Journal Article Epublish
PubMed: 40595653 DOI: 10.1038/s41541-025-01201-1
Preserved efficacy of lyophilized SARS-CoV-2 mRNA vaccine incorporating novel ionizable lipids after one year at 25 °C.
NPJ Vaccines 10(1):135
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
Affiliations
- Certest Pharma, Certest Biotec S. L. San Mateo de Gállego (Zaragoza), Spain.
- 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.
- Radiopharmacy and Translational Molecular Imaging Unit, University Clinic of Navarra. IdiSNA, Navarra Institute for Health Research, Pamplona, Spain.
- CIBA, Instituto de Investigacion Sanitaria Aragon (IISA), Zaragoza, Spain.
- CIBER en Enfermedades Infecciones (CIBERINFECT), Instituto de Salud Carlos III, Madrid, Spain.
- Dpto. Microbiologia, Radiologia, Pediatria y Salud Publica, Fac. Medicina, Universidad de Zaragoza, Zaragoza, Spain.
- Facultad de Veterinaria, IA2, Centro de Encefalopatías y Enfermedades Transmisibles Emergentes, Universidad de Zaragoza, Zaragoza, Spain.
- Certest Pharma, Certest Biotec S. L. San Mateo de Gállego (Zaragoza), Spain.
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.
MeSH
Sars-Cov-2, Untranslated Regions, Vaccines, Rna, Messenger, Immunity, Severe Acute Respiratory Syndrome-Related Coronavirus