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目的比较不同剂次重组乙型病毒性肝炎(乙肝)疫苗(汉逊酵母)(HepB-HPY)加强免疫效果。方法选择出生时完成乙肝疫苗(HepB)基础免疫的>5岁儿童1981例,采集血清,使用化学发光法检测乙肝病毒表面抗原(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1剂次、抗-HBs阴性者接种3剂次10μg HepB-HPY,免后1月采血检测抗-HBs。结果加强免疫前、加强免疫1剂次和3剂次HepB-HPY后抗-HBs阳性率分别为38.62%、95.66%和99.75%,三者两两之间差异均有统计学意义(χ2=73.794～1736.113,均P<0.05)。抗-HBs阴性者加强免疫1剂次和3剂次后抗-HBs阳转率分别为92.93%和99.67%,差异有统计学意义(χ2=77.582,P<0.05);加强免疫1剂次、3剂次HepB-HPY后抗-HBs几何平均浓度(GMC)分别为783.23 mIU/ml和2463.97 mIU/ml,抗体滴度差异有统计学意义(t=-14.201,P<0.05)。与免前抗体浓度水平<1 mIU/ml的儿童相比,抗-HBs滴度在1～10 mIU/ml的儿童加强免疫1剂后抗体阳转率和GMC都要更高,差异有统计学意义(所有P<0.05)。结论采用10μg HepB-HPY对5～8岁抗-HBs阴性儿童加强免疫1剂次、对9岁以上抗-HBs阴性儿童加强免疫3剂次,免疫效果良好。
Objective To compare different doses of recombinant hepatitis B (Hepatitis B) vaccine (Hansenula polymorpha) (HepB-HPY) to enhance the immune effect. Methods 1981 children> 5 years of age who completed the basic immunity of HepB at birth were enrolled and the serum was collected. (Anti-HBc), anti-HBs positive only one dose, anti-HBs negative three doses of 10μg HepB-HPY, anti-HBs tested after January without blood. Results The positive rates of anti-HBs in HepB-HPY group after one and three doses of boost were 38.62%, 95.66% and 99.75%, respectively. The difference between the two groups was statistically significant (χ2 = 73.794 ~ 1736.113, all P <0.05). The anti-HBs positive rate of anti-HBs positive rate was 92.93% and 99.67% after 1 and 3 doses respectively (χ2 = 77.582, P <0.05) The geometric mean concentrations of anti-HBs (GMC) of HepB-HPY after 3 doses were 783.23 mIU / ml and 2463.97 mIU / ml, respectively. The antibody titer was significantly different (t = -14.201, P <0.05). Anti-HBs titer of 1 ~ 10 mIU / ml in children with one dose of immunization after positive antibody positive rate and GMC were higher, the difference was statistically significant compared with children without pre-antibody concentration <1 mIU / ml Significance (all P <0.05). Conclusion 10μg of HepB-HPY was used to boost the immunity of children aged 5 ~ 8 years with anti-HBs for 1 dose, and the immunized children with anti-HBs more than 9 years of age were boosted 3 times with good immunization effect.