Efficacy Safety Study of Flu Vaccine in Immunodepression Patients
Condition: Inflammatory Bowel Disease (IBD)
MeSH terms: Intestinal Diseases; Inflammatory Bowel Diseases
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary purpose of the study is to compare the efficacy and safety of influenza vaccine
      in patients with inflammatory bowel disease (IBD) receiving immunosuppressive therapy with
      patients not receiving immunosuppressants .

      The main objective of the study is to evaluate the humoral immunogenicity of influenza
      vaccination in patients with IBD
    

Detailed description: 
      Annual vaccination against influenza is recommended for those at high risk of complications,
      particularly among patients with immunodeficiency including those resulting from
      immunosuppressive treatments administered for a chronic inflammatory bowel disease (IBD).
      However, published data showing that influenza vaccination coverage is low in this population
      (<30%) due to lack of data on the effectiveness of vaccination in these patients and the
      theoretical risk of negative impact on the evolution of IBD.

      To improve influenza vaccination coverage of the population treated by immunosuppressants for
      a chronic IBD, it is essential to have data on the effectiveness of vaccination in these
      populations.

      The research aims to evaluate the immunogenicity of influenza vaccination in patients
      followed for a chronic IBD.

      Factors in choice of study population were as follows:

        1. IBD is a common disease. Among the inflammatory diseases treated with immunosuppressants
           and reaching patients under 65 years, IBD are among the most frequent. They result from
           an abnormal immune response to gut flora and their management often requires the
           prescription of immunosuppressive drugs (azathioprine, methotrexate, in particular) and
           more recently TNF-blockers;

        2. the existence of vaccine recommendations published recently for specific patients on
           immunosuppressive therapy at greatest risk of complications related to influenza;

        3. the fact that vaccinations have not been implicated in the pathogenesis of the disease;

        4. data showing that vaccination recommendations are poorly followed in this population. A
           recently published work found vaccination coverage against influenza of only 28% in a
           cohort of 169 patients treated for IBD;

      The methodology chosen is a phase III, prospective, open, vaccine trial. The primary endpoint
      is the humoral immunogenicity induced by the vaccine.

      The study is scheduled on 2 successive years to assess the value of annual vaccination
      repeated in this population treated with immunosuppressants.

      There is a benefit for patients to participate in this study because they are all vaccinated
      against influenza and will benefit from a clinical and laboratory monitoring in this study.
      Moreover, these patients are taken to be vaccinated in the event of a pandemic influenza
    

Intervention name(s): Vaccine; Vaccine anti-H1N1
Intervention type(s): Drug; Biological
Intervention description(s): MUTAGRIP (2009-2010 winter) VAXIGRIP (2010-2011 winter); patients who received the vaccine anti-H1N1
Intervention MeSH terms: Vaccines
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: inflammatory bowel disease (IBD); immunosuppressed or non-immunosuppressed; influenza vaccine; antibody titers; seroprotective titers; vaccine-associated adverse events