Characterization of humoral and cellular immunity for tick-borne encephalitis (TBE) vaccination in allogeneic blood and marrow graft recipients: a pilot study
- Conditions
- Characterization of humoral and cellular immunity for tick-borne encephalitis (TBE) vaccination in allogeneic blood and marrow graft recipients: a pilot studyStudy group consists of patients 11 to 13 months after allogeneic stem cell transplantationControl group consists of healthy volunteers without previous TBE vaccinationTherapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2011-002928-41-AT
- Lead Sponsor
- Med. Uni. Wien, Klinik für Innere I
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 52
Adult patients =18 years who
-had undergone an allogeneic HSCT 11 to 13 months ago or
-healthy volunteers without previous TBE vaccination
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 52
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0
-Previous TBE vaccination following HSCT
-HSCT patients with extremely severe acute graft versus host disease (receiving prednisone >0.5 mg/kg bodyweight as part of a combination therapy or a three agent immunosuppressive treatment)
-Previous TBE virus infection, previous dengue virus infection or vaccination against yellow fever or Japanese encephalitis
-Any acute febrile illness in the 2 weeks prior to or at the time of enrolment
-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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method