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Diagnosis of Toxoplasma Gondii Infection by Exploration of Cellular Immunity (TOXCELL) (TOXCELL)

Primary Purpose

Toxoplasmosis, Toxoplasma Infections, Toxoplasmosis, Congenital

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
anti-Toxoplasma gondii IgG and IgM dosage
cellular test
Sponsored by
Centre Hospitalier Universitaire de Nice
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Toxoplasmosis

Eligibility Criteria

10 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Presence of known immunosuppression or immunosuppressive therapy (questionnaire).
  • HIV-positive people will be excluded due to the immunosuppressive action of HIV

Sites / Locations

  • CHU de NICE

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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..

Full Information

First Posted
March 29, 2021
Last Updated
March 29, 2021
Sponsor
Centre Hospitalier Universitaire de Nice
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1. Study Identification

Unique Protocol Identification Number
NCT04825600
Brief Title
Diagnosis of Toxoplasma Gondii Infection by Exploration of Cellular Immunity (TOXCELL)
Acronym
TOXCELL
Official Title
Diagnosis of Toxoplasma Gondii Infection by Exploration of Cellular Immunity
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
June 1, 2021 (Anticipated)
Primary Completion Date
January 1, 2023 (Anticipated)
Study Completion Date
January 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nice

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Toxoplasmosis, Toxoplasma Infections, Toxoplasmosis, Congenital, Toxoplasmosis Recurrent

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Diagnostic Test
Intervention Name(s)
anti-Toxoplasma gondii IgG and IgM dosage
Intervention Description
blood sample performed to check the toxoplasma serological diagnosis
Intervention Type
Diagnostic Test
Intervention Name(s)
cellular test
Intervention Description
blood sample performed to evaluate the anti T. gondii cellular immunity and to compare results to the toxoplasma serological diagnosis
Primary Outcome Measure Information:
Title
Implement a cell test with lymphocytic stimulation by toxoplasmic antigen and screening for T. gondii infection to assess cellular immunity against T. gondii
Description
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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Compare cell diagnosis with serological diagnosis and assess whether or not cellular and humoral immunity against T. gondii.
Description
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..
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: Presence of known immunosuppression or immunosuppressive therapy (questionnaire). HIV-positive people will be excluded due to the immunosuppressive action of HIV
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Karine LEPLUS
Phone
+33492036254
Email
leplus.k@chu-nice.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Christelle POMARES, PhD
Phone
+33492036254
Email
pomares.c@chu-nice.fr
Facility Information:
Facility Name
CHU de NICE
City
Nice
ZIP/Postal Code
06003
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karine LEPLUS
Phone
+33492036254
Email
leplus.k@chu-nice.fr

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
no data sharing plan is schedule

Learn more about this trial

Diagnosis of Toxoplasma Gondii Infection by Exploration of Cellular Immunity (TOXCELL)

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