Name (Synonyms) | Correlation | |
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drug20 | 1: Usual practice Wiki | 1.00 |
drug31 | 2: Usual practice + SYMBICORT RAPIHALER Wiki | 1.00 |
Name (Synonyms) | Correlation | |
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D012120 | Respiration Disorders NIH | 0.29 |
D012140 | Respiratory Tract Diseases NIH | 0.24 |
D003141 | Communicable Diseases NIH | 0.09 |
D007239 | Infection NIH | 0.06 |
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There is one clinical trial.
The purpose of the study is to assess safety, tolerability and immunogenicity of the drug "Gam-COVID-Vac ", a solution for intramuscular administration, with the participation of healthy volunteers Study objectives A safety and tolerability assessment of the drug "Gam-COVID-Vac ", solution for intramuscular administration, using single dose of each component (Stage 1). A safety and tolerability assessment of the drug "Gam-COVID-Vac ", solution for intramuscular administration, using prime-boost immunization according to the proposed scheme (Stage 2). Post-vaccination immunity assessment at different time points after vaccination by: - Determination of antigen-specific antibody titer in blood serum by ELISA by comparison with baseline values before the vaccine administration and at days 14, 21, 28, and 42 after vaccination (hereinafter, the countdown comes from the first time of the vaccine administration); - Determination of virus neutralizing antibody titer before and at days 14, 28, and 42 after vaccination; - Determination of antigen-specific cellular immunity (specific T-cell immunity) before the vaccine administration and at days 14 and 28 after vaccination.
Description: Determination of antibody levels against the SARS-CoV-2 glycoprotein S measured by an ELISA vs. baseline values
Measure: Changing ofantibody levels against the SARS-CoV-2 glycoprotein S in 42 days Time: at days 0,14, 21, 28, 42Description: Determination of Number of Participants With Adverse Events
Measure: Number of Participants With Adverse Events Time: through the whole study, an average of 180 daysDescription: Determination of virus neutralizing antibody titer
Measure: Changing of of virus neutralizing antibody titer Time: at days 0,14, 28, 42Description: Determination of antigen-specific cellular immunity (specific T-cell immunityin particular, IFN-gamma production or lymphoproliferation)
Measure: Changing of antigen-specific cellular immunity level Time: at days 0,14, 42