Immune Response in Dialysis Patients Vaccinated Against COVID-19

Covid19 Clinical Trial

— Sputnik-HD  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04805632
• Other study ID #: Sputnik_HD
• Status: Completed
• 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
• 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.

Related Conditions & MeSH terms

• Chronic Kidney Disease 5D
• COVID-19
• Covid19
• Kidney Diseases
• Renal Insufficiency, Chronic

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