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NCT Number: NCT07703787

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

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.

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Key information

Conditions

Lyme Borreliosis Bacterial Infections Bacterial Infections and Mycoses Borrelia Infections Gram-Negative Bacterial Infections Infections Lyme Disease Spirochaetales Infections Tick-Borne Diseases Vector Borne Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpitaux Universitaires de Strasbourg

Strasbourg, France

Location contact

Sarah HUSTACHE

CONTACT

[email protected]

+33 3 88 11 54 15 ext. 00 33

Yves HANSMANN

PRINCIPAL_INVESTIGATOR

Yves HANSMANN, MD

CONTACT

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Sarah HUSTACHE

CONTACT

[email protected]

+33 3 88 11 54 15 ext. 00 33

Sponsors and collaborators

Lead sponsor

University Hospital, Strasbourg, France

Other

Registry information

Acronym: LyTLymICS-AIM

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Jul 14, 2026
Registry last updated
Jul 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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