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

Completed

• Conditions: End Stage Kidney Disease

• Registration Number: NCT04815850
• Lead Sponsor: University of Leicester

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.

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 Timeline

• Study Start: 2021-03-01
• Study First Submitted: 2021-03-23
• Study First Submitted QC: 2021-03-24
• Study First Posted: 2021-03-25
• Primary Completion: 2022-02-15
• Status Verified: 2022-05
• Study Completion: 2022-12-05
• Last Update Submitted: 2023-04-20
• Last Update Posted: 2023-04-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 115

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in COVID-19 IgG Antibody (Relative Light Units)	1 month post first vaccine	Measured from a serum blood sample. Serum was tested for the presence of SARS-CoV-2 neutralising IgG and IgM antibodies directed against the receptor binding domain of the S1 spike protein, using the Siemens ADVIA Centaur XP/XPT assay and reported as positive or negative as per manufacturer guidelines (detectable antibody levels \>1RLU (relative light units) reported as positive to an upper limit of 10)

Trial Locations

Locations (1)

University Hospital Leicester NHS Trust; 🇬🇧 Leicester, Leicestershire, United Kingdom