Vaccination Against Influenza in Autoimmune Diseases (MAIVAX)

January 5, 2016 updated by: Assistance Publique - Hôpitaux de Paris

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)

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

234

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75014
        • Hopital Cochin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Evaluation of vaccines against flu
Biological: Evaluation of vaccines against flu
evaluate efficacy and tolerance
Other Names:
  • Evaluation of vaccines against flu in auto-imune diseases

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Time Frame: 3 weeks
Mesure of antibody level of 1/40, measured by hemagglutination, 3 weeks after the first injection and after the second injection
3 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Time Frame: 3 weeks
Antibody levels against H1N1 in the different groups of patients, defined according diseases and their treatment
3 weeks
Number of side effects related to vaccination
Time Frame: 3 weeks
3 weeks
Number of local side effects related to vaccination (erythema and/or pain at injection site)
Time Frame: 3 weeks
3 weeks
Number of patients who will develop influenza despite vaccination
Time Frame: 3 weeks
3 weeks
Number of patients who had antibodies against H1N1 before vaccination
Time Frame: 3 weeks
3 weeks
Number of hospitalisations and deaths related to influenza
Time Frame: 3 weeks
3 weeks
Number of flares of the autoimmune diseases that could be related to vaccination
Time Frame: 3 weeks
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
Time Frame: 18 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
Time Frame: 18 months
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Investigators

  • Principal Investigator: Loïc GUILLEVIN, MD PhD, Assistance Publique - Hôpitaux de Paris

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (Actual)

July 1, 2011

Study Completion (Actual)

February 1, 2012

Study Registration Dates

First Submitted

October 21, 2009

First Submitted That Met QC Criteria

February 8, 2010

First Posted (Estimate)

February 9, 2010

Study Record Updates

Last Update Posted (Estimate)

January 6, 2016

Last Update Submitted That Met QC Criteria

January 5, 2016

Last Verified

July 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P 090901

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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