Flow Cytometric Immune Monitoring of B. Afzelii-Specific T Lymphocytes
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Characterization of Borrelia afzelii-specific T-cell immune responses by multiparameter flow cytometry
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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
Exclusion Criteria
- •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)
Arms & Interventions
Lyme borreliosis / Acrodermatitis chronica atrophicans (ACA) group
Control group
Outcomes
Primary Outcomes
Characterization of Borrelia afzelii-specific T-cell immune responses by multiparameter flow cytometry
Time Frame: At study inclusion (baseline visit)
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.
Secondary Outcomes
No secondary outcomes reported