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

• Status: Recruiting
• Trial end date: 2023-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Liege
• Collaborator: Pfizer
• Treatments: Vaccines

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