【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。更多还原

【Abstract】 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 l 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/m1.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.更多还原