摘要
以北京和上海生物制品研究所生产的不同批号的乙型开炎血源疫苗,免疫HBsAg和HBeAg均阳性母亲及HBsAg阴性母亲的新生儿,以及不同年龄的儿童和成人HBV易感者,程序为0、1、6个月。在第一针后9～12个月采血,用RIA法检测抗-HBs,S/N≥10.0为阳性。观察不同批号疫苗兔疫后的抗-HBs阳转率。6个批号的疫苗,以30、10、10μg和30μg×3剂量免疫HBsAg和HBeAg均阳性母亲的新生儿210人,抗-HBs阳转率为74.46％～84.09％,7个批号以10μg×3免疫阴性母亲的新主儿1510人,抗-HBs阳转率为80.29％～96.24％;3个批号以10μg×3免疫易感儿童238人,2号批号以10μg×3疫易感成年人127人,抗-HBs阳转率前者为87％～100.0％,后者为90％～96％。如按S/N≥2.1计算,抗-HBs阳转率可全部达到90％以上。提示我国生产的乙肝疫苗对各年龄人群都有较好的免疫反应,个别批号间有些差异,但经统计处理多无显著意义。
3,633 HBV susceptibles were immunized with plasma-derived HB vaccine, manufactured by Beijing and Shanghai Vaccine and Serum Institutes. More than 26 Lots of vaccine were tested, blood samples were collected for assaying of anti-HBs or HBsAg by RIA 9 to 12 months after the first injection. The positive criteria of S/N value for both HBsAg and anti-HBs was 10. The vaccination schedule was 0,1,6 months. The results showed that the anti-HBs conversion rate was closely related to the dosage of vaccine. 210 infants born to HBsAg and HBeAg positive mother, 48 recieving 2 Lots of 3 doses of 30 μg/ml vaccine,the anti-HBs conversion rate was 84.09%, while 166 infants receiving 5 lots of 30μg, 10μg, 10μg/ml,the anti-HBs conversion rate was 74.76%-80%. There was no statistical difference between the batches of vaccine used. 1,510 neonates born to HBsAg negative mothers received 8 lots of 10μg/ml dose of Vaccine. The anti'-HBs conversion rate were 80.29%-96.24% (with signifcant difference between certain batches) . 5 batches of long/ml dose vaccine were used for susceptible children or adults with anti-HBs conversion rates of 87.78%-100%. And no significant difference was found between different batches.On the whole, the results confirmed that the quality of Chinese pla-sma-devired HBV vaccine was relatively stable in antigemcity between batches.
出处
《病毒学报》
CAS
CSCD
北大核心
1991年第A12期69-72,共4页
Chinese Journal of Virology
关键词
乙肝疫苗
免疫效果
血源
Hepatitis B vaccine Batch difference
