The purpose of this study is to evaluate immunogenicity, epidemiological efficacy and safety of medicinal product GamEvac-Combi - Combined Vector-Based Vaccine against Ebola Virus Disease, 0.5 ml+0.5 ml/dose
This clinical trial is designed as a double blind randomized placebo-controlled study to evaluate immunogenicity of medicinal product GamEvac-Combi - Combined Vector-Based Vaccine against Ebola Virus Disease, 0.5 ml+0.5 ml/dose. The study includes three periods: screening, administration of the investigated product and follow-up. Vaccine will be administered to groups of volunteers (each group will include not more than 40 volunteers at a time; a new group of volunteers cannot be hospitalized before the earlier vaccinated volunteers are discharged from the hospital. In total, 8 visits will be held, including a screening visit; two of the visits will take place during the inpatient stage and six - during the outpatient observation. Study design in the both facilities will be the same for all volunteers, except that the biomaterial collected for immunogenicity evaluation from volunteers included in the study in the Russian Federation will be delivered directly to the testing laboratory; biomaterial from volunteers included in the study in the Republic of Guinea will undergo primary specimen processing, be frozen and stored under the assigned temperature conditions in the research center and, as biomaterial is accumulated, it will be transported in a fridge to the study site. In addition, laboratory tests for such concomitant infectious diseases, as yellow fever, Denge fever, Ebola and Marburg virus diseases will be carried out for epidemiological indications (i.e. in the endemic regions if disease cases are reported).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
2,000
vaccination
vaccination
Centre de recherche en épidémiologie, microbiologie et de soins médicaux (CREMS) de Pastoria à Kindia
Kindia, Guinea
Infectious Disease Clinical Hospital No. 1 of the Moscow Healthcare Department
Moscow, Russia
determination of immunity duration by ELISA method
immunity duration determination by ELISA method includes time points in which the assessment of the immunity response (antibody titer) should be provided (21, 28, 42 days and 3, 6, 12 months after the vaccination respectively)
Time frame: the total Time Frame is 12 month after the vaccination
assessment of antigen-specific cell-mediated immune response
determination of specific T-cell- mediated response to Ebola virus proteins vs. baseline values and placebo
Time frame: on days 0 and 28
determination of immunity duration in virus neutralization reaction
Determination of the immunity duration will be provided by the assessment of the neutralizing antibody titer for a virus in virus neutralization reaction vs. baseline values and placebo
Time frame: on days 0 and 42
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