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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 (ANTISTAPH)

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ClinicalTrials.gov Identifier: NCT03643328
Recruitment Status : Recruiting
First Posted : August 22, 2018
Last Update Posted : August 22, 2018
Sponsor:
Collaborator:
Sanofi Pasteur, a Sanofi Company
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Saint Etienne

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.

Condition or disease Intervention/treatment Phase
Staphylococcus Aureus Biological: blood samples Biological: nasal swabs Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 55 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Ex Vivo Evaluation of Immunity Activation Face to Staphylococcus Aureus Antigens and Adjuvants of a Vaccine Candidate in Cells From Haemodialysis Patients
Actual Study Start Date : December 14, 2017
Estimated Primary Completion Date : July 15, 2020
Estimated Study Completion Date : July 15, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis

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.




Primary Outcome Measures :
  1. EX VIVO measure of innate immunity: functional capacity of neutrophils to S. aureus vaccine antigens [ Time Frame: Up to 12 months ]
    Measured by blood samples at 0, 6 and 12 months

  2. EX VIVO measure of innate immunity: induction of oxidative burst to S. aureus vaccine antigens [ Time Frame: Up to 12 months ]
    Measured by blood samples 0, 6 and 12 months

  3. EX VIVO measure of innate immunity : phenotype activation of different cell types from PBMCs (peripheral blood mononuclear cells) to S. aureus vaccine antigens [ Time Frame: Up to 12 months ]
    Measured by blood samples 0, 6 and 12 months.

  4. EX VIVO measures of innate immunity: chemokines and cytokines secretions to S. aureus vaccine antigens [ Time Frame: Up to 12 months ]
    Measured by blood samples 0, 6 and 12 months.

  5. EX VIVO measure of acquired immunity: measures of S. aureus antibodies titre in serum to S. aureus vaccine antigens [ Time Frame: Up to 12 months ]
    Measured by blood samples 0, 6 and 12 months.


Secondary Outcome Measures :
  1. Incidence of persistant portage of S. aureus in the nose haemodialysis patients. [ Time Frame: Months 0 and 6 and 12 ]
    Measured by nasal swabs.

  2. Analysis of the S. aureus clonal complexes of nasal carriage strains from haemodialysis patients. [ Time Frame: Months 0 and 6 and 12 ]
    Measured by nasal swabs.

  3. Number of infection by S. aureus in new haemodialysis patients. [ Time Frame: Month 12 ]
    By data collection

  4. EX VIVO measure of innate immunity: functional capacity of neutrophils to S. aureus vaccine adjuvants [ Time Frame: Months 0 and 6 and 12 ]
    Measured by blood samples.

  5. EX VIVO measure of innate immunity: induction of oxidative burst to S. aureus vaccine adjuvants [ Time Frame: Months 0 and 6 and 12 ]
    Measured by blood samples.

  6. EX VIVO measure of innate immunity : phenotype activation of different cell types from PBMCs (peripheral blood mononuclear cells) to S. aureus vaccine adjuvants [ Time Frame: Months 0 and 6 and 12 ]
    Measured by blood samples.

  7. EX VIVO measures of innate immunity: chemokines and cytokines secretions to S. aureus vaccine adjuvants [ Time Frame: Months 0 and 6 and 12 ]
    Measured by blood samples.

  8. EX VIVO measure of acquired immunity: measures of S. aureus antibodies titre in serum to S. aureus vaccine adjuvants [ Time Frame: Months 0 and 6 and 12 ]
    Measured by blood samples.

  9. Investigation of the presence of antigens of interest selected for the vaccine approach in strains of S. aureus in the nasal carriage [ Time Frame: Months 0 and 6 and 12 ]
    Measured by nasal swabs.

  10. Survival rate to S.aureus in the whole blood [ Time Frame: Months 0 and 6 and 12 ]
    Measured by blood samples. Expressed in percentage



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03643328


Contacts
Contact: Elisabeth BOTELHO-NEVERS, MD (0)477127789 ext +33 Elisabeth.Botelho-Nevers@chu-st-etienne.fr
Contact: Arnauld GARCIN, CRA (0)477120286 ext +33 arnauld.garcin@chu-st-etienne.fr

Locations
France
CHU de Saint-Etienne Recruiting
Saint Etienne, France, 42055
Principal Investigator: Elisabeth BOTELHO-NEVERS, MD         
Sub-Investigator: Philippe Berthelot, MD PhD         
Sub-Investigator: Eric Alamartine, MD PhD         
Sub-Investigator: Damien Thibaudin, MD         
Sub-Investigator: Christophe Mariat, MD PhD         
Sub-Investigator: Fréderic Lucht, MD PhD         
Sub-Investigator: Amandine Gagneux-Brunon, MD         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Saint Etienne
Sanofi Pasteur, a Sanofi Company
Investigators
Principal Investigator: Elisabeth BOTELHO-NEVERS, MD Centre Hospitalier Universitaire de Saint Etienne

Responsible Party: Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier: NCT03643328     History of Changes
Other Study ID Numbers: 1608178
ANSM ( Other Identifier: 2017-A00707-46 )
First Posted: August 22, 2018    Key Record Dates
Last Update Posted: August 22, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Centre Hospitalier Universitaire de Saint Etienne:
Staphylococcus Aureus
haemodialysis
vaccine
immune response

Additional relevant MeSH terms:
Vaccines
Immunologic Factors
Physiological Effects of Drugs