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| Name | Class |
|---|---|
| Wellcome Trust | OTHER |
| University Hospital Birmingham NHS Foundation Trust | OTHER |
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This study will investigate the function of the immune system in people with chronic kidney disease (CKD) compared to people with normal kidneys. The investigators will use standard vaccines - the seasonal flu vaccine and pneumococcal polysaccharide (Pneumovax) vaccine - to examine how the immune system responds to challenge. All subjects will receive these recommended vaccines as part of routine care. Blood and urine samples will be collected and tested at different time points to look at how the immune response develops to these vaccines and if there are any differences between people with CKD and those without. This will help us understand how CKD affects the function of the immune system.
Compared to the general population, people with CKD are known to get more infections and are more likely to have complications from them. Protective measures such as vaccinations for common infections are not as effective in patients with CKD as they are in people with healthy kidneys. The reasons why this happens are not very clear. It is known that with increasing age, the body's immune defences are weakened, but it is not yet clear how different this is in older people with CKD compared to older people with healthy kidneys. Understanding how CKD affects the body's immune defence to new infections is vital in helping to prevent severe consequences from infection and make vaccination more effective for this group of people. This project aims to look at the function of immune cells in CKD patients and people with normal kidney function, together with their responses to clinically recommended vaccinations, including Pneumococcus (common pneumonia organism) and the influenza virus (the flu).
Study participants are invited to receive the clinically recommended seasonal influenza and pneumococcal polysaccharide vaccines during the seasonal influenza vaccination season (September - December), mirroring routine care they would receive in the community. Information on age, gender and pre-existing health problems, together with blood and urine samples will be collected from CKD patients for comparison with healthy volunteers at the following timepoints: day of vaccination, day 7 and 28 and 6 months after vaccination.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chronic Kidney Disease (CKD) patients | Any gender, aged 65 years and over. Chronic kidney disease with eGFR between 15 and 60 ml/min. No immunological cause of kidney disease. Not immunosuppressed. To receive both seasonal influenza and pneumococcal polysaccharide vaccines as part of recommended clinical care. |
| |
| Healthy Control subjects | Any gender, aged 65 years and over. No known renal disease and eGFR 60ml/min or greater. Not immunosuppressed. To receive both seasonal influenza and pneumococcal polysaccharide vaccines as part of recommended clinical care. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Seasonal influenza and pneumococcal polysaccharide vaccines | Biological | Vaccination |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants achieving adequate humoral response to either vaccine | as assessed by vaccine-specific serum IgG levels | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants who maintain protective antibody titres to either vaccine at 6 months after vaccination | as assessed by vaccine-specific serum IgG levels | 6 months |
| Relationship between eGFR and immune cell subsets following vaccination |
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Inclusion Criteria:
Exclusion Criteria:
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CKD patients - individuals attending local tertiary care nephrology clinics.
Healthy control subjects - individuals accompanying CKD patients to nephrology clinics or individuals invited to participate from Birmingham 1000 Elders Cohort.
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| Name | Affiliation | Role |
|---|---|---|
| Lorraine Harper | University of Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospitals Birmingham NHS Foundation Trust | Birmingham | West Midlands | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33728434 | Derived | Wall N, Godlee A, Geh D, Jones C, Faustini S, Harvey R, Penn R, Chanouzas D, Nightingale P, O'Shea M, Richter A, Moss P, Cunningham A, Harper L. Latent Cytomegalovirus Infection and Previous Capsular Polysaccharide Vaccination Predict Poor Vaccine Responses in Older Adults, Independent of Chronic Kidney Disease. Clin Infect Dis. 2021 Aug 16;73(4):e880-e889. doi: 10.1093/cid/ciab078. |
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| ID | Term |
|---|---|
| D007154 | Immune System Diseases |
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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Serum, Plasma, Peripheral Blood Mononuclear Cells, Urine
investigatory outcome - will be assessed using flow cytometric techniques and established biochemical laboratory eGFR testing
| 6 months |
| Relationship between eGFR and reported infection rates | as assessed using established biochemical laboratory eGFR testing and participant reported infection-related events | 6 months |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |