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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04805632
Other study ID # Sputnik_HD
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 23, 2021
Est. completion date January 30, 2022

Study information

Verified date April 2024
Source Saint Petersburg State University, Russia
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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).


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.


Recruitment information / eligibility

Status Completed
Enrollment 52
Est. completion date January 30, 2022
Est. primary completion date January 30, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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


Locations

Country Name City State
Russian Federation Saint-Petersburg State University Hospital Saint Petersburg

Sponsors (1)

Lead Sponsor Collaborator
Saint Petersburg State University, Russia

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type Measure Description Time frame Safety issue
Primary Humoral response to vaccination against against SARS-CoV-2 as compared to controls SARS-CoV2 IgG levels 28 days after the second vaccination
Secondary Humoral response to vaccination against against SARS-CoV-2 SARS-CoV2 IgG levels 22 weeks after the second vaccination
Secondary T-cell response against SARS-CoV-2 SARS-CoV-2 specific T-cell subtype measured by interferon-? release assays (IGRA) 28 days after the second vaccination
Secondary T-cell response against SARS-CoV-2 SARS-CoV-2 specific T-cell subtype measured by interferon-? release assays (IGRA) 22 weeks after the second vaccination
Secondary SARS-CoV-2 incidence Survey of the incidence of SARS-CoV-2 infections over the study period 22 weeks after the second vaccination
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