskij Medicinskij Zurnal 2009; 24(2–2): 30–3 (In Russ.)

51. Afonina OS, Barkhaleva OA, Sarkisyan KA, Vorobieva MS, Movsesyants AA., Olefir YuV. 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). Epidemiology&Vaccinal Prevention. 2017; 1(92): 62–7 (In Russ.)

52. Vorovitch MF, Maikova GB, Chernokhaeva LL, Romanenko VV, Ankudinova AV, Khapchaev YuKh, et al. Immunogenicity and Safety of the Adult the Vaccine «Tick-EVac ». Vopr Virusol. 2017; 62(2): 73–80 (In Russ.)

53. Leonova GN, Pavlenko EV. Characterization of Neutralizing Antibodies to Far Eastern of Tick–Borne Encephalitis Virus Subtype and the Antibody Avidity for Four Tick–Borne Encephalitis Vaccines in Human. Vaccine. 2009; 27(21): 2899–904.

54. 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.

55. Afonina OS, Terekhina LL, Barkhaleva OA, Ladyzhenskaya IP, Sarkisyan KA, Vorobieva MS, et al. Experimental Studies Cross Immune Response to Antigens of the Virus Strains of Tick-Borne Encephalitis Different Genotypes in Balb/C Mice, Immunized with Various Embodiments of Tick-Borne Encephalitis Vaccine. Epidemiology&Vaccinal Prevention. 2014; 5(78): 88–96 (In Russ.)

56. Wittermann C, Schöndorf I, Gniel D. Antibody Response Following Administration of Two Paediatric Tick-Borne Encephalitis Vaccines Using Two Different Vaccination Schedules. Vaccine. 2009; 27(10): 1661–6.

57. Orlinger KK, Hofmeister Y, Fritz R, Holzer GW, Falkner FG, Unger B, et al. А Tick-Borne Encephalitis Vaccine Based on the European Prototype Strain Induced Broadly Active Cross- Neutralization Antibodies in Humans. Journal of Infectious diseases 2011; 203: 1556–64.

58. Pavlova BG, Stavitskaya IV, Gorbunov MA, Shtukaturova OV, Pomogayeva AP, Stronin OV, et al. Immunization of Children and Adolescents with Inactivated Vaccines against Tick- Borne Encephalitis. BIOpreparations. Prevention, Diagnosis, Treatment 2003; (1): 24–8 (In Russ.)

59. Pavlenko EV, Leonova GN, Majstrovskaja OS. Comparative Study of the Immunogenicity of Vaccines against Tick-Borne Encephalitis. Dal’nevostochnyj Zhurnal Infekcionnoj Patologii 2007; 11: 56–62 (In Russ.)

60. Kollaritsch H, Paulke-Korinek M, Holzmann H, Hombach J, Bjorvatn B, Barrett A. Vaccines and Vaccination against Tick-Borne Encephalitis. Expert Rev Vaccines. 2012; 11(9): 1103–19.

61. Kharit SM, Ruleva AA, Fridman IV, Nacharova EP, Alekseeva LA, Vasil’eva GA, et al. The Results of an Open, Randomized Comparative Clinical Study to Assess the Reactogenicity, Safety and Immunogenicity of the Vaccine EntseVir in Children Aged 3 to 17 Years. Epidemiology&Vaccinal Prevention. 2015; 14(2): 66–72 (In Russ.)

62. Ankudinova AV, Romanenko VV, Vorovich MF, Kovtun OP, Esyunina MS, Kiktenko AV, et al. Results of a Clinical Immunogenicity and Safety Trial of Tick-E-Vac 0.25 ml Vaccine (Pediatric Dosage). The Vestnik Uralskoi Meditsinskoi Akademicheskoi Nauki 2014; 5(51): 64–9 (In Russ.)

63. Leonova GN, Ternovoi VA, Pavlenko EV, Maistrovskaya OS, Protopopova EV, Loktev VB. Evaluation of Vaccine Encepur Adult for Induction of Human Neutralizing Antibodies against Recent Far Eastern Subtype Strains of Tick-Borne Encephalitis Virus. Vaccine. 2007; 25(5): 895–901.

64. Afonina OS, Barkhaleva OA, Sarkisyan KA, Vorobieva MS, Movsesyants AA., Olefir YuV. 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). Epidemiology&Vaccinal Prevention. 2017; 1(92): 62–7 (In Russ.)

65. Leonova GN, Pavlenko EV. Characterization of Neutralizing Antibodies to Far Eastern of Tick–Borne Encephalitis Virus Subtype and the Antibody Avidity for Four Tick–Borne Encephalitis Vaccines in Human. Vaccine. 2009; 27(21): 2899–904.

66. Afonina OS, Terekhina LL, Barkhaleva OA, Ladyzhenskaya IP, Sarkisyan KA, Vorobieva MS, et al. Experimental Studies Cross Immune Response to Antigens of the Virus Strains of Tick-Borne Encephalitis Different Genotypes in Balb/C Mice, Immunized with Various Embodiments of Tick-Borne Encephalitis Vaccine. Epidemiology&Vaccinal Prevention. 2014; 5(78): 88–96 (In Russ.)

67. Orlinger KK, Hofmeister Y, Fritz R, Holzer GW, Falkner FG, Unger B, et al. А Tick-Borne Encephalitis Vaccine Based on the European Prototype Strain Induced Broadly Active Cross- Neutralization Antibodies in Humans. Journal of Infectious diseases 2011; 203: 1556–64.

68. Pavlenko EV, Leonova GN, Majstrovskaja OS. Comparative Study of the Immunogenicity of Vaccines against Tick-Borne Encephalitis. Dal’nevostochnyj Zhurnal Infekcionnoj Patologii 2007; 11: 56–62 (In Russ.)


Review

For citations:


Kozlova T.Yu., Khantimirova L.M., Rukavishnikov A.V., Shevtsov V.A. Analysis of Efficacy and Safety of Tick-Borne Encephalitis Vaccines. BIOpreparations. Prevention, Diagnosis, Treatment. 2018;18(1):33-41. (In Russ.) https://doi.org/10.30895/2221-996X-2018-18-1-33-41

Views: 1972


Creative Commons License
This work is licensed under a Creative Commons Attribution 4.0 License.


ISSN 2221-996X (Print)
ISSN 2619-1156 (Online)