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 adenoviral-based vaccine against MERS - BVRS-GamVac.
Two-stage, open-dose, prospective, double-blind, randomized, placebo-controlled study in parallel groups The study will include volunteers of both sexes, aged 18-55 years inclusive. The study will involve 162 (will receive the study drug or placebo) healthy volunteers, of which the first stage, it is planned to vaccinate 40 person with the studied drug (at the same time, the participation of 8 spares \*), at the second phase - 122 people, of whom 88 will receive the study drug, and 34 will make up the control group of observation - they will be given a placebo drug. \* Volunteers are replaced by spares before the introduction of the drug, if the volunteer took the drug, then its replacement is not performed. Any volunteer who received a dose of the test drug 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
SINGLE
Enrollment
162
a vector vaccine for the prevention of the Middle East respiratory syndrome, lyophilisate for the preparation of a solution for intramuscular administration
placebo
Research Institute of Influenza
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: at days 0, 7, 14, 21, 28, 42, 56 and 90
Assessment of antigen-specific cell-mediated immune response
determination of specific T-cell- mediated response vs. baseline values (phase 1, phase 2) and placebo (phase 2)
Time frame: at 0 and 14 days from the start of vaccination compared to baseline values (day 0)
Neutralizing antibody levels
Determination of the neutralizing antibody titer for a virus in virus neutralization reaction vs. baseline values
Time frame: at days 0, 14 and 28
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