Investigating the Immune System in chrONIC Kidney Disease. (SONIC)
Investigating the Immune System in chrONIC Kidney Disease - the SONIC Study.
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
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 estudo
Inscrição (Real)
Contactos e Locais
Locais de estudo
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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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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
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.
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Modelos de observação: Controle de caso
- Perspectivas de Tempo: Prospectivo
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
|---|---|
|
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
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Proportion of participants achieving adequate humoral response to either vaccine
Prazo: 28 days
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as assessed by vaccine-specific serum IgG levels
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28 days
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Proportion of participants who maintain protective antibody titres to either vaccine at 6 months after vaccination
Prazo: 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
Prazo: 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
Prazo: 6 months
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as assessed using established biochemical laboratory eGFR testing and participant reported infection-related events
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6 months
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Lorraine Harper, University of Birmingham
Publicações e links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Antecipado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- RG_14-216
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