摘要
目的评价20μg重组乙型肝炎疫苗(酿酒酵母)[hepatitis B vaccine(Saccharomyces Cerevisiae),HepB-SC]应用于16岁及以上年龄健康成人的安全性和免疫原性。方法采用三臂试验设计,试验疫苗为深圳康泰生物制品股份有限公司(康泰公司)生产的20μg/支HepB-SC,对照疫苗分别为比利时葛兰素史克公司(GSK)生产的20μg/支和康泰公司生产的10μg/支HepB-SC。本研究共入选研究对象2 179人,采取2∶1配对,按0-1-6月程序,试验组免疫1 092人,20μg和10μg对照组分别免疫541和546人,观察接种后的安全性并检测首针免疫后7个月时的乙型肝炎表面抗体(抗-HBs)。结果试验疫苗与对照疫苗均具有较好的安全性,随访和不良反应观察中均未见有临床意义的严重不良事件。全程免疫后试验组抗-HBs阳转率与20μg对照组差异无统计学意义(98.22%vs 97.64%,P<0.05),但显著高于10μg对照组(98.22%vs 89.96%,P<0.01);免疫后抗-HBs水平试验组显著高于20μg对照组(1 770.81mIU/ml vs952.13mIU/ml,P<0.01)和10μg对照组(1 770.81mIU/ml vs 496.74mIU/ml,P<0.01)。结论 20μg重组乙型肝炎疫苗(酿酒酵母)应用于16岁及以上年龄健康人群具有良好的安全性和免疫原性。
Objective To evaluate the safety and immunogenicity of 20 μg hepatitis B vaccine from Saccharomyces Cerevisiae manufactured by Shenzhen Kangtai Biological Products Co. , Ltd （KT HepB-SC） in healthy adults of China. Methods This was a three-arm clinical trial. Test vaccine was the 20 μg KT HepB-SC, control vaccines were 20 μg HepB-SC from GSK （GSK HepB-SC） and 10μg KT HepB-SC. A total of 2 179 healthy adult volunteers were enrolled in this study with 1 092 in the 20 μg KT HepB-SC test group, 541 in the 20 μg GSK HepB-SC control group and 546 in the 10μg KT HepB-SC control group. The immunization was scheduled three doses at months 0, 1 and 6. Adverse reaction data within one month after vaccination were collected and blood samples were obtained on month 7 for anti-HBs detection. Results The 20μg/dose KT HepB-SC was safe. No severe adverse events or unex- pected events were reported during the follow-up. The anti-HBs seroconversion rate in the test group （98.22%） is similar to that in the 20 μg GSK HepB-SC control group （97. 64%）, but significantly higher than that in the 10 μg KT HepB-SC control group （89.96%, P〈0. 01）. Significant defferences were found in the anti-HBs GMC among these three groups （1 770.81 mIU/ml, 952.13 ml U/ml and 496.74 mlU/ml, respectively） （P〈0. 01）. Conclu- sions The 20 μg/dose KT HepB-SC is safe and effective to adults in China.
出处
《中国病毒病杂志》
CAS
2013年第5期353-357,共5页
Chinese Journal of Viral Diseases
基金
国家"十二五"艾滋病和病毒性肝炎等重大传染病防治科技重大专项(2012ZX10002001)
