Impact of the immune system on response to COVID-19 vaccine in allogeneic stem cell recipients

Phase 1

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

• Registration Number: EUCTR2021-000673-83-BE
• Lead Sponsor: CHU de Liège

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-02-19
• Last Update Posted: 8 October 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

Full protocol (3 vaccines, n=50)

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

Third dose vaccine only (n=20)

- Prior allogeneic hematopoietic stem cell transplantation 3 months to 5 years earlier (any donor type); patients > 5 years are also eligible if they are still on systemic immunosuppressive treatment.
- age > or = 18years at inclusion.
- written informed consent
- Prior vaccination with 2 doses of the Comirnaty® vaccine after allo-HCT
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 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

Full protocol (3 vaccines, n=50)

- HIV seropositivity
- Pregnancy
- Active malignant disease at inclusion
- Current grade III-IV acute GVHD
- In vitro T-cell depletion of the graft if vaccination within the 6 months after transplantation.
- Rituximab administration in the 6 months prior to study inclusion
- Prior documented COVID-19 infection occurring after allo-HCT

Third dose vaccine only (n=20)

- HIV seropositivity
- Pregnancy
- Active malignant disease at inclusion
- Current grade III-IV acute GVHD
- Rituximab administration in the 6 months prior to study inclusion for the third dose
- Subjects who were not previously vaccinated with a COVID-19 vaccine according to the scheme mentioned above
- Subjects who already received a third booster dose of a COVID-19 vaccine
- Prior documented COVID-19 infection occurring after allo-HCT

Study & Design

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