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

Centre Hospitalier Universitaire de Saint Etienne

Status: Completed

Conditions: Staphylococcus Aureus

Treatments: Biological: nasal swabs; Biological: blood samples

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03643328

ANSM (Other Identifier)

1608178

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

new haemodialysis patients.

Experimental group

Description:

There is an analyse of immune response against S. aureus from new haemodialysis patients by blood samples and nasal swabs.

Treatment:

Biological: nasal swabs

Biological: blood samples