Sarscov2 immunity Evaluation post-vaccination iN patIentS On Renal replacement therapy

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN52588893

Enrollment

750

Registered

2021-11-15

Start date

2021-08-02

Completion date

Unknown

Last updated

2021-12-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19 (SARS-CoV-2 infection) Infections and Infestations

Interventions

1. Assessment of immune response The measurement of SARS-CoV2 specific antibodies will be using the Elecsys Anti-SARS-CoV-2 S assay (Elecsys Anti-SARS-CoV-2 S.09289275500v1.0).

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria: 1. Pregnancy or breastfeeding 2. Active (haematological) malignancy 3. Inherited immune deficiency 4. Infection with Human Immunodeficiency Virus (HIV)

Design outcomes

Primary

Measure	Time frame
Level 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

Measure	Time frame
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 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 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	—

Measure

Time frame

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 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 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

—

Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026