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

NCT04447781 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 79

Last updated 2022-07-18

No results posted yet for this study

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.

Conditions

  • Coronavirus Infection
  • SARS-CoV 2

Interventions

BIOLOGICAL

INO-4800

\- Manufacturer: Inovio Pharmaceuticals Inc.

DEVICE

CELLECTRA® 2000

\- Manufacturer: Inovio Pharmaceuticals Inc.

OTHER

Saline-sodium citrate (SSC) buffer

\- Manufacturer: Inovio Pharmaceuticals Inc.

Sponsors & Collaborators

  • Coalition for Epidemic Preparedness Innovations

    collaborator OTHER

  • Inovio Pharmaceuticals

    collaborator INDUSTRY

  • International Vaccine Institute

    lead OTHER

Principal Investigators

  • Myoung-don Oh, MD · Seoul National University Hospital

  • Eu Suk Kim, MD · Seoul National University Bundang Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
SEQUENTIAL

Eligibility

Min Age
19 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-07-15
Primary Completion
2021-07-12
Completion
2022-05-25
FDA Drug
Yes
FDA Device
Yes

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Companies

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 NCT04447781 on ClinicalTrials.gov