BridgeMD
CRA-TBE
EU CTIS ID: 2023-509575-16-00
What this study is testing
The primary objective of the trial are to evaluate: the magnitude and durability of T-cell responses against TBEV as measured by our novel cytokine release assay in comparison with antibody levels evaluated using commercially available IgM assays (Euroimmun and ReaScan) and/or quantitative IgG assay (Euroimmun) among patients hospitalized for TBE at time of or within <6 months of enrollment. the magnitude and durability of T-cell responses against TBEV as measured using our cytokine release assay in comparison with a quantitative IgG assay against TBEV (Euroimmun) among patients previously hospitalized for TBE ≥6 months prior to enrollment. This will be performed in relation to time having lapsed from admission to hospital for TBE. the magnitude and durability of T-cell responses against TBEV as measured using our cytokine release assay in comparison with a quantitative IgG assay against TBEV (Euroimmun) among healthy or immunosuppressed research participants initiating vaccination against TBEV after enrollment. These participants will receive TBE vaccine (FSME-IMMUN Vuxen (Pfizer)) during the study and thus, constitute the only cohort undergoing low-intervention during the trial. the magnitude and durability of T-cell responses against TBEV as measured using our cytokine release assay in comparison with a quantitative IgG assay against TBEV (Euroimmun) among healthy or immunosuppressed research participants having undergone past vaccination against TBEV prior to enrollment. This will be performed in relation to the number of previous vaccine doses, time having lapsed after the most recent vaccine dose, and the vaccine manufacturer (FSME-IMMUN Vuxen (Pfizer) or/and Encepur (Bavarian Nordic)) if this is possible to establish retrospectively.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- The subject has given their written consent to participate in the clinical trial.
- Male and female research participants above or equal to 18 years of age.
You likely can't join if
- Women with ongoing pregnancy or breast feeding without prior history of hospitalization for TBE or vaccination against TBEV.
- Inability or unwillingness to provide informed consent or abide by the requirements of the clinical trial.
- Evidence of allergy or other known adverse reaction to components are part of the TBE vaccine (FSME-IMMUN Vuxen) for unvaccinated participants planning to undergo vaccination against TBEV in the clinical trial.
- Having a bleeding disorder or receiving preventive anticoagulation therapy which prevents the vaccine being administered intramuscularly, for individuals without prior history of hospitalization for TBE or prior vaccination against TBEV.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.