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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
50
Blood samples will be collected at inclusion, at 6 months and 12 months for hematological and immunological analyses.
Two nasal swabs will be collected at inclusion, at 6 months and 12 months for virology analyses.
CHU de Saint-Etienne
Saint-Etienne, France
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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to 12 months
Incidence of persistant portage of S. aureus in the nose haemodialysis patients.
Measured by nasal swabs.
Time frame: Months 0 and 6 and 12
Analysis of the S. aureus clonal complexes of nasal carriage strains from haemodialysis patients.
Measured by nasal swabs.
Time frame: Months 0 and 6 and 12
Number of infection by S. aureus in new haemodialysis patients.
By data collection
Time frame: Month 12
EX VIVO measure of innate immunity: functional capacity of neutrophils to S. aureus vaccine adjuvants
Measured by blood samples.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Months 0 and 6 and 12
Survival rate to S.aureus in the whole blood
Measured by blood samples. Expressed in percentage
Time frame: Months 0 and 6 and 12
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