Vaccination Against Influenza H1N1 in Rheumatic Diseases

Phase 2

• Conditions: Influenza; Rheumatic Diseases
• Interventions: Biological: Focetria (Monovalent MF59-Adjuvanted vaccine)

• Registration Number: NCT01006681
• Lead Sponsor: Tel-Aviv Sourasky Medical Center

Brief 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

Study Timeline

• Study First Submitted: 2009-10-31
• Status Verified: 2009-11
• Study Start: 2009-11
• Study First Submitted QC: 2009-11-02
• Last Update Submitted: 2009-11-02
• Study First Posted: 2009-11-03
• Last Update Posted: 2009-11-03
• Primary Completion: 2010-04
• Study Completion: 2010-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 400

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Monovalent MF59-Adjuvanted vaccine	Focetria (Monovalent MF59-Adjuvanted vaccine)	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Secondary Endpoint: Safety of the vaccine with regard to disease activity by changes in DAS, SLEDAI and BASDAI	4 weeks