Sarscov2 immunity Evaluation post-vaccination iN patIentS On Renal replacement therapy
Not Applicable
Active, not recruiting
- Conditions
- COVID-19 (SARS-CoV-2 infection)Infections and Infestations
- Registration Number
- ISRCTN52588893
- Lead Sponsor
- Royal Liverpool University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 750
Inclusion Criteria
1. Age of 18 years or older
2. Renal Replacement Therapy patients (dialysis and renal transplant) who have received the SARS-CoV-2 vaccine
3. A comparative arm of Renal Replacement Therapy patients (dialysis and renal transplant) who have refused the SARS-CoV-2 vaccine
4. Capable of understanding the purpose and risks of the study, fully informed and given informed consent
Exclusion Criteria
1. Pregnancy or breastfeeding
2. Active (haematological) malignancy
3. Inherited immune deficiency
4. Infection with Human Immunodeficiency Virus (HIV)
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method evel of antibody-based immune response measured using the Roche COVID-19 antibody quantitative assay (Elecsys Anti SARS CoV 2 S assay (Elecsys Anti-SARS-CoV-2 S.09289275500v1.0)) on day 21 after the second SARS-CoV-2 vaccine
- Secondary Outcome Measures
Name Time Method <br> 1. The longevity of immune response measured using the Roche COVID-19 antibody quantitative assay (Elecsys Anti SARS CoV 2 S assay [Elecsys Anti-SARS-CoV-2 S.09289275500v1.0]), measured monthly in dialysis patients and four monthly intervals (monthly if logistically possible) for renal transplant patients, up to 12 months following the second SARS-CoV-2 vaccine<br> 2. Disease rates measured using COVID-19 polymerase chain reaction (PCR) test, including hospitalisation and mortality measured using patient records at the end of the study<br> 3. HLA sensitisation in dialysis patients on the UK renal transplant waiting list and renal transplant patients measured by Luminex solid-phase assay (single antigen beads) at baseline and day 21 after the second SARS-CoV-2 vaccine<br>