A Double-blind Randomized Placebo-controlled Study of Safety and Immunogenicity of GamEvac-Lyo

Inclusion Criteria: * males and females within the age range from 18 to 55 years; * written informed consent; * subject body mass index (BMI): 18.5 ≤ BMI ≤ 30 * subject agrees to use effective contraceptive methods during the entire period of participation in the study (one of the following methods will be used: sexual abstinence; condoms (male or female with or without spermicidal agent); diaphragm or cervical cap with spermicidal agent; intrauterine device); * absence of severe allergic diseases in the medical history (anaphylactic shock, Quincke's edema, polymorphic exudative eczema, serum disease) * absence of allergic diseases relapses * absence of acute infectious diseases/relapses of chronic diseases at the time of vaccine administration and 7 days prior to the vaccination * no serious post-vaccination complications in patient's history following the earlier administration of immunobiological products * in medical history and based on the screening results, subject has no diseases of the gastrointestinal system, liver, kidneys, cardiovascular system, CNS, locomotion system, urogenital and endocrine systems that could affect the assessment of the study results * subject has a negative result of the blood or urine pregnancy test (for females of childbearing age) * subject has negative tests for HIV, hepatitis B and С, syphilis * subject has a negative result of the urine test for residual narcotic drugs * subject has no hematopoietic malignancies * subject has no malignant neoplasms * indicators of complete blood count test at a screening visit are not heigher/lower from 1,1\*ULN/LLN (upper limit of normal/lower limit of normal) * indicators of clinical biochemical analysis at a screening visit: blood urea nitrogen, creatinine, glutamic-pyruvic transaminase, glutamate-oxaloacetate-transaminase, blood glucose test, creatinkinase, total protein, bilirubin are not heigher/lower from 1,1\*ULN/LLN (upper limit of normal/lower limit of normal). Total cholesterol level from 3,6 mmol/L to 7,8 mmol/L. * absence of inflammatory or dystrophic myocardial changes based on ECG data. * absence of previous immunization with any vaccine against Ebola virus disease based on medical history data and during clinical trials as well Exclusion Criteria: * volunteer involvement in another study over the last 90 days * any immunization with vaccine over the last 30 days * presence of a concomitant illness in decompensation stage which might affect the course of the study (CNS organic lesion, decompensated cardiovascular diseases, any manifestations of kidney or acute liver failure, oncological diseases, diabetes mellitus) * subject has systolic blood pressure less than 100 mm Hg or greater than 139 mm Hg; diastolic blood pressure less than 60 mm Hg or greater than 90 mm Hg; heart rate lower than 60 beats per minute or above 90 beats per minute * any clinically significant laboratory abnormalities * subject has received treatment with steroids for the last 10 days * subject has received immunoglobulins or other blood products over the last 3 months * patient unwillingness to participate in the study * blood donation (at least 450 ml of blood or plasma) by subject in less than 2 months prior to the start of the study * subject has a history of the consumption of more than 5 units (0.25 l of pure alcohol) a week or drug abuse * subject smokes more than 10 cigarettes a day * positive results of urine test for narcotic drug residues * positive result of breath alcohol test (in the expired air sample) * subject has no ability to understand or follow the Protocol instructions * patient unwillingness to follow the procedures * pregnancy or breast feeding * subject has received immunosuppressive and/or immunomodulating agents within 6 months prior to the start of the study * history of regular injection or intranasal drug use; injection or intranasal drug use at the present time * subject has experienced symptoms of respiratory disease for the last 3 days * subject has exacerbation of allergic diseases or history of anaphylactic reactions or angioneurotic edema * previous history of hypersensitivity or allergic reactions to the administration of any vaccines * allergic reactions to the vaccine components