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Vaccination Against Influenza in Autoimmune Diseases (MAIVAX)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01065285
First received: October 21, 2009
Last updated: July 25, 2012
Last verified: July 2012
History of Changes
  Purpose

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 Intervention Phase
Autoimmune Diseases
 Biological: Evaluation of vaccines against flu
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    Mesure of antibody level of 1/40, measured by hemagglutination, 3 weeks after the first injection and after the second injection


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
  • Number of local side effects related to vaccination (erythema and/or pain at injection site) [ Time Frame: 3 weeks ] [ Designated as safety issue: Yes ]
  • Number of patients who will develop influenza despite vaccination [ Time Frame: 3 weeks ] [ Designated as safety issue: Yes ]
  • Number of patients who had antibodies against H1N1 before vaccination [ Time Frame: 3 weeks ] [ Designated as safety issue: Yes ]
  • Number of hospitalisations and deaths related to influenza [ Time Frame: 3 weeks ] [ Designated as safety issue: Yes ]
  • Number of flares of the autoimmune diseases that could be related to vaccination [ Time Frame: 3 weeks ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 234
Study Start Date: October 2009
Study Completion Date: February 2012
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01065285

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

No publications provided by Assistance Publique - Hôpitaux de Paris

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01065285     History of Changes
Other Study ID Numbers: P 090901
Study First Received: October 21, 2009
Last Updated: July 25, 2012
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Influenza
autoimmune diseases
vaccination
H1N1

Additional relevant MeSH terms:
Autoimmune Diseases
Influenza, Human
Immune System Diseases
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
 Respiratory Tract Infections
Respiratory Tract Diseases
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013