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OpenTrials
Completed

NCT Number: NCT01065285

Vaccination Against Influenza in Autoimmune Diseases

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hopital Cochin

Paris, 75014, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Evaluation of vaccines against flu

Biological

evaluate efficacy and tolerance

Other names: Evaluation of vaccines against flu in auto-imune diseases

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • URC-CIC Paris Descartes Necker Cochin

Registry information

Official study 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)

Acronym: MAIVAX

Important dates

Study start
2009
Primary completion
2011
Study completion
2012
First posted
Feb 9, 2010
Registry last updated
Nov 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.