Ultrix疫苗免疫原性主要参数的研究

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目的：进行FORT有限公司生产包含不同血清型流感病毒的Ultrix疫苗的临床研究：菌株包括H1N1 A/California/7/2009 (H1N1) pdm 09、H3N2 A/HongKong/4801/2014、NYMCX-263B (15/184) 和 B/Brisbane/60/2008 NYMCBX-35 (15/300) Victorialineage (2016年流行病季节)、并H1N1 A/Michigan/45/2015 NYMCX-275 (16/248) 、H3N2 A/HongKong/4801/2014、NYMCX-263B(15/184) 及 B/Brisbane/60/2008 NYMCBX-35 (15/300) Victorialineage (2017年流行病季节) 。

材料与方法：免疫原性主要参数的研究包括测定平均几何抗体效价、血清保护和血清转换水平，以及免疫接种后抗体效价增加4倍的个体相对数量。用显微法测定了血凝反应的免疫原性。用与疫苗株相同的流感病毒血清型抗原检测血清。

结果：Ultrix的血清保护率达到91.7—95.8% (2016年) 和93.8—97.9% (2017年) 。含有H1N1A/California血清型的Ultrix疫苗6个月后可达到最大的血清保护水平。在2016年和2017年接种疫苗期间，所有疫苗株的平均anti-НА几何水平增加了2.55-4.36倍，在2016年首次免疫21天后，超过70%的志愿者的抗体滴度增加了4倍。

结论：包含不同血清型流感病毒的Ultrix疫苗的临床研究结果证明免疫原性参数符合专利药品委员会 (CPMPEMEA、CPMP/EWP/1045/01) 及俄罗斯联邦国家药典第十三版 (SP RF XIII)的要求。

作者简介

Olga Evdokimova

Ryazan State Medical University

编辑信件的主要联系方式.
Email: olartemyeva@yandex.ru
ORCID iD: 0000-0002-5035-7302
SPIN 代码: 4822-7475
Researcher ID: G-7393-2019

MD, PhD, Associate Professor, Head of the Department of Microbiology

俄罗斯联邦, Ryazan

Stanislav Afanasiev

Scientific and Production Complex OOO FORT

Email: olartemyeva@yandex.ru
ORCID iD: 0000-0002-4222-2870
SPIN 代码: 7197-7329
Researcher ID: G-9232-2019

PhD in Pharmaceutical Sciences, Assistant Director of the Production Complex for Quality

俄罗斯联邦, Ryazan

Olga Antonova

Scientific and Production Complex OOO FORT

Email: olartemyeva@yandex.ru
ORCID iD: 0000-0002-2417-3892
SPIN 代码: 1266-3887
Researcher ID: 8100-2019

Head of Group of Virological Tests in Virological Laboratory of the Production Complex for Quality

俄罗斯联邦, Ryazan

Valentina Konopleva

Ryazan State Medical University

Email: olartemyeva@yandex.ru
ORCID iD: 0000-0002-6038-9113
SPIN 代码: 1352-9812
Researcher ID: G-7804-2019

MD, PhD, Associate Professor of the Department of Microbiology

俄罗斯联邦, Ryazan

Ilya Gorelov

Scientific and Production Complex OOO FORT

Email: olartemyeva@yandex.ru
ORCID iD: 0000-0001-7024-1254
SPIN 代码: 6128-8365
Researcher ID: G-7279-2019

Head of Technological Group of Production and Technical Department

俄罗斯联邦, Ryazan

Alla Kruglova

Ryazan State University S.A. Esenin

Email: olartemyeva@yandex.ru
ORCID iD: 0000-0003-1918-8835
SPIN 代码: 7789-1841
Researcher ID: G-9188-2019

PhD in Biological Sciences, Associate Professor of Biology and Methods of Teaching

俄罗斯联邦, Ryazan

Vladimir Biryukov

Diagnostic Center

Email: olartemyeva@yandex.ru
ORCID iD: 0000-0003-2704-5893
SPIN 代码: 8828-1240
Researcher ID: B-9161-2019

MD, PhD, Head of Consultative and Diagnostic Center

俄罗斯联邦, Ryazan

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版权所有 © Evdokimova O., Afanasiev S., Antonova O., Konopleva V., Gorelov I., Kruglova A., Biryukov V., 2020

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此作品已接受知识共享署名 4.0国际许可协议的许可
 


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