Humoral and Cellular Immunity for TBE Vaccination in Allogeneic HSCT Recipients
Tick Borne Encephalitis
About this trial
This is an interventional prevention trial for Tick Borne Encephalitis focused on measuring Marrow transplant recipients
Eligibility Criteria
Inclusion Criteria:
Male and female subjects will be eligible for participation in this study if they:
- Are ≥18 years on the day of screening
- Had undergone an allogeneic HSCT 11 to 13 months ago (study population)
- Are clinical healthy without previous TBE vaccination (control group)
- Have an understanding of the study, agree to its provisions, and give written informed consent prior to study entry
- If female and capable of bearing children - have a negative urine pregnancy test result at study entry and agree to employ adequate birth control measures for the duration of the study
Exclusion Criteria:
Subjects will be excluded from participation in this study if they:
- Have received a TBE vaccination following HSCT
- Suffer from extremely severe acute graft-versus host disease and therefore receive prednisone >0.5 mg/kg bodyweight as part of a combination therapy or a three agent immunosuppressive treatment (because in these HSCT patients any type of vaccination has to be postponed until immunosuppression is reduced to a double combination or prednisone <0.5 mg/kg bodyweight)
- Suffer from or have a history of previous TBE virus infection or vaccination, previous dengue virus infection or vaccination against yellow fever or Japanese encephalitis
- Have any acute febrile illness in the 2 weeks prior to or at the time of enrolment
- Have a history of severe allergic reactions or anaphylaxis after vaccination
- If female, are pregnant or lactating.
- If belonging to the healthy control group, are immunosuppressed (suffer from or have a history of immune mediated diseases, long-term use of corticosteroids, hemodialysis, chronic renal insufficiency, liver cirrhosis Child-Pugh class C, hematooncological malignant disease, solid organ transplant, HSCT)
Sites / Locations
- Medical University of Vienna, Department of Medicine I, Division of Infectious Diseases and Tropical Medicine
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
HSCT patients / TBE virus vaccine
healthy volunteers / TBE virus vaccine
Study population: patients who had undergone an allogeneic HSCT 11 to 13 months ago Eligible patients will receive at least two TBE vaccinations (study visit 1 - day 0, study visit 2 -1month after the first vaccination) with a total of two doses of the TBE vaccine FSME-IMMUN®. Whenever possible, the patients will receive complete primary vaccination with a third dose of TBE vaccine (study visit 9 - 9 to 12 months after the first vaccination).
Clinical healthy volunteers will receive at least two TBE vaccinations (study visit 1 - day 0, study visit 2 -1month after the first vaccination) with a total of two doses of the TBE vaccine FSME IMMUN®. Whenever possible, the volunteers will receive complete primary vaccination with a third dose of TBE vaccine FSME IMMUN® (study visit 9 - 12 months after the first vaccination).