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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| Format: | Article |
| Language: | English |
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Nature Portfolio
2025-07-01
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| Series: | npj Vaccines |
| Online Access: | https://doi.org/10.1038/s41541-025-01201-1 |
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| author | 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 |
| author_facet | 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 |
| author_sort | Elena Mata |
| collection | DOAJ |
| description | 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. |
| format | Article |
| id | doaj-art-3c0cdbdc844944f286da8499cb0a01a4 |
| institution | Kabale University |
| issn | 2059-0105 |
| language | English |
| publishDate | 2025-07-01 |
| publisher | Nature Portfolio |
| record_format | Article |
| series | npj Vaccines |
| spelling | doaj-art-3c0cdbdc844944f286da8499cb0a01a42025-08-20T04:01:24ZengNature Portfolionpj Vaccines2059-01052025-07-0110111910.1038/s41541-025-01201-1Preserved efficacy of lyophilized SARS-CoV-2 mRNA vaccine incorporating novel ionizable lipids after one year at 25 °CElena Mata0Esther Broset1Carlos Matute2Andrei Stoian3Susana Adame4Teresa Alejo5Alexandre López6Beatriz Andrés7Juan Heredero8Diego de Miguel9Javier Giménez-Warren10Verónica Lampaya11Diego Casabona12Alba Calvo13Gema Quincoces14Iván Peñuelas15Carlos Gamazo16Iratxe Uranga17Natacha Peña18Maykel Arias19Julián Pardo20Bernardino Moreno21Juan Badiola22Juan Martínez-Oliván23Esther Pérez-Herrán24Certest Pharma, Certest Biotec S. L.Certest Pharma, Certest Biotec S. L.Certest Pharma, Certest Biotec S. L.Certest Pharma, Certest Biotec S. L.Certest Pharma, Certest Biotec S. L.Certest Pharma, Certest Biotec S. L.Certest Pharma, Certest Biotec S. L.Certest Pharma, Certest Biotec S. L.Certest Pharma, Certest Biotec S. L.Certest Pharma, Certest Biotec S. L.Certest Pharma, Certest Biotec S. L.Certest Pharma, Certest Biotec S. L.Certest Pharma, Certest Biotec S. L.Department of Microbiology and Parasitology, University of Navarra; IdiSNA, Navarra Institute for Health ResearchRadiopharmacy and Translational Molecular Imaging Unit, University Clinic of Navarra. IdiSNA, Navarra Institute for Health ResearchRadiopharmacy and Translational Molecular Imaging Unit, University Clinic of Navarra. IdiSNA, Navarra Institute for Health ResearchDepartment of Microbiology and Parasitology, University of Navarra; IdiSNA, Navarra Institute for Health ResearchCIBA, Instituto de Investigacion Sanitaria Aragon (IISA)CIBA, Instituto de Investigacion Sanitaria Aragon (IISA)CIBA, Instituto de Investigacion Sanitaria Aragon (IISA)CIBA, Instituto de Investigacion Sanitaria Aragon (IISA)Facultad de Veterinaria, IA2, Centro de Encefalopatías y Enfermedades Transmisibles Emergentes, Universidad de ZaragozaFacultad de Veterinaria, IA2, Centro de Encefalopatías y Enfermedades Transmisibles Emergentes, Universidad de ZaragozaCertest Pharma, Certest Biotec S. L.Certest Pharma, Certest Biotec S. L.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.https://doi.org/10.1038/s41541-025-01201-1 |
| spellingShingle | 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 Preserved efficacy of lyophilized SARS-CoV-2 mRNA vaccine incorporating novel ionizable lipids after one year at 25 °C npj Vaccines |
| title | Preserved efficacy of lyophilized SARS-CoV-2 mRNA vaccine incorporating novel ionizable lipids after one year at 25 °C |
| title_full | Preserved efficacy of lyophilized SARS-CoV-2 mRNA vaccine incorporating novel ionizable lipids after one year at 25 °C |
| title_fullStr | Preserved efficacy of lyophilized SARS-CoV-2 mRNA vaccine incorporating novel ionizable lipids after one year at 25 °C |
| title_full_unstemmed | Preserved efficacy of lyophilized SARS-CoV-2 mRNA vaccine incorporating novel ionizable lipids after one year at 25 °C |
| title_short | Preserved efficacy of lyophilized SARS-CoV-2 mRNA vaccine incorporating novel ionizable lipids after one year at 25 °C |
| title_sort | preserved efficacy of lyophilized sars cov 2 mrna vaccine incorporating novel ionizable lipids after one year at 25 °c |
| url | https://doi.org/10.1038/s41541-025-01201-1 |
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