An Open Study on the Safety, Tolerability, and Immunogenicity of "Sputnik Light" Vaccine

Exclusion Criteria

• •1. Any vaccination / immunization performed within 14 days prior to enrollment in the study, or a planned vaccination within 14 days after being administered the study drug;
• •2. Steroid therapy (except hormonal contraceptives or drugs used as hormone replacement therapy for menopause) that has not been completed 30 days before enrollment;
• •3. Therapy with immunoglobulins or other blood products not completed 30 days before enrollment in the trial
• •4. Immunosuppressor therapy that was completed within 3 months before being included in the trial
• •5. A vaccination against COVID-2019 using any other drugs, including in the course of other clinical studies
• •6. Female subjects during pregnancy or breastfeeding (for women with preserved reproductive potential);
• •7. Acute coronary syndrome or stroke suffered less than one year before enrolling in the trial
• •8. Tuberculosis, chronic systemic infections;
• •9. Complicated allergic history (severe life-threatening allergic reactions), hypersensitivity or allergic reactions to the introduction of immunobiological drugs, known allergic reactions to the components of the drug, exacerbation of allergic diseases on the day of enrolling in the trial;
• •10. Neoplasms in a person's medical history (ICD codes C00-D09);
• •11. Donated blood or plasma (450+ ml) within 2 months before enrollment;
• •12. Splenectomy in the person's medical history;
• •13. Neutropenia (absolute neutrophil count \<1,000 mm3), agranulocytosis, significant blood loss, severe anemia (hemoglobin \<80 g/L), immunodeficiency in the medical history within 6 months before the enrollment;
• •14. Active form of a disease caused by the human immunodeficiency virus, syphilis, hepatitis B or C;
• •15. Anorexia, protein deficiency of any origin;
• •16. Large tattoos at the injection site (deltoid muscle area), which does not allow assessing the localized response to administering the study drug/placebo
• •17. Alcohol or drug addiction in the person's medical history;
• •18. Registered with a psychiatrist
• •19. Participation in any other interventional clinical Trial within 90 days before the start of this trial
• •20. Any other condition that the researching physician considers to be a hindrance to completing the trial as per the protocol;
• •21. Research facility staff and other employees directly involved in the trial (research team members) and their families.
• •22. Any related conditions that, in the opinion of the study physician, could serve as a hindrance to participating in the trial.