Vaccination Against Influenza H1N1 in Rheumatic Diseases

Influenza Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01006681
• Other study ID #: 0560-09
• Status: Not yet recruiting
• Phase: Phase 2
• First received: October 31, 2009
• Last updated: November 2, 2009
• Start date: November 2009
• Est. completion date: April 2010

Study information

• Verified date: November 2009
• Source: Tel-Aviv Sourasky Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 400
• Est. completion date: April 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Influenza
• Influenza, Human
• Rheumatic Diseases

Intervention

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
• 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
• Focetria (Monovalent MF59-Adjuvanted vaccine)
Monovalent MF59-Adjuvanted vaccine

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Tel-Aviv Sourasky Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Secondary Endpoint: Safety of the vaccine with regard to disease activity by changes in DAS, SLEDAI and BASDAI		4 weeks	Yes