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

GLS-5300 is a DNA plasmid vaccine that expresses the MERS CoV spike (S) glycoprotein.

Inclusion criteria

• 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).

Exclusion criteria

• 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;
• Prior major surgery or any radiation therapy within 4 weeks of group assignment;
• Any pre-excitation syndromes, e.g., Wolff-Parkinson-White syndrome; history of PSVT syndrome, history of prolonged QT 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 subjects 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;
• Not willing to allow storage and future use of samples for MERS-CoV related research
• 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.
• Presence of tattoos covering all possible injection sites.
• Healthcare workers participating in the medical examination of patients infection with MER