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

1. pregnant or lactating females. 2. participation in any clinical study with intake of any investigational drug interfering with the study primary endpoint 3. any concomitant disease affecting the effect of the therapeutic vaccine or interfering with the study primary endpoint 4. any immunosuppressive treatment except low dose corticosteroids (≤10mg prednisolone/day) 5. prior or current infection with sars-cov-2 tested serologically or by throat/nose swab (pcr) 6. history of guillain-barré syndrome 7. positive serological hiv, hepatitis b or c test. in case of positive hbsag, volunteer must provide prove of hepatitis b vaccination, otherwise volunteer must be excluded. 8. history of relevant central nervous system (cns) pathology or current relevant cns pathology (e.g. seizure, paresis, aphasia, cerebrovascular ischemia/hemorrhage, severe brain injuries, dementia, parkinson's disease, cerebellar disease, organic brain syndrome, psychosis, coordination or movement disorder, excluding febrile seizures as child) 9. baseline laboratory with lymphocyte count ≤ 1000/µl 10. only part i and ii: - acute or chronic, clinically significant psychiatric, hematologic, pulmonary, cardiovascular, or hepatic or renal functional abnormality as determined by the investigator based on medical history, physical exam, and/or laboratory screening test 11. all parts of the clinical trial * diabetes mellitus typ ii requiring drug treatment * chronic lung disease requiring drug treatment * any chronic liver disease or unknown liver abnormalities defined as: * alanin-aminotransferase (alt) and aspartat-aminotransferase (ast) ≤ 2.5 x uln (upper limit of normal) * gamma-glutamyl-transferase (γ-gt) ≤ 2.5 x uln * chronic renal failure defined as glomerular filtration rate (gfr) \< 40 ml/min/1,73m2 * serious pre-existing cardiovascular disease such as new york heart association (nyha) ≥ ii, coronary heart disease requiring coronary surgery or known peripheral arterial disease (pavk) ≥ grade 2 * sickle cell anemia * obesity (body mass index ≥ 30kg/m2) 12. hospitalization at study inclusion 13. administration of immunoglobulins and/or any blood products within 120 days preceding study entry or planned administration during the study period 14. history of blood donation within 30 days of enrolment or planned donations within the study period 15. known hypersensitivity to any of the components included in the covac-1 vaccine

1. pregnant or lactating females. 2. participation in any clinical study with intake of any investigational drug interfering with the study primary endpoint 3. any concomitant disease affecting the effect of the therapeutic vaccine or interfering with the study primary endpoint 4. any immunosuppressive treatment except low dose corticosteroids (≤10mg prednisolone/day) 5. prior or current infection with sars-cov-2 tested serologically or by throat/nose swab (pcr) 6. history of guillain-barré syndrome 7. positive serological hiv, hepatitis b or c test. in case of positive hbsag, volunteer must provide prove of hepatitis b vaccination, otherwise volunteer must be excluded. 8. history of relevant central nervous system (cns) pathology or current relevant cns pathology (e.g. seizure, paresis, aphasia, cerebrovascular ischemia/hemorrhage, severe brain injuries, dementia, parkinson's disease, cerebellar disease, organic brain syndrome, psychosis, coordination or movement disorder, excluding febrile seizures as child) 9. baseline laboratory with lymphocyte count ≤ 1000/µl 10. only part i and ii: - acute or chronic, clinically significant psychiatric, hematologic, pulmonary, cardiovascular, or hepatic or renal functional abnormality as determined by the investigator based on medical history, physical exam, and/or laboratory screening test 11. all parts of the clinical trial * diabetes mellitus typ ii requiring drug treatment * chronic lung disease requiring drug treatment * any chronic liver disease or unknown liver abnormalities defined as: * alanin-aminotransferase (alt) and aspartat-aminotransferase (ast) ≤ 2.5 x uln (upper limit of normal) * gamma-glutamyl-transferase (γ-gt) ≤ 2.5 x uln * chronic renal failure defined as glomerular filtration rate (gfr) \< 40 ml/min/1,73m2 * serious pre-existing cardiovascular disease such as new york heart association (nyha) ≥ ii, coronary heart disease requiring coronary surgery or known peripheral arterial disease (pavk) ≥ grade 2 * sickle cell anemia * obesity (body mass index ≥ 30kg/m2) 12. hospitalization at study inclusion 13. administration of immunoglobulins and/or any blood products within 120 days preceding study entry or planned administration during the study period 14. history of blood donation within 30 days of enrolment or planned donations within the study period 15. known hypersensitivity to any of the components included in the covac-1 vaccine

Nov. 16, 2021, 6:30 p.m. usa

pregnant or lactating females. participation in any clinical study with intake of any investigational drug interfering with the study primary endpoint any concomitant disease affecting the effect of the therapeutic vaccine or interfering with the study primary endpoint any immunosuppressive treatment except low dose corticosteroids (≤10mg prednisolone/day) prior or current infection with sars-cov-2 tested serologically or by throat/nose swab (pcr) history of guillain-barré syndrome positive serological hiv, hepatitis b or c test. in case of positive hbsag, volunteer must provide prove of hepatitis b vaccination, otherwise volunteer must be excluded. history of relevant central nervous system (cns) pathology or current relevant cns pathology (e.g. seizure, paresis, aphasia, cerebrovascular ischemia/hemorrhage, severe brain injuries, dementia, parkinson's disease, cerebellar disease, organic brain syndrome, psychosis, coordination or movement disorder, excluding febrile seizures as child) baseline laboratory with lymphocyte count ≤ 1000/µl only part i and ii: - acute or chronic, clinically significant psychiatric, hematologic, pulmonary, cardiovascular, or hepatic or renal functional abnormality as determined by the investigator based on medical history, physical exam, and/or laboratory screening test all parts of the clinical trial diabetes mellitus typ ii requiring drug treatment chronic lung disease requiring drug treatment any chronic liver disease or unknown liver abnormalities defined as: alanin-aminotransferase (alt) and aspartat-aminotransferase (ast) ≤ 2.5 x uln (upper limit of normal) gamma-glutamyl-transferase (γ-gt) ≤ 2.5 x uln chronic renal failure defined as glomerular filtration rate (gfr) < 40 ml/min/1,73m2 serious pre-existing cardiovascular disease such as new york heart association (nyha) ≥ ii, coronary heart disease requiring coronary surgery or known peripheral arterial disease (pavk) ≥ grade 2 sickle cell anemia obesity (body mass index ≥ 30kg/m2) hospitalization at study inclusion administration of immunoglobulins and/or any blood products within 120 days preceding study entry or planned administration during the study period history of blood donation within 30 days of enrolment or planned donations within the study period known hypersensitivity to any of the components included in the covac-1 vaccine

pregnant or lactating females. participation in any clinical study with intake of any investigational drug interfering with the study primary endpoint any concomitant disease affecting the effect of the therapeutic vaccine or interfering with the study primary endpoint any immunosuppressive treatment except low dose corticosteroids (≤10mg prednisolone/day) prior or current infection with sars-cov-2 tested serologically or by throat/nose swab (pcr) history of guillain-barré syndrome positive serological hiv, hepatitis b or c test. in case of positive hbsag, volunteer must provide prove of hepatitis b vaccination, otherwise volunteer must be excluded. history of relevant central nervous system (cns) pathology or current relevant cns pathology (e.g. seizure, paresis, aphasia, cerebrovascular ischemia/hemorrhage, severe brain injuries, dementia, parkinson's disease, cerebellar disease, organic brain syndrome, psychosis, coordination or movement disorder, excluding febrile seizures as child) baseline laboratory with lymphocyte count ≤ 1000/µl only part i and ii: - acute or chronic, clinically significant psychiatric, hematologic, pulmonary, cardiovascular, or hepatic or renal functional abnormality as determined by the investigator based on medical history, physical exam, and/or laboratory screening test all parts of the clinical trial diabetes mellitus typ ii requiring drug treatment chronic lung disease requiring drug treatment any chronic liver disease or unknown liver abnormalities defined as: alanin-aminotransferase (alt) and aspartat-aminotransferase (ast) ≤ 2.5 x uln (upper limit of normal) gamma-glutamyl-transferase (γ-gt) ≤ 2.5 x uln chronic renal failure defined as glomerular filtration rate (gfr) < 40 ml/min/1,73m2 serious pre-existing cardiovascular disease such as new york heart association (nyha) ≥ ii, coronary heart disease requiring coronary surgery or known peripheral arterial disease (pavk) ≥ grade 2 sickle cell anemia obesity (body mass index ≥ 30kg/m2) hospitalization at study inclusion administration of immunoglobulins and/or any blood products within 120 days preceding study entry or planned administration during the study period history of blood donation within 30 days of enrolment or planned donations within the study period known hypersensitivity to any of the components included in the covac-1 vaccine

Oct. 26, 2020, 11:31 p.m. usa

1. pregnant or lactating females. 2. participation in any clinical study with intake of any investigational drug interfering with the study primary endpoint 3. any concomitant disease affecting the effect of the therapeutic vaccine or interfering with the study primary endpoint 4. any immunosuppressive treatment except low dose corticosteroids (≤10mg prednisolone/day) 5. prior or current infection with sars-cov-2 tested serologically or by throat/nose swab (pcr) 6. history of guillain-barré syndrome 7. positive serological hiv, hepatitis b or c test. in case of positive hbsag, volunteer must provide prove of hepatitis b vaccination, otherwise volunteer must be excluded. 8. history of relevant central nervous system (cns) pathology or current relevant cns pathology (e.g. seizure, paresis, aphasia, cerebrovascular ischemia/hemorrhage, severe brain injuries, dementia, parkinson's disease, cerebellar disease, organic brain syndrome, psychosis, coordination or movement disorder, excluding febrile seizures as child) 9. baseline laboratory with lymphocyte count ≤ 1000/µl 10. only part i and ii: - acute or chronic, clinically significant psychiatric, hematologic, pulmonary, cardiovascular, or hepatic or renal functional abnormality as determined by the investigator based on medical history, physical exam, and/or laboratory screening test 11. all parts of the clinical trial - diabetes mellitus typ ii requiring drug treatment - chronic lung disease requiring drug treatment - any chronic liver disease or unknown liver abnormalities defined as: - alanin-aminotransferase (alt) and aspartat-aminotransferase (ast) ≤ 2.5 x uln (upper limit of normal) - gamma-glutamyl-transferase (γ-gt) ≤ 2.5 x uln - chronic renal failure defined as glomerular filtration rate (gfr) < 40 ml/min/1,73m2 - serious pre-existing cardiovascular disease such as new york heart association (nyha) ≥ ii, coronary heart disease requiring coronary surgery or known peripheral arterial disease (pavk) ≥ grade 2 - sickle cell anemia - obesity (body mass index ≥ 30kg/m2) 12. hospitalization at study inclusion 13. administration of immunoglobulins and/or any blood products within 120 days preceding study entry or planned administration during the study period 14. history of blood donation within 30 days of enrolment or planned donations within the study period 15. known hypersensitivity to any of the components included in the covac-1 vaccine

1. pregnant or lactating females. 2. participation in any clinical study with intake of any investigational drug interfering with the study primary endpoint 3. any concomitant disease affecting the effect of the therapeutic vaccine or interfering with the study primary endpoint 4. any immunosuppressive treatment except low dose corticosteroids (≤10mg prednisolone/day) 5. prior or current infection with sars-cov-2 tested serologically or by throat/nose swab (pcr) 6. history of guillain-barré syndrome 7. positive serological hiv, hepatitis b or c test. in case of positive hbsag, volunteer must provide prove of hepatitis b vaccination, otherwise volunteer must be excluded. 8. history of relevant central nervous system (cns) pathology or current relevant cns pathology (e.g. seizure, paresis, aphasia, cerebrovascular ischemia/hemorrhage, severe brain injuries, dementia, parkinson's disease, cerebellar disease, organic brain syndrome, psychosis, coordination or movement disorder, excluding febrile seizures as child) 9. baseline laboratory with lymphocyte count ≤ 1000/µl 10. only part i and ii: - acute or chronic, clinically significant psychiatric, hematologic, pulmonary, cardiovascular, or hepatic or renal functional abnormality as determined by the investigator based on medical history, physical exam, and/or laboratory screening test 11. all parts of the clinical trial - diabetes mellitus typ ii requiring drug treatment - chronic lung disease requiring drug treatment - any chronic liver disease or unknown liver abnormalities defined as: - alanin-aminotransferase (alt) and aspartat-aminotransferase (ast) ≤ 2.5 x uln (upper limit of normal) - gamma-glutamyl-transferase (γ-gt) ≤ 2.5 x uln - chronic renal failure defined as glomerular filtration rate (gfr) < 40 ml/min/1,73m2 - serious pre-existing cardiovascular disease such as new york heart association (nyha) ≥ ii, coronary heart disease requiring coronary surgery or known peripheral arterial disease (pavk) ≥ grade 2 - sickle cell anemia - obesity (body mass index ≥ 30kg/m2) 12. hospitalization at study inclusion 13. administration of immunoglobulins and/or any blood products within 120 days preceding study entry or planned administration during the study period 14. history of blood donation within 30 days of enrolment or planned donations within the study period 15. known hypersensitivity to any of the components included in the covac-1 vaccine