ClinicalTrials.gov
ClinicalTrials.gov Menu

Vaccination Against Influenza in Autoimmune Diseases (MAIVAX)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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

October 21, 2009
February 9, 2010
January 6, 2016
October 2009
July 2011   (Final data collection date for primary outcome measure)
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
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 ]
Complete list of historical versions of study NCT01065285 on ClinicalTrials.gov Archive Site
  • 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
  • Number of side effects related to vaccination [ Time Frame: 3 weeks ]
  • Number of local side effects related to vaccination (erythema and/or pain at injection site) [ Time Frame: 3 weeks ]
  • Number of patients who will develop influenza despite vaccination [ Time Frame: 3 weeks ]
  • Number of patients who had antibodies against H1N1 before vaccination [ Time Frame: 3 weeks ]
  • Number of hospitalisations and deaths related to influenza [ Time Frame: 3 weeks ]
  • Number of flares of the autoimmune diseases that could be related to vaccination [ Time Frame: 3 weeks ]
  • 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 ]
  • 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 ]
  • 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 ]
  • Number of side effects related to vaccination [ Time Frame: 3 weeks ]
  • Number of local side effects related to vaccination (erythema and/or pain at injection site) [ Time Frame: 3 weeks ]
  • Number of patients who will develop influenza despite vaccination [ Time Frame: 3 weeks ]
  • Number of patients who had antibodies against H1N1 before vaccination [ Time Frame: 3 weeks ]
  • Number of hospitalisations and deaths related to influenza [ Time Frame: 3 weeks ]
  • Number of flares of the autoimmune diseases that could be related to vaccination [ Time Frame: 3 weeks ]
Not Provided
Not Provided
 
Vaccination Against Influenza in Autoimmune Diseases
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)
The project is to evaluate immunogenicity, efficacy and tolerance of vaccination against influenza (seasonal and H1N1) in patients affected with systemic and autoimmune diseases.

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.

Interventional
Phase 4
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Autoimmune Diseases
Biological: Evaluation of vaccines against flu
evaluate efficacy and tolerance
Other Name: Evaluation of vaccines against flu in auto-imune diseases
Experimental: Evaluation of vaccines against flu
Evaluation of vaccines against flu
Intervention: Biological: Evaluation of vaccines against flu
Kostianovsky A, Charles P, Alves JF, Goulet M, Pagnoux C, Le Guern V, Mouthon L, Krivine A, Villiger P, Launay O, Guillevin L; French Vasculitis Study Group. Immunogenicity and safety of seasonal and 2009 pandemic A/H1N1 influenza vaccines for patients with autoimmune diseases: a prospective, monocentre trial on 199 patients. Clin Exp Rheumatol. 2012 Jan-Feb;30(1 Suppl 70):S83-9. Epub 2012 May 11.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
234
200
February 2012
July 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
France
 
 
NCT01065285
P 090901
No
Not Provided
Not Provided
Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
Not Provided
Principal Investigator: Loïc GUILLEVIN, MD PhD Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP