新生儿接种重组乙型肝炎疫苗长期效果观察  

An observation on the long-term efficacy of recombinant hepatitis B vaccines among the newborns

作　　者：董晓莲[1] 唐智峰[1] 王学才[1] 陈颖峰[1] 陈胜玉[1] 王晓丽[1] 范建良[1] 郑英杰[2] 

机构地区：[1]德清县疾病预防控制中心,浙江德清313200 [2]复旦大学公共卫生学院

出　　处：《预防医学》2017年第5期438-442,共5页CHINA PREVENTIVE MEDICINE JOURNAL

基　　金：浙江省科技计划项目(2012C33030)

摘　　要：目的观察新生儿接种重组乙型肝炎(乙肝)疫苗的长期免疫效果。方法于1996年10月7日—1997年5月31日在德清县招募135名符合纳入标准的新生儿,其中35人的母亲乙肝表面抗原(HBs Ag)阳性,设为阳性组;100人的母亲HBs Ag阴性,设为阴性组。所有新生儿按0-1-6月的程序接种重组乙肝疫苗(酿酒酵母),分别于12月龄、13岁(2010年)和15岁(2012年)进行随访,并检测乙肝相关血清学指标,评估重组乙肝疫苗的长期免疫效果。结果 135名新生儿12月龄时随访到123人(91.11%),2010年随访到95人(70.37%),2012年随访到46人(34.07%),三次随访研究对象HBs Ag检测结果均为阴性。阳性组2010年发现3例乙肝核心抗体(HBc Ab)阳性,2012年无新增阳性;12月龄、2010年、2012年乙肝表面抗体(HBs Ab)阳性率分别为88.89%、81.48%和80.00%;12月龄HBs Ab水平与2010年和2012年的HBs Ab水平均呈正相关(P<0.05)。阴性组未发现HBc Ab阳性者;12月龄、2010年、2012年HBs Ab阳性率分别为91.18%、54.41%和52.78%;12月龄HBs Ab水平与2010年、2012年的HBs Ab水平均无统计学关联(P>0.05)。校正母亲HBs Ag影响后,加强免疫与HBs Ab阳性率间不存在统计学关联(P>0.05)。结论重组乙肝疫苗基础免疫后13~15年内保护效果较好,普通人群不需要加强免疫;母亲未感染乙肝的新生儿完成基础免疫后,其青少年时期的HBs Ab水平与第12月龄时HBs Ab水平相关。Objective evaluate the long-term efficacy of the recombinant hepatitis B vaccines（HBV） among the newborns with vaccination at birth. Methods During 1996-1997,135 newborns were selected from Deqing according to the inclusion criterion. They were divided into 2 groups： a group of 35 newborns whose mother was HBs Ag positive） and a group of 100 newbornswhose mother was HBs Ag negative. All 135 newborns routinely received 3 doses of yeast-derived hepatitis B vaccines（i.e. the first dose at birth, the second dose at 1 month old, and the third dose at 6 months old）. Serological markers to HBV were repeatedly assessed at 3 follow-up stages（i.e. the first follow-up at 12 months,the second follow-up at 2010, the third follow-up at 2012）. Results Participants remained in the study at 3 follow-upstages were 123（91.11%）,95（70.37%） and 46（34.07%） respectively. Participants’ serum HBs Ag were negative at all 3 follow-up stages. Among participants whose mothers were HBs Ag positive, 3 participants were found to be HBc Ab positive in 2010,and no new HBc Ab positive participants were found in 2012. The rates of HBs Ab positive at 3 follow-up stages were 88.89%,81.48%,and 80.00% respectively. The HBs Ab geometric mean concentrations（GMCs） of participants at their 12 months old were significantly positively associated with those in 2010 and those in 2012（P〈0.05）. Among participants whose mothers were HBs Ag negative,no HBc Ab positive participants were found. The rates of HBs Ab positive at 3 follow-up stages were 91.18%,54.41%,and 52.78% respectively. No correlation was found among HBs Ab GMCs of participants at 12 months old, in 2010 and in 2012. No correlation was found between boost vaccination and the rate of HBs Ag positive, after adjustment of the HBs Ag status of their mothers. Conclusion The efficacy of the yeast-derived HBV could sustain for at least13-15 years, and the general population do not need booster immunization. After the 3-dose immunization, the HBs Ab levels of the healt

关 键 词：乙型肝炎疫苗 基因工程 新生儿 乙型肝炎抗体 

分 类 号：R186[医药卫生—流行病学]