Infliximab IBD Influenza Vaccine Study

Inflammatory Bowel Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01666535
• Other study ID #: REMICADEIBD4010
• Status: Completed
• Phase: N/A
• First received: August 8, 2012
• Last updated: May 5, 2016
• Start date: September 2012
• Est. completion date: August 2013

Study information

• Verified date: May 2016
• Source: University of Calgary
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 137
• Est. completion date: August 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 9 Years to 60 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Inflammatory Bowel Disease
• Inflammatory Bowel Diseases
• Intestinal Diseases

Intervention

Biological:
• Influenza vaccination

Locations

Country	Name	City	State
Canada	University of Calgary	Calgary	Alberta

Sponsors (2)

Lead Sponsor	Collaborator
University of Calgary	Janssen Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	Yes
Other	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	No
Primary	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	No
Secondary	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	No