Immunity after Tick Borne Encephalitis vaccination in stem cell transplanted patients

Antibody-mediated immune response after immunization with FSME-Immun(R) against Tick Borne Encephalitis(TBE) after hematopoietic autologous and allogeneic stem cell transplantation.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-003573-42-SE

Enrollment

Registered

2014-09-29

Start date

2014-11-11

Completion date

Unknown

Last updated

2024-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients have undergone allogeneic or autologous stem cell transplantation for hematological malignancies.

Interventions

Trade Name: FSME-Immun Product Name: FSME-immun Product Code: J07BA01 Pharmaceutical Form: Suspension for injection

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
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. 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. ;Timepoint(s) of evaluation of this end point: Titers as above will be assessed after each vaccination.	—

Measure

Time frame

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. 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. ;Timepoint(s) of evaluation of this end point: Titers as above will be assessed after each vaccination.

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Secondary

Measure	Time frame
Secondary end point(s): Safety.;Timepoint(s) of evaluation of this end point: After the last vaccination, approximately 13 months after inklusion.	—

Countries

Sweden

Contacts

Public ContactSahlgrenska University hospital

Dep of Clincial Research

kaj.stenlof@vgregion.se0046313421000

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026