Immunity after Tick Borne Encephalitis vaccination in stem cell transplanted patients
- Conditions
- Patients have undergone allogeneic or autologous stem cell transplantation for hematological malignancies.Therapeutic area: Body processes [G] - Immune system processes [G12]
- Registration Number
- EUCTR2014-003573-42-SE
- Lead Sponsor
- Västra Götalandsregionen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 90
1. Age 18 or above
2.Informed consent
FOR ALLO SCT PTS: myeloablative or reduced conditioning, sibling donor or matched unrelated donor, diagnosis of acute or chronic leukemia, lymphoma, myelofibrosis
FOR AUTO SCT PTS: Pts with multiple myeloma, chronic lymphocytic leukemia, lymphoma or solid tumour with established indication
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 75
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 15
1. Relapse
2. Ongoing infection
3. Allergy to egg, hen protein or lathex
4. Previous TBE-disease
5. Pregnancy or wish to get pregnant
6. Recent(3 months) treatment with iv or sc immunoglobulin
FOR ALLOSCT PATIENTS: Patients transplanted with chord blood or from haploidentical donor
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To quantify antibody-mediated immunity after TBE-vaccination in patients who have undergone allogeneic or autologous hematopoietic stem cell transplantation. ;Secondary Objective: 1.Safety.<br>2. To evaluate differences between subgroups of patients; autoSCT vs alloSCT, ongoing immunosuppression vs not, older vs younger pts, earlier TBE-vaccination vs not.;Primary end point(s): Post immunization titers of TBE-specific antibodies.<br>;Timepoint(s) of evaluation of this end point: Titers as above will be assessed after each vaccination.
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Safety.;Timepoint(s) of evaluation of this end point: After the last vaccination, approximately 13 months after inklusion.