Evaluation of Corfluvec Vaccine for the Prevention of COVID-19 in Healthy Volunteers

The aim of the study is to investigate the safety and immunogenicity of a two-component intranasal vaccine for the prevention of COVID-19 in healthy volunteers 18-60 years old

Inclusion Criteria:Availability of signed informed consentAdult men and women aged 18-60Diagnosed "healthy" according to the data of standard clinical, laboratory and instrumental examination methods, with the absence of clinically significant changesBody Mass Index (BMI): 18.5≤ BMI ≤30 kg/m2HI antibody titers ≤1:20 to influenza A/H1N1pdm09 and A/H3N2 (only for phase 1)Serum antibodies to the SARS-CoV-2 N-protein not higher than 100 BAU/mlThe ability and willingness to make entries in the diary of self-observation, as well as to carry out all the visits foreseen in the study for control medical observationNegative test for alcohol in exhaled airConsent to use effective contraceptive methods throughout their participation in the studyValues of the complete blood count and biochemical blood analysis (during the screening) within 0.9*reference range lower limit and 1,1 * reference range upper limitNegative tests for HIV, hepatitis B, hepatitis C, and syphilisExclusion Criteria:Contact with COVID-19 patients within 14 days prior to the start of the clinical studyPositive rapid test result for SARS-CoV-2 antigenParticipation in another clinical study within three months prior to the start of the current study; planning to participate in another study during the current study period.Immunization with any other non-study vaccine product, including COVID-19 vaccination within four weeks prior to enrollment in the current study, or refusal to postpone such until the end of the four-week period after completion of the current studyRegular use of nasal irrigation therapy during the last six months prior to enrollment in the current study or episodic use of the above method of treatment in the two weeks prior to the screeningHistory of frequent nosebleeds (>5) during the year prior to the current studyClinically significant anatomic pathology or the presence of surgical intervention in the sinus area, paranasal sinuses, or traumatic injuries of the nose within a month before screeningSymptoms of acute respiratory disease, including fever, or other acute illness at the time of screening or within two weeks prior to screeningTreatment with immunoglobulins or other blood derived medications in the three months prior to screening or planning such treatment during the period of participation in the current study; donation of blood/plasma (450 ml or more) less than 2 months prior to screeningThe presence or suspicion of the presence of various immunosuppressive or immunodeficiency conditions or continuous use (the drug was prescribed for more than 14 days without a break) of immunosuppressive drugs, immunomodulators for 6 months before the screeningHistory of bronchial asthmaHypersensitivity and the presence of severe allergic reactions, including Quincke's edema, anaphylactic shock after the previous administration of any vaccineHistory of wheezing after previous immunization with live influenza vaccineOther adverse events after immunization (fever above 40°C, syncope, non-febrile convulsions, anaphylaxis) when there is a minimal likelihood that they are associated with a previous administration of any vaccineSuspicion of hypersensitivity to any component of the study vaccine, including egg proteinSeasonal (in spring or autumn) increased sensitivity to the effects of natural factorsAcute or chronic clinically significant lung, cardiovascular, hepatic, endocrine, neurological, or psychiatric disorders, or impaired renal function identified by history, physical examination, or clinical laboratory findings that, in the opinion of the investigator, may influence the outcome of the studyHistory of leukemia or any other malignant diseases of the blood or solid malignant neoplasms of other organsHistory of thrombocytopenic purpura or bleeding disordersHistory of convulsionsThe presence or suspicion of the presence of various immunosuppressive or immunodeficiency conditions, including HIV infectionTuberculosis or residual changes after tuberculosis according to the anamnesis and / or available medical documentationChronic alcohol dependence or chronic use of illicit drugs, drug abuseClaustrophobia and social phobia according to history and / or available medical recordsFor women of reproductive age - lactation, pregnancy or suspected pregnancy, early postpartum periodPremenopausal women (last menstrual period <1 year prior to signing informed consent) who are not surgically sterile and women who are of reproductive potential but do not use or plan to use valid birth control throughout the study and do not agree to perform a urine pregnancy test while participating in the studyMilitary personnel undergoing military service on conscriptionPersons in custody in pre-trial detention centers and serving sentences in places of deprivation of libertySpecial diet (eg, vegetarian, vegan, salt-restricted) or lifestyle (night work, extreme physical activity)Any condition that, in the opinion of the investigator, may increase the risk to the health of a volunteer participating in the study or affect the results of the study