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| Name | Class |
|---|---|
| Institut National de la Santé Et de la Recherche Médicale, France | OTHER_GOV |
| University of Paris 5 - Rene Descartes | OTHER |
| Pierre and Marie Curie University | OTHER |
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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
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:
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 2 | Experimental | patients with IBD receiving immunosuppressants (TNF blockers excluded) (n=100) |
|
| 3 | Experimental | patients with IBD receiving immunosuppressants including TNF blockers (n=100) |
|
| 1 | Experimental | patients with IBD not receiving immunosuppressant (n=100) |
|
| 4 | Active Comparator | patients with IBD receiving immunosuppressants including TNF blockers (n=20) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vaccine | Drug | MUTAGRIP (2009-2010 winter) VAXIGRIP (2010-2011 winter) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 3-4 weeks after vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 3 weeks and 6 months after vaccination |
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Inclusion criteria :
Exclusion criteria :
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| Name | Affiliation | Role |
|---|---|---|
| Odile LAUNAY, MD PhD | Assistance Publique - Hôpitaux de Paris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CIC Vaccinologie Hopital Cochin | Paris | 75014 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24690681 | Result | 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. | |
| 26351392 | Derived |
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| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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| ID | Term |
|---|---|
| D014612 | Vaccines |
| ID | Term |
|---|---|
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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| Institut Pasteur |
| INDUSTRY |
| URC-CIC Paris Descartes Necker Cochin | OTHER |
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| Vaccine anti-H1N1 | Biological | patients who received the vaccine anti-H1N1 |
|
| 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 | 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 | 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 | 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) | 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 | After 3 weeks of vaccination |
| Number of influenza episodes and confirmed flu during each influenza peak season | 6 months after vaccination |
| Occurrence of medical visits, emergency room visits, hospital admissions and deaths throughout the course of the study | 18 months after vaccination |
| Occurrence and intensity of local and general adverse events within 5 days after vaccine administration | 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 | 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. | 6 months after vaccination |
| Launay 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. |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |