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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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18 January 2016 |
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Main ID: |
NCT01065285 |
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Date of registration:
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21/10/2009 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Vaccination Against Influenza in Autoimmune Diseases
MAIVAX |
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Scientific title:
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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) |
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Date of first enrolment:
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October 2009 |
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Target sample size:
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234 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01065285 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 4
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Countries of recruitment
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France
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Contacts
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Name:
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Loïc GUILLEVIN, MD PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Assistance Publique - Hôpitaux de Paris |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Autoimmune Diseases
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Intervention(s)
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Biological: Evaluation of vaccines against flu
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Primary Outcome(s)
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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]
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Secondary Outcome(s)
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Number of hospitalisations and deaths related to influenza
[Time Frame: 3 weeks]
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Number of patients who will develop influenza despite vaccination
[Time Frame: 3 weeks]
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Number of patients who had antibodies against H1N1 before vaccination
[Time Frame: 3 weeks]
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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]
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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]
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Number of side effects related to vaccination
[Time Frame: 3 weeks]
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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]
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Number of flares of the autoimmune diseases that could be related to vaccination
[Time Frame: 3 weeks]
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Number of local side effects related to vaccination (erythema and/or pain at injection site)
[Time Frame: 3 weeks]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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