A Phase 3 interventional study of anti-COVID19 mRNA-based vaccine (BNT162b2, Comirnaty®, commercialized by Pfizer) in Coronavirus Disease 2019 (Covid19) and Hematopoietic Neoplasms, sponsored by University of Liege. Status unknown at 1 site in Belgium. Open to participants aged 18 Years to 100 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-05-18.
Sponsored by University of Liege · Phase 3, Interventional, and Prevention
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.
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's planned enrollment of 50 is below the median of 100 across 4,099 interventional studies indexed under COVID-19.
Browse COVID-19 studies →University of Liege is the lead sponsor of 242 studies on the registry; 46 are open to participants now.
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Exclusion Criteria:
Injection of two doses (at Day 1 and Day 21) of the anti-COVID19 mRNA-based vaccine (BNT162b2, Comirnaty®, commercialized by Pfizer)
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.
Also known as: COVID-19 mRNA Vaccine, Pfizer
Quantification 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).
Time frame: Day 7 and Day 49
Number of participants with treatment-related adverse events as assessed by the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
To investigate the safety of the anti-COVID-19 mRNA Vaccine (BNT162b2, Comirnaty®, Pfizer). Safety will be reported in terms of incidence and severity of systemic adverse events (AEs). Incidence and nature of newly occurring immune related Adverse Events of grade ≥ 3 according to the Common Terminology Criteria for Adverse Events version 5.0 including information on vaccine specific safety.
Time frame: 12 months after first dose (Day 0)
This study is status unknown, as verified in May 2022. You cannot join it, but the record below documents what was studied.
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University of Liege