Phase I, Open Label Dose Ranging Safety Study of GLS-5300 in Healthy Volunteers
Study Details
Study Description
Brief Summary
The Middle East Respiratory Syndrome Coronavirus (MERS CoV), a virus related to Severe Acute respiratory syndrome coronavirus (SARS CoV), was first recognized as a cause of severe pulmonary infection in 2012. Infection with MERS CoV has been diagnosed in more than 1600 individuals with a mortality rate between 35% and 40%. GLS-5300 is a DNA plasmid vaccine that expresses the MERS CoV spike (S) glycoprotein. This study will evaluate the safety of GLS-5300 at one of three dose levels following a three-injection vaccination regimen followed by electroporation. The study will also assess immune responses over a 1 year period with respect to the generation of antibody and cellular responses.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Detailed Description
GLS-5300 is a DNA plasmid vaccine that expresses the MERS CoV spike (S) glycoprotein. Following administration of the vaccine, a specialized medical device, CELLECTRA®, will deliver brief electrical pulses in a process known as electroporation (EP), to help move DNA into cells more efficiently.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: GLS-5300 GLS-5300 at 0.67 mg DNA/dose |
Biological: GLS-5300
|
| Experimental: GLS-5300 at 2 mg DNA/dose GLS-5300 at 2 mg DNA/dose |
Biological: GLS-5300
|
| Experimental: GLS-5300 at 6 mg DNA/dose GLS-5300 at 6 mg DNA/dose |
Biological: GLS-5300
|
Outcome Measures
Primary Outcome Measures
- Mean change from baseline in safety laboratory measures [Day0 through Week 60]
- Incidence of solicited adverse events after vaccination [Day0 through Week 60]
- Incidence of unsolicited adverse events after vaccination [Day0 through Week 60]
- Incidence of serious adverse events [Day0 through Week 60]
Secondary Outcome Measures
- Binding antibody response to S protein [Day0 through Week 60 following the first dose]
- Neutralizing antibody response to S protein [Day0 through Week 60 following the first dose]
- T cell response [Day 0 through Week 60 following the first dose]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Age 18-50 years; military, civilian, male and female.
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Able to provide consent to participate and having signed an Informed Consent Form.
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Able and willing to comply with all study procedures.
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Women of child-bearing potential agree to remain sexually abstinent, use medically effective contraception (oral contraception, barrier methods, spermicide, etc.) or have a partner who is sterile from enrollment to 3 months following the last injection, or have a partner who is unable to induce pregnancy.
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Sexually active men who are considered sexually fertile must agree to use either a barrier method of contraception during the study, and agree to continue the use for at least 3 months following the last injection, or have a partner who is permanently sterile or unable to become pregnant;
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Normal screening ECG or screening ECG with no clinically significant findings;
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Screening labs must be within normal limits or have only Grade 0-1 findings;
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No history of clinically significant immunosuppressive or autoimmune disease.
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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 corticosteroids at a dose less than 20 mg/day).
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Willing to allow storage and future use of samples for MERS CoV related research
Exclusion Criteria:
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Administration of an investigational compound either currently or within 30 days of first dose;
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Previous receipt of an investigational product for the treatment or prevention of MERS CoV except if participant is verified to have received placebo;
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Previous infection with MERS CoV as assessed by self report and solicited exposure history;
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Administration of any vaccine within 4 weeks of first dose;
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A BMI greater than or equal to 35;
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Administration of any monoclonal or polyclonal antibody product within 4 weeks of the first dose;
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Administration of any blood product within 3 months of first dose;
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Pregnancy or breast feeding or have plans to become pregnant during the course of the study;
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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;
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Positive serologic test for hepatitis C (exception: successful treatment with confirmation of sustained virologic response);
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Baseline evidence of kidney disease as measured by creatinine greater than 1.5 (CKD Stage II or greater);
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Baseline screening lab(s) with Grade 2 or higher abnormality;
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Chronic liver disease or cirrhosis;
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Immunosuppressive illness including hematologic malignancy, history of solid organ or bone marrow transplantation;
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Current or anticipated concomitant immunosuppressive therapy (excluding inhaled, topical skin and/or eye drop-containing corticosteroids, low-dose methotrexate, or corticosteroids at a dose less than 20 mg/day);
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Current or anticipated treatment with TNF-α inhibitors such as infliximab, adalimumab, etanercept;
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Prior major surgery or any radiation therapy within 4 weeks of group assignment;
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Any pre-excitation syndromes, e.g., Wolff-Parkinson-White syndrome;
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Presence of a cardiac pacemaker or automatic implantable cardioverter defibrillator (AICD);
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Metal implants within 20 cm of the planned site(s) of injection;
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Presence of keloid scar formation or hypertrophic scar as a clinically significant medical condition at the planned site(s) of injection.
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Prisoner or participants who are compulsorily detained (involuntary incarceration) for treatment of either a physical or psychiatric illness;
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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; or
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Tattoos covering the injection site area h
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Any illness or condition that in the opinion of the investigator may affect the safety of the participant or the evaluation of any study endpoint.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Walter Reed Institute of Research | Silver Spring | Maryland | United States | 20910 |
Sponsors and Collaborators
- GeneOne Life Science, Inc.
- Inovio Pharmaceuticals
- Walter Reed Army Institute of Research (WRAIR)
Investigators
- Principal Investigator: Kayvon Modjarrad, MD, PhD, Walter Reed Army Institute of Research (WRAIR)
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- WRAIR 2274