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

NCT04825600 | Completed

• 1 other identifier: 20-AOI-07
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Toxoplasmosis; Toxoplasma Infections; Toxoplasmosis, Congenital; Toxoplasmosis Recurrent

Outcome Measures

Primary Outcomes (1)

• 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.

  12 months

Secondary Outcomes (1)

• Compare cell diagnosis with serological diagnosis and assess whether or not cellular and humoral immunity against T. gondii.

  24 months

Study Arms (4)

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

Interventions

anti-Toxoplasma gondii IgG and IgM dosage DIAGNOSTIC_TEST

blood sample performed to check the toxoplasma serological diagnosis

mother and child duo; toxo+; toxo+ more than 10 years; uninfected

cellular test DIAGNOSTIC_TEST

blood sample performed to evaluate the anti T. gondii cellular immunity and to compare results to the toxoplasma serological diagnosis

mother and child duo; toxo+; toxo+ more than 10 years; uninfected

Eligibility Criteria

• Age: 10 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (1)

CHU de NICE

Nice, 06003, France

Location

MeSH Terms

Conditions

Toxoplasmosis; Toxoplasmosis, Congenital

Condition Hierarchy (Ancestors)

Coccidiosis; Protozoan Infections; Parasitic Diseases; Infections; Central Nervous System Protozoal Infections; Central Nervous System Parasitic Infections; Central Nervous System Infections; Central Nervous System Diseases; Nervous System Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2021
• First Posted: April 1, 2021
• Study Start: November 17, 2021
• Primary Completion: November 13, 2023
• Study Completion: November 13, 2023
• Last Updated: October 15, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)