2025
Molecular Therapy Nucleic Acids (2025), doi: https://doi.org/10.1016/j.omtn.2025.102628.
Thermostable unit solid dose formulations for subcutaneous administration of DNA vaccines.
Viral Immunology Group, Discipline of Surgery, The Basil Hetzel Institute for Translational Health Research, The University of Adelaide, Adelaide, 5011, South Australia, Australia Instituto de Investigación, Desarrollo e Innovación en Biotecnología Sanitaria de Elche, Universidad Miguel Hernández, 03202, Elche, Spain aVaxziPen Ltd., 120 A&B Olympic Avenue, Abingdon, OX14 4SA, United Kingdom These authors contributed equally as first authors. These authors contributed equally as senior authors.
Service type: Stock strains
Abstract
The COVID-19 pandemic has highlighted the critical need for thermostable vaccines to ensure equitable distribution and accessibility, particularly in regions lacking cold-chain infrastructure. Here we present a thermostable, solid dose DNA vaccine (SDV) platform for subcutaneous delivery, based on a sugar–sugar alcohol–polymer formulation manufactured via lyophilization and compaction. Using luciferase (Luc) expressing plasmid as a model, we demonstrate that subcutaneous vaccination with SDV formulation of C57BL/6 mice results in efficient and durable transgene expression in vivo. In vitro stability assays confirmed that the SDV formulation maintained excellent thermostability after 30 days of storage at 4°C, 25°C, 37°C and 42°C. We next applied the SDV platform to a Zika virus (ZIKV) NS1 DNA vaccine and immunized BALB/c mice. ZIKV-SDV vaccination elicited robust NS1-specific antibody and T cell responses, and conferred protection following ZIKV challenge. These data establish the feasibility of lyophilized SDV DNA vaccines for needle-free thermostable delivery. By eliminating the need for reconstitution, refrigeration and skilled administration, SDV formulation has the potential to enhance the deployment, cost-effectiveness and shelf life of DNA vaccines in resource-limited settings.
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