不同厂家无硫柳汞流感病毒裂解疫苗在动物体内免疫原性的比较

Immunogenicity of thimerosal-free influenza virus split vaccine from various manufacturers in animals

目的比较长春生物制品研究所有限责任公司（简称长春公司）生产的无硫柳汞流感病毒裂解疫苗与国内外同类产品在动物体内的免疫原性。方法分别用长春公司、国外A公司及国内B公司生产的无硫柳汞流感病毒裂解疫苗,经后腿胫前肌肌肉注射免疫小鼠,以注射PBS的小鼠作为对照。于免疫前及免疫后14、21、28、35、42 d,经小鼠眼静脉采血,分离血清,采用血凝抑制试验（hemagglutination inhibition,HI）检测小鼠血清中的抗体滴度,并计算HI抗体几何平均滴度（GMT）、HI抗体阳转率、HI抗体GMT增长倍数和HI抗体保护率。结果各疫苗组小鼠血清中HI抗体GMT均明显高于相应时间点的PBS组（P〈0.01）,各疫苗组组间差异无统计学意义（P〉0.05）;免疫后28、35、42 d,各疫苗组的HI抗体阳转率为77%~100%,组间差异无统计学意义（P〉0.05）;各疫苗组HI抗体GMT较免疫前增长倍数均〉2.5倍,组间差异无统计学意义（P〉0.05）;各疫苗组的HI抗体保护率为62%~100%,组间差异无统计学意义（P〉0.05）。结论长春公司生产的无硫柳汞流感病毒裂解疫苗与国外A公司疫苗免疫原性水平相当,略高于国内B公司。

Objective To compare the immunogenicity of thimerosal-free influenza virus split vaccine produced by Changchun Institute of Biological Products Co., Ltd.（CIBP） with those of domestic and imported products of the same kind in animals. Methods Mice were immunized i. m. with the vaccine from CIBP, imported vaccine A and domestic vaccine B respectively, using PBS as control. Serum samples were collected before and 14, 21, 28, 35 and 42 d after immunization respectively and determined for antibody titer by hemagglutination inhibition（HI） test, based on which the GMT, positive conversion rate, increasing fold of GMT and protective rate of HI antibody were calculated. Results The GMTs of antibodies of various subtypes in sera of mice immunized with various vaccines were significantly higher than those with PBS（P〈0. 01）, which showed no significant difference in various vaccine groups（P〉0. 05）. The positive conversion rates of HI antibody 28, 35 and 42 d after immunization were 77% ~ 100%, which showed no significant difference in various vaccine groups（P〉0. 05）. The highest GMTs of antibodies of various subtypes increased by more than 2. 5 folds as compared with those before immunization, which showed no significant difference in various vaccine groups（P〉0. 05）. The protective rates of antibodies of various subtypes were 62% ~ 100%, which showed no significant difference in various vaccine groups（P〉0. 05）. Conclusion The immunogenicity of thimerosal-free influenza virus split vaccine manufactured by CIBP was equivalent to that of imported vaccine A, which was slightly higher than that of domestic vaccine B.