NCT02535052

Investigating the Immune System in chrONIC Kidney Disease.

Investigating the Immune System in chrONIC Kidney Disease - the SONIC Study.

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 43 (actual)
• Sponsor: University of Birmingham · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Immune System Diseases
• Chronic Kidney Disease

Interventions

Type	Name	Description
BIOLOGICAL	Seasonal influenza and pneumococcal polysaccharide vaccines	Vaccination

Timeline

• Start date: 2015-07-01
• Primary completion: 2017-08-01
• First posted: 2015-08-28
• Last updated: 2016-05-16

Locations

1 site across 1 country: United Kingdom