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

inclusion criteria: 1. healthy men and women aged 18 to 60 years old, inclusive. 2. written informed consent of the volunteer to participate in the clinical trial; 3. bmi within the range of 18.5 ≤ bwi ≤ 30 kg/m2 with the body weight of not less than 55 kg for men, not less than 45 kg for women and not more than 100 kg for volunteers of both sexes. 4. verified "healthy" status: no deviations from reference values of standard clinical, laboratory and instrumental examinations. 5. negative hiv 1\&2, rpr, hвsag and hcv rna tests. 6. hemodynamic and other vital signs are within normal limits (reference intervals are 60-90 beats/min at rest for hr, up to 22 per minute for rr, body temperature from 35.5 to 36.9 °c; systolic blood pressure (sbp) is considered normal in the range of 100-139 mmhg, diastolic blood pressure (dbp) - in the range of 60-89 mmhg); 7. volunteers able to fulfill requirements of the protocol (i.e., fill out the patient's diary, come to follow-up visits); 8. abstinence from alcohol for 14 days before the start of the trial and until the end of participation in the trial; 9. abstinence from smoking for 48 hours before the start of the trial and during hospitalization; 10. for fertile women - a negative result of the pregnancy test and consent to observe adequate methods of contraception during the trial and at least two months after vaccination; 11. for fertile men - consent to observe adequate methods of contraception during the trial and at least two months after vaccination, except for men after vasectomy with documented azoospermia, and their sexual partners should use methods of contraception that ensure more than 90% reliability or be incapable of conception after a surgical sterilization or have a natural menopause for at least 2 years

inclusion criteria: 1. healthy men and women aged 18 to 60 years old, inclusive. 2. written informed consent of the volunteer to participate in the clinical trial; 3. bmi within the range of 18.5 ≤ bwi ≤ 30 kg/m2 with the body weight of not less than 55 kg for men, not less than 45 kg for women and not more than 100 kg for volunteers of both sexes. 4. verified "healthy" status: no deviations from reference values of standard clinical, laboratory and instrumental examinations. 5. negative hiv 1\&2, rpr, hвsag and hcv rna tests. 6. hemodynamic and other vital signs are within normal limits (reference intervals are 60-90 beats/min at rest for hr, up to 22 per minute for rr, body temperature from 35.5 to 36.9 °c; systolic blood pressure (sbp) is considered normal in the range of 100-139 mmhg, diastolic blood pressure (dbp) - in the range of 60-89 mmhg); 7. volunteers able to fulfill requirements of the protocol (i.e., fill out the patient's diary, come to follow-up visits); 8. abstinence from alcohol for 14 days before the start of the trial and until the end of participation in the trial; 9. abstinence from smoking for 48 hours before the start of the trial and during hospitalization; 10. for fertile women - a negative result of the pregnancy test and consent to observe adequate methods of contraception during the trial and at least two months after vaccination; 11. for fertile men - consent to observe adequate methods of contraception during the trial and at least two months after vaccination, except for men after vasectomy with documented azoospermia, and their sexual partners should use methods of contraception that ensure more than 90% reliability or be incapable of conception after a surgical sterilization or have a natural menopause for at least 2 years

Dec. 16, 2021, 2 a.m. usa

inclusion criteria: healthy men and women aged 18 to 60 years old, inclusive. written informed consent of the volunteer to participate in the clinical trial; bmi within the range of 18.5 ≤ bwi ≤ 30 kg/m2 with the body weight of not less than 55 kg for men, not less than 45 kg for women and not more than 100 kg for volunteers of both sexes. verified "healthy" status: no deviations from reference values of standard clinical, laboratory and instrumental examinations. negative hiv 1&2, rpr, hвsag and hcv rna tests. hemodynamic and other vital signs are within normal limits (reference intervals are 60-90 beats/min at rest for hr, up to 22 per minute for rr, body temperature from 35.5 to 36.9 °c; systolic blood pressure (sbp) is considered normal in the range of 100-139 mmhg, diastolic blood pressure (dbp) - in the range of 60-89 mmhg); volunteers able to fulfill requirements of the protocol (i.e., fill out the patient's diary, come to follow-up visits); abstinence from alcohol for 14 days before the start of the trial and until the end of participation in the trial; abstinence from smoking for 48 hours before the start of the trial and during hospitalization; for fertile women - a negative result of the pregnancy test and consent to observe adequate methods of contraception during the trial and at least two months after vaccination; for fertile men - consent to observe adequate methods of contraception during the trial and at least two months after vaccination, except for men after vasectomy with documented azoospermia, and their sexual partners should use methods of contraception that ensure more than 90% reliability or be incapable of conception after a surgical sterilization or have a natural menopause for at least 2 years

inclusion criteria: healthy men and women aged 18 to 60 years old, inclusive. written informed consent of the volunteer to participate in the clinical trial; bmi within the range of 18.5 ≤ bwi ≤ 30 kg/m2 with the body weight of not less than 55 kg for men, not less than 45 kg for women and not more than 100 kg for volunteers of both sexes. verified "healthy" status: no deviations from reference values of standard clinical, laboratory and instrumental examinations. negative hiv 1&2, rpr, hвsag and hcv rna tests. hemodynamic and other vital signs are within normal limits (reference intervals are 60-90 beats/min at rest for hr, up to 22 per minute for rr, body temperature from 35.5 to 36.9 °c; systolic blood pressure (sbp) is considered normal in the range of 100-139 mmhg, diastolic blood pressure (dbp) - in the range of 60-89 mmhg); volunteers able to fulfill requirements of the protocol (i.e., fill out the patient's diary, come to follow-up visits); abstinence from alcohol for 14 days before the start of the trial and until the end of participation in the trial; abstinence from smoking for 48 hours before the start of the trial and during hospitalization; for fertile women - a negative result of the pregnancy test and consent to observe adequate methods of contraception during the trial and at least two months after vaccination; for fertile men - consent to observe adequate methods of contraception during the trial and at least two months after vaccination, except for men after vasectomy with documented azoospermia, and their sexual partners should use methods of contraception that ensure more than 90% reliability or be incapable of conception after a surgical sterilization or have a natural menopause for at least 2 years