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Clinical Trials/EUCTR2021-000673-83-BE
EUCTR2021-000673-83-BE
Active, not recruiting
Phase 1

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

CHU de Liège0 sites70 target enrollmentFebruary 19, 2021
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ConditionsAllogeneic hematopoietic stem cell recipientsTherapeutic area: Body processes [G] - Immune system processes [G12]
DrugsComirnaty

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Allogeneic hematopoietic stem cell recipients
Sponsor
CHU de Liège
Enrollment
70
Status
Active, not recruiting
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
February 19, 2021
End Date
TBD
Last Updated
4 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
CHU de Liège

Eligibility Criteria

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

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

Outcomes

Primary Outcomes

Not specified

Similar Trials

Unknown
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