Lyme BorreliosisLyTLymICS-AIMNCT07703787
Flow Cytometric Immune Monitoring of B. Afzelii-Specific T Lymphocytes
An observational study of Lyme Borreliosis and Lyme Disease, run by University Hospital, Strasbourg, France at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lyme Borreliosis, Lyme Disease
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2026to Mar 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Hôpitaux Universitaires de Strasbourg
Strasbourg
Sarah HUSTACHE, +33 3 88 11 54 15 ext. 00 33, dpidrci@chru-strasbourg.fr
Yves HANSMANN, MD
About this study
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
- Medical subject headings
- Lyme Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Lyme borreliosis / Acrodermatitis chronica atrophicans (ACA) group | Not described | |
| Control group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At study inclusion (baseline visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2026
- Study startSep 2026 (estimated)
- Primary completionMar 2029 (estimated)
- Study completionMar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lyme BorreliosisStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07703787
- Sponsor's protocol ID
- PRI 2025 n° HUS 9717
- Acronym
- LyTLymICS-AIM
- Status last verified
- Jul 2026
- First submitted
- 9 Jul 2026
- Last updated
- 14 Jul 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Flow Cytometric Immune Monitoring of B. Afzelii-Specific T Lymphocytes
- ClinicalTrials.gov ID
- NCT07703787
- Acronym / sponsor ID
- LyTLymICS-AIM / PRI 2025 n° HUS 9717
- Conditions
- Lyme Borreliosis, Lyme Disease
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Mar 2029 (estimated)
- Study completion
- Mar 2029 (estimated)
- First posted
- 14 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lyme borreliosis / Acrodermatitis chronica atrophicans (ACA) group | – | – |
| Control group | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lyme Borreliosis and Lyme Disease, run by University Hospital, Strasbourg, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sarah HUSTACHE (+33 3 88 11 54 15 ext. 00 33, dpidrci@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Characterization of Borrelia afzelii-specific T-cell immune responses by multiparameter flow cytometry (time frame: At study inclusion (baseline visit)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2026.