Vaccination Against Influenza H1N1 in Rheumatic Diseases

November 2, 2009 updated by: Tel-Aviv Sourasky Medical Center

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

400

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • Focetria
Biological: Focetria (Monovalent MF59-Adjuvanted vaccine)
Monovalent MF59-Adjuvanted vaccine
Other Names:
  • Focetria

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
4 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tel-Aviv Sourasky Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (Anticipated)

April 1, 2010

Study Completion (Anticipated)

April 1, 2010

Study Registration Dates

First Submitted

October 31, 2009

First Submitted That Met QC Criteria

November 2, 2009

First Posted (Estimate)

November 3, 2009

Study Record Updates

Last Update Posted (Estimate)

November 3, 2009

Last Update Submitted That Met QC Criteria

November 2, 2009

Last Verified

November 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0560-09

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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