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)
Latest Information Update: 05 Nov 2021
At a glance
- Drugs GLS 5300 (Primary)
- Indications Middle East respiratory syndrome coronavirus
- Focus Adverse reactions
- Sponsors GeneOne Life Science
- 10 Aug 2020 According to an Inovio Pharmaceuticals media release, interim results from this trial were presented at the American Society of Gene & Cell Therapy (ASGCT) Conference.
- 22 May 2020 Status changed from active, no longer recruiting to completed.
- 28 Apr 2020 According to an Inovio Pharmaceuticals media release, interim results from the trial have been selected for an oral presentation at the American Society of Gene & Cell Therapy (ASGCT) Conference to be held virtually from May 12-15, 2020.
Most Recent Events
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 | - |
Biomarker
NCT Number | Biomarker Name | Biomarker Function |
---|---|---|
NCT03721718 | Interferon Gamma (IFNg) | Outcome Measure |
Subjects
- Subject Type volunteers
-
Number
Planned: 60
Actual: 60
- Sex male & female
- Age Group 19-70 years
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
Actual : 30 May 2019
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End Dates
Planned : 01 Nov 2020
Actual : 22 Apr 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 |
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|
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)
Results
Adverse events
Interim data through week 16 from a phase I/IIa trial showed that middle East respiratory syndrome coronavirus vaccine was well-tolerated and no vaccine-associated severe adverse events were observed in the trial [2] .
Immunogenicity
Interim results through week 16 from the phase I/IIa trial showed strong antibody and T cell immune responses after 2 or 3 doses with 0.6 mg of middle East respiratory syndrome coronavirus vaccine. 100% binding and 92% neutralizing antibody responses against MERS-CoV was observed. Seroconversion after a 2 dose regimen at 0 and 8 weeks was observed in 88% of patients, as compared to 84% and 100% seroconversion after 2 doses and 3 doses respectively in patients receiving a 3 dose regimen given at 0, 4 and 12 weeks. Additionally, 92% of the vaccine recipients in both groups displayed the ability to neutralize the virus using a neutralization assay. Robust T cell responses were observed in 60% of vaccine recipients after the 2 dose regimen and 84% of those in the 3 dose group. A binding antibody response rate of 74% and neutralization antibody response rate of 48% was demonstrated by a single dose of 0.6 mg of middle east respiratory syndrome coronavirus vaccine intradermal vaccination [2] .
Publications
-
Inovio Pharmaceuticals. INOVIO and GeneOne Life Science Report Positive Phase 1/2a Clinical Data With DNA Vaccine INO-4700 for MERS Coronavirus at the American Society of Gene & Cell Therapy (ASGCT) Conference. Media-Rel 2020;.
Media Release
Trial Centres
Investigators
Investigator | Centre Name | Trial Centre Country |
---|---|---|
Eu Suk Kim, MD, PhD
82-31-787-7062
show details
eskim@snubh.org |
Seoul National University Bundang Hospital | South-Korea |
Joel Maslow, MD, PhD, MBA | GeneOne Life Science, Inc. |
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|
Myoung-don Oh, MD, PhD
82-2-2072-2945
show details
mdohmd@snu.ac.kr 82-2-2071-2945 |
Seoul National University Hospital | South-Korea |
Centres
Centre Name | Location | Trial Centre Country |
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GeneOne Life Science, Inc. |
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|
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|
Inovio Pharmaceuticals |
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|
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|
International Vaccine Institute |
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|
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|
Seoul National University Bundang Hospital | Seongnam | South-Korea |
Seoul National University Hospital | Seoul | South-Korea |
Trial History
Event Date | Event Type | Comment |
---|---|---|
10 Aug 2020 | Interim results | According to an Inovio Pharmaceuticals media release, interim results from this trial were presented at the American Society of Gene & Cell Therapy (ASGCT) Conference. Updated 13 Aug 2020 |
28 May 2020 | Other trial event | Last checked against ClinicalTrials.gov record. Updated 28 May 2020 |
27 May 2020 | Biomarker Update | Biomarkers information updated Updated 05 Nov 2021 |
22 May 2020 | Status change - completed | Status changed from active, no longer recruiting to completed. Updated 28 May 2020 |
28 Apr 2020 | Other trial event | According to an Inovio Pharmaceuticals media release, interim results from the trial have been selected for an oral presentation at the American Society of Gene & Cell Therapy (ASGCT) Conference to be held virtually from May 12-15, 2020. Updated 30 Apr 2020 |
28 Apr 2020 | Interim results | Interim data through week 16 presented in the Inovio Pharmaceuticals media release. Updated 30 Apr 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 |
Table of Contents
References
-
ClinicalTrials.gov: US National Institutes of Health. Trial-Reg 2023;.
Available from: URL: http://clinicaltrials.gov -
Inovio Pharmaceuticals. INOVIO and GeneOne Life Science Report Positive Phase 1/2a Clinical Data With DNA Vaccine INO-4700 for MERS Coronavirus at the American Society of Gene & Cell Therapy (ASGCT) Conference. Media-Rel 2020;.
Media Release -
Inovio Pharmaceuticals. Inovio's Positive First-in-Human MERS Vaccine Results Published in The Lancet Infectious Diseases. Media-Rel 2019;.
Media Release -
Inovio Pharmaceuticals. Inovio Pharmaceuticals Reports2018 Third Quarter Financial Results. Media-Rel 2018;.
Media Release -
Inovio Pharmaceuticals. Inovio Doses 1st Subject in Phase 1/2 Clinical Trial For Vaccine Against Deadly MERS Infection. Media-Rel 2018;.
Media Release -
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 -
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 -
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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