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

Phase 1

• Conditions: Allogeneic stem cell transplantation; Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2013-003403-19-SE
• Lead Sponsor: Karolinska University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-08-02
• Last Update Posted: 2 June 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 30

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

1. Patients < 3 months and > 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Analyze T-cell and B-cell immune response after influenzavaccination with Inflexal V.<br>;Secondary Objective: Clinical efficacy and safety after vaccination with Inflexal V in allogeneic stem cell transplant patients.<br><br>To analyze cellmediated and antibodymediated immune responses with additional techniques<br>;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<br><br>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

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Number of verified influensa cases after vaccination<br><br>Side effects<br><br>B-cell response defined as at least a two-fold increase in the number of influenza-specific antibodies analyzed by ELISA<br><br>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<br><br>Four weeks after vaccination for the laboratory endpoints