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Vaccination Against Influenza H1N1 in Rheumatic Diseases

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ClinicalTrials.gov Identifier: NCT01006681
Recruitment Status : Unknown
Verified November 2009 by Tel-Aviv Sourasky Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : November 3, 2009
Last Update Posted : November 3, 2009
Sponsor:
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Influenza Rheumatic Diseases Biological: Focetria (Monovalent MF59-Adjuvanted vaccine) Phase 2

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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
Study Start Date : November 2009
Estimated Primary Completion Date : April 2010
Estimated Study Completion Date : April 2010


Arm Intervention/treatment
Experimental: Monovalent MF59-Adjuvanted vaccine 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

Other Name: Focetria

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

Other Name: Focetria

Biological: Focetria (Monovalent MF59-Adjuvanted vaccine)
Monovalent MF59-Adjuvanted vaccine
Other Name: Focetria




Primary Outcome Measures :
  1. 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 [ Time Frame: 4 weeks ]

Secondary Outcome Measures :
  1. Secondary Endpoint: Safety of the vaccine with regard to disease activity by changes in DAS, SLEDAI and BASDAI [ Time Frame: 4 weeks ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ori Elkayam, Tel Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier: NCT01006681     History of Changes
Other Study ID Numbers: 0560-09
First Posted: November 3, 2009    Key Record Dates
Last Update Posted: November 3, 2009
Last Verified: November 2009

Keywords provided by Tel-Aviv Sourasky Medical Center:
rheumatoid
SLE
Psoriatic arthritis
Ankylosing
Influenza H1N1
Vaccine
Vaccination against H1N1 in rheumatic diseases

Additional relevant MeSH terms:
Influenza, Human
Arthritis, Psoriatic
Rheumatic Diseases
Collagen Diseases
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Spondylarthropathies
Spondylarthritis
Spondylitis
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Arthritis
Joint Diseases
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Connective Tissue Diseases
Vaccines
MF59 oil emulsion
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic