Phase I/II Study of COVID-19 DNA Vaccine (AG0302-COVID19 High-dose)

Exclusion Criteria

• •1. Subjects with symptoms of suspected COVID-19 infection (respiratory symptoms, headache, malaise, olfactory disorders, taste disorders, etc.)
• •2. Subjects with a history of COVID-19 (hearing from subjects)
• •3. Subjects with a history of vaccination for the prevention of COVID-19
• •4. Subjects who have participated in unapproved vaccine clinical trials within 1 year before the start of this study
• •5. Subjects with an axillary temperature of 37.5 degrees or higher at the time of screening
• •6. Subjects with an axillary temperature of 37.5 degrees or higher before the first vaccination
• •7. Subjects who have a history of anaphylaxis
• •8. Subjects who have a history of hypersensitivity to the ingredients of the investigational drug
• •9. Subjects who have a current or history of serious renal, cardiovascular, respiratory, liver, kidney, gastrointestinal, and neuropsychiatric diseases
• •10. Subjects with a history of convulsion or epilepsy
• •11. Subjects with a history of diagnosis of immunodeficiency
• •12. Subjects who have a close relative (within 3rd degree) of congenital immunodeficiency
• •13. Subjects who have current bronchial asthma
• •14. Subjects who have had a fever of 39.0 degrees or higher within 2 days after vaccination, or who have been suspected of having an allergy such as a systemic rash.
• •15. Females who wish to become pregnant from the time of obtaining consent to 12 weeks after the first vaccination, and pregnant females who are breast-feeding. In addition, females who may become pregnant and their male sexual partners should use appropriate contraceptives (pill), condoms, vasectomy, tubal ligation, diaphragm, intrauterine devices, spermicides, intrauterine hormone-releasing system, etc. from the study entry date until 12 weeks after the first vaccination
• •16. Subjects who have participated in clinical trials of other unapproved drugs and received the investigational drug within 4 weeks before the start of this clinical trial (starting from vaccination day)
• •17. Subjects who have been received a live vaccine, inactivated vaccine, or toxoid within 4 weeks before the start of this clinical trial (starting from vaccination day)
• •18. Subjects who have been administered with drugs that affect the immune system (excluding external preparations) such as immunomodulators (DMARDs, etc.), immunosuppressants, biologics, etc. within 4 weeks before vaccination
• •19. Subjects who received blood transfusion or gamma globulin therapy within 12 weeks before vaccination, or high-dose gamma globulin therapy (200 mg/kg or more) within 24 weeks before vaccination
• •20. Subjects who have a history of overseas travel within 4 weeks before the start of the clinical trial (starting from vaccination day)
• •21. Subjects who are unable to comply with the clinical trial protocol and follow up (for mental, family, social or geographical reasons)
• •22. Subjects who are judged to be ineligible for this clinical trial by the investigator