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

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

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...

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Main Authors: 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
Format: Article
Language:English
Published: Nature Portfolio 2025-07-01
Series:npj Vaccines
Online Access:https://doi.org/10.1038/s41541-025-01201-1
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Summary: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.
ISSN:2059-0105

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