Flow Cytometric Immune Monitoring of B. Afzelii-Specific T Lymphocytes
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Hospital, Strasbourg, France
About this trial
Lyme borreliosis diagnosis currently relies on clinical assessment and detection of Borrelia-specific antibodies. However, serology does not allow reliable assessment of active infection. Evaluation of the cellular immune response through Borrelia-specific T lymphocyte monitoring may provide complementary diagnostic and prognostic information.
This study aims to assess Borrelia afzelii-specific T-cell responses using multiparameter flow cytometry after stimulation with standardized peptide pools. This approach enables the characterization of CD4+ and CD8+ T cells, including polyfunctional immune responses.
The diagnostic and prognostic value of this immunomonitoring strategy will be evaluated in patients with acrodermatitis chronica atrophicans, a late manifestation of Lyme borreliosis associated with B. afzelii.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age ≥ 18 years
Subject informed of the results of the prior medical examination
Subject informed about the objectives, procedures, and potential risks of the study
Subject affiliated with a health insurance/social security scheme (beneficiary or dependent)
Disqualifiers
Body weight < 50 kg
Pregnancy or breastfeeding
Diabetes mellitus
Immunodeficiency or ongoing immunosuppressive treatment (including oral corticosteroids)
Trial population
A total of 20 adult participants will be enrolled, including 10 patients with late Lyme borreliosis presenting with acrodermatitis chronica atrophicans (ACA) associated with Borrelia afzelii and 10 healthy adult controls without a history of Lyme disease and with negative Lyme serology.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
20 Participants
are grouped into 2 trial groupsGroup A: Lyme borreliosis / Acrodermatitis chronica atrophicans (ACA) group
Group B: Control group
Trial outcomes
Primary outcomes
1
Characterization of Borrelia afzelii-specific T-cell immune responses by multiparameter flow cytometry
Descriptive analysis of antigen-specific T-cell responses after stimulation with Borrelia afzelii peptide pools using intracellular cytokine staining (ICS) and activation-induced marker (AIM) assays. Outcomes will include the polyfunctionality index of antigen-specific T cells, comparison of ICS and AIM responses, number of positive peptide pools, and magnitude of antigen-specific CD4+ and CD8+ T-cell responses.
Time frame
At study inclusion (baseline visit)Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: