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Low-Intervention Clinical Trial Evaluating a Novel Cytokine Release Assay for Tick-Borne Encephalitis (TBE) Among Healthy and Immunosuppressed Research Participants

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-509575-16-00
Acronym
2023-509575-16-00
Enrollment
100
Registered
2024-05-17
Start date
2024-08-19
Completion date
Unknown
Last updated
2025-02-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tick-borne encephalitis

Brief summary

Concentrations of cytokines detected using our novel rapid release assay (T-cell assay) for TBE in relation to antibody responses (B-cell assays) as measured by commercially available assays.

Detailed description

The duration of detectable T- and B-cell immune responses directed against TBEV after infection with TBE., The duration of detectable T- and B-cell immune responses directed against TBEV after vaccination against TBE., Are cross-reactive T- and B-cell immune responses directed against TBEV detectable after prior vaccination against other flaviviruses, e.g., Yellow Fever and Japanese Encephalitis, and if so, are these responses transient or persistent?

Interventions

DRUGFSME-IMMUN Vuxen
DRUGsuspension i förfylld spruta Vaccin mot fästingburen encefalit (helvirus inaktiverat)
DRUGEncepur (0
DRUG5 ml) Injektionsvätska
DRUGsuspension
DRUGi förfylld spruta Vaccin mot fästingburen encefalit (TBE)
DRUGinaktiverat

Sponsors

Vaestra Goetalandsregionen
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Concentrations of cytokines detected using our novel rapid release assay (T-cell assay) for TBE in relation to antibody responses (B-cell assays) as measured by commercially available assays.

Secondary

MeasureTime frame
The duration of detectable T- and B-cell immune responses directed against TBEV after infection with TBE., The duration of detectable T- and B-cell immune responses directed against TBEV after vaccination against TBE., Are cross-reactive T- and B-cell immune responses directed against TBEV detectable after prior vaccination against other flaviviruses, e.g., Yellow Fever and Japanese Encephalitis, and if so, are these responses transient or persistent?

Countries

Sweden

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026