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目的比较不同剂次重组乙型肝炎(乙肝)疫苗(酵母)[Hepatitis B vaccine made by recombinantdeoxyribonucleic acid(DNA)techniques in polymorpha Yeast,HepB-Y]加强免疫效果,为加强免疫决策提供依据。方法选择一周岁内完成乙肝疫苗(Hepatitis B vaccine,HepB)基础免疫的5岁以上儿童1728例,采集血清,使用化学发光法检测乙肝病毒表面抗原(Hepatitis B virus surface antigen,HBsAg)、乙肝病毒表面抗体(抗-HBs)、乙肝病毒核心抗体(抗-HBc),对仅抗-HBs阳性者接种5μg重组HepB-Y一剂次、抗-HBs阴性者接种三剂次,接种后1个月采血检测抗-HBs。结果加强免疫前、加强免疫一剂次和三剂次后抗-HBs阳性率分别为40.10%、94.04%、99.54%,三者两两之间抗-HBs阳性率差异均有统计学意义(P<0.05)。抗-HBs阴性者加强免疫一剂次、三剂次后抗-HBs阳转率分别为88.50%、99.42%,二者差异有统计学意义(P<0.05),加强一剂次后,各年龄组儿童抗-HBs阳转率随年龄增加呈下降趋势(P<0.05),加强三剂次后,各年龄组儿童抗-HBs阳转率与年龄未呈现相关性(P>0.05)。抗-HBs阴性者加强免疫一剂次、三剂次后几何平均滴度(geometric means of titer,GMT)分别为450.47IU/L、664.95IU/L,抗-HBs阳性者加强免疫一剂次后GMT为3 663.68IU/L。结论采用5μg重组HepB-Y对5岁以上抗-HBs阳性儿童加强免疫一剂次、对5岁以上抗-HBs阴性儿童加强免疫三剂次,免疫效果良好。
Objective To compare the effect of different doses of recombinant hepatitis B vaccine (Hepatitis B vaccine made by recombinant deoxyribonucleic acid (DNA) techniques in polymorpha Yeast, HepB-Y) to provide evidence for enhancing immune decision-making. Methods A total of 1728 children aged above 5 years old who had completed the basic immunization of Hepatitis B vaccine (HepB) within one year of age were enrolled in this study. Serum was collected for the detection of Hepatitis B virus surface antigen (HBsAg), hepatitis B virus surface (Anti-HBs) and hepatitis B virus core antibody (anti-HBc) were inoculated with 5μg of recombinant HepB-Y against anti-HBs positive only, and those with anti-HBs negative were inoculated three times and blood was collected one month after inoculation Anti-HBs test. Results The positive rates of anti-HBs in one dose and three doses after boosting were 40.10%, 94.04% and 99.54%, respectively. There was significant difference in the positive rate of anti-HBs between the two groups (P <0.05). The positive rate of anti-HBs was 88.50% and 99.42% respectively after three doses of anti-HBs immunization for one dose. The difference was statistically significant (P <0.05) The positive rate of anti-HBs in the children decreased with age (P <0.05). After three doses, the positive rates of anti-HBs in children of all ages were not correlated with age (P> 0.05). The anti-HBs-negative immunostimulants were given a dose of 450.47 IU / L and 664.95 IU / L respectively after three doses, and the anti-HBs-positive patients were boosted one dose later GMT is 3 663.68 IU / L. Conclusion 5μg of recombinant HepB-Y can enhance the immunity of children over 5 years old with anti-HBs one dose, and strengthen the immunity of children over 5 years old with anti-HBs three times. The immune effect is good.