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| ID | Type | Description | Link |
|---|---|---|---|
| ANSM | Other Identifier | 2017-A00707-46 |
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| Name | Class |
|---|---|
| Sanofi Pasteur, a Sanofi Company | INDUSTRY |
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S. aureus is a leading cause of severe infections notably in haemodialysis patients. These patients have a high risk of S. aureus nasal carriage, with a rate of persistent carriage near 30%. These carriers are particularly at risk of S. aureus infections as we previously shown. High risk of S. aureus infections such as bacteremia occurred notably in patients with dialysis catheters. Decolonization of carriers may prevent such infections however this approach has limits. Development of an effective S. aureus vaccine is crucial. To date, past vaccines tested (phase III) failed to achieve their end points. Target of only one or few antigens, absence of cellular response induction and possibly no impact on carriage are probably the reasons of the failures.
In an attempt to minimize failure in a clinical phase, ex vivo analysis of immune response of leucocytes of haemodialysis patients face to S. aureus and the impact of antigens and adjuvants of a candidate vaccine may help.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| new haemodialysis patients. | Experimental | There is an analyse of immune response against S. aureus from new haemodialysis patients by blood samples and nasal swabs. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| blood samples | Biological | Blood samples will be collected at inclusion, at 6 months and 12 months for hematological and immunological analyses. |
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| Measure | Description | Time Frame |
|---|---|---|
| EX VIVO measure of innate immunity: functional capacity of neutrophils to S. aureus vaccine antigens | Measured by blood samples at 0, 6 and 12 months | Up to 12 months |
| EX VIVO measure of innate immunity: induction of oxidative burst to S. aureus vaccine antigens | Measured by blood samples 0, 6 and 12 months | Up to 12 months |
| EX VIVO measure of innate immunity : phenotype activation of different cell types from PBMCs (peripheral blood mononuclear cells) to S. aureus vaccine antigens | Measured by blood samples 0, 6 and 12 months. | Up to 12 months |
| EX VIVO measures of innate immunity: chemokines and cytokines secretions to S. aureus vaccine antigens | Measured by blood samples 0, 6 and 12 months. | Up to 12 months |
| EX VIVO measure of acquired immunity: measures of S. aureus antibodies titre in serum to S. aureus vaccine antigens | Measured by blood samples 0, 6 and 12 months. | Up to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of persistant portage of S. aureus in the nose haemodialysis patients. | Measured by nasal swabs. | Months 0 and 6 and 12 |
| Analysis of the S. aureus clonal complexes of nasal carriage strains from haemodialysis patients. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elisabeth BOTELHO-NEVERS, MD | Centre Hospitalier Universitaire de Saint Etienne | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Saint-Etienne | Saint-Etienne | 42055 | France |
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| nasal swabs | Biological | Two nasal swabs will be collected at inclusion, at 6 months and 12 months for virology analyses. |
|
Measured by nasal swabs.
| Months 0 and 6 and 12 |
| Number of infection by S. aureus in new haemodialysis patients. | By data collection | Month 12 |
| EX VIVO measure of innate immunity: functional capacity of neutrophils to S. aureus vaccine adjuvants | Measured by blood samples. | Months 0 and 6 and 12 |
| EX VIVO measure of innate immunity: induction of oxidative burst to S. aureus vaccine adjuvants | Measured by blood samples. | Months 0 and 6 and 12 |
| EX VIVO measure of innate immunity : phenotype activation of different cell types from PBMCs (peripheral blood mononuclear cells) to S. aureus vaccine adjuvants | Measured by blood samples. | Months 0 and 6 and 12 |
| EX VIVO measures of innate immunity: chemokines and cytokines secretions to S. aureus vaccine adjuvants | Measured by blood samples. | Months 0 and 6 and 12 |
| EX VIVO measure of acquired immunity: measures of S. aureus antibodies titre in serum to S. aureus vaccine adjuvants | Measured by blood samples. | Months 0 and 6 and 12 |
| Investigation of the presence of antigens of interest selected for the vaccine approach in strains of S. aureus in the nasal carriage | Measured by nasal swabs. | Months 0 and 6 and 12 |
| Survival rate to S.aureus in the whole blood | Measured by blood samples. Expressed in percentage | Months 0 and 6 and 12 |
| ID | Term |
|---|---|
| D013203 | Staphylococcal Infections |
| ID | Term |
|---|---|
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
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