Safety, Tolerability and Immunogenicity of INO-4800 Followed by Electroporation in Healthy Volunteers for COVID19

This is an interventional prevention trial for Coronavirus Infection focused on measuring Coronavirus Infection, SARS-CoV 2, INO-4800 Read More

Inclusion Criteria:

• Able to communicate with investigator, and to provide informed consent and have signed Informed Consent Form (ICF) prior to screening procedures
• Adults aged 19 to 50 years (for Part A) or aged 19 to 64 (for Part B)
• Judged to be healthy by the Investigator on the basis of medical history, physical examination and vital signs performed at Screening
• Able and willing to comply with all study procedures
• Screening laboratory results within normal limits for testing laboratory or deemed not clinically significant by the Investigator
• Negative serological tests for Hepatitis B surface antigen (HBsAg), Hepatitis C antibody and Human Immunodeficiency Virus (HIV) antibody or rapid test at screening
• Screening ECG and Chest X-ray deemed by the Investigator as having no clinically significant findings (e.g. Wolff-Parkinson-White syndrome);

• Must meet one of the following criteria with respect to reproductive capacity:

  a. Women who are post-menopausal as defined by spontaneous amenorrhea for ≥ 12 months b. Surgically sterile or have a partner who is sterile (i.e., vasectomy in males or tubal ligation, absence of ovaries and/or uterus in females). In the case of vasectomy, subjects should wait six (6) months post-vasectomy prior to enrolling c. Use of medically effective contraception with a failure rate of < 1% per year when used consistently and correctly from screening until 3 months following last dose. Acceptable methods include (but not limited to): c-1. hormonal contraception including implants, injections or oral c-2. two barrier methods, e.g., condom and cervical cap (with spermicide) or diaphragm (with spermicide)

Exclusion Criteria:

• Pregnant or breastfeeding, or intending to become pregnant or father children within the projected duration of the trial starting with the screening visit until 3 months following last dose
• Positive serum pregnancy test during screening or positive urine pregnancy test prior to dosing
• Is currently participating in or has participated in a study with an investigational product within 6 months preceding Day 0
• Receipt of an investigational product for prophylaxis or treatment of COVID-19, MERS or SARS
• Body mass index (BMI) <18 or >30

• Current or history of the following medical conditions:

  1. Respiratory diseases (e.g., asthma, chronic obstructive pulmonary disease);
  2. Hypertension, resting systolic blood pressure >150 mm Hg or a diastolic blood pressure >95 mm Hg
  3. Malignancy within 5 years of screening
  4. Cardiovascular diseases (e.g., myocardial infarction, congestive heart failure, cardiomyopathy or clinically significant arrhythmias)
  5. Diabetes mellitus
  6. Use of immunoglobulin or blood products in last 6 months
  7. History of severe allergic reaction or anaphylaxis after immunization

• Immunosuppression as a result of underlying illness or treatment including:

  1. Primary immunodeficiencies
  2. Long term use (≥7 days) of oral or parenteral glucocorticoids at a dose of ≥20 mg/day of prednisone equivalent (use of inhaled, topical, nasal, otic, and ophthalmic corticosteroids are allowed)
  3. Current or anticipated during clinical trial use of disease modifying doses of anti-rheumatic drugs (e.g., azathioprine, cyclophosphamide, cyclosporine, methotrexate) and biologic disease modifying drugs such as TNF-α inhibitors (e.g., infliximab, adalimumab or etanercept)
  4. History of solid organ or bone marrow transplantation
  5. Any prior history of other clinically significant immunosuppressive or clinically diagnosed autoimmune disease that may jeopardize the safety of the subject or require therapy that would interfere with study assessments or endpoint evaluation, or otherwise impact the validity of the study results.

• Fewer than two acceptable sites available for ID injection and EP considering the deltoid and anterolateral quadriceps muscles. The following are unacceptable sites:

  1. Tattoos, keloids or hypertrophic scars located within 2 cm of intended administration site
  2. Implantable-Cardioverter-defibrillator (ICD) or pacemaker (to prevent a life-threatening arrhythmia) that is located ipsilateral to the deltoid injection site (unless deemed acceptable by a cardiologist)
  3. Any metal implants or implantable medical device within the electroporation site
• Prisoners or subjects who are compulsorily detained (involuntary incarceration)
• Reported active drug or alcohol or substance abuse or dependence.
• Current smoker or vaper (use of cigarette or e-cigarette at least once in last 30 days)
• Healthcare worker who may provide medical care to SARS-CoV-2 cases or occupationally in high risk for SARS-CoV-2 exposure during the study period
• Other condition deemed ineligible for the study at the discretion of investigator
• Employee of the study center directly involved with the proposed study or with study investigators
• Previously been laboratory-confirmed as SARS-CoV-2 infection or determined to be a close-contact of SARS-CoV-2 confirmed case by public health authorities (for Part A only)