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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。
OBJECTIVE: To evaluate the immunological effects of domestic recombinant (yeast) Hepatitis B (HBV) vaccine (YDV) and to establish an immunological kinetic model to predict the immune persistence of domestic YDV and to provide a reference for when to boost immunity after initial immunization. Methods A cohort study was conducted to track the titer of hepatitis B virus surface antibody (anti-HBs) in domestic YDV patients for 5 years. The immune dynamics model was established by curve fitting method, and its immune persistence was predicted. At 8 years after vaccination, the cohort was again tested for actual anti-HBs titer to test the reliability of the model predictions. Results The positive rate of anti-HBs decreased from 100% of the first year after inoculation to 73% after inoculation of YDV for 5 years. The geometric mean titer of anti-HBs decreased from 160 mlU / ml in the first year after inoculation to 53 mlU / ml. By the 8th year, the actual measured value dropped to 35mIU / ml, and the fitted model was Y = 16 5. 6 7exp (-0.09X), the coefficient of determination R2 was 0.98, and the result of the model prediction was 2 7mIU / ml, 8mIU / ml lower than the actual value. Conclusion According to the results of the model prediction, after 12 years of inoculation of domestic YDV, the anti-HBsGMT was 10 74 mIU / ml, which remained above the protective level of 10 mIU / ml. As the predicted value of the model is lower than the actual measured value at the 8th year, the reliability of the domestic YDV anti-HBsGMT for at least 12 years of predicting the result is certain.