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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 ,具有较好的安全性和免疫原性
Objective To observe the antibody responses of children immunized with different batches of recombinant yeast Hepatitis B vaccine. Methods From 1994 to 1999, 10 and 3 batches of domestic yeast hepatitis B vaccine were administered respectively according to 0, 1 and 6 months and 0, 1 and 2 months immunization programs. 12 10 and 3 54 children aged 6 to 12 years After 1 year antibody reaction, and were 2 to 5 years follow-up observation. Results Yeast hepatitis B vaccine is safe. According to the two immunization programs, the immunization rate of the 17 groups of children immunized with 10 batches of vaccines was higher than 90% at 1 month (T7) after complete immunization, and the antibody titers ranged from 96 0 4 to 619 0 1U / L, 0, 1, 6, and 0 respectively. The average positive rates of anti-HBs in groups 1 and 2 were 97 3 4% and 99 13%, respectively, with no or low response rates of 666% and 0 87%, respectively. Anti-antibody positive rate of decline after the slow rate of decline in antibody titer, but were in the first needle after 3 to 5 years to maintain a stable level. The geometric mean (GMT) values of 0, 1, and 6 antibody groups were significantly higher than those of 0, 1 and 2 groups (3 0 5 2 7; 115 0 5 U / L, P 0 01) No follow-up observation 0, 1, 6 group of antibodies lasting better than 0, 1, 2 group (P> 0.05). Conclusion The domestic yeast hepatitis B vaccine is stable and has good safety and immunogenicity