Infliximab IBD Influenza Vaccine Study

This study is not yet open for participant recruitment.

Verified August 2012 by University of Calgary

Sponsor:

Collaborator:

Janssen Inc.

Information provided by (Responsible Party):

Jennifer deBruyn, University of Calgary

ClinicalTrials.gov Identifier:

NCT01666535

First received: August 8, 2012

Last updated: August 10, 2012

Last verified: August 2012

History of Changes

Purpose

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.

Condition	Intervention
Inflammatory Bowel Disease	Biological: Influenza vaccination

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention
Official Title:	Effect of Influenza Vaccination Timing on Immune Response in Patients With Inflammatory Bowel Disease on Infliximab Therapy: A Randomized Equivalence Trial

Resource links provided by NLM:

MedlinePlus related topics: Flu

Drug Information available for: Infliximab Influenza Vaccines

U.S. FDA Resources

Further study details as provided by University of Calgary:

Primary Outcome Measures:

Serologic protection [ Time Frame: 28 days ± 3 days after influenza vaccination ] [ Designated as safety issue: No ]
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:

Immunogenic response [ Time Frame: 28 days ± 3 days after influenza vaccination ] [ Designated as safety issue: No ]
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 Outcome Measures:

Number of participants with serious adverse events [ Time Frame: 3 days post vaccination ] [ Designated as safety issue: Yes ]
To evaluate the number of participants with early serious adverse reactions (≤ 3 days post-vaccination)
Change in disease activity from baseline [ Time Frame: Four week post-vaccination ] [ Designated as safety issue: No ]
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

Estimated Enrollment:	180
Study Start Date:	August 2012
Estimated Study Completion Date:	August 2013
Estimated Primary Completion Date:	March 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Influenza vaccination Timing #1 Influenza vaccination administered on the same day as infliximab administration (Day 0 to 4).	Biological: Influenza vaccination
Influenza vaccination Timing #2 Influenza vaccination administered at the mid-point between infliximab infusions (Day 21 to 28)	Biological: Influenza vaccination

Eligibility

Ages Eligible for Study:	9 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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:

Pregnancy
Hypersensitivity reaction to previous dose of influenza vaccine
Known hypersensitivity to eggs or chicken or other components of influenza vaccine

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01666535

Contacts

Contact: Jennifer deBruyn

jennifer.debruyn@albertahealthservices.ca

Locations

Canada, Alberta
University of Calgary	Not yet recruiting
Calgary, Alberta, Canada, T3B 6A8
Contact: Jennifer deBruyn jennifer.debruyn@albertahealthservices.ca
Principal Investigator: Jennifer deBruyn, MD
Sub-Investigator: Remo Panaccione,, MD
Sub-Investigator: Iwona Wrobel, MD
Sub-Investigator: Cynthia Seow, MD

Sponsors and Collaborators

University of Calgary

Janssen Inc.

Investigators

Principal Investigator:

Jennifer deBruyn, MD

University of Calgary

More Information

No publications provided

Responsible Party:	Jennifer deBruyn, Assistant Professor, University of Calgary
ClinicalTrials.gov Identifier:	NCT01666535 History of Changes
Other Study ID Numbers:	REMICADEIBD4010
Study First Received:	August 8, 2012
Last Updated:	August 10, 2012
Health Authority:	Canada: Ethics Review Committee

Keywords provided by University of Calgary:

Influenza vaccine
Immune response
Remicade (infliximab)
Inflammatory bowel disease

Additional relevant MeSH terms:

Inflammatory Bowel Diseases
Influenza, Human
Intestinal Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases

Respiratory Tract Infections
Respiratory Tract Diseases
Infliximab
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions
Gastrointestinal Agents
Antirheumatic Agents
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on May 23, 2013

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