NCT04788459

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

A Phase I/II Study to Assess the Safety and Immunogenicity of COVID-eVax, a Candidate Plasmid DNA Vaccine for COVID-19, in Healthy Adult Volunteers

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 68 (actual)
• Sponsor: Takis · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• COVID-19
• Protection Against COVID-19 and Infections With SARS-CoV- 2
• COVID-19 Immunisation

Interventions

Type	Name	Description
BIOLOGICAL	COVID-eVax	Plasmid DNA Vaccine for COVID-19
DEVICE	Cliniporator® and EPSGun	IGEA Electroporation Device

Timeline

• Start date: 2021-02-25
• Primary completion: 2021-12-07
• Completion: 2021-12-07
• First posted: 2021-03-09
• Last updated: 2023-03-29

Locations

4 sites across 1 country: Italy