Cra-Tbe

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Vaestra Goetalandsregionen

Participant type

Healthy volunteers, Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Virus Diseases [C02]

Trial duration

19 Aug 2024 → ongoing

Decision date (initial)

2024-05-17

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Vetenskapsrådet (grant number 2022-05276)

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Diagnosis, Prophylaxis

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.

Secondary objectives 1

1. Secondary objectives of the trial are to evaluate: • the magnitude and durability of T- and B-cell responses directed against TBEV after TBE vaccination or natural infection. • the impact of baseline characteristics of research participants (including body mass index (BMI), weight, gender, age, host genetic factors (e.g., IFNL4 genotype), etc.) on the magnitude and durability of T- and B-cell responses against TBEV. • the impact of concomitant medication on the magnitude and durability of T- and B-cell responses against TBEV. • the impact of adverse events temporally associated with vaccination on the magnitude and durability of T- and B-cell responses against TBEV. • the magnitude and durability of cross-reactive T-cell and B-cell responses directed against TBEV after recent (≤6 months) vaccination against Yellow Fever among healthy participants (negative controls using live attenuated flavivirus vaccine). • the magnitude and durability of cross-reactive T- and B-cell responses directed against TBEV after recent (≤6 months) vaccination against Japanese Encephalitis among healthy participants (negative controls using formalin-inactivated flavivirus vaccine).

Conditions and MedDRA coding

Tick-borne encephalitis

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 2

1. The subject has given their written consent to participate in the clinical trial.
2. Male and female research participants above or equal to 18 years of age.

Exclusion criteria 4

1. Women with ongoing pregnancy or breast feeding without prior history of hospitalization for TBE or vaccination against TBEV.
2. Inability or unwillingness to provide informed consent or abide by the requirements of the clinical trial.
3. 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.
4. 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.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. 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 endpoints 3

1. The duration of detectable T- and B-cell immune responses directed against TBEV after infection with TBE.
2. The duration of detectable T- and B-cell immune responses directed against TBEV after vaccination against TBE.
3. 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?

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Vaestra Goetalandsregionen

Sponsor organisation

Vaestra Goetalandsregionen

Address

Regionens Hus

City

Vänersborg

Postcode

462 80

Country

Sweden

Scientific contact point

Organisation

Vaestra Goetalandsregionen

Contact name

Martin Lagging

Public contact point

Organisation

Vaestra Goetalandsregionen

Contact name

Martin Lagging

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 6 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications