Vaccination Against Influenza in Autoimmune Diseases

Autoimmune Diseases Clinical Trial

— MAIVAX  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01065285
• Other study ID #: P 090901
• Status: Completed
• Phase: Phase 4
• First received: October 21, 2009
• Last updated: January 5, 2016
• Start date: October 2009
• Est. completion date: February 2012

Study information

• Verified date: July 2012
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 234
• Est. completion date: February 2012
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Autoimmune Diseases

Intervention

Biological:
• Evaluation of vaccines against flu
evaluate efficacy and tolerance

Locations

Country	Name	City	State
France	Hopital Cochin	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

References & Publications (1)

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 wi — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	3 weeks	Yes
Secondary	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	3 weeks	Yes
Secondary	Number of side effects related to vaccination		3 weeks	Yes
Secondary	Number of local side effects related to vaccination (erythema and/or pain at injection site)		3 weeks	Yes
Secondary	Number of patients who will develop influenza despite vaccination		3 weeks	Yes
Secondary	Number of patients who had antibodies against H1N1 before vaccination		3 weeks	Yes
Secondary	Number of hospitalisations and deaths related to influenza		3 weeks	Yes
Secondary	Number of flares of the autoimmune diseases that could be related to vaccination		3 weeks	Yes
Secondary	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	Yes
Secondary	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	Yes