A Clinical Trial to Study the COVAC-1 Booster Dose in Generally Healthy Adults

Exclusion Criteria

• •1. Presence of any febrile illness or any known or suspected acute illness on the day of immunization.
• •2. Clinically significant bleeding disorder (e.g., clotting factor deficiency, coagulopathy, or platelet disorder), or prior history of significant bleeding or bruising following intramuscular injection or venipuncture.
• •3. Presence of an autoimmune disease.
• •4. Receiving systemic steroids in doses exceeding 20mg daily of prednisone or equivalent, for ≥ 14 days within 1 month, or has recently received any other cytotoxic or immunosuppressive drug within 6 months prior to the injection of the study vaccine.
• •5. Has a known malignancy diagnosed within the past 5 years. Participants with basal cell carcinoma or squamous cell carcinoma of the skin are not excluded.
• •6. Currently receiving systemic immunomodulatory therapy or received chemotherapy within the last 5 years excluding topical agents.
• •7. Has received blood products or immunoglobulins (IVIg or IMIg) within 3 months of study entry/baseline serologic evaluation.
• •8. Currently on anti-tuberculosis therapy.
• •9. Had SARS-CoV-2 infection within 4 months prior to study Day 0. A potential participant is considered to have COVID-19 infection base on one of the following:
• •* Positive polymerase chain reaction (PCR) or rapid antigen test.
• •* Documentation in a medical history report.
• •* Reported by candidate.
• •10. Has received any non-COVID-19 authorized vaccines (e.g., influenza) within 2 weeks prior to receiving study dose injection.
• •11. Has received any experimental SARS-CoV-2 / COVID-19 vaccines Receipt of SARSCoV-2/COVID-19 vaccines that were experimental at the time of administration but are currently authorized, more than 6 months prior to Day 0, will not lead to exclusion.
• •12. Planning to receive booster doses of any authorized COVID-19 vaccine during the first two months days from study vaccination.
• •13. Abnormal laboratory test results (hematology, biochemistry, and urinalysis) as compared to the local normal lab ranges. To exclude transient abnormalities, laboratory tests may be repeated once. Abnormal lab test results considered not clinically significant by the Investigator will not be exclusionary.
• •14. Has a history of any reaction or known sensitivity likely to be exacerbated by any component of the study vaccine.
• •15. Is currently participating in or has participated in a study of an investigational agent within 6 months prior to the injection of the booster vaccine under study.
• •17. Being a member of the study team, or an immediate family member or household member of a member on the study team.
• •18. Any condition, which in the opinion of the investigator may deem the participant inappropriate for the study.