重组乙型肝炎疫苗(酵母)免疫后10年的效果研究

目的研究评价重组乙型肝炎(乙肝)疫苗(酵母)(YDV)免疫的远期效果及加强免疫问题。方法对1995年出生,按照免疫程序全程免疫的儿童,追踪观察其免疫后10年乙肝病毒表面抗体(抗-HBs)的持久性。设免疫组与对照组,研究两组间乙肝病毒表面抗原(HBsAg)携带率差异及免疫保护效果;同时用免疫组儿童与实施免疫前同龄组儿童的HBsAg和乙肝病毒核心抗体(抗-HBc)阳性率对比分析疫苗免疫保护效果。结果抗-HBs阳性率、有效阳性率、几何平均浓度(GMC)逐年下降,分别由基础免疫后1年的92.08%、84.16%、29.21毫国际单位/毫升(mIU/ml)降至10年后的65.17%、40.45%和5.38mIU/ml;年均递减率分别为3.76%、7.82%和17.14%。抗-HBs阳性率下降速率较慢,而有效阳性率则较快,并显示随免疫时间的延长,各项指标的年均递减率逐年降低,推测免疫的低阳性率水平可能维持较长时间。免疫组的HBsAg携带率为0.41%,对照组为3.24%,差异有非常显著的统计学意义;两组对比计算的疫苗保护率为87.35%。实施免疫前后同龄儿童组HBsAg携带率比较计算的疫苗保护率为95.00%。免疫儿童抗-HBc的阳性率较实施免疫前同龄儿童降低了83.99%。结论YDV免疫后10年有较好的免疫持久性。

Study on Immune Effect of Recombinant Yeast-derived Hepatitis B Vaccine (YDV) After 10 Years Vaccination

Objective To study the immune forward effect on Recombinant Yeast-derived Hepatitis B Vaccine(YDV) and its boost problem.Methods The children born in 1995 had been vaccinated with full course of YDV 10 years ago were divided into immune group and control group,observed their level of carry rate of HBsAg and its protective effect.Meanwhile protective effect of positive rate of HBsAg and anti-HBc in immune group and reference group were analyzed.Result Positive rate of antiHBs was decreased from 92.08% to 65.17%,effective positive rate from 84.16% to 40.45% and the mean geometric titres(GMTs) from(29.21) mIU/mL to(5.38mIU/mL) compared with 1 year late basic vaccination.Decreased rate was 3.76%,7.82% and 17.14% respectively.The results showed immune time extending,each target decreased year by year,which showed low positive rate may keep longer time.Carry rate of HBsAg in immune group was 0.41%,in control group it was(3.24%),there was significant difference.According to comparative analysis,protected rate of vaccine was 87.35%.Compared their carry rate of HBsAg with before vaccination and after vaccination,protective rate of vaccine was(95.00%).Anti-HBc positive rate dropped 83.99%.Conclusion There is good immune persistence after 10 years YDV vaccination,protective effect of vaccine is better than PDV.