重组乙型肝炎疫苗(酵母)免疫后10年的效果研究

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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。 Objective To evaluate the long-term efficacy and immunization of recombinant hepatitis B (hepatitis B) vaccine (yeast) (YDV) immunization. Methods Children born in 1995 and immunized fully according to the immunization program were followed up for the persistence of hepatitis B virus surface antibody (anti-HBs) 10 years after immunization. The immunization group and the control group were used to study the difference of HBsAg carrier rate and immune protection effect between the two groups. At the same time, compared with the HBsAg and HBcAg antibody Positive rate of vaccine immunoprotection effect analysis. Results The positive rate of anti-HBs, effective positive rate and geometric mean concentration (GMC) decreased year by year from 92.08%, 84.16% and 29.21 mIU / ml at one year after basic immunization Of 65.17%, 40.45% and 5.38mIU / ml respectively; the average annual decline rates were 3.76%, 7.82% and 17.14% respectively. The anti-HBs positive rate decreased slowly, but the positive rate was faster, and showed that with the prolongation of immunization time, the average annual decline rate of each indicator decreased, presumably low level of immunization may be maintained for a long time. The carrying rate of HBsAg in the immunized group was 0.41%, while the control group was 3.24%. The difference was statistically significant. The vaccine protection rate of the two groups was 87.35%. Before and after the implementation of immunization of children with the same age group HBsAg carrier rate comparison calculated vaccine protection rate of 95.00%. The positive rate of anti-HBc in immunized children was reduced by 83.99% compared with that of the same pre-immune children. Conclusion YDV ten years after immunization has a good immune persistence.
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