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

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 (Universidad de Zaragoza) ; Moreno, Bernardino (Universidad de Zaragoza) ; Badiola, Juan (Universidad de Zaragoza) ; Martínez-Oliván, Juan ; Pérez-Herrán, Esther

Resumen: 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.

Idioma: Inglés

DOI: 10.1038/s41541-025-01201-1

Año: 2025

Publicado en: npj Vaccines 10, 135 (2025), 19
ISSN: 2059-0105

Financiación: info:eu-repo/grantAgreement/ES/AEI/PID2020-113963RB-I00
Financiación: info:eu-repo/grantAgreement/ES/DGA/B29-20R
Financiación: info:eu-repo/grantAgreement/ES/ISCIII/CB21-13-00087
Financiación: info:eu-repo/grantAgreement/ES/ISCIII/COV20-00308

Tipo y forma: Article (Published version)

Área (Departamento): Área Sanidad Animal (Dpto. Patología Animal)
Área (Departamento): Área Inmunología (Dpto. Microb.Ped.Radio.Sal.Pú.)