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

End Stage Kidney Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04815850
• Other study ID #: 0810
• Status: Completed
• Start date: March 1, 2021
• Est. completion date: December 5, 2022

Study information

• Verified date: May 2022
• Source: University of Leicester
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 115
• Est. completion date: December 5, 2022
• Est. primary completion date: February 15, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• End Stage Kidney Disease
• Kidney Diseases
• Kidney Failure, Chronic

Locations

Country	Name	City	State
United Kingdom	University Hospital Leicester NHS Trust	Leicester	Leicestershire

Sponsors (3)

Lead Sponsor	Collaborator
University of Leicester	Francis Crick Institute, Leicester Hospitals Charity

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in COVID-19 IgG antibody (RLU)	Measured from a serum blood sample	Baseline; 1 month post first vaccine; 1 month post second vaccine; 6 months post second vaccine