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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
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
Yes
Saint-Petersburg State University Hospital
Saint Petersburg, Russia
Start Date
March 23, 2021
Primary Completion Date
January 30, 2022
Completion Date
January 30, 2022
Last Updated
April 18, 2024
52
ACTUAL participants
Lead Sponsor
Saint Petersburg State University, Russia
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06355232