drugset / Trial / NCT04591184
A Clinical Trial of a Prophylactic Plasmid DNA Vaccine for COVID-19 [Covigenix VAX-001] in Adults
Phase 1/2
Completed
268 enrolled
Entos Pharmaceuticals Inc.
Aegis Life, Inc. · collabCanadian Institutes of Health Research (CIHR) · collabCentre national de recherche et de formation sur le paludisme · collabClinical Pharma Solutions Inc · collab
RandomizedParallel-groupTriple-blindPrevention
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.
Timeline
- Start
- 2021-04-07
- Primary completion
- 2023-12-06
- Completion
- 2023-12-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Covigenix VAX-001 | Vaccine | 0.1 mg | Intramuscular |
| Subject | Covigenix VAX-001 | Vaccine | 0.25 mg | Intramuscular |