国产流行性感冒病毒裂解疫苗安全性及免疫效果观察

目的 评价国产流行性感冒(简称流感)病毒裂解疫苗的安全性和免疫效果.方法 选择6岁～、16岁～和>60岁3个年龄段人群共606名,每个年龄段人群按数字表法随机分入试验组(共213名)、对照组1(共195名)和对照组2(共198名),分别接种国产流感疫苗和2种进口流感疫苗,比较三组人群接种后副反应发牛率、抗体阳转率、保护率及几何平均滴度(GMT)增长倍数的差异.率的比较采用X2检验,几何平均滴度(GMT)增长倍数采用方差分析,P<0.05为差异有统计学意义.结果 试验组、对照组1、对照组2副反应发生率分别为3.76%(8/213)、4.10%(8/195)和3.54%(7/198),差异无统计学意义(X2=0.87,P=0.93).3个组H1N1、H3N2和B(亚)型血凝抑制(H1)抗体总阳转率分别为89.2%(190/213)、63.4%(135/213)、86.4%(184/213),88.7%(173/195)、61.5%(120/195)、87.2%(170/195),87.9%(174/198)、61.6%(122/198)、84.8%(168/198),各(亚)型抗体总阳转率差异无统计学意义(X2H1N1=0.94,PH1N1=0.63;X2H1N2=0.94,PH3N2=0.63;X2B=0.75,PB=0.69);3个组H1N1、H3N2及B型H1抗体平均增长倍数分别为10.7、7.3、8.4倍,10.5、6.3、8.3倍,10.2、7.1、8.8倍,各(亚)型H1抗体GMT增长倍数差异无统计学意义(FH1N1=0.35,PH1N1=0.70;FH3N2=2.22,PH3N2=0.11;FB=1.51,PB=0.35);3个组H1N1、H3N2及B型H1抗体保护率分别为100%(213/213)、70.0%(149/213)、95.3%(203/213),100%(195/195)、66.7%(130/195)、97.9%(191/195),99.5%(197/198)、66.2%(131/198)、96.5%(191/198),各(亚)型抗体保护率差异无统计学意义(X2H1N1=2.04,PH1N1=0.36;X2H3N2=0.74,PH3N2=0.69;X2B=0.42,PB=0.82).结论 国产裂解流感疫苗具有良好的安全性和免疫效果,可用于群体性接种.

Safety and immunological effect of domestic split influenza virus vaccine

Objective To evaluate the safety and immunological effect of domestic split influenza virus vaccine. Methods All 606 subjects were divided into three groups by under 6, 16-60 and above 60 years old. Each age group was divided as study group(n=213) ,control group 1 (n=195) and control group 2(n=198) by Table of Random Number,one domestic vaccine and two imported vaccines were respectively inoculated in three group people. The differences of clinical side effect rate, antibody positive rate, protective rate and geometric mean titer (GMT) of these three vaccines were compared by using the statistical software with statistical significance of P<0. 05. Results The side effect rate of study group, control group 1 and control group 2 was 3.76% (8/213) ,4. 10% (8/195) ,and 3. 54% (7/198) ,respectively without statistical significance(X2=0. 87 ,P=0. 93). The positive seroconversion rates of HB1N1, H3N2 and B in these three groups were respectively 89. 2 % (190/213), 63.4% (135/213), 86. 4% (184/213), 88. 7 % (173/195), 61.5% (120/195), 87. 2% (170/195), 87.9% (174/198), 61.6% (122/198) and 84. 8% (168/198). There were no statistical significance in the total positive seroconversion rate of each antibody type(X2H1N1=0. 94, PH1N1=0. 63 ; X2H3N2=0. 94, PH3N2=0. 63 ; X2B=0. 75, PB=0. 69). The average growth multiple of H1 N1, H3N2 and B in these three groups were 10. 7,7.3,8.4,10. 5,6. 3,8. 3,10. 2,7. 1,8. 8 times. There were no statistical significances in the GMT growth multiple of each antibody type (FH1N1=0. 35, PH1N1=0. 70 ;FH3N2=2. 22,PH3N2=0. 11 ;FB=1.51 ,PB=0. 35). The antibody protective rates of H1N1 ,H3N2 and B were 100% (213/213) ,70. 0% (149/213) ,95.3% (203/213), 100% (195/195) ,66. 7% (130/195),97.9% (191/195) ,99. 5% (197/198), 66. 2% (131/198), 96. 5% (191/198) respectively. There was no statistical difference among the three vaccines(X2H1N1=2. 04,PH1N1=0. 36;X2H3N2=0. 74,PXH3N2=0. 69;X2B=0. 42, PB=0. 82). Conclusion The domestic influenza split vaccine might be suitable for colony vaccination for its having clinical safety and immunological effect.