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

NCT04788459 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2023-03-29

No results posted yet for this study

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

BIOLOGICAL

COVID-eVax

Plasmid DNA Vaccine for COVID-19

DEVICE

Cliniporator® and EPSGun

IGEA Electroporation Device

Sponsors & Collaborators

  • Rottapharm Biotech

    collaborator INDUSTRY

  • Takis

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-02-25
Primary Completion
2021-12-07
Completion
2021-12-07

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04788459 on ClinicalTrials.gov