Chronic Kidney Disease 5D, Covid19
Conditions
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.
Interventions
None listed
Sponsors
Saint Petersburg State University, Russia
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Humoral response to vaccination against against SARS-CoV-2 as compared to controls | 28 days after the second vaccination | SARS-CoV2 IgG levels |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Humoral response to vaccination against against SARS-CoV-2 | 22 weeks after the second vaccination | SARS-CoV2 IgG levels |
| T-cell response against SARS-CoV-2 | 28 days after the second vaccination | SARS-CoV-2 specific T-cell subtype measured by interferon-γ release assays (IGRA) |
| SARS-CoV-2 incidence | 22 weeks after the second vaccination | Survey of the incidence of SARS-CoV-2 infections over the study period |
Countries
Russia
Outcome results
None listed