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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 14, 2017

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 16, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 22, 2018

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 7, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 7, 2020

Completed
Last Updated

December 17, 2020

Status Verified

December 1, 2020

Enrollment Period

3 years

First QC Date

August 16, 2018

Last Update Submit

December 16, 2020

Conditions

Staphylococcus Aureus

Keywords

Staphylococcus Aureushaemodialysisvaccineimmune response

Outcome Measures

Primary Outcomes (5)

  • 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 Outcomes (10)

  • Incidence of persistant portage of S. aureus in the nose haemodialysis patients.

    Months 0 and 6 and 12

  • Analysis of the S. aureus clonal complexes of nasal carriage strains from haemodialysis patients.

    Months 0 and 6 and 12

  • Number of infection by S. aureus in new haemodialysis patients.

    Month 12

  • EX VIVO measure of innate immunity: functional capacity of neutrophils to S. aureus vaccine adjuvants

    Months 0 and 6 and 12

  • EX VIVO measure of innate immunity: induction of oxidative burst to S. aureus vaccine adjuvants

    Months 0 and 6 and 12

  • +5 more secondary outcomes

Study Arms (1)

new haemodialysis patients.

EXPERIMENTAL

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

Biological: blood samplesBiological: nasal swabs

Interventions

blood samplesBIOLOGICAL

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

new haemodialysis patients.
nasal swabsBIOLOGICAL

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

new haemodialysis patients.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient starting haemodialysis for chronic hemodialysis.
  • Patient starting haemodialysis on catheter
  • Patient who signed the informed consent form

You may not qualify if:

  • Pregnant woman
  • Patient who starts Haemodialysis for over 3 months
  • Patient with anemia (hemoglobin \<7 g / dL)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Saint-Etienne

Saint-Etienne, 42055, France

Location

MeSH Terms

Conditions

Staphylococcal Infections

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Elisabeth BOTELHO-NEVERS, MD

    Centre Hospitalier Universitaire de Saint Etienne

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 16, 2018

First Posted

August 22, 2018

Study Start

December 14, 2017

Primary Completion

December 7, 2020

Study Completion

December 7, 2020

Last Updated

December 17, 2020

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)