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在世界卫生组织/多边抗疫合作机制信使核糖核酸技术转让计划下生产的新冠信使核糖核酸候选疫苗阿弗里瓦克2121(武汉株)在仓鼠模型中的临床前评估。

Preclinical evaluation in hamster model of the mRNA COVID-19 vaccine candidate AfriVac 2121 (Wuhan) produced under the WHO/MPP mRNA Technology Transfer Programme.

作者信息

Bernadin Ornéllie, Cochin Maxime, Driouich Jean-Sélim, Laprie Caroline, Steigler Pia, Boukes Gerhardt, Fenner Caryn, de Lamballerie Xavier, Nougairède Antoine

机构信息

Unité des Virus Émergents (UVE: Aix-Marseille Univ, Università di Corsica, IRD 190, Inserm 1207, IRBA), France.

Laboratoire Vet-Histo, Marseille, France.

出版信息

Vaccine. 2024 Dec 2;42(26):126378. doi: 10.1016/j.vaccine.2024.126378. Epub 2024 Sep 21.

DOI:10.1016/j.vaccine.2024.126378
PMID:39307023
Abstract

During the COVID-19 pandemic, access to vaccines in low- and middle-income countries was limited and delayed. To address these disparities, the mRNA Technology Transfer Programme, coordinated and led by the World Health Organization and the Medicines Patent Pool, was launched. A consortium has been set up in South Africa to develop a platform for manufacturing mRNA vaccines. In this study, the preclinical evaluation of the mRNA COVID-19 vaccine candidate, AfriVac 2121 (Wuhan) manufactured in December 2022 was conducted. The hamster model was employed to assess the immunogenicity and efficacy of this COVID-19 mRNA vaccine candidate in comparison to a commercial mRNA vaccine (mRNA-1273, Moderna). Results revealed that a vaccine regimen consisting of two 5 μg doses of AfriVac 2121 (Wuhan) elicited a protective immune response against an ancestral B.1 strain of SARS-CoV-2 similar to that obtained with the mRNA-1273 vaccine. AfriVac 2121 (Wuhan) induced robust humoral immune responses against SARS-CoV-2 and protected hamsters against a SARS-CoV-2 challenge with the B.1 strain. These results have since enabled the further development of this platform for manufacturing mRNA vaccines.

摘要

在新冠疫情期间,低收入和中等收入国家获取疫苗的机会有限且延迟。为解决这些差异,由世界卫生组织和药品专利池协调并牵头的信使核糖核酸技术转让计划启动。在南非成立了一个联盟,以开发一个生产信使核糖核酸疫苗的平台。在本研究中,对2022年12月生产的信使核糖核酸新冠候选疫苗AfriVac 2121(武汉株)进行了临床前评估。采用仓鼠模型评估该新冠信使核糖核酸候选疫苗与一种商用信使核糖核酸疫苗(mRNA-1273,莫德纳公司)相比的免疫原性和效力。结果显示,由两剂5微克AfriVac 2121(武汉株)组成的疫苗接种方案引发了针对严重急性呼吸综合征冠状病毒2原始B.1毒株的保护性免疫反应,与mRNA-1273疫苗所产生的反应相似。AfriVac 2121(武汉株)诱导了针对严重急性呼吸综合征冠状病毒2的强大体液免疫反应,并保护仓鼠免受B.1毒株的严重急性呼吸综合征冠状病毒2攻击。这些结果推动了该信使核糖核酸疫苗生产平台的进一步开发。

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