Infliximab IBD Influenza Vaccine Study

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

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 Overview

• Status: Completed
• Conditions: Inflammatory Bowel Disease
• Intervention / Treatment: Biological: Influenza vaccination

• Study Type: Interventional
• Enrollment (Actual): 137
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T3B 6A8
      • University of Calgary

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 58 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with serious adverse events	To evaluate the number of participants with early serious adverse reactions (≤ 3 days post-vaccination)	3 days post vaccination
Change in disease activity from baseline	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	Four week post-vaccination

Collaborators and Investigators

• Sponsor: University of Calgary
• Collaborators: Janssen Inc.
• Investigators: Principal Investigator: Jennifer deBruyn, MD, University of Calgary

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (Actual): March 1, 2013
• Study Completion (Actual): August 1, 2013

Study Registration Dates

• First Submitted: August 8, 2012
• First Submitted That Met QC Criteria: August 10, 2012
• First Posted (Estimate): August 16, 2012

Study Record Updates

• Last Update Posted (Estimate): May 9, 2016
• Last Update Submitted That Met QC Criteria: May 5, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Keywords: Influenza vaccine; Inflammatory bowel disease; Immune response; Remicade (infliximab)
• Additional Relevant MeSH Terms: Digestive System Diseases; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Gastrointestinal Diseases; Gastroenteritis; Orthomyxoviridae Infections; Inflammatory Bowel Diseases; Influenza, Human; Intestinal Diseases
• Other Study ID Numbers: REMICADEIBD4010