Investigating the Immune System in chrONIC Kidney Disease. (SONIC)
Investigating the Immune System in chrONIC Kidney Disease - the SONIC Study.
Přehled studie
Postavení
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Aktuální)
Kontakty a umístění
Studijní místa
-
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West Midlands
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Birmingham, West Midlands, Spojené království
- University Hospitals Birmingham NHS Foundation Trust
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Metoda odběru vzorků
Studijní populace
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.
Popis
Inclusion Criteria:
- any gender
- aged 65 and over
Exclusion Criteria:
- Subjects who have had Pneumovax within last 5 years
- Subjects who have had current season's influenza vaccine
- CKD patients: eGFR less than 15ml/min or greater than 60ml/min, immune mediated cause of kidney disease.
- Healthy control subjects: known kidney disease, eGFR less than 60ml/min
- Subjects with comorbidities that are associated with an immunosuppressed state including, but not limited to, the following: Malignancy diagnosed within last 5 years except non-melanoma skin cancer; Solid organ (including kidney) or bone marrow transplant recipients; Blood borne viral infections: HIV, hepatitis B and C; Autoimmune disease e.g. vasculitis, rheumatoid arthritis; Previous splenectomy or asplenia from any other cause.
- Subjects currently taking any of the following immunosuppressive medications: Systemic corticosteroids e.g. prednisolone/dexamethasone; Chemotherapy agents e.g. cyclophosphamide, methotrexate, azathioprine; Biological therapies e.g. rituximab, infliximab, etanercept - including any administration within preceding 12 months.
- Subjects who have previously had a serious reaction to influenza vaccination, including anaphylaxis and Guillain-Barre Syndrome within 6 weeks of previous influenza vaccination
- Subjects who have a severe egg allergy (contraindication to influenza vaccination)
- Subjects who have previously had a serious reaction to the whole or any components of pneumococcal vaccination
- Subjects who have an active infection and/or are febrile on assessment
Studijní plán
Jak je studie koncipována?
Detaily designu
- Observační modely: Case-Control
- Časové perspektivy: Budoucí
Kohorty a intervence
Skupina / kohorta |
Intervence / Léčba |
|---|---|
|
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.
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Vaccination
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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.
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Vaccination
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Proportion of participants achieving adequate humoral response to either vaccine
Časové okno: 28 days
|
as assessed by vaccine-specific serum IgG levels
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28 days
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Proportion of participants who maintain protective antibody titres to either vaccine at 6 months after vaccination
Časové okno: 6 months
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as assessed by vaccine-specific serum IgG levels
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6 months
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Relationship between eGFR and immune cell subsets following vaccination
Časové okno: 6 months
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investigatory outcome - will be assessed using flow cytometric techniques and established biochemical laboratory eGFR testing
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6 months
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Relationship between eGFR and reported infection rates
Časové okno: 6 months
|
as assessed using established biochemical laboratory eGFR testing and participant reported infection-related events
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6 months
|
Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Lorraine Harper, University of Birmingham
Publikace a užitečné odkazy
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Očekávaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- RG_14-216
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