Open-Label Study of INO-4212 With or Without INO-9012, Administered IM or ID Followed by Electroporation in Healthy Volunteers

Exclusion Criteria

• •Administration of an investigational compound either currently or within 30 days of first dose;
• •Previous receipt of an investigational product in an interventional trial for the treatment or prevention of Ebola (exceptions: verified receipt of placebo only or participation in an observational study);
• •History of or 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 creatinine greater than 1.5 (CKD Stage II or greater);
• •Chronic liver disease or cirrhosis;
• •Immunosuppressive illness including hematologic malignancy, history of solid organ or bone marrow transplantation;
• •Any pre-excitation syndromes, e.g., Wolff-Parkinson-White syndrome;
• •Prior major surgery or radiation therapy within 4 weeks of randomization;
• •Pregnant, breast feeding, or considering becoming pregnant;
• •Less than two acceptable sites exist for intramuscular or intradermal injection and EP between use of the deltoid and lateral quadriceps muscles. A site for injection/EP is not acceptable if there are tattoos, keloids or hypertrophic scars within 2 cm of the injection/EP site.
• •Subject has significant acute or chronic medical illness if deemed by the practitioner that electroporation treatment could negatively impact the illness
• •Subject has unstable or life-threatening cardiac disease (e.g. unstable angina, class 3 or higher congestive heart failure)
• •Subject has an acute or chronic bleeding or clotting disorder that would contraindicate IM injections or use of blood thinners (e.g. anticoagulants or antiplatelet drugs) within 2 weeks;
• •Subject has a cardioverter-defibrillator or pacemaker (to prevent a life-threatening arrhythmia) that is located ipsilateral to the intended deltoid injection site (unless deemed acceptable by a Cardiologist);
• •Subject has metal implant or implantable medical device within the electroporation area;
• •Administration of any vaccine within 4 weeks of first dose;
• •Administration of any blood product within 3 months of first dose;
• •Current or anticipated concomitant immunosuppressive therapy (excluding inhaled, topical skin and/or eye drop-containing corticosteroids, or low-dose methotrexate). Systemic corticosteroids must be discontinued at least 4 weeks prior to first dose;
• •Current or anticipated treatment with TNF-α inhibitors such as infliximab, adalimumab, etanercept;
• •Active military service personnel;
• •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; or
• •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.