A Phase 3 Randomized Double Blind Efficacy and Safety Study of Oral Polio Vaccine and NA-831 for Covid-19

Exclusion Criteria

• •Is acutely ill or febrile 72 hours prior to or at Screening. Fever is defined as a body temperature ≥38.0°C/100.4°F. Participants meeting this criterion may be rescheduled within the relevant window periods. Afebrile participants with minor illnesses can be enrolled at the discretion of the Investigator.
• •Is pregnant or breastfeeding.
• •Known history of SARS-CoV-2 infection.
• •Prior administration of an investigational coronavirus (SARS-CoV, Middle East Respiratory Syndrome \[MERS\]-CoV) vaccine or current/planned simultaneous participation in another interventional study to prevent or treat COVID-19.
• •Demonstrated inability to comply with the study procedures.
• •An immediate family member or household member of this study's personnel.
• •History of anaphylaxis, urticaria, or other significant adverse reaction requiring medical intervention after receipt of a vaccine.
• •Bleeding disorder considered a contraindication to intramuscular injection or phlebotomy.
• •Has received or plans to receive a vaccine within 28 days prior to the first dose (Day 1) or plans to receive a non-study vaccine within 28 days prior to or after any dose of investigational product (except for seasonal influenza vaccine).
• •Has participated in an interventional clinical study within 28 days prior to the day of enrollment.
• •Immunosuppressive or immunodeficient state, including human immunodeficiency virus (HIV) infection, asplenia, and recurrent severe infections.
• •Has received systemic immunosuppressants or immune-modifying drugs for \>14 days in total within 6 months prior to Screening (for corticosteroids ≥20 milligram (mg)/day of prednisone equivalent). Topical tacrolimus is allowed if not used within 14 days prior to Screening.
• •Has received systemic immunoglobulins or blood products within 3 months prior to the day of Screening.
• •Has donated ≥450 milliliters (mL) of blood products within 28 days prior to Screening.