Efficacy Safety Study of Flu Vaccine in Immunodepression Patients

NCT ID: NCT01022749

Last Updated: 2025-11-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 228 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-09-30
• Study Completion Date: 2013-07-31

Brief 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 .

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:

1. 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;

2. the existence of vaccine recommendations published recently for specific patients on immunosuppressive therapy at greatest risk of complications related to influenza;

3. the fact that vaccinations have not been implicated in the pathogenesis of the disease;

4. 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)

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

2

patients with IBD receiving immunosuppressants (TNF blockers excluded) (n=100)

Group Type: EXPERIMENTAL

Vaccine

Intervention Type: DRUG

MUTAGRIP (2009-2010 winter) VAXIGRIP (2010-2011 winter)

3

patients with IBD receiving immunosuppressants including TNF blockers (n=100)

Group Type: EXPERIMENTAL

Vaccine

Intervention Type: DRUG

MUTAGRIP (2009-2010 winter) VAXIGRIP (2010-2011 winter)

1

patients with IBD not receiving immunosuppressant (n=100)

Group Type: EXPERIMENTAL

Vaccine

Intervention Type: DRUG

MUTAGRIP (2009-2010 winter) VAXIGRIP (2010-2011 winter)

4

patients with IBD receiving immunosuppressants including TNF blockers (n=20)

Group Type: ACTIVE_COMPARATOR

Vaccine anti-H1N1

Intervention Type: BIOLOGICAL

patients who received the vaccine anti-H1N1

Interventions

Vaccine

MUTAGRIP (2009-2010 winter) VAXIGRIP (2010-2011 winter)

Intervention Type: DRUG

Vaccine anti-H1N1

patients who received the vaccine anti-H1N1

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• 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)

Exclusion Criteria

• 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
• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institut National de la Santé Et de la Recherche Médicale, France

OTHER_GOV

Sponsor Role: collaborator

University of Paris 5 - Rene Descartes

OTHER

Sponsor Role: collaborator

Pierre and Marie Curie University

OTHER

Sponsor Role: collaborator

Institut Pasteur

INDUSTRY

Sponsor Role: collaborator

URC-CIC Paris Descartes Necker Cochin

OTHER

Sponsor Role: collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Odile LAUNAY, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

CIC Vaccinologie Hopital Cochin

Paris, , France

Countries

France

References

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.

Reference Type: RESULT

PMID: 24690681 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 26351392 (View on PubMed)

Other Identifiers

P 070165

Identifier Type: -

Identifier Source: org_study_id