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第二阶段预注血非稳定Covid-19 mRNA疫苗随机研究

Thanyawee Puthanakit^1,2,3, Eakachai Prompetchara^4,5, Sivaporn Gatechompol^6,7,8

¹Department of Pediatrics, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.

Scientific reports

|January 29, 2024

概括

在健康的成年人中,ChulaCov19 mRNA疫苗是安全有效的,产生高水平的中和抗体和T细胞反应. 第1阶段的结果显示,这种新型COVID-19疫苗候选人的免疫性和耐受性是有希望的.

科学领域:

疫苗学疫苗学疫苗学
免疫学免疫学免疫学
传染性疾病传染性疾病

背景情况:

由于COVID-19的流行,需要开发有效的疫苗.
mRNA疫苗技术为快速疫苗开发提供了一个有前途的平台.

研究的目的:

在健康成年人中评估ChulaCov19 mRNA疫苗的安全性和免疫性.
在接种疫苗后评估中和抗体反应和T细胞活性.

主要方法:

一个双盲,随机,安慰剂控制的第一阶段试验,涉及150名18-59岁的健康成年人.
参与者接受了ChulaCov19 (50μg) 或安慰剂的两个肌肉内注射剂量.
安全评估包括监测不良事件. 用微中和化抗体标位 (Micro-VNT50) 和T细胞IFN-γ-ELISpot测定来测量免疫性.

主要成果:

ChulaCov19被很好地容忍,大多数不良事件是轻度至中度和暂时的.
对野生型SARS-CoV-2的中和抗体的几何平均标位 (GMT) 在第50天达到1367 IU/mL.
用IFN-γ-ELISpot测量的T细胞反应在第二剂后一周达到峰值,随后下降.

结论:

ChulaCov19 50μg mRNA疫苗是安全的,在健康的成年人中引起强大的中和抗体和T细胞反应.
这些发现支持在更大的临床试验中进一步调查ChulaCov19.
ChulaCov19代表了一种潜在的新疫苗选择,用于打击COVID-19.

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