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用保护相关指标评估 COVID-19 疫苗。

Enabling the evaluation of COVID-19 vaccines with correlates of protection.

机构信息

Institute for Medical Immunology (IMI), European Plotkin Institute for Vaccinology (EPIV), Université libre de Bruxelles, 808 Route de Lennik, 1070, Brussels, Belgium.

Centre for the Evaluation of Vaccination, European Plotkin Institute for Vaccinology (EPIV), Vaccine & Infectious Disease Institute, University of Antwerp, Faculty of Medicine & Health Sciences, Vaccinopolis/University of Antwerp, Drie Eikenstraat 663, 2650, Edegem, Belgium.

出版信息

Biologicals. 2024 Feb;85:101723. doi: 10.1016/j.biologicals.2023.101723. Epub 2023 Nov 16.

Abstract

In February 2023, a meeting about correlates of protection (CoPs) against COVID-19 was organized by the International Alliance for Biological Standardization, the European Plotkin Institute for Vaccinology, and Vaccinopolis. The meeting aimed at reviewing the evidence, drawing conclusions, and identifying knowledge gaps. Collection of evidence is not straightforward. Neutralizing antibodies correlate with protection and are used for immunobridging studies within and between vaccine platforms for approval of new COVID-19 vaccines. In preparation for the next pandemic, it is vital that rapidly authorized initial vaccines are available to perform immunobridging studies very early. Additional components of the immune response likely contribute to protection against symptomatic infection. Current evidence is strongest for T lymphocytes and binding antibodies. Further studies are needed to consolidate this evidence and define their potential role in the evaluation of vaccines. For evaluation of mucosal vaccines, identifying CoPs against infection and transmission is key; further research is needed to identify and standardize methods suitable for clinical studies. CoPs for broadly protective beta-coronavirus vaccines remain a critical area of research. The knowledge, expertise, and capacity exist to conduct clinical studies using different designs in different populations to discover and validate CoPs, facilitating and accelerating evaluation of novel vaccines/vaccination platforms.

摘要

2023 年 2 月,国际生物标准化联盟、欧洲普特金疫苗学研究所和 Vaccinopolis 组织了一次关于 COVID-19 保护相关因素(CoPs)的会议。会议旨在审查证据、得出结论并确定知识空白。收集证据并不简单。中和抗体与保护相关,用于在疫苗平台内和平台之间进行免疫桥接研究,以批准新的 COVID-19 疫苗。为了为下一次大流行做好准备,至关重要的是,迅速授权的初始疫苗能够非常早期地进行免疫桥接研究。免疫反应的其他成分可能有助于预防有症状感染。目前,针对 T 淋巴细胞和结合抗体的证据最强。需要进一步的研究来巩固这一证据,并确定它们在疫苗评估中的潜在作用。对于粘膜疫苗的评估,确定针对感染和传播的 CoPs 是关键;需要进一步研究来确定和标准化适合临床研究的方法。针对广泛保护的β冠状病毒疫苗的 CoPs 仍然是一个关键的研究领域。现有的知识、专业知识和能力足以在不同人群中使用不同的设计进行临床研究,以发现和验证 CoPs,从而促进和加速对新型疫苗/接种平台的评估。

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