Staphylococcus Aureus
Conditions
Keywords
Staphylococcus Aureus, haemodialysis, vaccine, immune response
Brief summary
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.
Detailed description
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.
Interventions
BIOLOGICALblood samples
Blood samples will be collected at inclusion, at 6 months and 12 months for hematological and immunological analyses.
BIOLOGICALnasal swabs
Two nasal swabs will be collected at inclusion, at 6 months and 12 months for virology analyses.
Sponsors
Sanofi Pasteur, a Sanofi Company
Centre Hospitalier Universitaire de Saint Etienne
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient starting haemodialysis for chronic hemodialysis. * Patient starting haemodialysis on catheter * Patient who signed the informed consent form
Exclusion criteria
* Pregnant woman * Patient who starts Haemodialysis for over 3 months * Patient with anemia (hemoglobin \<7 g / dL)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| EX VIVO measure of acquired immunity: measures of S. aureus antibodies titre in serum to S. aureus vaccine antigens | Up to 12 months | Measured by blood samples 0, 6 and 12 months. |
| EX VIVO measure of innate immunity: functional capacity of neutrophils to S. aureus vaccine antigens | Up to 12 months | Measured by blood samples at 0, 6 and 12 months |
| EX VIVO measure of innate immunity: induction of oxidative burst to S. aureus vaccine antigens | Up to 12 months | Measured by blood samples 0, 6 and 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 | Up to 12 months | Measured by blood samples 0, 6 and 12 months. |
| EX VIVO measures of innate immunity: chemokines and cytokines secretions to S. aureus vaccine antigens | Up to 12 months | Measured by blood samples 0, 6 and 12 months. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| EX VIVO measure of innate immunity : phenotype activation of different cell types from PBMCs (peripheral blood mononuclear cells) to S. aureus vaccine adjuvants | Months 0 and 6 and 12 | Measured by blood samples. |
| EX VIVO measures of innate immunity: chemokines and cytokines secretions to S. aureus vaccine adjuvants | Months 0 and 6 and 12 | Measured by blood samples. |
| Incidence of persistant portage of S. aureus in the nose haemodialysis patients. | Months 0 and 6 and 12 | Measured by nasal swabs. |
| Investigation of the presence of antigens of interest selected for the vaccine approach in strains of S. aureus in the nasal carriage | Months 0 and 6 and 12 | Measured by nasal swabs. |
| Survival rate to S.aureus in the whole blood | Months 0 and 6 and 12 | Measured by blood samples. Expressed in percentage |
| EX VIVO measure of acquired immunity: measures of S. aureus antibodies titre in serum to S. aureus vaccine adjuvants | Months 0 and 6 and 12 | Measured by blood samples. |
| Analysis of the S. aureus clonal complexes of nasal carriage strains from haemodialysis patients. | Months 0 and 6 and 12 | Measured by nasal swabs. |
| Number of infection by S. aureus in new haemodialysis patients. | Month 12 | By data collection |
| EX VIVO measure of innate immunity: functional capacity of neutrophils to S. aureus vaccine adjuvants | Months 0 and 6 and 12 | Measured by blood samples. |
| EX VIVO measure of innate immunity: induction of oxidative burst to S. aureus vaccine adjuvants | Months 0 and 6 and 12 | Measured by blood samples. |
Countries
France
Outcome results
None listed