梅州市小学生甲型H1N1流感疫苗安全性和免疫效果评价

Evaluation on safety and immune effect of influenza A(H1N1) vaccine in primary students in Meizhou city

目的了解甲型H1N1流感疫苗的安全性和免疫效果,为甲型H1N1流感疫苗的科学使用提供依据。方法按照随机、对照临床试验原则,在梅州市平远县河头镇中心小学(农村组)和平远县第一小学(城镇组)选取符合条件的400人,随机抽取200人接种甲型H1N1流感疫苗,另200人不接种,均进行安全性以及流行病学监测。在接种组按单纯随机方法抽取60人作为免疫效果评估对象,在免疫前和免疫后1个月采血,采用血凝抑制实验方法测定HI抗体。结果共监测60人,免疫成功者50人,免疫成功率为83.33%,几何平均滴度(GMT)为1:736.23。城镇地区监测27人,免疫成功者23人,免疫成功率为85.19%,GMT为1:789.36;农村地区监测33人,免疫成功者27人,免疫成功率为81.82%,GMT为1∶701.45,不同地区免疫成功率差异无统计学意义(χ2=0.53,P>0.05)。对接种组和对照组400名对象开展长达6个月的流行病学监测,均未发生流感样病例。结论甲型H1N1流感疫苗具有良好的安全性和免疫保护效果。

Objective To evaluate the safety and immune effect of influenza A（H1N1）vaccine,and provide the scientific basis for the influenza A（H1N1）vaccine immunization. Methods A clinical trial was performed according to randomized controlled principle.400 qualified cases were selected in Hetou town central primary school（rural group）and Pingyuan first primary school （urban group）in Pingyuan county Meizhou city.200 cases were randomly selected for influenza A（H1N1） vaccine immunization,and the other 200 cases did not arrange vaccination.Two groups were observed for safety and epidemiological surveillance. In the vaccination group,60 cases were single randomly selected as evaluation object for immune effects.The blood samples were collected before immunization and 1 month after immunization,for measuring antibody against HI using hemagglutination inhibition. Results 60 cases were supervised,50 cases were immunization success,the immunization success rate was 83.33%, GMT for 1：736.23.27 cases were supervised in urban area,23 cases were immunization success,the immunization success rate was 85.19%,GMT for 1：789.36.33 cases were supervised in rural area,27 cases were immunization success,the immunization success rate was 81.82%, GMT for 1：701.45.No statistics signification in the immunization success rate between different areas （χ2= 0.53,P〉0.05）.The epidemiology supervised in immunization group and control group 400 cases for 6 months,no influenza-like illness case occur. Conclusion Influenza A（H1N1） vaccine is effective and safe.