Immune Response in Dialysis Patients Vaccinated Against COVID-19

Study Overview
=================
Brief Summary
-----------------
This is a prospective cohort study aimed to evaluate short- and mid-term immune response after SARS-CoV-2 vaccination using Gam-COVID-Vac (Sputnik V) vaccine in dialysis patients compared to the control group (medical staff).

Detailed Description
-----------------
Background and aims: Patients receiving kidney replacement therapy with dialysis are at high risk of infection and death from COVID-19. There is a lack of evidence whether SARS-CoV-2 vaccination is effective in this immunocompromised group. Study design: this is a prospective cohort study. Two cohorts will be included: dialysis patients and controls (medical staff), both vaccinated with Gam-COVID-Vac (Sputnik V) vaccine. Blood samples will be collected at 28 days and 22 weeks after after the second SARS-CoV-2 vaccine dose administration. The primary outcome is the level of SARS-CoV-2 IgG antibodies on day 28 after the second vaccination as compared to controls. The secondary outcomes are: 1) the level of SARS-CoV-2 IgG antibodies on week 22 after the second vaccination; 2) T cell subtype immunity measured by SARS-CoV-2 interferon-γ release assays (IGRA) 28 days and 22 weeks after the second vaccination.

Official Title
-----------------
A Comparison of Short-term and Mid-term Immune Response in Dialysis Patients and Staff Vaccinated Against SARS-CoV-2 Using Gam-COVID-Vac (Sputnik V) Vaccine

Conditions
-----------------
Covid19, Chronic Kidney Disease 5D

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age of 18 years or older Previously vaccinated against SARS-CoV-2 with two administrations of Gam-COVID-Vac (Sputnik V) vaccine Written informed consent. Exclusion Criteria: A history of previous COVID-19 disease Active malignancy of any localization Human Immunodeficiency Virus (HIV) infection Maintenance treatment with immunosuppressive therapy.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Dialysis<br>Patients on hemodialysis or peritoneal dialysis who received 2 administrations of Gam-COVID-Vac (Sputnik V) vaccine against SARS-CoV-2 infection | |
| Healthy<br>Medical staff who received 2 administrations of Gam-COVID-Vac (Sputnik V) vaccine against SARS-CoV-2 infection | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Humoral response to vaccination against against SARS-CoV-2 as compared to controls | SARS-CoV2 IgG levels | 28 days after the second vaccination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Humoral response to vaccination against against SARS-CoV-2 | SARS-CoV2 IgG levels | 22 weeks after the second vaccination | 
| T-cell response against SARS-CoV-2 | SARS-CoV-2 specific T-cell subtype measured by interferon-γ release assays (IGRA) | 28 days after the second vaccination | 
| T-cell response against SARS-CoV-2 | SARS-CoV-2 specific T-cell subtype measured by interferon-γ release assays (IGRA) | 22 weeks after the second vaccination | 
| SARS-CoV-2 incidence | Survey of the incidence of SARS-CoV-2 infections over the study period | 22 weeks after the second vaccination |