乙型肝炎基因工程疫苗的反应及效果观察

Clinical Trial of Hepatitis B Vaccine Produced by Recombinant Vaccinia Virus Systen

应用重组痘苗病毒表达的乙肝基因疫苗接种了100名7～9岁儿童。采用0、1、2月免疫程序,3个不同剂量组(20,10及5μg)均产生较高的抗体阳转率:3个月时大于96％、9个月时均达100％,免后2年仍在85％以上。9月时抗体水平达高峰,其抗体GMT分别为540.4(20μg),556.8 (10μg)及392.3m(?)u/ml(5μg)。没有观察到严重的副反应。与酵母重组疫苗(Merck产品)和血源疫苗的免疫效果比较无明显区别。表明重组痘苗病毒表达的乙肝疫苗是安全、有效的。

IOO children (7-9 years old) were immunized with hepetitis B vaccine produced by recombinant vaccinia virus system. 1,3,9 and 24 months after first dose anti-HBs were determined. Three groups of different dosage(20, 10 and 5 ug) all gave high positive rates: more than 96% at 3 month, 100 % at 9 month and more than 85% at 24 month. The antibody levels (GMT) were 540.4 for 20ug, 556.8 for 10ug and 392.3 mlu/ml for 5 ug respectively at 9 month. No serious side reaction was found. The immune efficacy of different vaccine was compared The results showed that there was no significand difference between yeast derived vaccine (from Merck) and vaccinia virus derived vaccine. The above results demonstrated the hepetitis B vaccine produced by recombinant vaccinia virus system was safe and effective.