Ex Vivo Evaluation of Immunity Activation Face to S. Aureus Antigens and Adjuvants of a Vaccine Candidate in Cells From Haemodialysis Patients (ANTISTAPH)
Primary Purpose
Staphylococcus Aureus
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
blood samples
nasal swabs
Sponsored by
About this trial
This is an interventional basic science trial for Staphylococcus Aureus focused on measuring Staphylococcus Aureus, haemodialysis, vaccine, immune response
Eligibility Criteria
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)
Sites / Locations
- CHU de Saint-Etienne
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
new haemodialysis patients.
Arm Description
There is an analyse of immune response against S. aureus from new haemodialysis patients by blood samples and nasal swabs.
Outcomes
Primary Outcome Measures
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
EX VIVO measure of innate immunity: induction of oxidative burst to S. aureus vaccine antigens
Measured by blood samples 0, 6 and 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.
EX VIVO measures of innate immunity: chemokines and cytokines secretions to S. aureus vaccine antigens
Measured by blood samples 0, 6 and 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.
Secondary Outcome Measures
Incidence of persistant portage of S. aureus in the nose haemodialysis patients.
Measured by nasal swabs.
Analysis of the S. aureus clonal complexes of nasal carriage strains from haemodialysis patients.
Measured by nasal swabs.
Number of infection by S. aureus in new haemodialysis patients.
By data collection
EX VIVO measure of innate immunity: functional capacity of neutrophils to S. aureus vaccine adjuvants
Measured by blood samples.
EX VIVO measure of innate immunity: induction of oxidative burst to S. aureus vaccine adjuvants
Measured by blood samples.
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.
EX VIVO measures of innate immunity: chemokines and cytokines secretions to S. aureus vaccine adjuvants
Measured by blood samples.
EX VIVO measure of acquired immunity: measures of S. aureus antibodies titre in serum to S. aureus vaccine adjuvants
Measured by blood samples.
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.
Survival rate to S.aureus in the whole blood
Measured by blood samples. Expressed in percentage
Full Information
NCT ID
NCT03643328
First Posted
August 16, 2018
Last Updated
December 16, 2020
Sponsor
Centre Hospitalier Universitaire de Saint Etienne
Collaborators
Sanofi Pasteur, a Sanofi Company
1. Study Identification
Unique Protocol Identification Number
NCT03643328
Brief Title
Ex Vivo Evaluation of Immunity Activation Face to S. Aureus Antigens and Adjuvants of a Vaccine Candidate in Cells From Haemodialysis Patients
Acronym
ANTISTAPH
Official Title
Ex Vivo Evaluation of Immunity Activation Face to Staphylococcus Aureus Antigens and Adjuvants of a Vaccine Candidate in Cells From Haemodialysis Patients
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
December 14, 2017 (Actual)
Primary Completion Date
December 7, 2020 (Actual)
Study Completion Date
December 7, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Saint Etienne
Collaborators
Sanofi Pasteur, a Sanofi Company
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Staphylococcus Aureus
Keywords
Staphylococcus Aureus, haemodialysis, vaccine, immune response
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
new haemodialysis patients.
Arm Type
Experimental
Arm Description
There is an analyse of immune response against S. aureus from new haemodialysis patients by blood samples and nasal swabs.
Intervention Type
Biological
Intervention Name(s)
blood samples
Intervention Description
Blood samples will be collected at inclusion, at 6 months and 12 months for hematological and immunological analyses.
Intervention Type
Biological
Intervention Name(s)
nasal swabs
Intervention Description
Two nasal swabs will be collected at inclusion, at 6 months and 12 months for virology analyses.
Primary Outcome Measure Information:
Title
EX VIVO measure of innate immunity: functional capacity of neutrophils to S. aureus vaccine antigens
Description
Measured by blood samples at 0, 6 and 12 months
Time Frame
Up to 12 months
Title
EX VIVO measure of innate immunity: induction of oxidative burst to S. aureus vaccine antigens
Description
Measured by blood samples 0, 6 and 12 months
Time Frame
Up to 12 months
Title
EX VIVO measure of innate immunity : phenotype activation of different cell types from PBMCs (peripheral blood mononuclear cells) to S. aureus vaccine antigens
Description
Measured by blood samples 0, 6 and 12 months.
Time Frame
Up to 12 months
Title
EX VIVO measures of innate immunity: chemokines and cytokines secretions to S. aureus vaccine antigens
Description
Measured by blood samples 0, 6 and 12 months.
Time Frame
Up to 12 months
Title
EX VIVO measure of acquired immunity: measures of S. aureus antibodies titre in serum to S. aureus vaccine antigens
Description
Measured by blood samples 0, 6 and 12 months.
Time Frame
Up to 12 months
Secondary Outcome Measure Information:
Title
Incidence of persistant portage of S. aureus in the nose haemodialysis patients.
Description
Measured by nasal swabs.
Time Frame
Months 0 and 6 and 12
Title
Analysis of the S. aureus clonal complexes of nasal carriage strains from haemodialysis patients.
Description
Measured by nasal swabs.
Time Frame
Months 0 and 6 and 12
Title
Number of infection by S. aureus in new haemodialysis patients.
Description
By data collection
Time Frame
Month 12
Title
EX VIVO measure of innate immunity: functional capacity of neutrophils to S. aureus vaccine adjuvants
Description
Measured by blood samples.
Time Frame
Months 0 and 6 and 12
Title
EX VIVO measure of innate immunity: induction of oxidative burst to S. aureus vaccine adjuvants
Description
Measured by blood samples.
Time Frame
Months 0 and 6 and 12
Title
EX VIVO measure of innate immunity : phenotype activation of different cell types from PBMCs (peripheral blood mononuclear cells) to S. aureus vaccine adjuvants
Description
Measured by blood samples.
Time Frame
Months 0 and 6 and 12
Title
EX VIVO measures of innate immunity: chemokines and cytokines secretions to S. aureus vaccine adjuvants
Description
Measured by blood samples.
Time Frame
Months 0 and 6 and 12
Title
EX VIVO measure of acquired immunity: measures of S. aureus antibodies titre in serum to S. aureus vaccine adjuvants
Description
Measured by blood samples.
Time Frame
Months 0 and 6 and 12
Title
Investigation of the presence of antigens of interest selected for the vaccine approach in strains of S. aureus in the nasal carriage
Description
Measured by nasal swabs.
Time Frame
Months 0 and 6 and 12
Title
Survival rate to S.aureus in the whole blood
Description
Measured by blood samples. Expressed in percentage
Time Frame
Months 0 and 6 and 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elisabeth BOTELHO-NEVERS, MD
Organizational Affiliation
Centre Hospitalier Universitaire de Saint Etienne
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Saint-Etienne
City
Saint Etienne
ZIP/Postal Code
42055
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Ex Vivo Evaluation of Immunity Activation Face to S. Aureus Antigens and Adjuvants of a Vaccine Candidate in Cells From Haemodialysis Patients
We'll reach out to this number within 24 hrs