Flow Cytometric Immune Monitoring of B. Afzelii-Specific T Lymphocytes

NCT07703787 | Not Yet Recruiting

• 1 other identifier: PRI 2025 n° HUS 9717
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Lyme Borreliosis; Lyme Disease

Outcome Measures

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.

  At study inclusion (baseline visit)

Study Arms (2)

Lyme borreliosis / Acrodermatitis chronica atrophicans (ACA) group

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

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)

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (1)

Hôpitaux Universitaires de Strasbourg

Strasbourg, France

Location

MeSH Terms

Conditions

Lyme Disease

Condition Hierarchy (Ancestors)

Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Borrelia Infections; Spirochaetales Infections; Tick-Borne Diseases; Vector Borne Diseases

Central Study Contacts

Sarah HUSTACHE

CONTACT

+33 3 88 11 54 15; dpidrci@chru-strasbourg.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2026
• First Posted: July 14, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): March 1, 2029
• Study Completion (Estimated): March 1, 2029
• Last Updated: July 14, 2026

Record last verified: 2026-07

Locations

FR (1)