COVID vaccine efficacy evaluation in ESKD patients.
Research type
Research Study
Full title
Sarscov2 immunity Evaluation post-vaccination iN patIents On Renal replacement therapy- SENIOR study
IRAS ID
297083
Contact name
Anirudh Rao
Contact email
Sponsor organisation
Liverpool University Hospital NHS Trust
ISRCTN Number
ISRCTN52588893
Duration of Study in the UK
1 years, 2 months, 15 days
Research summary
Coronavirus disease 2019 (COVID-19) is caused by a novel coronavirus that has resulted in a global pandemic. COVID-19 infection stimulates Human Leukocyte Antigen (HLA) to produce cytokine proteins, which leads to inflammation-causing lung damage. COVID-19 is associated with significant illness and death in patients with End-Stage Kidney Disease (ESKD). However, SARS-CoV-2 vaccination studies excluded patients with severe or uncontrolled medical conditions, such as patients with ESKD. Also, the immune response to either the infection or vaccination can cause the inducement of HLA antibodies.
Objective: To assess the effectiveness of SARS-CoV-2 vaccination by measuring antibodies and also infection rates in vaccinated patients with ESKD. To assess if SARS-CoV-2 vaccination causes HLA sensitisation.
Study design: Prospective cohort study Population: Dialysis and kidney transplant patients at Liverpool University Hospital NHS Foundation Trust.
Intervention:
Cohort 1 Vaccinated dialysis patients on the UK renal transplant waiting list: Blood will be drawn at baseline (stored sample), 3 weeks post 1st dose of the vaccine (stored sample), 3 weeks post 2nd dose, followed by monthly for 1 year.
Cohort 2 Vaccinated dialysis patients not on the UK renal transplant waiting list: Blood will be drawn 3 weeks post 2nd dose of the vaccine, followed by monthly for 1 year.
Cohort 3 Vaccinated renal transplant patients: at baseline (stored sample), 3 weeks post 1st dose (stored sample), 3 weeks post 2nd dose, followed by 4 monthly for 1 year(monthly if logistically possible).
Cohort 4 Unvaccinated dialysis and renal transplant patients: Will have no blood or serum samples taken.Study endpoints: The scale of antibody-based immune response after the first and second dose of the SARS-CoV-2 vaccinee. Participants will be classified as responders or non-responders. Secondary endpoints include the immune response's longevity 21 days following the second dose and 12 months, disease rates including hospitalisation and mortality and HLA sensitisation.
REC name
London - Queen Square Research Ethics Committee
REC reference
21/HRA/1753
Date of REC Opinion
1 Jul 2021
REC opinion
Further Information Favourable Opinion