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

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ClinicalTrials.gov Identifier: NCT04815850
Recruitment Status : Recruiting
First Posted : March 25, 2021
Last Update Posted : March 25, 2021
Sponsor:
Collaborators:
Leicester Hospitals Charity
The Francis Crick Institute
Information provided by (Responsible Party):
University of Leicester

Study Description
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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
End Stage Kidney Disease

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
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Study Type : Observational
Estimated 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 : March 1, 2021
Estimated Primary Completion Date : October 1, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
Patients on haemodialysis
Patients receiving haemodialysis
Healthy controls
Participants with no chronic kidney disease or history of immunosuppression


Outcome Measures
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Primary Outcome Measures :
  1. Change in COVID-19 IgG antibody (RLU) [ Time Frame: Baseline; 1 month post first vaccine; 1 month post second vaccine; 6 months post second vaccine ]
    Measured from a serum blood sample


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients receiving haemodialysis at Leicester General Hospital.
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04815850


Contacts
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Contact: Matthew PM Graham-Brown 0116 2584042 mgb23@le.ac.uk
Contact: Roseanne E Billany 0116 2584042 r.billany@leicester.ac.uk

Locations
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United Kingdom
University Hospital Leicester NHS Trust Recruiting
Leicester, Leicestershire, United Kingdom, LE5 4PW
Contact: Matthew Graham-Brown         
Sponsors and Collaborators
University of Leicester
Leicester Hospitals Charity
The Francis Crick Institute
Investigators
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Principal Investigator: Matthew PM Graham-Brown University of Leicester
More Information
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Responsible Party: University of Leicester
ClinicalTrials.gov Identifier: NCT04815850    
Other Study ID Numbers: 0810
First Posted: March 25, 2021    Key Record Dates
Last Update Posted: March 25, 2021
Last Verified: March 2021

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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:
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COVID-19
Kidney Diseases
Kidney Failure, Chronic
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
 Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency