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

1. laboratory confirmed sars-cov-2 infection, defined by rt-pcr test. 2. fever (oral temperature ≥ 37.5°c/axillary temperature ≥ 37.3°c) on the day of vaccination or within recent 72 hours. 3. medical history of severe acute respiratory syndrome (sars), middle east respiratory syndrome (mers) within 12 months, and covid-19 within 3 months prior to enrollment. 4. abnormal laboratory tests of clinical significance involving hematology, serum biochemistry, coagulation function, or urinalysis as determined by the investigator. 5. females who are pregnant or breastfeeding or those who plan to give birth in coming 12 months (including in female subjects or the female partners of male subjects). 6. participated in other clinical trials and received any other investigational products within 1 month (or 5 half-lives of the drug, whichever is longer) prior to enrollment or plan to receive any other investigational products during the study. 7. history of severe allergies to any vaccine or drug, such as urticaria, dyspnea, edema, abdominal pain and other symptoms after administration, especially hypersensitivity to the components of iccov. 8. have malignant tumor (except for skin basal cell carcinoma or carcinoma uterine cervix in situ) and immune disease (e.g., human immunodeficiency virus \[hiv\] infection, systemic lupus erythematosus, rheumatoid arthritis, asplenia or splenectomy, severe combined immunodeficiency disorder \[scid\], and other immune disease that may influence immune response at the investigator's discretion). 9. have other severe and/or uncontrolled conditions, including but not limited to, acute infectious disease, cardiovascular disease, respiratory disease, gastrointestinal disease, liver disease, renal disease, hematology disease, endocrine disorder, psychiatric condition and neurological illness (e.g., guillain-barre syndrome, uncontrolled epilepsy, etc.). mild/moderate well-controlled comorbidities are allowed to participate as deemed appropriate by the investigator. 10. received any investigational or licensed covid-19 vaccine other than described in inclusion criteria, or any investigational or approved vaccine against a coronavirus (including but not limited to sars-cov-1 and mers-cov) at any time prior to enrollment. 11. received any investigational or approved vaccines within 3 months prior to enrollment or plan to receive any other vaccines during the study. 12. received any blood products or immunoglobulin products within 3 months prior to enrollment or plan to receive that during the study. 13. received interferon, systemic corticosteroids, or other immunosuppressants/ immunomodulators (except for local application) for 14 or more consecutive days within 6 months prior to enrollment. 14. medical history or clinical manifestations of any physical or mental illness that may affect the subject's completion of this study. 15. needle phobia. 16. have contraindications for intramuscular administration, such as confirmed thrombocytopenia, any coagulation dysfunction, or being receiving anticoagulation therapy. 17. have contraindications for electroporation, such as implanted with pacemaker, implanted with automatic implantable cardioverter defibrillator (aicd), or abnormal electrocardiogram at screening as determined by the investigator. 18. any other conditions considered by the investigator as not suitable to participate in this study.

1. laboratory confirmed sars-cov-2 infection, defined by rt-pcr test. 2. fever (oral temperature ≥ 37.5°c/axillary temperature ≥ 37.3°c) on the day of vaccination or within recent 72 hours. 3. medical history of severe acute respiratory syndrome (sars), middle east respiratory syndrome (mers) within 12 months, and covid-19 within 3 months prior to enrollment. 4. abnormal laboratory tests of clinical significance involving hematology, serum biochemistry, coagulation function, or urinalysis as determined by the investigator. 5. females who are pregnant or breastfeeding or those who plan to give birth in coming 12 months (including in female subjects or the female partners of male subjects). 6. participated in other clinical trials and received any other investigational products within 1 month (or 5 half-lives of the drug, whichever is longer) prior to enrollment or plan to receive any other investigational products during the study. 7. history of severe allergies to any vaccine or drug, such as urticaria, dyspnea, edema, abdominal pain and other symptoms after administration, especially hypersensitivity to the components of iccov. 8. have malignant tumor (except for skin basal cell carcinoma or carcinoma uterine cervix in situ) and immune disease (e.g., human immunodeficiency virus \[hiv\] infection, systemic lupus erythematosus, rheumatoid arthritis, asplenia or splenectomy, severe combined immunodeficiency disorder \[scid\], and other immune disease that may influence immune response at the investigator's discretion). 9. have other severe and/or uncontrolled conditions, including but not limited to, acute infectious disease, cardiovascular disease, respiratory disease, gastrointestinal disease, liver disease, renal disease, hematology disease, endocrine disorder, psychiatric condition and neurological illness (e.g., guillain-barre syndrome, uncontrolled epilepsy, etc.). mild/moderate well-controlled comorbidities are allowed to participate as deemed appropriate by the investigator. 10. received any investigational or licensed covid-19 vaccine other than described in inclusion criteria, or any investigational or approved vaccine against a coronavirus (including but not limited to sars-cov-1 and mers-cov) at any time prior to enrollment. 11. received any investigational or approved vaccines within 3 months prior to enrollment or plan to receive any other vaccines during the study. 12. received any blood products or immunoglobulin products within 3 months prior to enrollment or plan to receive that during the study. 13. received interferon, systemic corticosteroids, or other immunosuppressants/ immunomodulators (except for local application) for 14 or more consecutive days within 6 months prior to enrollment. 14. medical history or clinical manifestations of any physical or mental illness that may affect the subject's completion of this study. 15. needle phobia. 16. have contraindications for intramuscular administration, such as confirmed thrombocytopenia, any coagulation dysfunction, or being receiving anticoagulation therapy. 17. have contraindications for electroporation, such as implanted with pacemaker, implanted with automatic implantable cardioverter defibrillator (aicd), or abnormal electrocardiogram at screening as determined by the investigator. 18. any other conditions considered by the investigator as not suitable to participate in this study.

June 16, 2023, 8 a.m. usa

laboratory confirmed sars-cov-2 infection, defined by rt-pcr test. fever (oral temperature ≥ 37.5°c/axillary temperature ≥ 37.3°c) on the day of vaccination or within recent 72 hours. medical history of severe acute respiratory syndrome (sars), middle east respiratory syndrome (mers) within 12 months, and covid-19 within 3 months prior to enrollment. abnormal laboratory tests of clinical significance involving hematology, serum biochemistry, coagulation function, or urinalysis as determined by the investigator. females who are pregnant or breastfeeding or those who plan to give birth in coming 12 months (including in female subjects or the female partners of male subjects). participated in other clinical trials and received any other investigational products within 1 month (or 5 half-lives of the drug, whichever is longer) prior to enrollment or plan to receive any other investigational products during the study. history of severe allergies to any vaccine or drug, such as urticaria, dyspnea, edema, abdominal pain and other symptoms after administration, especially hypersensitivity to the components of iccov. have malignant tumor (except for skin basal cell carcinoma or carcinoma uterine cervix in situ) and immune disease (e.g., human immunodeficiency virus [hiv] infection, systemic lupus erythematosus, rheumatoid arthritis, asplenia or splenectomy, severe combined immunodeficiency disorder [scid], and other immune disease that may influence immune response at the investigator's discretion). have other severe and/or uncontrolled conditions, including but not limited to, acute infectious disease, cardiovascular disease, respiratory disease, gastrointestinal disease, liver disease, renal disease, hematology disease, endocrine disorder, psychiatric condition and neurological illness (e.g., guillain-barre syndrome, uncontrolled epilepsy, etc.). mild/moderate well-controlled comorbidities are allowed to participate as deemed appropriate by the investigator. received any investigational or licensed covid-19 vaccine other than described in inclusion criteria, or any investigational or approved vaccine against a coronavirus (including but not limited to sars-cov-1 and mers-cov) at any time prior to enrollment. received any investigational or approved vaccines within 3 months prior to enrollment or plan to receive any other vaccines during the study. received any blood products or immunoglobulin products within 3 months prior to enrollment or plan to receive that during the study. received interferon, systemic corticosteroids, or other immunosuppressants/ immunomodulators (except for local application) for 14 or more consecutive days within 6 months prior to enrollment. medical history or clinical manifestations of any physical or mental illness that may affect the subject's completion of this study. needle phobia. have contraindications for intramuscular administration, such as confirmed thrombocytopenia, any coagulation dysfunction, or being receiving anticoagulation therapy. have contraindications for electroporation, such as implanted with pacemaker, implanted with automatic implantable cardioverter defibrillator (aicd), or abnormal electrocardiogram at screening as determined by the investigator. any other conditions considered by the investigator as not suitable to participate in this study.

laboratory confirmed sars-cov-2 infection, defined by rt-pcr test. fever (oral temperature ≥ 37.5°c/axillary temperature ≥ 37.3°c) on the day of vaccination or within recent 72 hours. medical history of severe acute respiratory syndrome (sars), middle east respiratory syndrome (mers) within 12 months, and covid-19 within 3 months prior to enrollment. abnormal laboratory tests of clinical significance involving hematology, serum biochemistry, coagulation function, or urinalysis as determined by the investigator. females who are pregnant or breastfeeding or those who plan to give birth in coming 12 months (including in female subjects or the female partners of male subjects). participated in other clinical trials and received any other investigational products within 1 month (or 5 half-lives of the drug, whichever is longer) prior to enrollment or plan to receive any other investigational products during the study. history of severe allergies to any vaccine or drug, such as urticaria, dyspnea, edema, abdominal pain and other symptoms after administration, especially hypersensitivity to the components of iccov. have malignant tumor (except for skin basal cell carcinoma or carcinoma uterine cervix in situ) and immune disease (e.g., human immunodeficiency virus [hiv] infection, systemic lupus erythematosus, rheumatoid arthritis, asplenia or splenectomy, severe combined immunodeficiency disorder [scid], and other immune disease that may influence immune response at the investigator's discretion). have other severe and/or uncontrolled conditions, including but not limited to, acute infectious disease, cardiovascular disease, respiratory disease, gastrointestinal disease, liver disease, renal disease, hematology disease, endocrine disorder, psychiatric condition and neurological illness (e.g., guillain-barre syndrome, uncontrolled epilepsy, etc.). mild/moderate well-controlled comorbidities are allowed to participate as deemed appropriate by the investigator. received any investigational or licensed covid-19 vaccine other than described in inclusion criteria, or any investigational or approved vaccine against a coronavirus (including but not limited to sars-cov-1 and mers-cov) at any time prior to enrollment. received any investigational or approved vaccines within 3 months prior to enrollment or plan to receive any other vaccines during the study. received any blood products or immunoglobulin products within 3 months prior to enrollment or plan to receive that during the study. received interferon, systemic corticosteroids, or other immunosuppressants/ immunomodulators (except for local application) for 14 or more consecutive days within 6 months prior to enrollment. medical history or clinical manifestations of any physical or mental illness that may affect the subject's completion of this study. needle phobia. have contraindications for intramuscular administration, such as confirmed thrombocytopenia, any coagulation dysfunction, or being receiving anticoagulation therapy. have contraindications for electroporation, such as implanted with pacemaker, implanted with automatic implantable cardioverter defibrillator (aicd), or abnormal electrocardiogram at screening as determined by the investigator. any other conditions considered by the investigator as not suitable to participate in this study.