Created at Source Raw Value Validated value
June 25, 2024, noon usa

- to participate in this study, all subjects must meet none of the exclusion criteria described: 1. female subject who is breastfeeding or plans to breastfeed from the time of the first vaccination through 60 days after the last vaccination. 2. has any medical disease or condition that, in the opinion of the participating site pi or appropriate sub-investigator, precludes study participation. 3. presence of self-reported or medically documented significant medical or psychiatric condition(s). 4. history of hypersensitivity or severe reactions to previous vaccinations (e.g., anaphylaxis, urticaria, other significant reaction requiring medical intervention). 5. history of hypersensitivity or severe reactions to products known to contain polyethylene glycol (peg). 6. subjects with a positive test result at screening for hepatitis b surface antigen, hepatitis c virus antibody, or human immunodeficiency virus types 1 or 2 antibodies. 7. known or suspected alcohol or drug abuse within the past 6 months prior to screening. 8. safety laboratory test results (hematology and chemistry) with a toxicity score ≥ grade 2 at screening. the inclusion of subjects with non-clinically significant (ncs) grade 1 laboratory or vital sign abnormalities is allowed based on investigator's discretion (e.g., oral temperature is less than 100.0°f (37.8°c); pulse no greater than 100 beats per minute; systolic bp is 85 to 150 mm hg, inclusive). 9. previous participation in other studies involving study intervention containing lipid nanoparticles. 10. clinical conditions representing a contraindication to intramuscular vaccination and blood draws. 11. chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs within 6 months prior to the first vaccine dose (for corticosteroids: prednisone ≥ 20 mg/day or equivalent). inhaled, nasal and topical steroids are allowed. 12. received immunoglobulins or any blood products within 3 months prior to any study vaccination. 13. received an investigational or non-registered medicinal product within 30 days prior to informed consent. 14. has any blood dyscrasias or significant disorder of coagulation. 15. has any chronic liver disease, including fatty liver. 16. received or plans to receive a licensed, live vaccine within 4 weeks before or after each vaccination. 17. received or plans to receive a licensed, inactivated vaccine within 2 weeks before or after each vaccination. 18. has an acute illness, as determined by the participating site pi or appropriate sub- investigator, with or without fever (oral temperature ≥38.0°c \[100.4°f\]) within 72 hours prior to each vaccination. 19. any medical, psychiatric, or occupational condition which, in the opinion of the investigator, might pose additional risk to the subject due to participation in the study or could interfere with evaluation of the study vaccine or interpretation of study results. 20. unknown vaccine status versus sars-cov-2. 21. receipt of emergency use authorization or other vaccines against sars-cov-2 infection within 90 days prior to administration of first dose (recruits in cohort 3 will be unimmunized; recruits in cohorts 1 and 2 will have completed their emergency use authorization (eua) vaccine regimen at least 90 days prior to enrolment). 22. regular smoking or vaping (more than three days per week). 23. study personnel or immediate family or household member of study personnel. 24. the subject has donated blood within 56 days of dosing.

- to participate in this study, all subjects must meet none of the exclusion criteria described: 1. female subject who is breastfeeding or plans to breastfeed from the time of the first vaccination through 60 days after the last vaccination. 2. has any medical disease or condition that, in the opinion of the participating site pi or appropriate sub-investigator, precludes study participation. 3. presence of self-reported or medically documented significant medical or psychiatric condition(s). 4. history of hypersensitivity or severe reactions to previous vaccinations (e.g., anaphylaxis, urticaria, other significant reaction requiring medical intervention). 5. history of hypersensitivity or severe reactions to products known to contain polyethylene glycol (peg). 6. subjects with a positive test result at screening for hepatitis b surface antigen, hepatitis c virus antibody, or human immunodeficiency virus types 1 or 2 antibodies. 7. known or suspected alcohol or drug abuse within the past 6 months prior to screening. 8. safety laboratory test results (hematology and chemistry) with a toxicity score ≥ grade 2 at screening. the inclusion of subjects with non-clinically significant (ncs) grade 1 laboratory or vital sign abnormalities is allowed based on investigator's discretion (e.g., oral temperature is less than 100.0°f (37.8°c); pulse no greater than 100 beats per minute; systolic bp is 85 to 150 mm hg, inclusive). 9. previous participation in other studies involving study intervention containing lipid nanoparticles. 10. clinical conditions representing a contraindication to intramuscular vaccination and blood draws. 11. chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs within 6 months prior to the first vaccine dose (for corticosteroids: prednisone ≥ 20 mg/day or equivalent). inhaled, nasal and topical steroids are allowed. 12. received immunoglobulins or any blood products within 3 months prior to any study vaccination. 13. received an investigational or non-registered medicinal product within 30 days prior to informed consent. 14. has any blood dyscrasias or significant disorder of coagulation. 15. has any chronic liver disease, including fatty liver. 16. received or plans to receive a licensed, live vaccine within 4 weeks before or after each vaccination. 17. received or plans to receive a licensed, inactivated vaccine within 2 weeks before or after each vaccination. 18. has an acute illness, as determined by the participating site pi or appropriate sub- investigator, with or without fever (oral temperature ≥38.0°c \[100.4°f\]) within 72 hours prior to each vaccination. 19. any medical, psychiatric, or occupational condition which, in the opinion of the investigator, might pose additional risk to the subject due to participation in the study or could interfere with evaluation of the study vaccine or interpretation of study results. 20. unknown vaccine status versus sars-cov-2. 21. receipt of emergency use authorization or other vaccines against sars-cov-2 infection within 90 days prior to administration of first dose (recruits in cohort 3 will be unimmunized; recruits in cohorts 1 and 2 will have completed their emergency use authorization (eua) vaccine regimen at least 90 days prior to enrolment). 22. regular smoking or vaping (more than three days per week). 23. study personnel or immediate family or household member of study personnel. 24. the subject has donated blood within 56 days of dosing.

Nov. 25, 2021, 9 p.m. usa

- to participate in this study, all subjects must meet none of the exclusion criteria described: female subject who is breastfeeding or plans to breastfeed from the time of the first vaccination through 60 days after the last vaccination. has any medical disease or condition that, in the opinion of the participating site pi or appropriate sub-investigator, precludes study participation. presence of self-reported or medically documented significant medical or psychiatric condition(s). history of hypersensitivity or severe reactions to previous vaccinations (e.g., anaphylaxis, urticaria, other significant reaction requiring medical intervention). history of hypersensitivity or severe reactions to products known to contain polyethylene glycol (peg). subjects with a positive test result at screening for hepatitis b surface antigen, hepatitis c virus antibody, or human immunodeficiency virus types 1 or 2 antibodies. known or suspected alcohol or drug abuse within the past 6 months prior to screening. safety laboratory test results (hematology and chemistry) with a toxicity score ≥ grade 2 at screening. the inclusion of subjects with non-clinically significant (ncs) grade 1 laboratory or vital sign abnormalities is allowed based on investigator's discretion (e.g., oral temperature is less than 100.0°f (37.8°c); pulse no greater than 100 beats per minute; systolic bp is 85 to 150 mm hg, inclusive). previous participation in other studies involving study intervention containing lipid nanoparticles. clinical conditions representing a contraindication to intramuscular vaccination and blood draws. chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs within 6 months prior to the first vaccine dose (for corticosteroids: prednisone ≥ 20 mg/day or equivalent). inhaled, nasal and topical steroids are allowed. received immunoglobulins or any blood products within 3 months prior to any study vaccination. received an investigational or non-registered medicinal product within 30 days prior to informed consent. has any blood dyscrasias or significant disorder of coagulation. has any chronic liver disease, including fatty liver. received or plans to receive a licensed, live vaccine within 4 weeks before or after each vaccination. received or plans to receive a licensed, inactivated vaccine within 2 weeks before or after each vaccination. has an acute illness, as determined by the participating site pi or appropriate sub- investigator, with or without fever (oral temperature ≥38.0°c [100.4°f]) within 72 hours prior to each vaccination. any medical, psychiatric, or occupational condition which, in the opinion of the investigator, might pose additional risk to the subject due to participation in the study or could interfere with evaluation of the study vaccine or interpretation of study results. unknown vaccine status versus sars-cov-2. receipt of emergency use authorization or other vaccines against sars-cov-2 infection within 90 days prior to administration of first dose (recruits in cohort 3 will be unimmunized; recruits in cohorts 1 and 2 will have completed their emergency use authorization (eua) vaccine regimen at least 90 days prior to enrolment). regular smoking or vaping (more than three days per week). study personnel or immediate family or household member of study personnel. the subject has donated blood within 56 days of dosing.

- to participate in this study, all subjects must meet none of the exclusion criteria described: female subject who is breastfeeding or plans to breastfeed from the time of the first vaccination through 60 days after the last vaccination. has any medical disease or condition that, in the opinion of the participating site pi or appropriate sub-investigator, precludes study participation. presence of self-reported or medically documented significant medical or psychiatric condition(s). history of hypersensitivity or severe reactions to previous vaccinations (e.g., anaphylaxis, urticaria, other significant reaction requiring medical intervention). history of hypersensitivity or severe reactions to products known to contain polyethylene glycol (peg). subjects with a positive test result at screening for hepatitis b surface antigen, hepatitis c virus antibody, or human immunodeficiency virus types 1 or 2 antibodies. known or suspected alcohol or drug abuse within the past 6 months prior to screening. safety laboratory test results (hematology and chemistry) with a toxicity score ≥ grade 2 at screening. the inclusion of subjects with non-clinically significant (ncs) grade 1 laboratory or vital sign abnormalities is allowed based on investigator's discretion (e.g., oral temperature is less than 100.0°f (37.8°c); pulse no greater than 100 beats per minute; systolic bp is 85 to 150 mm hg, inclusive). previous participation in other studies involving study intervention containing lipid nanoparticles. clinical conditions representing a contraindication to intramuscular vaccination and blood draws. chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs within 6 months prior to the first vaccine dose (for corticosteroids: prednisone ≥ 20 mg/day or equivalent). inhaled, nasal and topical steroids are allowed. received immunoglobulins or any blood products within 3 months prior to any study vaccination. received an investigational or non-registered medicinal product within 30 days prior to informed consent. has any blood dyscrasias or significant disorder of coagulation. has any chronic liver disease, including fatty liver. received or plans to receive a licensed, live vaccine within 4 weeks before or after each vaccination. received or plans to receive a licensed, inactivated vaccine within 2 weeks before or after each vaccination. has an acute illness, as determined by the participating site pi or appropriate sub- investigator, with or without fever (oral temperature ≥38.0°c [100.4°f]) within 72 hours prior to each vaccination. any medical, psychiatric, or occupational condition which, in the opinion of the investigator, might pose additional risk to the subject due to participation in the study or could interfere with evaluation of the study vaccine or interpretation of study results. unknown vaccine status versus sars-cov-2. receipt of emergency use authorization or other vaccines against sars-cov-2 infection within 90 days prior to administration of first dose (recruits in cohort 3 will be unimmunized; recruits in cohorts 1 and 2 will have completed their emergency use authorization (eua) vaccine regimen at least 90 days prior to enrolment). regular smoking or vaping (more than three days per week). study personnel or immediate family or household member of study personnel. the subject has donated blood within 56 days of dosing.