Clinical Trial of Efficacy, Safety, and Immunogenicity of Gam-COVID-Vac Vaccine Against COVID-19 (RESIST)
Covid19 Prevention
About this trial
This is an interventional prevention trial for Covid19 Prevention focused on measuring COVID-19, vector vaccine, SARS-CoV-2, adenoviral vector
Eligibility Criteria
Inclusion Criteria:
- Written informed consent of a subject to participate in the trial
- Males and females aged ≥18 y.o.;
- Negative HIV, hepatitis, and syphilis test results
- Negative anti-SARS CoV2 IgM and IgG antibodies test carried out with the enzyme immunoassay method
- Negative COVID-2019 PCR test result at the screening visit
- No COVID-2019 in the past medical history
- No contact with COVID-2019 diseased persons within at least 14 days before the enrollment (according to trial subjects)
- Consent to use effective contraception methods during the trial
- Negative urine pregnancy test at the screening visit (for child-bearing age women)
- Negative drugs or psychostimulants urine test at the screening visit
- Negative alcohol test at the screening visit
- No evident vaccine-induced reactions or complications after receiving immunobiological products in the past medical history
- No acute infectious and/or respiratory diseases within at least 14 days before the enrollment.
Exclusion Criteria:
- Any vaccination/immunization within 30 days before the enrollment;
- Steroids (except hormonal contraceptives) and/or immunoglobulins or other blood products therapy not finished 30 days before the enrollment
- Immunosuppressors therapy finished within 3 months before the enrollment
- Pregnancy or breast-feeding
- Acute coronary syndrome or stroke suffered less than one year before the enrollment
- Tuberculosis, chronic systemic infections
- Drug allergy (anaphylactic shock, Quincke's edema, polymorphic exudative eczema, atopy, serum disease), hypersensitivity or allergic reaction to immunobiological products, known allergic reactions to study drug components, acute exacerbation of allergic diseases on the enrollment day
- Neoplasms in the past medical history (ICD codes C00-D09)
- Donated blood or plasma (450+ ml) within 2 months before the enrollment
- History of splenectomy;
- Neutropenia (absolute neutrophil count <1,000/mm3), agranulocytosis, significant blood loss, severe anemia (hemoglobin <80 g/L), immunodeficiency in the past medical history within 6 months before the enrollment
- Active form of a disease caused by the human immunodeficiency virus, syphilis, hepatitis B or C
- Anorexia, protein deficiency of any origin
- Big-size tattoos at the injection site (deltoid muscle area), which does not allow assessing the local response to the study drug/placebo administration
- Alcohol or drug addiction in the past medical history
- Participation in any other interventional clinical trial
- Any other condition that the study physician considers as a barrier to the trial completion as per the protocol
- Study center staff or other employees directly involved in the trial, or their families.
If a subject has any contraindications to vaccination based on the Guidelines on Detection, Investigation and Prevention, of Vaccination-induced Side Reactions (approved by the Ministry of Healthcare of Russia on Apr. 12, 2019, the vaccination may be postponed for a period of time specified in the document.
Sites / Locations
- ARCHIMED V Clinic of new medical technologies limited liability company
- Hadassah LTD
- Medsi Group of companies joint-stock company"
- Niarmedic Plus
- State budgetary healthcare institution of the city of Moscow "City clinical hospital No. 52 of the Moscow city health Department"
- State Budgetary Healthcare Institution, Moscow, Consultation and Diagnosis Polyclinic No. 121, Moscow Healthcare Department
- State Budgetary Healthcare Institution, Moscow, M. Konchalovsky Municipal Clinical Hospital, Moscow Healthcare Department
- State Budgetary Healthcare Institution, Moscow, M. Zhadkevich Municipal Clinical Hospital, Moscow Healthcare Department
- State Budgetary Healthcare Institution, Moscow, Municipal Polyclinic No. 115, Moscow Healthcare Department
- State Budgetary Healthcare Institution, Moscow, Municipal Polyclinic No. 2, Moscow Healthcare Department
- State Budgetary Healthcare Institution, Moscow, Municipal Polyclinic No. 210, Moscow Healthcare Department
- State Budgetary Healthcare Institution, Moscow, Municipal Polyclinic No. 212, Moscow Healthcare Department
- State Budgetary Healthcare Institution, Moscow, Municipal Polyclinic No. 219, Moscow Healthcare Department
- State Budgetary Healthcare Institution, Moscow, Municipal Polyclinic No. 220, Moscow Healthcare Department
- State Budgetary Healthcare Institution, Municipal Polyclinic No. 62, Moscow Healthcare Department
- State budgetary institution of health care of the city of Moscow " city polyclinic No. 109 Of the Department of health of the city of Moscow"
- State budgetary institution of health care of the city of Moscow " city polyclinic No. 170 Of the Department of health of the city of Moscow"
- State budgetary institution of health care of the city of Moscow " city polyclinic No. 36 Of the Department of health of the city of Moscow"
- State budgetary institution of health care of the city of Moscow " city polyclinic No. 46 Of the Department of health of the city of Moscow"
- State budgetary institution of health care of the city of Moscow " city polyclinic No. 6 Of the Department of health of the city of Moscow"
- State budgetary institution of health care of the city of Moscow " city polyclinic No. 68 Of the Department of health of the city of Moscow"
- State budgetary institution of health care of the city of Moscow "Diagnostic center No. 5 with polyclinic Department Of the Department of health of the city of Moscow"
- State budgetary institution of health care of the city of Moscow "Diagnostic clinical center No. 1 Of the Department of health of the city of Moscow"
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Primary Group
Control Group
Gam-COVID-Vac combined vector vaccine, 0,5ml/dose+0,5 ml/dose prime-boost immunization in days 1 (component I rAd26-S) and 21(component II rAd5-S)
placebo, 0,5ml/dose+0,5 ml/dose immunization in days 1 and 21