Created at Source Raw Value Validated value
June 1, 2023, 4 a.m. irct

Provides written informed consent prior to initiation of any study procedures Be able to understand the purpose and risks of the study and willing and able to comply with planned study procedures and be available for all study visits Agrees to perform all study procedures, including the collection of venous blood per protocol 18 to 50 years of age, inclusive Body Mass Index 18-35 kg/m2 Women of childbearing potential must agree to use a reliable method of contraception from the time of enrollment until sixty days after receiving the intervention and negative urine or serum pregnancy test within 24 hours prior to intervention administration Male subjects of childbearing potential with a female partner of childbearing potential agree to use effective contraception from intervention through 60 days after Male subjects agree to refrain from sperm donation from the time of intervention through 60 days after In good health as determined by medical history and physical examination and the opinion of the principal investigator Has received 3 doses of inactivated Sinopharm or COVIran Barekat vaccine and the time interval from receiving the last dose of vaccine to receiving clinical study intervention at least 90 days and maximum 18 months, vaccination history must be checked and approved through the vaccination record Normal vital signs at the screening visit and at the time of intervention including: temperature less than 38.0 °C; pulse no greater than 100 beats per minute; systolic blood pressure 90 to 140 mmHg and diastolic blood pressure 60 to 90 mmHg; Oxygen saturation≥ 95%; respiration rate 12 to 20 BPM Clinical screening laboratory evaluations (WBC, Hgb, PLTs, ALT, AST, BUN, Cr, ALP, T.Bili, Lipase, PT, PTT, TSH, T4, FBS, and CRP) are within acceptable normal reference ranges Agree to refrain from donating blood or plasma during the study (outside of this study)

Provides written informed consent prior to initiation of any study procedures Be able to understand the purpose and risks of the study and willing and able to comply with planned study procedures and be available for all study visits Agrees to perform all study procedures, including the collection of venous blood per protocol 18 to 50 years of age, inclusive Body Mass Index 18-35 kg/m2 Women of childbearing potential must agree to use a reliable method of contraception from the time of enrollment until sixty days after receiving the intervention and negative urine or serum pregnancy test within 24 hours prior to intervention administration Male subjects of childbearing potential with a female partner of childbearing potential agree to use effective contraception from intervention through 60 days after Male subjects agree to refrain from sperm donation from the time of intervention through 60 days after In good health as determined by medical history and physical examination and the opinion of the principal investigator Has received 3 doses of inactivated Sinopharm or COVIran Barekat vaccine and the time interval from receiving the last dose of vaccine to receiving clinical study intervention at least 90 days and maximum 18 months, vaccination history must be checked and approved through the vaccination record Normal vital signs at the screening visit and at the time of intervention including: temperature less than 38.0 °C; pulse no greater than 100 beats per minute; systolic blood pressure 90 to 140 mmHg and diastolic blood pressure 60 to 90 mmHg; Oxygen saturation≥ 95%; respiration rate 12 to 20 BPM Clinical screening laboratory evaluations (WBC, Hgb, PLTs, ALT, AST, BUN, Cr, ALP, T.Bili, Lipase, PT, PTT, TSH, T4, FBS, and CRP) are within acceptable normal reference ranges Agree to refrain from donating blood or plasma during the study (outside of this study)

Feb. 8, 2023, 4:24 a.m. irct

Provides written informed consent prior to initiation of any study procedures Be able to understand the purpose and risks of the study and willing and able to comply with planned study procedures and be available for all study visits Agrees to perform all study procedures, including the collection of venous blood per protocol 18 to 50 years of age, inclusive Body Mass Index 18-35 kg/m2 Women of childbearing potential must agree to use a reliable method of contraception from the time of enrollment until sixty days after receiving the intervention and negative urine or serum pregnancy test within 24 hours prior to intervention administration Male subjects of childbearing potential with a female partner of childbearing potential agree to use effective contraception from intervention through 60 days after Male subjects agree to refrain from sperm donation from the time of intervention through 60 days after In good health as determined by medical history and physical examination and the opinion of the principal investigator Has received 3 doses of Sinopharm vaccine and the time interval from receiving the last dose of Sinopharm vaccine to receiving clinical study intervention at least 90 days and maximum 12 months, vaccination history must be checked and approved through the vaccination record Normal vital signs at the screening visit and at the time of intervention including: temperature less than 38.0 °C; pulse no greater than 100 beats per minute; systolic blood pressure 90 to 140 mmHg and diastolic blood pressure 60 to 90 mmHg; Oxygen saturation≥ 95%; respiration rate 12 to 16 BPM Clinical screening laboratory evaluations (WBC, Hgb, PLTs, ALT, AST, BUN, Cr, ALP, T.Bili, Lipase, PT, PTT, TSH, T4, FBS, and CRP) are within acceptable normal reference ranges Agree to refrain from donating blood or plasma during the study (outside of this study)

Provides written informed consent prior to initiation of any study procedures Be able to understand the purpose and risks of the study and willing and able to comply with planned study procedures and be available for all study visits Agrees to perform all study procedures, including the collection of venous blood per protocol 18 to 50 years of age, inclusive Body Mass Index 18-35 kg/m2 Women of childbearing potential must agree to use a reliable method of contraception from the time of enrollment until sixty days after receiving the intervention and negative urine or serum pregnancy test within 24 hours prior to intervention administration Male subjects of childbearing potential with a female partner of childbearing potential agree to use effective contraception from intervention through 60 days after Male subjects agree to refrain from sperm donation from the time of intervention through 60 days after In good health as determined by medical history and physical examination and the opinion of the principal investigator Has received 3 doses of Sinopharm vaccine and the time interval from receiving the last dose of Sinopharm vaccine to receiving clinical study intervention at least 90 days and maximum 12 months, vaccination history must be checked and approved through the vaccination record Normal vital signs at the screening visit and at the time of intervention including: temperature less than 38.0 °C; pulse no greater than 100 beats per minute; systolic blood pressure 90 to 140 mmHg and diastolic blood pressure 60 to 90 mmHg; Oxygen saturation≥ 95%; respiration rate 12 to 16 BPM Clinical screening laboratory evaluations (WBC, Hgb, PLTs, ALT, AST, BUN, Cr, ALP, T.Bili, Lipase, PT, PTT, TSH, T4, FBS, and CRP) are within acceptable normal reference ranges Agree to refrain from donating blood or plasma during the study (outside of this study)