Vaccination Against Influenza in Autoimmune Diseases

Study Overview
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Brief Summary
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The project is to evaluate immunogenicity, efficacy and tolerance of vaccination against influenza (seasonal and H1N1) in patients affected with systemic and autoimmune diseases.

Detailed Description
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This prospective study concentrates on patients with vasculitis, systemic sclerosis, Sjögren's syndrome, systemic lupus erythematosus and other connective tissue diseases. Patients responding to the inclusion criteria, will receive vaccine against seasonal influenza then, 3 weeks later, vaccine against H1N1 influenza. According to the results of ongoing trials a second injection of H1N1 vaccine has been scheduled 3 weeks later. At each consultation a blood sample will be taken to evaluate immunogenicity of vaccination. Two additional consultations have been scheduled: one month after the last vaccine administration and at 6 month, in order to evaluate the occurrence of late side effects.

Official Title
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Evaluation of Vaccination Against Influenza (Seasonal and H1N1) in Patients Presenting Systemic or Autoimmune Diseases Treated or Not With Steroids, and/or Immunosuppressant, and/or Biotherapy: an Open, Prospective Trial (MAIVAX)

Conditions
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Autoimmune Diseases

Intervention / Treatment
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* Biological: Evaluation of vaccines against flu


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients presenting autoimmune and systemic diseases, treating or not with steroids, and/or immunosuppressants and/or biotherapies, especially vasculitis, scleroderma, Sjogren's syndrome and systemic lupus (main groups) Exclusion Criteria: Absence of informed consent Disease which did not responded to the above criteria Active infection at time of vaccination HIV infection History of Guillain-Barre syndrome Allergy to one component of the vaccine

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Evaluation of vaccines against flu<br>Evaluation of vaccines against flu | Biological: Evaluation of vaccines against flu<br>* evaluate efficacy and tolerance<br>* Other names: Evaluation of vaccines against flu in auto-imune diseases;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Protection against H1N1 influenza, defined by antibody level of 1/40, measured by hemagglutination, 3 weeks after the first injection and after the second injection | Mesure of antibody level of 1/40, measured by hemagglutination, 3 weeks after the first injection and after the second injection | 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antibody levels against H1N1 in the different groups of patients, defined according diseases and their treatment (comparison of patients treated by immunosuppressants or not treated) | Antibody levels against H1N1 in the different groups of patients, defined according diseases and their treatment | 3 weeks | 
| Number of side effects related to vaccination |  | 3 weeks | 
| Number of local side effects related to vaccination (erythema and/or pain at injection site) |  | 3 weeks | 
| Number of patients who will develop influenza despite vaccination |  | 3 weeks | 
| Number of patients who had antibodies against H1N1 before vaccination |  | 3 weeks | 
| Number of hospitalisations and deaths related to influenza |  | 3 weeks | 
| Number of flares of the autoimmune diseases that could be related to vaccination |  | 3 weeks | 
| Determine if the induction of LT-CD4 to J21-28 anti-jams is correlated to the concentrations of antibody anti-vaccines measured in 6 months |  | 18 months | 
| Determine if the basal concentrations of LT-CD4 anti-jam to J21-J28 are correlated to the concentrations of antibody anti-vaccines measured in 6 months |  | 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Influenza, autoimmune diseases, vaccination, H1N1