新生儿5μg和10μg重组酵母乙型肝炎疫苗初免后抗体免疫应答比较

Comparison on the antibody response after primary immunization of 5 μg and 10 μg hepatitis B vaccine made by recombinant DNA techniques among newborns

目的比较新生儿接种5μg和10μg重组酵母乙型肝炎（乙肝）疫苗后抗-HBs血清应答状况。方法以山东、江苏、上海、广西、北京5省（自治区、直辖市）为研究现场，采用5lag重组啤酒酵母乙肝疫苗（HepB-SC）和10μg重组汉逊酵母乙肝疫苗（HepB—HP），按照“0—1—6”免疫程序完成初免的7—12月龄健康婴儿。调查对象采用问卷调查并采集静脉血，应用化学发光微粒子免疫分析法（cMIA）定量检测抗-HBs。抗-HBs〈10mlU／ml者采用CMIA检测HBsAg，HBsAg阴性者采用巢式PCR方法检测HBV-DNA。比较不同HepB初免后的抗体应答率和抗体水平，采用多因素分析方法确定HepB种类对抗体阳转率和抗体水平的影响。结果共观察8947名5ggHepB-SC初免（5嵋组）和4576名10ggHepB—HP初免（10μg组）婴儿。5rtg组无应答、低应答、正常应答和高应答率分别为1．88％、15．18％、61．42％和21．52％，10gg组分别为0．15％、2．16％、29．42％和68．26％；5μg组无应答、低应答和正常应答率高于10μg组，高应答率低于10嵋组，各应答率之间差异均有统计学意义（P〈0．01）。5μg组和10嵋组初免后抗一HBs几何平均浓度分别为354．81mlU／ml（95％CI：338．84～363．08mIU／m1）和1778．28mlU／ml（95％CI：1698．24～1819．70mlU／m1），差异有统计学意义（F=4517．17，P〈0．001）。多因素分析显示，排除采血月龄、性别、出生体重、早产、母亲分娩前HBsAg状态等因素影响，两种HepB初免后抗体阳性率和抗体水平的差异仍有统计学意义。结论新生儿使用10μg HepB．HP初免抗体应答优于5ggHepB—SC。

Objective To compare the antibody response induced by primary immunization with 5 μg and 10 μghepatitis B vaccine made by recombinant DNA techniques among the newborns. Methods Healthy infants who had completed primary immunization with 5 μg hepatitis B vaccine made by recombinant dexyribonucleic acid techniques in Saccharomyces （Hep-SC） or 10 μg hepatitis B vaccine made by recombinant dexyribonucleic acid techniques in Hansenula polymorpha （HepB-HP） were included in the study. Kids under study were 7-12 months of age and had been on 0-1-6 schedule. Standardized questionnaire was used and blood samples were collected. The titer of antibody to hepatitis B surface antigen （anti-HBs） was detected by Chemiluminescence Microparticle Imunoassay （CMIA）. If anti-HBs happened to be under 10 mIU/ml, HBV DNA was further detected by nested-PCR to distinguish occult hepatitis B virus infection. Sero-conversion rate and titer of anti-HBs were compared between the two kinds of hepatitis B vaccines. Multivariate analysis was used to find the relationship between the kind of hepatitis B vaccine as well as the antibody response after debugging the other influencing factors including month-age, gender, birth-weight, premature birth and mother＇ s HBsAg status. Results 8947 infants vaccinated with 5 μg HepB-SC and 4576 infants vaccinated with 10 μg HepB-HP were investigated. In the 5 μg group, the rates of non-, low-, normal- and high-response were 1.88%, 15.18%, 61.42% and 21.52% respectively. In the 10 μg group, the corresponding rates were 0.15%, 2.16%, 29.42% and 68.26% respectively, The non-, low-, normal- response rates were all higher in 5μg group than in 10 μg group （P〈0.01）, while the high-response rate was much higher in 10 g g group than in 5 g g group （P〈0.01）. The geometric mean concentration （GMC） of anti-HBs were 354.81 mIU/ml （95% CI： 338.84-363.08 mlU/ml） and 1778.28 mIU/ml （95%C1：1698.24-1819.70 mIU/ml） in the 5μg group and 10 μg group respectively. The GMC was statistically higher in the 10 μg group than in the 5 μg group （P〈0.001）. The sero- conversion rate and GMC were significantly different between the two groups even after debugging the other influencing factors. Conclusion Better anti-HBs response could be achieved by primary immunization with 10 μg HepB-HP than with 5 μg HepB-SC among newborns.