NCT04805632

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 16, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 18, 2021

Completed
5 days until next milestone

Study Start

First participant enrolled

March 23, 2021

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2022

Completed
Last Updated

April 18, 2024

Status Verified

April 1, 2024

Enrollment Period

10 months

First QC Date

March 16, 2021

Last Update Submit

April 16, 2024

Conditions

Covid19Chronic Kidney Disease 5D

Outcome Measures

Primary Outcomes (1)

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

    SARS-CoV2 IgG levels

    28 days after the second vaccination

Secondary Outcomes (4)

  • Humoral response to vaccination against against SARS-CoV-2

    22 weeks after the second vaccination

  • T-cell response against SARS-CoV-2

    28 days after the second vaccination

  • T-cell response against SARS-CoV-2

    22 weeks after the second vaccination

  • SARS-CoV-2 incidence

    22 weeks after the second vaccination

Study Arms (2)

Dialysis

Patients on hemodialysis or peritoneal dialysis who received 2 administrations of Gam-COVID-Vac (Sputnik V) vaccine against SARS-CoV-2 infection

Healthy

Medical staff who received 2 administrations of Gam-COVID-Vac (Sputnik V) vaccine against SARS-CoV-2 infection

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subjects ≥ 18 years old who were vaccinated twice against SARS-CoV-2 using Gam-COVID-Vac (Sputnik V) vaccine.

You may qualify if:

  • 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.

You may not qualify if:

  • A history of previous COVID-19 disease
  • Active malignancy of any localization
  • Human Immunodeficiency Virus (HIV) infection
  • Maintenance treatment with immunosuppressive therapy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Saint-Petersburg State University Hospital

Saint Petersburg, 190103, Russia

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator, MD

Study Record Dates

First Submitted

March 16, 2021

First Posted

March 18, 2021

Study Start

March 23, 2021

Primary Completion

January 30, 2022

Study Completion

January 30, 2022

Last Updated

April 18, 2024

Record last verified: 2024-04

Locations

RU(1)