Study of Safety and Immunogenicity of BVRS-GamVac-Combi

Exclusion Criteria

• •1. Volunteer participation in any other study over the past 90 days;
• •2. Any vaccination in the last 30 days;
• •3. Acute infectious and non-infectious diseases, exacerbations of chronic diseases within 4 weeks prior to screening;
• •4. subject has received treatment with steroids for the last 10 days;
• •5. subject has received immunoglobulins or other blood products over the last 3 months;
• •6. subject has received immunosuppressive and/or immunomodulating agents within 6 months prior to the start of the study;
• •7. Pregnancy or lactation;
• •8. subject has systolic blood pressure less than 100 mm Hg or greater than 139 mm Hg; diastolic blood pressure less than 60 mm Hg or greater than 90 mm Hg; heart rate lower than 60 beats per minute or above 100 beats per minute;
• •9. A burdened allergic history (anaphylactic shock, Quincke's edema, polymorphic exudative eczema, atopy, a history of serum sickness, hypersensitivity or allergic reactions to the introduction of any vaccines in history, known allergic reactions to vaccine components, etc.);
• •10. Diabetes mellitus or other forms of impaired glucose tolerance;
• •11. presence of a concomitant illness in decompensation stage which might affect the course of the study (CNS organic lesion, decompensated cardiovascular diseases, any manifestations of kidney or acute liver failure, oncological diseases, diabetes mellitus);
• •12. subject has a a history of neoplasms (ICD codes C00-D09);
• •13. blood donation (at least 450 ml of blood or plasma) by subject in less than 2 months prior to the start of the study;
• •14. Reception of narcotic and psychostimulating drugs at present or in the anamnesis;
• •15. subject has a history of the consumption of more than 5 units alcohol per week, alcohol intake within 48 hours before the injection of the test drug;
• •16. subject smokes more than 10 cigarettes a day;
• •17. subject has a planned hospitalization and / or surgery during the period of participation in the study, as well as 4 weeks before the estimated date of vaccination.
• •18. subject has any condition that, according to the researcher's doctor, may be a contraindication to participation in the study.