drugset / Trial / NCT04447781

Safety, Tolerability and Immunogenicity of INO-4800 Followed by Electroporation in Healthy Volunteers for COVID19

NCT04447781 ↗

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

EvaluationDrugModalityDoseRoute
Subject RELUSCOVTOGENE RALAPLASMID Vaccine 1 mg Other
Subject RELUSCOVTOGENE RALAPLASMID Vaccine 2 mg Other

Indications