Immune System DiseasesSONICNCT02535052
Investigating the Immune System in chrONIC Kidney Disease.
An observational study of Immune System Diseases and Chronic Kidney Disease, run by University of Birmingham at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Immune System Diseases, Chronic Kidney Disease
- What is being tested?
- Seasonal influenza and pneumococcal polysaccharide vaccines
- Type of treatment
- Vaccines
- How many people
- 43 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jul 2015to Aug 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: 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.
Who may be able to join
- any gender
- aged 65 and over
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University Hospitals Birmingham NHS Foundation Trust
Birmingham, West Midlands
About this study
Official title: Investigating the Immune System in chrONIC Kidney Disease - the SONIC Study.
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.
Read the 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
- Being tested
- Seasonal influenza and pneumococcal polysaccharide vaccines
- Medical subject headings
- Immune System Diseases, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Seasonal influenza and pneumococcal polysaccharide vaccinesBiological
Vaccination
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Biological: Seasonal influenza and pneumococcal polysaccharide vaccines | |
| 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. Receives: Biological: Seasonal influenza and pneumococcal polysaccharide vaccines |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants achieving adequate humoral response to either vaccine
as assessed by vaccine-specific serum IgG levels
Measured: 28 days
Secondary outcomes (3)
Proportion of participants who maintain protective antibody titres to either vaccine at 6 months after vaccination
as assessed by vaccine-specific serum IgG levels
Measured: 6 months
Relationship between eGFR and immune cell subsets following vaccination
investigatory outcome - will be assessed using flow cytometric techniques and established biochemical laboratory eGFR testing
Measured: 6 months
Relationship between eGFR and reported infection rates
as assessed using established biochemical laboratory eGFR testing and participant reported infection-related events
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2015 (estimated)
- Study startJul 2015
- Primary completionAug 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Immune System DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- Wellcome Trust, University Hospital Birmingham NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Lorraine Harper, Principal investigator, University of Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02535052
- Sponsor's protocol ID
- RG_14-216
- Acronym
- SONIC
- Status last verified
- May 2016
- First submitted
- 25 Aug 2015
- Last updated
- 16 May 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Wall N, Godlee A, Geh D, Jones C, Faustini S, Harvey R, Penn R, Chanouzas D, Nightingale P, O'Shea M, Richter A, Moss P, Cunningham A, Harper L. Latent Cytomegalovirus Infection and Previous Capsular Polysaccharide Vaccination Predict Poor Vaccine Responses in Older Adults, Independent of Chronic Kidney Disease. Clin Infect Dis. 2021 Aug 16;73(4):e880-e889. doi: 10.1093/cid/ciab078.
PubMed 33728434
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Immune System in chrONIC Kidney Disease - the SONIC Study.
- ClinicalTrials.gov ID
- NCT02535052
- Acronym / sponsor ID
- SONIC / RG_14-216
- Conditions
- Immune System Diseases, Chronic Kidney Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 43 participants (actual)
- Lead sponsor
- University of BirminghamUniversity, hospital or other
- Collaborators
- Wellcome Trust, University Hospital Birmingham NHS Foundation Trust
- Study start
- Jul 2015
- Primary completion
- Aug 2017 (estimated)
- First posted
- 28 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chronic Kidney Disease (CKD) patients | – | Biological: Seasonal influenza and pneumococcal polysaccharide vaccinesAny 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. |
| Healthy Control subjects | – | Biological: Seasonal influenza and pneumococcal polysaccharide vaccinesAny 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- 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.
Key inclusion criteria (2 listed)
- any gender
- aged 65 and over
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Seasonal influenza and pneumococcal polysaccharide vaccinesVaccination | Biological | Chronic Kidney Disease (CKD) patients, Healthy Control subjects |
Primary outcome
Proportion of participants achieving adequate humoral response to either vaccine
Time frame: 28 days
as assessed by vaccine-specific serum IgG levels
3 secondary outcomes
Proportion of participants who maintain protective antibody titres to either vaccine at 6 months after vaccination
Time frame: 6 months
Relationship between eGFR and immune cell subsets following vaccination
Time frame: 6 months
Relationship between eGFR and reported infection rates
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2016.
- Derived from this study: PubMed 33728434Wall N, Godlee A, Geh D, Jones C, Faustini S, Harvey R, Penn R, Chanouzas D, Nightingale P, O'Shea M, Richter A, Moss P, Cunningham A, Harper L. Latent Cytomegalovirus Infection and Previous Capsular Polysaccharide Vaccination Predict Poor Vaccine Responses in Older Adults, Independent of Chronic Kidney Disease. Clin Infect Dis. 2021 Aug 16;73(4):e880-e889. doi: 10.1093/cid/ciab078.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lorraine Harper principal investigator
University of Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Immune System Diseases and Chronic Kidney Disease, run by University of Birmingham at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants achieving adequate humoral response to either vaccine (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02535052, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2016.