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

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  Active, not recruiting
Sponsor:
Information provided by:
Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier:
NCT01019837
First received: November 22, 2009
Last updated: November 23, 2009
Last verified: November 2009
  Purpose

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 Intervention
Influenza H1N1
Biological: Focetria (Monovalent MF59-Adjuvanted vaccine)

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

Resource links provided by NLM:


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

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 [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 200
Study Start Date: November 2009
Estimated Study Completion Date: April 2010
Estimated Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)
Other Name: Focetria (Monovalent MF59-Adjuvanted vaccine)

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
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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)
  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.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01019837

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

No publications provided

Responsible Party: Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier: NCT01019837     History of Changes
Other Study ID Numbers: TASMC-09-ID-553-CTIL
Study First Received: November 22, 2009
Last Updated: November 23, 2009
Health Authority: Israel: Ministry of Health

Keywords provided by Tel-Aviv Sourasky Medical Center:
Vaccine

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

ClinicalTrials.gov processed this record on September 14, 2014