Leishmaniasis, CutaneousAsymptoleishNCT03303898
ASYMPTOMATIC CARRIER OF LEISHMANIA INFANTUM, MEDISERRANEAN VISCERAL LEISHMANIOSIS AGENT: STUDY OF IMMUNE RESPONSE -
A study testing Blood sampling in people with Leishmaniasis, Cutaneous, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial summary
Leishmaniasis is considered by the WHO as emerging and uncontrolled diseases. They are the second leading cause of death and the fourth leading cause of morbidity in tropical diseases. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Leishmaniasis, Cutaneous
- What is being tested?
- Blood sampling
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 10 Nov 2017to 1 Sep 2021
- 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 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male and Female
- Age between 18 and 80 years
- PCR and western blot positive to L. Infantum (these exams will be redone as part of the study).
- Signature of informed consent
- Affiliation to a social security scheme
- Male or Female
Show all 10Show fewer
- Age between 18 and 80 years
- PCR and western blot negative Leishmania (these exams will be redone as part of the study).
- Signature of informed consent
- Affiliation to a social security scheme
Who cannot join
- Presence of known immunosuppression or immunosuppressive therapy. -HIV-positive people will be excluded because of the immunosuppressive action of HIV on the immune system. HIV status will be determined by interrogation.
- Pregnant women will be excluded. A urinary pregnancy test (taken from the inclusion proposal) will be performed for women of child-bearing age. The results will be communicated to the patient by a doctor of her choice.
- Persons under guardianship
- Presence of known immunosuppression or immunosuppressive therapy. -HIV-positive people will be excluded because of the immunosuppressive action of HIV on the immune system. HIV status will be determined by interrogation.
- Pregnant women will be excluded. A urinary pregnancy test (taken from the inclusion proposal) will be performed for women of child-bearing age. The results will be communicated to the patient by a doctor of her choice.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: ASYMPTOMATIC CARRIER OF LEISHMANIA INFANTUM, MEDISERRANEAN VISCERAL LEISHMANIOSIS AGENT: STUDY OF IMMUNE RESPONSE - POSTULATE PRIOR TO HUMAN VACCINAL TRIALS Immune Response of Asymptomatic Carriers to L. Infantum
Leishmaniasis is considered by the WHO as emerging and uncontrolled diseases. They are the second leading cause of death and the fourth leading cause of morbidity in tropical diseases. Leishmaniasis is parasitic reticulo-endotheliosis, the pathogenic agent of which is a flagellated protozoan belonging to the genus Leishmania. It is estimated that there are about 2 million new cases per year. Effective treatments against visceral leishmaniasis are few and resistance problems appear. To date, only a canine vaccine is available protecting dogs from the development of canine leishmaniasis to L. infantum. In man, in parallel clinical cases, leishmaniasis is characterized by a large number of asymptomatic carriers. This is the case in the Alpes-Maritimes where 50% of the inhabitants of the hinterland of Nice are carriers of the parasite.
the investigators wish to study the protective immune response to the parasite and more particularly to the asymptomatic carriers. Indeed, these patients were infected with the parasite and did not develop the disease. Understanding the protective immune response in these patients against the parasite is therefore paramount in the development of a human leishmaniasis vaccine.
For this purpose, the investigator wants to make an ex vivo study of the immune response of lymphocytes coming from asymptomatic carriers after stimulation by Leishmania vaccine peptides. It also wants to describe the immune response, after stimulation by these peptides, in the lymphocytes of subjects asymptomatic carriers and lymphocytes from subjects not infected with the parasite and comparing them. This study is unicentric and non-randomized. It wishes to recruit 20 asymptomatic carriers of L. Infantum and 10 uninfected subjects. They will be selected from our database. A simple blood sample will be taken. After verification by quantitative PCR and western blotting of their status towards leishmaniasis, the team will divide them into two groups (asymptomatic or healthy). Then the blood samples will be sent to the team of Jean Loup Lemesre of the Laboratory INTERTRYP - UMR177 of the IRD in Montpellier. ELISPOT analysis and assay of cytokines and proteases to describe the immune response of the two groups and to compare them. In addition, cell typing will be performed by flow cytometry to determine the type of lymphocytes involved in the immune response against Leishmania peptides. HLA typing will also be performed to validate the HLA coverage of the peptides tested. Finally, an analysis of the transcryptome will be carried out, which will allow to identify the differential expression of genes and metabolic pathways involved in the immune response and thus to understand how asymptomatic people can control the infection.
- Conditions
- Leishmaniasis, Cutaneous
- Being tested
- Blood sampling
- Medical subject headings
- Leishmaniasis, Cutaneous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplingProcedure or surgery
sampling of 7 blood tubes
| Study group | Role | What they receive |
|---|---|---|
| asymptomatic carriers | Other | Not described Receives: Procedure: Blood sampling |
| uninfected patient | Other | Not described Receives: Procedure: Blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
immune response of lymphocytes from asymptomatic carriers
decription of immune response of lymphocytes from asymptomatic carriers after stimulation by Leishmania vaccine peptides in ex vivo ELIPSPOT: Presence or absence of immune response.
Measured: 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2017
- Study start10 Nov 2017
- Primary completion10 Nov 2017
- Study completion1 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Leishmaniasis, CutaneousStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03303898
- Sponsor's protocol ID
- 17-AOI-04
- Acronym
- Asymptoleish
- Status last verified
- Mar 2022
- First submitted
- 3 Oct 2017
- Last updated
- 18 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ASYMPTOMATIC CARRIER OF LEISHMANIA INFANTUM, MEDISERRANEAN VISCERAL LEISHMANIOSIS AGENT: STUDY OF IMMUNE RESPONSE - POSTULATE PRIOR TO HUMAN VACCINAL TRIALS Immune Response of Asymptomatic Carriers to L. Infantum
- ClinicalTrials.gov ID
- NCT03303898
- Acronym / sponsor ID
- Asymptoleish / 17-AOI-04
- Conditions
- Leishmaniasis, Cutaneous
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 10 Nov 2017 (actual)
- Primary completion
- 10 Nov 2017 (actual)
- Study completion
- 1 Sep 2021 (actual)
- First posted
- 6 Oct 2017 (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.
Leishmaniasis is considered by the WHO as emerging and uncontrolled diseases. They are the second leading cause of death and the fourth leading cause of morbidity in tropical diseases. Leishmaniasis is parasitic reticulo-endotheliosis, the pathogenic agent of which is a flagellated protozoan belonging to the genus Leishmania. It is estimated that there are about 2 million new cases per year. Effective treatments against visceral leishmaniasis are few and resistance problems appear. To date, only a canine vaccine is available protecting dogs from the development of canine leishmaniasis to L. infantum. In man, in parallel clinical cases, leishmaniasis is characterized by a large number of asymptomatic carriers. This is the case in the Alpes-Maritimes where 50% of the inhabitants of the hinterland of Nice are carriers of the parasite.
the investigators wish to study the protective immune response to the parasite and more particularly to the asymptomatic carriers. Indeed, these patients were infected with the parasite and did not develop the disease. Understanding the protective immune response in these patients against the parasite is therefore paramount in the development of a human leishmaniasis vaccine.
For this purpose, the investigator wants to make an ex vivo study of the immune response of lymphocytes coming from asymptomatic carriers after stimulation by Leishmania vaccine peptides. It also wants to describe the immune response, after stimulation by these peptides, in the lymphocytes of subjects asymptomatic carriers and lymphocytes from subjects not infected with the parasite and comparing them. This study is unicentric and non-randomized. It wishes to recruit 20 asymptomatic carriers of L. Infantum and 10 uninfected subjects. They will be selected from our database. A simple blood sample will be taken. After verification by quantitative PCR and western blotting of their status towards leishmaniasis, the team will divide them into two groups (asymptomatic or healthy). Then the blood samples will be sent to the team of Jean Loup Lemesre of the Laboratory INTERTRYP - UMR177 of the IRD in Montpellier. ELISPOT analysis and assay of cytokines and proteases to describe the immune response of the two groups and to compare them. In addition, cell typing will be performed by flow cytometry to determine the type of lymphocytes involved in the immune response against Leishmania peptides. HLA typing will also be performed to validate the HLA coverage of the peptides tested. Finally, an analysis of the transcryptome will be carried out, which will allow to identify the differential expression of genes and metabolic pathways involved in the immune response and thus to understand how asymptomatic people can control the infection.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| asymptomatic carriers | Other | Procedure: Blood sampling |
| uninfected patient | Other | Procedure: Blood sampling |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Male and Female
- Age between 18 and 80 years
- PCR and western blot positive to L. Infantum (these exams will be redone as part of the study).
- Signature of informed consent
- Affiliation to a social security scheme
Key exclusion criteria (5 listed)
- Presence of known immunosuppression or immunosuppressive therapy. -HIV-positive people will be excluded because of the immunosuppressive action of HIV on the immune system. HIV status will be determined by interrogation.
- Pregnant women will be excluded. A urinary pregnancy test (taken from the inclusion proposal) will be performed for women of child-bearing age. The results will be communicated to the patient by a doctor of her choice.
- Persons under guardianship
- Presence of known immunosuppression or immunosuppressive therapy. -HIV-positive people will be excluded because of the immunosuppressive action of HIV on the immune system. HIV status will be determined by interrogation.
- Pregnant women will be excluded. A urinary pregnancy test (taken from the inclusion proposal) will be performed for women of child-bearing age. The results will be communicated to the patient by a doctor of her choice.
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 samplingsampling of 7 blood tubes | Procedure or surgery | asymptomatic carriers, uninfected patient |
Primary outcome
immune response of lymphocytes from asymptomatic carriers
Time frame: 15 months
decription of immune response of lymphocytes from asymptomatic carriers after stimulation by Leishmania vaccine peptides in ex vivo ELIPSPOT: Presence or absence of immune response.
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 18 Mar 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 sampling in people with Leishmaniasis, Cutaneous, run by Centre Hospitalier Universitaire de Nice 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 10 inclusion and 5 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 18 Mar 2022. 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?
immune response of lymphocytes from asymptomatic carriers (time frame: 15 months). 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 18 Mar 2022.