The present study is a prospective phase IV study. All participants will receive theanti-Coronavirus Disease 2019 (COVID-19) Vaccine (messenger Ribonucleic acid-basedvaccine, BNT162b2 or Comirnaty®, commercialized by Pfizer-BioNTech) being authorized inthe European Union since December 2020. The vaccine is administered intramuscularly afterdilution as a series of two doses at least 21 days apart.
The central question is whether allo-hematopoietic cell transplantation (allo-HCT)
recipients can develop protective immunity against COVID-19 upon vaccination. This
question needs to be answered urgently and would help the hematologist to provide
recommendation / best treatment for these patients. In this pilot project Cov-Allo, this
important question will be addressed in a cohort in which allo-HCT recipients will be
vaccinated with the mRNA available COVID-19 vaccine according to the Belgian vaccination
program. The primary objective is to assess immune response after administration of
COVID-19 mRNA Vaccine BNT162b2 (Comirnaty®; Pfizer-BioNTech) in a population of 50
patients allo-HCT recipients. This number is based on the availabilities of vaccines and
eligible patients. Moreover, as the study is observational and exploratory, no sample
size calculation could be provided for this study.
Drug: anti-COVID19 mRNA-based vaccine (BNT162b2, Comirnaty®, commercialized by Pfizer)
Participants will receive the COVID-19 mRNA Vaccine BNT162b2 (Comirnaty®). The vaccine is
administered intramuscularly after dilution as a series of two doses at least 21 days
apart.
Other Name: COVID-19 mRNA Vaccine,Pfizer
Inclusion Criteria:
- prior allogeneic hematopoietic stem cell transplantation 3 months to 5 years earlier
(any donor type)
- age > or = 18 years at inclusion.
- written informed consent
Exclusion Criteria:
- HIV seropositivity
- Pregnancy
- Active malignant disease at inclusion
- Current grade III-IV acute Graft Versus Host Disease (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
CHU Liège, Domaine du Sart-Tilman
Liège, Belgium
Investigator: Frédéric MD Baron, MD
Contact: +3243667201
F.Baron@chuliege.be
Frédéric MD Baron, Dr. MD
+3243667201
F.Baron@chuliege.be
Frédéric MD Baron, Principal Investigator
Centre Hospitalier Universitaire de Liege