NCT01006681

Vaccination Against Influenza H1N1 in Rheumatic Diseases

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 400 (estimated)
• Sponsor: Tel-Aviv Sourasky Medical Center · Other Government
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

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

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

Conditions

• Influenza
• Rheumatic Diseases

Interventions

Type	Name	Description
BIOLOGICAL	Focetria (Monovalent MF59-Adjuvanted vaccine)	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
BIOLOGICAL	Focetria (Monovalent MF59-Adjuvanted vaccine)	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
BIOLOGICAL	Focetria (Monovalent MF59-Adjuvanted vaccine)	Monovalent MF59-Adjuvanted vaccine

Timeline

• Start date: 2009-11-01
• Primary completion: 2010-04-01
• Completion: 2010-04-01
• First posted: 2009-11-03
• Last updated: 2009-11-03