Study of immune responses after vaccination with an influenza vaccine (Inflexal V) in patients who have undergone hematopoietic allogeneic stem cell transplantation.

Study of T- and B-cell immunity after vaccination with a virosomebased influenza vaccine (Inflexal V) in patients who have undergone hematopoietic allogeneic stem cell transplantation.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-003403-19-SE

Enrollment

Registered

2013-08-02

Start date

2013-09-25

Completion date

Unknown

Last updated

2020-06-02

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

Conditions

Allogeneic stem cell transplantation

Interventions

Trade Name: Inflexal V Pharmaceutical Form: Injection

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Adult allogeneic stem cell transplant patients who has undergone transplant 3-24 months before transplantation and who shall get influenza vaccine according to national and international guidelines. 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 25 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 5

Exclusion criteria

Exclusion criteria: 1. Patients 24 months after HSCT 2. Patients who has been influenzavaccinated during the actual season. 3. Patients who has been diagnosed with influenza during the actual season. 4. Patients with severe acute GVHD (grade III-IV) 5. Patienter with extensive or severe chronic GVHD treated with photopheresis or mesenchymal stem cells 6. Patients treated with drugs produced by gene- or celltherapeutical techniques 7. Patients with relapse of the original disease undergoing or planned to undergo chemotherapy 8. Patients treated with iv or sc immune globulins 9. Patients requiring platelet transfusions 10. Patienter allergic to any of the in the vaccine included substances. 11. Patients who are pregnant or nursing 12. Patients not giving informed consent

Design outcomes

Primary

Measure	Time frame
Main Objective: Analyze T-cell and B-cell immune response after influenzavaccination with Inflexal V. ;Secondary Objective: Clinical efficacy and safety after vaccination with Inflexal V in allogeneic stem cell transplant patients. To analyze cellmediated and antibodymediated immune responses with additional techniques ;Primary end point(s): B-cell response defined as a 4-fold increase in HI titer or achievement of = 1:40 in HI after vaccination T-cell response defined as more than a 2-fold increase in the number of influenza-specific gamma-interferon producing T-cells after vaccination.;Timepoint(s) of evaluation of this end point: 4 weeks after vaccination	—

Measure

Time frame

Main Objective: Analyze T-cell and B-cell immune response after influenzavaccination with Inflexal V. ;Secondary Objective: Clinical efficacy and safety after vaccination with Inflexal V in allogeneic stem cell transplant patients. To analyze cellmediated and antibodymediated immune responses with additional techniques ;Primary end point(s): B-cell response defined as a 4-fold increase in HI titer or achievement of = 1:40 in HI after vaccination T-cell response defined as more than a 2-fold increase in the number of influenza-specific gamma-interferon producing T-cells after vaccination.;Timepoint(s) of evaluation of this end point: 4 weeks after vaccination

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Secondary

Measure	Time frame
Secondary end point(s): Number of verified influensa cases after vaccination Side effects B-cell response defined as at least a two-fold increase in the number of influenza-specific antibodies analyzed by ELISA CD8+ T-cellresponse defined as more than a 2-fold increase in the number of influenza-specific Cd8+ cells analyzed by tetramertechnology;Timepoint(s) of evaluation of this end point: Six months after vaccination for the clinical endpoints Four weeks after vaccination for the laboratory endpoints	—

Measure

Time frame

Secondary end point(s): Number of verified influensa cases after vaccination Side effects B-cell response defined as at least a two-fold increase in the number of influenza-specific antibodies analyzed by ELISA CD8+ T-cellresponse defined as more than a 2-fold increase in the number of influenza-specific Cd8+ cells analyzed by tetramertechnology;Timepoint(s) of evaluation of this end point: Six months after vaccination for the clinical endpoints Four weeks after vaccination for the laboratory endpoints

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Countries

Sweden

Contacts

Public ContactDept. of Hematology

Karolinska University Hospital

per.ljungman@ki.se46858582507

Outcome results

None listed

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