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N-蛋白疫苗对COVID-19有效:3期,随机,双盲,安慰剂控制的临床试验

Sevastyan O Rabdano¹, Ellina A Ruzanova¹, Anastasiya E Vertyachikh¹

¹Saint Petersburg Scientific Research Institute of Vaccines and Serums of the Federal Medical-Biological Agency of Russia (SPbSRIVS), Saint Petersburg, Russia.

The Journal of infection

|September 28, 2024

概括

一种新的核体 (N) 蛋白COVID-19疫苗显示,对症状感染的有效性为85.2%. 这种N蛋白疫苗为针对SARS-CoV-2变种的更广泛保护提供了有希望的替代方案.

科学领域:

免疫学免疫学免疫学
疫苗学疫苗学疫苗学
传染性疾病传染性疾病

背景情况:

目前针对尖峰 (S) 蛋白的COVID-19疫苗面临SARS-CoV-2免疫逃生变体带来的挑战.
一些个人无法通过基于S蛋白的疫苗获得足够的免疫力,因此需要采用替代策略.
存在对提供更广泛,更持久保护的疫苗的需求,以对抗不断演变的SARS-CoV-2菌株.

研究的目的:

为了评估新型COVID-19疫苗的疗效和安全性.
该疫苗基于SARS-CoV-2的全长重组核囊 (N) 蛋白质.

主要方法:

一个前性的,多中心的,随机的,双盲的,安慰剂控制的第三期临床试验在俄罗斯进行.
5229名成年参与者接受了单次肌肉注射N蛋白疫苗 (50微克) 或安慰剂,比例为2:1.
主要结局是PCR确认的COVID-19症状发病率>15天接种疫苗后180天.

主要成果:

疫苗的疗效为85.2% (95%CI:67.4-93.3;p < 0.0001),疫苗组的COVID-19症状为0.23%,而安慰剂组的1.55%.
副作用主要是轻微的,包括局部注射部位反应.
没有任何严重的不良事件被归因于疫苗.

结论:

基于N蛋白质的COVID-19疫苗显示出显著的疗效和良好的安全性.
这种疫苗是全球疫苗接种工作的宝贵补充,特别是针对免疫逃生变体.
结果支持开发和部署N蛋白疫苗,作为预防COVID-19的替代策略.

关键词:

在 COVID-19 疫情中,临床试验临床试验是指临床试验的临床试验.核体蛋白质是一种核体蛋白质.第三阶段第三阶段疫苗疫苗疫苗疫苗

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Conjugated Proteins

Conjugated Proteins

Simple proteins and protein complexes contain only amino acids. In contrast, many other proteins, called conjugated proteins, covalently bond with non-protein moieties.
Nucleoproteins are protein complexes that contain nucleic acids, categorized as deoxyribonucleoproteins (DNPs) or ribonucleoproteins (RNPs) respectively. The nucleosome is a typical example of a DNP where nuclear DNA is associated with histone proteins. The major antigen for the Covid-19 virus SARS-CoV is an RNP that is critical...