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Borrelia B-cell Diagnostics

ConditionsLyme DiseaseBorrelia Infections
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age1-17
SponsorUniversity Children's Hospital, Zurich

About this trial

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. 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. 2. 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. 3. 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. 4. Collection of clinical data about symptoms, severity, routine laboratory and diagnostic test results, treatment, and outcome of LD. 5. 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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Patients presenting at the ED with differential diagnosis of LD according to the treating physician

Disqualifiers

Patients will be excluded in cases of primary or secondary immunodeficiency

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • venous blood puncture

    Procedure/Surgery

    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.

Treatment groups

502 Participants
are divided into 2 treatment groups
Group A: LD_Diff_Diag1 intervention
Group B: Heathy_Control1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

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University Children's Hospital, Zurich

Lead sponsor

University of Zurich

Collaborator

Source ClinicalTrials.gov
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