Email this article A study of the main parameters of immunogenicity of Ultrix vaccine
- Authors: Evdokimova O.V.1, Afanasiev S.V.2, Antonova O.A.2, Konopleva V.I.1, Gorelov I.S.2, Kruglova A.P.3, Biryukov V.V.4
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Affiliations:
- Ryazan State Medical University
- Scientific and Production Complex OOO FORT
- Ryazan State University S.A. Esenin
- Diagnostic Center
- Issue: Vol 28, No 1 (2020)
- Pages: 21-29
- Section: Original study
- URL: https://journals.rcsi.science/pavlovj/article/view/11934
- DOI: https://doi.org/10.23888/PAVLOVJ202028121-29
- ID: 11934
Cite item
Abstract
Aim. Clinical trial of Ultrix vaccine of OOO FORT manufacture containing different serotypes of influenza virus: H1N1 A/California/7/2009 (H1N1) pdm 09, H3N2 A/HongKong/ 4801/2014, NYMCX-263B(15/184) and B/Brisbane/60/2008 NYMCBX-35 (15/300) Victo-rialineage strains (epidemiological season of 2016) and H1N1 A/Michigan/45/2015 NYMCX-275 (16/248), H3N2 A/HongKong/4801/2014, NYMCX-263B(15/184) иB/Brisbane/60/2008 NYMCBX-35 (15/300) Victorialineage strains (epidemiological season of 2017).
Materials and Methods. A study of the basic parameters of immunogenicity included determination of the geometric mean value of the antibody titer, of seroprotection and seroconversion and of relative number of individuals with 4-fold increase in the antibody titer after vaccination. Immunogenicity was determined by a micromethod in hemagglutination inhibition reaction. Sera were tested with diagnosticums obtained from serotypes of influenza virus identical to vaccinal strains.
Results. The level of seroprotection with Ultrix made 91.7-95.8% (2016) and 93.8-97.9% (2017). The maximal level of seroprotection was achieved in 6 months after vaccination with Ultrix containing H1N1A/California serotype. 2.55-4.36-Fold increase in the geometric mean value of anti-HA to all vaccinal strains was found in vaccination in 2016 and 2017, and 4-fold increase in antibody titer in more than 70% of volunteers on the 21st day after the first immunization in 2016.
Conclusion. The obtained results of clinical trials of Ultrix vaccine with different antigenic composition confirms the correspondence of the immunogenicity parameters of the drug to the requirements of the Committee for Proprietary Medical Products (CPMPEMEA, CPMP/ EWP/1045/01) and of State Pharmacopoeia of RF of XIII edition (SP SP XIII).
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##article.viewOnOriginalSite##About the authors
Olga V. Evdokimova
Ryazan State Medical University
Author for correspondence.
Email: olartemyeva@yandex.ru
ORCID iD: 0000-0002-5035-7302
SPIN-code: 4822-7475
ResearcherId: G-7393-2019
MD, PhD, Associate Professor, Head of the Department of Microbiology
Russian Federation, RyazanStanislav V. Afanasiev
Scientific and Production Complex OOO FORT
Email: olartemyeva@yandex.ru
ORCID iD: 0000-0002-4222-2870
SPIN-code: 7197-7329
ResearcherId: G-9232-2019
PhD in Pharmaceutical Sciences, Assistant Director of the Production Complex for Quality
Russian Federation, RyazanOlga A. Antonova
Scientific and Production Complex OOO FORT
Email: olartemyeva@yandex.ru
ORCID iD: 0000-0002-2417-3892
SPIN-code: 1266-3887
ResearcherId: 8100-2019
Head of Group of Virological Tests in Virological Laboratory of the Production Complex for Quality
Russian Federation, RyazanValentina I. Konopleva
Ryazan State Medical University
Email: olartemyeva@yandex.ru
ORCID iD: 0000-0002-6038-9113
SPIN-code: 1352-9812
ResearcherId: G-7804-2019
MD, PhD, Associate Professor of the Department of Microbiology
Russian Federation, RyazanIlya S. Gorelov
Scientific and Production Complex OOO FORT
Email: olartemyeva@yandex.ru
ORCID iD: 0000-0001-7024-1254
SPIN-code: 6128-8365
ResearcherId: G-7279-2019
Head of Technological Group of Production and Technical Department
Russian Federation, RyazanAlla P. Kruglova
Ryazan State University S.A. Esenin
Email: olartemyeva@yandex.ru
ORCID iD: 0000-0003-1918-8835
SPIN-code: 7789-1841
ResearcherId: G-9188-2019
PhD in Biological Sciences, Associate Professor of Biology and Methods of Teaching
Russian Federation, RyazanVladimir V. Biryukov
Diagnostic Center
Email: olartemyeva@yandex.ru
ORCID iD: 0000-0003-2704-5893
SPIN-code: 8828-1240
ResearcherId: B-9161-2019
MD, PhD, Head of Consultative and Diagnostic Center
Russian Federation, RyazanReferences
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