COVID antibody testing following vaccination in dialysis patients [COVID-19]
Research type
Research Study
Full title
COVID antibody response including spike and nucleocapsid proteins following vaccination in the dialysis dependent patients
IRAS ID
297170
Contact name
Lauren Floyd
Contact email
Sponsor organisation
Lancashire Teaching Hospitals NHS Foundation Trust
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
Research Summary
The aim of our study is to look at the COVID antibody response following exposure to COVID-19 and/ or following vaccination with any of the 3 nationally approved vaccines – Pfizer/BioNTech, Oxford-AstraZeneca or Moderna vaccine.On the 25th January 2021 we commenced a COVID vaccination programme for all dialysis patients as well as some immunosuppressed patients such as those with ANCA associated vasculitis or renal transplantation in accordance with the UK government advice and guidelines. We now wish to assess patient’s antibody response by testing for both nucleocapsid and spike proteins. This will tell us if the patient has developed antibodies as a result of natural immunity and COVID exposure, post vaccination immunity or both.
It is recognised that immunosuppressed patients including those on regular haemodialysis or those receiving immunosuppressive may not generate a full immune response to the COVID- 19 vaccine. The aim of this study is to quantify the antibody response to the vaccine and identify those patients that may still be vulnerable to COVID-19 despite vaccination.
COVID-19 remains a novel virus and being able to identify patients at ongoing risk due to poor or reduced immune responses will allow for further management options in the future such as isolation during dialysis or further vaccinations in the future.
Summary of Results
The aim of our study was to look at the COVID-19 antibody response following exposure to COVID-19 and/ or following vaccination with any of the 3 nationally approved vaccines – Pfizer/BioNTech, Oxford-AstraZeneca or Moderna vaccine.On the 25th January 2021 we commenced a COVID-19 vaccination programme for all dialysis patients in accordance with the UK government advice and guidelines. In June 2021 we began a IRAS approved research trial assessing COVID-19 antibody response in patients with dialysis dependence.
We analysed both nucleocapsid and anti-spike antibodies as a measure of infection and immune response to COVID-19 vaccination. The tests were done monthly alongside patient’s routine dialysis bloods to provide consistent, longitudinal data.
In total 575 dialysis patients were recruited to the study from all dialysis satellite units across Lancashire. Serial bloods antibody tests were captured in the majority of patients with 146 patients completing the full 8 monthly serial blood tests.
Our study found that 97.7% of our dialysis depend patients developed evidence of SARS-CoV-2 Anti-spike antibodies with 66.2% developing maximum antibody titres (>2500 U/ml). There was no difference in antibody response to vaccination type. Age and immunosuppressive medication were associated with a reduced response to the vaccine.
The initial study end date was June 2022. Due to the wealth of accumulating evidence and literature on the topic worldwide, we felt that continuing the study would not lead to any new or novel findings. Furthermore, the data shows excellent antibody response in dialysis patients and therefore continuing to take monthly blood tests offers no significant benefit for patients or the service/ care we provide. The study was closed early in February 2022.
REC name
South West - Cornwall & Plymouth Research Ethics Committee
REC reference
21/SW/0036
Date of REC Opinion
15 Apr 2021
REC opinion
Further Information Favourable Opinion