新生儿接种不同剂量重组乙肝疫苗安全性评价

Safety assessment on recombinant hepatitis B vaccine of different doses among newborns

目的评价未感染或感染乙肝病毒(HBV)母亲所产新生儿接种10μg/0.5mL重组(酿酒酵母)乙肝疫苗(HepB SCY)安全性。方法研究设计为随机、对照和盲法条件下的III期疫苗临床试验。根据母亲血清乙肝表面抗原与乙肝e抗原筛查结果,将新生儿分为阴性、单阳与双阳3组,分别纳入326、93、87例研究对象。各组新生儿均采用0、1、6月免疫程序按1∶1比例随机接种10μg或5μg HepB-SCY。接种后1个月内进行安全性观察。结果阴性组、单阳组与双阳组接种2种剂型疫苗后,各组不同剂次内总体及全身不良反应发生率差异均无统计学意义(P值均>0.05)。双阳组2种剂型总体不良反应发生率随接种剂次增加而增加,仅双阳组10μg剂型1级局部不良反应发生率高于5μg剂型。除双阳组注射部位疼痛外,各组其他不良反应症状间差异均无统计学意义(P值均>0.05)。不良反应主要发生在接种后30 min^3d。结论 10μg/0.5mL剂型HepB-SCY应用在未感染或感染HBV母亲所产新生儿人群中具有良好的安全性。

Objective To evaluate safety of 10 μg/0.5 mL hepatitis B （HB） recombinant vaccine （originated from Saccharo- myces cereviside, HepB-SCY） to newborns with HB-uninfected or HB-infected mothers. Method A controlled blinded phase III clinical trial on HepB SCY was conducted. Newborns were derided to negative group,single positive group and double positive group based on maternal HB surface antigen （HBsAg） and HB e antigen （HBeAg）. A total of 326, 93, and 87 subjects were recruited in negative group, single positive group and double positive group, respectively. Subjects were randomly alloca-ted （in 1：1 ratio） to receive three dose of 10 μg or 5 vg HepB-SCY within 24 h, at 1 month and 6 month. Adverse reactions （AR） within 1 month were observed. Results There were no significant difference within total incidence of AR and systemic AR of each dose amongst three groups （all P〉0.05）. The total incidence of AR of double positive group increased upon additional vaccination for both doses. The incidence of injection-site AR （grade 1） in 10 μg group was higher than that of 5 μg group. Except for pain at the injection site in double positive group, no statistical difference of incidences for other AR syndromes amongst other groups were found（all P〉0. 05）. Most of AR appeared within 30 m to 3 d after vaccination. Conclusion 10μg/0.5 mL HepB-SCY was safe and well tolerated for newborns born with HB-uninfected and HB-infected mothers.