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A Phase 1/2 Clinical Trial of INOVIO's COVID-19 Vaccine Candidate (INO-4800) in South Korea

Trial Profile

A Phase 1/2 Clinical Trial of INOVIO's COVID-19 Vaccine Candidate (INO-4800) in South Korea

Status: Planning
Phase of Trial: Phase I/II

Latest Information Update: 16 Apr 2020

At a glance

  • Drugs INO 4800 (Primary)
  • Indications COVID 2019 infections
  • Focus Adverse reactions; Therapeutic Use
  • Most Recent Events

    • 16 Apr 2020 According to an Inovio Pharmaceuticals media release, Plumbline Life Sciences of South Korea also collaborated on this project. Korea Centers for Disease Control and Prevention (KCDC) and the KNIH and has also pledged their support for IVIs testing efforts.
    • 16 Apr 2020 According to an Inovio Pharmaceuticals media release, the period of clinical trial screening will be shortened to seven days (down from 30 days) for substances with experience in use and within 15 days for new materials. Additionally, vaccines developed with a proven safety platform, such as INOVIO's DNA platform, will be exempt from toxicology tests which will minimize data submission and expedite clinical trials.
    • 16 Apr 2020 According to an Inovio Pharmaceuticals media release, the current news follows the announcement from the Korean Ministry of Food and Drug Safety made on 13th Apr that they will adopt a fast-track approval process for COVID-19 vaccine and treatment clinical trials.

Trial Overview

Purpose

This phase 1/2 clinical trial will evaluate COVID-19 vaccine candidate (INO-4800) in South Korea.

Diseases Treated

Indication Qualifiers Patient Segments
COVID 2019 infections prevention -

Subjects

  • Subject Type patients
  • Sex male & female

Trial Details

Organisations

  • Affiliations Inovio Pharmaceuticals

Trial Dates

Other Details

  • Design prospective
  • Phase of Trial Phase I/II
  • Location South Korea
  • Focus Adverse reactions; Therapeutic Use

Interventions

Drugs Route Formulation
INO 4800Primary Drug Parenteral
-

COVID-19 vaccine candidate (INO-4800)

Trial Centres

Centres

Centre Name Location Trial Centre Country
International Vaccine Institute (IVI)
-
-

Trial History

Event Date Event Type Comment
16 Apr 2020 Other trial event According to an Inovio Pharmaceuticals media release, Plumbline Life Sciences of South Korea also collaborated on this project. Korea Centers for Disease Control and Prevention (KCDC) and the KNIH and has also pledged their support for IVIs testing efforts. Updated 20 Apr 2020
16 Apr 2020 Other trial event According to an Inovio Pharmaceuticals media release, the period of clinical trial screening will be shortened to seven days (down from 30 days) for substances with experience in use and within 15 days for new materials. Additionally, vaccines developed with a proven safety platform, such as INOVIO's DNA platform, will be exempt from toxicology tests which will minimize data submission and expedite clinical trials. Updated 20 Apr 2020
16 Apr 2020 Other trial event According to an Inovio Pharmaceuticals media release, the current news follows the announcement from the Korean Ministry of Food and Drug Safety made on 13th Apr that they will adopt a fast-track approval process for COVID-19 vaccine and treatment clinical trials. Updated 20 Apr 2020
16 Apr 2020 Other trial event According to an Inovio Pharmaceuticals media release, IVI will conduct this trial in parallel to INOVIOs Phase 1 INO-4800 study (NCT04336410) currently underway in the US since 6th Apr 2020 with 40 healthy adults receiving the vaccine candidate and eventually expanding to older adults. Updated 20 Apr 2020
16 Apr 2020 Other trial event According to an Inovio Pharmaceuticals media release, the International Vaccine Institute (IVI) announced today that the Coalition for Epidemic Preparedness Innovations (CEPI) has granted $6.9 million funding to INOVIO to work with IVI and the Korea National Institute of Health (KNIH) for this Phase 1/2 clinical trial of COVID-19 vaccine candidate (INO-4800) in South Korea. Updated 20 Apr 2020
09 Mar 2020 New trial record New trial record Updated 09 Mar 2020
03 Mar 2020 Other trial event According to Inovio Pharmaceuticals, Inc. media release, the company plans to publish/present results in Fall 2020. Updated 09 Mar 2020
03 Mar 2020 Other trial event According to Inovio Pharmaceuticals, Inc. media release,the company plans to initiate this trial in April 2020. Updated 09 Mar 2020

References

  1. Inovio Pharmaceuticals. Inovio Accelerates Timeline for COVID-19 DNA Vaccine INO-4800. Media-Rel 2020;.

    Media Release
  2. Inovio Pharmaceuticals. IVI, INOVIO, and KNIH to Partner with CEPI in Phase 1/2 Clinical Trial of INOVIO's COVID-19 DNA Vaccine in South Korea. Media-Rel 2020;.

    Media Release
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