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Phenotyping Seroconversion Following Vaccination Against COVID-19 in Patients on Haemodialysis Study

Sponsor
University of Leicester (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04815850
Collaborator
Leicester Hospitals Charity (Other), The Francis Crick Institute (Other)
150
Enrollment
1
Location
34
Anticipated Duration (Months)
4.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Patients on haemodialysis are at higher risk of getting a severe form of COVID-19 if they become infected. Vaccinations are soon to arrive and offer great hope of controlling the current pandemic. It is likely that patients on haemodialysis will be amongst the first people to be offered vaccination against COVID-19 when they become available. While any vaccines offered to these patients will be safe to receive, the effectiveness of the vaccines at giving immunity to being infected with COVID-19 are not known as they have not been explicitly tested in patients on haemodialysis. This study will involve having 3 blood tests to test for an antibody response following vaccination for COVID-19. The first will be 1 month after the first vaccination dose to look at the initial antibody response and the second and third will be 1 month and 6 months after the second vaccination dose.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Patients with end stage kidney disease (ESKD) on haemodialysis are more likely to suffer poorer outcomes following infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. This is likely to be because these patients have higher levels of co-morbid diseases and they are relatively immunosuppressed due to the effects of advanced kidney disease. The humoral response against common viral vaccination is known to be blunted in patients with ESKD and there are data to suggest seroconversion following infection with COVID-19 is blunted in patients with kidney disease. A successful programme of vaccination will undoubtedly improve outcomes for patients on haemodialysis, but vaccine testing programmes have not included patients with ESKD. Whilst initial press-coverage of the efficacy of vaccines which are available for use is promising, they are untested in patients on haemodialysis who are known to be relatively immunosuppressed as a result of their renal disease and as such the efficacy for this patient group is not known.

    This study will phenotype the IgG antibody response to vaccination for COVID-19 in 100 patients on haemodialysis compared to 50 healthy volunteers. Antibody testing will be conducted at 1 month post first vaccination dose and 1 month and 6 months post second vaccination dose. This will give crucial information as to the efficacy of the vaccine and inform possible requirements for re-vaccination.

    This study will:

    1. Phenotype the 1 month IgG antibody response to the first vaccination dose and the 1 month and 6 month response to the second vaccination dose for COVID-19 in patients on haemodialysis

    2. Compare the 1 month IgG antibody response to the first vaccination dose and the 1 month and 6 month response to the second vaccination dose for COVID-19 between patients on haemodialysis and healthy volunteers

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    150 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Phenotyping Seroconversion Following Vaccination Against COVID-19 in Patients on Haemodialysis Study
    Actual Study Start Date :
    Mar 1, 2021
    Anticipated Primary Completion Date :
    Oct 1, 2023
    Anticipated Study Completion Date :
    Dec 31, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    Patients on haemodialysis

    Patients receiving haemodialysis
    Healthy controls

    Participants with no chronic kidney disease or history of immunosuppression

    Outcome Measures

    Primary Outcome Measures

    1. Change in COVID-19 IgG antibody (RLU) [Baseline; 1 month post first vaccine; 1 month post second vaccine; 6 months post second vaccine]

      Measured from a serum blood sample

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • End stage kidney disease on haemodialysis

    • Able and willing to give informed consent

    • Have completed or due to complete vaccination against COVID-19

    Exclusion Criteria:

    • Acute kidney injury requiring temporary haemodialysis

    • Unable to give informed consent

    • Pregnancy

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University Hospital Leicester NHS Trust Leicester Leicestershire United Kingdom LE5 4PW

    Sponsors and Collaborators

    • University of Leicester
    • Leicester Hospitals Charity
    • The Francis Crick Institute

    Investigators

    • Principal Investigator: Matthew PM Graham-Brown, University of Leicester

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Leicester
    ClinicalTrials.gov Identifier:
    NCT04815850
    Other Study ID Numbers:
    • 0810
    First Posted:
    Mar 25, 2021
    Last Update Posted:
    Jun 1, 2022
    Last Verified:
    May 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University of Leicester
    haemodialysis
    COVID-19
    seroconversion
    chronic kidney disease
    Additional relevant MeSH terms:
    COVID-19
    Kidney Diseases
    Kidney Failure, Chronic

    Study Results

    No Results Posted as of Jun 1, 2022