国产重组酵母乙型肝炎疫苗抗体反应观察

梁争论; 李河民; 荆庆; 吴小音; 钟熙; 王佑春; 时景璞; 尹爱红; 杨超美; 张华远

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

摘要

摘要:
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1210和354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96.04~619.01U/L之间, 0, 1, 6和0, 1, 2组抗-HBs阳转率均值分别为97.34%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(305.27;115.05U/L, P < 0.01), 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 > 0.05)。
结论国产酵母乙肝疫苗生产稳定, 具有较好的安全性和免疫原性

Abstract:
Objective To evaluate the immune efficacy and safety of multi-lots hepatitis B vaccines(YDV)derived from yeast on children with different immune schedules.
Methods 1564 of 6 to 12 years old healthy children were randomly divided into 17 groups selected athenan, Liaoning, Shandong and Sichuan province, 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.
Results No serious side effects were reported.At one month after the 3 doses(T7), seroprotective rates of anti-HBs for all 17 groups were all above 90%.The range of mean geometrictitres (GMT)of anti-HBs was from 96.04-619.01IU/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 showed 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 ser oprotective rates of 0, 1, 6 and 0, 1, 2 group were at the same level(P > 0.05).
Conclusion YDV was safety and immunogenicity to vaccinate children.

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