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Keep this study
Lead
Saint Petersburg State University, Russia
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.
Age
18–any
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
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.
You may not be if
A history of previous COVID-19 disease
Active malignancy of any localization
Human Immunodeficiency Virus (HIV) infection
Maintenance treatment with immunosuppressive therapy.
Clareo Health | Immune Response in Dialysis Patients Vaccinated Against COVID-19