Vaccination Against Influenza in Autoimmune Diseases

Phase 4

Completed

• Conditions: Autoimmune Diseases
• Interventions: Biological: Evaluation of vaccines against flu

• Registration Number: NCT01065285
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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 Timeline

• Study Start: 2009-10
• Study First Submitted: 2009-10-21
• Study First Submitted QC: 2010-02-08
• Study First Posted: 2010-02-09
• Primary Completion: 2011-07
• Study Completion: 2012-02
• Status Verified: 2012-07
• Last Update Submitted: 2016-01-05
• Last Update Posted: 2016-01-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 234

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)

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Evaluation of vaccines against flu	Evaluation of vaccines against flu	Evaluation of vaccines against flu

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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)	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	3 weeks
Number of local side effects related to vaccination (erythema and/or pain at injection site)	3 weeks
Number of patients who will develop influenza despite vaccination	3 weeks
Number of patients who had antibodies against H1N1 before vaccination	3 weeks
Number of hospitalisations and deaths related to influenza	3 weeks
Number of flares of the autoimmune diseases that could be related to vaccination	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	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	18 months

Trial Locations

Locations (1)

Hopital Cochin; 🇫🇷 Paris, France