Immune Response in Dialysis Patients Vaccinated Against COVID-19
NCT ID: NCT04805632
Last Updated: 2024-04-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
52 participants
OBSERVATIONAL
2021-03-23
2022-01-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Dialysis
Patients on hemodialysis or peritoneal dialysis who received 2 administrations of Gam-COVID-Vac (Sputnik V) vaccine against SARS-CoV-2 infection
No interventions assigned to this group
Healthy
Medical staff who received 2 administrations of Gam-COVID-Vac (Sputnik V) vaccine against SARS-CoV-2 infection
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Previously vaccinated against SARS-CoV-2 with two administrations of Gam-COVID-Vac (Sputnik V) vaccine
* Written informed consent.
Exclusion Criteria
* Active malignancy of any localization
* Human Immunodeficiency Virus (HIV) infection
* Maintenance treatment with immunosuppressive therapy.
18 Years
ALL
Yes
Sponsors
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Saint Petersburg State University, Russia
OTHER
Responsible Party
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Ekaterina Parshina
Principal investigator, MD
Locations
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Saint-Petersburg State University Hospital
Saint Petersburg, , Russia
Countries
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Other Identifiers
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Sputnik_HD
Identifier Type: -
Identifier Source: org_study_id
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