An observational study in Lyme Disease and Borrelia Infections, sponsored by University Children's Hospital, Zurich. Recruiting at 1 site in Switzerland. Open to participants aged 1 Month to 17 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-28.
Sponsored by University Children's Hospital, Zurich · Observational
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.
Project population
Inclusion criteria: Children, 0-17 years of age, at University Children's Hospital Zurich:
Exclusion criteria: Primary or secondary immunodeficiency.
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.
97 studies on the registry are indexed under Lyme Disease; 26 are open to participants now.
This study's planned enrollment of 502 is above the median of 400 across 42 observational studies indexed under Lyme Disease.
Browse Lyme Disease studies →University Children's Hospital, Zurich is the lead sponsor of 95 studies on the registry; 23 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
LD differential diagnosis cohort: Patients presenting at the ED with differential diagnosis of LD according to the treating physician
Procedure: venous blood puncture
Previously healthy patients (HC) with routine blood investigations presenting at the ED or PID outpatient department
Procedure: venous blood 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.
Also known as: lumbar puncture, joint puncture
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)
Time frame: 10/2023 - 10/2026
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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 10/2023 - 10/2028
Plan to share: 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.
Supporting information: Study protocol, Statistical analysis plan, Clinical study report
Time frame: Project data are stored for at least 15 years. Biological data will be collected for 5 years with a start in 2023 until 2028 and destroyed after 10 years of study closure.
Access criteria: Access is authorized to personnel who require the data to fulfil their duties within the scope of the research.
No publications or documents are linked to this record.
Started Apr 2024 (actual). Primary completion is estimated for Nov 2026, 30 months after the start.
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University Children's Hospital, Zurich