Sarcoidosis Clinical Trial
Official title:
Determination of the Efficacy and Safety of the Seasonal Influenza Vaccine Among Patients Suffering From Sarcoidosis.
Sarcoidosis is an inflammatory disease of unknown origin that can affect all organs, especially the lungs and mediastinum. Some location of sarcoidosis may require treatment with corticosteroids or immunosuppressors.Although seasonal influenza vaccination can be recommended in sarcoidosis in some subgroups at risk (respiratory failure, pulmonary fibrosis, age over 65, use of immunosuppressive therapy, etc ...), the investigators presently have no data on the efficacy and safety (absence of adverse reactions) of seasonal influenza vaccination in sarcoidosis.Especially it is not known whether the seasonal influenza vaccine provides the same rate and same type of vaccine response in sarcoidosis patients than in the general population. Similarly, it is unclear whether the vaccine response is modified by the severity of the disease and treatment with corticosteroids and immunosuppressors.Based on what is known in systemic lupus and rheumatoid arthritis, which are both inflammatory and autoimmune diseases, the investigators expect at best a 50% vaccine response in patients with sarcoidosis and a 85% vaccination response in healthy controls. The demonstration of a vaccine response could allow reconsidering new vaccine approaches in sarcoidosis.
Data on vaccination in sarcoidosis are largely insufficient. It is thus unclear whether the vaccine response is modified according to the clinical phenotype of the disease and/or treatment with corticosteroids and immunosuppressants. However, sarcoidosis is accompanied by numerous disturbances of the immune system, including a tendency to anergy which may affect the efficacy of the vaccine, especially when the disease is active and severe. In addition, the tolerance of influenza vaccination in patients with sarcoidosis has not been studied yet.The influenza vaccination in sarcoidosis is a common practice among medical specialists who care for patients with sarcoidosis, either internists or lung specialists.. However, the practice of this vaccination is not based on scientific evidence, because there are no data establishing the efficacy and safety of influenza vaccination in sarcoidosis.Thus, it is possible that the influenza vaccine is less immunogenic in patients with sarcoidosis than in healthy adults, which may reduce the clinical effectiveness of vaccination. It therefore seems essential to determine the efficacy and safety of this vaccine, which is widely practiced. Poor efficiency could lead to the development of different vaccination strategies, based in particular on the administration of adjuvanted vaccines. ;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04008069 -
Sarilumab in Patients With Glucocorticoid-Dependent Sarcoidosis
|
Phase 2 | |
Recruiting |
NCT02807025 -
Nasal, Tracheal and Bronchial Mucosal Lining Fluid(MLF) Sampling From Patients With Respiratory Diseases
|
N/A | |
Completed |
NCT01615484 -
Ex-vivo Perfusion and Ventilation of Lungs Recovered From Non-Heart-Beating Donors to Assess Transplant Suitability
|
N/A | |
Completed |
NCT00274352 -
A Study of Adalimumab to Treat Sarcoidosis of the Skin
|
Phase 2 | |
Completed |
NCT00326534 -
Rickettsial Genesis to Sarcoidosis in Denmark
|
N/A | |
Completed |
NCT00373555 -
Endobronchial Ultrasonography in the Diagnosis of Sarcoidosis
|
N/A | |
Recruiting |
NCT00470327 -
A Study of the Natural Progression of Interstitial Lung Disease (ILD)
|
||
Completed |
NCT00512967 -
The Occurence of Inflammation and Oxidative Stress in Lung Diseases
|
N/A | |
Recruiting |
NCT01745237 -
Delayed-Enhancement Cardiovascular Magnetic Resonance in Patients With Sarcoidosis
|
||
Completed |
NCT00369980 -
Diagnostic Usefulness of Fluorine–18-α–Methyltyrosine PET in Combination With 18F-FDG in Sarcoidosis Patient
|
N/A | |
Completed |
NCT00379275 -
Eye and Immunogenetic Features of Sarcoidosis
|
N/A | |
Completed |
NCT00366509 -
Role of Helicobacter Pylori and Its Toxins in Lung and Digestive System Diseases
|
||
Completed |
NCT06396910 -
TB and Sarcoidosis Granuloma
|
||
Completed |
NCT04156789 -
Obstructive Sleep Apnoea in Sarcoidosis
|
||
Recruiting |
NCT02916459 -
EBUS-TBNA vs Flex 19G EBUS-TBNA
|
N/A | |
Recruiting |
NCT02827734 -
Evaluation of Novel Lung Function Parameters in Patients With Interstitial Lung Disease (ILD)
|
||
Completed |
NCT02546388 -
Somatostatin Receptor Imaging in Patients With Suspected Cardiac Sarcoidosis
|
N/A | |
Completed |
NCT01139710 -
Sarcoidosis-associated Pulmonary Hypertension
|
N/A | |
Terminated |
NCT00747461 -
Interventional Cryotherapy for the Eradication of Benign Airway Disease ("ICE the BAD")
|
Phase 4 | |
Completed |
NCT00555347 -
Use of Armodafinil for Fatigue in Sarcoidosis
|
Phase 2/Phase 3 |