Phase I, Open Label Dose Ranging Safety Study of GLS-5300 in Healthy Volunteers

Completed · Phase 1

Conditions studied: Healthy

In brief

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.

Key facts

Study ID

NCT02670187

Run by

GeneOne Life Science, Inc.

People needed

75

Starts

2016-02-01

Expected to finish

2017-09-01

Last updated by the study team

2019-01-09

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Age 18-50 years; military, civilian, male and female.
• Able to provide consent to participate and having signed an Informed Consent Form.
• Able and willing to comply with all study procedures.
• 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.
• 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;
• Normal screening ECG or screening ECG with no clinically significant findings;
• Screening labs 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 corticosteroids at a dose less than 20 mg/day).
• Willing to allow storage and future use of samples for MERS CoV related research

You may not qualify if…

• Administration of an investigational compound either currently or within 30 days of first dose;
• Previous receipt of an investigational product for the treatment or prevention of MERS CoV except if participant is verified to have received placebo;
• Previous infection with MERS CoV as assessed by self report and solicited exposure history;
• Administration of any vaccine within 4 weeks of first dose;
• A BMI greater than or equal to 35;
• 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 have 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 hepatitis C (exception: successful treatment with confirmation of sustained virologic response);
• Baseline evidence of kidney disease as measured by creatinine greater than 1.5 (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 corticosteroids at a dose less than 20 mg/day);
• Current or anticipated treatment with TNF-α inhibitors such as infliximab, adalimumab, etanercept;
• Prior major surgery or any radiation therapy within 4 weeks of group assignment;
• Any pre-excitation syndromes, e.g., Wolff-Parkinson-White syndrome;
• Presence of a cardiac pacemaker or automatic implantable cardioverter defibrillator (AICD);
• Metal implants within 20 cm of the planned site(s) of injection;
• Presence of keloid scar formation or hypertrophic scar as a clinically significant medical condition at the planned site(s) of injection.
• Prisoner or participants who are compulsorily detained (involuntary incarceration) for treatment of either a physical or psychiatric illness;
• 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
• Tattoos covering the injection site area h
• 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.

Where it is running

• Walter Reed Institute of Research — Silver Spring, Maryland, United States

Full record on ClinicalTrials.gov

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