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Phase 1 Open-label Study to Evaluate the Safety, Tolerability and Immunogenicity of INO-4800, a Prophylactic Vaccine Against SARS-CoV-2, Administered Intradermally Followed by Electroporation in Healthy Volunteers

Trial Profile

Phase 1 Open-label Study to Evaluate the Safety, Tolerability and Immunogenicity of INO-4800, a Prophylactic Vaccine Against SARS-CoV-2, Administered Intradermally Followed by Electroporation in Healthy Volunteers

Status: Active, no longer recruiting
Phase of Trial: Phase I

Latest Information Update: 30 Apr 2020

At a glance

  • Drugs INO 4800 (Primary)
  • Indications COVID 2019 infections
  • Focus Adverse reactions; First in man; Pharmacodynamics
  • Sponsors Inovio Pharmaceuticals
  • Most Recent Events

    • 30 Apr 2020 According to an Inovio Pharmaceuticals media release, INOVIO plans to produce one million doses of INO-4800 by the end of 2020.
    • 30 Apr 2020 According to an Inovio Pharmaceuticals media release, INOVIO today announced that it has entered into an agreement to expand its manufacturing partnership with the German contract manufacturer Richter-Helm BioLogics GmbH & Co. KG, to support large-scale manufacturing of INOVIOs investigational DNA vaccine INO-4800, which currently is in Phase 1 clinical testing in the U.S. (NCT04336410) for COVID-19 and could potentially advance to Phase 2/3 efficacy trial (CT profile 320589) this summer.
    • 28 Apr 2020 Status changed from recruiting to active, no longer recruiting according to an Inovio Pharmaceuticals media release.

Trial Overview

Purpose

This is an open-label trial to evaluate the safety, tolerability and immunological profile of INO-4800 administered by intradermal (ID) injection followed by electroporation (EP) using CELLECTRA® 2000 device in healthy adult volunteers.

Primary Endpoints

Percentage of Participants with Adverse Events (AEs)

time_frame: Baseline up to Week 52

Percentage of Participants with Administration (Injection) Site Reactions

time_frame: Day 0 up to Week 52

Percentage of Participants with Adverse Events of Special Interest (AESIs)

time_frame: Baseline up to Week 52

Change from Baseline in Antigen-Specific Binding Antibody Titers

time_frame: Baseline up to Week 52

Change from Baseline in Antigen-Specific Interferon-Gamma (IFN-γ) Cellular Immune Response

time_frame: Baseline up to Week 52

Diseases Treated

Indication Qualifiers Patient Segments
COVID 2019 infections prevention -

Subjects

  • Subject Type patients
  • Number

    Planned: 40

    Actual: 40

  • Sex male & female
  • Age Group 18-50 years; adult

Patient Inclusion Criteria

- Judged to be healthy by the Investigator on the basis of medical history, physical examination and vital signs performed at screening. - Able and willing to comply with all study procedures. - Screening laboratory results within normal limits or deemed not clinically significant by the Investigator. - Body Mass Index of 18-30 kg/m^2, inclusive, at screening. - Negative serological tests for Hepatitis B surface antigen (HBsAg), Hepatitis C antibody and Human Immunodeficiency Virus (HIV) antibody at screening. - Screening electrocardiogram (ECG) deemed by the Investigator as having no clinically significant findings (e.g. Wolff-Parkinson-White syndrome). - Use of medically effective contraception with a failure rate of < 1% per year when used consistently and correctly from screening until 3 months following last dose, be post-menopausal, be surgically sterile or have a partner who is sterile.

Patient Exclusion Criteria

- Pregnant or breastfeeding or intending to become pregnant or father children within the projected duration of the trial from screening until 3 months following last dose. - Is currently participating in or has participated in a study with an investigational product within 30 days preceding Day 0. - Previous exposure to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) or receipt of an investigational product for the prevention or treatment of COVID-19, middle east respiratory syndrome (MERS), or severe acute respiratory syndrome (SARS). - In a current occupation with high risk of exposure to SARS-CoV-2 (e.g., health care workers or emergency response personnel having direct interactions with or providing direct care to patients). - Current or history of the following medical conditions: - Respiratory diseases - Hypersensitivity or severe allergic reactions to vaccines or drugs - Diagnosis of diabetes mellitus - Hypertension - Malignancy within 5 years of screening - Cardiovascular diseases - Immunosuppression as a result of underlying illness or treatment including: - Primary immunodeficiencies - Long term use (≥7 days) of oral or parenteral glucocorticoids - Current or anticipated use of disease-modifying doses of anti-rheumatic drugs and biologic disease-modifying drugs - History of solid organ or bone marrow transplantation - Prior history of other clinically significant immunosuppressive or clinically diagnosed autoimmune disease - Fewer than two acceptable sites available for intradermal (ID) injection and electroporation (EP) considering the deltoid and anterolateral quadriceps muscles. - Reported smoking, vaping, or active drug, alcohol or substance abuse or dependence. - Any physical examination findings and/or history of any illness that, in the opinion of the study investigator, might confound the results of the study or pose an additional risk to the patient by their participation in the study

Trial Details

Identifiers

Identifier Owner
NCT04336410 ClinicalTrials.gov: US National Institutes of Health
COVID19-001 -

Organisations

  • Sponsors Inovio Pharmaceuticals
  • Affiliations Inovio Pharmaceuticals

Trial Dates

  • Initiation Dates

    Planned : 01 Apr 2020

    Actual : 03 Apr 2020

  • Primary Completion Dates

    Planned : 01 Apr 2021

  • End Dates

    Planned : 01 Apr 2021

Other Details

  • Design multicentre; open; prospective; sequential
  • Phase of Trial Phase I
  • Location USA
  • Focus Adverse reactions; First in man; Pharmacodynamics

Interventions

Drugs Route Formulation
INO 4800Primary Drug Intradermal Injection

Group 1: INO-4800

Participants will receive one ID injection of 1.0 milligram (mg) of INO-4800 followed by EP using the CELLECTRA® 2000 device per dosing visit.
Drug: INO-4800 (INO-4800 will be administered ID on Day 0 and Week 4.)
Device: CELLECTRA® 2000 (EP using the CELLECTRA® 2000 device will be administered following ID delivery of INO-4800 on Day 0 and Week 4.)

Group 2: INO-4800

Participants will receive two ID injections of 1.0 mg (total 2.0 mg per dosing visit) of INO-4800 followed by EP using the CELLECTRA® 2000 device per dosing visit.
Drug: INO-4800 (INO-4800 will be administered ID on Day 0 and Week 4.)
Device: CELLECTRA® 2000 (EP using the CELLECTRA® 2000 device will be administered following ID delivery of INO-4800 on Day 0 and Week 4.)

Trial Centres

Investigators

Investigator Centre Name Trial Centre Country
Inovio Call Center
(267) 440-4237
clinical.trials@inovio.com
show details
Inovio Pharmaceuticals
-
Program Manager Barbara Bradshaw
clinicaltrialsKC@amrllc.com
show details
Center for Pharmaceutical Research USA
Program Manager Eileen Donaghy
eileen.donaghy2@pennmedicine.upenn.edu
show details
University of Pennsylvania USA
ShuPing Yang, MD, PhD Inovio Pharmaceuticals
-

Centres

Centre Name Location Trial Centre Country
Center for Pharmaceutical Research Kansas City, Missouri USA
Coalition for Epidemic Preparedness Innovations (CEPI)
-
-
Inovio Pharmaceuticals
-
-
Inovio Pharmaceuticals
-
-
University of Pennsylvania Philadelphia, Pennsylvania USA

Trial History

Event Date Event Type Comment
30 Apr 2020 Other trial event According to an Inovio Pharmaceuticals media release, INOVIO plans to produce one million doses of INO-4800 by the end of 2020. Updated 08 May 2020
30 Apr 2020 Other trial event According to an Inovio Pharmaceuticals media release, INOVIO today announced that it has entered into an agreement to expand its manufacturing partnership with the German contract manufacturer Richter-Helm BioLogics GmbH & Co. KG, to support large-scale manufacturing of INOVIOs investigational DNA vaccine INO-4800, which currently is in Phase 1 clinical testing in the U.S. (NCT04336410) for COVID-19 and could potentially advance to Phase 2/3 efficacy trial (CT profile 320589) this summer. Updated 08 May 2020
28 Apr 2020 Status change - active, no longer recruiting Status changed from recruiting to active, no longer recruiting according to an Inovio Pharmaceuticals media release. Updated 30 Apr 2020
28 Apr 2020 Other trial event According to an Inovio Pharmaceuticals media release, Lead Principal Investigator of this study is Pablo Tebas, M.D., infectious disease specialist and Professor of Medicine at the Hospital of the University of Pennsylvania Updated 30 Apr 2020
28 Apr 2020 Other trial event According to an Inovio Pharmaceuticals media release, this trial is fully enrolled with all 40 healthy volunteers receiving their first dose, with interim immune responses and safety results expected in late June. Updated 30 Apr 2020
27 Apr 2020 Other trial event Last checked against ClinicalTrials.gov record. Updated 27 Apr 2020
21 Apr 2020 Completion date Planned End Date changed from 1 Nov 2020 to 1 Apr 2021. Updated 27 Apr 2020
21 Apr 2020 Other trial event Planned primary completion date changed from 1 Nov 2020 to 1 Apr 2021. Updated 27 Apr 2020
08 Apr 2020 Other trial event New source identified and integrated ClinicalTrials.gov: (US National Institutes of Health: NCT04336410). Updated 13 Apr 2020
07 Apr 2020 Status change - recruiting Status changed from not yet recruiting to recruiting. Updated 13 Apr 2020
06 Apr 2020 Other trial event According to an Inovio Pharmaceuticals media release, Pablo Tebas is the principal investigator of this study. Updated 08 Apr 2020
06 Apr 2020 Other trial event According to an Inovio Pharmaceuticals media release, the initial immune responses and safety data from the study are expected by late summer 2020. Updated 08 Apr 2020
06 Apr 2020 Other trial event According to an Inovio Pharmaceuticals media release, this study will enroll up to 40 healthy adult volunteers in Philadelphia, PA (at the Perelman School of Medicine at the University of Pennsylvania) and Kansas City, MO (at the Center for Pharmaceutical Research), where screening of potential participants has already begun. Study supplies of INO-4800 arrived at the sites last week. Updated 08 Apr 2020
06 Apr 2020 Other trial event According to an Inovio Pharmaceuticals media release, the U.S. Food and Drug Administration has accepted the company's Investigational New Drug (IND) application for INO-4800 to prevent COVID-19 infection, paving the way for Phase 1 clinical testing of INO-4800 in healthy volunteers beginning this week. The first dosing is planned for today. Updated 08 Apr 2020
06 Apr 2020 Status change - recruiting Status changed from planning to recruiting, according to an Inovio Pharmaceuticals media release. Updated 08 Apr 2020
12 Mar 2020 Other trial event According to an Inovio Pharmaceuticals media release, the company plans to advance this study in April 2020. Updated 16 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 an Inovio Pharmaceuticals media release, the company plans to initiate this trial in April 2020. Updated 09 Mar 2020
05 Feb 2020 New trial record New trial record Updated 05 Feb 2020
30 Jan 2020 Other trial event According to an Inovio Pharmaceuticals media release, recently announced that it is developing INO-4800 through Phase 1 human testing in the U.S. to evaluate safety and immunogenicity with the support of an initial grant up to $9 million from the Coalition for Epidemic Preparedness Innovations (CEPI). Updated 05 Feb 2020

References

  1. Inovio Pharmaceuticals. INOVIO Completes Enrollment in the Phase 1 U.S. Trial of INO-4800 for COVID-19 DNA Vaccine; Interim Results Expected in June. Media-Rel 2020;.

    Media Release
  2. Inovio Pharmaceuticals. Inovio Collaborating With Beijing Advaccine To Advance INO-4800 Vaccine Against New Coronavirus In China. Media-Rel 2020;.

    Media Release
  3. Inovio Pharmaceuticals. INOVIO and Richter-Helm BioLogics will expand existing DNA manufacturing agreement to support large-scale manufacturing of INO-4800INO-4800 Phase 2/3 U.S. clinical trial being prepared to start this summer. Media-Rel 2020;.

    Media Release
  4. Inovio Pharmaceuticals. INOVIO Receives New $5 Million Grant to Accelerate Scale Up of Smart Delivery Device for Its COVID-19 Vaccine. Media-Rel 2020;.

    Media Release
  5. ClinicalTrials.gov: US National Institutes of Health. Trial-Reg 2016;.

    Available from: URL: http://clinicaltrials.gov
  6. Inovio Pharmaceuticals. Inovio Accelerates Timeline for COVID-19 DNA Vaccine INO-4800. Media-Rel 2020;.

    Media Release
  7. Inovio Pharmaceuticals. INOVIO Initiates Phase 1 Clinical Trial Of Its COVID-19 Vaccine and Plans First Dose Today. Media-Rel 2020;.

    Media Release
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