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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01065285
Other study ID # P 090901
Secondary ID
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


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
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