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重组DNA乙肝疫苗的临床研究概述

Overview of clinical studies with hepatitis B vaccine made by recombinant DNA.

作者信息

Zajac B A, West D J, McAleer W J, Scolnick E M

出版信息

J Infect. 1986 Jul;13 Suppl A:39-45. doi: 10.1016/s0163-4453(86)92668-x.

DOI:10.1016/s0163-4453(86)92668-x
PMID:2943814
Abstract

The Merck, Sharp and Dohme hepatitis B vaccine formulated from HBsAg produced by a recombinant strain of Saccharomyces cerevisiae has proven to be highly immunogenic and safe. A 10 micrograms dose of the vaccine produced an anti-HBs response of greater than or equal to 10 IU/l in 91% or more of healthy adults who completed the three-dose regimen. Children responded well to all levels of vaccine antigen utilised but developed maximum anti-HBs titres with 5 micrograms doses. The age of the vaccine recipient affected responsiveness. Younger adults (20-29 years) responded more rapidly and with higher anti-HBs titres than did older adults (greater than or equal to 50 years). Children responded faster and with higher anti-HBs levels than younger adults. Clinical reactions reported after vaccination were mild and transient.

摘要

由重组酿酒酵母菌株产生的乙肝表面抗原(HBsAg)制备的默克、夏普和多贺美乙肝疫苗已被证明具有高度免疫原性且安全。10微克剂量的该疫苗在完成三剂接种方案的91%或更多健康成年人中产生了大于或等于10 IU/l的抗-HBs反应。儿童对所有使用水平的疫苗抗原反应良好,但在5微克剂量时产生最高抗-HBs滴度。疫苗接种者的年龄影响反应性。较年轻的成年人(20 - 29岁)比年长成年人(大于或等于50岁)反应更快且抗-HBs滴度更高。儿童比年轻成年人反应更快且抗-HBs水平更高。接种疫苗后报告的临床反应轻微且短暂。

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