国产流行性感冒裂解疫苗临床安全性与免疫原性评价

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;比较两种疫苗免疫后临床反应率、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发热反应率分别为1.4%和2.1%(P>0.05),局部反应率分别为1.6%和1.7%(P>0.05);试验疫苗流感病毒H1N1、H3N2及B(亚)型的HI抗体总阳转率分别为75.30%、75.30%、42.59%;对照疫苗流感病毒H1N1、H3N2及B(亚)型的HI抗体总阳转率分别为75.10%、77.08%、39.52%;三(亚)型流感抗体总阳转率无统计学意义。三(亚)型流感抗体增长倍数均无统计学意义。三(亚)型流感HI抗体达到保护水平的保护率均无统计学意义。结论国产流感裂解疫苗发热反应和局部反应与进口同类疫苗无差异,免疫后抗体阳转率较高,抗体滴度上升幅度较大,具有良好的临床安全性和免疫原性。

Evaluation of safety and immunogenicity of plit influenza virus vaccine

Objective To evaluate the safety and immunogenicity of split influenza virus vaccine.Methods Samples were chosen by cluster and random method,and divided into split vaccination group and the homo-imported influenza vaccination group.Results After injection,the fever-reaction rates of trial group and control group were 1.4% and 2.1%((P>0.05)),the local reaction rates were(1.6%) and (1.7%)((P>0.05)).After immunization,the antibody positive rates of trail and control groups did not appeared statistically significant(H3N2:(75.30%) vs 75.10%,H1N1:75.30% vs 77.08%, B:(42.59%) vs(39.52%)).For GMT of type H1N1,H3H2 and B antibody,trial group increased averagely(15.8),(5.1) and 5.8 times,control group increased 16.0,5.3 and 5.6times.Conclusions Influenza split vaccine made in Dalian Kunyang company its safety and immunogenicity were good as homo-imported vaccine.