Infliximab IBD Influenza Vaccine Study

Study Overview
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Brief Summary
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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.

Official Title
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Effect of Influenza Vaccination Timing on Immune Response in Patients With Inflammatory Bowel Disease on Infliximab Therapy: A Randomized Equivalence Trial

Conditions
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Inflammatory Bowel Disease

Intervention / Treatment
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* Biological: Influenza vaccination


Participation Criteria
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Eligibility Criteria
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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: Pregnancy Hypersensitivity reaction to previous dose of influenza vaccine Known hypersensitivity to eggs or chicken or other components of influenza vaccine

Ages Eligible for Study
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Minimum Age: 9 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Influenza vaccination Timing #1<br>Influenza vaccination administered on the same day as infliximab administration (Day 0 to 4). | Biological: Influenza vaccination<br> <br> |
| Other: Influenza vaccination Timing #2<br>Influenza vaccination administered at the mid-point between infliximab infusions (Day 21 to 28) | Biological: Influenza vaccination<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serologic protection | 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. | 28 days ± 3 days after influenza vaccination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immunogenic response | To compare the proportion of IBD patients on maintenance infliximab who mount an immunogenic response 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). Immunogenicity will be defined as a fourfold or greater differences in titer between pre and post-vaccination sera. | 28 days ± 3 days after influenza vaccination | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Influenza vaccine, Immune response, Remicade (infliximab), Inflammatory bowel disease