Clinical trial NCT04815850: Phenotyping Seroconversion Following Vaccination Against COVID-19 in Patients on Haemodialysis Study
Official title: Phenotyping Seroconversion Following Vaccination Against COVID-19 in Patients on Haemodialysis Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: End Stage Kidney Disease
Keywords: haemodialysis
COVID-19
seroconversion
chronic kidney disease
Lead sponsor: University of Leicester
Sponsor class: OTHER
Collaborators: name: Leicester Hospitals Charity
name: Francis Crick Institute
First posted: 2021-03-25
Enrollment: 115
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients receiving haemodialysis at Leicester General Hospital.

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

Eligibility 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

Primary outcomes:
measure: Change in COVID-19 IgG Antibody (Relative Light Units)
timeFrame: 1 month post first vaccine
Secondary outcomes:
Other outcomes:
Locations:
city: Leicester
country: United Kingdom
facility: University Hospital Leicester NHS Trust
state: Leicestershire
Study officials:
affiliation: University of Leicester
name: Matthew PM Graham-Brown
role: PRINCIPAL_INVESTIGATOR
References: