Immunogenicity, Efficacy and Safety Trial of the Convacell Vaccine in Healthy Volunteers Aged 18 Years and Older

Exclusion Criteria

• •History of influenza or acute respiratory viral infection (ARVI) within 2 months before the start of the trial;
• •A serious post-vaccination reaction (temperature above 40 °C, hyperemia or edema more than 8 cm in diameter) or complications (collapse or shock-like condition that developed within 48 hours after vaccination; convulsions accompanied or not accompanied by a fever due to any previous vaccination);
• •Fever, cough, and shortness of breath within 30 days before vaccination;
• •History of COVID-19 within 6 months before screening;
• •The level of IgG antibodies to the SARS-CoV-2 N-protein according to semi-quantitative test (Architect, Abbott) ≥ 3 (positivity rate) at screening;
• •Positive result of the COVID-19 PCR test or antigen COVID-19 test (rapid test);
• •Body temperature ≥ 37,3°C.
• •History of allergies;
• •Any vaccination within 30 days before the screening;
• •History of leukemia, tuberculosis, cancer, autoimmune diseases;
• •History of Quincke's edema;
• •Positive blood test results for HIV, syphilis, hepatitis B/C according to the examination during the screening period (only for Stage IIb) or according to the history (for Stage III). It is acceptable to use the results of previously performed tests, if their prescription does not exceed 60 days before the date of the screening or based on history;
• •Volunteers who received immunoglobulin during the last three months before the trial;
• •History of long-term use (more than 14 days) of immunosuppressants or other immunomodulatory drugs for six months before the trial;
• •Treatment with glucocorticosteroids, including in small doses, as well as local use of drugs containing steroids (\> 10 mg of prednisolone or its equivalent for more than 14 days before the screening);
• •History of any confirmed or suspected immunosuppressive or immunodeficiency condition;
• •History of splenectomy;
• •History of chronic diseases of the cardiovascular, bronchopulmonary, neuroendocrine systems, the gastrointestinal tract, liver, kidneys, hematopoietic or immune systems, mental disease in the acute stage or in the decompensation stage (according to history and / or examination on the screening);
• •Transfusion of blood or blood components within 4 months before screening;
• •Any acute infectious diseases during the screening period or past illnesses within 3 months before the screening visit, any chronic infectious diseases in the acute stage during the screening period;
• •Consumption of more than 10 units of alcohol per week or history of alcohol addiction, drug addiction or abuse of pharmaceutical products;
• •Smoking of more than 10 cigarettes per day;
• •Participation in another clinical trial within the last 90 days;
• •Pregnancy or lactation;
• •Coagulopathy, hemophilia, bleeding disorder;
• •Participation in previous clinical trials of the Convacell vaccine, a subunit recombinant vaccine for the prevention of coronavirus infection caused by SARS-CoV-2 virus, or any other vaccines to prevent coronavirus infection caused by the virus SARS-CoV-2 for 6 months before screening;
• •History of anticovid plasma use;
• •Vaccination against COVID-19 within 6 months before screening.