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Impact of the Immune System on Response to Anti-Coronavirus Disease 19 (COVID-19) Vaccine in Allogeneic Stem Cell Recipients (Covid Vaccin Allo)

NCT04951323

UnknownPhase 3

Sponsor: University of Liege

Conditions: Coronavirus Disease 2019 (Covid19), Hematopoietic Neoplasms

Interventions: anti-COVID19 mRNA-based vaccine (BNT162b2, Comirnaty®, commercialized by Pfizer)

Countries: Belgium

The present study is a prospective phase IV study. All participants will receive the anti-Coronavirus Disease 2019 (COVID-19) Vaccine (messenger Ribonucleic acid-based vaccine, BNT162b2 or Comirnaty®, commercialized by Pfizer-BioNTech) being authorized in the European Union since December 2020. The vaccine is administered intramuscularly after dilution as a series of two doses at least 21 days apart.

Eligibility overview

Sex: ALL

Age: 18 Years to 100 Years

Healthy volunteers: Yes

Study type: INTERVENTIONAL

Eligibility criteria

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

Locations (1)

Liège, Belgium