重组酵母乙型肝炎疫苗的成人免疫效果分析

Analysis on immune-effects of recombinant yeast hepatitis B vaccine on adults

目的 了解重组酵母乙型肝炎（乙肝）疫苗在成年人中的免疫效果.方法 选择16～ 60岁知情同意、乙肝5项指标阴性的研究对象800人,按0-1-6程序接种重组酵母乙肝疫苗,并于第1针接种后第7个月和第12个月分别采集静脉血5 mL,采用雅培微粒子化学发光免疫分析法（Abbott试剂盒）检测乙肝表面抗体（HBsAb）.结果 HBsAb阳转率、达到长期保护性水平率第7个月分别为92.95％ （95％CI：90.79％～ 94.74％）、83.02％（95％CI：80.02％～ 85.74％）;第12个月分别为86.47％（95％CI：83.71％～ 88.93％）、67.48％ （95％CI：63.86％～ 70.96％）.抗体几何平均浓度（GMC）第7个月为（1 032.49±14.41）IU/L,第12个月为（249.59±12.01）IU/L.不同时间、年龄组、性别间差异均有统计学意义（P值均＜0.05）.结论 成年人接种重组酵母乙肝20 μg疫苗,年龄小者免疫效果好,女性免疫效果好于男性,并有加强免疫的必要性.

Objective To evaluate immune-effect of recombinant yeast hepatitis B vaccine on adults. Methods A total of 800 subjects were selected in Danyang County of Jiangsu Province, who were aged 16-60, with informed consent and negative on 5 indicators for hepatitis B. All subjects were inoculated with 20 μg recombinant yeast hepatitis B vaccine on 0-1-6 month schedule, 5ml blood samples were collected at 7 month and 12 month after the first dose of vaccination. HBsAb level was de- tected by Abbott chemiluminescence kit. Results At 7 month and 12 month, HBsAh sero-conversion rates were 92.95% （95%CI：90.79%-94.74%）and 86.47%（95%CI： 83.71%- 88.93%） ,respectively; while rates that HBsAb level acquiredfor long term protection were 83.02% （95%CI：80.02% - 85.74%）and 67.48% （95%CI：63.86%-70.96%）,respectively. GMC of HBsAb at 7 month and 12 month were（1 032.49±14.41）IU/L and（249.59±12.01）IU/L, respectively. Significant difference was observed on different time points, age groups and genders （all P〈0. 05）. Conclusion For adults inoculated with 20 μg recombinant yeast hepatitis B vaccine, better immune-effect was observed on younger subjects and female subjects, additional inoculation is necessary.