Phase I-II open prospective, two-stage, non-randomized study in healthy volunteers.
Screening Period = up to 7 days All screening procedures must be executed within the shortest possible time frame before the scheduled date for Visit 1 (drug administration). The laboratory and instrumental examination data obtained within 14 days before the screening will be recorded as the screening data. The trial will include 110 volunteers that will be administered the study drug. Outpatient observation will be done over the course of 4 visits: on day 10, 28, and 42 following drug administration Along with that, the study will be continued in accordance with the Protocol, accompanied by all the prescribed procedures and visits up to 180 days of observation. Visit No. 0 (outpatient): screening Visit No. 1 (outpatient): vaccination Visits No. 2, 3, 4, 5, and 8: follow-up on days 10, 28, 42, 90, and180 after vaccination. On days 120 and 150, visits 6 and 7 will be accomplished by telephone contact / telemedicine conference or, if necessary, in the form of an in-person visit. Any volunteer who received a dose of the study drug will be registered as a trial participant, and his/her data will be used to help assess the drug's safety and tolerability.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
110
solution for intramuscular injection Composition for 1 dose (0.5 ml)
ECO-Safety
Saint Petersburg, Russia
Changing of antibody levels against the SARS-CoV-2 glycoprotein S
Determination of antibody levels against the SARS-CoV-2 glycoprotein S measured by an ELISA vs. baseline values
Time frame: at days 0,10, 28, 42, 180
Number of Participants With Adverse Events
Determination of Number of Participants With Adverse Events
Time frame: through the whole study, an average of 180 days
Changing of of virus neutralizing antibody titer
Determination of changing of virus neutralizing antibody titer from baseline scores and at day 28 and 42
Time frame: at days 0, 28, 42
Changing of antigen-specific cellular immunity level
Determination of antigen-specific cellular immunity
Time frame: at days 0, 10
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