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Impact of Immunosuppression in IBD Patients on Response to Influenza Vaccine

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ClinicalTrials.gov Identifier: NCT00542776
Recruitment Status : Completed
First Posted : October 11, 2007
Last Update Posted : May 1, 2008
Sponsor:
Collaborator:
Thrasher Research Fund
Information provided by:
Boston Children’s Hospital

Brief Summary:
The purpose of this study is to compare the efficacy and safety of influenza vaccine in patients with inflammatory bowel disease (IBD) on immunosuppressive therapy with IBD patients on aminosalicylates and healthy historical controls.

Condition or disease Intervention/treatment
Inflammatory Bowel Disease (IBD) Immunosuppressed or Non-Immunosuppressed Influenza Vaccine Antibody Titers Seroprotective Titers Other: blood draw

  Show Detailed Description

Study Type : Observational
Actual Enrollment : 146 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Impact of Immunosuppression in Patients With Inflammatory Bowel Disease on Responsiveness to Influenza Vaccine
Study Start Date : October 2007
Actual Primary Completion Date : February 2008
Actual Study Completion Date : February 2008

Resource links provided by the National Library of Medicine

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

Group/Cohort Intervention/treatment
1
IBD patients on immunosuppressive therapy
Other: blood draw
drawing blood for seroprotection and antibody titers to the 3 strains of influenza on Day 1 and Month 1 (3-8 weeks)
2
IBD patients on non-immunosuppressive therapy (e.g., aminosalicylates, antibiotics) or on no medications
Other: blood draw
drawing blood for seroprotection and antibody titers to the 3 strains of influenza on Day 1 and Month 1 (3-8 weeks)



Primary Outcome Measures :
  1. seroprotection rate [ Time Frame: 3-8 weeks after vaccination ]

Secondary Outcome Measures :
  1. vaccine-associated adverse events [ Time Frame: up to 8 weeks after vaccination ]
  2. antibody titer levels [ Time Frame: 3-8 weeks after vaccination ]

Biospecimen Retention:   Samples Without DNA
Blood for seroprotection rate and antibody titers


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Ages Eligible for Study:   5 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients aged 5 years and older with documented inflammatory bowel disease (Crohn's disease, ulcerative colitis, indeterminate colitis)
Criteria

Inclusion Criteria:

  1. Crohn's disease, ulcerative colitis, or indeterminate colitis diagnosed by standard clinical, radiographic, endoscopic, and histologic criteria.
  2. Age 5 years and older
  3. Actively or previously followed by a gastroenterologist at Children's Hospital Boston
  4. On non-immunosuppressants (aminosalicylates, antibiotics, or no medications) and/or immunosuppressants (steroids, immunomodulators, TNF-alpha inhibitors) for the past 30 days. Standard concomitant medications (e.g. antihistamines, acetaminophen) will be allowed.

Exclusion Criteria:

  1. History of bleeding disorder that would make hematoma likely (eg hemophilia, von Willebrand's disease)
  2. Received influenza vaccination during the current influenza season
  3. Contraindications to the influenza vaccine (such as severe allergic reaction to prior influenza vaccine)
  4. Fever within 48 hr prior to injection
  5. Receipt of another vaccination within 2 days of influenza vaccine dose (and no other vaccines planned for 2 days after influenza vaccine)

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): NCT00542776


Locations
United States, Massachusetts
Children's Hospital Boston
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Boston Children’s Hospital
Thrasher Research Fund
Investigators
Principal Investigator: Ying Lu, MD Boston Children’s Hospital

Publications:

Responsible Party: Ying Lu, MD, Children's Hospital Boston
ClinicalTrials.gov Identifier: NCT00542776     History of Changes
Other Study ID Numbers: 07-09-0345
First Posted: October 11, 2007    Key Record Dates
Last Update Posted: May 1, 2008
Last Verified: December 2007

Keywords provided by Boston Children’s Hospital:
inflammatory bowel disease (IBD)
immunosuppressed or non-immunosuppressed
influenza vaccine
antibody titers
seroprotective titers
vaccine-associated adverse events

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
Immunologic Factors
Physiological Effects of Drugs