重组乙型肝炎疫苗(酵母)按不同免疫程序接种成人的免疫原性研究  

Immunogenicity of Different Schedules Recombinant Yeast-derived Hepatitis B Vaccine on Adults

作　　者：庞志钊[1] 宋立志[2] 董微[3] 何坤芳 张济[3] 张勇[5] 曹惠霖[5] 

机构地区：[1]石家庄市卫生防疫站,河北石家庄050011 [2]山东省疾病预防控制中心,济南250014 [3]济南市疾病预防控制中心,山东济南250013 [4]济阳县卫生防疫站,山东济阳251400 [5]中国疾病预防控制中心病毒病预防控制所,北京100052

出　　处：《中国计划免疫》2006年第2期109-111,共3页Chinese Journal of Vaccines and Immunization

基　　金：中国肝炎防治基金会资助

摘　　要：目的探讨重组乙型肝炎(乙肝)疫苗(酵母)对成人的免疫原性。方法在济阳县乡村随机整群选择健康的15~40岁乙肝病毒(HBV)易感者591人,按0、1、6个月和0、6个月免疫程序,接种广东省深圳康泰生物制品有限公司生产的重组乙肝疫苗(酵母),每剂10μg/1.0ml。结果全程免疫后1个月时,0、1、6个月和0、6个月两种免疫程序的有效乙肝病毒表面抗体(抗-HBs)阳转率分别为95.91%、86.08%,两种免疫程序产生有效抗-HBs,抗体几何平均浓度(GMC)分别为332.5毫国际单位/毫升(mIU/ml)(95%CI为279.17mIU/ml^396.03mIU/ml)和227.4mIU/ml(95%CI为186.34mIU/ml^277.51mIU/ml)。0、1、6个月免疫程序的有效抗-HBs阳转率和GMC均高于0、6个月程序,差异有显著的统计学意义。结论10μg/ml重组乙肝疫苗(酵母)接种15~40岁人群的免疫原性良好,其长期效果需进一步随访。Objective To study the immunogenicity of recombinant yeast-derived Hepatitis B vaccine. Methods 591 HBV susceptible patients of 15- 40 years old from Jiyang Village in Jinan County. They were vaccined in two groups （0,1,6 months and 0,6 months） with 10 R512.61g/1.0 mL of YDV made by Shenzhen Kangtai Biological Products. Results The results showed that the effective seroconversion rate of anti-HBs were 95.9196, 86.0896, the mean geometric concentration （GMC） of anti-HBs were 332.5 mIU/mL） （95 96 CI279.17～396.03mIU/mL） and 227.4 mIU/mL （95% CI186.34～ 277.51 mIU/mL） after 1 month of full vaccination in 0, 1, 6 months group and 0, 6 months group respectively. Conclusion The effective seroconversion rates and GMC in 0, 1, 6 months group was significantly higher than the group of 0, 6 months. 10μg/1.0 mL YDV was immunogenic to vaccinate 15～40 years adults. The long-term immune efficacy was necessary to follow up. 　

关 键 词：重组乙型肝炎疫苗(酵母) 成人免疫 免疫原性 

分 类 号：R186[医药卫生—流行病学] R512.61[医药卫生—公共卫生与预防医学]