国产重组(酵母)乙型肝炎疫苗的免疫动力学研究

目的　评价国产重组(酵母)乙型肝炎(乙肝)疫苗(YDV)的免疫学效果,建立免疫动力学模型,以预测国产YDV的免疫持久性,为初次免疫后何时进行加强免疫提供参考依据。方法　采用队列研究的方法,对接种国产YDV者的乙肝病毒表面抗体(抗HBs)滴度进行了5年的追踪观察。利用曲线拟合方法建立免疫动力学模型,并对其免疫持久性进行预测。在接种疫苗后第8年,再次对研究队列进行抗 HBs滴度实际测定,以检验模型预测结果的可靠性。结果　接种YDV5年后,抗HBs阳性率由接种后第1年的10 0 %下降到73% ,抗 HBs几何平均滴度(GMT)由接种后第1年的16 0mIU/ml下降到5 3mIU/ml。到第8年时,实际测定值下降到35mIU/ml,所拟合的模型为Y =16 5 . 6 7exp(- 0 .0 19X) ,决定系数R2 为0 . 98,模型预测的结果为2 7mIU/ml,比实际值低8mIU/ml。结论　按照模型预测的结果,接种国产YDV 12年后,其抗 HBsGMT为10 74mIU/ml,仍维持在10mIU/ml的保护性水平以上。由于在第8年时,模型预测值低于实际测定值,因此国产YDV的抗HBsGMT至少可维持12年的预测结果有一定的可靠性。

Study on the Dynamic Model of Anti-HbsAg''''s Titer of Hepatitis B DNA Recombinant Yeast-derived Vaccine (YDV) Made in China

Objective To establish the dynamic model for evaluate and predicte correctly the effect of the immunity and the persistence of DNA recombinant yeast-derived vaccine (YDV) made in China. Methods The cohort study,which had been undertaken for 5 years (from 1994 to 1999) on the vaccine was carried out.In 2002,fullow-up study on the cohort was done to further test the result of the previous study. All in all,the cohort study was extended for 8 years (from 1994 to 2002). Results The results of the research shows that after 5 years period of immunization,the positive rate of anti-HBsAg for YDV is 73% and anti-HBsAg is 53mIU/mL.The study in the year of 2002 shows that the anti-HBs in the remaining cohort is 35mIU/mL for YDV.The result demonstrates that the anti-HBsAg of YDV is maintained at a moderate level. Conclusion According to the dynamic model of YDV done by the author, it is possible that the long-time persistence of anti-HBs will be maintained for 12 years.