Impact of the immune system on response to inactivated influenza vaccine (IIV) in allogeneic stem cell recipients

Phase 1

• Conditions: Allogeneic hematopoietic stem cell recipients; Therapeutic area: Body processes [G] - Immune system processes [G12]

• Registration Number: EUCTR2022-003041-35-BE
• Lead Sponsor: CHU de Liège

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-09-08
• Last Update Posted: 26 February 2024

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

- prior allogeneic hematopoietic stem cell transplantation 3 months to 5 years earlier (any donor type except cord blood transplantation); patients > 5 years are also eligible if they are still on systemic immunosuppressive treatment for chronic GVHD.
- age> or = 18 years at inclusion.
- written informed consent

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 85
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 15

Exclusion Criteria

- HIV seropositivity
- Pregnancy
- Active malignant disease
- Current grade III-IV acute GVHD
- In vitro T-cell depletion of the graft if vaccination within 6 months after transplantation.
- Rituximab administration in the 6 months prior to inclusion
- IVIg in the 3 months before vaccination.
- Prior post-transplant IIV vaccination in the 9 months prior inclusion

Study & Design

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