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Vaccination Against Influenza in Autoimmune Diseases (MAIVAX)

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ClinicalTrials.gov Identifier: NCT01065285
Recruitment Status : Completed
First Posted : February 9, 2010
Last Update Posted : January 6, 2016
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Study Description
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Brief Summary:
The project is to evaluate immunogenicity, efficacy and tolerance of vaccination against influenza (seasonal and H1N1) in patients affected with systemic and autoimmune diseases.

Condition or disease Intervention/treatment Phase
Autoimmune Diseases Biological: Evaluation of vaccines against flu Phase 4

Detailed Description:

This prospective study concentrates on patients with vasculitis, systemic sclerosis, Sjögren's syndrome, systemic lupus erythematosus and other connective tissue diseases.

Patients responding to the inclusion criteria, will receive vaccine against seasonal influenza then, 3 weeks later, vaccine against H1N1 influenza. According to the results of ongoing trials a second injection of H1N1 vaccine has been scheduled 3 weeks later. At each consultation a blood sample will be taken to evaluate immunogenicity of vaccination. Two additional consultations have been scheduled: one month after the last vaccine administration and at 6 month, in order to evaluate the occurrence of late side effects.


Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 234 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of Vaccination Against Influenza (Seasonal and H1N1) in Patients Presenting Systemic or Autoimmune Diseases Treated or Not With Steroids, and/or Immunosuppressant, and/or Biotherapy: an Open, Prospective Trial (MAIVAX)
Study Start Date : October 2009
Actual Primary Completion Date : July 2011
Actual Study Completion Date : February 2012

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Evaluation of vaccines against flu
Evaluation of vaccines against flu
 Biological: Evaluation of vaccines against flu
evaluate efficacy and tolerance
Other Name: Evaluation of vaccines against flu in auto-imune diseases


Outcome Measures
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Primary Outcome Measures :
  1. Protection against H1N1 influenza, defined by antibody level of 1/40, measured by hemagglutination, 3 weeks after the first injection and after the second injection [ Time Frame: 3 weeks ]
    Mesure of antibody level of 1/40, measured by hemagglutination, 3 weeks after the first injection and after the second injection


Secondary Outcome Measures :
  1. Antibody levels against H1N1 in the different groups of patients, defined according diseases and their treatment (comparison of patients treated by immunosuppressants or not treated) [ Time Frame: 3 weeks ]
    Antibody levels against H1N1 in the different groups of patients, defined according diseases and their treatment

  2. Number of side effects related to vaccination [ Time Frame: 3 weeks ]
  3. Number of local side effects related to vaccination (erythema and/or pain at injection site) [ Time Frame: 3 weeks ]
  4. Number of patients who will develop influenza despite vaccination [ Time Frame: 3 weeks ]
  5. Number of patients who had antibodies against H1N1 before vaccination [ Time Frame: 3 weeks ]
  6. Number of hospitalisations and deaths related to influenza [ Time Frame: 3 weeks ]
  7. Number of flares of the autoimmune diseases that could be related to vaccination [ Time Frame: 3 weeks ]
  8. Determine if the induction of LT-CD4 to J21-28 anti-jams is correlated to the concentrations of antibody anti-vaccines measured in 6 months [ Time Frame: 18 months ]
  9. Determine if the basal concentrations of LT-CD4 anti-jam to J21-J28 are correlated to the concentrations of antibody anti-vaccines measured in 6 months [ Time Frame: 18 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patients presenting autoimmune and systemic diseases,
  • treating or not with steroids, and/or immunosuppressants and/or biotherapies, especially vasculitis, scleroderma, Sjogren's syndrome and systemic lupus (main groups)

Exclusion Criteria:

  • Absence of informed consent
  • Disease which did not responded to the above criteria
  • Active infection at time of vaccination
  • HIV infection
  • History of Guillain-Barre syndrome
  • Allergy to one component of the vaccine
Contacts and Locations
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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): NCT01065285


Locations
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France
Hopital Cochin
Paris, France, 75014
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: Loïc GUILLEVIN, MD PhD Assistance Publique - Hôpitaux de Paris
More Information
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Publications of Results:

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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01065285     History of Changes
Other Study ID Numbers: P 090901
First Posted: February 9, 2010    Key Record Dates
Last Update Posted: January 6, 2016
Last Verified: July 2012
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Influenza
autoimmune diseases
vaccination
H1N1
Additional relevant MeSH terms:
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Influenza, Human
Autoimmune Diseases
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
 Respiratory Tract Diseases
Immune System Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs