目的 探讨四价流感病毒裂解疫苗的安全性和免疫原性。方法 使用世界卫生组织推荐的北半球疫苗株制备四价流感病毒裂解疫苗,检定合格后,用于开展全面的动物毒理试验和免疫原性研究。结果 ICR小鼠毒理试验结果显示,疫苗最大耐受量MTD大于1 200 μg/kg;家兔免疫原性试验结果显示,血凝抑制抗体滴度大于1∶40,阳转率达到100%,血清中的中和抗体能够保护鸡胚不受流感病毒感染。结论 动物试验表明,该疫苗显示出良好的安全性和免疫原性。
Abstract
Objective To evaluate the safety and immunogenicity of quadrivalent influenza split-viron vaccine. Methods The quadrivalent influenza split-viron vaccine was prepared by using the northern hemisphere vaccine strain recommended by WHO.After being qualified, it can be used for comprehensive animal toxicological test and immunogenicity study. Results The toxicological test of ICR mice showed that the maximum tolerated dose(MTD) of the vaccine was more than 1200 ug/kg, and the immunogenicity test of rabbits showed that the titer of hemagglutination inhibitory antibody was more than 1:40 and the positive conversion rate was 100%.The neutralizing antibody in serum could protect chicken embryos from influenza virus infection. Conclusion Animal tests showed that the vaccine showed good safety and immunogenicity.
关键词
四价流感病毒裂解疫苗 /
安全性 /
免疫原性 /
中和抗体 /
血凝抑制抗体
Key words
Quadrivalent influenza split-virion vaccine /
Safety /
Immunogenicity /
Neutralization antibody /
Hemagglutination inhibition antibody
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参考文献
[1] WORLD HEALTH ORGANIZATION,Influenza (Seasonal)[EB/OL] ,(2018-11-06)[2019-02-15] https://www.who.int/news-room/fact-sheets/detail/influenza-(seasonal).
[2] Belongia EA,Kieke BA,Donahue JG,et,al.Effectiveness of inactivated influenza vaccines varied substantially with antigenic match from the 2004-2005 season to the 2006-2007 season[J].J Infect Dis,2009,199(2):159–167.
[3] Wang SY, Liu SZ, Chu K, et al.Immunogenicity and safety of an inactivatedquadrivalent influenza vaccine candidate versus inactivated trivalent influenza vaccines in participants >/=3 years of age: a double-blind, randomized, parallel-controlled phase III clinical trial in China[J].Expert Rev Vaccines,2017,16(11):1155-1169.
[4] Langley JM, Carmona Martinez A,Chatterjee A, et al.Immunogenicity and safety of an inactivated quadrivalent influenza vaccine candidate:a phase III randomized controlled trial in children[J].J Infect Dis,2013,208(4):544-553.
[5] Sano K, Ogawa H.Lectins: Methods in Molecular Biology (Methods and Protocols)[M].New York, Humana Press, 2014, 47-52.
[6] 王朝云,艾星,杨志敏,等.关于季节性流感灭活疫苗临床试验技术评价的考虑[J].中国新药杂志,2015,24(23):2660-2663.
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