Ex Vivo Evaluation of Immunity Activation Face to S. Aureus Antigens and Adjuvants of a Vaccine Candidate in Cells From Haemodialysis Patients
- Conditions
- Staphylococcus Aureus
- Interventions
- Biological: blood samplesBiological: nasal swabs
- Registration Number
- NCT03643328
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
- Patient starting haemodialysis for chronic hemodialysis.
- Patient starting haemodialysis on catheter
- Patient who signed the informed consent form
- Pregnant woman
- Patient who starts Haemodialysis for over 3 months
- Patient with anemia (hemoglobin <7 g / dL)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description new haemodialysis patients. nasal swabs There is an analyse of immune response against S. aureus from new haemodialysis patients by blood samples and nasal swabs. new haemodialysis patients. blood samples There is an analyse of immune response against S. aureus from new haemodialysis patients by blood samples and nasal swabs.
- Primary Outcome Measures
Name Time Method 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 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 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.
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
- Secondary Outcome Measures
Name Time Method Number of infection by S. aureus in new haemodialysis patients. Month 12 By data collection
Incidence of persistant portage of S. aureus in the nose haemodialysis patients. Months 0 and 6 and 12 Measured by nasal swabs.
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.
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.
Analysis of the S. aureus clonal complexes of nasal carriage strains from haemodialysis patients. Months 0 and 6 and 12 Measured by nasal swabs.
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.
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.
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.
Survival rate to S.aureus in the whole blood Months 0 and 6 and 12 Measured by blood samples. Expressed in percentage
Trial Locations
- Locations (1)
CHU de Saint-Etienne
🇫🇷Saint Etienne, France