Inflammatory Bowel Disease
Conditions
Keywords
Influenza vaccine, Immune response, Remicade (infliximab), Inflammatory bowel disease
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.
Interventions
BIOLOGICALInfluenza vaccination
Sponsors
Janssen Inc.
University of Calgary
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
9 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serologic protection | 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
| Measure | Time frame | Description |
|---|---|---|
| Immunogenic response | 28 days ± 3 days after influenza vaccination | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with serious adverse events | 3 days post vaccination | To evaluate the number of participants with early serious adverse reactions (≤ 3 days post-vaccination) |
| Change in disease activity from baseline | Four week post-vaccination | To evaluate the change in disease activity score from baseline using the validated instruments of the Pediatric Ulcerative Colitis Activity Index for participants with Ulcerative Coltiis and the Harvey Bradshaw Index for participants with Crohn's Disease |
Countries
Canada
Outcome results
None listed