Burden of Tick-borne Encephalitis and Cost-effectiveness of Vaccination in the Czech Republic

NCT07274046 | Recruiting

• 2 other identifiers: TBE-CZ-OBS-2023-0106_SM_FNB_002
• Study Type: observational
• Target: 209
• Locations: 1 country
• Sites: 4

Brief Summary

This observational study follows children and adults who were hospitalized with tick-borne encephalitis (TBE) in the Czech Republic. The aim is to better understand how individuals recover from TBE, which symptoms may persist after the infection, and which patients may require additional support during their recovery. Participants are examined several times after hospital discharge (at 2-4 weeks, 3 months, 6 months, and 12 months) to observe changes in symptoms, functional status, and daily activities. Follow-up assessments include evaluation of common post-infection problems such as tiredness, headaches, memory or concentration difficulties, sleep issues, or limb weakness. Symptoms lasting for several months are categorized as post-encephalitic syndrome (PES). The study also assesses how TBE affects daily functioning, school and work performance, and overall quality of life using questionnaires and short functional assessments. In addition, the study includes a public-health component that estimates the broader impact of TBE in the population and evaluates the potential benefits of vaccination in preventing long-term health complications. The findings aim to support improved patient care, follow-up planning, and evidence-based public-health decision-making in the Czech Republic.

Conditions

Tick Borne Encephalitis (TBE)

Keywords

tick-borne encephalitis; sequelae; post-encephalitic syndrome; age; TBEV; encephalitis; cost-effectiveness

Outcome Measures

Primary Outcomes (1)

• Presence and Severity of Post-Encephalitic Syndrome (PES)

  PES is defined as the presence of ≥1 neurological, cognitive, or functional symptom persisting ≥6 months after acute TBE. PES severity is graded as: Mild: mRankin = 1, no limitation of usual activities Moderate: mRankin = 2 and/or limited but preserved independence, or poor self-perceived health (MEHM) Severe: mRankin ≥3, severe limitation of daily activities, very poor self-perceived health, or death.

  6 months post-discharge and 12 months post-discharge

Secondary Outcomes (11)

• Persistent Motor Deficit

  6 months post-discharge and 12 months post-discharge

• Acute Disease Severity Classification

  During index hospitalization

• Functional Status by Modified Rankin Scale (mRankin)

  2-4 weeks post-discharge; 3 months; 6 months; 12 months

• Self-perceived Health and Activity Limitation (MEHM Score)

  2-4 weeks post-discharge; 3 months; 6 months; 12 months

• Persistence or Resolution of Individual PES Symptoms (Structured Symptom Checklist)

  2-4 weeks post-discharge; 3 months; 6 months; 12 months

Study Arms (1)

TBE cohort

Children and adults hospitalized with confirmed tick-borne encephalitis, followed prospectively for 12 months.

Other: No intervention

Interventions

No intervention OTHER

Observational study only. Participants receive standard clinical care; no experimental or study-specific interventions are administered.

TBE cohort

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Hospitalized children and adults with confirmed tick-borne encephalitis (TBE) treated at four infectious disease centers in the Czech Republic. All participants had clinical symptoms of central nervous system involvement, cerebrospinal fluid pleocytosis, and laboratory confirmation of TBEV infection. Patients were enrolled during their acute hospitalization and followed prospectively for up to 12 months as part of a standardized clinical and functional outcome assessment program.

You may qualify if:

• Hospitalization due to suspected central nervous system (CNS) infection.
• Laboratory-confirmed TBE, defined as:
• the presence of CNS symptoms and cerebrospinal fluid pleocytosis (\>5 × 10⁶/L) and TBEV IgM and IgG seropositivity in serum, or detection of TBEV IgM in CSF in previously vaccinated individuals.
• All age groups (children and adults).
• Ability to participate in scheduled follow-up (in person or via telephone).
• Informed consent provided by the patient or legal guardian (for minors).

You may not qualify if:

• Alternative diagnosis explaining the CNS symptoms
• Missing essential clinical or laboratory data required to confirm TBE or assess outcomes.
• Refusal or inability to provide informed consent.
• Inability to complete follow-up assessments, including situations where reliable contact cannot be maintained.
• Coexisting severe neurological disorder unrelated to TBE that prevents meaningful evaluation of sequelae (e.g., advanced neurodegenerative disease, severe preexisting motor disability).

Sponsors & Collaborators

• Hospital Pardubice: collaborator
• Bulovka Hospital: collaborator
• Charles University, Czech Republic: lead
• České Budějovice Hospital: collaborator
• University Hospital Ostrava: collaborator

Study Sites (4)

České Budějovice Hospital

České Budějovice, Jihočeský kraj, 37001, Czechia

RECRUITING

Ostrava University Hospital

Ostrava, Moravskoslezský kraj, 70800, Czechia

RECRUITING

Pardubická nemocnice

Pardubice, Pardubický kraj, 53001, Czechia

RECRUITING

Bulovka University Hospital

Prague, Prague, 18081, Czechia

RECRUITING

MeSH Terms

Conditions

Encephalitis, Tick-Borne; Encephalitis

Condition Hierarchy (Ancestors)

Encephalitis, Arbovirus; Encephalitis, Viral; Central Nervous System Viral Diseases; Central Nervous System Infections; Infections; Infectious Encephalitis; Arbovirus Infections; Vector Borne Diseases; Tick-Borne Diseases; Virus Diseases; RNA Virus Infections; Flavivirus Infections; Flaviviridae Infections; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neuroinflammatory Diseases

Central Study Contacts

Martin Slížek, MD

CONTACT

00420602269494; martin.slizek89@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Department of Infectious Diseases

Study Record Dates

• First Submitted: November 19, 2025
• First Posted: December 10, 2025
• Study Start: April 1, 2023
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 10, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (4)