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Efficacy Safety Study of Flu Vaccine in Immunodepression Patients (MICIVAX)

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ClinicalTrials.gov Identifier: NCT01022749
Recruitment Status : Completed
First Posted : December 1, 2009
Last Update Posted : August 5, 2013
Sponsor:
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
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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


Condition or disease Intervention/treatment Phase
Inflammatory Bowel Disease (IBD) Drug: Vaccine Biological: Vaccine anti-H1N1 Phase 3

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


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 228 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : September 2009
Actual Primary Completion Date : July 2011
Actual Study Completion Date : July 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Arm Intervention/treatment
Experimental: 2
patients with IBD receiving immunosuppressants (TNF blockers excluded) (n=100)
Drug: Vaccine
MUTAGRIP (2009-2010 winter) VAXIGRIP (2010-2011 winter)

Experimental: 3
patients with IBD receiving immunosuppressants including TNF blockers (n=100)
Drug: Vaccine
MUTAGRIP (2009-2010 winter) VAXIGRIP (2010-2011 winter)

Experimental: 1
patients with IBD not receiving immunosuppressant (n=100)
Drug: Vaccine
MUTAGRIP (2009-2010 winter) VAXIGRIP (2010-2011 winter)

Active Comparator: 4
patients with IBD receiving immunosuppressants including TNF blockers (n=20)
Biological: Vaccine anti-H1N1
patients who received the vaccine anti-H1N1




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Seroconversion factor [ Time Frame: 3 weeks and 6 months after vaccination ]
    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

  2. Seroprotection rate against the three vaccine strains [ Time Frame: 3 or 4 weeks after of vaccination ]
    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. Seroprotection rate in the general population [ Time Frame: 3 weeks and 6 months after vaccination ]
    The seroprotection rate in the general population and according to the three groups of patients

  4. Seroconversion rate, geometric mean titers ratio before and after vaccination by haemagglutination inhibition assay [ Time Frame: after 3 weeks of vaccination ]
    The seroconversion rate, geometric mean titers ratio before and after vaccination by haemagglutination inhibition (HI) assay before and after vaccination

  5. 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 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)

  6. 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 ]
  7. Number of influenza episodes and confirmed flu during each influenza peak season [ Time Frame: 6 months after vaccination ]
  8. Occurrence of medical visits, emergency room visits, hospital admissions and deaths throughout the course of the study [ Time Frame: 18 months after vaccination ]
  9. Occurrence and intensity of local and general adverse events within 5 days after vaccine administration [ Time Frame: 5 days after vaccination ]
  10. Search of the determining factors to the influenza vaccine response [ Time Frame: 18 months after vaccination ]
    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

  11. Sub-immunological study [ Time Frame: 6 months after vaccination ]
    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.



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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01022749


Locations
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France
CIC Vaccinologie Hopital Cochin
Paris, France, 75014
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Institut National de la Santé Et de la Recherche Médicale, France
University of Paris 5 - Rene Descartes
Pierre and Marie Curie University
Institut Pasteur
Investigators
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Principal Investigator: Odile LAUNAY, MD PhD Assistance Publique - Hôpitaux de Paris

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01022749     History of Changes
Other Study ID Numbers: P 070165
First Posted: December 1, 2009    Key Record Dates
Last Update Posted: August 5, 2013
Last Verified: July 2013

Keywords provided by Assistance Publique - Hôpitaux de Paris:
inflammatory bowel disease (IBD)
immunosuppressed or non-immunosuppressed
influenza vaccine
antibody titers
seroprotective titers
vaccine-associated adverse events

Additional relevant MeSH terms:
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Intestinal Diseases
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
Vaccines
Immunologic Factors
Physiological Effects of Drugs