重组(酵母)乙型肝炎疫苗免疫后6年的效果观察

Study on Immune Effect of Recombinant Yeast-derived Hepatitis B Vaccine (YDV) 6 Years After Immunization

为观察重组 (酵母 )乙型肝炎 (乙肝 )疫苗 (YDV)免疫的长期效果及其免疫记忆反应 ,对 1995年出生并按照免疫程序全程接种YDV的儿童进行免疫后 6年乙肝病毒表面抗体 (抗 HBs)变化动态的连续观察。同时筛选该年龄组YDV免疫 5年后 ,经血清学检测抗 HBs<2 1mIU/ml的儿童 ,观察其YDV加强免疫 1针 (5 μg)后的免疫反应。结果显示 :抗 HBs阳性 (≥ 2 1mIU/ml)率、有效阳性 (≥ 10mIU/ml)率、几何平均滴度 (GMT)逐年下降 ,分别由基础免疫后 1年的 92 0 8%、84 16 %、2 9 2 1mIU/ml,降至 6年后的 6 8 6 9%、4 1 4 1%、6 0 8mIU/ml。抗 HBs阳性率下降速度较慢 ,每年平均降低 4 6 8% ;抗 HBs有效阳性率、GMT的下降速率较快 ,年均分别下降 8 5 5 %、4 6 3mIU/ml。对YDV免疫 5年后抗 HBs <2 1mIU/ml的儿童 ,加强免疫YDV 1针后的抗 HBs阳性率、有效阳性率均达到10 0 % ,GMT达基础免疫 1年时水平的 8 33倍 ,表明YDV免疫后同样产生特异性体液和细胞免疫记忆。由于YDV与血源乙肝疫苗在理化性质等方面的不同 ,是否也有同样长期的免疫记忆和保护效果 ,尚需进一步观察。

To observe the long-term effect of Recombinant Yeast-derive d Hepatitis B Vaccine (YDV) and its memory reaction,we continuously ob served the anti-HBs trends among c hildren born in 1995, 6 years after fully vaccinated YDV following the immunization schedule.Meanwhile th e children in the same age group w ith anti-HBs<2.1mIU/ml 5 years aft er YDV immunization were observed the immune reaction after one boost er dose(5μg) of YDV.The results sh owed that the positive(≥2.1mIU/ml) rate, the effective positive(≥10mIU /ml) rate, and the mean geometric t iters(GMTs) of anti-HBs were 92.08 %, 84.16%, and 29.2mIUml respectivel y 1 year after primary vacctination and decreased to 68.69%,41.41%, and 6.08mIU/ml respecively 6 years lat er.The positive rate of anti-HBs d ecreased 4.68% each year which was slow,but the effective positive ra te and the GMTs of anti-HBs decrea sed 8.55% and 4.66mIU/ml respective ly each year which were more quick ly.To the children with anti-HBs<2. 1mIU/ml 5 years after YDV immumiza tion and anti-HBs positive rate and effective positive rate both reach ed 100% after booster dose of YDV. GMT of anti-HBs after booster dose was 8.33 time higher than that in 1 year after primary immunization, which showed that the specific bod y fluid and cellular immune memory could be produced after YDV immuni zation. Due to the difference of ph ysicochemical property between YDV and PDV,whether YDV had long-term immune memory and protective effec t need to be further observed.