国产流行性感冒裂解疫苗临床反应与免疫原性观察

目的　评价国产流行性感冒裂解疫苗的临床反应和免疫原性。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观察 ;比较两种疫苗免疫后的反应率、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 1针接种后全身反应率分别为 1 .79%和 3. 32 % ,局部反应率分别为 1 .5 4 %和2 . 37% ;试验组、对照组中的婴幼儿 2针全程免疫后全身反应率分别为 5. 0 8%和 7 .6 9% ,局部反应率分别为 5 . 0 8%和 3.85 %。试验组免后H1N1、H3 N2 、B型抗体阳转率分别为 91. 36 %、86 . 36 %和 83. 18% ,对照组分别为 93 .13%、84 . 73%和 75 .5 7% ,两组比较差异无显著意义。非易感者免后H1N1、H3 N2 、B型抗体GMT与免前相比 ,试验组分别为免前的 18 2 8、9 30和 8 6 1倍 ,对照组分别为免前的 18 16、8 4 5和 5 . 77倍。试验组免后H1N1、H3 N2 、B型抗体保护率分别为 86 . 82 %、99. 0 9%和 96 . 36 % ,对照组分别为 96. 18%、96 .18%和 92 . 37%。结论　国产流感裂解疫苗具有与进口同类疫苗相似的临床反应及良好的免疫原性。

A Clinical Trial of Adverse Reaction and Immunogenicity of Domestic Lytic Influenza Virus Vaccine

Objective To evaluate the adverse reaction and immunogenicity of domestic lytic influenza virus vaccine in humans.Methods Divide the subjects at various ages into trial and control groups by random cluster sampling and inoculate with domestic and imported lytic influenza virus vaccines respectively.Compare the adverse reaction rates,antibody positive conversion rates and GMTs of the 2 groups.Results The systemic reaction rates after one dose were 1.79% and 3.32%,while local reaction rates were 1.54% and 2.37% in trial and control groups respectively.The systemic reaction rates after two doses in infants were 5.08% and 7.69%,while local reaction rates were 5.08% and 3.85% in trial and control groups respectively.The positive conversion rates of antibodis of types H 1N 1,H 3N 2 and B were 91.36%,86.36% and 83.18% respectively in trial group,which showed no significant difference with those in control group (93.13%,84.73% and 75.57% respectively).The GMTs of antibodies of types H 1N 1,H 3N 2 and B in non-susceptible subjects in trial group increased by 18.28,9.30 and 8.61 folds,while those in control group increased by 18.16,8.45 and 5.77 folds respectively.The protective rates against antigens of types H 1N 1,H 3N 2 and B were 86.82%,99.09% and 96.36% in trial group,and 96.18%,96.18% and 92.37% in control group respectively.Conclusion Both adverse reaction rate and immunogenicity of domestic lytic influenza virus vaccine were similar to those of importd vaccine.