Infliximab IBD Influenza Vaccine Study

Not Applicable

Completed

• Conditions: Inflammatory Bowel Disease
• Interventions: Biological: Influenza vaccination

• Registration Number: NCT01666535
• Lead Sponsor: University of Calgary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-08-08
• Study First Submitted QC: 2012-08-10
• Study First Posted: 2012-08-16
• Study Start: 2012-09
• Primary Completion: 2013-03
• Study Completion: 2013-08
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-05
• Last Update Posted: 2016-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 137

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Influenza vaccination Timing #1	Influenza vaccination	Influenza vaccination administered on the same day as infliximab administration (Day 0 to 4).
Influenza vaccination Timing #2	Influenza vaccination	Influenza vaccination administered at the mid-point between infliximab infusions (Day 21 to 28)

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

University of Calgary; 🇨🇦 Calgary, Alberta, Canada