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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
50
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.
CHU Liège, Domaine du Sart-Tilman
Liège, Belgium
RECRUITINGQuantification of anti-SARS-CoV-2 receptor binding domain specific IgG
The primary endpoint is the quantification of different anti-SARS-CoV-2 specific IgG antibodies after vaccination (at Day 49) in allo-HCT recipients.
Time frame: Day 49 after first injection (D0)
Evolution of anti-SARS-CoV-2 receptor binding domain specific IgG
To study the evolution anti-RBD IgG titers from day +49 (day 28 after the second dose) to 6 months after the second dose.
Time frame: 6 months after day 21
Titration of neutralizing antibodies
To analyze the titer of neutralizing antibodies at Day 49 as well as at 6 months after the second dose (at Day 21).
Time frame: 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).
This point aims at trying to find correlations between patient immunity at vaccination and response to vaccination and also to correlate pre-vaccination clinical factors (such as delay from transplantation to vaccination in days, presence or not of moderate/severe chronic GVHD (assessed using the NIH criteria), administration of rituximab in the year before vaccination) response to the vaccine defined as detectable specific anti-SARS-CoV-2 RBD specific IgG.
Time frame: 49 days after the first dose
Efficacy of the immune response to the vaccine to prevent COVID-19
Incidence of SARS-CoV-2 infection occurring after vaccination
Time frame: 12 months after first dose (Day 0)
Assessment of T cell and B cell response to the vaccine
Measuring SARS-Cov2 specific T cells (by intracellular cytokine staining) and B cells (by Elispot).
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Time frame: Day 7 and Day 49