drugset / Trial / NCT04447781
Safety, Tolerability and Immunogenicity of INO-4800 Followed by Electroporation in Healthy Volunteers for COVID19
Phase 1/2
Completed
79 enrolled
International Vaccine Institute
Coalition for Epidemic Preparedness Innovations · collabInovio Pharmaceuticals · collab
RandomizedSequentialTriple-blindPrevention
Summary
This is a phase I/IIa trial to evaluate the safety, tolerability and immunological profile of INO-4800 administered by intradermal (ID) injection followed by electroporation (EP) using the CELLECTRA® 2000 device in healthy adults aged 19 to 64 years in Republic of Korea. INO- 4800 contains the plasmid pGX9501, which encodes for the full length of the Spike glycoprotein of SARS-CoV-2. The primary objective of this trial is to evaluate the tolerability, safety, and immunogenicity of INO-4800 administered by ID injection followed by EP in healthy adults in the Part A and Part B. Enrollment into Part A, and Part B will proceed sequentially.
Timeline
- Start
- 2020-07-15
- Primary completion
- 2021-07-12
- Completion
- 2022-05-25
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | RELUSCOVTOGENE RALAPLASMID | Vaccine | 1 mg | Other |
| Subject | RELUSCOVTOGENE RALAPLASMID | Vaccine | 2 mg | Other |