Infliximab IBD Influenza Vaccine Study

University of Calgary137 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

137

Conditions

Inflammatory Bowel Disease

Interventions

Eligibility

Sex: ALLMin age: 9 YearsMax age: 60 Years

Medical Language ↔ Plain English

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: 1. Pregnancy 2. Hypersensitivity reaction to previous dose of influenza vaccine 3. Known hypersensitivity to eggs or chicken or other components of influenza vaccine

Outcomes

Primary Outcomes

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.

Time frame: 28 days ± 3 days after influenza vaccination

Secondary Outcomes

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.