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SARS-CoV-2自我放大RNA疫苗表达定RBD的安全性和免疫性:一个随机的,盲目观察者第一阶段研究

Wataru Akahata¹, Takashi Sekida¹, Takuto Nogimori²

¹VLP Therapeutics Japan, Inc., Marunouchi, Minato-ku, Tokyo 105-0003, Japan.

Cell reports. Medicine

|August 16, 2023

概括

VLPCOV-01是一种新型的自我放大RNA (saRNA) 疫苗,在1期研究中证明了针对SARS-CoV-2的强大和持续的免疫球蛋白G (IgG) 标位. 这种saRNA疫苗平台显示出有效的低剂量管理的潜力.

科学领域:

疫苗学疫苗学疫苗学
分子生物学分子生物学
免疫学免疫学免疫学

背景情况:

严重急性呼吸道综合征冠状病毒2 (SARS-CoV-2) 需要持续开发疫苗.
自放大RNA (saRNA) 是一个有前途的新型疫苗平台.
脂质纳米粒子 (LNP) 封装增强了RNA疫苗的输送和稳定性.

研究的目的:

为了评估VLPCOV-01的安全性和免疫性,LNP封装的saRNA疫苗表达SARS-CoV-2受体结合域 (RBD).
为了比较VLPCOV-01不同剂量的免疫反应与基准mRNA疫苗 (BNT162b2) 和安慰剂.

主要方法:

一个1期随机化,安慰剂控制的研究 (jRCT2051210164) 涉及参与者先前接种了BNT162b2.2.的疫苗.
参与者接受了一剂VLPCOV-01 (0.3,1.0或3.0微克),BNT162b2 (30微克) 或安慰剂的肌肉注射剂量.
通过不良事件评估安全性,通过免疫球蛋白G (IgG) 和中和抗体标位评估免疫性.

主要成果:

没有报告VLPCOV-01.1的严重不良事件.
VLPCOV-01诱导了针对SARS-CoV-2 RBD的强大而持久的IgG标位,维持了长达26周的时间.
对VLPCOV-01的几何平均IgG标位在5,037至12,873之间,在某些剂量下超过了BNT162b2 (3,166) 的标位.
观察到对各种SARS-CoV-2变体的中和抗体标位.

结论:

在低剂量时,VLPCOV-01是安全的和免疫的.
该saRNA疫苗平台展示了有效的SARS-CoV-2疫苗接种的潜力.
持续的抗体反应支持VLPCOV-01.1的长期疗效.

关键词:

在 COVID-19 疫情中,在RBD抗原中,RBD抗原是这就是SARS-CoV-2病毒.增强疫苗的疫苗增强剂.免疫性免疫性免疫性关于安全的安全问题自强化RNA的自强化RNA.

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