A candidate vaccine based on the hepatitis C E1 protein: tolerability and immunogenicity in healthy volunteers
A candidate vaccine based on the hepatitis C E1 protein: tolerability and immunogenicity in healthy volunteers
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DOI：
10.1016/j.vaccine.2004.02.002
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发表时间：
2004-08-13
期刊：
影响因子：
5.5
通讯作者：
Maertens, G
中科院分区：
文献类型：
--
作者：
Leroux-Roels, G;Depla, E;Maertens, G
丙型肝炎病毒E1蛋白作为候选疫苗的耐受性和免疫原性是在I期单臂研究中进行的。20名健康男性志愿者分别于0周、3周和6周经三角肌注射明矾上吸附的重组E20杯。在第26周，19名受试者接受了第四次(加强)剂量的治疗。候选治疗性疫苗耐受性良好。三种疫苗剂量诱导了明显的体液抗E1反应，第四剂疫苗增强了这种反应。在所有疫苗接受者中都激发了对E1的强烈、特异的细胞免疫反应，其中除了一名受试者外，所有受试者都有明显的Th1型反应。(C)2004爱思唯尔有限公司。保留所有权利。
The tolerability and immunogenicity of the hepatitis C virus E1 protein as a candidate vaccine was examined in a Phase I, single-arm study. Twenty healthy male volunteers were injected in the deltoid muscle at weeks 0, 3 and 6 with 20 mug recombinant E1 adsorbed on alum. A fourth (booster) dose was administered to 19 subjects at week 26. The candidate therapeutic vaccine was well tolerated. Three vaccine doses induced a clear humoral anti-E1 response that was boosted by a fourth dose. A strong, specific cellular immune response towards E1 was elicited in all vaccine recipients, which included a clear Th1 type response in all but one of the subjects. (C) 2004 Elsevier Ltd. All rights reserved.