| 张丽,张卫,吕静静,张继娟,刘甲野,颜丙玉,冯艺,梁晓峰,崔富强,王富珍,张国民,徐爱强.5μg和10μg重组乙型肝炎疫苗初次免疫正常应答和高应答新生儿5年抗体持久性比较[J].中华流行病学杂志,2017,38(9):1156-1160 |
| 5μg和10μg重组乙型肝炎疫苗初次免疫正常应答和高应答新生儿5年抗体持久性比较 |
| Comparison of antibody persistence after primary immunization with 5 μg and 10 μg recombinant hepatitis B vaccine among newborns with normal and high response:a five-year following-up |
| 收稿日期:2017-01-16 出版日期:2017-09-09 |
| DOI：10.3760/cma.j.issn.0254-6450.2017.09.002 |
| 中文关键词: 乙型肝炎疫苗 免疫剂量 抗体持久性 新生儿 |
| 英文关键词: Hepatitis B vaccine Vaccine dosage Antibody persistence Newborn |
| 基金项目:国家科技重大专项（2012ZX10002-001，2013ZX10004-902）；山东省医药卫生科技发展计划（2009QZ017，2014WS0373）；山东省泰山学者工程（TS201511105） |
| 作者 | 单位 | E-mail | | 张丽 | 250014 济南, 山东省疾病预防控制中心免疫预防管理所 山东省传染病控制重点实验室 | | | 张卫 | 100013 北京市疾病预防控制中心免疫预防管理所 | | | 吕静静 | 250014 济南, 山东省疾病预防控制中心免疫预防管理所 山东省传染病控制重点实验室 | | | 张继娟 | 250117 济南, 山东省肿瘤医院药剂科 | | | 刘甲野 | 250014 济南, 山东省疾病预防控制中心免疫预防管理所 山东省传染病控制重点实验室 | | | 颜丙玉 | 250014 济南, 山东省疾病预防控制中心免疫预防管理所 山东省传染病控制重点实验室 | | | 冯艺 | 250014 济南, 山东省疾病预防控制中心免疫预防管理所 山东省传染病控制重点实验室 | | | 梁晓峰 | 100050 北京, 中国疾病预防控制中心免疫规划中心 | | | 崔富强 | 100050 北京, 中国疾病预防控制中心免疫规划中心 | | | 王富珍 | 100050 北京, 中国疾病预防控制中心免疫规划中心 | | | 张国民 | 100050 北京, 中国疾病预防控制中心免疫规划中心 | | | 徐爱强 | 250014 济南, 山东省疾病预防控制中心免疫预防管理所 山东省传染病控制重点实验室 | aqxuepi@163.com |
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| 中文摘要: |
| 目的 比较5 μg和10 μg乙型肝炎疫苗（HepB）初次免疫（初免）正常应答和高应答新生儿初免后5年的抗体持久性。方法 选用5 μg（重组啤酒酵母）和10 μg（重组汉逊酵母）HepB，按照"0-1-6"程序完成3剂次初免的新生儿，并在接种第3剂次后1~6个月（T0）和5年（T1）后分别采集静脉血，采用化学发光微粒子免疫分析法（CMIA）定量检测抗-HBs，比较两剂量接种后正常应答和高应答（T0时抗-HBs ≥ 100 mIU/ml）者T1时的抗体阳性率（抗-HBs ≥ 10 mIU/ml）和平均抗体浓度（GMC）；通过多因素分析探讨接种剂量与抗体持久性的关系。结果 HepB 5 μg组和10 μg组分别共有1 883名和1 495名观察对象纳入分析，T1时抗-HBs阳性率分别为49.92%（943/1 883）和75.92%（1 135/1 495），差异有统计学意义（χ2=237.75，P<0.001）；GMC分别为10.23（95%CI：9.38~11.16）mIU/ml和28.91（95%CI：26.65~31.35）mIU/ml，差异有统计学意义（F=280.36，P<0.001）。10 μg组T1时抗-HBs阴转者抗-HBs滴度分布与5 μg组的差异有统计学意义（χ2=39.75，P<0.001）。多因素分析显示，排除其他因素影响后，HepB初免剂量与T1时抗-HBs阳性率和抗-HBs滴度均独立相关[P<0.001，OR=1.44（95%CI：1.20~1.73）；P<0.001，β=0.27（95%CI：0.14~0.40）]。结论 新生儿使用10 μg重组HepB初免后5年抗-HBs持久性优于5 μg重组HepB。 |
| 英文摘要: |
| Objective To compare the antibody persistence 5 years after primary immunization with 5 μg and 10 μg recombinant hepatitis B vaccine (HepB) among newborns with normal and high response. Methods Newborns who completed three doses of 5 μg HepB made by recombinant dexyribonucleic acid technique in Saccharomyces (HepB-SC) or 10 μg HepB made by recombinant dexyribonucleic acid technique in Hansenula polymorpha (HepB-HP) were recruited. Standardized questionnaire was used and blood samples were collected 1-6 months (T0) and five years (T1) after the third dose respectively. The titer of anti-HBs was detected by chemiluminescence microparticle imunoassay (CMIA). Those who achieved normal or high antibody response (anti-HBs titer ≥ 100 mIU/ml) were included in the study and the positive rate (≥ 10 mIU/ml) and titer of anti-HBs at T1 were compared between 5 μg HepB group and 10 μg HepB group. Multivariable analysis was conducted to identify the independent factors associated with the antibody persistence. Results The positive rate of anti-HBs at T1 was 49.92% (943/1 883) and 75.92% (1 135/1 495) respectively in 5 μg HepB group and 10μg HepB group, the difference was significant (χ2=237.75, P<0.001). The anti-HBs geometric mean concentrations at T1 were 10.23 mIU/ml (95%CI:9.38-11.16) and 28.91 mIU/ml (95%CI:26.65-31.35) in the two groups respectively, the difference was also significant (F=280.36, P<0.001). Among those whose anti-HBs titer was <10 mIU/ml at T1, the distributions of anti-HBs titer were significantly different between 5 μg HepB group and 10 μg HepB group (χ2=39.75, P<0.001). The multivariable analysis showed that dosage of HepB was independently associated with both positive rate and titer of anti-HBs at T1 after excluding the other factors[P<0.001, OR=1.44 (95%CI:1.20-1.73); P<0.001, β=0.27 (95%CI:0.14-0.40)]. Conclusion Five year anti-HBs persistence after primary immunization with 10 μg HepB might be better than that after primary immunization with 5 μg HepB among infants who achieved normal or high anti-HBs response after primary HepB immunization. |
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