Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Evaluate the Safety, Tolerability and Immunogenicity Study of GLS-5300 in Healthy Volunteers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03721718
Recruitment Status : Completed
First Posted : October 26, 2018
Last Update Posted : May 27, 2020
Sponsor:
Collaborators:
Inovio Pharmaceuticals
International Vaccine Institute
Information provided by (Responsible Party):
GeneOne Life Science, Inc.

Tracking Information
First Submitted Date  ICMJE September 11, 2018
First Posted Date  ICMJE October 26, 2018
Last Update Posted Date May 27, 2020
Actual Study Start Date  ICMJE August 28, 2018
Actual Primary Completion Date May 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 25, 2018)
  • Incidence of adverse events [ Time Frame: Day0 through up to 60 weeks ]
    Incidence of Adverse events by System organ class (SOC); preferred term (PT); severity and relationship to study treatment and schedule
  • Administration (injection) site reactions [ Time Frame: Day0 through up to 60 weeks ]
    Administration (injection) site reactions described by frequency
  • Changes in safety laboratory parameters [ Time Frame: Day0 through up to 60 weeks ]
    Number of participants with changes based on frequency in safety lab parameters in Complete Blood Count and Liver panel tests" or similar.
  • Administration (injection) site pain [ Time Frame: Administration (injection) site pain ]
    Administration (injection) site pain as described by Visual Analog Scale (VAS)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 25, 2018)
  • Cellular Immune Responses [ Time Frame: Day0 through up to 60 weeks ]
    Antigen specific cellular immune responses to MERS-CoV as determined by Interferon-gamma (IFN-γ) ELISpot
  • Binding antibody titers [ Time Frame: Day0 through up to 60 weeks ]
    Binding antibody titers against MERS-CoV for a 2 and 3 dose vaccination regimens
  • Neutralizing antibodies [ Time Frame: Day0 through up to 60 weeks ]
    Titers of neutralizing antibodies against MERS-CoV
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluate the Safety, Tolerability and Immunogenicity Study of GLS-5300 in Healthy Volunteers
Official Title  ICMJE 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)
Brief Summary The Middle East Respiratory Syndrome Coronavirus (MERS CoV), is a cause of severe and highly fatal lower respiratory tract infection, first identified in 2012. As of August 2018, there have been 2229 cases reported with a case fatality rate >35%. In 2015 an individual returning to South Korea served as the index case for an outbreak of 186 individuals, of who, >20% died. GLS-5300 is a DNA plasmid vaccine that expresses the MERS CoV spike (S) glycoprotein. This Phase I/IIa study will evaluate the safety, tolerability and immunogenicity of GLS-5300 administered intradermally (ID) followed by electroporation at 0.3 and 0.6 mg/dose assessing 2 and 3-dose regimens.
Detailed Description GLS-5300 is a DNA plasmid vaccine that expresses the MERS CoV spike (S) glycoprotein.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Healthy
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: GLS-5300 with ID Cellectra electroporation
    GLS-5300 at 0.3mg DNA/dose
    Interventions:
    • Biological: GLS-5300
    • Device: Cellectra 2000 Electroporation
  • Experimental: GLS-5300 at 0.3mg DNA/dose with ID Cellectra electroporation
    GLS-5300 at 0.3mg DNA/dose
    Interventions:
    • Biological: GLS-5300
    • Device: Cellectra 2000 Electroporation
  • Experimental: GLS-5300 at 0.6mg DNA/dose (3 dose regimen)
    GLS-5300 at 0.6mg DNA/dose with ID Cellectra electroporation
    Interventions:
    • Biological: GLS-5300
    • Device: Cellectra 2000 Electroporation
  • Experimental: GLS-5300 at 0.6mg DNA/dose (2 dose regimen)
    GLS-5300 at 0.6mg DNA/dose with ID Cellectra electroporation
    Interventions:
    • Biological: GLS-5300
    • Device: Cellectra 2000 Electroporation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 25, 2018)
60
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 22, 2020
Actual Primary Completion Date May 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03721718
Other Study ID Numbers  ICMJE MERS-002
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party GeneOne Life Science, Inc.
Study Sponsor  ICMJE GeneOne Life Science, Inc.
Collaborators  ICMJE
  • Inovio Pharmaceuticals
  • International Vaccine Institute
Investigators  ICMJE
Study Chair: Joel Maslow, MD, PhD, MBA GeneOne Life Science, Inc.
PRS Account GeneOne Life Science, Inc.
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP