Platform Trial to Compare Homologous Boost of Authorized COVID-19 Vaccines and Heterologous Boost With UB-612 Vaccine

Exclusion Criteria

• •1. Known history of COVID-19 or SARS-CoV-2 infection within six (6) months prior to vaccination (Day 1).
• •2. Receipt of a booster COVID-19 vaccination in addition to the primary vaccine series.
• •3. Presence of fever \>100.4°F/38°C or other signs or symptoms of COVID-19 (e.g., chills, cough, shortness of breath or difficulty breathing, fatigue, muscle or body aches, headache, new loss of taste or smell, sore throat, congestion or runny nose, nausea or vomiting, or diarrhea) within 1 week prior to Day 1 study product injection. Screening and/or study product injection may be rescheduled at the discretion of the investigator.
• •4. Clinical manifestations of systemic diseases considered by the investigator to impact safety or immunogenicity.
• •5. Prior history of pericarditis or myocarditis of any etiology.
• •6. Prior history of thrombosis of major vessels, including cerebrovascular or splanchnic thrombosis or of thrombosis with thrombocytopenia syndrome
• •7. History of anaphylaxis (vaccine related or not).
• •8. Chronic kidney disease with dialysis.
• •9. Receipt of systemic corticosteroids (≥0.5 mg/kg per day of prednisone or equivalent)for ≥7 days is prohibited from 28 days before enrollment through conclusion of the study. Topical, inhaled, intra-nasal, intra-articular or intra-bursal administration of corticosteroids is permitted.
• •10. Receipt of any cytotoxic or immunosuppressive drug or biologics six (6) months prior to Day 1 visit.
• •11. Receipt of any investigational drug within six (6) months prior to Day 1 visit.
• •12. Subject received or plans to receive a live attenuated vaccine or licensed adjuvanted(non-aluminum compound) vaccination within 28 days before or after planned administration of study vaccine (Day 1) or another type of vaccine (including influenza vaccine) within 14 days prior to or after planned administration of study vaccine on Day1 visit.
• •13. Human immunodeficiency virus (HIV) or hepatitis B surface antigen (HBsAg) positive; hepatitis C virus (HCV) antibody positive subjects may be tested for RNA and if negative may be enrolled.
• •14. Any Grade 2 or greater clinical or laboratory abnormalities at screening results.
• •Grade 1 abnormal clinical or laboratory adverse event screening test results which, according to the investigator, are non-clinically significant would not disqualify a potential subject. Clinical or laboratory screening tests may be repeated once to exclude transient abnormalities.
• •15. Immunocompromised state (weakened immune system) from solid organ transplant, immunosuppressive or immunodeficient state, autoimmune diseases, asplenia and, recurrent severe infections.
• •16. Have an active malignancy or history of metastatic or hematologic malignancy except non-melanoma skin cancers.
• •17. Pregnant or breastfeeding female, or female who intends to become pregnant during the study period.
• •18. Administration of immunoglobulins and/or any blood products within the 120 days preceding Day 1 or planned administration during the study period.
• •19. Bleeding disorder considered a contraindication to intramuscular injection or phlebotomy.
• •20. Bilateral tattoos or scars at the deltoid sites of intramuscular (IM) injection that would obscure examination of injection site reactions.
• •21. Behavioral, cognitive, or psychiatric disease that, in the opinion of the Principal Investigator or his or her representative physician, affects the subject's ability to understand and cooperate with all study protocol requirements.
• •22. Any alcohol or drug abuse over the 12 months prior to enrollment in the study that has caused medical, professional, or family problems, indicated by clinical history.
• •23. Grade 2 or higher hypertension (systolic \>160 mm Hg and/or diastolic \>100 mm Hg).
• •24. Any other condition that, in the opinion of the Principal Investigator or his/her representative physician, could put the safety/rights of potential subjects at risk or prevent them from complying with the study protocol.