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

NCT ID: NCT03643328

Last Updated: 2020-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-14

Study Completion Date

2020-12-07

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.

Conditions

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Staphylococcus Aureus

Keywords

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Staphylococcus Aureus haemodialysis vaccine immune response

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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new haemodialysis patients.

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

Group Type EXPERIMENTAL

blood samples

Intervention Type BIOLOGICAL

Blood samples will be collected at inclusion, at 6 months and 12 months for hematological and immunological analyses.

nasal swabs

Intervention Type BIOLOGICAL

Two nasal swabs will be collected at inclusion, at 6 months and 12 months for virology analyses.

Interventions

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blood samples

Blood samples will be collected at inclusion, at 6 months and 12 months for hematological and immunological analyses.

Intervention Type BIOLOGICAL

nasal swabs

Two nasal swabs will be collected at inclusion, at 6 months and 12 months for virology analyses.

Intervention Type BIOLOGICAL

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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sanofi Pasteur, a Sanofi Company

INDUSTRY

Sponsor Role collaborator

Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Elisabeth BOTELHO-NEVERS, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire de Saint Etienne

Locations

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CHU de Saint-Etienne

Saint-Etienne, , France

Site Status

Countries

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France

Other Identifiers

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ANSM

Identifier Type: OTHER

Identifier Source: secondary_id

1608178

Identifier Type: -

Identifier Source: org_study_id