Evaluation of the safety and immunological and epidemiological efficacy of the Russian polymer-subunit adjuvant influenza vaccine in persons aged 60 years and older


DOI: https://dx.doi.org/10.18565/epidem.2018.3.76-82

Romanenko V.V., Chebykina T.V., Ankudinova A.V., Osipova I.V., Lioznov D.A., Martsevich S.Yu., Kilyachina A.S.

1 Center for Hygiene and Epidemiology in the Sverdlovsk Region, Yekaterinburg, Russia; 2 Ural State Medical University, Ministry of Health of Russia, Yekaterinburg, Russia; 3 Yekaterinburg Medical Research Center for Prophylaxis and Health Protection in Industrial Workers, Russian Federal Service for Supervision of Consumer Rights Protection and Human Well-Being, Yekaterinburg, Russia 4 OOO «ASKO-MED-PLUS», Barnaul, Russia; 5 State Research Center for Preventive Medicine, Ministry of Health of Russia, Moscow, Russia; 6 Academician I.P. Pavlov First Saint Petersburg State Medical University, Ministry of Health of Russia, Saint Petersburg, Russia
Influenza remains a major public health problem worldwide. The main risk group is people over 60 years of age.
Objective. To investigate the safety, reactogenicity, immunological and epidemiological efficiencies of the adjuvant trivalent inactivated polymer-subunit influenza vaccine Grippol® plus in people over 60 years of age.
Subjects and methods. The investigation enrolled 480 patients aged 60 years and older who were divided into 2 groups: 1) 241 persons unvaccinated against influenza; 2) 239 people vaccinated with Grippol® plus. The safety and reactogenicity of the vaccine were evaluated by the presence/absence of systemic and local reactions and adverse events. The antigenic activity of the vaccine was examined in the hemagglutination-inhibition test in accordance with the conventional procedure.
Results. At 21–28 days after vaccination, the immunological efficiency indicators (seroprotection, seroconversion, the multiplicity of antibody titer growth) complied with the international standards and persisted within 6 months. No differences were detected in the immunogenicity indicators and in the frequency of local and common reactions between Groups 2 and 3 (p> 0.05). The incidence of acute respiratory viral infections was 2.08 times lower than that in Group 1 (p < 0.05).
Conclusion. The adjuvant polymer-subunit vaccine Grippol® plus demonstrated the high profile of areactogenicity, immunological and epidemiological efficiencies when immunizing people over 60 years of age.
Keywords: people aged over 60 years, Grippol® plus vaccine, immunological and epidemiological efficiencies, safety
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For citation: Romanenko V.V., Chebykina T.V., Ankudinova A.V., Osipova I.V., Lioznov D.A., Martsevich S.Yu., Kilyachina A.S. Evaluation of the safety and immunological and epidemiological efficacy of the russian polymer-subunit adjuvant influenza vaccine in persons aged 60 years and older.Èpidemiologiâ i infekcionnye bolezni. Аktual'nye voprosy 2018; (3):76–82


About the Autors

For correspondence:
Viktor V. Romanenko, МD, Associate Professor, Department of Epidemiology, Ural State Medical University, Ministry of Health of Russia; Epidemiologist, Center for Hygiene and Epidemiology in the Sverdlovsk Region
Address: 3, Repin St., Yekaterinburg 620028, Russia
Telеphone: +7(343) 214-86-90
E-mail: Romanenko.V47@gmail.com
Information about the authors:
Tatiana V. Chebykina, Senior Teacher, Department of Public Health and Health Care, Ural State Medical University, Ministry of Health of Russia, Yekaterinburg, Russia; e-mail: chebykina11@ mail.ru
Anna V. Ankudinova, Cand. Med. Sci., Academic Secretary, Yekaterinburg Medical Research Center for Prophylaxis and Health Protection in Industrial Workers, Russian Federal Service for Supervision of Consumer Rights Protection and Human Well-Being; Assistant Lecturer, Department of Hygiene and Ecology, Ural State Medical University, Ministry of Health of Russia, Yekaterinburg, Russia; е-mail: doctorankudinova2007@gmail.com
Prof. Irina V. Osipova, MD, Head, Principal Doctor, OOO ASKO-MED-PLUS, Barnaul, Russia; e-mail: i.v.osipova@gmail.com
Dmitry A. Lioznov, MD, State Research Center of Preventive Medicine, Ministry of Health of Russia, Saint Petersburg, Russia; e-mail: dlioznov@yandex.ru
Prof. Sergey Yu. Martsevich, MD, Head, Academician I.P. Pavlov First Saint Petersburg State Medical University, Ministry of Health of Russia, Saint Petersburg Russia; e-mail: SMartsevich@gnicpm.ru
Anastasia S. Kilyachina, Cand. Med. Sci., Head, Virology Department, Center for Hygiene and Epidemiology in the Sverdlovsk Region, Yekaterinburg Russia; е-mail:Kilyachina_AS@66. rospotrebnadzor.ru


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