冻干的新型可电离脂质包裹的严重急性呼吸综合征冠状病毒2（SARS-CoV-2）信使核糖核酸（mRNA）疫苗在25摄氏度下保存一年后的疗效维持情况

Preserved efficacy of lyophilized SARS-CoV-2 mRNA vaccine incorporating novel ionizable lipids after one year at 25 °C.

作者信息

Mata Elena, Broset Esther, Matute Carlos, Stoian Andrei, Adame Susana, Alejo Teresa, López Alexandre, Andrés Beatriz, Heredero Juan, de Miguel Diego, Giménez-Warren Javier, Lampaya Verónica, Casabona Diego, Calvo Alba, Quincoces Gema, Peñuelas Iván, Gamazo Carlos, Uranga Iratxe, Peña Natacha, Arias Maykel, Pardo Julián, Moreno Bernardino, Badiola Juan, Martínez-Oliván Juan, Pérez-Herrán Esther

机构信息

Certest Pharma, Certest Biotec S. L., San Mateo de Gállego (Zaragoza), Spain.

Department of Microbiology and Parasitology, University of Navarra; IdiSNA, Navarra Institute for Health Research, Pamplona, Spain.

出版信息

NPJ Vaccines. 2025 Jul 1;10(1):135. doi: 10.1038/s41541-025-01201-1.

DOI:10.1038/s41541-025-01201-1

PMID:40595653

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12218998/

Abstract

mRNA vaccines have shown great efficacy against SARS-CoV-2, yet challenges remain in optimizing vaccine components to achieve enhanced immune response and vaccine stability. In this study, we developed CPVax-CoV, a new lyophilized mRNA vaccine that features novel thiolactone-based ionizable lipids and newly designed untranslated regions (UTRs) for enhanced expression. Incorporation of these optimized components into our vaccine candidate CPVax-CoV significantly improved immune responses in mice compared to commercially available mRNA vaccines. Moreover, lyophilized CPVax-CoV has proven to be thermostable, maintaining its biological activity for up to one year at 4 °C and 25 °C after lyophilization, overcoming the cold-chain limitations of current mRNA vaccines. This vaccine demonstrates protective efficacy against ancestral SARS-CoV-2 and the Omicron XBB variant, offering a scalable solution for global distribution and pandemic preparedness. These findings underscore the potential of this platform for future next-generation mRNA vaccine development.

摘要

信使核糖核酸（mRNA）疫苗已显示出对严重急性呼吸综合征冠状病毒2（SARS-CoV-2）具有强大的效力，但在优化疫苗成分以实现增强的免疫反应和疫苗稳定性方面仍存在挑战。在本研究中，我们开发了CPVax-CoV，这是一种新型冻干mRNA疫苗，其特点是具有新型硫内酯基可电离脂质和新设计的非翻译区（UTR）以增强表达。与市售mRNA疫苗相比，将这些优化成分纳入我们的候选疫苗CPVax-CoV可显著改善小鼠的免疫反应。此外，冻干的CPVax-CoV已被证明具有热稳定性，冻干后在4°C和25°C下可保持其生物活性长达一年，克服了当前mRNA疫苗的冷链限制。该疫苗对原始SARS-CoV-2和奥密克戎XBB变体显示出保护效力，为全球分发和大流行防范提供了可扩展的解决方案。这些发现强调了该平台在未来下一代mRNA疫苗开发中的潜力。