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Efficacy and Safety of Vaccination Against Influenza H1N1 in Patients With Inflammatory Bowel Diseases (IBD) Treated Immunomodulators and Biologics

Primary Purpose

Influenza H1N1

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Focetria (Monovalent MF59-Adjuvanted vaccine)
Sponsored by
Tel-Aviv Sourasky Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Influenza H1N1 focused on measuring Vaccine

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Patients suffering from IBD (inflammatory bowel disease): UC/ CD
  2. Able to firm an informed consent
  3. Aged - 18-65
  4. Candidates to receive vaccination against H1N1, according to the recommendation of the Ministry of Health
  5. patients who treated with immunomodulators and biologics

Exclusion Criteria:

  1. Allergy to eggs
  2. Known allergy to seasonal influenza vaccine
  3. Pregnant women
  4. Patients who inoculate another vaccine in the past 3 weeks (except vaccine fot seasonal influenza
  5. Patients without worsening in their disease condition (stable condition)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Monovalent MF59- Adjuvanted vaccine

    Arm Description

    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

    Outcomes

    Primary Outcome Measures

    Proportion of patients who will achieve a titer of antibodies above 1/40 within the groups of patients in comparison with healthy subjects

    Secondary Outcome Measures

    Safety of the vaccine with regard to disease activity by changes in Crohn's Disease Activity Index (CDAI) and MAYO score

    Full Information

    First Posted
    November 22, 2009
    Last Updated
    November 23, 2009
    Sponsor
    Tel-Aviv Sourasky Medical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01019837
    Brief Title
    Efficacy and Safety of Vaccination Against Influenza H1N1 in Patients With Inflammatory Bowel Diseases (IBD) Treated Immunomodulators and Biologics
    Official Title
    Efficacy and Safety of Vaccination Against Influenza H1N1 in Patients With Inflammatory Bowel Diseases Treated With Immunomodulators and Biologics
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2009
    Overall Recruitment Status
    Unknown status
    Study Start Date
    November 2009 (undefined)
    Primary Completion Date
    November 2009 (Anticipated)
    Study Completion Date
    April 2010 (Anticipated)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Tel-Aviv Sourasky Medical Center

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The spread of Influenza H1N1 has prompted the development of vaccines against this virus. IBD 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. We would like to estimate the efficacy and safety of vaccination against influenza H1N1 in patients with IBD who treated with immunomodulatory drugs.
    Detailed Description
    200 patients with IBD 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 : CDAI and MAYO score

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Influenza H1N1
    Keywords
    Vaccine

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    200 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Monovalent MF59- Adjuvanted vaccine
    Arm Type
    Experimental
    Arm Description
    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
    Intervention Type
    Biological
    Intervention Name(s)
    Focetria (Monovalent MF59-Adjuvanted vaccine)
    Intervention Description
    Biological: Focetria (Monovalent MF59-Adjuvanted vaccine)
    Primary Outcome Measure Information:
    Title
    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 Measure Information:
    Title
    Safety of the vaccine with regard to disease activity by changes in Crohn's Disease Activity Index (CDAI) and MAYO score
    Time Frame
    4 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Patients suffering from IBD (inflammatory bowel disease): UC/ CD Able to firm an informed consent Aged - 18-65 Candidates to receive vaccination against H1N1, according to the recommendation of the Ministry of Health patients who treated with immunomodulators and biologics Exclusion Criteria: Allergy to eggs Known allergy to seasonal influenza vaccine Pregnant women Patients who inoculate another vaccine in the past 3 weeks (except vaccine fot seasonal influenza Patients without worsening in their disease condition (stable condition)
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Iris Dotan, Dr.
    Organizational Affiliation
    Tel-Aviv Sourasky Medical Center
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    Efficacy and Safety of Vaccination Against Influenza H1N1 in Patients With Inflammatory Bowel Diseases (IBD) Treated Immunomodulators and Biologics

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