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一种含前S抗原的新型重组乙型肝炎疫苗的反应原性和免疫原性:初步报告。

Reactogenicity and immunogenicity of a new recombinant hepatitis B vaccine containing Pre S antigens: a preliminary report.

作者信息

Hourvitz A, Mosseri R, Solomon A, Yehezkelli Y, Atsmon J, Danon Y L, Koren R, Shouval D

机构信息

Medical Corps, Israel Defence Forces, Jerusalem, Israel.

出版信息

J Viral Hepat. 1996 Jan;3(1):37-42. doi: 10.1111/j.1365-2893.1996.tb00079.x.

DOI:10.1111/j.1365-2893.1996.tb00079.x
PMID:8736239
Abstract

A new vaccine against hepatitis B virus (HBV) infection, produced in mammalian Chinese hamster ovary (CHO) cells, contains the small(s), middle (Pre S2) and large (Pre S1) surface proteins of HBV. Three injections of a 5-micrograms or 10-micrograms dose were administered intramuscularly (i.m.) at 0, 1 and 6 months to a group of 105 young adults, who were monitored for a period of 6 months after the third injection. Seroconversion rates were 100% after the second injection of the 5-micrograms or 10-micrograms dose. Geometric mean titres of HBsAb at 1 month after the third injection were 12,156 mIU ml-1 and 13,482 mIU ml-1 in those receiving the 5-micrograms and 10-micrograms dose respectively. The vaccine was well tolerated with no significant adverse events. These preliminary results suggest that the Pre S-s recombinant vaccine, produced in mammalian cells, is highly immunogenic, leading to 100% seroconversion in the population tested after injection of only two doses of 5 micrograms.

摘要

一种在哺乳动物中国仓鼠卵巢(CHO)细胞中生产的新型乙型肝炎病毒(HBV)感染疫苗,包含HBV的小(S)、中(前S2)和大(前S1)表面蛋白。对一组105名年轻成年人在0、1和6个月时进行三次肌肉注射(i.m.),剂量分别为5微克或10微克,并在第三次注射后监测6个月。第二次注射5微克或10微克剂量后血清转化率为100%。在接受5微克和10微克剂量的人群中,第三次注射后1个月时HBsAb的几何平均滴度分别为12,156 mIU/ml和13,482 mIU/ml。该疫苗耐受性良好,无明显不良事件。这些初步结果表明,在哺乳动物细胞中生产的前S重组疫苗具有高度免疫原性,在仅注射两剂5微克后,受试人群中的血清转化率达100%。

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