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May 20, 2021, 1:30 a.m. eu

1. Individuals with laboratory-confirmed SARS-CoV-2 infection (e.g., a positive RT-PCR or Rapid COVID-19 antigen test). 2. Individuals with behavioral or cognitive impairment (including drug and alcohol abuse) in the opinion of the Investigator. 3. Individuals with any progressive or severe neurologic disorder, seizure disorder, or history of Guillian-Barré syndrome. 4. Individuals who receive treatment with immunosuppressive therapy, including cytotoxic agents or systemic corticosteroids, e.g., for cancer or an autoimmune disease, or planned receipt during the study period. If a short-term course of systemic corticosteroids have been administered for treatment of an acute illness, participants should not be enrolled into the study until corticosteroid therapy has been discontinued for at least 30 days before the first study vaccination. A unique dose of systemic steroids on a single day would be allowed, as well as inhaled/nebulized, intra-articular, intrabursal, or topical (skin or eyes) corticosteroids are permitted. 5. Individuals who are pregnant, or breastfeeding, or planning to become pregnant during the study period. 6. Individuals who have a history of severe adverse reaction associated with a vaccine or severe allergic reaction (e.g., anaphylaxis) to any component of the study vaccine (SCB-2019, CpG 1018 Adjuvant and Aluminum hydroxide/SCB-2019 components as outlined in the latest IB). 7. Individuals who have a history of malignancy within 1 year before screening (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix which have been cured, or other malignancies with minimal risk of recurrence). 8. Individuals who have received any other investigational product within 30 days prior to Day 1 or intent to participate in another clinical study at any time during the conduct of this study. 9. Individuals who have received previous vaccination with any coronavirus vaccine. 10. Individuals who have received any other licensed vaccines within 14 days prior to enrollment in this study or who are planning to receive any vaccine up to 14 days after the second vaccination. 11. Individuals with known bleeding disorder that would, in the opinion of the investigator, contraindicate intramuscular injection. 12. Individuals who received any blood/plasma products or immunoglobulins within 60 days prior to Day 1 or plan to receive it during the study period. 13. Individuals with any condition that, in the opinion of the Investigator, may increase the risk of study participation or interfere with the assessment of the primary study objectives 14. Individuals with fever >37.8°C (≥100.04°F, irrespective of method), or any acute illness at baseline (Day 1) or within 3 days of randomization. Participants meeting this criterion may be rescheduled within the relevant window. Afebrile participants with minor illnesses can be enrolled at the discretion of the investigator.

1. Individuals with laboratory-confirmed SARS-CoV-2 infection (e.g., a positive RT-PCR or Rapid COVID-19 antigen test). 2. Individuals with behavioral or cognitive impairment (including drug and alcohol abuse) in the opinion of the Investigator. 3. Individuals with any progressive or severe neurologic disorder, seizure disorder, or history of Guillian-Barré syndrome. 4. Individuals who receive treatment with immunosuppressive therapy, including cytotoxic agents or systemic corticosteroids, e.g., for cancer or an autoimmune disease, or planned receipt during the study period. If a short-term course of systemic corticosteroids have been administered for treatment of an acute illness, participants should not be enrolled into the study until corticosteroid therapy has been discontinued for at least 30 days before the first study vaccination. A unique dose of systemic steroids on a single day would be allowed, as well as inhaled/nebulized, intra-articular, intrabursal, or topical (skin or eyes) corticosteroids are permitted. 5. Individuals who are pregnant, or breastfeeding, or planning to become pregnant during the study period. 6. Individuals who have a history of severe adverse reaction associated with a vaccine or severe allergic reaction (e.g., anaphylaxis) to any component of the study vaccine (SCB-2019, CpG 1018 Adjuvant and Aluminum hydroxide/SCB-2019 components as outlined in the latest IB). 7. Individuals who have a history of malignancy within 1 year before screening (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix which have been cured, or other malignancies with minimal risk of recurrence). 8. Individuals who have received any other investigational product within 30 days prior to Day 1 or intent to participate in another clinical study at any time during the conduct of this study. 9. Individuals who have received previous vaccination with any coronavirus vaccine. 10. Individuals who have received any other licensed vaccines within 14 days prior to enrollment in this study or who are planning to receive any vaccine up to 14 days after the second vaccination. 11. Individuals with known bleeding disorder that would, in the opinion of the investigator, contraindicate intramuscular injection. 12. Individuals who received any blood/plasma products or immunoglobulins within 60 days prior to Day 1 or plan to receive it during the study period. 13. Individuals with any condition that, in the opinion of the Investigator, may increase the risk of study participation or interfere with the assessment of the primary study objectives 14. Individuals with fever >37.8°C (≥100.04°F, irrespective of method), or any acute illness at baseline (Day 1) or within 3 days of randomization. Participants meeting this criterion may be rescheduled within the relevant window. Afebrile participants with minor illnesses can be enrolled at the discretion of the investigator.