ToxoplasmosisTOXCELLNCT04825600
Diagnosis of Toxoplasma Gondii Infection by Exploration of Cellular Immunity (TOXCELL)
A study testing anti-Toxoplasma gondii IgG and IgM dosage and cellular test in people with Toxoplasmosis and Toxoplasma Infections, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial summary
Toxoplasmosis is a parasitic disease caused by Toxoplasma gondii and transmitted to humans through the consumption of raw or undercooked infected meat and / or by poorly washed vegetables. Read more about this study
- Who is it for?
- Ages 10 years and olderHealthy volunteers can take part
- Conditions the study is for
- Toxoplasmosis, Toxoplasma Infections, Toxoplasmosis, Congenital
- What is being tested?
- anti-Toxoplasma gondii IgG and IgM dosage and cellular test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteFrance
- Study dates
- 17 Nov 2021to 13 Nov 2023
- 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 10 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients over 15 years of age, for minor patients signature of both parents or parent authority representative
- Unknown HIV (questionnaire)
- Non-immunocompromised (questionnaire)
- Known serological status with toxoplasmosis
- Social Security Affiliate
- Informed Consent Signature
Who cannot join
- Presence of known immunosuppression or immunosuppressive therapy (questionnaire).
- HIV-positive people will be excluded due to the immunosuppressive action of HIV
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Diagnosis of Toxoplasma Gondii Infection by Exploration of Cellular Immunity
Toxoplasmosis is a parasitic disease caused by Toxoplasma gondii and transmitted to humans through the consumption of raw or undercooked infected meat and / or by poorly washed vegetables. It can be transmitted from the pregnant woman to the fetus when infection occurs during pregnancy leading to congenital toxoplasmosis. Once infected, it is considered that the subject harbors cyst forms of the parasite in the muscles and brain for life with a risk of reactivation when immunocompromised. Recently, questions have been raised about the persistence of these cysts.
Currently, only serological diagnosis can demonstrate the infection. This is done by detecting IgM and IgG directed against the parasite. Although humoral immunity is useful to diagnose toxoplasmosis, the cellular immunity is responsible of the main protective role during infection with the secretion of cytokines such as gamma interferon. In some situations, the serological diagnosis is limited: in immunocompromised subjects, some immunocompetent patients, in children with congenital toxoplasmosis, in which the anti T. gondii antibodies are no longer detectable. In order to have a true evaluation of the capacities of the immune system of each individual against T. gondii infection, it is necessary to evaluate the effector immune cells.
Read more
The main objective of this protocol is to set up a cellular test with the stimulation of lymphocyte by T. gondii. For this objective, 20 subjects (10 positive, 10 negative for Toxoplasmosis serology) will be included. The secondary objective will be to compare the cellular diagnosis (evaluation by ELISA of the secretion of gamma interferon in the supernatant of cells stimulated by the Ag) with the serological diagnosis (IgG and IgM Alinity Abbott and Western blot LD Bio) in 3 groups of 10 patients: chronically infected patients, uninfected patients, patients with congenital toxoplasmosis as well as to assess the persistence or not of cellular and humoral immunity against T. gondii in 10 patients who had acute toxoplasmosis with a known date infection more than 10 years. Thus, 60 patients will be included for a total study period of 24 months.
This study will thus allow the sponsor to have a clear understanding whether a subject is able or not to react against T. gondii infection.
Read the detailed description
Toxoplasmosis is a parasitic disease caused by Toxoplasma gondii and transmitted to humans through the consumption of raw or undercooked infected meat and / or by poorly washed vegetables. It can be transmitted from the pregnant woman to the fetus when infection occurs during pregnancy leading to congenital toxoplasmosis. Once infected, it is considered that the subject harbors cyst forms of the parasite in the muscles and brain for life with a risk of reactivation when immunocompromised. Recently, questions have been raised about the persistence of these cysts.
Currently, only serological diagnosis can demonstrate the infection. This is done by detecting IgM and IgG directed against the parasite. Although humoral immunity is useful to diagnose toxoplasmosis, the cellular immunity is responsible of the main protective role during infection with the secretion of cytokines such as gamma interferon. In some situations, the serological diagnosis is limited: in immunocompromised subjects, some immunocompetent patients, in children with congenital toxoplasmosis, in which the anti T. gondii antibodies are no longer detectable. In order to have a true evaluation of the capacities of the immune system of each individual against T. gondii infection, it is necessary to evaluate the effector immune cells.
The main objective of this protocol is to set up a cellular test with the stimulation of lymphocyte by T. gondii. For this objective, 20 subjects (10 positive, 10 negative for Toxoplasmosis serology) will be included. The secondary objective will be to compare the cellular diagnosis (evaluation by ELISA of the secretion of gamma interferon in the supernatant of cells stimulated by the Ag) with the serological diagnosis (IgG and IgM Alinity Abbott and Western blot LD Bio) in 3 groups of 10 patients: chronically infected patients, uninfected patients, patients with congenital toxoplasmosis as well as to assess the persistence or not of cellular and humoral immunity against T. gondii in 10 patients who had acute toxoplasmosis with a known date infection more than 10 years. Thus, 60 patients will be included for a total study period of 24 months.
The patients included must be over 15 years of age, unknown HIV (questionnaire), not immunocompromised (questionnaire), with a known T. gondii serological status, affiliated with social security and having signed the informed consent form. Patients with known immunosuppression or immunosuppressive therapy (questionnaire) will be included.
The patients thus selected will be included in the study. This study will allow the sponsor to acquire knowledge of the real immunity of the patients, if they harbor cysts with a risk of reactivation in case of immunosuppression and, for pregnant women known with congenital toxoplasmosis, whether lymphocytes from these women are able to react against T. gondii.
- Being tested
- anti-Toxoplasma gondii IgG and IgM dosage, cellular test
- Medical subject headings
- Toxoplasmosis, Toxoplasmosis, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anti-Toxoplasma gondii IgG and IgM dosageDiagnostic test
blood sample performed to check the toxoplasma serological diagnosis
cellular testDiagnostic test
blood sample performed to evaluate the anti T. gondii cellular immunity and to compare results to the toxoplasma serological diagnosis
| Study group | Role | What they receive |
|---|---|---|
| toxo+ | Other | Not described Receives: Diagnostic Test: anti-Toxoplasma gondii IgG and IgM dosage; Diagnostic Test: cellular test |
| uninfected | Other | Not described Receives: Diagnostic Test: anti-Toxoplasma gondii IgG and IgM dosage; Diagnostic Test: cellular test |
| mother and child duo | Other | Not described Receives: Diagnostic Test: anti-Toxoplasma gondii IgG and IgM dosage; Diagnostic Test: cellular test |
| toxo+ more than 10 years | Other | Not described Receives: Diagnostic Test: anti-Toxoplasma gondii IgG and IgM dosage; Diagnostic Test: cellular test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implement a cell test with lymphocytic stimulation by toxoplasmic antigen and screening for T. gondii infection to assess cellular immunity against T. gondii
to develop the cell test locally and optimize it. Cell immunity will be evaluated by assay of gamma interferon secretion in the supernatant of patient cells stimulated by parasitic antigen. For this, we will carry out the Toxoféron set up in Lyon and we will compare its realization to from the globular cap and from a ficoll that allows to select the cells of immunity.
Measured: 12 months
Secondary outcomes (1)
Compare cell diagnosis with serological diagnosis and assess whether or not cellular and humoral immunity against T. gondii.
will perform cellular tests and serological diagnosis. Serological diagnosis will be made by the detection of IgG and IgM anti Toxoplasmic by chemiluminescence (ABBOTT reagent on automaton ALINITY i) and by the realization of Western Blot confirmation TOXO LDBIO II. The subject will be considered positive for serological antibody diagnosis if he has positive or doubtful IgG and a Western blot positive..
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2021
- Study start17 Nov 2021
- Primary completion13 Nov 2023
- Study completion13 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ToxoplasmosisStudies 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 66 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
- NCT04825600
- Sponsor's protocol ID
- 20-AOI-07
- Acronym
- TOXCELL
- Status last verified
- Oct 2024
- First submitted
- 29 Mar 2021
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: no data sharing plan is schedule
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnosis of Toxoplasma Gondii Infection by Exploration of Cellular Immunity
- ClinicalTrials.gov ID
- NCT04825600
- Acronym / sponsor ID
- TOXCELL / 20-AOI-07
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 17 Nov 2021 (actual)
- Primary completion
- 13 Nov 2023 (actual)
- Study completion
- 13 Nov 2023 (actual)
- First posted
- 1 Apr 2021 (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.
Toxoplasmosis is a parasitic disease caused by Toxoplasma gondii and transmitted to humans through the consumption of raw or undercooked infected meat and / or by poorly washed vegetables. It can be transmitted from the pregnant woman to the fetus when infection occurs during pregnancy leading to congenital toxoplasmosis. Once infected, it is considered that the subject harbors cyst forms of the parasite in the muscles and brain for life with a risk of reactivation when immunocompromised. Recently, questions have been raised about the persistence of these cysts.
Currently, only serological diagnosis can demonstrate the infection. This is done by detecting IgM and IgG directed against the parasite. Although humoral immunity is useful to diagnose toxoplasmosis, the cellular immunity is responsible of the main protective role during infection with the secretion of cytokines such as gamma interferon. In some situations, the serological diagnosis is limited: in immunocompromised subjects, some immunocompetent patients, in children with congenital toxoplasmosis, in which the anti T. gondii antibodies are no longer detectable. In order to have a true evaluation of the capacities of the immune system of each individual against T. gondii infection, it is necessary to evaluate the effector immune cells.
The main objective of this protocol is to set up a cellular test with the stimulation of lymphocyte by T. gondii. For this objective, 20 subjects (10 positive, 10 negative for Toxoplasmosis serology) will be included. The secondary objective will be to compare the cellular diagnosis (evaluation by ELISA of the secretion of gamma interferon in the supernatant of cells stimulated by the Ag) with the serological diagnosis (IgG and IgM Alinity Abbott and Western blot LD Bio) in 3 groups of 10 patients: chronically infected patients, uninfected patients, patients with congenital toxoplasmosis as well as to assess the persistence or not of cellular and humoral immunity against T. gondii in 10 patients who had acute toxoplasmosis with a known date infection more than 10 years. Thus, 60 patients will be included for a total study period of 24 months.
This study will thus allow the sponsor to have a clear understanding whether a subject is able or not to react against T. gondii infection.
Detailed description
Toxoplasmosis is a parasitic disease caused by Toxoplasma gondii and transmitted to humans through the consumption of raw or undercooked infected meat and / or by poorly washed vegetables. It can be transmitted from the pregnant woman to the fetus when infection occurs during pregnancy leading to congenital toxoplasmosis. Once infected, it is considered that the subject harbors cyst forms of the parasite in the muscles and brain for life with a risk of reactivation when immunocompromised. Recently, questions have been raised about the persistence of these cysts.
Currently, only serological diagnosis can demonstrate the infection. This is done by detecting IgM and IgG directed against the parasite. Although humoral immunity is useful to diagnose toxoplasmosis, the cellular immunity is responsible of the main protective role during infection with the secretion of cytokines such as gamma interferon. In some situations, the serological diagnosis is limited: in immunocompromised subjects, some immunocompetent patients, in children with congenital toxoplasmosis, in which the anti T. gondii antibodies are no longer detectable. In order to have a true evaluation of the capacities of the immune system of each individual against T. gondii infection, it is necessary to evaluate the effector immune cells.
The main objective of this protocol is to set up a cellular test with the stimulation of lymphocyte by T. gondii. For this objective, 20 subjects (10 positive, 10 negative for Toxoplasmosis serology) will be included. The secondary objective will be to compare the cellular diagnosis (evaluation by ELISA of the secretion of gamma interferon in the supernatant of cells stimulated by the Ag) with the serological diagnosis (IgG and IgM Alinity Abbott and Western blot LD Bio) in 3 groups of 10 patients: chronically infected patients, uninfected patients, patients with congenital toxoplasmosis as well as to assess the persistence or not of cellular and humoral immunity against T. gondii in 10 patients who had acute toxoplasmosis with a known date infection more than 10 years. Thus, 60 patients will be included for a total study period of 24 months.
The patients included must be over 15 years of age, unknown HIV (questionnaire), not immunocompromised (questionnaire), with a known T. gondii serological status, affiliated with social security and having signed the informed consent form. Patients with known immunosuppression or immunosuppressive therapy (questionnaire) will be included.
The patients thus selected will be included in the study. This study will allow the sponsor to acquire knowledge of the real immunity of the patients, if they harbor cysts with a risk of reactivation in case of immunosuppression and, for pregnant women known with congenital toxoplasmosis, whether lymphocytes from these women are able to react against T. gondii.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| toxo+ | Other | Diagnostic Test: anti-Toxoplasma gondii IgG and IgM dosage, Diagnostic Test: cellular test |
| uninfected | Other | Diagnostic Test: anti-Toxoplasma gondii IgG and IgM dosage, Diagnostic Test: cellular test |
| mother and child duo | Other | Diagnostic Test: anti-Toxoplasma gondii IgG and IgM dosage, Diagnostic Test: cellular test |
| toxo+ more than 10 years | Other | Diagnostic Test: anti-Toxoplasma gondii IgG and IgM dosage, Diagnostic Test: cellular test |
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Patients over 15 years of age, for minor patients signature of both parents or parent authority representative
- Unknown HIV (questionnaire)
- Non-immunocompromised (questionnaire)
- Known serological status with toxoplasmosis
- Social Security Affiliate
Key exclusion criteria (2 listed)
- Presence of known immunosuppression or immunosuppressive therapy (questionnaire).
- HIV-positive people will be excluded due to the immunosuppressive action of HIV
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 |
|---|---|---|
| anti-Toxoplasma gondii IgG and IgM dosageblood sample performed to check the toxoplasma serological diagnosis | Diagnostic test | mother and child duo, toxo+, toxo+ more than 10 years, uninfected |
| cellular testblood sample performed to evaluate the anti T. gondii cellular immunity and to compare results to the toxoplasma serological diagnosis | Diagnostic test | mother and child duo, toxo+, toxo+ more than 10 years, uninfected |
Primary outcome
Implement a cell test with lymphocytic stimulation by toxoplasmic antigen and screening for T. gondii infection to assess cellular immunity against T. gondii
Time frame: 12 months
to develop the cell test locally and optimize it. Cell immunity will be evaluated by assay of gamma interferon secretion in the supernatant of patient cells stimulated by parasitic antigen. For this, we will carry out the Toxoféron set up in Lyon and we will compare its realization to from the globular cap and from a ficoll that allows to select the cells of immunity.
1 secondary outcome
Compare cell diagnosis with serological diagnosis and assess whether or not cellular and humoral immunity against T. gondii.
Time frame: 24 months
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 15 Oct 2024.
- Individual participant dataSharing planned: No. no data sharing plan is schedule
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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 anti-Toxoplasma gondii IgG and IgM dosage and cellular test in people with Toxoplasmosis and Toxoplasma Infections, 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 6 inclusion and 2 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 15 Oct 2024. 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?
Implement a cell test with lymphocytic stimulation by toxoplasmic antigen and screening for T. gondii infection to assess cellular immunity against T. gondii (time frame: 12 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 15 Oct 2024.