Effect of Influenza Vaccination Timing on Immune Response in Patients With Inflammatory Bowel Disease on Infliximab Therapy: A Randomized Equivalence Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Inflammatory Bowel Disease
- Sponsor
- University of Calgary
- Enrollment
- 137
- Locations
- 1
- Primary Endpoint
- Serologic protection
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
The investigators will compare the immunogenicity of influenza vaccine in adults and children with inflammatory bowel disease by timing of vaccine in relation to maintenance infliximab dosing. The primary objective is to compare the proportion of IBD patients on maintenance infliximab who mount serologic protection to each component of the influenza vaccination between patients vaccinated on day of infliximab infusion (Day 0 to 4) and patients vaccinated at the mid-point between infliximab infusions (Day 21 to 28). Serologic protection will be defined by a hemagglutination-inhibition titer ≥ 1:40. The secondary objective is to compare the proportion of IBD patients who mount an immunogenic response (≥ 4-fold increase from pre to post-vaccination titer) to each component of the influenza vaccination between patients vaccinated on day of infliximab infusion and those vaccinated at the mid-point.
Investigators
Jennifer deBruyn
Assistant Professor
University of Calgary
Eligibility Criteria
Inclusion Criteria
- •Diagnosis of IBD established by accepted criteria
- •On maintenance infliximab administered every 6 to 8 weeks (already received at least 6 weeks of infliximab)
- •Between ages 9 and 60 years
Exclusion Criteria
- •Hypersensitivity reaction to previous dose of influenza vaccine
- •Known hypersensitivity to eggs or chicken or other components of influenza vaccine
Outcomes
Primary Outcomes
Serologic protection
Time Frame: 28 days ± 3 days after influenza vaccination
To compare the proportion of IBD patients on maintenance infliximab who mount serologic protection to each component of the influenza vaccination between patients vaccinated on day of infliximab infusion (Day 0 to 4) and patients vaccinated at the mid-point between infliximab infusions (Day 21 to 28). Serologic protection will be defined by a hemagglutination-inhibition titer ≥ 1:40.
Secondary Outcomes
- Immunogenic response(28 days ± 3 days after influenza vaccination)