Clinical trial NCT03643328: Ex Vivo Evaluation of Immunity Activation Face to S. Aureus Antigens and Adjuvants of a Vaccine Candidate in Cells From Haemodialysis Patients
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
Overall status: COMPLETED
Phase: NA
Conditions: Staphylococcus Aureus
Keywords: Staphylococcus Aureus
haemodialysis
vaccine
immune response
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
Collaborators: name: Sanofi Pasteur, a Sanofi Company
First posted: 2018-08-22
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.

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)

Primary outcomes:
measure: EX VIVO measure of innate immunity: functional capacity of neutrophils to S. aureus vaccine antigens
timeFrame: Up to 12 months
measure: EX VIVO measure of innate immunity: induction of oxidative burst to S. aureus vaccine antigens
timeFrame: Up to 12 months
measure: EX VIVO measure of innate immunity : phenotype activation of different cell types from PBMCs (peripheral blood mononuclear cells) to S. aureus vaccine antigens
timeFrame: Up to 12 months
measure: EX VIVO measures of innate immunity: chemokines and cytokines secretions to S. aureus vaccine antigens
timeFrame: Up to 12 months
measure: EX VIVO measure of acquired immunity: measures of S. aureus antibodies titre in serum to S. aureus vaccine antigens
timeFrame: Up to 12 months
Secondary outcomes:
measure: Incidence of persistant portage of S. aureus in the nose haemodialysis patients.
timeFrame: Months 0 and 6 and 12
measure: Analysis of the S. aureus clonal complexes of nasal carriage strains from haemodialysis patients.
timeFrame: Months 0 and 6 and 12
measure: Number of infection by S. aureus in new haemodialysis patients.
timeFrame: Month 12
measure: EX VIVO measure of innate immunity: functional capacity of neutrophils to S. aureus vaccine adjuvants
timeFrame: Months 0 and 6 and 12
measure: EX VIVO measure of innate immunity: induction of oxidative burst to S. aureus vaccine adjuvants
timeFrame: Months 0 and 6 and 12
measure: EX VIVO measure of innate immunity : phenotype activation of different cell types from PBMCs (peripheral blood mononuclear cells) to S. aureus vaccine adjuvants
timeFrame: Months 0 and 6 and 12
measure: EX VIVO measures of innate immunity: chemokines and cytokines secretions to S. aureus vaccine adjuvants
timeFrame: Months 0 and 6 and 12
measure: EX VIVO measure of acquired immunity: measures of S. aureus antibodies titre in serum to S. aureus vaccine adjuvants
timeFrame: Months 0 and 6 and 12
measure: Investigation of the presence of antigens of interest selected for the vaccine approach in strains of S. aureus in the nasal carriage
timeFrame: Months 0 and 6 and 12
measure: Survival rate to S.aureus in the whole blood
timeFrame: Months 0 and 6 and 12
Other outcomes:
Locations:
city: Saint Etienne
country: France
facility: CHU de Saint-Etienne
Study officials:
affiliation: Centre Hospitalier Universitaire de Saint Etienne
name: Elisabeth BOTELHO-NEVERS, MD
role: PRINCIPAL_INVESTIGATOR
References: