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A Phase I/IIa, Dose-Ranging Trial to Evaluate Safety, Tolerability and Immunogenicity of INO-4800, a Prophylactic Vaccine Against SARS-CoV-2, Administered Intradermally Followed by Electroporation in Healthy Volunteers

Trial Profile

A Phase I/IIa, Dose-Ranging Trial to Evaluate Safety, Tolerability and Immunogenicity of INO-4800, a Prophylactic Vaccine Against SARS-CoV-2, Administered Intradermally Followed by Electroporation in Healthy Volunteers

Status: Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 21 Aug 2020

At a glance

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

    • 18 Aug 2020 Status changed from not yet recruiting to recruiting.
    • 10 Aug 2020 According to an Inovio Pharmaceuticals media release, this trial is approved in South Korea.
    • 04 Jun 2020 According to an Inovio Pharmaceuticals media release, the International Vaccine Institute (IVI), and Seoul National University Hospital have entered into a partnership to start this trial.

Trial Overview

Purpose

The purpose of this 2 stage, Phase 1/2 clinical trial will assess the safety, tolerability, and immunogenicity of the INO-4800 vaccine in healthy adults. Phase 1 portion will enroll 40 healthy adults aged 19-50 years in the Phase 1 portion and will further expand to enroll an additional 120 people aged 19-64 years in the Phase 2 portion.

Primary Endpoints

Primary Outcome Measures

description: Percentage of participants with seroconversion of SARS-CoV-2 Spike glycoprotein antigen-specific antibody titers from baseline by binding assays [Immunogenicity]
Incidence of adverse events among participants during the study period [Safety and Tolerability]
Percentage of Participants with Administration (Injection) Site Reactions [Safety and Tolerability]
Incidence of Adverse Events of Special Interest (AESIs) among participants during the study period [Safety and Tolerability]
time_frame: Baseline up to Week 52

Diseases Treated

Indication Qualifiers Patient Segments
COVID 2019 infections prevention -

Subjects

  • Subject Type patients
  • Number

    Planned: 160

  • Sex male & female
  • Age Group 19-64 years; adult

Patient Inclusion Criteria

- Able to communicate with investigator, and to provide informed consent and have signed Informed Consent Form (ICF) prior to screening procedures - Adults aged 19 to 50 years (for Part A) or aged 19 to 64 (for Part B) - 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 for testing laboratory or deemed not clinically significant by the Investigator - Negative serological tests for Hepatitis B surface antigen (HBsAg), Hepatitis C antibody and Human Immunodeficiency Virus (HIV) antibody or rapid test at screening - Screening ECG and Chest X-ray deemed by the Investigator as having no clinically significant findings (e.g. Wolff-Parkinson-White syndrome); - Must meet one of the following criteria with respect to reproductive capacity: a. Women who are post-menopausal as defined by spontaneous amenorrhea for ≥ 12 months b. Surgically sterile or have a partner who is sterile (i.e., vasectomy in males or tubal ligation, absence of ovaries and/or uterus in females). In the case of vasectomy, subjects should wait six (6) months post-vasectomy prior to enrolling c. 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. Acceptable methods include (but not limited to): c-1. hormonal contraception including implants, injections or oral c-2. two barrier methods, e.g., condom and cervical cap (with spermicide) or diaphragm (with spermicide)

Patient Exclusion Criteria

- Pregnant or breastfeeding, or intending to become pregnant or father children within the projected duration of the trial starting with the screening visit until 3 months following last dose - Positive serum pregnancy test during screening or positive urine pregnancy test prior to dosing - Is currently participating in or has participated in a study with an investigational product within 6 months preceding Day 0 - Receipt of an investigational product for prophylaxis or treatment of COVID-19, MERS or SARS - Body mass index (BMI) <18 or >30 - Current or history of the following medical conditions: 1. Respiratory diseases (e.g., asthma, chronic obstructive pulmonary disease); 2. Hypertension, resting systolic blood pressure >150 mm Hg or a diastolic blood pressure >95 mm Hg 3. Malignancy within 5 years of screening 4. Cardiovascular diseases (e.g., myocardial infarction, congestive heart failure, cardiomyopathy or clinically significant arrhythmias) 5. Diabetes mellitus 6. Use of immunoglobulin or blood products in last 6 months 7. History of severe allergic reaction or anaphylaxis after immunization - Immunosuppression as a result of underlying illness or treatment including: 1. Primary immunodeficiencies 2. Long term use (≥7 days) of oral or parenteral glucocorticoids at a dose of ≥20 mg/day of prednisone equivalent (use of inhaled, topical, nasal, otic, and ophthalmic corticosteroids are allowed) 3. Current or anticipated during clinical trial use of disease modifying doses of anti-rheumatic drugs (e.g., azathioprine, cyclophosphamide, cyclosporine, methotrexate) and biologic disease modifying drugs such as TNF-α inhibitors (e.g., infliximab, adalimumab or etanercept) 4. History of solid organ or bone marrow transplantation 5. Any prior history of other clinically significant immunosuppressive or clinically diagnosed autoimmune disease that may jeopardize the safety of the subject or require therapy that would interfere with study assessments or endpoint evaluation, or otherwise impact the validity of the study results. - Fewer than two acceptable sites available for ID injection and EP considering the deltoid and anterolateral quadriceps muscles. The following are unacceptable sites: 1. Tattoos, keloids or hypertrophic scars located within 2 cm of intended administration site 2. Implantable-Cardioverter-defibrillator (ICD) or pacemaker (to prevent a life-threatening arrhythmia) that is located ipsilateral to the deltoid injection site (unless deemed acceptable by a cardiologist) 3. Any metal implants or implantable medical device within the electroporation site - Prisoners or subjects who are compulsorily detained (involuntary incarceration) - Reported active drug or alcohol or substance abuse or dependence. - Current smoker or vaper (use of cigarette or e-cigarette at least once in last 30 days) - Healthcare worker who may provide medical care to SARS-CoV-2 cases or occupationally in high risk for SARS-CoV-2 exposure during the study period - Other condition deemed ineligible for the study at the discretion of investigator - Employee of the study center directly involved with the proposed study or with study investigators - Previously been laboratory-confirmed as SARS-CoV-2 infection or determined to be a close-contact of SARS-CoV-2 confirmed case by public health authorities (for Part A only)

Trial Details

Identifiers

Identifier Owner
NCT04447781 ClinicalTrials.gov: US National Institutes of Health
IVI-COVID19-001 -

Organisations

  • Affiliations Inovio Pharmaceuticals

Trial Dates

  • Initiation Dates

    Planned : 22 Jun 2020

    Actual : 15 Jul 2020

  • Primary Completion Dates

    Planned : 22 Feb 2022

  • End Dates

    Planned : 22 Feb 2022

Other Details

  • Design double-blind; multicentre; open; prospective; randomised; sequential
  • Phase of Trial Phase I/II
  • Location South Korea
  • Focus Adverse reactions; Therapeutic Use

Interventions

Drugs Route Formulation
INO 4800Primary Drug Intradermal Injection

Group 1 (Part A)

Number of Subjects: 20 subjects
ID Injection of INO-4800 1mg/dose + EP using CELLECTRA® 2000 (dosing at Day 0 and Week 4)
Biological: INO-4800 (- Manufacturer: Inovio Pharmaceuticals Inc.)
Device: CELLECTRA® 2000 (- Manufacturer: Inovio Pharmaceuticals Inc.)

Group 2 (Part A)

Number of Subjects: 20 subjects
ID Injection of INO-4800 2mg/dose + EP using CELLECTRA® 2000 (dosing at Day 0 and Week 4)
Biological: INO-4800 (- Manufacturer: Inovio Pharmaceuticals Inc.)
Device: CELLECTRA® 2000 (- Manufacturer: Inovio Pharmaceuticals Inc.)

Group 3 (Part B)

Number of Subjects: 90 subjects
ID Injection of INO-4800 1mg or 2mg/dose + EP using CELLECTRA® 2000 (dosing at Day 0 and Week 4)
Biological: INO-4800 (- Manufacturer: Inovio Pharmaceuticals Inc.)
Device: CELLECTRA® 2000 (- Manufacturer: Inovio Pharmaceuticals Inc.)

Group 4 (Part B, Placebo)

Number of Subjects: 30 subjects
ID Injection of Placebo (SSC) 1mg or 2mg/dose + EP using CELLECTRA® 2000 (dosing at Day 0 and Week 4)
Device: CELLECTRA® 2000 (- Manufacturer: Inovio Pharmaceuticals Inc.)
Other: Saline-sodium citrate (SSC) buffer (- Manufacturer: Inovio Pharmaceuticals Inc.) Other Name: Placebo

Trial Centres

Investigators

Investigator Centre Name Trial Centre Country
Anh Wartel, MD
82 2 881 1274
Anh.Wartel@ivi.int
show details
-
Chulwoo Rhee, MD,MSc
82 2 881 1229
Daniel.Rhee@ivi.int
show details
-
Eu Suk Kim, MD Seoul National University Bundang Hospital
-
Myoung-don Oh, MD Seoul National University Hospital
-

Centres

Centre Name Location Trial Centre Country
-
-
-
Coalition for Epidemic Preparedness Innovations
-
-
Inovio Pharmaceuticals
-
-
International Vaccine Institute (IVI)
-
-
Seoul National University Bundang Hospital
-
-
Seoul National University Hospital
-
-

Trial History

Event Date Event Type Comment
21 Aug 2020 Other trial event Last checked against ClinicalTrials.gov record. Updated 21 Aug 2020
18 Aug 2020 Status change - recruiting Status changed from not yet recruiting to recruiting. Updated 21 Aug 2020
10 Aug 2020 Other trial event According to an Inovio Pharmaceuticals media release, this trial is approved in South Korea. Updated 13 Aug 2020
29 Jun 2020 Other trial event New source identified and integrated ClinicalTrials.gov: (US National Institutes of Health: NCT04447781). Updated 29 Jun 2020
04 Jun 2020 Other trial event According to an Inovio Pharmaceuticals media release, the International Vaccine Institute (IVI), and Seoul National University Hospital have entered into a partnership to start this trial. Updated 11 Jun 2020
04 Jun 2020 Other trial event According to an Inovio Pharmaceuticals media release, Prof. Myung Don Oh of (Seoul National University Hospital) will lead this trial. The study is expected to start in June 2020. Updated 11 Jun 2020
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 AS, IVI. INOVIO and IVI Partner with Seoul National University Hospital to Start Phase 1/2 Clinical Trial of INOVIO's COVID-19 DNA Vaccine (INO-4800) in South Korea. 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
  3. ClinicalTrials.gov: US National Institutes of Health. Trial-Reg 2016;.

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

    Media Release
  5. Inovio Pharmaceuticals. INOVIO Reports Second Quarter 2020 Financial Results; Provides DNA Medicines Clinical Program Mid-Year Update. Media-Rel 2020;.

    Media Release
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