The Middle East respiratory syndrome coronavirus (MERS-CoV) was identified in 2012 during the first Middle East respiratory syndrome (MERS) outbreak. MERS-CoV causes an acute lower-respiratory infection in humans, with a fatality rate of \~34.5%. The aim of the study is to assess the safety and immunogenicity of heterologous adenoviral-based vaccine against MERS - BVRS-GamVac-Combi.
The study will include volunteers of both sexes, aged 18-55 years inclusive. The study will involve 268 (will receive the vaccine or placebo) healthy volunteers. At the first stage, it is planned: * study the safety of component 1 - 40 volunteers and 4 spares \* * study the safety of prime-boost vaccination with component 1 and component 2 with an interval of 21 days in half and full dose - 40 volunteers and 4 spares \* At the second phase, it is planned to study the safety and immunogenicity of the vaccine as part of a placebo-controlled randomized trial - 188 people, of whom 138 will receive the vaccine, and 50 will make up the control group of observation - they will be given a placebo. Data from 20 volunteers from the first phase who received the drug in selected dose will be included in the analysis of safety and immunogenicity of the second phase. * Volunteers are replaced by spares before the introduction of the drug, if the volunteer took the drug, then the replacement is not performed. Any volunteer who received a dose of the vaccine will be considered as included in the study, the data available on it will be used in assessing the safety and tolerability of the drug.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
268
"BVRS-GamVac-Combi", a combined vector vaccine for the prevention of Middle East respiratory syndrome, lyophilisate for the preparation of a solution for intramuscular administration
placebo
ECO-Safety
Saint Petersburg, Russia
RECRUITINGNumber of Participants With Adverse Events
Determination of Number of Participants With Adverse Events
Time frame: through the whole study, an average of 180 days
Number of Participants With Serious Adverse Events
Determination of Number of Participants With Serious Adverse Events
Time frame: through the whole study, an average of 180 days
Number of Participants with Solicited Local and Systemic Adverse Events
Determination of Number of Participants with Solicited Local and Systemic Adverse Events
Time frame: through the whole study, an average of 180 days
Antibody levels against the MERS-CoV glycoprotein S measured by an enzyme-linked immunosorbent assay (ELISA)
Determination of antibody levels against the MERS-CoV glycoprotein S measured by an ELISA vs. baseline values (phase 1, phase 2) and placebo (phase 2)
Time frame: Time Frame for group 1 phase 1: at days 0, 7, 14, 21, 28, 42, 56 and 90. Time Frame for group 2 phase 1 and phase 2: at days 0, 7, 14, 21, 28, 35, 42, 56 and 90
Assessment of antigen-specific cell-mediated immune response
determination of specific T-cell- mediated response vs. baseline values and placebo
Time frame: at 0, 14 and 28 days from the start of vaccination compared to baseline values (phase 1, phase 2) and placebo (phase 2)
Neutralizing antibody levels
Determination of the neutralizing antibody titer for a virus in virus neutralization reaction vs. baseline values and placebo
Time frame: at days 0, 14 and 28 from the start of vaccination compared to baseline values
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