Covid19 Prevention Clinical Trial
— RESISTOfficial title:
Randomized Double-blind Placebo-controlled Multi-center Clinical Trial in Parallel Assignment of Efficacy, Safety, and Immunogenicity of Gam-COVID-Vac Combined Vector Vaccine in SARS-СoV-2 Infection Prophylactic Treatment
Randomized, double-blind (blinded for the trial subject and the study physician), placebo controlled, multi-center clinical trial in parallel assignment of efficacy, immunogenicity, and safety of the Gam-COVID-Vac combined vector vaccine against the SARS-CoV-2-induced coronavirus infection in adults in the SARS-СoV-2 infection prophylactic treatment.
| Status | Active, not recruiting |
| Enrollment | 33758 |
| Est. completion date | May 1, 2021 |
| Est. primary completion date | May 1, 2021 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years to 111 Years |
| Eligibility | Inclusion Criteria: 1. Written informed consent of a subject to participate in the trial 2. Males and females aged =18 y.o.; 3. Negative HIV, hepatitis, and syphilis test results 4. Negative anti-SARS CoV2 IgM and IgG antibodies test carried out with the enzyme immunoassay method 5. Negative COVID-2019 PCR test result at the screening visit 6. No COVID-2019 in the past medical history 7. No contact with COVID-2019 diseased persons within at least 14 days before the enrollment (according to trial subjects) 8. Consent to use effective contraception methods during the trial 9. Negative urine pregnancy test at the screening visit (for child-bearing age women) 10. Negative drugs or psychostimulants urine test at the screening visit 11. Negative alcohol test at the screening visit 12. No evident vaccine-induced reactions or complications after receiving immunobiological products in the past medical history 13. No acute infectious and/or respiratory diseases within at least 14 days before the enrollment. Exclusion Criteria: 1. Any vaccination/immunization within 30 days before the enrollment; 2. Steroids (except hormonal contraceptives) and/or immunoglobulins or other blood products therapy not finished 30 days before the enrollment 3. Immunosuppressors therapy finished within 3 months before the enrollment 4. Pregnancy or breast-feeding 5. Acute coronary syndrome or stroke suffered less than one year before the enrollment 6. Tuberculosis, chronic systemic infections 7. 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 8. Neoplasms in the past medical history (ICD codes C00-D09) 9. Donated blood or plasma (450+ ml) within 2 months before the enrollment 10. History of splenectomy; 11. 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 12. Active form of a disease caused by the human immunodeficiency virus, syphilis, hepatitis B or C 13. Anorexia, protein deficiency of any origin 14. Big-size tattoos at the injection site (deltoid muscle area), which does not allow assessing the local response to the study drug/placebo administration 15. Alcohol or drug addiction in the past medical history 16. Participation in any other interventional clinical trial 17. Any other condition that the study physician considers as a barrier to the trial completion as per the protocol 18. 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. |
| Country | Name | City | State |
|---|---|---|---|
| Russian Federation | ARCHIMED V Clinic of new medical technologies limited liability company | Moscow | |
| Russian Federation | Hadassah LTD | Moscow | |
| Russian Federation | Medsi Group of companies joint-stock company" | Moscow | |
| Russian Federation | Niarmedic Plus | Moscow | |
| Russian Federation | State budgetary healthcare institution of the city of Moscow "City clinical hospital No. 52 of the Moscow city health Department" | Moscow | |
| Russian Federation | State Budgetary Healthcare Institution, Moscow, Consultation and Diagnosis Polyclinic No. 121, Moscow Healthcare Department | Moscow | |
| Russian Federation | State Budgetary Healthcare Institution, Moscow, M. Konchalovsky Municipal Clinical Hospital, Moscow Healthcare Department | Moscow | |
| Russian Federation | State Budgetary Healthcare Institution, Moscow, M. Zhadkevich Municipal Clinical Hospital, Moscow Healthcare Department | Moscow | |
| Russian Federation | State Budgetary Healthcare Institution, Moscow, Municipal Polyclinic No. 115, Moscow Healthcare Department | Moscow | |
| Russian Federation | State Budgetary Healthcare Institution, Moscow, Municipal Polyclinic No. 2, Moscow Healthcare Department | Moscow | |
| Russian Federation | State Budgetary Healthcare Institution, Moscow, Municipal Polyclinic No. 210, Moscow Healthcare Department | Moscow | |
| Russian Federation | State Budgetary Healthcare Institution, Moscow, Municipal Polyclinic No. 212, Moscow Healthcare Department | Moscow | |
| Russian Federation | State Budgetary Healthcare Institution, Moscow, Municipal Polyclinic No. 219, Moscow Healthcare Department | Moscow | |
| Russian Federation | State Budgetary Healthcare Institution, Moscow, Municipal Polyclinic No. 220, Moscow Healthcare Department | Moscow | |
| Russian Federation | State Budgetary Healthcare Institution, Municipal Polyclinic No. 62, Moscow Healthcare Department | Moscow | |
| Russian Federation | 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" | Moscow | |
| Russian Federation | 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" | Moscow | |
| Russian Federation | 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" | Moscow | |
| Russian Federation | 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" | Moscow | |
| Russian Federation | 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" | Moscow | |
| Russian Federation | 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" | Moscow | |
| Russian Federation | 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" | Moscow | |
| Russian Federation | 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" | Moscow |
| Lead Sponsor | Collaborator |
|---|---|
| Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation | CRO: Crocus Medical BV, Government of the city of Moscow |
Russian Federation,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | percentage of trial subjects with coronavirus disease 2019 (COVID-19) developed within 6 months after the first dose | Demonstrate the superiority of Gam-COVID-Vac combined vector vaccine against the SARS-CoV-2-induced coronavirus infection compared to placebo, based on the percentage of trial subjects with coronavirus disease 2019 (COVID-19) developed within 6 months after the second dose of the study drug/placebo, as confirmed with the method of polymerase chain reaction (PCR) | through the whole study, an average of 180 days | |
| Secondary | the severity of the clinical course of COVID-19 | Assess the efficacy of the Gam-COVID-Vac combined vector vaccine against the SARS-CoV-2-induced coronavirus compared to placebo, based on the severity of the clinical course of COVID-19 | through the whole study, an average of 180 days | |
| Secondary | Changing of antibody levels against the SARS-CoV-2 glycoprotein S | Assess the immunogenicity of the Gam-COVID-Vac combined vector vaccine against the SARS-CoV-2-induced coronavirus infection compared to placebo, based on the geometric mean titer of SARS-CoV-2 glycoprotein-specific antibodies | day before injecting the first dose of the study drug/placebo and 42±2 and 180±14 days after the first dose | |
| Secondary | Changing of antigen-specific cellular immunity level | Describe the strength of cell-mediated immune response induced by the use of the Gam-COVID-Vac combined vector vaccine against the SARS-CoV-2-induced coronavirus infection compared to placebo | the drug administration day before injecting the first dose of the study drug/placebo and 28±2 days after the first dose | |
| Secondary | Changing of of virus neutralizing antibody titer | Geometric mean virus-neutralizing antibodies titer | the drug administration day before injecting the first dose of the study drug/placebo and 42±2 days after the first dose | |
| Secondary | Incidence of adverse events in trial subjects | Incidence of adverse events in trial subjects compared to placebo | through the whole study, an average of 180 days | |
| Secondary | Severity of adverse events in trial subjects | Severity of adverse events in trial subjects compared to placebo | through the whole study, an average of 180 days | |
| Secondary | estimation of the proportion of study subjects with antibodies to the N-protein of the virus SARS-CoV-2 | Percentage of study subjects with antibodies to the N-protein of the SARS - CoV-2 virus that appeared after vaccination |
day before injecting the first dose of the study drug/placebo and 42±2 and 180±14 days after the first dose |