Immune Response in Dialysis Patients Vaccinated Against COVID-19

Completed

• Conditions: Covid19; Chronic Kidney Disease 5D

• Registration Number: NCT04805632
• Lead Sponsor: Saint Petersburg State University, Russia

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.

Study Timeline

• Study First Submitted: 2021-03-16
• Study First Submitted QC: 2021-03-16
• Study First Posted: 2021-03-18
• Study Start: 2021-03-23
• Primary Completion: 2022-01-30
• Study Completion: 2022-01-30
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-16
• Last Update Posted: 2024-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Humoral response to vaccination against against SARS-CoV-2 as compared to controls	28 days after the second vaccination	SARS-CoV2 IgG levels

Secondary Outcome Measures

Name	Time	Method
T-cell response against SARS-CoV-2	22 weeks 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
Humoral response to vaccination against against SARS-CoV-2	22 weeks after the second vaccination	SARS-CoV2 IgG levels

Trial Locations

Locations (1)

Saint-Petersburg State University Hospital; 🇷🇺 Saint Petersburg, Russian Federation