重组乙型肝炎疫苗(酿酒酵母)免疫12年保护效果及持久性分析

Study on Effect and Duration of Hepatitis B Vaccine Made by Deoxyribonucleic Acid Techniques with Saccharomyces Cerevisiae Yeast after Long-term Vaccination

目的了解重组乙型肝炎(乙肝)疫苗(酿酒酵母)[Hepatitis B Vaccine(HepB)Made by Recombinant Deoxyribonucleic Acid(DNA)Techniques in Saccharomyces Cerevisiae Yeast,HepB-SCY]对新生儿的长期免疫效果和免疫持久性,为预防控制乙肝和HepB免疫策略提供参考。方法用横断面调查和分层整群抽样的方法,在HepB免疫效果长期监测点收集1997～2008年出生、全程接种HepB-SCY人群的血清样本和资料;用微粒子酶免疫法检测乙肝病毒(Hepatitis B Virus,HBV)感染指标,结合HepB免疫史进行分析。结果收集免疫人群样本9343例,乙肝病毒表面抗原(HBV Surface Antigen,HBsAg)平均阳性率为0.98%,抗乙肝病毒核心抗原抗体(Antibody to HBV Core Antigen,Anti-HBc)阳性率为3.16%,HBV感染率为3.37%;抗乙肝病毒表面抗原抗体(Antibody to HBsAg,Anti-HBs)平均阳性率为63.78%,从免疫后1年的91.16%逐渐下降至免疫后12年的50.53%;HepB首剂(HepB1)及时接种人群的HBsAg阳性率为0.89%,显著低于未及时接种人群的2.73%。结论 HepB-SCY免疫人群的HBsAg阳性率显著下降,免疫12年后保护效果良好,无证据表明需要进行再免疫。HepB1及时接种对预防HBV传播至关重要,提高HepB1及时接种率是预防控制乙肝的关键措施之一。

Objective To evaluate the long-term effectiveness and duration of hepatitis B vaccine （HepB） made by recombinant deoxyribonucleic acid techniques in saccharomyces cerevisiae yeast （HepB-SCY）after vaccinated to newborns, and to provide evidence for formulating the strategies of Hepatitis B prevention and control. Method A cross-sectional investigation was carried out in 6 HepB surveillance sites to collect blood samples and vaccination history information of 1997-2008 birth cohorts, which have been vaccinated by HepB-SCY. The serum samples were taken to test hepatitis B virus （HBV） infective markers by the method of microparticle enzyme immunoassay （MEIA）. The data was analyzed combining with vaccination information. Result 9343 participants were enrolled. The average HBV surface antigen （HBsAg） prevalence is 0.98%, antibody to HBV core antigen （Anti-HBc） prevalence is 3.16%, HBV infection rate is 3.37%. The average antibody to HBsAg （Anti-HBs） positive rate is 63.78%. the Anti-HBs Positive rale decr^n~o from O1 16;% to 50.53% after vaccinated by HepB-SCY from 1 year to 12 years. The HBsAg prevalence of participants who received first dose of HepB-SCY within 24 hours is 0.89%. It is lower statistically than 2.73% of those who did not received first dose of HepB-SCY timely. Conclusion The HBsAg prevalence of participants decreased dramatically. It shows that the effectiveness of HepB-SCY is fine and stable after vaccinated for 12 years. It is not suggested to carry out booster immunization. Timely first play an important role to prevent HBV. It is one of important measures to enhance coverage rate of timely first dose for control HBV infection.