新生儿接种不同种类乙型肝炎疫苗安全性和免疫应答的研究  

Study on Safety and Immunologic Response with Different Hepatitis B Vaccine of Primary Vaccination for Infants

作　　者：周绍英[1] 边国林[1] 马瑞[1] 倪红霞[1] 董红军[1] 史宏辉[2] 胡丹标[3] 

机构地区：[1]宁波市疾病预防控制中心,浙江宁波315010 [2]余姚市疾病预防控制中心,浙江余姚315400 [3]宁海县疾病预防控制中心,浙江宁海315600

出　　处：《中国疫苗和免疫》2012年第1期26-30,共5页Chinese Journal of Vaccines and Immunization

基　　金：国家科学技术"艾滋病和病毒性肝炎等重大传染病防治"重大专项"我国乙型病毒性肝炎流行规律和防治对策研究"课题(编号2008ZXl0002-001)

摘　　要：目的了解新生儿接种不同种类乙型肝炎(乙肝)疫苗(Hepatitis B Vaccine,HepB)的安全性和免疫应答。方法选择浙江省余姚市、宁海县2009年7月1日～12月31日在本地产院分娩的新生儿,分别按0、1、6个月免疫程序接种10微克(g)重组HepB(汉逊酵母)[HepB Made by Recombinant Deoxyribonucleic Acid(DNA)Techniques in Hansenula Polymorpha Yeast,HepB-HPY]和5g重组HepB(酿酒酵母)[HepB Made by RecombinantDNA Techniques in Saccharomyces Cerevisiae Yeast,HepB-SCY],在接种后7d进行安全性评价,并对母亲乙肝病毒表面抗原[Hepatitis B Virus(HBV)Surface Antigen,HBsAg]阴性的本地新生儿全程免疫后1个月及6个月,分别采集血标本进行免疫应答评价。结果 5g HepB-SCY和10g HepB-HPY不良反应发生率分别为44.16/10万和35.74/10万,差异无统计学意义。在全程接种后1个月及6个月,5g HepB-SCY和l0g HepB-HPY的抗乙肝病毒表面抗原抗体(Antibody to HBsAg,Anti-HBs)阳性率分别为99.81%、98.26%和99.81%、99.22%,差异无统计学意义;Anti-HBs的几何平均浓度(Geometry Mean Concentration,GMC)分别为762.71毫国际单位/毫升(mIU/ml)、257.59mIU/ml和2796.82mIU/ml、704.02mIU/ml,差异有统计学意义,10g HepB-HPY组均高于5g HepB-SCY组。Anti-HBs低/无应答(<100mIU/ml)率分别为5.61%、23.60%和1.36%、5.04%,差异有统计学意义,5g HepB-SCY组均高于10g HepB-HPY组。结论 10g HepB-HPY具有与5g HepB-SCY相同的安全性,但免疫应答优于5g HepB-SCY。Objective To know the safety and immunologic response with different hepatitis B vaccine （HepB） in infants. Methods The infants born from July 1, 2009 to December 31, 2009 in Ninghai county received a 0.5ml of 5-μg HepB made by recombinant deoxyribonucleic acid （DNA） techniques in saccharomyces cerevisiae yeast （HepB-SCY）and those in Yuyao received a 0.5ml of 10-μg HepB made by recombinant DNA techniques in hansenula polymorpha yeast （HepB-HPY）（0, 1, 6 month schedule）. Safety was evaluated at 7 days after vaccination. In which, the local infants who accepted 3 doses HepB and born from hepatitis B virus （HBV）surface antigen （HBsAg）negative mother were selected and their blood specimens were collected at 1 month and 6 months after vaccination of 3 doses for testing antibody. Results There was no statistical significant difference about adverse reaction rate of HepB-SCY group （44.16/100,000） and HepB-HPY group （35.74/100,000）. At 1 month and 6 months after vaccination of 3 doses, the antibody to HBsAg （Anti-HBs）positive rate of HepB-SCY group were 99.81%, 98.26% and HepB-HPY group were 99.81%, 99.22%, no statistical significant difference about HepB- SCY group and HepB-HPY group. The geometric mean concentration （GMC） of Anti-HBs in HepB- SCY group were 762.71mlU/ml, 257.59mIU/ml and in HepB-HPY group were 2796.82mIU/ml, 704.02mlU/ml. There was statistical significant difference about HepB-SCY group and HepB-HPY group and GMC of HepB-HPY group were higher than that of HepB-SCY group. The percent of 〈 100mIU/ml in HepB-SCY group were 5.61%, 23.60% and in HepB-HPY group were 1.36~, 5.04%. There was statistical significant difference about HepB- SCY group, and HepB-HPY group, and HepB-SCY group were higher than that of HepB-HPY group. Conclusion The safety was similar with HepB-SCY and HepB-HPY, but the immunologic response of HepB-HPY was better than that of HepB-SCY.

关 键 词：新生儿 乙型肝炎疫苗 安全性 免疫应答 

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]