Evaluate the Safety, Tolerability and Immunogenicity Study of GLS-5300 in Healthy Volunteers
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)
1 other identifier
interventional
60
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 healthy
Started Aug 2018
Longer than P75 for phase_1 healthy
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 28, 2018
CompletedFirst Submitted
Initial submission to the registry
September 11, 2018
CompletedFirst Posted
Study publicly available on registry
October 26, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
April 22, 2020
CompletedMay 27, 2020
May 1, 2020
9 months
September 11, 2018
May 22, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Incidence of adverse events
Incidence of Adverse events by System organ class (SOC); preferred term (PT); severity and relationship to study treatment and schedule
Day0 through up to 60 weeks
Administration (injection) site reactions
Administration (injection) site reactions described by frequency
Day0 through up to 60 weeks
Changes in safety laboratory parameters
Number of participants with changes based on frequency in safety lab parameters in Complete Blood Count and Liver panel tests" or similar.
Day0 through up to 60 weeks
Administration (injection) site pain
Administration (injection) site pain as described by Visual Analog Scale (VAS)
Administration (injection) site pain
Secondary Outcomes (3)
Cellular Immune Responses
Day0 through up to 60 weeks
Binding antibody titers
Day0 through up to 60 weeks
Neutralizing antibodies
Day0 through up to 60 weeks
Study Arms (4)
GLS-5300 with ID Cellectra electroporation
EXPERIMENTALGLS-5300 at 0.3mg DNA/dose
GLS-5300 at 0.3mg DNA/dose with ID Cellectra electroporation
EXPERIMENTALGLS-5300 at 0.3mg DNA/dose
GLS-5300 at 0.6mg DNA/dose (3 dose regimen)
EXPERIMENTALGLS-5300 at 0.6mg DNA/dose with ID Cellectra electroporation
GLS-5300 at 0.6mg DNA/dose (2 dose regimen)
EXPERIMENTALGLS-5300 at 0.6mg DNA/dose with ID Cellectra electroporation
Interventions
\[Part A\] 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)
GLS-5300 administered ID followed by Cellectra 2000 Electroporation
Eligibility Criteria
You may qualify if:
- Age 19-70 years;
- Able to provide consent to participate and having signed an Informed Consent Form (ICF);
- Able and willing to comply with all study procedures;
- 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.
- Normal screening ECG or screening ECG with no clinically significant findings;
- Screening laboratory must be within normal limits or have only Grade 0-1 findings;
- No history of clinically significant immunosuppressive or autoimmune disease.
- 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).
You may not qualify if:
- Administration of an investigational compound either currently or within 90 days of first dose;
- 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;
- Previous infection with MERS-CoV;
- Administration of any vaccine within 4 weeks of first dose;
- Administration of any monoclonal or polyclonal antibody product within 4 weeks of the first dose
- Administration of any blood product within 3 months of first dose;
- Pregnancy or breast feeding or plans to become pregnant during the course of the study;
- 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;
- Positive serologic test for HIV, Hepatitis B surface antigen, or hepatitis C (exception: successful treatment with confirmation of sustained virologic response);
- Baseline evidence of kidney disease as measured by creatinine greater than 1.5mg/dL (CKD Stage II or greater);
- Baseline screening lab(s) with Grade 2 or higher abnormality;
- Chronic liver disease or cirrhosis;
- Immunosuppressive illness including hematologic malignancy, history of solid organ or bone marrow transplantation;
- 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);
- Past (within 6 months), current or anticipated treatment with TNF-α inhibitors such as infliximab, adalimumab, etanercept, or other monoclonal antibody;
- +11 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GeneOne Life Science, Inc.lead
- Inovio Pharmaceuticalscollaborator
- International Vaccine Institutecollaborator
Study Sites (2)
Seoul National University Bundang Hospital
Seongnam, South Korea
Seoul National University Hospital
Seoul, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Joel Maslow, MD, PhD, MBA
GeneOne Life Science, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 11, 2018
First Posted
October 26, 2018
Study Start
August 28, 2018
Primary Completion
May 30, 2019
Study Completion
April 22, 2020
Last Updated
May 27, 2020
Record last verified: 2020-05