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含乙肝病毒表面蛋白前S成分的重组DNA乙肝疫苗与不含前S成分疫苗的免疫原性比较研究

Study on the comparative immunogenicity of a recombinant DNA hepatitis B vaccine containing pre-S components of the HBV coat protein with non pre-S containing vaccines.

作者信息

Yap I, Guan R, Chan S H

机构信息

Department of Medicine, National University of Singapore.

出版信息

J Gastroenterol Hepatol. 1995 Jan-Feb;10(1):51-5. doi: 10.1111/j.1440-1746.1995.tb01047.x.

DOI:10.1111/j.1440-1746.1995.tb01047.x
PMID:7620108
Abstract

A new recombinant hepatitis B vaccine (SCI-B-VAC), derived from Chinese hamster ovary (CHO) cells and consisting of both the major S protein and the minor pre-S1 and pre-S2 proteins of the viral coat were compared with two yeast-derived vaccines containing only S proteins (B-Hepavac II and Engerix-B) for immunogenicity in human volunteers in a randomized controlled study. Two hundred and ninety-five healthy subjects completed the 12 month follow up. There was no difference in the mean age and sex distribution among the three study groups. Seroconversion rates for all the three groups were similar at months 6, 9 and 12. However, hepatitis B surface antibody (anti-HBs) geometric mean titres (GMT) were significantly higher with 10 micrograms SCI-B-VAC and 20 micrograms Engerix-B than with 10 micrograms B-Hepavac-II at months 6, 9 and 12. SCI-B-VAC at month 6 also showed a significantly higher anti-HBs GMT than Engerix-B (295 vs 143 miu/mL, P < 0.02).

摘要

在一项随机对照研究中,将一种源自中国仓鼠卵巢(CHO)细胞、由病毒衣壳的主要S蛋白以及次要前S1和前S2蛋白组成的新型重组乙型肝炎疫苗(SCI - B - VAC),与两种仅含S蛋白的酵母源疫苗(B - Hepavac II和Engerix - B)在人类志愿者中进行免疫原性比较。295名健康受试者完成了12个月的随访。三个研究组的平均年龄和性别分布无差异。在第6、9和12个月时,三组的血清转化率相似。然而,在第6、9和12个月时,10微克的SCI - B - VAC和20微克的Engerix - B的乙型肝炎表面抗体(抗 - HBs)几何平均滴度(GMT)显著高于10微克的B - Hepavac - II。在第6个月时,SCI - B - VAC的抗 - HBs GMT也显著高于Engerix - B(295对143 miu/mL,P < 0.02)。

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