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

Staphylococcus Aureus Clinical Trial

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Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03643328
• Other study ID #: 1608178
• Secondary ID: ANSM
• Status: Completed
• Phase: N/A
• Start date: December 14, 2017
• Est. completion date: December 7, 2020

Study information

• Verified date: December 2020
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 7, 2020
• Est. primary completion date: December 7, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Staphylococcus Aureus

Intervention

Biological:
• blood samples
Blood samples will be collected at inclusion, at 6 months and 12 months for hematological and immunological analyses.
• nasal swabs
Two nasal swabs will be collected at inclusion, at 6 months and 12 months for virology analyses.

Locations

Country	Name	City	State
France	CHU de Saint-Etienne	Saint Etienne

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne	Sanofi Pasteur, a Sanofi Company

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Incidence of persistant portage of S. aureus in the nose haemodialysis patients.	Measured by nasal swabs.	Months 0 and 6 and 12
Secondary	Analysis of the S. aureus clonal complexes of nasal carriage strains from haemodialysis patients.	Measured by nasal swabs.	Months 0 and 6 and 12
Secondary	Number of infection by S. aureus in new haemodialysis patients.	By data collection	Month 12
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Survival rate to S.aureus in the whole blood	Measured by blood samples. Expressed in percentage	Months 0 and 6 and 12