The purpose of this study: to assess the safety, tolerability and immunogenicity of the drug "Gam-COVID-Vac", a solution for intramuscular injection, at various times after vaccination in volunteers over 60 years of age
An open-ended prospective non-randomized study involving volunteers over the age of 60. The study will include 110 volunteers. who will receive the test drug according to the prime-boost scheme: the introduction of component 1 will be carried out on the 1st day, and component 2 - on the 21st day of the study. Outpatient monitoring will be performed during 4 visits: on the 7th, 14th, 28th, and 42nd days after the vaccine administration Also two visits will be performed in the phone contact mode for 90 and 180 days
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
110
combined vector vaccine, 0,5ml/dose+0,5 ml/dose prime-boost immunization in days 1 (component I rAd26-S) and 21(component II rAd5-S)
Federal state budgetary institution "Central clinical hospital with polyclinic" Of the office Of the President of the Russian Federation
Moscow, Russia
Changing of antibody levels against the SARS-CoV-2 glycoprotein S in 42 days
Determination of antibody levels against the SARS-CoV-2 glycoprotein S measured by an ELISA vs. baseline values
Time frame: at days 0, 21, 28, 42
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 virus neutralizing antibody titer
Time frame: at days 0, 28, 42
Changing of antigen-specific cellular immunity level
Determination of antigen-specific cellular immunity
Time frame: Time Frame: at days 0,28
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