Nat Commun:1期临床试验结果:单剂量ChAdOx1 Chik疫苗可诱导针对基孔肯雅病毒的中和抗体 

2021-08-01 haibei MedSci原创

最近,研究人员在Nature Communications杂志发文介绍了候选模拟腺病毒载体疫苗ChAdOx1 Chik的首次人体试验结果。

1951年,基孔肯雅病毒(CHIKV)在坦桑尼亚首次出现,其随后在肯尼亚、印度洋(2004-2006年)和美洲(2013-2017年)的一系列爆发中再次出现。基孔肯雅病毒已成为一个主要的国际健康问题,对公众健康产生了急性和长期影响。目前,在非洲、亚洲、欧洲和美洲的100多个国家都发现了CHIKV。

CHIKV是一种Togaviridae家族的RNAα病毒,在城市环境中由埃及伊蚊和白纹伊蚊传播给人类。这两种蚊子已经分散到各大洲,埃及伊蚊主要存在于热带和亚热带地区,白纹伊蚊则在温带地区更常见。它们在全球范围内的迅速扩张说明,基孔肯雅热(CHIKF)可能会在热带地区之外造成更大的负担。

对于CHIKV感染主要的关注点是感染者的持续和致残的多关节痛。最近,研究人员在Nature Communications杂志发文介绍了候选模拟腺病毒载体疫苗ChAdOx1 Chik的首次人体试验结果。该疫苗表达了CHIKV全长结构多聚蛋白(Capsid, E3, E2, 6k和E1)。

在一项剂量递增、开放标签、非随机和非对照的1期试验中,研究人员招募了24名18-50岁的成年健康志愿者(注册号为NCT03590392)。参与者以三种预先确定的剂量之一接受ChAdOx1 Chik的单次肌肉注射,并被随访6个月。该研究的主要目标是评估ChAdOx1 Chik的安全性和耐受性。次要目标是评估体液和细胞免疫原性。

T细胞反应率随时间的变化

结果显示,ChAdOx1 Chik在所有测试剂量下都是安全的,没有出现严重不良反应的报告。绝大多数的不良事件是轻度或中度的,并且是自限性的。

此外,单一剂量的疫苗可诱发针对CHIKV结构抗原的IgG和T细胞反应。在所有参与者中都发现了针对CHIKV四系的广义中和抗体,并且在接种后2周就发现了这种抗体。

总之,该研究结果表明,ChAdOx1 Chik具体良好的安全性、耐受性和单剂量后100%的PRNT50血清转换。

 

原始出处:

Pedro M. Folegatti et al.A single dose of ChAdOx1 Chik vaccine induces neutralizing antibodies against four chikungunya virus lineages in a phase 1 clinical trial. Nature Communications (2021). 

 

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    2021-12-14 liye789132251
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    2022-03-29 liuli5079
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    2021-08-01 148c6444m63暂无昵称

    可以,不错

    0

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