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

IF 6.9 1区医学 Q1 IMMUNOLOGY

NPJ Vaccines Pub Date : 2025-07-01 DOI:10.1038/s41541-025-01201-1

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

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引用次数: 0

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.

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含新型可电离脂质的SARS-CoV-2 mRNA冻干疫苗在25℃下保存1年后的效力。

mRNA疫苗已显示出对SARS-CoV-2的良好疗效，但在优化疫苗成分以增强免疫反应和疫苗稳定性方面仍存在挑战。在这项研究中，我们开发了CPVax-CoV，这是一种新的冻干mRNA疫苗，具有新的基于硫代内酯的可电离脂质和新设计的非翻译区（UTRs），用于增强表达。与市售mRNA疫苗相比，将这些优化的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已被证明具有耐热性，在冻干后的4°C和25°C下可保持长达一年的生物活性，克服了目前mRNA疫苗的冷链限制。该疫苗显示出对祖先SARS-CoV-2和Omicron XBB变体的保护功效，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。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

NPJ Vaccines Immunology and Microbiology-Immunology

CiteScore

11.90

自引率

4.30%

发文量

146

审稿时长

11 weeks

期刊介绍： Online-only and open access, npj Vaccines is dedicated to highlighting the most important scientific advances in vaccine research and development.