Immunogenicity of COVID-eVax Is Moderately Impacted by Temperature and Molecular Isoforms
D'Alessio, F.; Lione, L.; Salvatori, E.; Bucci, F.; Muzi, A.; Roscilli, G.; Conforti, A.; Compagnone, M.; Pinto, E.; Battistuzzi, G.; Aurisicchio, L.; Palombo, F.
Show abstract
DNA integrity is a key issue in gene therapy and genetic vaccine approaches based on plasmid DNA. In contrast to messenger RNA that requires a controlled cold chain for efficacy, DNA molecules are considered to be more stable. In this study, we challenged this concept by characterizing the immunological response induced by a plasmid DNA vaccine delivered using electroporation. As a model, we used COVID-eVax, which is a plasmid DNA vaccine that targets the receptor binding domain (RBD) of the SARS-CoV-2 spike protein. Increased nicked DNA was produced by using either an accelerated stability protocol or a lyophilization protocol. Surprisingly, the immune response induced in vivo was only minimally affected by the percentage of open circular DNA. This result suggests that plasmid DNA vaccines, such as COVID-eVax that has completed a phase I clinical trial, retain their efficacy upon storage at higher temperatures and this feature may facilitate their use in low-/middle-income countries.
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