连续三批甲型肝炎灭活疫苗在儿童中应用的免疫原性和安全性研究

目的 考核连续三批甲肝灭活疫苗孩尔来福(R)临床应用的免疫原性和安全性及质量的稳定性、批间一致性.方法 采用随机双盲设对照的临床试验设计,试验用疫苗为连续三批次的孩尔来福(R)和进口对照疫苗.受试者为400名1～8岁抗-Hav阴性健康儿童,随机分配到四个试验组,每组100人,孩尔来福(R)剂量为每支250 U/0.5 ml,对照疫苗剂量为每支720 Elu/0.5 ml,按照0和6个月程序接种疫苗.接种后进行30 min即时反应观察以及24、48、72 h的随访观察,并在第一针免疫后1、6、7个月采血检测甲肝抗体.结果 四个试验组免后7个月抗体阳转率均为100%;三批孩尔来福(R)的GMT为3237.06～3814.14 mIU/ml,差异无统计学意义;对照疫苗GMT为1467.49 mIU/ml.接种疫苗后孩尔来福(R)和对照疫苗组不良反应发生率在1%～5%之间,以轻度和中度发热为主,未见严重不良反应发生.结论 孩尔来福(R)质量稳定,批间一致性和安全性良好.

Immunogenicity and safety of three consecutive lots on a inactivated hepatitis A vaccine: a double-blind,randomized and controlled trial in children

Objective To evaluate the immunogenicity, safety, stability and consistency of three consecutive lots of a inactivated hepatitis A vaccine (Healive(R)). Methods A double-blind, randomized and controlled clinical trial was conducted in healthy volunteers aged from 1 to 8 years. Totally, 400 subjects were enrolled and assigned into four groups, each receiving one of the three lots of Healive(R) or an licensed control vaccine in 0 and 6th month. Safety was assessed through a 30 minutes and three days observation,thereafter. Anti-HAV titers were determined on the 1st, 6th and 7th month after the vaccination.Results Seroconversion rate of four groups were all 100% by the end of the schedule while GMTs of Healive(R) were 3237.06-3814.14 mIU/ml but were not significantly different. GMT of control vaccine was 1467.49 mIU/ml. Healive(R) and control vaccine were well tolerated with 1%-5% incidence of overall adverse reactions in which most of them were mild and moderate. No severe adverse reaction was reported.Conclusion The three consecutive lots of Healive(R) were well consistent as indicated by immunogenicity and safety while immunogenicity was better than the vaccine used as control.