Vaccination Against Influenza H1N1 in Rheumatic Diseases

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2009 by Tel-Aviv Sourasky Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier:
NCT01006681
First received: October 31, 2009
Last updated: November 2, 2009
Last verified: November 2009
  Purpose

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 Intervention Phase
Influenza
Rheumatic Diseases
Biological: Focetria (Monovalent MF59-Adjuvanted vaccine)
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Tel-Aviv Sourasky Medical Center:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Secondary Endpoint: Safety of the vaccine with regard to disease activity by changes in DAS, SLEDAI and BASDAI [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 400
Study Start Date: November 2009
Estimated Study Completion Date: April 2010
Estimated Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided by Tel-Aviv Sourasky Medical Center

Additional 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
Study First Received: October 31, 2009
Last Updated: November 2, 2009
Health Authority: Israel: Ministry of Health

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:
Arthritis
Arthritis, Psoriatic
Influenza, Human
Lupus Erythematosus, Systemic
Rheumatic Diseases
Spondylitis, Ankylosing
Joint Diseases
Musculoskeletal Diseases
Spondylarthropathies
Spondylarthritis
Spondylitis
Spinal Diseases
Bone Diseases
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Ankylosis

ClinicalTrials.gov processed this record on July 31, 2014