Application of a TBE-Vaccine in Obese Persons (NCT04017052) | Clinical Trial Compass
UnknownPhase 4
Application of a TBE-Vaccine in Obese Persons
Austria73 participantsStarted 2015-04-15
Plain-language summary
Obese people have an altered immune responsiveness. The present study investigates whether this influences immune responses to booster vaccinations (i. e. booster vaccination with TBE vaccine "FSME Immun") and if a modification of vaccination schedules is needed.
Obese adults (BMI \>30) \>18 - 60 years are compared with adults with normal weight (BMI \<25) concerning TBE-NT- antibody titers, TBE- NT antibody titer course and cellular immunity. Metabolic parameters and sexual hormones will be tested and compared as well.
Who can participate
Age range
18 Years – 60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
main Inclusion Criteria:
* willingness to sign written informed consent form
* completed primary TBE immunization and at least 1 booster vaccination
* participants of both sexes between 18 and 60 years of age
main Exclusion Criteria:
* age \< 18 and \> 60 years
* BMI 25-30
* previous TBE infection
* pregnancy or breast feeding
* acute infection on day of inclusion (day 0) or at visit 5 (36 months), body temperature \> 37,9°C
* concomitant medications: systemic cortison therapy, chemotherapy, immunotherapy (allergy) immunsuppressive therapy 4 weeks prior or during the study
* administration of other vaccines 4 weeks before/after day 0
* planned surgery within 2 weeks before/after TBE booster
* any contraindication to administration of FSME-Immun® vaccine according to manufacturer's instructions
* malignant diseases within 5 years prior to the study
* autoimmune diseases
* kidney insufficiency, dialysis
* drug addiction
* plasma donor
* receipt of blood transfusions or immunoglobulins within 3 months prior to study entry / within 3 months prior to visit 5
* Severe disease with hospitalization or surgery 3 months before or during the study
* participation in a clinical trial simultaneously to visit 1-4 with receipt of vaccination and/or investigational product within one month before booster
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.