【摘要】 本文报告用转基因细胞B43分泌的乙型肝炎病毒表面抗原主蛋白经纯化制成的87-4批重组疫苗进行临床接种观察的结果,同时用8723-1批血源疫苗作对照。疫苗接种采用0、1、2月各接种1针的方案。重组疫苗共接种111名8～13岁儿童,分为20μg、10μg及5μg 3组,血源疫苗分为20μg、10μg 2组。所有儿童接种前检查乙型肝炎病毒表面抗原、抗体及核心抗体均阴性.20μg组1针后1个月,重组疫苗阳转率60.5％,血源疫苗为31％;2针后1个月,两种疫苗的阳转率分别为100％和72.4％;血源疫苗3针后1个月阳转率也仅79.3％。3针后1个月两种疫苗的抗体几何平均滴度(GMT)分别为492.7和207.4mIU。但重组疫苗6个月后血清抗体的GMT为628mIU。10μg组1针后1个月的阳转率重组疫苗为21.7％,血源疫苗为20.9％;2针后1个月分别为87％及62.8％;3针后1个月分别为100％及81.4％。抗体GMT分别为163.7和129.6mIU.5μg组的重组疫苗免疫后6个月100％阳转,其GMT为56mIU。结论认为无论从阳转率或几何平均滴度分析判断,重组疫苗均优于血源疫苗。更多还原

【Abstract】 The major protein of hepatitis B virus surface antigen ( HBsAg ) secre-tied by a transgenic cell line, named B43 was purified and 4 batches of experimental hepatitis vaccine were produced. Batch 87-4 was used to immunize Balb/C mice. The ED50 was more than 2 folds higher than most batches of blood derived vaccines. In this paper, clinical trial was carried out with this batch of recombinant hepatitis B vaccine (RV) in 111 8-13 years old children together with a batch of blood-derived vaccine ( BDV ) as control in 72 chitdren. All, children were anti-HBs, anti-HBc and HBsAg negative. 111 children were divided into 3 groups, 72 children divided into 2 groups, each group inoculated intramusculary with RV at dosages of 20, 10 and 5μg and with BDV at dosages of 20 and 10μg respectively, following a 0, 1, 2 months schedule. Their anti-HBs titer were examined after 1, 2, 3 and 6 months by Abbott AUSAB. The antibody conversion rates of 20μg groups of RV an BDV were 60.5% (23/38) and 31% (9/29) respectively after one month, 100% ( 38/38 ) and 72.4% ( 21/29 ) after 2 months, 100% (38/38) and 79.3% (23/29) after 3 months. The GMT of their anti-HBsi tter were 492.7 and 207.4 mIU respectively after 3 months, but the RV titer rose to 628 mIU after 6 months. Conversion rates of 10μg groups of RV and BDV were 21.7% ( 10/46 ) and 20.9 ( 9/43 ) after one month,87%(40/46)and 62.8%(27/43 ) after 2 months, 100% ( 46/46 ) and 81.4% (37/43) after 3 months respectively. GMT of their anti-HBs were 163.7 and 129.6 mIU after 3 months, the RV titer rose to 384mIU after 6 months. The 5μg group of RV showed 100% ( 40/40) sero-conversion after 6 months with a GMT 56mIU. Our conclusion is that the recombinant vaccine is more potent than blood derived hepatitis B vaccine in human clinical trial.更多还原