Created at Source Raw Value Validated value
Nov. 16, 2021, 6:30 p.m. usa

subjects eligible to participate in this trial must not meet any of the following

subjects eligible to participate in this trial must not meet any of the following

Aug. 26, 2021, 7:30 p.m. usa

subjects eligible to participate in this trial must not meet any of the following exclusion criteria: 1. history of prior confirmed coronavirus disease 2019 (covid-19) 2. positive for anti-nucleoprotein severe acute respiratory syndrome coronavirus 2 (sars-cov-2) specific antibody by enzyme-linked immunosorbent assay (elisa) or by nasal swab polymerase chain reaction (pcr) at screening. 3. body mass index (bmi) > 30 kg/m^2 for stage 1 participants and bmi > 35 kg/m^2 for stage 2 participants. 4. presence of medical comorbidities that would place the subject at increased risk for severe covid-19* *chronic kidney disease, chronic lung disease (including moderate-to-severe asthma), chronic heart disease (heart failure, coronary artery disease or cardiomyopathies), cerebrovascular disease, diabetes mellitus, chronic liver disease, sickle cell disease 5. increased risk of occupational exposure to sars-cov-2 (healthcare workers and emergency response personnel)* *applies to stage 1 participants only 6. prior receipt of an investigational sars-cov-2 vaccine (including under eua)*, approved or investigational adenovirus-vectored vaccines**, or any other approved or investigational vaccine likely to impact the interpretation of the trial data *exclusion of prior receipt of covid-19 eua vaccines applies to stage 1 participants only **with the exception of prior receipt of johnson & johnson/janssen ad 26 covid-19 eua vaccine which is permitted for groups 8 and 12 7. on current treatment or prevention agents with activity against sars-cov-2 8. current smoking or vaping or history of smoking or vaping in prior year* *applies to stage 1 participants only 9. breastfeeding, pregnant, or planning to become pregnant during the course of the study. 10. participation in another research study involving receipt of an investigational product in the 60 days preceding enrolment or planned use during the study period 11. receipt or planned receipt of any live, attenuated vaccine within 28 days before or after study vaccination 12. receipt or planned receipt of any subunit or killed vaccine within 14 days before or after vaccination 13. administration of immunoglobulins and/or any blood products within the three months preceding the planned administration of first study vaccination or at any time during the study 14. any confirmed or suspected immunosuppressive or immunodeficient state, including human immunodeficiency virus (hiv) infection, asplenia, recurrent, severe infections and chronic (more than 14 continuous days) immunosuppressant medication within the past 6 months (inhaled, ophthalmic, and topical steroids are allowed) 15. history of allergic disease or reactions likely to be exacerbated by any component of the vaccine, including urticaria, respiratory difficulty or abdominal pain (or any immediate allergic reaction of any severity to polysorbate due to potential cross-reactive hypersensitivity with the polyethylene glycol component of the vaccine) 16. any history of hereditary angioedema, acquired angioedema, or idiopathic angioedema 17. any history of anaphylaxis, including but not limited to reaction to vaccination 18. any history of severe allergic drug reaction 19. history of cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ) 20. history of serious ongoing, unstable psychiatric condition that in the opinion of the investigator would interfere with study participation 21. seizure in the past 3 years or treatment for seizure disorder in the past 3 years 22. bleeding disorder (e.g., factor deficiency, coagulopathy, or platelet disorder), or prior history of significant bleeding or bruising following im injections or venipuncture or family history of bleeding disorder 23. recent (within the past 3 months) surgery, immobility, chronic infection, or head trauma that could increase the risks of thrombosis. 24. suspected or known current alcohol abuse. suspected or known drug abuse in the 5 years preceding enrollment 25. seropositive for hiv, hepatitis b surface antigen (hbsag), or seropositive for hepatitis c virus (antibodies to hcv) 26. have an acute illness* within 72 hours prior to study vaccination *an acute illness which is nearly resolved with only minor residual symptoms remaining is allowable if, in the opinion of the site pi or appropriate sub-investigator, the residual symptoms will not interfere with the ability to assess safety parameters as required by the protocol 27. history of venous or arterial thrombosis or any known thrombophilic condition including heparin-induced thrombocytopenia (hit) or family history of thrombosis. 28. history of guillain-barre syndrome (gbs). 29. receiving heparin treatment or on medications associated with increased risk of bleeding or thrombosis. 30. any other condition that in the opinion of the investigator would pose a health risk to the participant if enrolled or could interfere with evaluation of the trial vaccine or interpretation of study results

subjects eligible to participate in this trial must not meet any of the following exclusion criteria: 1. history of prior confirmed coronavirus disease 2019 (covid-19) 2. positive for anti-nucleoprotein severe acute respiratory syndrome coronavirus 2 (sars-cov-2) specific antibody by enzyme-linked immunosorbent assay (elisa) or by nasal swab polymerase chain reaction (pcr) at screening. 3. body mass index (bmi) > 30 kg/m^2 for stage 1 participants and bmi > 35 kg/m^2 for stage 2 participants. 4. presence of medical comorbidities that would place the subject at increased risk for severe covid-19* *chronic kidney disease, chronic lung disease (including moderate-to-severe asthma), chronic heart disease (heart failure, coronary artery disease or cardiomyopathies), cerebrovascular disease, diabetes mellitus, chronic liver disease, sickle cell disease 5. increased risk of occupational exposure to sars-cov-2 (healthcare workers and emergency response personnel)* *applies to stage 1 participants only 6. prior receipt of an investigational sars-cov-2 vaccine (including under eua)*, approved or investigational adenovirus-vectored vaccines**, or any other approved or investigational vaccine likely to impact the interpretation of the trial data *exclusion of prior receipt of covid-19 eua vaccines applies to stage 1 participants only **with the exception of prior receipt of johnson & johnson/janssen ad 26 covid-19 eua vaccine which is permitted for groups 8 and 12 7. on current treatment or prevention agents with activity against sars-cov-2 8. current smoking or vaping or history of smoking or vaping in prior year* *applies to stage 1 participants only 9. breastfeeding, pregnant, or planning to become pregnant during the course of the study. 10. participation in another research study involving receipt of an investigational product in the 60 days preceding enrolment or planned use during the study period 11. receipt or planned receipt of any live, attenuated vaccine within 28 days before or after study vaccination 12. receipt or planned receipt of any subunit or killed vaccine within 14 days before or after vaccination 13. administration of immunoglobulins and/or any blood products within the three months preceding the planned administration of first study vaccination or at any time during the study 14. any confirmed or suspected immunosuppressive or immunodeficient state, including human immunodeficiency virus (hiv) infection, asplenia, recurrent, severe infections and chronic (more than 14 continuous days) immunosuppressant medication within the past 6 months (inhaled, ophthalmic, and topical steroids are allowed) 15. history of allergic disease or reactions likely to be exacerbated by any component of the vaccine, including urticaria, respiratory difficulty or abdominal pain (or any immediate allergic reaction of any severity to polysorbate due to potential cross-reactive hypersensitivity with the polyethylene glycol component of the vaccine) 16. any history of hereditary angioedema, acquired angioedema, or idiopathic angioedema 17. any history of anaphylaxis, including but not limited to reaction to vaccination 18. any history of severe allergic drug reaction 19. history of cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ) 20. history of serious ongoing, unstable psychiatric condition that in the opinion of the investigator would interfere with study participation 21. seizure in the past 3 years or treatment for seizure disorder in the past 3 years 22. bleeding disorder (e.g., factor deficiency, coagulopathy, or platelet disorder), or prior history of significant bleeding or bruising following im injections or venipuncture or family history of bleeding disorder 23. recent (within the past 3 months) surgery, immobility, chronic infection, or head trauma that could increase the risks of thrombosis. 24. suspected or known current alcohol abuse. suspected or known drug abuse in the 5 years preceding enrollment 25. seropositive for hiv, hepatitis b surface antigen (hbsag), or seropositive for hepatitis c virus (antibodies to hcv) 26. have an acute illness* within 72 hours prior to study vaccination *an acute illness which is nearly resolved with only minor residual symptoms remaining is allowable if, in the opinion of the site pi or appropriate sub-investigator, the residual symptoms will not interfere with the ability to assess safety parameters as required by the protocol 27. history of venous or arterial thrombosis or any known thrombophilic condition including heparin-induced thrombocytopenia (hit) or family history of thrombosis. 28. history of guillain-barre syndrome (gbs). 29. receiving heparin treatment or on medications associated with increased risk of bleeding or thrombosis. 30. any other condition that in the opinion of the investigator would pose a health risk to the participant if enrolled or could interfere with evaluation of the trial vaccine or interpretation of study results

June 25, 2021, 2 a.m. usa

subjects eligible to participate in this trial must not meet any of the following exclusion criteria: 1. history of prior confirmed coronavirus disease 2019 (covid-19) 2. positive for anti-nucleoprotein severe acute respiratory syndrome coronavirus 2 (sars-cov-2) specific antibody by enzyme-linked immunosorbent assay (elisa) or by nasal swab polymerase chain reaction (pcr) at screening. 3. body mass index (bmi) > 30 kg/m^2 for stage 1 participants and bmi > 35 kg/m^2 for stage 2 participants. 4. presence of medical comorbidities that would place the subject at increased risk for severe covid-19* *chronic kidney disease, chronic lung disease (including moderate-to-severe asthma), chronic heart disease (heart failure, coronary artery disease or cardiomyopathies), cerebrovascular disease, diabetes mellitus, chronic liver disease, sickle cell disease 5. increased risk of occupational exposure to sars-cov-2 (healthcare workers and emergency response personnel)* *applies to stage 1 participants only 6. prior receipt of an investigational sars-cov-2 vaccine (including under emergency use authorization [eua])*, approved or investigational adenovirus-vectored vaccines**, or any other approved or investigational vaccine likely to impact the interpretation of the trial data *exclusion of prior receipt of covid-19 eua vaccines applies to stage 1 participants only **with the exception of prior receipt of johnson and johnson/janssen sars-cov-2 eua vaccine which is permitted for group 14 7. on current treatment or prevention agents with activity against sars-cov-2 8. current smoking or vaping or history of smoking or vaping in prior year* *applies to stage 1 participants only 9. breastfeeding, pregnant, or planning to become pregnant during the course of the study. 10. participation in another research study involving receipt of an investigational product in the 60 days preceding enrolment or planned use during the study period 11. receipt or planned receipt of any live, attenuated vaccine within 28 days before or after study vaccination 12. receipt or planned receipt of any subunit or killed vaccine within 14 days before or after vaccination 13. administration of immunoglobulins and/or any blood products within the three months preceding the planned administration of first study vaccination or at any time during the study 14. any confirmed or suspected immunosuppressive or immunodeficient state, including hiv infection, asplenia, recurrent, severe infections and chronic (more than 14 continuous days) immunosuppressant medication within the past 6 months (inhaled, ophthalmic and topical steroids are allowed) 15. history of allergic disease or reactions likely to be exacerbated by any component of the vaccine, including urticaria, respiratory difficulty or abdominal pain (or any immediate allergic reaction of any severity to polysorbate due to potential cross-reactive hypersensitivity with the polyethylene glycol component of the vaccine) 16. any history of hereditary angioedema, acquired angioedema, or idiopathic angioedema 17. any history of anaphylaxis, including but not limited to reaction to vaccination 18. any history of severe allergic drug reaction 19. history of cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ) 20. history of serious ongoing, unstable psychiatric condition that in the opinion of the investigator would interfere with study participation 21. seizure in the past 3 years or treatment for seizure disorder in the past 3 years 22. bleeding disorder (e.g., factor deficiency, coagulopathy or platelet disorder), or prior history of significant bleeding or bruising following im injections or venipuncture 23. suspected or known current alcohol abuse. suspected or known drug abuse in the 5 years preceding enrollment 24. seropositive for hiv, hepatitis b surface antigen (hbsag) or seropositive for hepatitis c virus (antibodies to hcv) 25. have an acute illness* within 72 hours prior to study vaccination *an acute illness which is nearly resolved with only minor residual symptoms remaining is allowable if, in the opinion of the site pi or appropriate sub-investigator, the residual symptoms will not interfere with the ability to assess safety parameters as required by the protocol 26. history of venous or arterial thrombosis or any known thrombophilic condition including heparin-induced thrombocytopenia (hit). 27. any other condition that in the opinion of the investigator would pose a health risk to the participant if enrolled or could interfere with evaluation of the trial vaccine or interpretation of study results

subjects eligible to participate in this trial must not meet any of the following exclusion criteria: 1. history of prior confirmed coronavirus disease 2019 (covid-19) 2. positive for anti-nucleoprotein severe acute respiratory syndrome coronavirus 2 (sars-cov-2) specific antibody by enzyme-linked immunosorbent assay (elisa) or by nasal swab polymerase chain reaction (pcr) at screening. 3. body mass index (bmi) > 30 kg/m^2 for stage 1 participants and bmi > 35 kg/m^2 for stage 2 participants. 4. presence of medical comorbidities that would place the subject at increased risk for severe covid-19* *chronic kidney disease, chronic lung disease (including moderate-to-severe asthma), chronic heart disease (heart failure, coronary artery disease or cardiomyopathies), cerebrovascular disease, diabetes mellitus, chronic liver disease, sickle cell disease 5. increased risk of occupational exposure to sars-cov-2 (healthcare workers and emergency response personnel)* *applies to stage 1 participants only 6. prior receipt of an investigational sars-cov-2 vaccine (including under emergency use authorization [eua])*, approved or investigational adenovirus-vectored vaccines**, or any other approved or investigational vaccine likely to impact the interpretation of the trial data *exclusion of prior receipt of covid-19 eua vaccines applies to stage 1 participants only **with the exception of prior receipt of johnson and johnson/janssen sars-cov-2 eua vaccine which is permitted for group 14 7. on current treatment or prevention agents with activity against sars-cov-2 8. current smoking or vaping or history of smoking or vaping in prior year* *applies to stage 1 participants only 9. breastfeeding, pregnant, or planning to become pregnant during the course of the study. 10. participation in another research study involving receipt of an investigational product in the 60 days preceding enrolment or planned use during the study period 11. receipt or planned receipt of any live, attenuated vaccine within 28 days before or after study vaccination 12. receipt or planned receipt of any subunit or killed vaccine within 14 days before or after vaccination 13. administration of immunoglobulins and/or any blood products within the three months preceding the planned administration of first study vaccination or at any time during the study 14. any confirmed or suspected immunosuppressive or immunodeficient state, including hiv infection, asplenia, recurrent, severe infections and chronic (more than 14 continuous days) immunosuppressant medication within the past 6 months (inhaled, ophthalmic and topical steroids are allowed) 15. history of allergic disease or reactions likely to be exacerbated by any component of the vaccine, including urticaria, respiratory difficulty or abdominal pain (or any immediate allergic reaction of any severity to polysorbate due to potential cross-reactive hypersensitivity with the polyethylene glycol component of the vaccine) 16. any history of hereditary angioedema, acquired angioedema, or idiopathic angioedema 17. any history of anaphylaxis, including but not limited to reaction to vaccination 18. any history of severe allergic drug reaction 19. history of cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ) 20. history of serious ongoing, unstable psychiatric condition that in the opinion of the investigator would interfere with study participation 21. seizure in the past 3 years or treatment for seizure disorder in the past 3 years 22. bleeding disorder (e.g., factor deficiency, coagulopathy or platelet disorder), or prior history of significant bleeding or bruising following im injections or venipuncture 23. suspected or known current alcohol abuse. suspected or known drug abuse in the 5 years preceding enrollment 24. seropositive for hiv, hepatitis b surface antigen (hbsag) or seropositive for hepatitis c virus (antibodies to hcv) 25. have an acute illness* within 72 hours prior to study vaccination *an acute illness which is nearly resolved with only minor residual symptoms remaining is allowable if, in the opinion of the site pi or appropriate sub-investigator, the residual symptoms will not interfere with the ability to assess safety parameters as required by the protocol 26. history of venous or arterial thrombosis or any known thrombophilic condition including heparin-induced thrombocytopenia (hit). 27. any other condition that in the opinion of the investigator would pose a health risk to the participant if enrolled or could interfere with evaluation of the trial vaccine or interpretation of study results

May 12, 2021, 12:31 a.m. usa

subjects eligible to participate in this trial must not meet any of the following exclusion criteria: 1. history of prior confirmed coronavirus disease 2019 (covid-19) 2. positive for severe acute respiratory syndrome coronavirus 2 (sars-cov-2) by enzyme-linked immunosorbent assay (elisa) or by nasal swab polymerase chain reaction (pcr) at screening. 3. presence of medical comorbidities that would place the subject at increased risk for severe covid-19* *chronic kidney disease, chronic lung disease (including moderate-to-severe asthma), chronic heart disease (heart failure, coronary artery disease or cardiomyopathies), cerebrovascular disease, body mass index(bmi) > / = 30 kg/m2, diabetes mellitus, chronic liver disease, sickle cell disease 4. increased risk of occupational exposure to sars-cov-2 (healthcare workers and emergency response personnel) 5. prior receipt of an investigational sars-cov-2 vaccine (including under emergency use authorization [eua]), approved or investigational adenovirus vectored vaccines, approved or investigational vaccines with an lnp component, or any other approved or investigational vaccine likely to impact the interpretation of the trial data 6. on current treatment or prevention agents with activity against sars-cov-2 7. current smoking or vaping 8. history of smoking or vaping in prior year 9. breastfeeding, pregnant, or planning to become pregnant during the course of the study. 10. participation in another research study involving receipt of an investigational product in the 60 days preceding enrolment or planned use during the study period 11. receipt or planned receipt of any live, attenuated vaccine within 28 days before or after study vaccination 12. receipt or planned receipt of any subunit or killed vaccine within 14 days before or after vaccination 13. administration of immunoglobulins and/or any blood products within the three months preceding the planned administration of first study vaccination or at any time during the study 14. any confirmed or suspected immunosuppressive or immunodeficient state, including hiv infection, asplenia, recurrent, severe infections and chronic (more than 14 continuous days) immunosuppressant medication within the past 6 months (inhaled, ophthalmic and topical steroids are allowed) 15. history of allergic disease or reactions likely to be exacerbated by any component of the vaccine, including urticaria, respiratory difficulty or abdominal pain (or any immediate allergic reaction of any severity to polysorbate due to potential cross-reactive hypersensitivity with the polyethylene glycol component of the vaccine) 16. any history of hereditary angioedema, acquired angioedema, or idiopathic angioedema 17. any history of anaphylaxis, including but not limited to reaction to vaccination 18. any history of severe allergic drug reaction 19. history of cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ) 20. history of serious ongoing, unstable psychiatric condition that in the opinion of the investigator would interfere with study participation 21. seizure in the past 3 years or treatment for seizure disorder in the past 3 years 22. bleeding disorder (e.g., factor deficiency, coagulopathy or platelet disorder), or prior history of significant bleeding or bruising following im injections or venipuncture 23. suspected or known current alcohol abuse. suspected or known drug abuse in the 5 years preceding enrollment 24. seropositive for hiv, hepatitis b surface antigen (hbsag) or seropositive for hepatitis c virus (antibodies to hcv) 25. have an acute illness* within 72 hours prior to study vaccination *an acute illness which is nearly resolved with only minor residual symptoms remaining is allowable if, in the opinion of the site pi or appropriate sub-investigator, the residual symptoms will not interfere with the ability to assess safety parameters as required by the protocol 26. history of venous or arterial thrombosis or any known thrombophilic condition including heparin-induced thrombocytopenia (hit). 27. any other condition that in the opinion of the investigator would pose a health risk to the participant if enrolled or could interfere with evaluation of the trial vaccine or interpretation of study results

subjects eligible to participate in this trial must not meet any of the following exclusion criteria: 1. history of prior confirmed coronavirus disease 2019 (covid-19) 2. positive for severe acute respiratory syndrome coronavirus 2 (sars-cov-2) by enzyme-linked immunosorbent assay (elisa) or by nasal swab polymerase chain reaction (pcr) at screening. 3. presence of medical comorbidities that would place the subject at increased risk for severe covid-19* *chronic kidney disease, chronic lung disease (including moderate-to-severe asthma), chronic heart disease (heart failure, coronary artery disease or cardiomyopathies), cerebrovascular disease, body mass index(bmi) > / = 30 kg/m2, diabetes mellitus, chronic liver disease, sickle cell disease 4. increased risk of occupational exposure to sars-cov-2 (healthcare workers and emergency response personnel) 5. prior receipt of an investigational sars-cov-2 vaccine (including under emergency use authorization [eua]), approved or investigational adenovirus vectored vaccines, approved or investigational vaccines with an lnp component, or any other approved or investigational vaccine likely to impact the interpretation of the trial data 6. on current treatment or prevention agents with activity against sars-cov-2 7. current smoking or vaping 8. history of smoking or vaping in prior year 9. breastfeeding, pregnant, or planning to become pregnant during the course of the study. 10. participation in another research study involving receipt of an investigational product in the 60 days preceding enrolment or planned use during the study period 11. receipt or planned receipt of any live, attenuated vaccine within 28 days before or after study vaccination 12. receipt or planned receipt of any subunit or killed vaccine within 14 days before or after vaccination 13. administration of immunoglobulins and/or any blood products within the three months preceding the planned administration of first study vaccination or at any time during the study 14. any confirmed or suspected immunosuppressive or immunodeficient state, including hiv infection, asplenia, recurrent, severe infections and chronic (more than 14 continuous days) immunosuppressant medication within the past 6 months (inhaled, ophthalmic and topical steroids are allowed) 15. history of allergic disease or reactions likely to be exacerbated by any component of the vaccine, including urticaria, respiratory difficulty or abdominal pain (or any immediate allergic reaction of any severity to polysorbate due to potential cross-reactive hypersensitivity with the polyethylene glycol component of the vaccine) 16. any history of hereditary angioedema, acquired angioedema, or idiopathic angioedema 17. any history of anaphylaxis, including but not limited to reaction to vaccination 18. any history of severe allergic drug reaction 19. history of cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ) 20. history of serious ongoing, unstable psychiatric condition that in the opinion of the investigator would interfere with study participation 21. seizure in the past 3 years or treatment for seizure disorder in the past 3 years 22. bleeding disorder (e.g., factor deficiency, coagulopathy or platelet disorder), or prior history of significant bleeding or bruising following im injections or venipuncture 23. suspected or known current alcohol abuse. suspected or known drug abuse in the 5 years preceding enrollment 24. seropositive for hiv, hepatitis b surface antigen (hbsag) or seropositive for hepatitis c virus (antibodies to hcv) 25. have an acute illness* within 72 hours prior to study vaccination *an acute illness which is nearly resolved with only minor residual symptoms remaining is allowable if, in the opinion of the site pi or appropriate sub-investigator, the residual symptoms will not interfere with the ability to assess safety parameters as required by the protocol 26. history of venous or arterial thrombosis or any known thrombophilic condition including heparin-induced thrombocytopenia (hit). 27. any other condition that in the opinion of the investigator would pose a health risk to the participant if enrolled or could interfere with evaluation of the trial vaccine or interpretation of study results

March 2, 2021, 12:31 a.m. usa

subjects eligible to participate in this trial must not meet any of the following exclusion criteria: 1. history of prior confirmed coronavirus disease 2019 (covid-19) 2. positive for severe acute respiratory syndrome coronavirus 2 (sars-cov-2) by enzyme-linked immunosorbent assay (elisa) or by nasal swab polymerase chain reaction (pcr) at screening. 3. presence of medical comorbidities that would place the subject at increased risk for severe covid-19* *chronic kidney disease, chronic lung disease (including moderate-to-severe asthma), chronic heart disease (heart failure, coronary artery disease or cardiomyopathies), cerebrovascular disease, body mass index(bmi) > / = 30 kg/m2, diabetes mellitus, chronic liver disease, sickle cell disease 4. increased risk of occupational exposure to sars-cov-2 (healthcare workers and emergency response personnel) 5. prior receipt of an investigational sars-cov-2 vaccine (including under emergency use authorization [eua]), approved or investigational adenovirus vectored vaccines, approved or investigational vaccines with an lnp component, or any other approved or investigational vaccine likely to impact the interpretation of the trial data 6. on current treatment or prevention agents with activity against sars-cov-2 7. current smoking or vaping 8. history of smoking or vaping in prior year 9. breastfeeding, pregnant, or planning to become pregnant during the course of the study. 10. participation in another research study involving receipt of an investigational product in the 60 days preceding enrolment or planned use during the study period 11. receipt or planned receipt of any live, attenuated vaccine within 28 days before or after study vaccination 12. receipt or planned receipt of any subunit or killed vaccine within 14 days before or after vaccination 13. administration of immunoglobulins and/or any blood products within the three months preceding the planned administration of first study vaccination or at any time during the study 14. any confirmed or suspected immunosuppressive or immunodeficient state, including hiv infection, asplenia, recurrent, severe infections and chronic (more than 14 continuous days) immunosuppressant medication within the past 6 months (inhaled, ophthalmic and topical steroids are allowed) 15. history of allergic disease or reactions likely to be exacerbated by any component of the vaccine, including urticaria, respiratory difficulty or abdominal pain (or any immediate allergic reaction of any severity to polysorbate due to potential cross-reactive hypersensitivity with the polyethylene glycol component of the vaccine) 16. any history of hereditary angioedema, acquired angioedema, or idiopathic angioedema 17. any history of anaphylaxis, including but not limited to reaction to vaccination 18. any history of severe allergic drug reaction 19. history of cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ) 20. history of serious ongoing, unstable psychiatric condition that in the opinion of the investigator would interfere with study participation 21. seizure in the past 3 years or treatment for seizure disorder in the past 3 years 22. bleeding disorder (e.g., factor deficiency, coagulopathy or platelet disorder), or prior history of significant bleeding or bruising following im injections or venipuncture 23. suspected or known current alcohol abuse. suspected or known drug abuse in the 5 years preceding enrollment 24. seropositive for hiv, hepatitis b surface antigen (hbsag) or seropositive for hepatitis c virus (antibodies to hcv) 25. have an acute illness* within 72 hours prior to study vaccination *an acute illness which is nearly resolved with only minor residual symptoms remaining is allowable if, in the opinion of the site pi or appropriate sub-investigator, the residual symptoms will not interfere with the ability to assess safety parameters as required by the protocol 26. any other condition that in the opinion of the investigator would pose a health risk to the participant if enrolled or could interfere with evaluation of the trial vaccine or interpretation of study results

subjects eligible to participate in this trial must not meet any of the following exclusion criteria: 1. history of prior confirmed coronavirus disease 2019 (covid-19) 2. positive for severe acute respiratory syndrome coronavirus 2 (sars-cov-2) by enzyme-linked immunosorbent assay (elisa) or by nasal swab polymerase chain reaction (pcr) at screening. 3. presence of medical comorbidities that would place the subject at increased risk for severe covid-19* *chronic kidney disease, chronic lung disease (including moderate-to-severe asthma), chronic heart disease (heart failure, coronary artery disease or cardiomyopathies), cerebrovascular disease, body mass index(bmi) > / = 30 kg/m2, diabetes mellitus, chronic liver disease, sickle cell disease 4. increased risk of occupational exposure to sars-cov-2 (healthcare workers and emergency response personnel) 5. prior receipt of an investigational sars-cov-2 vaccine (including under emergency use authorization [eua]), approved or investigational adenovirus vectored vaccines, approved or investigational vaccines with an lnp component, or any other approved or investigational vaccine likely to impact the interpretation of the trial data 6. on current treatment or prevention agents with activity against sars-cov-2 7. current smoking or vaping 8. history of smoking or vaping in prior year 9. breastfeeding, pregnant, or planning to become pregnant during the course of the study. 10. participation in another research study involving receipt of an investigational product in the 60 days preceding enrolment or planned use during the study period 11. receipt or planned receipt of any live, attenuated vaccine within 28 days before or after study vaccination 12. receipt or planned receipt of any subunit or killed vaccine within 14 days before or after vaccination 13. administration of immunoglobulins and/or any blood products within the three months preceding the planned administration of first study vaccination or at any time during the study 14. any confirmed or suspected immunosuppressive or immunodeficient state, including hiv infection, asplenia, recurrent, severe infections and chronic (more than 14 continuous days) immunosuppressant medication within the past 6 months (inhaled, ophthalmic and topical steroids are allowed) 15. history of allergic disease or reactions likely to be exacerbated by any component of the vaccine, including urticaria, respiratory difficulty or abdominal pain (or any immediate allergic reaction of any severity to polysorbate due to potential cross-reactive hypersensitivity with the polyethylene glycol component of the vaccine) 16. any history of hereditary angioedema, acquired angioedema, or idiopathic angioedema 17. any history of anaphylaxis, including but not limited to reaction to vaccination 18. any history of severe allergic drug reaction 19. history of cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ) 20. history of serious ongoing, unstable psychiatric condition that in the opinion of the investigator would interfere with study participation 21. seizure in the past 3 years or treatment for seizure disorder in the past 3 years 22. bleeding disorder (e.g., factor deficiency, coagulopathy or platelet disorder), or prior history of significant bleeding or bruising following im injections or venipuncture 23. suspected or known current alcohol abuse. suspected or known drug abuse in the 5 years preceding enrollment 24. seropositive for hiv, hepatitis b surface antigen (hbsag) or seropositive for hepatitis c virus (antibodies to hcv) 25. have an acute illness* within 72 hours prior to study vaccination *an acute illness which is nearly resolved with only minor residual symptoms remaining is allowable if, in the opinion of the site pi or appropriate sub-investigator, the residual symptoms will not interfere with the ability to assess safety parameters as required by the protocol 26. any other condition that in the opinion of the investigator would pose a health risk to the participant if enrolled or could interfere with evaluation of the trial vaccine or interpretation of study results