Efficacy and Safety of Influenza Vaccine During Sarcoidosis
Condition: Sarcoidosis; Influenza Vaccine
MeSH terms: Influenza, Human; Sarcoidosis
Study type: Interventional
Phase: Phase 3

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Seasonal influenza vaccine available for the 2012-2013 vaccine campaign
Intervention type(s): Drug
Intervention description(s): Single injection of the vaccine at D0 (0.5mL intra-muscularly or subcutaneous for patient under anticoagulant treatment)
Intervention MeSH terms: Vaccines
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: sarcoidosis; healthy volunteers