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| Name | Class |
|---|---|
| URC-CIC Paris Descartes Necker Cochin | OTHER |
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The project is to evaluate immunogenicity, efficacy and tolerance of vaccination against influenza (seasonal and H1N1) in patients affected with systemic and autoimmune diseases.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Evaluation of vaccines against flu | Experimental | Evaluation of vaccines against flu |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Evaluation of vaccines against flu | Biological | evaluate efficacy and tolerance |
|
| 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 | Mesure of antibody level of 1/40, measured by hemagglutination, 3 weeks after the first injection and after the second injection | 3 weeks |
| 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) | Antibody levels against H1N1 in the different groups of patients, defined according diseases and their treatment | 3 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Loïc GUILLEVIN, MD PhD | Assistance Publique - Hôpitaux de Paris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hopital Cochin | Paris | 75014 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22640652 | Result | 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. |
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| ID | Term |
|---|---|
| D001327 | Autoimmune Diseases |
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D007154 | Immune System Diseases |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
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| Number of side effects related to vaccination |
| 3 weeks |
| Number of local side effects related to vaccination (erythema and/or pain at injection site) | 3 weeks |
| Number of patients who will develop influenza despite vaccination | 3 weeks |
| Number of patients who had antibodies against H1N1 before vaccination | 3 weeks |
| Number of hospitalisations and deaths related to influenza | 3 weeks |
| Number of flares of the autoimmune diseases that could be related to vaccination | 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 | 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 | 18 months |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |