Vaccination Against Influenza in Autoimmune Diseases (MAIVAX)

Assistance Publique - Hôpitaux de Paris

Status and phase: Completed; Phase 4

Conditions: Autoimmune Diseases

Treatments: Biological: Evaluation of vaccines against flu

Study type: Interventional

Funder types: Other

Identifiers

NCT01065285

P 090901

Details and patient eligibility

About

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

Full 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.

Enrollment: 234 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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234 participants in 1 patient group

Evaluation of vaccines against flu

Experimental group

Description:

Evaluation of vaccines against flu

Treatment:

Biological: Evaluation of vaccines against flu