Ex Vivo Evaluation of Immunity Activation Face to S. Aureus Antigens and Adjuvants of a Vaccine Candidate in Cells From Haemodialysis Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Ex Vivo Evaluation of Immunity Activation Face to Staphylococcus Aureus Antigens and Adjuvants of a Vaccine Candidate in Cells From Haemodialysis Patients

Conditions
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Staphylococcus Aureus

Intervention / Treatment
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* Biological: blood samples
* Biological: nasal swabs


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: new haemodialysis patients.<br>There is an analyse of immune response against S. aureus from new haemodialysis patients by blood samples and nasal swabs. | Biological: blood samples<br>* Blood samples will be collected at inclusion, at 6 months and 12 months for hematological and immunological analyses.<br>Biological: nasal swabs<br>* Two nasal swabs will be collected at inclusion, at 6 months and 12 months for virology analyses.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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vaccine, Staphylococcus Aureus, haemodialysis, immune response