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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

Tracking Information
First Submitted Date  ICMJE October 21, 2009
First Posted Date  ICMJE February 9, 2010
Last Update Posted Date January 6, 2016
Study Start Date  ICMJE October 2009
Actual Primary Completion Date July 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 23, 2011)
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
Original Primary Outcome Measures  ICMJE
 (submitted: February 8, 2010)
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 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 18, 2011)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: February 8, 2010)
  • 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Vaccination Against Influenza in Autoimmune Diseases
Official Title  ICMJE 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)
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Autoimmune Diseases
Intervention  ICMJE Biological: Evaluation of vaccines against flu
evaluate efficacy and tolerance
Other Name: Evaluation of vaccines against flu in auto-imune diseases
Study Arms  ICMJE Experimental: Evaluation of vaccines against flu
Evaluation of vaccines against flu
Intervention: Biological: Evaluation of vaccines against flu
Publications * 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.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 18, 2011)
234
Original Estimated Enrollment  ICMJE
 (submitted: February 8, 2010)
200
Actual Study Completion Date  ICMJE February 2012
Actual Primary Completion Date July 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01065285
Other Study ID Numbers  ICMJE P 090901
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Assistance Publique - Hôpitaux de Paris
Study Sponsor  ICMJE Assistance Publique - Hôpitaux de Paris
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Loïc GUILLEVIN, MD PhD Assistance Publique - Hôpitaux de Paris
PRS Account Assistance Publique - Hôpitaux de Paris
Verification Date July 2012

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