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NCT Number: NCT03643328

Ex Vivo Evaluation of Immunity Activation Face to S. 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.

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Key information

Conditions

Staphylococcus Aureus Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Infections Staphylococcal Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Saint-Etienne

Saint-Etienne, 42055, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

blood samples

Biological

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

nasal swabs

Biological

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Collaborators

  • Sanofi Pasteur, a Sanofi Company

Registry information

Official study title

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

Acronym: ANTISTAPH

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Aug 22, 2018
Registry last updated
Dec 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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