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).
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.
Study Type
OBSERVATIONAL
Enrollment
52
Saint-Petersburg State University Hospital
Saint Petersburg, Russia
Humoral response to vaccination against against SARS-CoV-2 as compared to controls
SARS-CoV2 IgG levels
Time frame: 28 days after the second vaccination
Humoral response to vaccination against against SARS-CoV-2
SARS-CoV2 IgG levels
Time frame: 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)
Time frame: 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)
Time frame: 22 weeks after the second vaccination
SARS-CoV-2 incidence
Survey of the incidence of SARS-CoV-2 infections over the study period
Time frame: 22 weeks after the second vaccination
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