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在成年人中进行COVID-19RNA疫苗BNT162b1的I/II期研究

Mark J Mulligan^1,2, Kirsten E Lyke³, Nicholas Kitchin⁴

¹New York University Langone Vaccine Center, New York, NY, USA.

|August 14, 2020

概括

这项研究评估了BNT162b1,一种针对COVID-19的mRNA疫苗,用于健康的成年人. 该疫苗的安全性取决于剂量,并诱导显著的中和抗体反应,支持进一步的临床开发.

科学领域:

疫苗学
传染性疾病
免疫学

背景情况:

由SARS-CoV-2引起的COVID-19大流行需要紧急开发疫苗.
BNT162b1是一种针对SARS-CoV-2受体结合域 (RBD) 的mRNA疫苗候选.

研究的目的:

在剂量升级研究中评估BNT162b1的安全性,耐受性和免疫性.
为进一步临床试验确定最佳剂量.

主要方法:

这是一项与安慰剂对照,观察者盲目的剂量升级研究,涉及45名健康成年人 (18至55岁).
参与者接受了两剂10μg,30μg或100μg的BNT162b1,分隔21天.
测量了安全性,局部反应,全身事件和免疫性 (RBD结合IgG和中和抗体).

主要成果:

局部和全身反应依赖于剂量,一般为轻度至中度,过时.
结合RBD的IgG度和中和抗体标位随着剂量和第二次疫苗接种而增加.
几何平均中和位数达到康复期血清的1. 9~4. 6倍.
由于反应性增加,100μg剂量并没有在30μg剂量上显著增加免疫性.

结论:

BNT162b1具有剂量依赖的安全性,并诱导强大的免疫性.
30微克的剂量显示出反应性和免疫性的良好平衡.
这些发现支持进一步评估BNT162b1作为COVID-19疫苗候选者.

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