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Completed

NCT Number: NCT01666535

Infliximab IBD Influenza Vaccine Study

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.

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Key information

Conditions

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

Age range

9 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Calgary

Calgary, Alberta, T3B 6A8, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Influenza vaccination

Biological

Primary outcomes

  1. Serologic protection

    Time frame: 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 outcomes

  1. Immunogenic response

    Time frame: 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.

Other outcomes

  1. Number of participants with serious adverse events

    Time frame: 3 days post vaccination

    To evaluate the number of participants with early serious adverse reactions (≤ 3 days post-vaccination)

  2. Change in disease activity from baseline

    Time frame: Four week post-vaccination

    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

Sponsors and collaborators

Lead sponsor

University of Calgary

Other

Collaborators

  • Janssen Inc.

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Aug 16, 2012
Registry last updated
May 9, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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