Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Total specific anti-SARS-CoV-2 antibodies |
The proportion of the volunteers with an increased level of the total specific anti-SARS-CoV-2 antibodies by 4 times or more (ELISA test) |
21 days after the second administration of the study drug/placebo |
|
Primary |
Total specific anti-SARS-CoV-2 antibodies |
The proportion of the volunteers with an increased level of the total specific anti-SARS-CoV-2 antibodies by 4 times or more (ELISA test) |
90±5 days after the first administration of the study drug/placebo |
|
Primary |
Neutralizing anti-SARS-CoV-2 antibodies |
The proportion of the volunteers tested positive for the presence of neutralizing anti-SARS-CoV-2 antibodies (SARS-CoV-2 Surrogate Virus Neutralization Test) |
21 days after the second administration of the study drug/placebo |
|
Primary |
Neutralizing anti-SARS-CoV-2 antibodies |
The proportion of the volunteers tested positive for the presence of neutralizing anti-SARS-CoV-2 antibodies (SARS-CoV-2 Surrogate Virus Neutralization Test) |
90±5 days after the first administration of the study drug/placebo |
|
Primary |
Adverse events |
The proportion of the volunteers with any adverse events |
Within 50 days of the first dose of the study drug/placebo |
|
Primary |
Severe adverse events |
The proportion of the volunteers with severe adverse events |
Within 50 days of the first dose of the study drug/placebo |
|
Secondary |
Total specific anti-SARS-CoV-2 antibodies |
The proportion of the volunteers with an increased level of the total specific anti-SARS-CoV-2 antibodies by 4 times or more (ELISA test) |
180±5 days after the first administration of the study drug/placebo |
|
Secondary |
IgG-specific anti-SARS-CoV-2 antibodies |
The proportion of the volunteers with an increased level of the IgG-specific anti-SARS-CoV-2 antibodies by 4 times or more (ELISA test) |
21 days after the second administration of the study drug/placebo |
|
Secondary |
IgG-specific anti-SARS-CoV-2 antibodies |
The proportion of the volunteers with an increased level of the IgG-specific anti-SARS-CoV-2 antibodies by 4 times or more (ELISA test) |
90±5 days after the first dose of the study drug/placebo |
|
Secondary |
IgG-specific anti-SARS-CoV-2 antibodies |
The proportion of the volunteers with an increased level of the IgG-specific anti-SARS-CoV-2 antibodies by 4 times or more (ELISA test) |
180±5 days after the first dose of the study drug/placebo |
|
Secondary |
IgM-specific anti-SARS-CoV-2 antibodies |
The proportion of the volunteers with an increased level of the IgM-specific anti-SARS-CoV-2 antibodies by 4 times or more (ELISA test) |
21 days after the second administration of the study drug/placebo |
|
Secondary |
IgM-specific anti-SARS-CoV-2 antibodies |
The proportion of the volunteers with an increased level of the IgM-specific anti-SARS-CoV-2 antibodies by 4 times or more (ELISA test) |
90±5 days after the first dose of the study drug/placebo |
|
Secondary |
IgM-specific anti-SARS-CoV-2 antibodies |
The proportion of the volunteers with an increased level of the IgM-specific anti-SARS-CoV-2 antibodies by 4 times or more (ELISA test) |
180±5 days after the first dose of the study drug/placebo |
|
Secondary |
Neutralizing anti-SARS-CoV-2 antibodies |
The proportion of the volunteers tested positive for the presence of neutralizing anti-SARS-CoV-2 antibodies (SARS-CoV-2 Surrogate Virus Neutralization Test) |
180±5 days after the first administration of the study drug/placebo |
|
Secondary |
Geometric mean titers of the total anti-SARS-CoV-2 antibodies |
The proportion of the volunteers with geometric mean titers of the total anti-SARS-CoV-2 antibodies (ELISA test) |
21 days after the second administration of the study drug/placebo |
|
Secondary |
Geometric mean titers of the total anti-SARS-CoV-2 antibodies |
The proportion of the volunteers with geometric mean titers of the total anti-SARS-CoV-2 antibodies (ELISA test) |
90±5 days after the first administration of the study drug/placebo |
|
Secondary |
Geometric mean titers of the total anti-SARS-CoV-2 antibodies |
The proportion of the volunteers with geometric mean titers of the total anti-SARS-CoV-2 antibodies (ELISA test) |
180±5 days after the first administration of the study drug/placebo |
|
Secondary |
Geometric mean titers of the IgG-specific anti-SARS-CoV-2 antibodies |
The proportion of the volunteers with geometric mean titers of the IgG-specific anti-SARS-CoV-2 antibodies (ELISA test) |
21 days after the second administration of the study drug/placebo |
|
Secondary |
Geometric mean titers of the IgG-specific anti-SARS-CoV-2 antibodies |
The proportion of the volunteers with geometric mean titers of the IgG-specific anti-SARS-CoV-2 antibodies (ELISA test) |
90±5 days after the first administration of the study drug/placebo |
|
Secondary |
Geometric mean titers of the IgG-specific anti-SARS-CoV-2 antibodies |
The proportion of the volunteers with geometric mean titers of the IgG-specific anti-SARS-CoV-2 antibodies (ELISA test) |
180±5 days after the first administration of the study drug/placebo |
|
Secondary |
Geometric mean titers of the IgM-specific anti-SARS-CoV-2 antibodies |
The proportion of the volunteers with geometric mean titers of the IgM-specific anti-SARS-CoV-2 antibodies (ELISA test) |
21 days after the second administration of the study drug/placebo |
|
Secondary |
Geometric mean titers of the IgM-specific anti-SARS-CoV-2 antibodies |
The proportion of the volunteers with geometric mean titers of the IgM-specific anti-SARS-CoV-2 antibodies (ELISA test) |
90±5 days after the first administration of the study drug/placebo |
|
Secondary |
Geometric mean titers of the IgM-specific anti-SARS-CoV-2 antibodies |
The proportion of the volunteers with geometric mean titers of the IgM-specific anti-SARS-CoV-2 antibodies (ELISA test) |
180±5 days after the first administration of the study drug/placebo |
|
Secondary |
Specific anti-SARS-CoV-2 cellular immune response (Phase 1) |
The proportion of the volunteers with a specific anti-SARS-CoV-2 cellular immune response (flow cytometry) |
21 days after the second dose of the study drug (only in Phase 1) |
|
Secondary |
Specific anti-SARS-CoV-2 cellular immune response (Phase 1) |
The proportion of the volunteers with a specific anti-SARS-CoV-2 cellular immune response (flow cytometry) |
90±5 days after the first dose of the study drug (only in Phase 1) |
|
Secondary |
Specific anti-SARS-CoV-2 cellular immune response |
The proportion of the volunteers with a specific anti-SARS-CoV-2 cellular immune response (ELISPOT) |
21 days after the second dose of the study drug/placebo |
|
Secondary |
Specific anti-SARS-CoV-2 cellular immune response |
The proportion of the volunteers with a specific anti-SARS-CoV-2 cellular immune response (ELISPOT) |
90±5 days after the first dose of the study drug/placebo |
|
Secondary |
Specific anti-SARS-CoV-2 cellular immune response |
The proportion of the volunteers with a specific anti-SARS-CoV-2 cellular immune response (ELISPOT) |
180±5 days after the first dose of the study drug/placebo |
|
Secondary |
COVID-19 symptoms |
The proportion of the volunteers with at least one COVID-19 symptom (fever, chills, dyspnoea, difficulty breathing, cough, sore throat, fatigue, muscle pain, loss or decrease in taste and/or odor, nasal congestion, runny nose, headache, nausea, vomiting, diarrhea) and a PCR-confirmed SARS-CoV-2 infection |
From the 7th day after the second administration of the study drug/placebo till the 90±5 day after the first dose of study drug/placebo |
|
Secondary |
COVID-19 symptoms |
The proportion of the volunteers with at least one COVID-19 symptom (fever, chills, dyspnoea, difficulty breathing, cough, sore throat, fatigue, muscle pain, loss or decrease in taste and/or odor, nasal congestion, runny nose, headache, nausea, vomiting, diarrhea) and a PCR-confirmed SARS-CoV-2 infection |
From the 7th day after the second administration of the study drug/placebo till the 180±5 day after the first dose of study drug/placebo |
|
Secondary |
Moderate, severe or extremely severe course of COVID-19, or lethal outcome |
The proportion of the volunteers with COVID-19 of moderate, severe or extremely severe course, or with a lethal outcome, and a PCR-confirmed SARS-CoV-2 infection |
From the 7th day after the second administration of the study drug/placebo till the 90±5 day after the first dose of the study drug/placebo |
|
Secondary |
Moderate, severe or extremely severe course of COVID-19, or lethal outcome |
The proportion of the volunteers with COVID-19 of moderate, severe or extremely severe course, or with a lethal outcome, and a PCR-confirmed SARS-CoV-2 infection |
From the 7th day after the second administration of the study drug/placebo till the 180±5 day after the first dose of the study drug/placebo |
|
Secondary |
Severe or extremely severe course of COVID-19, or lethal outcome |
The proportion of the volunteers with COVID-19 of severe or extremely severe course, or with a lethal outcome, and a PCR-confirmed SARS-CoV-2 infection |
From the 7th day after the second administration of the study drug/placebo till the 90±5 day after the first dose of the study drug/placebo |
|
Secondary |
Severe or extremely severe course of COVID-19, or lethal outcome |
The proportion of the volunteers with COVID-19 of severe or extremely severe course, or with a lethal outcome, and a PCR-confirmed SARS-CoV-2 infection |
From the 7th day after the second administration of the study drug/placebo till the 180±5 day after the first dose of the study drug/placebo |
|
Secondary |
Lethal outcome |
The proportion of the volunteers with lethal outcome, and a PCR-confirmed SARS-CoV-2 infection |
From the 7th day after the second administration of the study drug/placebo till the 90±5 day after the first dose of the study drug/placebo |
|
Secondary |
Lethal outcome |
The proportion of the volunteers with lethal outcome, and a PCR-confirmed SARS-CoV-2 infection |
From the 7th day after the second administration of the study drug/placebo till the 180±5 day after the first dose of the study drug/placebo |
|
Secondary |
Allergic reactions |
The proportion of the volunteers with immediate side effects (allergic reactions) |
Within 2 hours of the first study drug/placebo administration |
|
Secondary |
Allergic reactions |
The proportion of the volunteers with immediate side effects (allergic reactions) |
Within 2 hours of the second study drug/placebo administration |
|
Secondary |
Local post-vaccination reactions |
The proportion of the volunteers with local post-vaccination reactions |
Within 7 days after the first administration of the study drug/placebo |
|
Secondary |
Local post-vaccination reactions |
The proportion of the volunteers with local post-vaccination reactions |
Within 7 days after the second administration of the study drug/placebo |
|
Secondary |
Severe local post-vaccination reactions |
The proportion of the volunteers with >grade 3 of local post-vaccination reactions |
Within 7 days of the first study drug/placebo administration |
|
Secondary |
Severe local post-vaccination reactions |
The proportion of the volunteers with >grade 3 of local post-vaccination reactions |
Within 7 days of the second study drug/placebo administration |
|
Secondary |
Systemic post-vaccination reactions |
The proportion of the volunteers with systemic post-vaccination reactions |
Within 7 days after the first administration of the study drug/placebo |
|
Secondary |
Systemic post-vaccination reactions |
The proportion of the volunteers with systemic post-vaccination reactions |
Within 7 days after the second administration of the study drug/placebo |
|
Secondary |
Severe systemic post-vaccination reactions |
The proportion of the volunteers with >grade 3 of severe systemic post-vaccination reactions |
Within 7 days after the first administration of the study drug/placebo |
|
Secondary |
Severe systemic post-vaccination reactions |
The proportion of the volunteers with >grade 3 of severe systemic post-vaccination reactions |
Within 7 days after the second administration of the study drug/placebo |
|
Secondary |
Any adverse events |
The proportion of the volunteers with any adverse events |
Within 90±5 days after the first dose of the study drug/placebo |
|
Secondary |
Any adverse events |
The proportion of the volunteers with any adverse events |
Within 180±5 days after the first dose of the study drug/placebo |
|
Secondary |
Adverse events of special interest |
The proportion of the volunteers with adverse events of special interest, adverse reactions that require medical attention, with newly developed chronic diseases |
Within 50 days after the first dose of the study drug/placebo |
|
Secondary |
Adverse events of special interest |
The proportion of the volunteers with adverse events of special interest, adverse reactions that require medical attention, with newly developed chronic diseases |
Within 90±5 days after the first dose of the study drug/placebo |
|
Secondary |
Adverse events of special interest |
The proportion of the volunteers with adverse events of special interest, adverse reactions that require medical attention, with newly developed chronic diseases |
Within 180±5 days after the first dose of the study drug/placebo |
|
Secondary |
Severe adverse events |
The proportion of the volunteers with severe adverse events |
Within 90±5 days after the first dose of the study drug/placebo |
|
Secondary |
Severe adverse events |
The proportion of the volunteers with severe adverse events |
Within 180±5 days after the first dose of the study drug/placebo |
|
Secondary |
Prematurely terminated participation |
The proportion of the volunteers who prematurely terminated their participation in the study due to the development of adverse events or severe adverse events associated with the use of the study drug |
Within 50 days after the administration of the first dose of the study drug/placebo |
|
Secondary |
Prematurely terminated participation |
The proportion of the volunteers who prematurely terminated their participation in the study due to the development of adverse events or severe adverse events associated with the use of the study drug |
Within 90±5 days after the administration of the first dose of the study drug/placebo |
|
Secondary |
Prematurely terminated participation |
The proportion of the volunteers who prematurely terminated their participation in the study due to the development of adverse events or severe adverse events associated with the use of the study drug |
Within 180±5 days after the administration of the first dose of the study drug/placebo |
|