Impact of Immunosuppression in IBD Patients on Response to Influenza Vaccine

This study has been completed.
Sponsor:
Collaborator:
Thrasher Research Fund
Information provided by:
Children's Hospital Boston
ClinicalTrials.gov Identifier:
NCT00542776
First received: October 9, 2007
Last updated: April 30, 2008
Last verified: December 2007
  Purpose

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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Impact of Immunosuppression in Patients With Inflammatory Bowel Disease on Responsiveness to Influenza Vaccine

Resource links provided by NLM:


Further study details as provided by Children's Hospital Boston:

Primary Outcome Measures:
  • seroprotection rate [ Time Frame: 3-8 weeks after vaccination ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • vaccine-associated adverse events [ Time Frame: up to 8 weeks after vaccination ] [ Designated as safety issue: Yes ]
  • antibody titer levels [ Time Frame: 3-8 weeks after vaccination ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Blood for seroprotection rate and antibody titers


Enrollment: 146
Study Start Date: October 2007
Study Completion Date: February 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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)

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   5 Years and older
Genders Eligible for Study:   Both
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00542776

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

Publications:

Responsible Party: Ying Lu, MD, Children's Hospital Boston
ClinicalTrials.gov Identifier: NCT00542776     History of Changes
Other Study ID Numbers: 07-09-0345
Study First Received: October 9, 2007
Last Updated: April 30, 2008
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on April 23, 2014