Flow Cytometric Immune Monitoring of B. Afzelii-Specific T Lymphocytes
Starting soon
Conditions studied: Lyme Borreliosis, Lyme Disease
In brief
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.
Key facts
- Study ID
- NCT07703787
- Run by
- University Hospital, Strasbourg, France
- People needed
- 20
- Starts
- 2026-09-01
- Expected to finish
- 2029-03-01
- Last updated by the study team
- 2026-07-14
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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)
- Subject having provided dated and signed informed consent
- Lyme borreliosis/acrordermatitis chronica atrophicans (ACA) group:
- Subject presenting clinical and biological criteria or Borrelia identification confirming chronic atrophic acrodermatitis, with appropriate antibiotic treatment initiated less than 18 months ago or untreated
- Control group: Healthy subject with no history of Lyme disease and negative Lyme serology
You may not qualify if…
- Body weight < 50 kg
- Pregnancy or breastfeeding
- Diabetes mellitus
- Immunodeficiency or ongoing immunosuppressive treatment (including oral corticosteroids)
- Contraindication to local anesthesia with lidocaine, with or without adrenaline
- Inability to provide informed consent (emergency situation, inability to understand study information, …)
- Participation in another clinical trial
- Legal protection measures (guardianship, curatorship, or legal safeguard)
Where it is running
- Hôpitaux Universitaires de Strasbourg — Strasbourg, France
Full record on ClinicalTrials.gov
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