LANCET:rVSV∆G-ZEBOV-GP埃博拉疫苗候选物的安全性和免疫原性

2017-06-10 MedSci MedSci原创

之前报道重组腺病毒5型埃载体的博拉病毒疫苗对于健康的塞拉利昂人是安全并且具有高度免疫原性。近日,国际杂志 《LANCET》上在线发表一项关于rVSV∆G-ZEBOV-GP埃博拉病毒疫苗候选物的安全性和免疫原性的研究。

之前报道重组腺病毒5型埃载体的博拉病毒疫苗对于健康的塞拉利昂人是安全并且具有高度免疫原性。近日,国际杂志 《LANCET》上在线发表一项关于rVSVG-ZEBOV-GP埃博拉病毒疫苗候选物的安全性和免疫原性的研究。

rVSVΔG-ZEBOV-GP是由水泡性口炎病毒 - 印第安纳组成的活减毒重组疫苗,其中水泡性口炎病毒包膜糖蛋白(G)被扎伊尔埃博拉病毒(Kikwit菌株)的包膜糖蛋白(GP)代替。在本项临床I期的双盲,安慰剂对照,剂量反应研究中,研究人员在美国八个研究地点登记并随机分配健康成年人(年龄18-61岁)通过肌肉注射接受单次注射疫苗或安慰剂。在第1队列,参与者被分配接受3×10 33×10 43×10 53×106 PFU剂量的rVSVΔG-ZEBOV-GP或安慰剂。在第2队列,参与者被分配接受3×10 69×10 62×10 7,或1×108 PFU剂量的rVSVΔG-ZEBOV-GP或安慰剂。参与者由研究统计人员通过计算机生成的随机化列表集中分配给疫苗组或安慰剂。主要安全性结果是在调整意向治疗人群(所有随机分配的接受疫苗或安慰剂的受试者)14天内发生不良事件,免疫原性的主要结果是第28天的IgG ELISA抗体滴度。加强关节炎和皮炎的监测直至56天。本研究已在ClinicalTrials.gov登记,编号NCT02314923

研究认为rVSVΔG-ZEBOV-GP具有良好的耐受性,并能快速引起结合和中和抗体,能够保持至360天。免疫原性结果支持选择2×107PFU剂量。

原始出处:

D Gray Heppner,et al.Safety and immunogenicity of the rVSVG-ZEBOV-GP Ebola virus vaccine candidate in healthy adults: a phase 1b randomised, multicentre, double-blind, placebo-controlled, dose-response study.june.2017

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    2018-03-18 howi
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    2017-06-11 1dd7a091m35(暂无匿称)

    原来如此。。。。。。。。。

    0

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    2017-06-10 158****8818

    这个很好啊,以后埃博拉有办法啦

    0

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