新生儿及以上人群接种不同剂量重组乙型肝炎疫苗(酿酒酵母)的免疫学效果观察分析  

Immunogenicity of Different Doses of Hepatitis B Vaccine Made by Recombinant Deoxyribonucleic Acid Techniques in Saccharomyces Cereviside Yeast among Newborn and Infant

作　　者：马福宝[1] 梁晓峰 张龙华 康国栋[1] 阎绍红 郭绍红 崔富强 董春明 李黎 陈海平 杨云凯 

机构地区：[1]江苏省疾病预防控制中心,南京210009 [2].国疾病预防控制中心免疫规划中心,北京100050 [3]响水县疾病预防控制中心,江苏响水224600 [4]内蒙古自治区疾病预防控制中心,呼和浩特010020 [5]北京天坛生物制品股份有限公司,北京100024

出　　处：《中国疫苗和免疫》2013年第6期485-491,共7页Chinese Journal of Vaccines and Immunization

基　　金：艾滋病和病毒性肝炎等重大传染病防治国家科学技术重大专项“我国乙型病毒性肝炎免疫预防策略研究项目”(编号2008ZX10002-001)

摘　　要：目的观察新生儿及以上人群接种10微克(?g)/0.5毫升(ml)和5?g/0.5ml重组乙型肝炎(乙肝)疫苗(酿酒酵母)(Hepatitis B Vaccine Made by Recombinant Deoxyribonucleic Acid Techniques in Saccharomyces Cereviside Yeast,HepB-SCY)的免疫学效果,以及对乙肝病毒表面抗原[Hepatitis B Virus(HBV)Surface Antigen,HBsAg]阳性母亲的新生儿免疫后阻断母婴传播的效果。方法采用随机、对照和盲法的临床试验,各组按1︰1比例分别接种10?g和5?g HepB-SCY。将新生儿分三组:即母亲HBsAg和乙肝病毒e抗原(HBV e Antigen,HBeAg)均为阴性组,母亲HBsAg阳性、HBeAg阴性组,母亲HBsAg和HBeAg均为阳性组。将非新生儿人群分成1月龄~5岁、6~15岁、≥16岁组。检测各组免疫前、后抗乙肝病毒表面抗原抗体(Antibody to HBsAg,Anti-HBs)阳转率和HBsAg阳性母亲的新生儿阻断HBV母婴传播的保护率。结果 10?g HepB-SCY对新生儿及以上人群全程免疫后,Anti-HBs阳转率为95.27%~98.86%,Anti-HBs几何平均浓度(Geometrics Mean Concentration,GMC)为340.87毫国际单位/毫升(mIU/ml)~837.56mIU/ml;与使用5?g HepB-SCY全程免疫后的Anti-HBs阳转率91.3%~98.8%和GMC 220.86 mIU/ml^701.30 mIU/ml相比,各年龄组间Anti-HBs的阳转率差异无统计学意义,GMC除新生儿组(?2=4.012,P=0.045)外,其余各组间差异亦无统计学意义。10?g和5?g HepB-SCY在HBsAg和HBeAg双阳性组全程免疫后,Anti-HBs阳转率分别为90.70%和88.6%,阻断HBV母婴传播保护率分别为92.25%和84.85%,两组间差异无统计学意义。在HBsAg单阳性组中,Anti-HBs阳转率分别为95.7%和100.0%、保护率分别为95.75%和100.0%,两组间差异无统计学意义。结论 10?g和5?g HepB-SCY对新生儿及以上人群均有良好的免疫原性,除新生儿组Anti-HBs阳转率差异有统计学意义外,其余指标的的差异均无统计学意义,且对HBsAg阳性母亲的新生儿阻断HBV母婴传播的保护率的差异亦无统计学意义。临床试验注册国家药品食品监督管理局《药Objective To evaluate the immunogenicity of 10μg/0.5ml and 5μg/0.5ml hepatitis B vaccine made by recombinant deoxyribonucleic acid techniques in saccharomyces cereviside yeast （HepB-SCY） among newborn and Infants. And evaluate the effect of HepB- SCY for blocking mother-to-infant transmission of hepatitis Bvirus（HBV）.Method Randomiaed,controlled,and blinded clinical/trial was performed,subjects were immunized the 10μg and 5μg HepB-SCY by the ratio of 1：1 respectively.The newborn were divided into three groups：1）mothers who are HBV surface antigen （HBsAg）negative and HBV e antigen （HBeAg）negative;2）HBsAg positive and HBeAg negative;3）HBeAg positive and HBeAg positive.Other age groups were divided into 1 month old to 5 years old age group,6 to 15 years old age group and ≥16years old age group.Geometrics mean concentration（GMC） of Antibody to HBsAg（Anti-HBs） and positive conversion rate were evaluated among different age groups. Blocking the motherto-infant transmission of HBV was also calculated. Result After the whole course vaccination of lOμgHepB-SCY, positive seroconversion rate of Anti-HBs was ranged from 95.27% to 98.86%. GMC of AntiHBs was ranged from 340.87 to 837.56 milli international units/ml （mlU/ml） in different groups. Thepositive seroconversion rate of subjects who immunized the whole course of 5μg HepB-SCY was rangedfrom 91.3% to 98.8%, and GMC of Anti-HBs was ranged from 220.86 to 701.30 mlU/ml. There wereno significant differences of positive seroconversion rate among different age groups, and there wereno significant differences of Anti-HBs concentration among different age group except for the newborngroup （X^2=4.012, P=0.045）. The positive seroconversion rate of the 10μg and 5μg HepB-SCY in HBsAgpositive and HBeAg positive mother group were 90.7% and 88.6% respectively. And the rate of blockingmother-to-infant transmission of HBV were 92.25% and 84.85% respectively, there was no significantdifference in positive seroconversion rate between two

关 键 词：重组乙型肝炎疫苗(酿酒酵母) 不同剂量 抗乙型肝炎病毒表面抗原抗体 阳转率 阻断母婴乙型肝炎 病毒传播保护率 

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]