Safety and Immunogenicity of COVID-eVax, a Candidate Plasmid DNA Vaccine for COVID-19, in Healthy Adult Volunteers

Summary

This is a multicentre, open-label Phase 1/2 study, with a first-in-human (FIH) dose escalation part (Phase 1 study) followed by an open-label single arm (or two-arms, randomized) dose expansion part (Phase 2 study). The vaccine will be administered by intramuscular (IM) injection followed by electroporation (EP) applied to the injection site. The study is aimed at assessing the safety and immunogenicity of COVID-eVax, a DNA plasmid-based vaccine whose target antigen is a portion of the S protein of SARS-CoV-2 virus (the Receptor Binding Domain located in the CTD1 of the S1 region of the S protein). In animal models COVID-eVax was safe and induced high immunological humoral and cellular response.

Timeline

Start

2021-02-25

Primary completion

2021-12-07

Completion

2021-12-07

Outcome

Outcome not reported

Stopped: “The good progress of the Italian national vaccination campaign against COVID-19 made impossible to complete the study as planned.”

Drugs

Indications