四价流感病毒裂解疫苗免疫原性及安全性试验研究

Experimental study on immunogenicity and safety of Influenza Vaccine(Split Virion),Inactivated,Quadrivalent

目的通过动物试验评价四价流感病毒裂解疫苗的免疫原性及安全性,为临床应用提供参考依据。方法将疫苗免疫NIH小鼠,应用血凝抑制试验检测小鼠血清抗体效价,评价疫苗免疫原性,用SPSS软件对数据进行单因素方差分析;采用小鼠、豚鼠腹腔注射给药方式进行异常毒性试验;采用小鼠后肢肌肉多点注射给药方式进行急性毒性试验;采用豚鼠腹腔注射免疫和静脉给药激发方式进行全身过敏性试验;采用家兔腿部肌肉注射给药方式进行肌肉刺激试验。结果免疫四价流感病毒裂解疫苗组与免疫流感病毒裂解疫苗(三价)组小鼠间,相同采血时间,同一亚型特异性抗体效价不存在显著差异(P>0.05);异常毒性、急性毒性、全身过敏性和肌肉刺激试验均符合安全标准。结论四价流感病毒裂解疫苗与流感病毒裂解疫苗(三价)各型免疫原性上不存在差异,且具有较好的安全性。

Objective To evaluate the immunogenicity and safety of Influenza Vaccine(Split Virion),Inactivated,Quadrivalent through animal experiments,and to provide reference for clinical application.Methods The NIH mice were immunized with the vaccine,and the serum antibody titer was detected by hemagglutination inhibition test to evaluate the immunogenicity of the vaccine,SPSS software was used to conduct one way ANOVA analysis on the data;the abnormal toxicity test was carried out by intraperitoneal injection in mice and guinea pigs;the acute toxicity test was carried out by multi-point injection of mice hind limb muscle;the systemic allergy test was carried out by intraperitoneal injection and intravenous administration in guinea pigs;the muscle stimulation test was carried out by intramuscular injection into the legs of rabbits.Results There were no significant differences in the mice,in the same blood sampling time,and in the titer of the same subtype specific antibody between the Influenza Vaccine(Split Virion),Inactivated,Quadrivalent group and the Influenza Vaccine(Split Virion),Inactivated,Trivalent group(P>0.05);abnormal toxicity,acute toxicity,systemic allergy and muscle stimulation tests all met safety standards.Conclusion There is no difference in the immunogenicity between the Influenza Vaccine(Split Virion),Inactivated,Quadrivalent and the Influenza Vaccine(Split Virion),Inactivated,Trivalent,and the Influenza Vaccine(Split Virion),Inactivated,Quadrivalent has better security.