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Phase I/IIa, Open-label, Dose Ranging Study to Evaluate the Safety, Tolerability and Immunogenicity of GLS-5300, Administered ID Followed by CELLECTRA 2000 (Electroporation, EP)

Trial Profile

Phase I/IIa, Open-label, Dose Ranging Study to Evaluate the Safety, Tolerability and Immunogenicity of GLS-5300, Administered ID Followed by CELLECTRA 2000 (Electroporation, EP)

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

Latest Information Update: 17 Jan 2020

At a glance

  • Drugs GLS 5300 (Primary)
  • Indications Middle East respiratory syndrome coronavirus
  • Focus Adverse reactions
  • Sponsors GeneOne Life Science
  • Most Recent Events

    • 25 Jul 2019 According to an Inovio Pharmaceuticals media release, interim data from this trial is expected later in 2019.
    • 25 Jul 2019 According to an Inovio Pharmaceuticals media release, based on the data from this study the company is planning a Phase 2 MERS vaccine trial to be conducted in areas of the world where outbreaks have occurred.
    • 25 Mar 2019 Status changed from recruiting to active, no longer recruiting.

Trial Overview

Purpose

This phase 1b/2a trial will evaluate the responses of GLS-5300 delivered intradermally.

Primary Endpoints

Incidence of adverse events

description: Incidence of Adverse events by System organ class (SOC); preferred term (PT); severity and relationship to study treatment and schedule
time_frame: Day0 through up to 60 weeks

Administration (injection) site reactions

description: Administration (injection) site reactions described by frequency
time_frame: Day0 through up to 60 weeks

Changes in safety laboratory parameters

description: Number of participants with changes based on frequency in safety lab parameters in Complete Blood Count and Liver panel tests" or similar.
time_frame: Day0 through up to 60 weeks

Administration (injection) site pain

description: Administration (injection) site pain as described by Visual Analog Scale (VAS)
time_frame: Administration (injection) site pain

Other Endpoints

Cellular Immune Responses

description: Antigen specific cellular immune responses to MERS-CoV as determined by Interferon-gamma (IFN-γ) ELISpot
time_frame: Day0 through up to 60 weeks

Binding antibody titers

description: Binding antibody titers against MERS-CoV for a 2 and 3 dose vaccination regimens
time_frame: Day0 through up to 60 weeks

Neutralizing antibodies

description: Titers of neutralizing antibodies against MERS-CoV
time_frame: Day0 through up to 60 weeks [1]

Diseases Treated

Indication Qualifiers Patient Segments
Middle East respiratory syndrome coronavirus prevention -

Subjects

  • Subject Type volunteers
  • Number

    Planned: 60

  • Sex male & female
  • Age Group 19-70 years; adult; elderly

Patient Inclusion Criteria

1. Age 19-70 years; 2. Able to provide consent to participate and having signed an Informed Consent Form (ICF); 3. Able and willing to comply with all study procedures; 4. Women of child-bearing potential agree to either remain sexually abstinent, use medically effective contraception (oral contraception, barrier methods, spermicide, etc.) or have a partner who is sterile during this trials , or have a partner who is medically unable to induce pregnancy. 5. Normal screening ECG or screening ECG with no clinically significant findings; 6. Screening laboratory must be within normal limits or have only Grade 0-1 findings; 7. No history of clinically significant immunosuppressive or autoimmune disease. 8. Not currently or within the previous 4 weeks taking immunosuppressive agents (excluding inhaled, topical skin and/or eye drop-containing corticosteroids, low-dose methotrexate, or prednisone at a dose less than or equal to 10 mg/day or steroid equivalent).

Patient Exclusion Criteria

1. Administration of an investigational compound either currently or within 90 days of first dose; 2. Previous receipt of an investigational product for the treatment or prevention of MERS-CoV or SARS-CoV except if subject is verified to have received placebo; 3. Previous infection with MERS-CoV; 4. Administration of any vaccine within 4 weeks of first dose; 5. Administration of any monoclonal or polyclonal antibody product within 4 weeks of the first dose 6. Administration of any blood product within 3 months of first dose; 7. Pregnancy or breast feeding or plans to become pregnant during the course of the study; 8. History of positive serologic test for HIV, hepatitis B surface antigen (HBsAg); or any potentially communicable infectious disease as determined by the Principal Investigator or Medical Monitor; 9. Positive serologic test for HIV, Hepatitis B surface antigen, or hepatitis C (exception: successful treatment with confirmation of sustained virologic response); 10. Baseline evidence of kidney disease as measured by creatinine greater than 1.5mg/dL (CKD Stage II or greater); 11. Baseline screening lab(s) with Grade 2 or higher abnormality; 12. Chronic liver disease or cirrhosis; 13. Immunosuppressive illness including hematologic malignancy, history of solid organ or bone marrow transplantation; 14. Current or anticipated concomitant immunosuppressive therapy (excluding inhaled, topical skin and/or eye drop-containing corticosteroids, low-dose methotrexate, or prednisone at a dose greater than 10 mg/day or steroid equivalent); 15. Past (within 6 months), current or anticipated treatment with TNF-α inhibitors such as infliximab, adalimumab, etanercept, or other monoclonal antibody; 16. Prior major surgery or any radiation therapy within 4 weeks of group assignment; 17. Any pre-excitation syndromes, e.g., Wolff-Parkinson-White syndrome; history of PSVT syndrome, history of prolonged QT syndrome; 18. Presence of a cardiac pacemaker or automatic implantable cardioverter defibrillator (AICD); 19. Metal implants within 20 cm of the planned site(s) of injection; 20. Presence of keloid scar formation or hypertrophic scar as a clinically significant medical condition at the planned site(s) of injection. 21. Prisoner or subjects who are compulsorily detained (involuntary incarceration) for treatment of either a physical or psychiatric illness; 22. Active drug or alcohol use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements or assessment of immunologic endpoints; 23. Not willing to allow storage and future use of samples for MERS-CoV related research 24. Any illness or condition that in the opinion of the investigator may affect the safety of the subject or the evaluation of any study endpoint. 25. Presence of tattoos covering all possible injection sites. 26. Healthcare workers participating in the medical examination of patients infection with MER

Trial Details

Identifiers

Identifier Owner
NCT03721718 ClinicalTrials.gov: US National Institutes of Health
MERS002 -

Organisations

  • Sponsors GeneOne Life Science
  • Affiliations GeneOne Life Science; Inovio Pharmaceuticals

Trial Dates

  • Initiation Dates

    Actual : 28 Aug 2018

  • Primary Completion Dates

    Planned : 01 Sep 2020

  • End Dates

    Planned : 01 Nov 2020

Other Details

  • Design multicentre; open; parallel; prospective; randomised
  • Phase of Trial Phase I/II
  • Location South Korea
  • Focus Adverse reactions

Interventions

Drugs Route Formulation
GLS 5300Primary Drug Intradermal
-

GLS-5300 at 0.3mg DNA/dose with ID Cellectra electroporation

GLS-5300 at 0.3mg DNA/dose Biological: GLS-5300 ([Part A] GLS-5300 0.3 mg at 0, 4, and 12 weeks (N=5) [Part B] GLS-5300 0.3 mg at 0, 4, and 12 weeks (N=5) GLS-5300 0.6 mg at 0, 4, and 12 weeks (N=25) GLS-5300 0.6 mg at 0 and 8 weeks (N=25)) Device: Cellectra 2000 Electroporation (GLS-5300 administered ID followed by Cellectra 2000 Electroporation)

GLS-5300 at 0.6mg DNA/dose (2 dose regimen)

GLS-5300 at 0.6mg DNA/dose with ID Cellectra electroporation Biological: GLS-5300 ([Part A] GLS-5300 0.3 mg at 0, 4, and 12 weeks (N=5) [Part B] GLS-5300 0.3 mg at 0, 4, and 12 weeks (N=5) GLS-5300 0.6 mg at 0, 4, and 12 weeks (N=25) GLS-5300 0.6 mg at 0 and 8 weeks (N=25)) Device: Cellectra 2000 Electroporation (GLS-5300 administered ID followed by Cellectra 2000 Electroporation)

GLS-5300 at 0.6mg DNA/dose (3 dose regimen)

GLS-5300 at 0.6mg DNA/dose with ID Cellectra electroporation Biological: GLS-5300 ([Part A] GLS-5300 0.3 mg at 0, 4, and 12 weeks (N=5) [Part B] GLS-5300 0.3 mg at 0, 4, and 12 weeks (N=5) GLS-5300 0.6 mg at 0, 4, and 12 weeks (N=25) GLS-5300 0.6 mg at 0 and 8 weeks (N=25)) Device: Cellectra 2000 Electroporation (GLS-5300 administered ID followed by Cellectra 2000 Electroporation)

GLS-5300 with ID Cellectra electroporation

GLS-5300 at 0.3mg DNA/dose Biological: GLS-5300 ([Part A] GLS-5300 0.3 mg at 0, 4, and 12 weeks (N=5) [Part B] GLS-5300 0.3 mg at 0, 4, and 12 weeks (N=5) GLS-5300 0.6 mg at 0, 4, and 12 weeks (N=25) GLS-5300 0.6 mg at 0 and 8 weeks (N=25)) Device: Cellectra 2000 Electroporation (GLS-5300 administered ID followed by Cellectra 2000 Electroporation)

Trial Centres

Investigators

Investigator Centre Name Trial Centre Country
Eu Suk Kim, MD, PhD
82-31-787-7062
eskim@snubh.org
show details
Seoul National University Bundang Hospital South-Korea
Joel Maslow, MD, PhD, MBA GeneOne Life Science, Inc.
-
Myoung-don Oh, MD, PhD
82-2-2072-2945
mdohmd@snu.ac.kr
82-2-2071-2945
show details
Seoul National University Hospital South-Korea

Centres

Centre Name Location Trial Centre Country
GeneOne Life Science, Inc.
-
-
Inovio Pharmaceuticals
-
-
International Vaccine Institute
-
-
Seoul National University Bundang Hospital Seongnam South-Korea
Seoul National University Hospital Seoul South-Korea

Trial History

Event Date Event Type Comment
17 Jan 2020 Other trial event Last checked against ClinicalTrials.gov record. Updated 17 Jan 2020
25 Jul 2019 Other trial event According to an Inovio Pharmaceuticals media release, interim data from this trial is expected later in 2019. Updated 29 Jul 2019
25 Jul 2019 Other trial event According to an Inovio Pharmaceuticals media release, based on the data from this study the company is planning a Phase 2 MERS vaccine trial to be conducted in areas of the world where outbreaks have occurred. Updated 29 Jul 2019
25 Mar 2019 Status change - active, no longer recruiting Status changed from recruiting to active, no longer recruiting. Updated 01 Apr 2019
08 Nov 2018 Other trial event According to an Inovio Pharmaceuticals media release, interim results from this trial are expecte in 2019. Updated 24 Nov 2018
01 Nov 2018 Other trial event New source identified and integrated (ClinicalTrials.gov; NCT03721718). Updated 01 Nov 2018
05 Sep 2018 Other trial event According to an Inovio Pharmaceuticals media release, Leveraging results from this study, Inovio expects to advance its MERS vaccine into a Phase 2 field trial in the Middle East in 2019 with CEPI funding. Updated 16 Sep 2018
05 Sep 2018 Status change - recruiting According to an Inovio Pharmaceuticals media release, Status changed from planning to recruiting. Updated 16 Sep 2018
05 Sep 2018 Other trial event According to an Inovio Pharmaceuticals media release, today announced the dosing of the first subject in this study. Updated 16 Sep 2018
27 Jun 2018 Other trial event According to an Inovio Pharmaceuticals media release, the company plans to begin this study in the third quarter of 2018. Updated 04 Jul 2018
20 Sep 2017 New trial record New trial record Updated 20 Sep 2017
18 Sep 2017 Other trial event According to an Inovio Pharmaceuticals media release, The International Vaccine Institute (IVI) is fully funding this trial utilizing a $34 million grant Samsung Foundation Updated 20 Sep 2017

References

  1. ClinicalTrials.gov: US National Institutes of Health. Trial-Reg 2016;.

    Available from: URL: http://clinicaltrials.gov
  2. Inovio Pharmaceuticals. Inovio's Positive First-in-Human MERS Vaccine Results Published in The Lancet Infectious Diseases. Media-Rel 2019;.

    Media Release
  3. Inovio Pharmaceuticals. Inovio Pharmaceuticals Reports2018 Third Quarter Financial Results. Media-Rel 2018;.

    Media Release
  4. Inovio Pharmaceuticals. Inovio Doses 1st Subject in Phase 1/2 Clinical Trial For Vaccine Against Deadly MERS Infection. Media-Rel 2018;.

    Media Release
  5. Inovio Pharmaceuticals. Inovio and Partners Initiate Phase 1/2a Clinical Trial To Further Advance Its Vaccine Against Deadly MERS Infection. Media-Rel 2017;.

    Media Release
  6. Inovio Pharmaceuticals. Inovios MERS Vaccine Generates High Levels of Antibodies and Induces Broad-based T Cell Responses in Phase 1 Study. Media-Rel 2018;.

    Media Release
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