Characterization of humoral and cellular immunity for tick-borne encephalitis (TBE) vaccination in allogeneic blood and marrow graft recipients: a pilot study

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-002928-41-AT

Enrollment

Registered

2012-11-23

Start date

2013-01-14

Completion date

Unknown

Last updated

2021-11-15

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

Conditions

Characterization of humoral and cellular immunity for tick-borne encephalitis (TBE) vaccination in allogeneic blood and marrow graft recipients: a pilot study Study group consists of patients 11 to 13 months after allogeneic stem cell transplantation Control group consists of healthy volunteers without previous TBE vaccination

Interventions

Trade Name: FSME Immun Product Name: FSME Immun Pharmaceutical Form: Injection

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: -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

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess the humoral immunogenicity to a TBE vaccination in allogeneic blood and marrow graft (HSCT) recipients compared to healthy volunteers without previous TBE vaccination, by measuring the quantitative antibody levels using neutralization test (NT) and enzyme-linked immunosorbent assay test (ELISA);Secondary Objective: -To assess cellular immunogenicity of the TBE vaccination in allogeneic HSCT recipients, by measuring the lymphocyte proliferation and cytokine levels after in vitro stimulation with peripheral blood mononuclear cells with whole aluminium hydroxide-free and human albumin-free TBE antigen -To assess the immune status in HSCT recipients prior to and after vaccination, as measured by quantitative immunoglobulin levels and by immunofluorescence staining of peripheral blood T and B lymphocytes and flow cytometry analyses;Primary end point(s): To assess the immunogenicity of the TBE vaccination in allogeneic HSCT recipients compared to the healthy volunteers without previous TBE vaccination, the outcome of the neutralization test (NT) will be assessed four weeks after the second vaccination. Therefore, the number of subjects with NT titers against TBE virus >10 (=seroconversion rate), assumed to be the threshold for antibody-mediated protection, will be evaluated. ;Timepoint(s) of evaluation of this end point: see above	—

Measure

Time frame

Main Objective: To assess the humoral immunogenicity to a TBE vaccination in allogeneic blood and marrow graft (HSCT) recipients compared to healthy volunteers without previous TBE vaccination, by measuring the quantitative antibody levels using neutralization test (NT) and enzyme-linked immunosorbent assay test (ELISA);Secondary Objective: -To assess cellular immunogenicity of the TBE vaccination in allogeneic HSCT recipients, by measuring the lymphocyte proliferation and cytokine levels after in vitro stimulation with peripheral blood mononuclear cells with whole aluminium hydroxide-free and human albumin-free TBE antigen -To assess the immune status in HSCT recipients prior to and after vaccination, as measured by quantitative immunoglobulin levels and by immunofluorescence staining of peripheral blood T and B lymphocytes and flow cytometry analyses;Primary end point(s): To assess the immunogenicity of the TBE vaccination in allogeneic HSCT recipients compared to the healthy volunteers without previous TBE vaccination, the outcome of the neutralization test (NT) will be assessed four weeks after the second vaccination. Therefore, the number of subjects with NT titers against TBE virus >10 (=seroconversion rate), assumed to be the threshold for antibody-mediated protection, will be evaluated. ;Timepoint(s) of evaluation of this end point: see above

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Secondary

Measure	Time frame
Secondary end point(s): • Antibody concentrations of TBE ELISA (validated in-house test, Department of Virology, Medical University of Vienna) before and four weeks after the second and third vaccination. o Increase of antibody response. o Number of subjects with seroconversion defined when patients reach antibody levels above the cut-off of TBE ELISA. • Antibody concentrations of NT titers after the third vaccination compared to the second vaccination. o Increase of antibody response. o Number of subjects with NT titers against TBE virus >10. • Evaluation of cellular immunity before and one week after the second and third vaccination. o by measuring lymphocyte proliferation after in vitro stimulation with peripheral blood mononuclear cells with whole aluminium hydroxide-free and human albumin-free TBE antigen o by measuring of cytokines after in vitro stimulation with peripheral blood mononuclear cells with whole aluminium hydroxide-free and human albumin-free TBE antigen • Evaluation of immune reconstitution and quantitative immunoglobulin levels at baseline and every following 12 weeks throughout the study in HSCT recipients only. ;Timepoint(s) of evaluation of this end point: see above	—

Measure

Time frame

Secondary end point(s): • Antibody concentrations of TBE ELISA (validated in-house test, Department of Virology, Medical University of Vienna) before and four weeks after the second and third vaccination. o Increase of antibody response. o Number of subjects with seroconversion defined when patients reach antibody levels above the cut-off of TBE ELISA. • Antibody concentrations of NT titers after the third vaccination compared to the second vaccination. o Increase of antibody response. o Number of subjects with NT titers against TBE virus >10. • Evaluation of cellular immunity before and one week after the second and third vaccination. o by measuring lymphocyte proliferation after in vitro stimulation with peripheral blood mononuclear cells with whole aluminium hydroxide-free and human albumin-free TBE antigen o by measuring of cytokines after in vitro stimulation with peripheral blood mononuclear cells with whole aluminium hydroxide-free and human albumin-free TBE antigen • Evaluation of immune reconstitution and quantitative immunoglobulin levels at baseline and every following 12 weeks throughout the study in HSCT recipients only. ;Timepoint(s) of evaluation of this end point: see above

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Countries

Austria

Contacts

Public ContactChristina Forstner

Med. Uni Wien

christina.a.forstner@meduniwien.ac.at+431404004440

Outcome results

None listed

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