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

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ClinicalTrials.gov Identifier: NCT01019837
Recruitment Status : Unknown
Verified November 2009 by Tel-Aviv Sourasky Medical Center.
Recruitment status was:  Active, not recruiting
First Posted : November 25, 2009
Last Update Posted : November 25, 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. 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.

Condition or disease Intervention/treatment Phase
Influenza H1N1 Biological: Focetria (Monovalent MF59-Adjuvanted vaccine) Not Applicable

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Efficacy and Safety of Vaccination Against Influenza H1N1 in Patients With Inflammatory Bowel Diseases Treated With Immunomodulators and Biologics
Study Start Date : November 2009
Estimated Primary Completion Date : November 2009
Estimated Study Completion Date : April 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Monovalent MF59- Adjuvanted vaccine
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
Biological: Focetria (Monovalent MF59-Adjuvanted vaccine)
Biological: Focetria (Monovalent MF59-Adjuvanted vaccine)



Primary Outcome Measures :
  1. 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. 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 ]


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

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01019837


Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
Investigators
Study Director: Iris Dotan, Dr. Tel-Aviv Sourasky Medical Center

Responsible Party: Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier: NCT01019837     History of Changes
Other Study ID Numbers: TASMC-09-ID-553-CTIL
First Posted: November 25, 2009    Key Record Dates
Last Update Posted: November 25, 2009
Last Verified: November 2009

Keywords provided by Tel-Aviv Sourasky Medical Center:
Vaccine

Additional relevant MeSH terms:
Influenza, Human
Intestinal Diseases
Inflammatory Bowel Diseases
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
Vaccines
MF59 oil emulsion
Immunologic Factors
Adjuvants, Immunologic
Physiological Effects of Drugs