国产重组酵母乙型肝炎疫苗抗体反应观察

Evaluation on responses of domestic multi-lots hepatitis B vaccine

目的 观察多批次国产重组酵母乙肝疫苗不同免疫程序免疫儿童的抗体反应。方法 1994～ 1999年 ,按 0 ,1,6月和 0 ,1,2月免疫程序 ,分别应用 10批和 3批国产酵母乙肝疫苗 ,免疫 12 10和 3 54名 6～ 12岁儿童 ,观察免后 1年抗体反应 ,并分别进行 2～ 5年的随访观察。结果 酵母乙肝疫苗的安全性好。按 2种免疫程序、应用 10批疫苗免疫的 17组儿童在完成全程免疫后 1个月 (T7)时 ,抗体阳转率均高于 90 % ,抗体滴度范围在 96 0 4～ 619 0 1U /L之间 ,0 ,1,6和 0 ,1,2组抗 -HBs阳转率均值分别为 97 3 4 %和 99 13 % ,无、低应答率为 2 66%和 0 87%。免后抗体阳转率下降速率慢 ,抗体滴度下降快 ,但均在首针免后 3～ 5年保持一个稳定水平。 0 ,1,6组抗体峰值几何均值(GMT)显著高于 0 ,1,2组 (3 0 5 2 7;115 0 5U/L ,P <0 0 1) ,但免后 3～ 4年的随访观察未发现 0 ,1,6组抗体持久性优于 0 ,1,2组 (P >0 0 5)。结论 国产酵母乙肝疫苗生产稳定 。

ObjectiveTo evaluate the immune efficacy and safety of m ulti-lots hepatitis B vaccines(YDV) derived from yeast on children with differen t immune schedules.Methods1564 of 6 to 12 years old healthy children were r andomly divided into 17 groups selected at Henan,Liaoning,Shandong and Sichuan p rovince,whose HBsAg,anti-HBs,anti-HBc were all negative,vaccinated with 10 lots of YDV according to 0,1,6 or 0,1,2 month schedule.Test serum anti-HBs at 3,7,12, 24,36,48 and 60 months after the first dose.ResultsNo serious side effects were reported.At one mont h after the 3 doses (T7),seroprotective rates of anti-HBs for all 17 groups were all above 90%.The range of mean geometric titres (GMT) of anti-HBs was from 96. 04-619.01?IU/L.The average of seroprotective for 0,1,6 and 0,1,2 group were 97. 34% and 99 13%,with lower noresponse rates (2.66% ,0.87%).Follow-up study showe d that anti-HBs declined rapidly ,but slowly for seroprotective rate.GMT of anti -HBs of 0,1,6 group significantly higher than that of 0,1,2 group (305.27 vs 115 .05?IU/L,P<0.01).At 3 to 4 years after the first dose,anti-HBs GMT and sero protective rates of 0, 1,6 and 0,1,2 group were at the same level(P>0.05).ConclusionYDV was safety and immunogenicity to vaccinate children.