两种流行性感冒病毒裂解疫苗安全性与免疫原性研究

Evaluation of safety and immunogenicity of two defferent-type split influenza virus vaccines

目的:评价国产流行性感冒裂解疫苗的安全性和免疫原性。方法:按整群随机抽样原则,以进口同类疫苗作为对照开展现场临床试验;比较两种疫苗免后不良反应率、抗体阳转率、保护率及几何平均滴度(GMT)。结果:试验组及对照组接种后全身不良反应率分别为2.7%和3.6%(P>0.05),局部不良反应率分别为7.2%和9.6%(P>0.05);试验疫苗流感病毒HIN1、H3N2及B(亚)型的HI抗体总阳转率分别为81.6%,92.4%和78.0%;对照疫苗流感病毒HIN1、H3N2及B(亚)型的HI抗体总阳转率分别为87.1%,88.3%和80.8%,三(亚)型流感抗体总阳转率差异无统计学意义;三(亚)型流感HI抗体达到保护水平的保护率的比较中,只有婴幼儿试验组和对照组的免后B型HI抗体滴度≥1∶40,差异有统计学意义,试验组大于对照组,其余3组差异无统计学意义;三(亚)型流感抗体免后GMT的差异亦无统计学意义。结论:国产流感裂解疫苗全身和局部不良反应与进口同类疫苗无差异,免后抗体阳转率较高,抗体滴度上升幅度较大,具有良好的安全性和免疫原性。

Objective To evaluate the safety and immunogenicity of two defferent -type split influenza virus vaccines. Methods Samples were chosen by cluster and random rnethod,and divided into trial group（administrated split influenza virus vaccines made in Hua-lan Biological Product Institute, China） and control group（administrated split influenza virus vaccines made in Aventis Pasteur Company, French）. Results A{ter immunization, the systemic and local adverse events of trial group and control group did not appeared statistically significant （2. 70/oo vs 3. 6%, P〉0. 05 and7 . 20/00 vs 9. 6%, P〉0. 05 ）. Three sub-type split influenza virus （HIN1, H3N2 and B type）antibody positive rates of trail and control groups did not appeared statistically significant （81.6% vs 87. 1%, P〉0. 05; 92. 4% vs 88. 3 %, P〉0. 05 ; 78. 0% vs 81.8%, P〉0. 05%） , the antibody protective rate ,GMT and average increased times also did not appeared statistically significant（95. 6% vs 95. 9%, P〉0. 05. 8. 77 vs 8. 37, P〉0. 05. 111.6 vs 101.1, P〉0. 05） . Conclusions Split influenza virus vaccines made in Hua -lan Biological Product Institute its safety and immunogenicity were as good as homo vaccine made in Aventis Pasteur Company.