Efficacy Safety Study of Flu Vaccine in Immunodepression Patients

NCT01022749 | Completed Phase 3

• 1 other identifier: P 070165
• Study Type: interventional
• Target: 228
• Locations: 1 country
• Sites: 1

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

Conditions

Inflammatory Bowel Disease (IBD)

Keywords

inflammatory bowel disease (IBD); immunosuppressed or non-immunosuppressed; influenza vaccine; antibody titers; seroprotective titers; vaccine-associated adverse events

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (11)

• Seroconversion factor

  3 weeks and 6 months after vaccination

• Seroprotection rate against the three vaccine strains

  3 or 4 weeks after of vaccination

• Seroprotection rate in the general population

  3 weeks and 6 months after vaccination

• Seroconversion rate, geometric mean titers ratio before and after vaccination by haemagglutination inhibition assay

  after 3 weeks of vaccination

• Comparison of seroprotection rates for each of the three vaccine strains obtained in each of three groups

  3 weeks and 6 months of vaccination

Study Arms (4)

2

EXPERIMENTAL

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

Drug: Vaccine

3

EXPERIMENTAL

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

Drug: Vaccine

1

EXPERIMENTAL

patients with IBD not receiving immunosuppressant (n=100)

Drug: Vaccine

4

ACTIVE COMPARATOR

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

Biological: Vaccine anti-H1N1

Interventions

Vaccine DRUG

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

1; 2; 3

Vaccine anti-H1N1 BIOLOGICAL

patients who received the vaccine anti-H1N1

4

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Institut National de la Santé Et de la Recherche Médicale, France: collaborator
• University of Paris 5 - Rene Descartes: collaborator
• Pierre and Marie Curie University: collaborator
• Institut Pasteur: collaborator
• URC-CIC Paris Descartes Necker Cochin: collaborator

Study Sites (1)

CIC Vaccinologie Hopital Cochin

Paris, 75014, France

Location

Related Publications (2)

• 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.

  PMID: 24690681 RESULT

• 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.

  PMID: 26351392 DERIVED

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Influenza, Human

Interventions

Vaccines

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Biological Products; Complex Mixtures

Study Officials

• Odile LAUNAY, MD PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2009
• First Posted: December 1, 2009
• Study Start: September 1, 2009
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2013
• Last Updated: November 20, 2025

Record last verified: 2025-10

Locations

FR (1)