【摘要】 目的 探讨急性淋巴细胞白血病(Acute lymphoblastic leukemia, ALL)儿童乙型肝炎疫苗(Hepatitis B vaccine, HepB)加强免疫的免疫原性和安全性。方法 在上海市某医院招募已接种3剂次HepB、乙肝表面抗体(Hepatitis B surface antibody, HBsAb)阴性且病情稳定的3-17岁ALL儿童，按0-1-6月程序接受3剂次HepB加强免疫，检测免疫前和免疫后1个月血清乙肝表面抗体(Hepatitis B surface antibody, HBsAb),观察每剂次接种后1周内不良反应，分析HBsAb阳转率、几何平均浓度(Geometric mean concentration, GMC)和不良反应发生率。结果 共入组99例受试者，HepB加强免疫后HBsAb阳转率为100%;免疫后GMC为336.59(95%CI:281.66-398.30)mIU/mL,是免疫前的148.38(95%CI:141.99-155.38)倍；免疫后总不良反应发生率为1.35%(4/297),均为低热和局部红肿。结论 ALL儿童在临床治疗病情稳定后HepB加强免疫的免疫原性和安全性良好。更多还原

【Abstract】 Objective To explore immunogenicity and safety of hepatitis B vaccine(HepB) booster doses in children with acute lymphoblastic leukemia(ALL).Methods We recruited 3-17-year-old children from a hospital of Shanghai who had stable ALL, had previously received 3 doses of HepB, and were negative to hepatitis B surface antibody(HBsAb). Each subject received 3 HepB booster doses in a 0-1-6-month schedule. We tested sera for HBsAb before and 1 month after vaccination and observed for adverse reactions within one week after each dose to determine HBsAb seroconversion rates, geometric mean concentrations(GMCs), and incidences of adverse reactions.Results We enrolled 99 children with ALL. The HBsAb seroconversion rate after HepB booster vaccination was 100% and the GMC was 336.59(95% CI: 281.66-398.30) mIU/mL, which was 148.38(95% CI: 141.99-155.38) times higher than before vaccination. The overall incidence of adverse reactions following vaccination was 1.35%(4/297); all reactions consisted of low-grade fever or injection-site redness/swelling.Conclusions HepB booster vaccination in a 0-1-6 schedule was immunogenic and safe among children with ALL who were clinically stable after treatment.更多还原