Created at Source Raw Value Validated value
March 27, 2022, 4 p.m. usa

individuals who meet any of the following criteria below will be excluded from the study (ineligible). i. participation in another experimental protocol and/or receipt of any investigational product within the last 3 months prior to screening; ii. individuals infected with sars-cov-2 confirmed by rt-pcr; iii. treatment with immunosuppressive drugs (e.g., oral or injectable steroidal anti-inflammatory drugs, such as prednisone, or high-dose inhalation) or cytotoxic therapies (e.g., chemotherapeutic drugs or radiation) within the last 6 months prior to screening; iv. individuals who have received transfusion of blood, plasma, or immunoglobulins in the last 3 months prior to screening; v. donation of blood products (platelets, whole blood, plasma, etc.) in the last month before screening (1 month before screening); vi. received any vaccinations in the last month before screening or have any immunizations planned during the study, with the exception of seasonal influenza vaccine, which can be given after 30 days after the second injection of the study; vii. individuals who have been immunized with any vaccine for sars-cov-2 at any time who have neutralizing antibody titers greater than 40% in plasma samples tested at 1:40 dilution; viii. history of autoimmune disease or other causes of immunosuppressive states; ix. history of any other acute or chronic disease (including cardiovascular, pulmonary, neurological, hepatic, rheumatic, hematological, metabolic or renal disorders, uncontrolled hypertension) or use of medications that, in the opinion of the principal investigator, may interfere with the safety or immunogenicity evaluation of the vaccine; x. skin rash, tattoos or any other dermatological condition that may adversely affect the vaccine injection site or interfere with its evaluation; xi. bmi ≥ 32; xii. hypertension (systolic > 150 or diastolic > 95); xiii. history of significant psychiatric illness with current medication use; xiv. known or suspected alcohol or drug abuse in the last 6 months prior to screening; xv. chronic tobacco user (> 20 packs/year); xvi. individuals with a history of prior anaphylaxis or severe allergic reaction to unknown vaccines or allergens; xvii. individuals unlikely to cooperate with the requirements of the study protocol.

individuals who meet any of the following criteria below will be excluded from the study (ineligible). i. participation in another experimental protocol and/or receipt of any investigational product within the last 3 months prior to screening; ii. individuals infected with sars-cov-2 confirmed by rt-pcr; iii. treatment with immunosuppressive drugs (e.g., oral or injectable steroidal anti-inflammatory drugs, such as prednisone, or high-dose inhalation) or cytotoxic therapies (e.g., chemotherapeutic drugs or radiation) within the last 6 months prior to screening; iv. individuals who have received transfusion of blood, plasma, or immunoglobulins in the last 3 months prior to screening; v. donation of blood products (platelets, whole blood, plasma, etc.) in the last month before screening (1 month before screening); vi. received any vaccinations in the last month before screening or have any immunizations planned during the study, with the exception of seasonal influenza vaccine, which can be given after 30 days after the second injection of the study; vii. individuals who have been immunized with any vaccine for sars-cov-2 at any time who have neutralizing antibody titers greater than 40% in plasma samples tested at 1:40 dilution; viii. history of autoimmune disease or other causes of immunosuppressive states; ix. history of any other acute or chronic disease (including cardiovascular, pulmonary, neurological, hepatic, rheumatic, hematological, metabolic or renal disorders, uncontrolled hypertension) or use of medications that, in the opinion of the principal investigator, may interfere with the safety or immunogenicity evaluation of the vaccine; x. skin rash, tattoos or any other dermatological condition that may adversely affect the vaccine injection site or interfere with its evaluation; xi. bmi ≥ 32; xii. hypertension (systolic > 150 or diastolic > 95); xiii. history of significant psychiatric illness with current medication use; xiv. known or suspected alcohol or drug abuse in the last 6 months prior to screening; xv. chronic tobacco user (> 20 packs/year); xvi. individuals with a history of prior anaphylaxis or severe allergic reaction to unknown vaccines or allergens; xvii. individuals unlikely to cooperate with the requirements of the study protocol.

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

participation in another experimental protocol and/or receipt of any investigational products within the past 3 months prior to screening. individuals infected with sars-cov-2 confirmed by rt-pcr or previously exposed to sars-cov-2 infection confirmed by detection of total igg antibodies by elisa; treatment with immunosuppressive drugs (e.g., oral or injected steroids, such as prednisone; high dose inhaled steroids) or cytotoxic therapies (e.g., chemotherapy drugs or radiation) in the past 6 months prior to screening history of blood, plasma or immunogloblulin transfusion within past 3 months prior to screening. donation of blood products (platelets, whole blood, plasma, etc.) in the last month before screening (1 month before screening) . received any vaccinations in the last month before screening or have any immunizations planned during the study, with the exception of seasonal influenza vaccine, which can be given after 30 days after the second injection of the study. participants who have been immunized with any vaccine for sars-cov-2 (or other covid-19 prevention treatment) at any time; history of autoimmune disease or other causes of immunosuppressive states. history of any other acute or chronic illness (including cardiovascular, pulmonary, neurological, hepatic, rheumatic, hematological, metabolic or renal disorders, uncontrolled hypertension), or use of medication that, in the opinion of the principal investigator, may interfere with the evaluation of the safety or immunogenicity of the vaccine. skin rash, tattoos, or any other dermatological condition that could adversely affect the vaccine injection site or interfere with its evaluation. bmi ≥ 32. hypertension (systolic > 150 or diastolic > 95). history of significant psychiatric illness with current use of medication. known or suspected alcohol or drug abuse within the past 6 months prior to screening. chronic tobacco user (> 20 pack years). individuals with a history of previous anaphylaxis or severe allergic reaction to unknown vaccines or allergens. individuals unlikely to cooperate with the requirements of the study protocol.

participation in another experimental protocol and/or receipt of any investigational products within the past 3 months prior to screening. individuals infected with sars-cov-2 confirmed by rt-pcr or previously exposed to sars-cov-2 infection confirmed by detection of total igg antibodies by elisa; treatment with immunosuppressive drugs (e.g., oral or injected steroids, such as prednisone; high dose inhaled steroids) or cytotoxic therapies (e.g., chemotherapy drugs or radiation) in the past 6 months prior to screening history of blood, plasma or immunogloblulin transfusion within past 3 months prior to screening. donation of blood products (platelets, whole blood, plasma, etc.) in the last month before screening (1 month before screening) . received any vaccinations in the last month before screening or have any immunizations planned during the study, with the exception of seasonal influenza vaccine, which can be given after 30 days after the second injection of the study. participants who have been immunized with any vaccine for sars-cov-2 (or other covid-19 prevention treatment) at any time; history of autoimmune disease or other causes of immunosuppressive states. history of any other acute or chronic illness (including cardiovascular, pulmonary, neurological, hepatic, rheumatic, hematological, metabolic or renal disorders, uncontrolled hypertension), or use of medication that, in the opinion of the principal investigator, may interfere with the evaluation of the safety or immunogenicity of the vaccine. skin rash, tattoos, or any other dermatological condition that could adversely affect the vaccine injection site or interfere with its evaluation. bmi ≥ 32. hypertension (systolic > 150 or diastolic > 95). history of significant psychiatric illness with current use of medication. known or suspected alcohol or drug abuse within the past 6 months prior to screening. chronic tobacco user (> 20 pack years). individuals with a history of previous anaphylaxis or severe allergic reaction to unknown vaccines or allergens. individuals unlikely to cooperate with the requirements of the study protocol.

Aug. 5, 2021, 2:30 p.m. usa

1. participation in another experimental protocol and/or receipt of any investigational products within the past 3 months prior to screening. 2. individuals infected with sars-cov-2 confirmed by rt-pcr or previously exposed to sars-cov-2 infection confirmed by detection of total igg antibodies by elisa; 3. treatment with immunosuppressive drugs (e.g., oral or injected steroids, such as prednisone; high dose inhaled steroids) or cytotoxic therapies (e.g., chemotherapy drugs or radiation) in the past 6 months prior to screening 4. history of blood, plasma or immunogloblulin transfusion within past 3 months prior to screening. 5. donation of blood products (platelets, whole blood, plasma, etc.) in the last month before screening (1 month before screening) . 6. received any vaccinations in the last month before screening or have any immunizations planned during the study, with the exception of seasonal influenza vaccine, which can be given after 30 days after the second injection of the study. 7. participants who have been immunized with any vaccine for sars-cov-2 (or other covid-19 prevention treatment) at any time; 8. history of autoimmune disease or other causes of immunosuppressive states. 9. history of any other acute or chronic illness (including cardiovascular, pulmonary, neurological, hepatic, rheumatic, hematological, metabolic or renal disorders, uncontrolled hypertension), or use of medication that, in the opinion of the principal investigator, may interfere with the evaluation of the safety or immunogenicity of the vaccine. 10. skin rash, tattoos, or any other dermatological condition that could adversely affect the vaccine injection site or interfere with its evaluation. 11. bmi ≥ 32. 12. hypertension (systolic > 150 or diastolic > 95). 13. history of significant psychiatric illness with current use of medication. 14. known or suspected alcohol or drug abuse within the past 6 months prior to screening. 15. chronic tobacco user (> 20 pack years). 16. individuals with a history of previous anaphylaxis or severe allergic reaction to unknown vaccines or allergens. 17. individuals unlikely to cooperate with the requirements of the study protocol.

1. participation in another experimental protocol and/or receipt of any investigational products within the past 3 months prior to screening. 2. individuals infected with sars-cov-2 confirmed by rt-pcr or previously exposed to sars-cov-2 infection confirmed by detection of total igg antibodies by elisa; 3. treatment with immunosuppressive drugs (e.g., oral or injected steroids, such as prednisone; high dose inhaled steroids) or cytotoxic therapies (e.g., chemotherapy drugs or radiation) in the past 6 months prior to screening 4. history of blood, plasma or immunogloblulin transfusion within past 3 months prior to screening. 5. donation of blood products (platelets, whole blood, plasma, etc.) in the last month before screening (1 month before screening) . 6. received any vaccinations in the last month before screening or have any immunizations planned during the study, with the exception of seasonal influenza vaccine, which can be given after 30 days after the second injection of the study. 7. participants who have been immunized with any vaccine for sars-cov-2 (or other covid-19 prevention treatment) at any time; 8. history of autoimmune disease or other causes of immunosuppressive states. 9. history of any other acute or chronic illness (including cardiovascular, pulmonary, neurological, hepatic, rheumatic, hematological, metabolic or renal disorders, uncontrolled hypertension), or use of medication that, in the opinion of the principal investigator, may interfere with the evaluation of the safety or immunogenicity of the vaccine. 10. skin rash, tattoos, or any other dermatological condition that could adversely affect the vaccine injection site or interfere with its evaluation. 11. bmi ≥ 32. 12. hypertension (systolic > 150 or diastolic > 95). 13. history of significant psychiatric illness with current use of medication. 14. known or suspected alcohol or drug abuse within the past 6 months prior to screening. 15. chronic tobacco user (> 20 pack years). 16. individuals with a history of previous anaphylaxis or severe allergic reaction to unknown vaccines or allergens. 17. individuals unlikely to cooperate with the requirements of the study protocol.

April 16, 2021, 12:31 a.m. usa

1. participation in another experimental protocol and/or receipt of any investigational products within the past 3 months prior to screening. 2. treatment with immunosuppressive drugs (e.g., oral or injected steroids, such as prednisone; high dose inhaled steroids) or cytotoxic therapies (e.g., chemotherapy drugs or radiation) in the past 6 months prior to screening (except for participants who were diagnosed with covid-19 and received corticosteroids as an anti-inflammatory for more than 3 weeks). 3. received a blood transfusion within past 3 months prior to screening. 4. donated blood products (platelets, whole blood, plasma, etc.) within past one month prior to screening. 5. received any vaccine within past 1 month prior to screening or have any planned immunizations while on study, with the exception of seasonal influenza vaccine which can be given after 1 month post the second study injection. 6. history of autoimmune disease or other causes of immunosuppressive states. 7. history of any other acute or chronic illness (including cardiovascular, pulmonary, neurological, hepatic, rheumatic, hematological, metabolic or renal disorders, uncontrolled hypertension), or use of medication that, in the opinion of the principal investigator, may interfere with the evaluation of the safety or immunogenicity of the vaccine. 8. rash, tattoos, or any other dermatological condition that could adversely affect the vaccine injection site or interfere with its evaluation. 9. bmi ≥ 32. 10. hypertension (systolic > 150 or diastolic > 95). 11. history of significant psychiatric illness with current use of medication. 12. known or suspected alcohol or drug abuse within the past 6 months prior to screening. 13. chronic tobacco user (> 20 pack years). 14. subjects with a history of previous anaphylaxis or severe allergic reaction to vaccines or unknown allergens. 15. subjects who are unlikely to cooperate with the requirements of the study protocol. -

1. participation in another experimental protocol and/or receipt of any investigational products within the past 3 months prior to screening. 2. treatment with immunosuppressive drugs (e.g., oral or injected steroids, such as prednisone; high dose inhaled steroids) or cytotoxic therapies (e.g., chemotherapy drugs or radiation) in the past 6 months prior to screening (except for participants who were diagnosed with covid-19 and received corticosteroids as an anti-inflammatory for more than 3 weeks). 3. received a blood transfusion within past 3 months prior to screening. 4. donated blood products (platelets, whole blood, plasma, etc.) within past one month prior to screening. 5. received any vaccine within past 1 month prior to screening or have any planned immunizations while on study, with the exception of seasonal influenza vaccine which can be given after 1 month post the second study injection. 6. history of autoimmune disease or other causes of immunosuppressive states. 7. history of any other acute or chronic illness (including cardiovascular, pulmonary, neurological, hepatic, rheumatic, hematological, metabolic or renal disorders, uncontrolled hypertension), or use of medication that, in the opinion of the principal investigator, may interfere with the evaluation of the safety or immunogenicity of the vaccine. 8. rash, tattoos, or any other dermatological condition that could adversely affect the vaccine injection site or interfere with its evaluation. 9. bmi ≥ 32. 10. hypertension (systolic > 150 or diastolic > 95). 11. history of significant psychiatric illness with current use of medication. 12. known or suspected alcohol or drug abuse within the past 6 months prior to screening. 13. chronic tobacco user (> 20 pack years). 14. subjects with a history of previous anaphylaxis or severe allergic reaction to vaccines or unknown allergens. 15. subjects who are unlikely to cooperate with the requirements of the study protocol. -