国产季节性流行性感冒病毒裂解疫苗的安全性和免疫原性的研究与评价

A Study and Evaluation on Safety and Immunogenicity of the Domestic Inactivated Trivalent Split Virus Influenza Vaccine

目的研究评价国产流行性感冒(流感)病毒裂解疫苗[Influenza Vaccine(Split Varion),Inactivated;InfV-Sp]的安全性和免疫原性。方法以赛诺菲-巴斯德公司生产的InfV-Sp为对照,采用整群随机抽样的方法确定研究对象,分3～、18～、≥60岁三个年龄组,经受种者知情同意后,随机接种国产和进口InfV-Sp,观察记录接种后的局部和全身反应,并于接种前及接种后30d分别采集血液标本,测定免疫前、后血清中三个型别流感毒株的特异性抗体,对国产InfV-Sp的安全性和免疫原性进行评价。结果国产和进口InfV-Sp的发热(腋温>37℃)率分别为17.6%和18.6%,其中弱反应(37.1～37.5℃)发生率分别为16.1%和17.6%,差异无统计学意义(χ2=0.078,P>0.05);中反应(37.6～38.5℃)发生率分别为1.5%和0.5%,强反应(≥38.6℃)发生率分别为0和0.5%,差异均无统计学意义(χ2中=0.317、χ2强=0.316,P均>0.05)。国产InfV-SpH1N1、H3N2、B三个型别血凝抑制(Hemagglutination Inhibition,HI)抗体阳转率分别为80.8%、69.2%、55.1%,进口InfV-SpH1N1、H3N2、B型HI抗体阳转率分别为80.6%、70.6%、50.2%,差异均无统计学意义[χ2(H1N1)=0.957、χ2(H3N2)=0.751、χ2(B)=0.337,P均>0.05]。接种国产InfV-Sp可使H1N1、H3N2、B型HI抗体几何平均滴度(Geometric MeanTiter,GMT)分别升高21.1、13.0、5.7倍,接种进口InfV-Sp可使H1N1、H3N2、B型HI抗体的GMT分别升高20.1、14.6、4.8倍[t(H1N1)=-0.802、t(H3N2)=-1.688、t(B)=1.001,P均>0.05]。国产InfV-Sp可使H1N1、H3N2、B型流感的易感率分别下降96.8%、94.6%、92.0%,进口InfV-Sp可使H1N1、H3N2、B型流感的易感率分别下降99.3%、93.9%、90.5%。结论国产与进口InfV-Sp相比,具有同等安全性和免疫原性。

Objective To evaluate the safety and immunogenicity of the domestic inactivated trivalent split virus influenza vaccine.Method Selecting the subjects by cluster sampling and dividing them randomly into the test（Beijing Tiantan＇s InfV-Sp） and control groups（SanofiPasteur＇s InfV-Sp）.Giving the vaccination after signing the＂Consent Form for Immunization with the InfV-Sp＂.Observing the local and systemic reaction.The serum samples were collected before and 30-days after vaccination and the Hemagglutination Inhibition（HI） antibody against H1N1、H3N2 、B Flu viruses strains were tested.Results The fever reaction（axillary temperature37℃） rate of domestic and imported InfVSp were 17.6% and 18.6%,and the low-grade fever reaction（37.1～37.5℃） were 16.1% and 17.6% respectively,No statistical difference between them was found（χ2=0.078,P0.05）,and the middlegrade fever reaction（37.6～38.5℃） were 1.5% and 0.5% respectively,and the high-grade fever reaction（≥38.6℃） were 0 and 0.5% respectively,There were not statistical difference between them（χ2（middle）= 0.317,χ2（high）=0.316,P0.05）.The positive seroconnversion rate of H1N1、H3N2、B flu virus strains in domestic InfV-Sp were 80.8%、 69.2%、55.1%,and those in imported InfV-Sp were 80.6%、70.6%、50.2%[χ2（H1N1）=0.957,P0.05;χ2（H3N2）=0.751,P0.05;χ2（B）=0.337,P0.05].The geometric mean titer of the HI-antibody against H1N1、H3N2、B flu virus strains increased 21.1、13.0、5.7 times in domestic InfV-Sp respectively,and 20.1、14.6、4.8 times in imported InfV-Sp accordingly[t（H1N1）=-0.802,P0.05;t（H3N2）=-1.688,P0.05;t（B）=1.001,P0.05],The rate of population susceptibility to H1N1、H3N2 and B flu virus strains deceased by 96.8%、94.6% and 92.0% respectively in domestic InfV-Sp,and 99.3%、93.9% and 90.5% in imported InfV-Sp.Conclusion Compared the imported InfV-Sp with the domestic InfVSp,both of them have the excellent safety and immunogenicity.