Trials / Completed
CompletedNCT03643328
Ex Vivo Evaluation of Immunity Activation Face to S. Aureus Antigens and Adjuvants of a Vaccine Candidate in Cells From Haemodialysis Patients
Ex Vivo Evaluation of Immunity Activation Face to Staphylococcus Aureus Antigens and Adjuvants of a Vaccine Candidate in Cells From Haemodialysis Patients
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 50 (actual)
- Sponsor
- Centre Hospitalier Universitaire de Saint Etienne · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2017-12-14
- Primary completion
- 2020-12-07
- Completion
- 2020-12-07
- First posted
- 2018-08-22
- Last updated
- 2020-12-17
Locations
1 site across 1 country: France
Source: ClinicalTrials.gov record NCT03643328. Inclusion in this directory is not an endorsement.