Created at Source Raw Value Validated value
March 26, 2021, 2:21 p.m. oms

1. Participation in any other COVID-19 prophylactic drug trials during the duration of the study. Note: Participation in COVID-19 treatment trials is allowed in the event of hospitalization due to COVID-19. The study team should be informed as soon as possible. 2. Positive HIV antibody testing results. 3. Participation in SARS-CoV-2 serological surveys where participants are informed of their serostatus during the duration of the study. Note: Disclosure of serostatus post enrolment may accidentally unblind participants to group allocation. Participation in this trial can only be allowed if volunteers are kept blinded to their serology results from local/national serological surveys 4. Planned receipt of any licensed or investigational vaccine, other than the study intervention, within 14 days before and after study vaccination 5. Prior receipt of an investigational or licensed COVID-19 vaccine. 6. Administration of immunoglobulins and/or any blood products within three months prior to the planned administration of the investigational products (IPs). 7. Any confirmed or suspected immunosuppressive or immunodeficient state, positive HIV status, asplenia, recurrent severe infections and chronic use (more than 14 days) of immunosuppressant medication within the past 6 months. Topical steroids or short-term (course lasting =14 days) oral steroids are not an exclusion criteria. 8. History of allergic disease or reactions likely to be exacerbated by any component of Recombinant COVID-19 vaccine (Sf9 cells) 9. Any history of angioedema 10. Pregnancy, lactation or willingness/intention to become pregnant within 90 days after receiving study vaccine 11. Current diagnosis or treatment of cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ) 12. History of serious psychiatric condition likely to affect participation in the study 13. Bleeding disorder (e.g. factor deficiency, coagulopathy or platelet disorder), or prior history of significant bleeding

1. Participation in any other COVID-19 prophylactic drug trials during the duration of the study. Note: Participation in COVID-19 treatment trials is allowed in the event of hospitalization due to COVID-19. The study team should be informed as soon as possible. 2. Positive HIV antibody testing results. 3. Participation in SARS-CoV-2 serological surveys where participants are informed of their serostatus during the duration of the study. Note: Disclosure of serostatus post enrolment may accidentally unblind participants to group allocation. Participation in this trial can only be allowed if volunteers are kept blinded to their serology results from local/national serological surveys 4. Planned receipt of any licensed or investigational vaccine, other than the study intervention, within 14 days before and after study vaccination 5. Prior receipt of an investigational or licensed COVID-19 vaccine. 6. Administration of immunoglobulins and/or any blood products within three months prior to the planned administration of the investigational products (IPs). 7. Any confirmed or suspected immunosuppressive or immunodeficient state, positive HIV status, asplenia, recurrent severe infections and chronic use (more than 14 days) of immunosuppressant medication within the past 6 months. Topical steroids or short-term (course lasting =14 days) oral steroids are not an exclusion criteria. 8. History of allergic disease or reactions likely to be exacerbated by any component of Recombinant COVID-19 vaccine (Sf9 cells) 9. Any history of angioedema 10. Pregnancy, lactation or willingness/intention to become pregnant within 90 days after receiving study vaccine 11. Current diagnosis or treatment of cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ) 12. History of serious psychiatric condition likely to affect participation in the study 13. Bleeding disorder (e.g. factor deficiency, coagulopathy or platelet disorder), or prior history of significant bleeding