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Study on Tick-Borne Encephalitis: Evaluating T-Cell Responses Using Cytokine Release Assay in Healthy and Immunosuppressed Patients with TBE Vaccines

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying Tick-borne Encephalitis (TBE), a disease caused by a virus transmitted through tick bites. The study will use two vaccines: FSME-IMMUN Vuxen and Encepur. These vaccines are designed to protect against the TBE virus. The purpose of the study is to evaluate how the immune system responds to these vaccines, particularly looking at the body's T-cell and B-cell responses, which are types of immune cells that help fight infections.

Participants in the study will receive the TBE vaccine through an injection into the muscle. For those receiving the FSME-IMMUN Vuxen vaccine, the schedule includes four doses over eight months. The study will compare the immune responses of people who are healthy and those who have weakened immune systems. Some participants will have been vaccinated before joining the study, while others will start their vaccination during the study.

The study will also explore how long the immune responses last after vaccination or infection with the TBE virus. Additionally, it will investigate whether previous vaccinations against other similar viruses, like Yellow Fever or Japanese Encephalitis, affect the immune response to the TBE virus. The study aims to provide valuable insights into the effectiveness and durability of the immune response generated by the TBE vaccines.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, ensure that written consent has been provided. Participation is open to individuals who are 18 years of age or older.

  2. Step 2

    Vaccination

    Participants who are starting vaccination against tick-borne encephalitis virus (TBEV) will receive the FSME-IMMUN Vuxen vaccine. This vaccine is administered as an intramuscular injection, which means it is given directly into a muscle.

  3. Step 3

    Monitoring immune response

    The study will evaluate the body's immune response to the TBEV vaccine. This involves measuring the levels of certain proteins called cytokines, which are part of the immune response, and comparing them to antibody levels. Antibodies are proteins that help fight infections.

  4. Step 4

    Follow-up assessments

    Participants will undergo follow-up assessments to monitor the duration of the immune response. This includes checking how long the immune system continues to respond to the TBEV after vaccination.

  5. Step 5

    Completion of study

    The study is expected to continue until December 31, 2026. Participants will be informed about the completion of the study and any relevant findings related to their participation.

Who can join the trial?

3 criteria

  • The person must have given their written consent to participate in the clinical trial. This means they have agreed in writing to be part of the study.
  • Both men and women can participate.
  • Participants must be 18 years of age or older.

Who cannot join the trial?

5 criteria

  • Patients who have not been hospitalized for tick-borne encephalitis (TBE) within the last 6 months.
  • Patients who have not been previously hospitalized for TBE at least 6 months prior to enrollment.
  • Patients who are not healthy or are not immunosuppressed and are not initiating vaccination against TBEV after enrollment.
  • Patients who have not undergone past vaccination against TBEV prior to enrollment.
  • Patients who cannot establish the number of previous vaccine doses, the time since the most recent vaccine dose, or the vaccine manufacturer.
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Investigated drugs

  • FSME-IMMUN Vuxen

    is a vaccine used to protect against tick-borne encephalitis (TBE), a viral infection that can affect the brain. This vaccine helps your immune system recognize and fight the virus if you are exposed to it in the future. In this clinical trial, some participants will receive this vaccine to see how their immune system responds over time.

  • Encepur

    is another vaccine that provides protection against tick-borne encephalitis (TBE). Like FSME-IMMUN Vuxen, it works by stimulating your immune system to recognize and combat the virus. This trial will look at how well the immune system responds to this vaccine, especially in people who have been vaccinated in the past.

What is already known about the treatment

FSME-IMMUN Vuxen – This medication is administered as an injection and is used to vaccinate against tick-borne encephalitis (TBE), a viral infection transmitted by tick bites. It is currently used in medical practice to help prevent TBE, especially in areas where the disease is common. The vaccine works by stimulating the body's immune system to produce antibodies and T-cell responses that can recognize and fight the virus if exposed in the future. It belongs to the pharmacological class of vaccines, which are substances designed to provide immunity against specific diseases.

Investigated diseases

Tick-borne encephalitis – Tick-borne encephalitis is a viral infection that affects the central nervous system. It is transmitted to humans through the bite of infected ticks. The disease often begins with flu-like symptoms such as fever, headache, and fatigue. In some cases, it can progress to more severe symptoms, including confusion, seizures, and difficulty moving. The virus can cause inflammation of the brain and surrounding tissues, leading to neurological complications. Recovery can be slow, and some individuals may experience long-term neurological issues.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-509575-16-00Protocol code2023-509575-16-00Estimated enrolment100 patientsSponsorVaestra Goetalandsregionen

sourced from the EU Clinical Trials Register and site verification

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