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.
Key words
Quadrivalent influenza split-virion vaccine /
Safety /
Immunogenicity /
Neutralization antibody /
Hemagglutination inhibition antibody
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References
[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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