Infliximab IBD Influenza Vaccine Study

University of Calgary

Status: Completed

Conditions: Inflammatory Bowel Disease

Treatments: Biological: Influenza vaccination

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01666535

REMICADEIBD4010

Details and patient eligibility

About

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.

Enrollment: 137 patients

Sex: All

Ages: 9 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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137 participants in 2 patient groups

Influenza vaccination Timing #1

Other group

Description:

Influenza vaccination administered on the same day as infliximab administration (Day 0 to 4).

Treatment:

Biological: Influenza vaccination

Influenza vaccination Timing #2

Other group

Description:

Influenza vaccination administered at the mid-point between infliximab infusions (Day 21 to 28)

Treatment:

Biological: Influenza vaccination