Results of a Clinical Immunogenicity and Safety Trial of “Tick-E-Vac” 0.25 ml Vaccine (Pediatric Dosage)
Ankudinova A. V., Romanenko V. V.,
Vorovich M. F., Kovtun O. P., Esyunina M. S., Kiktenko A. V., Kilyachina A. S., Averyanov O. Yu.
The Center for Hygiene and Epidemiology in the Sverdlovsk Region, Federal Budget-funded Institution of Public Health,
Yekaterinburg, Russian Federation;
The Ural State Medical Academy of the Russian Ministry of Health, Yekaterinburg, Russian Federation;
The Federal State Unitary Enterprise on Manufacture of Bacterial and Viral Preparations of the Chumakov Institute of Poliomyelitis and Viral Encephalitises of the Russian Academy of Medical Sciences,
Moscow, Russian Federation;
The Federal Service for Surveillance in the Sphere of Consumer Rights Protection and Human Welfare (Rospotrebnadzor),
Yekaterinburg, Russian Federation;
Municipal Children’s Hospital No. 11,
Yekaterinburg, Russian Federation
Abstract.
The objective of the clinical trial was to assess tolerability, reactogenicity, safety, and immunogenicity of a novel Russian Tick-E-Vac 0.25 ml vaccine (pediatric dosage) produced by the Federal State Unitary Enterprise on Manufacture of Bacterial and Viral Preparations of the Chumakov Institute of Poliomyelitis and Viral Encephalitises of the Russian Academy of Medical Sciences in volunteers aged 1 to 16. The obtained results showed good tolerability and high safety profile of the vaccine. Tick-E-Vac meets all modern criteria of immunogenicity established for vaccines against tick-borne encephalitis and is not inferior to FSME-IMMUN Junior vaccine already available on the market.
Keywords:
tick-borne encephalitis, children, Tick-E-Vac, FSME-IMMUN Junior, safety, immunogenicity
REFERENCES
1. Aitov K.A., Malov I.V., Borisov V.A., Zlobin V.I. Clinical characteristics of tick-borne encephalitis in the Irkutsk Region. VestnikUralskoyGosudarstvennoyMeditsinskoyAkademii. 2010; 21: 27-32. (in Russian)
2. Beletskaya G.V., Lozinskiy I.N., Ben I.I. etal. Current tick-borne natural focal infectious diseases in Ukraine. Zhurnal infektologii. 2014; 2(6): 17. (in Russian)
3. KorotkovYu.S. Climate change and dynamics of tick-borne encephalitis. Meditsinskaya virusologiya. 2013; XXVII (1): 72.(in Russian)
4. Kilian P., Danielova V., Ruzek D. Tick-borne encephalitis in the Czech Republic: the past, the present and the future. Zhurnal infektsionnoy patologii. Irkutsk. 2012; 19(3): 18. (in Russian)
5. Suss J. Tick-borne encephalitis 2010: Epidemiology, risk areas, and virus strains in Europe and Asia – An overview. Ticks and Tick-bornediseases. 2011; 2: 2-15.
6. World Health Organization Weekly Epidemiological Record (WER) 10 June 2011, 24 (86): 241-256.
7. Aitov K.A., Zlobin V.I., Tuvakov M.K. et al. Nosological diversity of tick-borne infections in the Irkutsk Region. Zhurnal infektologii. 2014; 2(6): 9. (in Russian)
8. Balakhonov S.V., Pakskina N.D., Nikitin A.Ya. et al. Epidemiological situation of tick-borne in the Russian Federation in 2012 and predictions for 2013. Problemy osobo opasnykh infektsiy. 2013; 1: 34-37. (in Russian)
9. Gerasimov S.G., Smirnova L.V., Razumovskiy S.L., Karan L.S., Kolyasnikova N.M., Bochkova N.G. Current epidemiological situation of tick-borne encephalitis in the Kostroma Region (the Russian Central Federal District). Meditsinskaya virusologiya. 2013; XXVII (1): 55. (in Russian)
10. Druzhinina T.A., Shishkina L.A. Transformation of the epidemic process of tick-borne encephalitis under the influence of natural and social factors. Meditsinskayavirusologiya. 2013; XXVII (1): 57. (in Russian)
11. Zlobin V.I., Malov I.V., Lvov D.K. Epidemiology and prevention of tick-borne encephalitis in the Russian Federation. In: Vlasov V.R., Repin V.E. Tick-borne infections in Siberia. Novosibirsk: Publishing House of the Siberian Branch of the Russian Academy of Sciences. 2011; pp. 73-83. (in Russian)
12. About the results of surveillance over tick-borne encephalitis in the epidemiological season 2009 (excerpts from letter № 01/15412-9-32 of Rospotrebnadzor dated 16.10.2009). Epidemiologiya i vaktsinoprofilaktika. 2009; 5(48): 80. (in Russian)
13. About the situation with respect to tick-borne encephalitis in the Russian Federation (press release issued on 10.06.14). Epidemiologiya i vaktsinoprofilaktika. 2014; 3(76): 55. (in Russian)
14. DoroginaYu.V. Environmental epidemiological features of the combined focus of tick-borne encephalitis and tick-borne borrelioses in a megalopolis and improvement of their epidemiologic control actions. Synopsis of the dissertation… Candidate of Medical Sciences – Nizhniy Novgorod: 2012. 20 p. (in Russian)
15. Druzhinina T.A., Shishkina L.A., Baranova N.S., Gerasimov S.G. Tick-borne encephalitis in the Yaroslavl Region. Pest-Management. 2011; 1: 19-22. (in Russian)
16. Kolyasnikova N.M. Monitoring of the structure of populations of the virus of tick-borne encephalitis in the Ural, West Siberian and North-Western regions of Russia (virology and molecular biology studies). Synopsis of the dissertation… Candidate of Medical Sciences – Moscow: 2008. 26 p. (in Russian)
17. Luchinina S.V., Stepanova O.N., Pogodina V.V., Stenko E.A., Chirkova G.G., Gerasimov S.G., Kolesnikova L.I. Current epidemiological situation on tick-borne encephalitis in the Chelyabinsk Region. Epidemiologiya i vaktsinoprofilaktika. 2014; 2(75): 32-37. (in Russian)
18. Volkova L.I., Kovtun O.P. Age aspects of epidemiology and clinical picture of tick-borne encephalitis. Zhurnal nevrologii i psikhiatrii. 2008; 10(108): 61-64. (in Russian)
19. Yegemberdiyeva R.A., Duysenova A.K., Seydulayeva L.B., Baykhozhayeva R.Zh. Clinical and epidemiologic characteristics of tick-borne encephalitis in Kazakhstan. Zhurnal infektologii. 2014; 2(6): 35-36. (in Russian)
20. Konkova-Reidman A.B. Mono- and mixed infections of ixodid tick-borne borrelioses and tick-borne encephalitis: the clinical picture, epidemiology and immune-related aspects of treatment. Synopsis of the dissertation… Doctor of Medical Sciences – Saint Petersburg; 2013. 32 p. (in Russian)
21. Konkova-Reidman A.B., Zlobin V.I. Clinical and epidemiologic characteristics of tick-borne encephalitis in the Southern Urals. Sibirskiy meditsinskiy zhurnal. 2011; 4: 92-95. (in Russian)
22. Radionova O.A., Kuimova I.V. Ixodid tick-borne borrelioses – distinctive features of the disease in children. Zhurnal infectologii. 2014; 2(6): 80. (in Russian)
23. Pogodina V.V., Levina L.S., Skrynnik S.M. et al. Tick-borne encephalitis with a fulminant clinical course and a lethal outcome in a repeatedly vaccinated patient. Voprosyvirusologii. 2013; 2: 33-37. (in Russian)
24. Romanenko V.V. Immune prevention of infectious diseases in the system of children’s health management in a constituent of the Russian Federation. Synopsis of the dissertation… Doctor of Medical Sciences. Ekaterinburg: 2012. 61 p. (in Russian)
25. Tick-borne encephalitis prevention strategies. In: Zlobin V.I., Malov I.V., Kozlova I.V., Verkhozina M.M., Demina T.V., DzhioyevYu.P., Borisov V.A., Isayeva E.I., Morozova O.V., Grishechkin A.E., Konkova-Reidman A.B. Proceedings of the Russian Scientific and Practical Conference “Vaccinology 2010. Improvement of immunobiological means of prevention, diagnosis and treatment of infectious diseases”. Moscow, 2010. P. 51. (in Russian)
26. Subbotin A.V., Semenov V.A., Smirnov V.D. et al. A case of developing chronic tick-borne encephalitis in a vaccinated patient. Epidemiologiya i vaktsinoprofilaktika. 2014; 3 (76): 104-108. (in Russian)
27. Heinz F., Holzman H., Essl A., Kundt M. The analysis of efficiency of vaccination of the population of Austrian natural foci against tick-borne encephalitis. Voprosy virusologii. 2008; 2: 19-27. (in Russian)
28. Vorobyova M.S., Ladyzhenskaya I.P., Barkhaleva O.A. et al. The immune response to express-immunization against tick-borne encephalitis using Encevir (Russia) and FSME-Immun (Austria) vaccines. Epidemiologiya i vaktsinoprofilaktika. 2009; 5(48): 61-65. (in Russian)
29. Instructions for use of a tissue-culture purified concentrated inactivated dry vaccine against tick-borne encephalitis. Russian Head State Sanitary Doctor, 2009. (in Russian)
30. Instructions for use of TICK-E-VAC. The Russian Ministry of Health and Social Development, 2012; LP 001584-150312. (in Russian)
Authors
Ankudinova Anna V.
ankudinova_AV@66.rospotrebnadzor.ru
Center for Hygiene and Epidemiology in the Sverdlovsk Region, Federal Budget-funded Institution of Public Health, epidemiologist
3 Otdelnylane, Yekaterinburg 620078Russian Federation
Romanenko Viktor V.
Ural State Medical Academy of the Russian Ministry of Health, Doctor of Medical Sciences, Assistant of the Department for Pediatrics and Neonatology of the Faculty of Advanced Training and Retraining
3 Repina str., Yekaterinburg 620028Russian Federation
Vorovich Michael F.
Federal State Unitary Enterprise on Manufacture of Bacterial and Viral Preparations of the Chumakov Institute of Poliomyelitis and Viral Encephalitises of the Russian Academy of Medical Sciences, Candidate of Biological Sciences, Head of the Department for TBE VaccineVilageInstitute of Poliomyelitis, Moscow 142782Russian Federation
Kovtun Olga P.
Ural State Medical Academy of the Russian Ministry of Health, Doctor of Medical Sciences, Professor, Pro-rector for Research, Head of the Department for Pediatrics and Neonatology of the Faculty of Advanced Training and Retraining
3 Repina str., Yekaterinburg 620028 Russian Federation
Esyunina Maria S.
Sverdlovsk Regional Office of the Federal Service for Surveillance in the Sphere of Consumer Rights Protection and Human Welfare (Rospotrebnadzor), leading specialistexpert
3 Otdelnylane, Yekaterinburg 620078 Russian Federation
KiktenkoAleksandr V.
Federal State Unitary Enterprise on Manufacture of Bacterial and Viral Preparations of the Chumakov Institute of Poliomyelitis and Viral Encephalitises of the Russian Academy of Medical Sciences, Candidate of Medical Sciences, Advisor
Vilage Institute of Poliomyelitis, Moscow 142782Russian Federation
Kilyachina Anastasia S.
Center for Hygiene and Epidemiology in the Sverdlovsk Region, Federal Budget-funded Institution of Public Health, Candidate of Medical Sciences, Virologist of the Laboratory for Control of Biological Factors
3 Otdelnylane, Yekaterinburg 620078 Russian Federation
Averyanov Oleg Yu.
Municipal Children’s Hospital No. 11, Head Doctor
48 Nagornajastr.,Yekaterinburg, 620028Russian Federation