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

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

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.

Study Overview

• Status: Completed
• Conditions: Staphylococcus Aureus
• Intervention / Treatment: Biological: blood samples; Biological: nasal swabs

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Saint Etienne, France, 42055
    • CHU de Saint-Etienne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne
• Collaborators: Sanofi Pasteur, a Sanofi Company
• Investigators: Principal Investigator: Elisabeth BOTELHO-NEVERS, MD, Centre Hospitalier Universitaire de Saint Etienne

Study record dates

Study Major Dates

• Study Start (Actual): December 14, 2017
• Primary Completion (Actual): December 7, 2020
• Study Completion (Actual): December 7, 2020

Study Registration Dates

• First Submitted: August 16, 2018
• First Submitted That Met QC Criteria: August 21, 2018
• First Posted (Actual): August 22, 2018

Study Record Updates

• Last Update Posted (Actual): December 17, 2020
• Last Update Submitted That Met QC Criteria: December 16, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: vaccine; Staphylococcus Aureus; haemodialysis; immune response
• Additional Relevant MeSH Terms: Infections; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Staphylococcal Infections
• Other Study ID Numbers: 1608178; ANSM (Other Identifier: 2022-A02513-40)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No