Vaccination Against Influenza H1N1 in Rheumatic Diseases

Study Overview
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Brief Summary
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The spread of Influenza H1N1 has prompted the development of vaccines against this virus. Immunocompromised patients are at increased risk of developing complications of Influenza H1N1. The efficacy and safety of H1N1 vaccination have not been evaluated in this population of patients.

Detailed Description
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100 patients with Rheumatoid Arthritis (RA), 50 patients with Systemic Lupus Erythematosus (SLE), 50 patients with spondyloarthropathies (Psoriatic arthritis (PsA) and Ankylosing Spondylitis (AS) and 200 healthy subjects will participate in the study. All the subjects will be vaccinated with Focetria (Novartis) and will be evaluated the day of vaccination and 4 weeks later. The evaluation will include: Efficacy of the vaccine: Blood will be drawn on day 0 and 4 weeks later and tested for the presence of antibodies against A/California17/2009/H1N1 by hemagglutination inhibition test. Safety of the vaccine: Records of adverse event Assessment of disease activity : RA - Disease activity score (DAS 28), SLE - SLEDAI, PsA - DAS 28 and PASI, AS- BASDAI, ESR, CRP

Official Title
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Efficacy and Safety of Vaccination Against Influenza H1N1 in Patients With Rheumatoid Arthritis, Systemic Lupus Erythematosus, Psoriatic Arthritis and Ankylosing Spondylitis Treated With Immunomodulatory Drugs

Conditions
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Influenza, Rheumatic Diseases

Intervention / Treatment
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* Biological: Focetria (Monovalent MF59-Adjuvanted vaccine)
* Biological: Focetria (Monovalent MF59-Adjuvanted vaccine)
* Biological: Focetria (Monovalent MF59-Adjuvanted vaccine)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients suffering from: Rheumatoid Arthritis, Systemic Lupus Erythematosus, Ankylosing Spondylitis, Psoriatic Arthritis Able to firm an informed consent Aged - 18-65 Candidates to receive vaccination against H1N1, according to the recommendation of the Ministry of Health Exclusion Criteria: Allergy to eggs Known allergy to seasonal influenza vaccine Pregnant women

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Monovalent MF59-Adjuvanted vaccine<br> | Biological: Focetria (Monovalent MF59-Adjuvanted vaccine)<br>* 7.5 mcg Hemagglutinin H1/InfluezaA/California/7/2009 ,9.75 mg squalene MF59, 1.175 mg polysort80, 1.175 mg sorbitan trioleate Intra muscular<br>* Other names: Focetria;Biological: Focetria (Monovalent MF59-Adjuvanted vaccine)<br>* 7.5 mg Hemagglutinin H1/InfluezaA/California/7/2009, 9.75 mg squalene MF59, 1.175 mg polysirate 80, 1.175 mg sorbitan trioleate Intramuscular injection<br>* Other names: Focetria;Biological: Focetria (Monovalent MF59-Adjuvanted vaccine)<br>* Monovalent MF59-Adjuvanted vaccine<br>* Other names: Focetria;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Endpoint : Proportion of patients who will achieve a titer of antibodies above 1/40 within the groups of patients in comparison with healthy subjects |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary Endpoint: Safety of the vaccine with regard to disease activity by changes in DAS, SLEDAI and BASDAI |  | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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rheumatoid, SLE, Psoriatic arthritis, Ankylosing, Influenza H1N1, Vaccine, Vaccination against H1N1 in rheumatic diseases