CAJ | 학술논문

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.
목적 고핵련속삼비갑간멸활역묘해이래복(R)림상응용적면역원성화안전성급질량적은정성、비간일치성.방법 채용수궤쌍맹설대조적림상시험설계,시험용역묘위련속삼비차적해이래복(R)화진구대조역묘.수시자위400명1～8세항-Hav음성건강인동,수궤분배도사개시험조,매조100인,해이래복(R)제량위매지250 U/0.5 ml,대조역묘제량위매지720 Elu/0.5 ml,안조0화6개월정서접충역묘.접충후진행30 min즉시반응관찰이급24、48、72 h적수방관찰,병재제일침면역후1、6、7개월채혈검측갑간항체.결과 사개시험조면후7개월항체양전솔균위100%;삼비해이래복(R)적GMT위3237.06～3814.14 mIU/ml,차이무통계학의의;대조역묘GMT위1467.49 mIU/ml.접충역묘후해이래복(R)화대조역묘조불량반응발생솔재1%～5%지간,이경도화중도발열위주,미견엄중불량반응발생.결론 해이래복(R)질량은정,비간일치성화안전성량호.
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.