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Trial record 5 of 10 for:    Gam COVID | Russia

Immune Response in Dialysis Patients Vaccinated Against COVID-19 (Sputnik-HD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04805632
Recruitment Status : Active, not recruiting
First Posted : March 18, 2021
Last Update Posted : September 28, 2021
Sponsor:
Information provided by (Responsible Party):
Ekaterina Parshina, Saint Petersburg State University, Russia

Tracking Information
First Submitted Date March 16, 2021
First Posted Date March 18, 2021
Last Update Posted Date September 28, 2021
Actual Study Start Date March 23, 2021
Estimated Primary Completion Date January 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 16, 2021)
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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: March 16, 2021)
  • Humoral response to vaccination against against SARS-CoV-2 [ Time Frame: 22 weeks after the second vaccination ]
    SARS-CoV2 IgG levels
  • 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)
  • 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)
  • 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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Immune Response in Dialysis Patients Vaccinated Against COVID-19
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
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).
Detailed 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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Subjects ≥ 18 years old who were vaccinated twice against SARS-CoV-2 using Gam-COVID-Vac (Sputnik V) vaccine.
Condition
  • Covid19
  • Chronic Kidney Disease 5D
Intervention Not Provided
Study Groups/Cohorts
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Estimated Enrollment
 (submitted: March 16, 2021)
42
Original Estimated Enrollment Same as current
Estimated Study Completion Date January 2022
Estimated Primary Completion Date January 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Russian Federation
Removed Location Countries  
 
Administrative Information
NCT Number NCT04805632
Other Study ID Numbers Sputnik_HD
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Ekaterina Parshina, Saint Petersburg State University, Russia
Study Sponsor Saint Petersburg State University, Russia
Collaborators Not Provided
Investigators Not Provided
PRS Account Saint Petersburg State University, Russia
Verification Date September 2021