Inflammatory Bowel DiseaseNCT01666535
Infliximab IBD Influenza Vaccine Study
A study testing Influenza vaccination in people with Inflammatory Bowel Disease, run by University of Calgary at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 9 to 60 years
- Conditions the study is for
- Inflammatory Bowel Disease
- What is being tested?
- Influenza vaccination
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 137 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2012to Aug 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- Pregnancy
- Hypersensitivity reaction to previous dose of influenza vaccine
- Known hypersensitivity to eggs or chicken or other components of influenza vaccine
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Inflammatory Bowel Disease
- Being tested
- Influenza vaccination
- Keywords
- Influenza vaccine, Immune response, Remicade (infliximab), Inflammatory bowel disease
- Medical subject headings
- Inflammatory Bowel Diseases, Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Influenza vaccinationBiological
| Study group | Role | What they receive |
|---|---|---|
| Influenza vaccination Timing #1 | Other | Influenza vaccination administered on the same day as infliximab administration (Day 0 to 4). Receives: Biological: Influenza vaccination |
| Influenza vaccination Timing #2 | Other | Influenza vaccination administered at the mid-point between infliximab infusions (Day 21 to 28) Receives: Biological: Influenza vaccination |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 28 days ± 3 days after influenza vaccination
Secondary outcomes (1)
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.
Measured: 28 days ± 3 days after influenza vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2012 (estimated)
- Study startSep 2012
- Primary completionMar 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseaseStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 137 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Collaborators
- Janssen Inc.
- Responsible party
- Principal investigator, Jennifer deBruyn, University of Calgary
- Investigators
- Jennifer deBruyn, MD, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01666535
- Sponsor's protocol ID
- REMICADEIBD4010
- Status last verified
- May 2016
- First submitted
- 8 Aug 2012
- Last updated
- 9 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Influenza Vaccination Timing on Immune Response in Patients With Inflammatory Bowel Disease on Infliximab Therapy: A Randomized Equivalence Trial
- ClinicalTrials.gov ID
- NCT01666535
- Acronym / sponsor ID
- REMICADEIBD4010
- Conditions
- Inflammatory Bowel Disease
- Keywords
- Influenza vaccine, Immune response, Remicade (infliximab), Inflammatory bowel disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 137 participants (actual)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Collaborators
- Janssen Inc.
- Study start
- Sep 2012
- Primary completion
- Mar 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 16 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Influenza vaccination Timing #1 | Other | Biological: Influenza vaccinationInfluenza vaccination administered on the same day as infliximab administration (Day 0 to 4). |
| Influenza vaccination Timing #2 | Other | Biological: Influenza vaccinationInfluenza vaccination administered at the mid-point between infliximab infusions (Day 21 to 28) |
Who may qualify
- Ages
- 9 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Pregnancy
- Hypersensitivity reaction to previous dose of influenza vaccine
- Known hypersensitivity to eggs or chicken or other components of influenza vaccine
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Influenza vaccination | Biological | Influenza vaccination Timing #1, Influenza vaccination Timing #2 |
Primary outcome
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.
1 secondary outcome
Immunogenic response
Time frame: 28 days ± 3 days after influenza vaccination
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer deBruyn, MD principal investigator
University of Calgary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Influenza vaccination in people with Inflammatory Bowel Disease, run by University of Calgary at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serologic protection (time frame: 28 days ± 3 days after influenza vaccination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2016.