Investigation of the immunogenicity, efficacy, and tolerability of the Russian vaccine Ultrix® among people at high risk for the infection and morbidity of influenza and acute respiratory viral infections


Selkova E.P., Grenkova T.A., Aleshkin V.А., Gudova N.V., . Lytkina I.N., Mikhailova E.V., Yashina A.Ya., Fedyakina I.T.

1G.N. Gabrichevsky Moscow Research Institute of Epidemiology and Microbiology, Russian Federal Service for Supervision of Consumer Rights Protection and Human Welfare; 2V.I. Razumovsky Saratov State Medical University, Ministry of Health of Russia; 3D.I. Ivanovsky Institute of Virology, Ministry of Health of Russia, Honorary Academician N.F Gamaleya Federal Research Center for Epidemiology and Microbiology, Ministry of Health of Russia, Moscow
The latest-generation vaccines include virosomal ones that activate humoral and cell-mediated immunity and induce high immunogenicity and long-term protective immunity. The paper gives the results of the investigations of the Russian influenza vaccine Ultrix®, which were conducted in the 2014–2015 epidemic season and confirmed its good tolerability, high immunogenic activity against influenza H1N1, H3N2, and B influenza viruses, as well as epidemiological efficacy against influenza and acute respiratory viral infections.

Literature


1. Gosudarstvennyiy doklad «O sostoyanii sanitarno-epidemiologicheskogo blagopoluchiya naseleniya v Rossiyskoy Federatsii v 2014 godu» [The state report «About a condition of sanitary and epidemiologic wellbeing of the population in the Russian Federation in 2014»]. http://rospotrebnadzor.ru/upload/iblock/22c/gd_2014_seb_dlya-sayta.pdf. (In Russ.).


2. Huckriede A., Bungener L., Stegmann T., Daemen T., Medema J., Palache A.M., Wilschut J. The virocome concept for influenza vaccines. Vaccine 2005; 23(Suppl. 1): S26–S38.


3. Kanra G., Marchisio P., Feiterna-Sperling C. Comparison of immunogenicity and tolerability of a virosome-adjuvanted and a split influenza vaccine in children. Pediatr. Infect. Dis. J. 2004; 23(4): 300–306.


4. Bruijn I.A., Nauta J., Gerez L., Palache A.M. Virosomal influenza vaccine: a safe and effective influenza vaccine with high efficacy in elderly and subjects with low pre-vaccination titers. Virus Res. 2004; 103(1–2): 139–145.


5. Zverev V.V., Mihajlova N.A., Korovkin S.A., Mironov A.N., Mel’nikov S.Ja., Erofeeva M.K., Dyldina N.V., Nikonorov I.Ju., Maksakova V.L. [Development and deployment in practice of health care of the Russian Federation of the new domestic split virosomalny flu vaccine]. Lechashhij Vrach 2008; 9: 68–70. (In Russ.).


6. Kiselev O.I., Korovkin S.A., Mironov A.N., Mel’nikov S.Ja., Dyldina N.V., Erofeeva M.K., Sominina A.A., Vojcehovskaja E.M., Stukova M.A. [Results of clinical trial of a reaktogennost, safety and an immunogenicity of a vaccine of «Ultriks®» on the elderly contingent (of 60 years is also more senior)]. Еpidemiologiya i Vakcinoprofilaktika 2008; 4: 36–39. (In Russ.).


7. Korovkin S.A., Mironov A.N., Mel’nikov S.Ja., Mihajlova N.A., Kostinov M.P., Dyldina N.V., Zhirova S.N. [An assessment of a reaktogennost, safety and an immunogenicity of the virosomalny split inactivated influenzal vaccine of «Ultriks®» in the I phase of clinical trial]. Zhurnal Mikrobiologii, Epidemiologii i Immunologii 2009; 1: 26–31. (In Russ.).


8. Zverev V.V., Kiselev O.I., Korovkin S.A., Mironov A.N., Mel’nikov S.Ja., Mihajlova N.A., Kostinov M.P., Erofeeva M.K., Sominina A.A., Dyldina N.V., Zhirova S.N., Stukova M.A. [Clinical trial of the new inactivated influenzal vaccine of «Ultriks®»]. Zhurnal Mikrobiologii, Epidemiologii i Immunologii 2009; 2: 35–40. (In Russ.).


9. Nikonorov I., Maksakova V., Fel’dbljum I., Konshina O., Erofeeva M.[ A domestic preparation for prevention of flu of the last generation]. Vrach 2014; 3: 67–72. (In Russ.).


10. Metodyi opredeleniya kachestva immunobiologicheskih preparatov dlya profilaktiki grippa. Metodicheskie ukazaniya MU 3.3.2.1758-03. [Methods of determination of quality of immunobiological preparations for prevention of flu. HOWTO MU 3.3.2.1758-03]. Moscow, 2003. (In Russ.).


11. Concept Paper on the Revision of the CPMP/BWP Note for Guidance on Harmonization of Requirements for Influenza Vaccines (CPMP/BWP/214/96). London, 31 May, 2001/CPMP/EWP/1045/01.


About the Autors


For correspondence:
Grenkova Tatyana Arkadyevna, Cand. Med. Sci.; Leading Researcher, Laboratory for Diagnosis and Prevention of Infectious Diseases, G.N. Gabrichevsky Moscow Research Institute of Epidemiology and Microbiology, Russian Federal Service for Supervision of Consumer Rights Protection and Human Welfare
Address: 10, Admiral Makarov, Moscow 125212
Telephone: +7(499) 747-64-73
E-mail: g4209761@bk.ru


Similar Articles


Бионика Медиа