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乙型肝炎基因重组疫苗接种小学生抗体反应比较 |
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梁争论１ 李成明１ 荆庆２ 向真３ 杨超美３ 任玲君２ 李河民１
【摘要】 目的 观察国产乙型肝炎基因重组疫苗的安全性和免疫学效果，为制定免疫策略提供依据。方法 应用2批国产、2批进口酵母乙肝疫苗和4批国产仓鼠卵巢细胞(CHO)乙型肝炎疫苗，对550名小学生进行了1年免疫效果观察。结果 未发现所有接种对象出现严重副反应。完成3针免疫后1个月时，&127;接种各疫苗组的抗体阳转率均达90%以上，其后开始缓慢下降。除两组外，2批国产酵母疫苗组免疫后7个月时抗体滴度显著低于进口酵母疫苗和国产CHO疫苗组，但在第一针免疫后1年时,与Merck公司疫苗和CHO疫苗差异无显著性。除Amgen公司酵母疫苗外,其他各批疫苗抗体滴度峰值均出现在免疫后7个月。2批国产酵母及2批同年CHO疫苗不同批号间抗体阳转率和抗体滴度差异均无显著性。结论 国产乙型肝炎基因重组疫苗的安全性好，对小学生免疫效果达到进口基因重组疫苗水平。
【关键词】 肝炎疫苗，乙型 肝炎抗体，乙型 接种
Antibody Reaction to Immunization with Different Recombinant Hepatitis B Vaccine in Primary School Children Liang Zhenglun*, Li Chengming, Jing Qing, et al. *National Institute for the Control of Pharmaceuticals and Biological Products, Beijing 100050
【Abstract】 Objective To evaluate the safety and immunogenicity of local produced hepatitis B (HB) vaccine and to lay a basis for formulating an immunization strategy. Methods Two batches of local produced and two batches of imported yeast derived recombinant HB vaccine (YDV), and four batches of local produced Chinese hamster ovary cell derived recombinant HB vaccine (CHOV) were administered to 550 children in primary schools to study their immunogenicity one year after immunization. Results No severe adverse reaction was found in all vaccinee. Positive seroconversion rate was more than 90 percent one month after completion of three-dose immunization with all kinds of HB vaccine mentioned above, and then declined slowly. Titer of antibody against hepatitis B surface antigen (anti-HBs) in those vaccinated with two batches of local produced YDV, except four groups, was significantly lower than that in those with imported YDV and local produced CHOV seven months after first-dose immunization, but no difference between local produced YDV and imported Merck vaccine and CHOV was found one year after immunization. Mean geometric titer (GMT) of anti-HBs reached the peak seven months after immunization in those vaccinated with [1] [2] [3] 下一页
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