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目的了解上海市新生儿接种重组乙型肝炎(乙肝)疫苗(酵母)[Hepatitis B Vaccine Made by RecombinantDeoxyribonucleic Acid Techniques in Yeast,HepB-Y]后的低/无应答情况。方法对上海市三个区(县)2008～2009年出生的2047名新生儿,按0、1、6个月免疫程序接种HepB。采用化学发光微粒子免疫分析法检测抗乙肝病毒表面抗原抗体[Antibody to Hepatitis B Virus Surface Antigen(HBsAg),Anti-HBs],并对其家长进行问卷调查,以了解婴儿出生和疫苗接种情况。结果新生儿接种HepB后,血清Anti-HBs的几何平均浓度(Geometric Mean Concentration,GMC)为408.04毫国际单位/毫升(mIU/ml)。婴儿的低(10～99 mIU/ml)/无(<10mIU/ml)应答率为17.00%,其中无应答率为1.86%,低应答率为15.14%。13～18月龄的低/无应答率(23.03%)高于7～12月龄(6.62%)(χ2=358.518,P<0.05);接种5微克(μg)HepB(酿酒酵母)(SaccharomycesCerevisaie Yeast,HepB-SCY)婴儿的低/无应答率(21.68%)高于接种10μg HepB(汉逊酵母)(HansenulaPolymoarpha Yeast,Hep-HPY)的婴儿(3.10%)(χ2=415.024,P<0.05);早产儿的低/无应答率(31.74%)高于足月儿(16.53%)(χ2=18.140,P<0.05);孕期HBsAg阳性母亲的婴儿的无应答率(7.62%)高于HBsAg阴性母亲的婴儿(1.54%)(χ2=18.140,P<0.05)。低出生体重儿的低/无应答率(14.58%)虽低于正常体重儿(17.01%),但差异无统计学意义(χ2=3.652,P>0.05)。结论月龄、疫苗种类、是否早产、母亲孕期HBsAg状态对婴儿的应答情况有影响。对早产儿及母亲HBsAg阳性儿等高危婴儿应进行Anti-HBs的滴度监测。
Objective To investigate the low / non-response status of Hepatitis B Vaccine Made by Recombinant Deoxyribonucleic Acid Techniques in Yeast (HepB-Y) in Shanghai Newborns inoculated with recombinant Hepatitis B virus (Yeast). Methods Totally 2047 newborns born in three districts (counties) in Shanghai from 2008 to 2009 were vaccinated with HepB for 0,1,6 months. Antibody to Hepatitis B Virus Surface Antigen (HBsAg), Anti-HBs was detected by chemiluminescence microparticle immunoassay and parents were surveyed to find out about the birth and vaccination of infants. Results Geometric Mean Concentration (GMC) of serum Anti-HBs was 408.04 milliUUIU / ml (mlIU / ml) after inoculation of HepB in neonates. Infants with low (10 ~ 99 mIU / ml) / no (<10mIU / ml) response rate of 17.00%, of which no response rate of 1.86%, low response rate of 15.14%. The low / non-response rate (23.03%) of 13-18 months old was higher than that of 7-12 months old (6.62%) (χ2 = 358.518, P <0.05) (21.68%) in infants with HepB-SCY was higher than that in infants with 10μg HepB (Hep-HPY) (χ2 = 415.024, P <0.05) The low / non-response rate of preterm infants (31.74%) was higher than that of term infants (16.53%) (χ2 = 18.140, P <0.05). The nonresponse rate of prenatal infants with HBsAg positive mothers (7.62%) was higher than that of HBsAg negative mothers Of infants (1.54%) (χ2 = 18.140, P <0.05). The low / no response rate of low birth weight children (14.58%) was lower than that of normal weight children (17.01%), but the difference was not statistically significant (χ2 = 3.652, P> 0.05). Conclusion The age of month, the type of vaccine, whether or not premature delivery, and the HBsAg status of mothers during pregnancy influence the response of infants. Anti-HBs titers should be monitored for high-risk infants such as preterm and mothers of HBsAg-positive infants.