Lyme DiseaseBRILLIANTNCT06045416
Borrelia B-cell Diagnostics
An observational study of Lyme Disease and Borrelia Infections, run by University Children's Hospital, Zurich at 1 site in Switzerland.
Trial summary
The investigators propose a single center, prospective observational study in children with Lyme disease (LD), the Borrelia B-cell diagnostics (BRILLIANT) study, to assess the immune response against Borrelia burgdorferi (Bb) with the following main objectives: 1. Read more about this study
- Who is it for?
- Ages 1 month to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Lyme Disease, Borrelia Infections
- What is being tested?
- venous blood puncture
- Type of treatment
- Surgery or procedure
- How many people
- 502 participants
- Where
- 1 siteSwitzerland
- Study dates
- 2 Apr 2024to 1 Nov 2028
- How long will I take part?
- 6 Months
- 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 1 month to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Children from 0-17 years of age presenting with signs and symptoms suspicious for LD are included in the study. Previously healthy children with routine blood investigation are enrolled as healthy controls.
Who may be able to join
- Patients presenting at the ED with differential diagnosis of LD according to the treating physician
Who cannot join
- Patients will be excluded in cases of primary or secondary immunodeficiency
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Christoph Berger, MD contact
Switzerland1 site, 1 recruiting
- Recruiting
Chidren's Hospital Zurich
Zurich
Patrick M Meyer Sauteur, MD PhD, 0041 44 266 78 96, patrick.meyersauteur@kispi.uzh.ch
About this study
Official title: Extensive Investigation of Immune Responses Against Borrelia Burgdorferi to Improve Diagnosis of Lyme Disease in Children: an Observational Study (BRILLIANT Study)
The investigators propose a single center, prospective observational study in children with Lyme disease (LD), the Borrelia B-cell diagnostics (BRILLIANT) study, to assess the immune response against Borrelia burgdorferi (Bb) with the following main objectives:
- Development of Bb-specific ASC ELISpot as a new test method for diagnosis of early LD. There is an urgent unmet clinical need for a better diagnostic tool for early LD, as the current standard two-tier testing has low sensitivity in recently infected patients and may show false positive results in recovered patients due to long-term persistence of antibodies against Bb. The measurement of Bb-specific ASC with the ELISpot assay my has the potential to overcome these issues and to improve diagnosis in early LD.
- Extensive analysis of the immune response in LD. The immune response in LD is not well understood. Large-scale studies assessing the detailed immune cell subsets/phenotypes present in blood, CSF, or synovial fluid of LD patients with respective manifestations are lacking.
- Isolation and characterization of causative Bb species. Existing literature suggests that Bb genospecies and/or genotypes may determine virulence and manifestations, but large-scale studies assessing Bb genospecies/genotypes in different manifestation of LD are lacking.
- Collection of clinical data about symptoms, severity, routine laboratory and diagnostic test results, treatment, and outcome of LD.
- Biobanking samples for analysis in the future.
Read more
Project population
Inclusion criteria: Children, 0-17 years of age, at University Children's Hospital Zurich:
- LD differential diagnosis cohort: Patients presenting at the ED with differential diagnosis of LD according to the treating physician.
- Control cohort: Previously healthy patients (HC) with routine blood investigations presenting at the ED or PID outpatient department
Exclusion criteria: Primary or secondary immunodeficiency.
Read the detailed description
Background:
Lyme disease (LD) is the most common tick born disease in Europe. It is caused by an infection with several genospecies of the spirochaetal bacteria Borrelia burgdorferi (Bb).
Although classical disease manifestations are well-known, the clinical presentation in children is often variable and inconclusive, which results in delayed diagnosis and treatment.
Methods/design:
The investigators are conducting an observational cohort study in children with LD. Study site is the University Children's Hospital Zurich. 502 patients will be enrolled. Children from 0-17 years of age presenting with signs and symptoms suspicious for LD are included in the study. Previously healthy children with routine blood investigation are enrolled as healthy controls. Patients will be excluded in cases of primary or secondary immunodeficiency.
Clinical and routine laboratory data regarding course and outcome, as well as venous blood samples are collected at first hospital contact and follow up visits (FUP). FUPs are scheduled at 28 days, 3 months and 6 months after hospital admission. Cerebrospinal fluid (CSF) and synovial fluid (SF) will be collected for the study only if sampling is indicated due to diagnostic or therapeutic reasons.
Primary objectives are to assess Bb-specific ASCs in blood using ELISpot assay, in order to develop new diagnostic tool for early LD. In addition, the investigators will examine immune response in patients with various LD manifestations using flow cytometry, ELISA assay, and ELISpot assay. Finally, the investigators will perform whole genome sequencing of causative Bb-species isolated from patients to investigate potential differences in virulence and associations with clinical presentations.
Discussion:
This single-centre, observational cohort study will improve the understanding of immunological response in LD in children. It will also provide new information about the virulence of distinct LD causing Bb-genospecies and will test a new approach in the diagnosis of early LD.
- Conditions
- Lyme Disease, Borrelia Infections
- Being tested
- venous blood puncture
- Keywords
- Borrelia burgdorferi, Lyme disease, Borrelia specific ASCs, Borrelia strains
- Medical subject headings
- Lyme Disease, Borrelia Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
venous blood punctureProcedure or surgery
Also called lumbar puncture, joint puncture
Venous blood puncture performed at first hospital contact, and at 28 days, 3 month, and 6 months after hospital admission.
Lumbar puncture and joint puncture for the study will be performed if it is indicated due to diagnostic or therapeutic reasons.
| Study group | Role | What they receive |
|---|---|---|
| LD_Diff_Diag | LD differential diagnosis cohort: Patients presenting at the ED with differential diagnosis of LD according to the treating physician Receives: Procedure: venous blood puncture | |
| Heathy_Control | Previously healthy patients (HC) with routine blood investigations presenting at the ED or PID outpatient department Receives: Procedure: venous blood puncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Bb-specific ASCs per 10^6 PBMCs
Method:
Quantification of Bb-specific ASCs (IgM, IgG, IgA) per 10^6 PBMCs using ELISpot assay
Time: 0 d (hospital admission), (1-14 d), 28 d, 3 m, and 6 m (after hospital admission)
Measured: 10/2023 - 10/2026
Secondary outcomes (5)
Measurement of percentage and median fluorescence intensity (MFI) of immune cell subsets in blood, CSF and SF
Method:
Measuring percentage and MFI of innate and adaptive immune cell subsets using established panels for flow cytometry
- innate immune cells: DC, GC, Nk-cells
- adaptive immune cells: Tc-cells and Th-cell subsets (Th1, Th2, Th17, Treg), B-cells
Time: 0 d (hospital admission), (1-14 d), 28 d, 3 m, and 6 m (after hospital admission)
Measured: 10/2023 - 10/2028
Concentration of serum antibody levels (IU/mL)
Method:
Measuring total serum IgM, IgG, IgA antibody levels using Enzyme-linked immunosorbant assay (ELISA)
Time: 0 d (hospital admission), (1-14 d), 28 d, 3 m, and 6 m (after hospital admission)
Measured: 10/2023 - 10/2028
Number of Bb-specific T cells per 10^6 PBMCs
Method:
Quantification of Bb-specific INF-gamma-secreting T cells per 10^6 PBMCs using INF-gamma ELISpot assay.
Time: 0 d (hospital admission), (1-14 d), 28 d, 3 m, and 6 m (after hospital admission)
Measured: 10/2023 - 10/2028
Concentration of plasma and CSF cytokine/chemokine levels (pg/mL)
Method:
Analysis of plasma and CSF cytokine/chemokine profiles using Multiplex Bead Array Kits
- pro-inflammatory cytokines: interferon gamma (IFN-γ), Tumor necrosis factor A (TNF-α), IL-1, IL-17, IL-6 and IL-8
- anti-inflammatory cytokines: IL-10 and IL-13
- chemokines: Stromal cell-derived factor 1 (CXCL12), B cell-attracting chemokine 1 (CXCL13), IFN-γ inducible protein (IP-10/CXCL-10)
Time: 0 d (hospital admission), (1-14 d), 28 d, 3 m, and 6 m (after hospital admission)
Measured: 10/2023 - 10/2028
Portion of Bb positive LD patients by culture/PCR, identification of Bb species in LD patients
Method:
Bb culture and PCR out of blood, CSF and SF samples
Identification of Bb genospecies using PCR and whole genome sequencing (WGS)
- Expected Bb genospecies: Bb sensu stricto, B. garinii, B. afzelii, B. spielmanii, B. mayonii
Time: 0 d (hospital admission), (1-14 d), 28 d, 3 m, and 6 m (after hospital admission)
Measured: 10/2023 - 10/2028
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start2 Apr 2024
- Primary completion1 Nov 2026 (estimated)
- Study completion1 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lyme DiseaseStudies of the same condition, open and under way.
- 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
- 502 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- University Children's Hospital, Zurich
- Sponsor type
- University, hospital or other
- Collaborators
- University of Zurich
- Responsible party
- Sponsor
- Investigators
- Patrick M Meyer Sauteur, MD PhD, Principal investigator, Division of infectious diseases Univesity Children's Hospital ZurichChristoph Berger, MD, Study director, Division of infectious diseases Univesity Children's Hospital Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06045416
- Sponsor's protocol ID
- 2023-00528
- Other IDs
- 2023
- Acronym
- BRILLIANT
- Status last verified
- Apr 2026
- First submitted
- 13 Sep 2023
- Last updated
- 28 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be handled with uttermost discretion and is only accessible to authorized personnel who require the data to fulfil their duties within the scope of the research. On the CRFs and other project specific documents, participants are only identified by a unique participant number. Biological material will be stored in coded manner with unique participant numbers in restricted areas at the Children's Research Center and the IMM. Collaborators will not be granted access to the key or any personal patient information.
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extensive Investigation of Immune Responses Against Borrelia Burgdorferi to Improve Diagnosis of Lyme Disease in Children: an Observational Study (BRILLIANT Study)
- ClinicalTrials.gov ID
- NCT06045416
- Acronym / sponsor ID
- BRILLIANT / 2023-00528
- Conditions
- Lyme Disease, Borrelia Infections
- Keywords
- Borrelia burgdorferi, Lyme disease, Borrelia specific ASCs, Borrelia strains
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 502 participants (estimated)
- Lead sponsor
- University Children's Hospital, ZurichUniversity, hospital or other
- Collaborators
- University of Zurich
- Study start
- 2 Apr 2024 (actual)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 1 Nov 2028 (estimated)
- First posted
- 21 Sep 2023 (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.
The investigators propose a single center, prospective observational study in children with Lyme disease (LD), the Borrelia B-cell diagnostics (BRILLIANT) study, to assess the immune response against Borrelia burgdorferi (Bb) with the following main objectives:
- Development of Bb-specific ASC ELISpot as a new test method for diagnosis of early LD. There is an urgent unmet clinical need for a better diagnostic tool for early LD, as the current standard two-tier testing has low sensitivity in recently infected patients and may show false positive results in recovered patients due to long-term persistence of antibodies against Bb. The measurement of Bb-specific ASC with the ELISpot assay my has the potential to overcome these issues and to improve diagnosis in early LD.
- Extensive analysis of the immune response in LD. The immune response in LD is not well understood. Large-scale studies assessing the detailed immune cell subsets/phenotypes present in blood, CSF, or synovial fluid of LD patients with respective manifestations are lacking.
- Isolation and characterization of causative Bb species. Existing literature suggests that Bb genospecies and/or genotypes may determine virulence and manifestations, but large-scale studies assessing Bb genospecies/genotypes in different manifestation of LD are lacking.
- Collection of clinical data about symptoms, severity, routine laboratory and diagnostic test results, treatment, and outcome of LD.
- Biobanking samples for analysis in the future.
Project population
Inclusion criteria: Children, 0-17 years of age, at University Children's Hospital Zurich:
- LD differential diagnosis cohort: Patients presenting at the ED with differential diagnosis of LD according to the treating physician.
- Control cohort: Previously healthy patients (HC) with routine blood investigations presenting at the ED or PID outpatient department
Exclusion criteria: Primary or secondary immunodeficiency.
Detailed description
Background:
Lyme disease (LD) is the most common tick born disease in Europe. It is caused by an infection with several genospecies of the spirochaetal bacteria Borrelia burgdorferi (Bb).
Although classical disease manifestations are well-known, the clinical presentation in children is often variable and inconclusive, which results in delayed diagnosis and treatment.
Methods/design:
The investigators are conducting an observational cohort study in children with LD. Study site is the University Children's Hospital Zurich. 502 patients will be enrolled. Children from 0-17 years of age presenting with signs and symptoms suspicious for LD are included in the study. Previously healthy children with routine blood investigation are enrolled as healthy controls. Patients will be excluded in cases of primary or secondary immunodeficiency.
Clinical and routine laboratory data regarding course and outcome, as well as venous blood samples are collected at first hospital contact and follow up visits (FUP). FUPs are scheduled at 28 days, 3 months and 6 months after hospital admission. Cerebrospinal fluid (CSF) and synovial fluid (SF) will be collected for the study only if sampling is indicated due to diagnostic or therapeutic reasons.
Primary objectives are to assess Bb-specific ASCs in blood using ELISpot assay, in order to develop new diagnostic tool for early LD. In addition, the investigators will examine immune response in patients with various LD manifestations using flow cytometry, ELISA assay, and ELISpot assay. Finally, the investigators will perform whole genome sequencing of causative Bb-species isolated from patients to investigate potential differences in virulence and associations with clinical presentations.
Discussion:
This single-centre, observational cohort study will improve the understanding of immunological response in LD in children. It will also provide new information about the virulence of distinct LD causing Bb-genospecies and will test a new approach in the diagnosis of early LD.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LD_Diff_Diag | – | Procedure: venous blood punctureLD differential diagnosis cohort: Patients presenting at the ED with differential diagnosis of LD according to the treating physician |
| Heathy_Control | – | Procedure: venous blood puncturePreviously healthy patients (HC) with routine blood investigations presenting at the ED or PID outpatient department |
Who may qualify
- Ages
- 1 month to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children from 0-17 years of age presenting with signs and symptoms suspicious for LD are included in the study. Previously healthy children with routine blood investigation are enrolled as healthy controls.
Key inclusion criteria (1 listed)
- Patients presenting at the ED with differential diagnosis of LD according to the treating physician
Key exclusion criteria (1 listed)
- Patients will be excluded in cases of primary or secondary immunodeficiency
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| venous blood punctureAlso: lumbar puncture, joint punctureVenous blood puncture performed at first hospital contact, and at 28 days, 3 month, and 6 months after hospital admission. Lumbar puncture and joint puncture for the study will be performed if it is indicated due to diagnostic or therapeutic reasons. | Procedure or surgery | Heathy_Control, LD_Diff_Diag |
Primary outcome
Number of Bb-specific ASCs per 10^6 PBMCs
Time frame: 10/2023 - 10/2026
Method: Quantification of Bb-specific ASCs (IgM, IgG, IgA) per 10^6 PBMCs using ELISpot assay Time: 0 d (hospital admission), (1-14 d), 28 d, 3 m, and 6 m (after hospital admission)
5 secondary outcomes
Measurement of percentage and median fluorescence intensity (MFI) of immune cell subsets in blood, CSF and SF
Time frame: 10/2023 - 10/2028
Concentration of serum antibody levels (IU/mL)
Time frame: 10/2023 - 10/2028
Number of Bb-specific T cells per 10^6 PBMCs
Time frame: 10/2023 - 10/2028
Concentration of plasma and CSF cytokine/chemokine levels (pg/mL)
Time frame: 10/2023 - 10/2028
Portion of Bb positive LD patients by culture/PCR, identification of Bb species in LD patients
Time frame: 10/2023 - 10/2028
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 28 Apr 2026.
- Individual participant dataSharing planned: Yes. Data will be handled with uttermost discretion and is only accessible to authorized personnel who require the data to fulfil their duties within the scope of the research. On the CRFs and other project specific documents, participants are only identified by a unique participant number. Biological material will be stored in coded manner with unique participant numbers in restricted areas at the Children's Research Center and the IMM. Collaborators will not be granted access to the key or any personal patient information.
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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.
Christoph Berger, MD contact
Patrick M Meyer Sauteur, MD PhD principal investigator
Division of infectious diseases Univesity Children's Hospital Zurich
Christoph Berger, MD study director
Division of infectious diseases Univesity Children's Hospital Zurich
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 Disease and Borrelia Infections, run by University Children's Hospital, Zurich at 1 site in Switzerland.
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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 28 Apr 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 Switzerland. 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 Patrick M Meyer Sauteur, MD PhD (0041 44 266 78 96, patrick.meyersauteur@kispi.uzh.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Bb-specific ASCs per 10^6 PBMCs (time frame: 10/2023 - 10/2026). 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 28 Apr 2026.