Staphylococcus AureusANTISTAPHNCT03643328
Ex Vivo Evaluation of Immunity Activation Face to S. Aureus Antigens and Adjuvants of a Vaccine Candidate in Cells From Haemodialysis Patients
A study testing blood samples and nasal swabs in people with Staphylococcus Aureus, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Staphylococcus Aureus
- What is being tested?
- blood samples and nasal swabs
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 14 Dec 2017to 7 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient starting haemodialysis for chronic hemodialysis.
- Patient starting haemodialysis on catheter
- Patient who signed the informed consent form
Who cannot join
- Pregnant woman
- Patient who starts Haemodialysis for over 3 months
- Patient with anemia (hemoglobin <7 g / dL)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ex Vivo Evaluation of Immunity Activation Face to Staphylococcus Aureus Antigens and Adjuvants of a Vaccine Candidate in Cells From Haemodialysis Patients
- 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.
Read the 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
- Staphylococcus Aureus
- Being tested
- blood samples, nasal swabs
- Keywords
- Staphylococcus Aureus, haemodialysis, vaccine, immune response
- Medical subject headings
- Staphylococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood samplesBiological
Blood samples will be collected at inclusion, at 6 months and 12 months for hematological and immunological analyses.
nasal swabsBiological
Two nasal swabs will be collected at inclusion, at 6 months and 12 months for virology analyses.
| Study group | Role | What they receive |
|---|---|---|
| new haemodialysis patients. | Experimental | There is an analyse of immune response against S. aureus from new haemodialysis patients by blood samples and nasal swabs. Receives: Biological: blood samples; Biological: nasal swabs |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Up to 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
Measured: Up to 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.
Measured: Up to 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.
Measured: Up to 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.
Measured: Up to 12 months
Secondary outcomes (10)
Incidence of persistant portage of S. aureus in the nose haemodialysis patients.
Measured by nasal swabs.
Measured: Months 0 and 6 and 12
Analysis of the S. aureus clonal complexes of nasal carriage strains from haemodialysis patients.
Measured by nasal swabs.
Measured: Months 0 and 6 and 12
Number of infection by S. aureus in new haemodialysis patients.
By data collection
Measured: Month 12
EX VIVO measure of innate immunity: functional capacity of neutrophils to S. aureus vaccine adjuvants
Measured by blood samples.
Measured: Months 0 and 6 and 12
EX VIVO measure of innate immunity: induction of oxidative burst to S. aureus vaccine adjuvants
Measured by blood samples.
Measured: Months 0 and 6 and 12
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.
Measured: Months 0 and 6 and 12
EX VIVO measures of innate immunity: chemokines and cytokines secretions to S. aureus vaccine adjuvants
Measured by blood samples.
Measured: Months 0 and 6 and 12
EX VIVO measure of acquired immunity: measures of S. aureus antibodies titre in serum to S. aureus vaccine adjuvants
Measured by blood samples.
Measured: Months 0 and 6 and 12
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.
Measured: Months 0 and 6 and 12
Survival rate to S.aureus in the whole blood
Measured by blood samples. Expressed in percentage
Measured: Months 0 and 6 and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2018
- Study start14 Dec 2017
- Primary completion7 Dec 2020
- Study completion7 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Staphylococcus AureusStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Sanofi Pasteur, a Sanofi Company
- Responsible party
- Sponsor
- Investigators
- Elisabeth BOTELHO-NEVERS, MD, Principal investigator, Centre Hospitalier Universitaire de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03643328
- Sponsor's protocol ID
- 1608178
- Other IDs
- ANSM
- Acronym
- ANTISTAPH
- Status last verified
- Dec 2020
- First submitted
- 16 Aug 2018
- Last updated
- 17 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ex Vivo Evaluation of Immunity Activation Face to Staphylococcus Aureus Antigens and Adjuvants of a Vaccine Candidate in Cells From Haemodialysis Patients
- ClinicalTrials.gov ID
- NCT03643328
- Acronym / sponsor ID
- ANTISTAPH / 1608178
- Conditions
- Staphylococcus Aureus
- Keywords
- Staphylococcus Aureus, haemodialysis, vaccine, immune response
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Collaborators
- Sanofi Pasteur, a Sanofi Company
- Study start
- 14 Dec 2017 (actual)
- Primary completion
- 7 Dec 2020 (actual)
- Study completion
- 7 Dec 2020 (actual)
- First posted
- 22 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| new haemodialysis patients. | Experimental | Biological: blood samples, Biological: nasal swabsThere is an analyse of immune response against S. aureus from new haemodialysis patients by blood samples and nasal swabs. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient starting haemodialysis for chronic hemodialysis.
- Patient starting haemodialysis on catheter
- Patient who signed the informed consent form
Key exclusion criteria (3 listed)
- Pregnant woman
- Patient who starts Haemodialysis for over 3 months
- Patient with anemia (hemoglobin <7 g / dL)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood samplesBlood samples will be collected at inclusion, at 6 months and 12 months for hematological and immunological analyses. | Biological | new haemodialysis patients. |
| nasal swabsTwo nasal swabs will be collected at inclusion, at 6 months and 12 months for virology analyses. | Biological | new haemodialysis patients. |
Primary outcome
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
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
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.
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.
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.
10 secondary outcomes
Incidence of persistant portage of S. aureus in the nose haemodialysis patients.
Time frame: Months 0 and 6 and 12
Analysis of the S. aureus clonal complexes of nasal carriage strains from haemodialysis patients.
Time frame: Months 0 and 6 and 12
Number of infection by S. aureus in new haemodialysis patients.
Time frame: Month 12
EX VIVO measure of innate immunity: functional capacity of neutrophils to S. aureus vaccine adjuvants
Time frame: Months 0 and 6 and 12
EX VIVO measure of innate immunity: induction of oxidative burst to S. aureus vaccine adjuvants
Time frame: Months 0 and 6 and 12
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
EX VIVO measures of innate immunity: chemokines and cytokines secretions to S. aureus vaccine adjuvants
Time frame: Months 0 and 6 and 12
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
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
Survival rate to S.aureus in the whole blood
Time frame: Months 0 and 6 and 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2020.
- Individual participant dataSharing planned: No
Related trials for Staphylococcus Aureus
RecruitingObservational study
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Bacteria Infection Mechanism
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Methicillin-Resistant Staphylococcus Aureus Colonization
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Combination Cefazolin With Ertapenem for Methicillin-susceptible Staphylococcus Aureus Bacteremia
Staphylococcus Aureus Bacteremia, Staphylococcus Aureus Septicemia
Active, not recruitingPhase 1/2
A Study to Evaluate AZD7760 Safety and Pharmacokinetics in Healthy Adults (Phase I) and Adults With End-stage Kidney Disease on Hemodialysis With a Central Venous Catheter (Phase IIa)
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Not yet recruiting
Bacterial Decolonization to Prevent Severe Radiation Dermatitis in Head and Neck Squamous Cell Carcinoma
HNSCC
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elisabeth BOTELHO-NEVERS, MD principal investigator
Centre Hospitalier Universitaire de Saint Etienne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing blood samples and nasal swabs in people with Staphylococcus Aureus, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EX VIVO measure of innate immunity: functional capacity of neutrophils to S. aureus vaccine antigens (time frame: Up to 12 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2020.