• Medical staff of clinics and polyclinics
• A history of severe acute respiratory syndrome (SARS) or Middle East respiratory syndrome (MERS) orother coronavirus infection
• History of contacts with confirmed or suspected cases of SARS-CoV-2 infection within 1 month
• Positive IgM or IgG to SARS-CoV-2, found at screening (for volunteers of Phases I and II)
• Positive PCR test for SARS-CoV-2 at screening
• Clinically and/or laboratory (according to PCR) confirmed disease with SARS-CoV-2 coronavirus at thecurrent time or in history
• Serious post-vaccination reaction (temperature above 40 C, hyperemia or edema more than 8 cm indiameter) or complication (collapse or shock-like state that developed within 48 hours after vaccination
• convulsions, accompanied or not accompanied by a febrile state) to any previous vaccination in history
• Aggravated allergic history (anaphylactic shock, Quincke's edema, polymorphic exudative eczema,atopy, history of serum sickness, history of hypersensitivity or allergic reactions to the administration ofany vaccines, known allergic reactions to vaccine components, etc.)
• History of Guillain-Barré syndrome (acute polyradiculitis)
• Previous vaccination with rabies vaccines less than 2 months before immunization or plannedvaccination with rabies vaccines within 1 month after immunization with investigational vaccines
• Vaccination with any other vaccine within 1 month preceding vaccination
• A history of leukemia, tuberculosis, cancer, autoimmune diseases
• Positive blood test for HIV, syphilis, hepatitis B/C
• Volunteers who received immunoglobulin preparations or blood transfusions within the last 3 monthsprior to the start of the study based on the history
• Long-term use (more than 14 days) of immunosuppressants or other immunomodulatory drugs duringthe six months preceding the study, according to the history
• Any history of any confirmed or suspected immunosuppressive or immunodeficient condition
• Chronic diseases of the cardiovascular, bronchopulmonary, neuroendocrine systems, gastrointestinaltract, liver, kidneys, hematopoietic, immune systems, mental illness in exacerbation stage ordecompensation stage (recovery earlier than 4 weeks before vaccination) in history
• Disorder of blood clotting, a tendency to thrombosis in the anamnesis
• Progressive neurological pathology, a history of convulsive syndrome
• Diabetes mellitus, hyperthyroidism or other endocrine diseases in history
• Treatment with glucocorticosteroids, including low doses, as well as topical use of drugs containingsteroids (> 10 mg prednisolone, or an equivalent, for more than 14 days in the last three months)
• According to the anamnesis, the volunteer was/is registered in a tuberculosis dispensary and/or anarcological dispensary and/or a neuropsychiatric dispensary and/or others
• Acute infectious diseases (recovery earlier than 4 weeks before vaccination) according to the history
• Taking more than 10 units of alcohol per week or anamnestic information about alcoholism, drugaddiction, or drug abuse
• Smoking more than 10 cigarettes a day
• Participation in any other clinical study within the last 3 months
• Pregnancy or breastfeeding
• Axillary temperature at the time of vaccination is more than 37.0 °C
• Body mass index less than 18 or more than 28 kg/m2
• Serious concomitant diseases or pathological conditions not listed above, which, according to theinvestigator, could complicate the evaluation of the study results, including pathological deviations fromthe age norms and laboratory norms of blood and urine parameters, clinically significant, according tothe investigator

Protocol

NR

Statistical plan

*

Data-sharing stated: Unclear
Data accessibility: “All data produced in the present work are contained in the manuscript”. C corresponding author: Ilya V Gordeychuk, gordeychuk_iv@chumakovs.su