成人接种重组酵母乙肝疫苗后免疫效果的评价

Immunogenicity and Safety of Recombinant Yeast-Derived Hepatitis B Vaccine on Adults

目的 :探讨重组酵母乙型肝炎疫苗 (YDV)对成人的免疫效果及安全性。方法 :在辽宁省北票市部分学校选择 2 2～ 5 8岁教师 12 4人 ,一般健康状况良好 ,乙型肝炎表面抗原 (HBsAg)、乙型肝炎表面抗体 (抗 HBs)、乙型肝炎核心抗体 (抗 HBc) 3项指标均为阴性 ,体温正常。按 0 ,1,6个月程序 ,每剂 5 μg/ 0 .5ml接种卫生部北京生物制品研究所生产的YDV。结果 :免疫后 3,7,12 ,2 4个月时 ,抗 HBs阳转率分别为 35 .0 %、83.3%、6 5 .5 %、37.2 % (P <0 .0 1) ,在 7个月时达到高峰 ,以后又急剧下降。女性抗 HBs阳转率均高于男性。小于 35岁组的抗体阳转率高于 35岁以上组 ,但仅在免疫后 12个月时二者有显著性差异。免疫 3d后局部和全身未见不良反应。结论 :YDV对成人具有良好的免疫原性和安全性 ,其抗 HBs持续时间有待进一步观察。

Objective: Our aim was to study the immunogenicity and safety of recombinant yeast derived hepatitis B vaccine (YDV) on adults. Methods: We randomly selected 124 healthy teachers , who were 22 to 58 years old in Beipiao city, Liaoning province .Their HBs antigen ,anti HBs antibody and anti HBc antibody were all negative and body temperature was normal.They were vaccinated with 5 μg/0.5 ml of YDV at beginning and the 1st and 6th month.Results: The positive rates of anti HBs were 35.0%,83.3 %,65.5 %,37.2%(P<0.01) at the 3th,7th,12th and 24th months respectively. The positive rates of anti HBs became the highest at the 7th month, then decreased sharply. The positive rates of anti HBs were always higher in women compared with male, the positive rates of anti HBs in below 35 year old group is higher compared with the over 35 year old group, but it was significantly different only at the 12th month. Local or systematic addictive reactions were not found in all the subjects in 3 days after injection. Conclusion: The YDV is effective and safety to adults. The last duration of anti HBs should be observed further.