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目的了解新生儿重组乙型肝炎(乙肝)疫苗(酿酒酵母)[Hepatitis B Vaccine(HepB)Made by Recombinant Deoxyribonucleic Acid(DNA)Techniques in Saccharom yces cerevisiae Yeast,HepB-SCY]初次免疫(初免)的血清学效果,以及低/无应答状况和影响因素,探索不同再免疫方案的血清学效果。方法对1212名按照0、1、6个月免疫程序完成5微克(μg)HepB-SCY3剂免疫≥1个月的7～12月龄儿童,采血分离血清,用化学发光微粒子免疫分析法(Chemilum inescence Microparticle Immunoassay,CMIA)定量检测抗乙肝病毒表面抗原抗体[Antibody to Hepatitis B Virus(HBV)Surface Antigen,Anti-HBs(HBsAg)]。对低/无应答者随机分为2组,分别用5μg HepB-SCY或10μg HepB(汉逊酵母)(HepB Mabe By Becombinant DNA Fediniguesin Hansenula palym orpha Yeast,HepB-HPY)再免疫3剂,并分别检测再免疫1剂和3剂后的Anti-HBs。结果 HepB-SCY3剂初免后,Anti-HBs阳性[≥10毫国际单位/毫升(mIU/ml)]率、正常应答(Anti-HBs≥100m IU/ml)率、低应答(HBsAg阴性,10m IU/ml≤Anti-HBs<100m IU/ml)率、无应答(Anti-HBs<10m IU/ml,且HBV DNA和HBsAg均阴性)率和HBsAg阳性率,分别为98.43%、87.05%、11.39%、0.99%和0.58%。多因素Logistic回归分析显示,母亲HBsAg阳性的新生儿初免后的Anti-HBs应答率,低于母亲HBsAg阴性的新生儿[比值比(Odds Ratio,OR)=2.409,P=0.015]。低/无应答者使用HepB-SCY或HepB-HPY再免疫1剂(145例)及3剂(136例)后,Anti-HBs阳转率从再免疫前的91.72%分别上升到97.93%和99.26%,正常应答率分别达到82.76%和96.32%,Anti-HBs几何平均浓度(Geometry Mean Concentration,GMC)比再免疫前上升7.86倍和19.7倍。其中5μg HepB-SCY组再免疫3剂后的Anti-HBs应答率,明显高于再免疫1剂者(Χ2=12.54,P<0.001);10μg HepB-HPY组再免疫3剂者,与再免疫1剂的应答率差异无统计学意义(Χ2=2.58,P=0.108)。两种疫苗再免疫1剂比再免疫前(HepB-HPY组u=10.32,P<0.001;HepB-SCY组u=-8.53,P<0.001)、再免疫3剂比再免疫1剂(HepB-HPY组u=-3.59,P<0.001;HepB-SCY组u=4.30,P<0.001)的Anti-HBsGMC均有显著提高。不同疫苗相同再免疫剂次后的Anti-HBs应答率(1剂Χ2=1.293,P=0.255;3剂Χ2=1.691,P=0.193)或Anti-HBsGMC(1剂u=1.33,P=0.19;3剂u=-1.60,P=0.11)的差异均无统计学意义。结论母亲HBsAg阳性是影响新生儿初免Anti-HBs应答率的危险因素。两种疫苗相同的再免疫剂次的血清学效果差异无统计学意义,再免疫3剂的Anti-HBsGMC均比再免疫1剂的明显升高;Anti-HBs应答率5μg HepB-SCY再免疫3剂明显高于再免疫1剂,但10μg HepB-HPY再免疫3剂与再免疫1剂差异无统计学意义。
Objective To investigate the effect of primary immunization (primary immunization) on serum of neonates with Hepatitis B Vaccine (HepB) Made by Recombinant Deoxyribonucleic Acid (DNA) Techniques in Saccharomyces cerevisiae Yeast, HepB-SCY] Learning effects, and low / no response status and influencing factors to explore the serological effects of different re-immunization programs. Methods A total of 1212 children aged 7 ~ 12 months who were immunized with 5 μg (μg) HepB-SCY3 for 0, 1, and 6 months after immunization were collected. Blood was collected by serum and analyzed by chemiluminescence microparticle immunoassay (Microparticle Immunoassay, CMIA) for quantitative detection of anti-HBeAg (Antibody to Hepatitis B Virus (HBsAg) Antibody). The low / non-responders were randomly divided into two groups and re-immunized with 5μg HepB-SCY or 10μg HepB (HepB Mabe By Becombinant DNA Fediniguesin Hansenula palym orpha Yeast, HepB-HPY) respectively and tested separately Anti-HBs after re-immunization of 1 and 3 doses. Results After HepB-SCY3 was primed, the positive rate of Anti-HBs [≥10 mIU / ml], the rate of normal response (Anti-HBs≥100m IU / ml), the low response (HBsAg-negative, IU / ml≤nti-HBs <100mIU / ml), non-response (Anti-HBs <10mIU / ml, and negative for both HBV DNA and HBsAg) and HBsAg positive rates were 98.43%, 87.05%, 11.39 %, 0.99% and 0.58%. Multivariate logistic regression analysis showed that the response rate of anti-HBs after maternal HBsAg-positive neonatal immunization was lower than that of mothers with HBsAg-negative neonatal parity (odds ratio = 2.409, P = 0.015). Anti-HBs positive rate increased from 91.72% before re-immunization to 97.93% and 99.26 after re-immunization with HepB-SCY or HepB-HPY (145 cases) and 3 doses (136 cases) %, And the normal response rate reached 82.76% and 96.32% respectively. The anti-HBs Geometry Mean Concentration (GMC) increased 7.86 times and 19.7 times than before immunization. The response rate of Anti-HBs in 3μg of HepB-SCY 5μg immunized group was significantly higher than that in re-immunized 1 part (Χ2 = 12.54, P <0.001) There was no significant difference in the response rate of 1 dose (χ2 = 2.58, P = 0.108). One of the two vaccines was then re-immunized compared to the other three immunizations (HepB-HPY group, u = 10.32, P <0.001; HepB-SCY group, u = -8.53, HPY group u = -3.59, P <0.001; HepB-SCY group u = 4.30, P <0.001) of Anti-HBsGMC were significantly increased. The anti-HBs response rate (1 dose X2 = 1.293, P = 0.255; 3 doses X2 = 1.691, P = 0.193) or Anti-HBsGMC (1 dose u = 1.33, P = 0.19; 3 doses u = -1.60, P = 0.11) showed no significant difference. Conclusion The positive HBsAg of mothers is the risk factor of neonatal anti-HBs response rate. There was no significant difference in the serological effects between the two vaccines with the same level of re-immunization agent. Anti-HBsGMC with three doses of re-immunization was significantly higher than that with one re-immunization dose. The response rate of Anti-HBs with 5μg HepB-SCY was Agent was significantly higher than the re-immunization of a dose, but 10μg HepB-HPY three re-immunization and immunization of a dose difference was not statistically significant.