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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 the sulfur-free HgL influenza virus split vaccine produced by Changchun Institute of Biological Products Co., Ltd. (Changchun Company) with that of similar products at home and abroad in animals. Methods The mice were immunized intramuscularly with the anterior tibialis anterior muscle by injection of the vaccine containing neither thimerosal-induced influenza virus produced by Changchun Company, A foreign company and domestic company B, respectively. The mice injected with PBS were used as control. Serum was collected from the ophthalmic vein of mice at 14,21,28,35 and 42 d before and after immunization, serum was separated, and the antibody titers in serum were measured by hemagglutination inhibition (HI) HI antibody geometric mean titer (GMT), HI antibody positive rate, HI antibody GMT fold increase and HI antibody protection rate. Results The serum levels of HI antibody in each vaccine group were significantly higher than those in PBS group at the corresponding time point (P <0.01). There was no significant difference between the vaccine groups (P> 0.05) d, the positive rate of HI antibody in each vaccine group was 77% -100%, with no significant difference between the two groups (P> 0.05). The GMT of HI antibody in each vaccine group was> 2.5 times higher than that before immunization, There was no statistical significance (P> 0.05). The HI antibody protection rate of each vaccine group was 62% -100%, with no significant difference between the two groups (P> 0.05). Conclusions Changchun-based Sulfulose-free Mercury-free Fluids Lysis Vaccine has the same immunogenicity as that of foreign company A vaccine, which is slightly higher than that of domestic Company B.