Vaccination Against Influenza in Autoimmune Diseases

Assistance Publique - Hôpitaux de Paris234 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

234

Conditions

Autoimmune Diseases

Interventions

Evaluation of vaccines against fluBIOLOGICAL

evaluate efficacy and tolerance

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Hopital Cochin

Paris, France

Outcomes

Primary Outcomes

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

Mesure of antibody level of 1/40, measured by hemagglutination, 3 weeks after the first injection and after the second injection

Time frame: 3 weeks

Secondary Outcomes

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)

Antibody levels against H1N1 in the different groups of patients, defined according diseases and their treatment

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

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

Data from ClinicalTrials.gov

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