Investigating the Immune System in chrONIC Kidney Disease. (SONIC)
Investigating the Immune System in chrONIC Kidney Disease - the SONIC Study.
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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West Midlands
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Birmingham, West Midlands, Reino Unido
- University Hospitals Birmingham NHS Foundation Trust
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
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.
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: Control de caso
- Perspectivas temporales: Futuro
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
|
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.
|
Vaccination
|
|
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.
|
Vaccination
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Proportion of participants achieving adequate humoral response to either vaccine
Periodo de tiempo: 28 days
|
as assessed by vaccine-specific serum IgG levels
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28 days
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Proportion of participants who maintain protective antibody titres to either vaccine at 6 months after vaccination
Periodo de tiempo: 6 months
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as assessed by vaccine-specific serum IgG levels
|
6 months
|
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Relationship between eGFR and immune cell subsets following vaccination
Periodo de tiempo: 6 months
|
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
Periodo de tiempo: 6 months
|
as assessed using established biochemical laboratory eGFR testing and participant reported infection-related events
|
6 months
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Lorraine Harper, University of Birmingham
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- RG_14-216
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