CovidResearchTrials by Shray Alag


CovidResearchTrials Covid 19 Research using Clinical Trials (Home Page)


Gam-COVID-VacWiki

Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (2)


Name (Synonyms) Correlation
drug20 1: Usual practice Wiki 1.00
drug31 2: Usual practice + SYMBICORT RAPIHALER Wiki 1.00

Correlated MeSH Terms (4)


Name (Synonyms) Correlation
D012120 Respiration Disorders NIH 0.29
D012140 Respiratory Tract Diseases NIH 0.24
D003141 Communicable Diseases NIH 0.09
D007239 Infection NIH 0.06

Correlated HPO Terms (0)


Name (Synonyms) Correlation

There is one clinical trial.

Clinical Trials


1 An Open Study of the Safety, Tolerability and Immunogenicity of the Drug "Gam-COVID-Vac" a Solution for Intramuscular Injection With the Participation of Healthy Volunteers

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.

NCT04436471 Preventive Immunization COVID-19 Biological: Gam-COVID-Vac

Primary Outcomes

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, 42

Description: Determination of Number of Participants With Adverse Events

Measure: Number of Participants With Adverse Events

Time: through the whole study, an average of 180 days

Secondary Outcomes

Description: Determination of virus neutralizing antibody titer

Measure: Changing of of virus neutralizing antibody titer

Time: at days 0,14, 28, 42

Description: 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


No related HPO nodes (Using clinical trials)