Immunogenicity and Safety Study of SARS-CoV-2 DNA Vaccine (ICCOV)

Inclusion Criteria

• •1. Able and willing to comply with all study requirements.
• •2. Give informed consent and sign informed consent form (ICF). For subjects who are unable to read or write, the consent must be witnessed by a literate third party not involved in the study.
• •3. BMI in between 18.5 and 30.0 kg/m2 (including upper and lower limits).
• •4. For each group, meet the following criteria regarding age, COVID-19 vaccination history (as confirmed by COVID-19 vaccination records), and SARS-CoV-2 infection history (as confirmed by the investigator according to WHO definitions, Appendix III):
• •Group 1: Adult-CoronaVac® group
• •\- Aged 18-59 AND received 2 to 4 homologous doses of CoronaVac® at least 3 months prior to enrollment AND without SARS-CoV-2 infection history.
• •Group 2: Adult-Comirnaty® group
• •\- Aged 18-59 AND received 2 to 4 heterologous doses of CoronaVac® and Comirnaty® at least 3 months prior to enrollment AND without SARS-CoV-2 infection history; OR
• •Group 3: Adult-mixed group
• •* Aged 18-59 AND received 2 to 4 heterologous doses of CoronaVac® and Comirnaty® at least 3 months prior to enrollment AND without SARS-CoV-2 infection history; OR
• •* Aged 18-59 AND received 2 to 4 heterologous doses of CoronaVac® and Comirnaty® at least 3 months prior to enrollment AND recovered from SARS-CoV-2 infection at least 3 months prior to enrollment; OR
• •* Aged 18-59 AND received 2 to 4 homologous doses of CoronaVac® or Comirnaty® at least 3 months prior to enrollment AND recovered from SARS-CoV-2 infection at least 3 months prior to enrollment.
• •Group 4: Elderly-mixed group
• •* Aged 60-75 AND received 2 to 4 heterologous doses of CoronaVac® and Comirnaty® at least 3 months prior to enrollment AND without SARS-CoV-2 infection history; OR
• •* Aged 60-75 AND received 2 to 4 heterologous doses of CoronaVac® and Comirnaty® at least 3 months prior to enrollment AND recovered from SARS-CoV-2 infection at least 3 months prior to enrollment; OR
• •* Aged 60-75 AND received 2 to 4 homologous doses of CoronaVac® or Comirnaty® at least 3 months prior to enrollment AND without SARS-CoV-2 infection history; OR
• •* Aged 60-75 AND received 2 to 4 homologous doses of CoronaVac® or Comirnaty® at least 3 months prior to enrollment AND recovered from SARS-CoV-2 infection at least 3 months prior to enrollment.
• •11. Received any investigational or approved vaccines within 3 months prior to enrollment or plan to receive any other vaccines during the study.
• •12. Received any blood products or immunoglobulin products within 3 months prior to enrollment or plan to receive that during the study.
• •13. Received interferon, systemic corticosteroids, or other immunosuppressants/ immunomodulators (except for local application) for 14 or more consecutive days within 6 months prior to enrollment.
• •14. Medical history or clinical manifestations of any physical or mental illness that may affect the subject's completion of this study.
• •15. Needle phobia.
• •16. Have contraindications for intramuscular administration, such as confirmed thrombocytopenia, any coagulation dysfunction, or being receiving anticoagulation therapy.
• •17. Have contraindications for electroporation, such as implanted with pacemaker, implanted with Automatic Implantable Cardioverter Defibrillator (AICD), or abnormal electrocardiogram at screening as determined by the investigator.
• •18. Any other conditions considered by the investigator as not suitable to participate in this study.