Impact of the Immune System on Response to COVID-19 Vaccine in Allogeneic Stem Cell Recipients (Covid Vaccin Allo)
Overview
- Phase
- Phase 3
- Intervention
- anti-COVID19 mRNA-based vaccine (BNT162b2, Comirnaty®, commercialized by Pfizer)
- Conditions
- Coronavirus Disease 2019 (Covid19)
- Sponsor
- University of Liege
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Quantification of anti-SARS-CoV-2 receptor binding domain specific IgG
- Last Updated
- 3 years ago
Overview
Brief 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.
Detailed Description
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.
Investigators
Frédéric Baron
Professor
University of Liege
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
Arms & Interventions
Injection of anti-COVID19 mRNA-based vaccine (BNT162b2, Comirnaty®, commercialized by Pfizer)
Injection of two doses (at Day 1 and Day 21) of the anti-COVID19 mRNA-based vaccine (BNT162b2, Comirnaty®, commercialized by Pfizer)
Intervention: anti-COVID19 mRNA-based vaccine (BNT162b2, Comirnaty®, commercialized by Pfizer)
Outcomes
Primary Outcomes
Quantification of anti-SARS-CoV-2 receptor binding domain specific IgG
Time Frame: Day 49 after first injection (D0)
The primary endpoint is the quantification of different anti-SARS-CoV-2 specific IgG antibodies after vaccination (at Day 49) in allo-HCT recipients.
Secondary Outcomes
- Evolution of anti-SARS-CoV-2 receptor binding domain specific IgG(6 months after day 21)
- Titration of neutralizing antibodies(Day 49 and 6 months after Day 21)
- Clinical factors predicting response to vaccine (defined as detectable specific anti-SARS-CoV-2 RBD specific IgG).(49 days after the first dose)
- Efficacy of the immune response to the vaccine to prevent COVID-19(12 months after first dose (Day 0))
- Assessment of T cell and B cell response to the vaccine(Day 7 and Day 49)