Inflammatory Bowel Disease (IBD)Phase 3MICIVAXNCT01022749
Efficacy Safety Study of Flu Vaccine in Immunodepression Patients
A Phase 3 study testing Vaccine and Vaccine anti-H1N1 in people with Inflammatory Bowel Disease (IBD), run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The primary purpose of the study is to compare the efficacy and safety of influenza vaccine in patients with inflammatory bowel disease (IBD) receiving immunosuppressive therapy with patients not receiving immunosuppressants . Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Inflammatory Bowel Disease (IBD)
- What is being tested?
- Vaccine and Vaccine anti-H1N1
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 228 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2009to Jul 2013
- Phase
- Phase 3
- 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 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- informed consent signed
- Age between 18 to 64
- Patient suffering from chronic inflammatory bowel disease (Crohn's disease, ulcerative colitis, or indeterminate colitis)
- For patients receiving at least one immunosuppressive or anti-TNF therapy: treatment introduced for at least 3 months
- Patient willing to participate in the study throughout its duration and acceptance procedures related to the study (blood samples, self questionnaires, nasal swab and telephone follow-up)
Who cannot join
- Patient treated by corticosteroid alone without immunosuppressive or anti-TNF
- For women, being pregnant or positive pregnancy test
- Known allergy to any component of the study vaccine or a history of hypersensitivity reaction to influenza vaccination
- Fever (at least 37.5°C measured orally) or acute infection in the week prior to vaccination
- Received influenza vaccination in the 6 months preceding enrollment
- Known history of progressive neuropathy or Guillain-Barre
Show all 11Show fewer
- Known infection with HIV and/or HBV (Ag-HBs positive) and/or HCV
- Other causes of severe immune deficiency
- Cellular therapy, immunoglobulin infusions, of blood products or monoclonal antibodies (except anti-TNF) in the 3 months prior to vaccination
- Patient deprived of freedom by an administrative or court order
- Patient non affiliated to a health social security system
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective, Multicentre, Open-label Study Evaluating the Immunogenicity and Safety of Influenza Vaccine in Patients With Inflammatory Bowel Disease (IBD) Receiving or Not Immunosuppressive Therapy
The primary purpose of the study is to compare the efficacy and safety of influenza vaccine in patients with inflammatory bowel disease (IBD) receiving immunosuppressive therapy with patients not receiving immunosuppressants .
The main objective of the study is to evaluate the humoral immunogenicity of influenza vaccination in patients with IBD
Read the detailed description
Annual vaccination against influenza is recommended for those at high risk of complications, particularly among patients with immunodeficiency including those resulting from immunosuppressive treatments administered for a chronic inflammatory bowel disease (IBD). However, published data showing that influenza vaccination coverage is low in this population (<30%) due to lack of data on the effectiveness of vaccination in these patients and the theoretical risk of negative impact on the evolution of IBD.
To improve influenza vaccination coverage of the population treated by immunosuppressants for a chronic IBD, it is essential to have data on the effectiveness of vaccination in these populations.
The research aims to evaluate the immunogenicity of influenza vaccination in patients followed for a chronic IBD.
Factors in choice of study population were as follows:
- IBD is a common disease. Among the inflammatory diseases treated with immunosuppressants and reaching patients under 65 years, IBD are among the most frequent. They result from an abnormal immune response to gut flora and their management often requires the prescription of immunosuppressive drugs (azathioprine, methotrexate, in particular) and more recently TNF-blockers;
- the existence of vaccine recommendations published recently for specific patients on immunosuppressive therapy at greatest risk of complications related to influenza;
- the fact that vaccinations have not been implicated in the pathogenesis of the disease;
- data showing that vaccination recommendations are poorly followed in this population. A recently published work found vaccination coverage against influenza of only 28% in a cohort of 169 patients treated for IBD;
The methodology chosen is a phase III, prospective, open, vaccine trial. The primary endpoint is the humoral immunogenicity induced by the vaccine.
The study is scheduled on 2 successive years to assess the value of annual vaccination repeated in this population treated with immunosuppressants.
There is a benefit for patients to participate in this study because they are all vaccinated against influenza and will benefit from a clinical and laboratory monitoring in this study. Moreover, these patients are taken to be vaccinated in the event of a pandemic influenza
- Conditions
- Inflammatory Bowel Disease (IBD)
- Being tested
- Vaccine, Vaccine anti-H1N1
- Keywords
- inflammatory bowel disease (IBD), immunosuppressed or non-immunosuppressed, influenza vaccine, antibody titers, seroprotective titers, vaccine-associated adverse events
- 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.
VaccineDrug
MUTAGRIP (2009-2010 winter) VAXIGRIP (2010-2011 winter)
Vaccine anti-H1N1Biological
patients who received the vaccine anti-H1N1
| Study group | Role | What they receive |
|---|---|---|
| 2 | Experimental | patients with IBD receiving immunosuppressants (TNF blockers excluded) (n=100) Receives: Drug: Vaccine |
| 3 | Experimental | patients with IBD receiving immunosuppressants including TNF blockers (n=100) Receives: Drug: Vaccine |
| 1 | Experimental | patients with IBD not receiving immunosuppressant (n=100) Receives: Drug: Vaccine |
| 4 | Active comparator | patients with IBD receiving immunosuppressants including TNF blockers (n=20) Receives: Biological: Vaccine anti-H1N1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seroconversion rate
Seroconversion rate in the overall population, defined as the geometric mean titers ratio post / pre-vaccination for each of the three vaccine strains
Measured: 3-4 weeks after vaccination
Secondary outcomes (11)
Seroconversion factor
The seroconversion factor obtained for each of the three vaccine strains will be compared between each of the three groups (patients not receiving treatment, patients receiving immunosuppressants and patients receiving immunosuppressants including TNF) defined as the geometric mean titers ratio post / pre-vaccination for each of the three vaccine strains
Measured: 3 weeks and 6 months after vaccination
Seroprotection rate against the three vaccine strains
The seroprotection rate (defined as the proportion of subjects attaining an anti-hemagglutinin titer ≥1:40) obtained 3-4 weeks after flu vaccination, against the three vaccine strains
Measured: 3 or 4 weeks after of vaccination
Seroprotection rate in the general population
The seroprotection rate in the general population and according to the three groups of patients
Measured: 3 weeks and 6 months after vaccination
Seroconversion rate, geometric mean titers ratio before and after vaccination by haemagglutination inhibition assay
The seroconversion rate, geometric mean titers ratio before and after vaccination by haemagglutination inhibition (HI) assay before and after vaccination
Measured: after 3 weeks of vaccination
Comparison of seroprotection rates for each of the three vaccine strains obtained in each of three groups
Comparison of seroprotection rates for each of the three vaccine strains obtained in each of three groups (patients not receiving treatment, patients receiving immunosuppressants and patients, receiving immunosuppressants including TNF)
Measured: 3 weeks and 6 months of vaccination
Comparison of seroconversion factors obtained after 1 or 2 vaccinations in each of three groups of inflammatory bowel disease (IBD) and in the entire population
Measured: After 3 weeks of vaccination
Number of influenza episodes and confirmed flu during each influenza peak season
Measured: 6 months after vaccination
Occurrence of medical visits, emergency room visits, hospital admissions and deaths throughout the course of the study
Measured: 18 months after vaccination
Occurrence and intensity of local and general adverse events within 5 days after vaccine administration
Measured: 5 days after vaccination
Search of the determining factors to the influenza vaccine response
Search of the determining factors to the influenza vaccine response: sex, age, previous vaccination against influenza, chronic smoking, the presence of other comorbidities (diabetes, renal failure, cirrhosis, ..), the nature of the IBD, the nature of the treatment of IBD and their duration, the number of immunosuppressive treatments associated and Disease Activity Index score of IBD at the vaccination time
Measured: 18 months after vaccination
Sub-immunological study
Sub-immunological study each year of the study, the first and the second year (n=60, 20 patients per group): To determine if the LT-CD4 induction at J21-28 is correlated with the antibody anti-vaccines concentration measured within 6 months. To determine if the basal concentrations of anti-flu LT-CD4 at J21-J28 is correlated with the antibody anti-vaccines concentrations measured within 6 months.
Measured: 6 months after vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2009 (estimated)
- Study startSep 2009
- Primary completionJul 2011
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Inflammatory Bowel Disease (IBD)Studies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 228 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France, University of Paris 5 - Rene Descartes, Pierre and Marie Curie University, Institut Pasteur, URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Odile LAUNAY, MD PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01022749
- Sponsor's protocol ID
- P 070165
- Acronym
- MICIVAX
- Status last verified
- Oct 2025
- First submitted
- 30 Nov 2009
- Last updated
- 20 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Loison E, Poirier-Beaudouin B, Seffer V, Paoletti A, Abitbol V, Tartour E, Launay O, Gougeon ML. Suppression by thimerosal of ex-vivo CD4+ T cell response to influenza vaccine and induction of apoptosis in primary memory T cells. PLoS One. 2014 Apr 1;9(4):e92705. doi: 10.1371/journal.pone.0092705. eCollection 2014.
PubMed 24690681Launay O, Abitbol V, Krivine A, Slama LB, Bourreille A, Dupas JL, Hebuterne X, Savoye G, Deplanque D, Bouhnik Y, Pelletier AL, Galtier F, Laharie D, Nachury M, Zerbib F, Allez M, Bommelaer G, Duclos B, Lucht F, Gougeon ML, Tartour E, Rozenberg F, Hanslik T, Beaugerie L, Carrat F; MICIVAX Study Group. Immunogenicity and Safety of Influenza Vaccine in Inflammatory Bowel Disease Patients Treated or not with Immunomodulators and/or Biologics: A Two-year Prospective Study. J Crohns Colitis. 2015 Dec;9(12):1096-107. doi: 10.1093/ecco-jcc/jjv152. Epub 2015 Sep 7.
PubMed 26351392
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multicentre, Open-label Study Evaluating the Immunogenicity and Safety of Influenza Vaccine in Patients With Inflammatory Bowel Disease (IBD) Receiving or Not Immunosuppressive Therapy
- ClinicalTrials.gov ID
- NCT01022749
- Acronym / sponsor ID
- MICIVAX / P 070165
- Conditions
- Inflammatory Bowel Disease (IBD)
- Keywords
- inflammatory bowel disease (IBD), immunosuppressed or non-immunosuppressed, influenza vaccine, antibody titers, seroprotective titers, vaccine-associated adverse events
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 228 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France, University of Paris 5 - Rene Descartes, Pierre and Marie Curie University, Institut Pasteur, URC-CIC Paris Descartes Necker Cochin
- Study start
- Sep 2009
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 1 Dec 2009 (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 primary purpose of the study is to compare the efficacy and safety of influenza vaccine in patients with inflammatory bowel disease (IBD) receiving immunosuppressive therapy with patients not receiving immunosuppressants .
The main objective of the study is to evaluate the humoral immunogenicity of influenza vaccination in patients with IBD
Detailed description
Annual vaccination against influenza is recommended for those at high risk of complications, particularly among patients with immunodeficiency including those resulting from immunosuppressive treatments administered for a chronic inflammatory bowel disease (IBD). However, published data showing that influenza vaccination coverage is low in this population (<30%) due to lack of data on the effectiveness of vaccination in these patients and the theoretical risk of negative impact on the evolution of IBD.
To improve influenza vaccination coverage of the population treated by immunosuppressants for a chronic IBD, it is essential to have data on the effectiveness of vaccination in these populations.
The research aims to evaluate the immunogenicity of influenza vaccination in patients followed for a chronic IBD.
Factors in choice of study population were as follows:
- IBD is a common disease. Among the inflammatory diseases treated with immunosuppressants and reaching patients under 65 years, IBD are among the most frequent. They result from an abnormal immune response to gut flora and their management often requires the prescription of immunosuppressive drugs (azathioprine, methotrexate, in particular) and more recently TNF-blockers;
- the existence of vaccine recommendations published recently for specific patients on immunosuppressive therapy at greatest risk of complications related to influenza;
- the fact that vaccinations have not been implicated in the pathogenesis of the disease;
- data showing that vaccination recommendations are poorly followed in this population. A recently published work found vaccination coverage against influenza of only 28% in a cohort of 169 patients treated for IBD;
The methodology chosen is a phase III, prospective, open, vaccine trial. The primary endpoint is the humoral immunogenicity induced by the vaccine.
The study is scheduled on 2 successive years to assess the value of annual vaccination repeated in this population treated with immunosuppressants.
There is a benefit for patients to participate in this study because they are all vaccinated against influenza and will benefit from a clinical and laboratory monitoring in this study. Moreover, these patients are taken to be vaccinated in the event of a pandemic influenza
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 2 | Experimental | Drug: Vaccinepatients with IBD receiving immunosuppressants (TNF blockers excluded) (n=100) |
| 3 | Experimental | Drug: Vaccinepatients with IBD receiving immunosuppressants including TNF blockers (n=100) |
| 1 | Experimental | Drug: Vaccinepatients with IBD not receiving immunosuppressant (n=100) |
| 4 | Active comparator | Biological: Vaccine anti-H1N1patients with IBD receiving immunosuppressants including TNF blockers (n=20) |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- informed consent signed
- Age between 18 to 64
- Patient suffering from chronic inflammatory bowel disease (Crohn's disease, ulcerative colitis, or indeterminate colitis)
- For patients receiving at least one immunosuppressive or anti-TNF therapy: treatment introduced for at least 3 months
- Patient willing to participate in the study throughout its duration and acceptance procedures related to the study (blood samples, self questionnaires, nasal swab and telephone follow-up)
Key exclusion criteria (11 listed)
- Patient treated by corticosteroid alone without immunosuppressive or anti-TNF
- For women, being pregnant or positive pregnancy test
- Known allergy to any component of the study vaccine or a history of hypersensitivity reaction to influenza vaccination
- Fever (at least 37.5°C measured orally) or acute infection in the week prior to vaccination
- Received influenza vaccination in the 6 months preceding enrollment
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 |
|---|---|---|
| VaccineMUTAGRIP (2009-2010 winter) VAXIGRIP (2010-2011 winter) | Drug | 1, 2, 3 |
| Vaccine anti-H1N1patients who received the vaccine anti-H1N1 | Biological | 4 |
Primary outcome
Seroconversion rate
Time frame: 3-4 weeks after vaccination
Seroconversion rate in the overall population, defined as the geometric mean titers ratio post / pre-vaccination for each of the three vaccine strains
11 secondary outcomes
Seroconversion factor
Time frame: 3 weeks and 6 months after vaccination
Seroprotection rate against the three vaccine strains
Time frame: 3 or 4 weeks after of vaccination
Seroprotection rate in the general population
Time frame: 3 weeks and 6 months after vaccination
Seroconversion rate, geometric mean titers ratio before and after vaccination by haemagglutination inhibition assay
Time frame: after 3 weeks of vaccination
Comparison of seroprotection rates for each of the three vaccine strains obtained in each of three groups
Time frame: 3 weeks and 6 months of vaccination
Comparison of seroconversion factors obtained after 1 or 2 vaccinations in each of three groups of inflammatory bowel disease (IBD) and in the entire population
Time frame: After 3 weeks of vaccination
Number of influenza episodes and confirmed flu during each influenza peak season
Time frame: 6 months after vaccination
Occurrence of medical visits, emergency room visits, hospital admissions and deaths throughout the course of the study
Time frame: 18 months after vaccination
Occurrence and intensity of local and general adverse events within 5 days after vaccine administration
Time frame: 5 days after vaccination
Search of the determining factors to the influenza vaccine response
Time frame: 18 months after vaccination
Sub-immunological study
Time frame: 6 months after 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 20 Nov 2025.
- Results publication: PubMed 24690681Loison E, Poirier-Beaudouin B, Seffer V, Paoletti A, Abitbol V, Tartour E, Launay O, Gougeon ML. Suppression by thimerosal of ex-vivo CD4+ T cell response to influenza vaccine and induction of apoptosis in primary memory T cells. PLoS One. 2014 Apr 1;9(4):e92705. doi: 10.1371/journal.pone.0092705. eCollection 2014.
- Derived from this study: PubMed 26351392Launay O, Abitbol V, Krivine A, Slama LB, Bourreille A, Dupas JL, Hebuterne X, Savoye G, Deplanque D, Bouhnik Y, Pelletier AL, Galtier F, Laharie D, Nachury M, Zerbib F, Allez M, Bommelaer G, Duclos B, Lucht F, Gougeon ML, Tartour E, Rozenberg F, Hanslik T, Beaugerie L, Carrat F; MICIVAX Study Group. Immunogenicity and Safety of Influenza Vaccine in Inflammatory Bowel Disease Patients Treated or not with Immunomodulators and/or Biologics: A Two-year Prospective Study. J Crohns Colitis. 2015 Dec;9(12):1096-107. doi: 10.1093/ecco-jcc/jjv152. Epub 2015 Sep 7.
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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.
Odile LAUNAY, MD PhD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Vaccine and Vaccine anti-H1N1 in people with Inflammatory Bowel Disease (IBD), run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 5 inclusion and 11 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 20 Nov 2025. 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 France. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Seroconversion rate (time frame: 3-4 weeks after vaccination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01022749, which also lists 2 linked publications.
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 20 Nov 2025.