新生儿重组酵母乙型肝炎疫苗免疫11年效果随访

A Follow-up on Efficacy of Immunization of Yeast-derived Recombinant Hepatitis B Vaccine after 11 Years

目的评价新生儿接种国产重组(酵母)乙型肝炎疫苗后11年的免疫效果。方法对上海市黄浦区1997年出生并接种重组(酵母)乙型肝炎疫苗的新生儿于免疫后11年进行随访,采血检测乙型肝炎病毒表面抗原(HBsAg),乙型肝炎病毒表面抗体(抗-HBs)和乙型肝炎病毒核心抗体(抗-HBc),1998年开始对乙型肝炎免疫人群开展急性乙型肝炎发病监测。结果随访检测HBsAg阳性率为0.54%,较免疫前本底的HBsAg阳性率呈较大幅度下降,疫苗保护率为88.05%(95%可信区间为85.17%～91.17%)。接受重组(酵母)乙型肝炎疫苗免疫的对象中,无一例急性乙型肝炎病例报告。结论重组(酵母)乙型肝炎疫苗有较好的远期保护效果,免疫人群尚无再免疫的需要。

[Objective]To evaluate the immune efficacy after 11 years＇ Immunization of domestic yeast-derived recombinant hepatitis B vaccine in newborns. [Methods]A follow-up on children who were born in 1997 and vaccinated with domestic yeast-derived recombinant hepatitis B vaccine at their birth was implemented to test the HBsAg,anti-HBs and anti-HBc.The incidence of acute hepatitis B among subjects with hepatitis B vaccinated was monitored since 1998. [Results]The positive rate of HBsAg was 0.54%,compared with that before vaccination in the same area,the positive rate of HBsAg showed a substantially decrease,the vaccine protective efficacy was 88.05%（95% confidence intervals 85.17%~91.17%）.Acute hepatitis B was not found in children immunized with yeast-derived recombinant hepatitis B vaccine. [Conclusion]The domestic yeast recombinant hepatitis B vaccine has a long-term protective effect,and a booster dose is not necessary currently.