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目的比较中国医学科学院北京协和医学院医学生物学研究所制备的季节性流行性感冒病毒裂解疫苗[Seasonal Influenza Vaccine(Split Virion),Inactivated;sInfV-Sp],与赛诺菲巴斯德生物制品有限公司制备的sInfV-Sp在小鼠中的安全性和免疫效果。方法 用sInfV-Sp于腹腔内接种ICR(Institute of Cancer Research)小鼠(美国癌症研究所选育的Swiss小鼠分送各国饲养实验,各国称为ICR),每天称取体重,免疫后21d眼眶采血分离血清,用微量血凝抑制(Hem agglutination Inhibition,HI)试验测定小鼠血清中特异性抗体,计算几何平均滴度(Geometric Mean Titer,GMT)、抗体阳转率、保护率及GMT增长倍数。结果免疫后小鼠体重逐渐增加,组间差异无统计学意义(F=0.015,P=0.985);接种sInfV-Sp的HI抗体阳转率(2=0.00～0.640,P=0.313～1.00)、保护率(2=0.082～0.351,P=0.5540～0.774)及H1N1型、H3N2型和B型HI抗体GMT差异均无统计学意义,GMT增长>4倍。结论两种sInfV-Sp均有良好的安全性和免疫原性。
Objective To compare Seasonal Influenza Vaccine (Split Virion), Inactivated; sInfV-Sp prepared by Institute of Medical Biology, Chinese Academy of Medical Sciences and Peking Union Medical College, Company-prepared sInfV-Sp in mice for safety and immune effects. Methods SInfV-Sp was intraperitoneally inoculated intraperitoneally with ICR (Institute of Cancer Research) mice (Swiss mice bred by the American Cancer Institute were divided into countries and fed with ICRs). Body weight was weighed every day. After 21 days of immunization, Sera were separated from serum and the serum specific antibodies were detected by Hem agglutination inhibition (HI) test. Geometric Mean Titer (GMT), antibody positive rate, protection rate and multiplication of GMT . Results The body weight of mice immunized with SInfV-Sp increased gradually after vaccination, with no significant difference between the two groups (F = 0.015, P = 0.985) There was no significant difference in the GMT between the protection rate (2 = 0.082-0.351, P = 0.5540-0.774) and the H1N1, H3N2 and HI HI antibodies, and the GMT increased> 4 times. Conclusion Both sInfV-Sp have good safety and immunogenicity.