COVID-19 vaccine efficacy evaluation in kidney failure patients
| ISRCTN | ISRCTN52588893 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN52588893 |
| IRAS number | 297083 |
| Secondary identifying numbers | IRAS 297083, CPMS 49460 |
- Submission date
- 12/11/2021
- Registration date
- 15/11/2021
- Last edited
- 07/12/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Plain English summary of protocol
Background and study aims
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.
The aim of this study is to determine the scale of antibody-based immune response 21 days after the first and second dose of the SARS-CoV-2 vaccine in dialysis and renal transplant patients.
Who can participate?
Dialysis or kidney transplant patients who are 18 years or older who have received or refused the SARS-CoV-2 vaccine
What does the study involve?
Patients will be asked to donate samples of blood. Some will be newly obtained blood samples between 5-14 samples, depending on the group. Some blood samples are previously collected and stored samples between 2-4 samples, collected as part of routine care. The existing samples (stored samples) would have been collected if patients have a kidney transplant or are currently or previously on the national kidney transplant list. This study is meant to be convenient to participants with the timing of blood samples required for research around the participants routine clinical monitoring,
• Dialysis patients: Monthly along with routine monthly blood tests.
• Kidney transplant patients: 4 monthly intervals (monthly if logistically possible) along with blood tests required for the clinic visits or other routine blood monitoring (for example, drug levels). Hence the frequency of visits to the hospital is not anticipated to increase.
During the study, the following information will be collected (age, gender, ethnicity), medical history, including details of medical condition and treatment, whether you have had coronavirus infection before, details of vaccination. Information will be collected from medical records from the time patient enters the study for a period of up to 12 months after receiving a vaccination.
What are the possible benefits and risks of participating?
Benefits: There may be no direct benefit to patients from taking part in this study. However, this study will inform if normalisation of life after vaccination is feasible, such as:
• The safety of immunosuppressed kidney transplant patients coming out of shielding.
• Dialysis patients moving between shifts (Monday/Wednesday/Friday and Tuesday/Thursday/Saturday)
• The safety of dialysis and transplant patients to return to work
The information gained from this study may help to improve how patients with kidney failure are vaccinated for coronavirus in the future.
There are no major risks. Having blood taken may cause some discomfort, bleeding or bruising where the needle enters the body and, in rare cases, light-headedness and fainting.
Where is the study run from?
Liverpool University Hospitals NHS Trust (UK)
When is the study starting and how long is it expected to run for?
March 2021 to October 2022
Who is funding the study?
The study is funded by Roche with a materials only grant
Who is the main contact?
Dr Anirudh Rao
anirudhrao@nhs.net
Contact information
Scientific
Royal Liverpool University Hospital
Prescot Street
Liverpool
L7 8XP
United Kingdom
 ORCID ID |
0000-0002-3202-2832 |
|---|---|
| Phone | +44 (0)151 7063702 |
| anirudhrao@nhs.net |
Study information
| Study design | Prospective observational cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Longitudinal study |
| Study setting(s) | Hospital |
| Study type | Prevention |
| Participant information sheet | 40663_PIS_V2_01Jun21.pdf |
| Scientific title | Sarscov2 immunity Evaluation post-vaccination iN patIentS On Renal replacement therapy |
| Study acronym | SENIOR |
| Study objectives | 1. SARS-CoV-2 vaccination in dialysis patients and kidney transplant recipients will induce an antibody-based immune response. 2. SARS CoV-2 vaccine could induce HLA antibodies (sensitisation) in transplant patients and those on the waiting list for a renal transplant. |
| Ethics approval(s) | Approved 01/07/2021, Queens Square Research Ethics Committee (HRA NRES Centre Bristol 3rd floor, Block B, Whitefriars Lewins Mead, Bristol, BS1 2NT, UK; +44 (0)207 104 8061; queensquare.rec@hra.nhs.uk), ref: 21/HRA/1753 |
| Health condition(s) or problem(s) studied | COVID-19 (SARS-CoV-2 infection) |
| Intervention | 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). This study is a pragmatic study with the timing of blood samples required for study in the three cohorts centred around the patients routine clinical monitoring, monthly in dialysis patients, and 4 monthly intervals (monthly if logistically possible) for renal transplant patients. Dialysis patients will have their study samples monthly with their routine monthly blood monitoring on dialysis by nurses. Home dialysis patients will self-obtain the study samples with their routine monthly blood monitoring. Renal transplant patients will have their study samples at 4 monthly intervals (monthly if logistically possible) and blood tests are taken for their clinic visits by the trust phlebotomy service. Given that the substantial proportion of participants will have had their first dose of the SARS-CoV2 vaccine, this study intends to utilise stored samples (HLA-specific antibodies and Post-Transplant Save Serum) at Liverpool University Hospitals NHS Foundation Trust pathology department(s) / diagnostic archive(s) for the baseline samples. The study’s blood sampling schedule for assessment of immune response in the four cohorts is detailed below. Cohort 1 Vaccinated dialysis patients on the UK renal transplant waiting list Blood/serum for antibody to COVID 19 vaccination at baseline (stored sample-transplant listing blood tests), 21 days post 1st dose of the SARS-CoV-2 vaccine (stored sample -transplant listing blood tests), 21 days post 2nd dose of the SARS-CoV-2 vaccine and monthly after that for 1 year from the date of the 2nd SARS-CoV-2 vaccine Cohort 2 Vaccinated dialysis patients not on the UK renal transplant waiting list Blood/serum for antibody to COVID 19 vaccination at 21 days post 2nd dose of the SARS-CoV-2 vaccine and monthly after that for 1 year from the date of the 2nd SARS-CoV-2 vaccine Cohort 3: Vaccinated renal transplant patients Blood/serum for antibody to COVID 19 vaccination at baseline (stored sample -transplant listing blood tests), 21 days post 1st dose of the SARS-CoV-2 vaccine (stored sample -transplant listing blood tests), 21 days post 2nd dose of the SARS-CoV-2 vaccine, and 4 monthly after that for 1 year (monthly if logistically possible) from the date of the 2nd SARS-CoV-2 vaccine Cohort 4: Unvaccinated dialysis and renal transplant patients Will have no blood or serum samples taken. 2. Evaluation of other parameters: 2.1. Incentre haemodialysis dialysis patients (vaccinated and unvaccinated) will have weekly SARS-CoV-2 PCR monitoring as a routine standard of clinical care and not a study intervention as per the current trust’s policy. 2.2. Home dialysis and renal transplant patients (vaccinated and unvaccinated) will have COVID-19 PCR, as indicated by symptoms at COVID-19 testing centres. This data will be collected for 12 months after the first vaccine dose. 2.3. HLA-specific antibodies in dialysis patients on the UK renal transplant waiting list and transplant patients will be assessed for sensitisation by Luminex solid-phase assay (single antigen beads) as a routine standard of clinical care. This is routine and done after a clinically significant event such as infection, blood transfusion, pregnancy or vaccination. |
| Intervention type | Biological/Vaccine |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | |
| Primary outcome measure | 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 outcome measures | 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 |
| Overall study start date | 30/03/2021 |
| Completion date | 15/10/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 750 |
| Key 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 |
| Key exclusion criteria | 1. Pregnancy or breastfeeding 2. Active (haematological) malignancy 3. Inherited immune deficiency 4. Infection with Human Immunodeficiency Virus (HIV) |
| Date of first enrolment | 02/08/2021 |
| Date of final enrolment | 01/02/2022 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
Prescot Street
Liverpool
L7 8XP
United Kingdom
Lower Ln
Liverpool
L9 7AL
United Kingdom
Sponsor information
Hospital/treatment centre
Prescot Street
Liverpool
L7 8XP
England
United Kingdom
| Phone | +44 (0)151 706 3702 |
|---|---|
| RGT@RLBUHT.nhs.uk | |
| Website | https://www.rlbuht.nhs.uk/our-hospitals/royal-liverpool-university-hospital/ |
"ROR" |
https://ror.org/01ycr6b80 |
Funders
Funder type
Industry
Private sector organisation / For-profit companies (industry)
- Alternative name(s)
- Roche Diagnostics Corporation
- Location
- United States of America
Results and Publications
| Intention to publish date | 01/11/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | The results of the study will be published in a high-impact peer-review journal. The results will also be published in conferences as either poster or oral presentations. |
| IPD sharing plan | Only aggregate data will be reported. Participant data will not be shared or reported. The datasets generated during and/or analysed during the current study are not expected to be made available as ethics permission has not been sought for this and the access to the de-identified data will be only accessible to the research team. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version 2 | 01/06/2021 | 15/11/2021 | No | Yes |
| Protocol file | version 2 | 01/06/2021 | 15/11/2021 | No | No |
| HRA research summary | 28/06/2023 | No | No |
Additional files
Editorial Notes
07/12/2021: Internal review.
15/11/2021: Trial's existence confirmed by the Queens Square Research Ethics Committee.
