10微克/剂重组乙型肝炎疫苗(酿酒酵母)接种新生儿的安全性评价研究  

Safety EvaIuation of 10μg/Dose Hepatitis B Vaccine Made by Recombinant Deoxyribonucleic Acid Techniques in Saccharomyces Cerevisciae Yeast among Newborns

作　　者：曾滢 李杰[2] 宋雪芳 潘红星[3] 张艺飓[3] 梁争论[4] 朱凤才[3] 

机构地区：[1]深圳康泰生物制品股份有限公司,广东深圳518057 [2]北京大学医学部,北京100191 [3]江苏省疾病预防控制中心,南京210009 [4]中国食品药品检定研究院,北京100050

出　　处：《中国疫苗和免疫》2011年第6期490-493,515,共5页Chinese Journal of Vaccines and Immunization

基　　金：国家科学技术重大专项艾滋病和病毒性肝炎等重大传染病防治专项"我国乙型病毒性肝炎免疫预防策略研究"课题(编号2008ZX10002-001);"乙型肝炎疫苗质量控制和评价研究"课题(编号2009ZX10004-802)

摘　　要：目的评价广东省深圳康泰生物制品股份有限公司(康泰公司)生产的10微克(μg)/剂重组乙型肝炎疫苗(酿酒酵母)(Hepatitis B Vaccine Made by Recombinant Deoxyribonucleic Acid Techniquesin Saccharomyces Cerevisciae Yeast,HepB-SCY),接种新生儿的安全性。方法将1197名出生时健康的新生儿随机分为3组:试验组(599人)接种10μg/剂康泰公司生产的HepB-SCY;10μg对照组(300人)接种10μg/剂GlaxoSmithKline Biologicals S.A.(GSK)生产的HepB-SCY;5μg对照组(298人)接种5μg/剂康泰公司生产的HepB-SCY。对受试者进行接种后安全性观察和随访。结果试验组和两个对照组局部和全身不良反应症状、不良反应发生率分级间差异均无统计学意义(P>0.05)。结论康泰公司生产的10μg/剂HepB-SCY接种新生儿有良好的安全性,常见不良反应为疼痛、发热和皮肤黏膜。临床试验注册国家食品药品监督管理局《药物临床试验批件》Objective To evaluate the safety of lOng hepatitis B vaccine made by recombinant ibonucleic acid techniques in saccharomyces cerevisciae yeast （HepB-SCY）produced by Shenzhen deoxyr- Kangtai biological products CO., LTD among newborns. Methods 1197 newborns were enrolled in this study, and they were randomly divided into 3 groups. 599 of the 1197 neonates were included in group 1 as test group, and received 10μg/dose HepB-SCY vaccine. 300 of the 1197 neonates in group 2 received 10μg/ dose HepB-SCY produced by GlaxoSmithKline Biologicals S. A. 298 neonates in group 3 received 5μg/ dose HepB-SCY produced by Shenzhen Kangtai. Adverse reactions were observed for all the subjects after vaccination. Results There was no significant difference of injection-site adverse reaction and systemic adverse reaction among test group and control groups （P〉0.05）. Conclusion The 10μg HepB-SCY produced by Shenzhen Kangtai was safe. The adverse mucocutaneous. Clinical Trial Registration State 2006L01434 reactions commonly seen were pain, fever, skin and Food and Drug Administration. Approval Number： 2006L01434

关 键 词：重组乙型肝炎疫苗(酿酒酵母) 新生儿 安全性 不良反应 

分 类 号：R186[医药卫生—流行病学] R512.62[医药卫生—公共卫生与预防医学]