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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 understand the safety and immune effect of Influenza A (H1N1) vaccine and provide a scientific basis for the scientific use of Influenza A (H1N1) vaccine. Methods According to the principle of randomized controlled clinical trial, 400 eligible persons were selected in Hetaizhong Central Elementary School (Rural Group) and Pingyuan Primary School (Town Group) in Pingyuan County of Meizhou City, and 200 people were randomly selected to receive Influenza A (H1N1) Vaccines and another 200 were not vaccinated, both for safety and epidemiological surveillance. In the vaccination group, 60 individuals were randomly selected as the assessment of immune effect. Blood samples were collected before immunization and at 1 month after immunization. The HI antibody was determined by the hemagglutination inhibition test. Results A total of 60 people were monitored, and 50 people were immunized successfully. The rate of successful immunization was 83.33%. The geometric mean titer (GMT) was 1: 736.23. In the urban area, 27 people were immunized and 23 people were immunized successfully. The success rate of immunization was 85.19% and the GMT was 1: 789.36. In rural areas, 33 people were immunized and 27 were immunized successfully. The immune success rate was 81.82% and the GMT was 1:701.45. There was no significant difference in the success rates of immunization in different regions (χ2 = 0.53, P> 0.05). The vaccination group and the control group of 400 subjects for up to 6 months of epidemiological surveillance, were not influenza-like cases. Conclusion Influenza A H1N1 influenza vaccine has good safety and immune protection.