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A Clinical Trial of a Prophylactic Plasmid DNA Vaccine for COVID-19 [Covigenix VAX-001] in Adults

NCT04591184 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 268

Last updated 2024-02-20

No results posted yet for this study

Summary

This study is a Phase I/II clinical study in healthy adults designed to assess the safety, tolerability, and immunogenicity of receiving 2 IM injections of Covigenix VAX-001/-1b, 28 days apart. Covigenix VAX-001/-1b is a plasmid DNA vaccine that expresses key antigenic determinants from SARS-CoV-2 and uses Entos Pharmaceuticals' Fusogenix PLV platform.

The phase I part of this study was completed in Canada. The phase II part of the study will be completed in Burkina Faso, Senegal and South Africa.

Conditions

Interventions

BIOLOGICAL

Covigenix VAX-001 placebo

Placebo vaccine

BIOLOGICAL

Covigenix VAX-001

Active Covigenix VAX-001

Sponsors & Collaborators

  • Aegis Life, Inc.

    collaborator UNKNOWN

  • Canadian Institutes of Health Research (CIHR)

    collaborator OTHER_GOV

  • Clinical Pharma Solutions Inc

    collaborator UNKNOWN

  • Centre national de recherche et de formation sur le paludisme (CNRFP)

    collaborator UNKNOWN

  • Entos Pharmaceuticals Inc.

    lead INDUSTRY

Principal Investigators

  • Joakem Tazanu Fossung · Clinical Pharma Solutions

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2021-04-07
Primary Completion
2023-12-06
Completion
2023-12-06

Countries

  • Burkina Faso
  • Canada
  • Senegal
  • South Africa

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 NCT04591184 on ClinicalTrials.gov