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OpenTrials
Completed

NCT Number: NCT04805632

Immune Response in Dialysis Patients Vaccinated Against COVID-19

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).

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Key information

Conditions

Covid19 COVID-19 Chronic Kidney Disease 5D Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Saint-Petersburg State University Hospital

Saint Petersburg, 190103, Russia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Humoral response to vaccination against against SARS-CoV-2 as compared to controls

    Time frame: 28 days after the second vaccination

    SARS-CoV2 IgG levels

Secondary outcomes

  1. Humoral response to vaccination against against SARS-CoV-2

    Time frame: 22 weeks after the second vaccination

    SARS-CoV2 IgG levels

  2. T-cell response against SARS-CoV-2

    Time frame: 28 days after the second vaccination

    SARS-CoV-2 specific T-cell subtype measured by interferon-γ release assays (IGRA)

  3. T-cell response against SARS-CoV-2

    Time frame: 22 weeks after the second vaccination

    SARS-CoV-2 specific T-cell subtype measured by interferon-γ release assays (IGRA)

  4. SARS-CoV-2 incidence

    Time frame: 22 weeks after the second vaccination

    Survey of the incidence of SARS-CoV-2 infections over the study period

Sponsors and collaborators

Lead sponsor

Saint Petersburg State University, Russia

Other

Registry information

Official study title

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

Acronym: Sputnik-HD

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Mar 18, 2021
Registry last updated
Apr 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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