Investigating the Immune System in chrONIC Kidney Disease - the SONIC Study.
试验速览
- 阶段
- 不适用
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- Proportion of participants achieving adequate humoral response to either vaccine
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •any gender
- •aged 65 and over
排除标准
- •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
结局指标
主要结局
Proportion of participants achieving adequate humoral response to either vaccine
时间窗: 28 days
as assessed by vaccine-specific serum IgG levels
次要结局
- Proportion of participants who maintain protective antibody titres to either vaccine at 6 months after vaccination(6 months)
- Relationship between eGFR and immune cell subsets following vaccination(6 months)
- Relationship between eGFR and reported infection rates(6 months)