Clinical trial NCT01065285: Vaccination Against Influenza in Autoimmune Diseases
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Autoimmune Diseases
Keywords: Influenza
autoimmune diseases
vaccination
H1N1
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2010-02-09
Enrollment: 234
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: 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
timeFrame: 3 weeks
Secondary outcomes:
measure: 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)
timeFrame: 3 weeks
measure: Number of side effects related to vaccination
timeFrame: 3 weeks
measure: Number of local side effects related to vaccination (erythema and/or pain at injection site)
timeFrame: 3 weeks
measure: Number of patients who will develop influenza despite vaccination
timeFrame: 3 weeks
measure: Number of patients who had antibodies against H1N1 before vaccination
timeFrame: 3 weeks
measure: Number of hospitalisations and deaths related to influenza
timeFrame: 3 weeks
measure: Number of flares of the autoimmune diseases that could be related to vaccination
timeFrame: 3 weeks
measure: 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
timeFrame: 18 months
measure: 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
timeFrame: 18 months
Other outcomes:
Locations:
city: Paris
country: France
facility: Hopital Cochin
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Loïc GUILLEVIN, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kostianovsky A, Charles P, Alves JF, Goulet M, Pagnoux C, Le Guern V, Mouthon L, Krivine A, Villiger P, Launay O, Guillevin L; French Vasculitis Study Group. Immunogenicity and safety of seasonal and 2009 pandemic A/H1N1 influenza vaccines for patients with autoimmune diseases: a prospective, monocentre trial on 199 patients. Clin Exp Rheumatol. 2012 Jan-Feb;30(1 Suppl 70):S83-9. Epub 2012 May 11.