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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)

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ClinicalTrials.gov Identifier: NCT04951323
Recruitment Status : Recruiting
First Posted : July 6, 2021
Last Update Posted : July 6, 2021
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Frédéric Baron, University of Liege

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.

Condition or disease Intervention/treatment Phase
Coronavirus Disease 2019 (Covid19) Hematopoietic Neoplasms Drug: anti-COVID19 mRNA-based vaccine (BNT162b2, Comirnaty®, commercialized by Pfizer) Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Impact of the Immune System on Response to COVID-19 Vaccine in Allogeneic Stem Cell Recipients (Covid Vaccin Allo)
Actual Study Start Date : March 22, 2021
Estimated Primary Completion Date : August 1, 2021
Estimated Study Completion Date : January 1, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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)
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.
Other Names:
  • COVID-19 mRNA Vaccine
  • Pfizer




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Evolution of anti-SARS-CoV-2 receptor binding domain specific IgG [ Time Frame: 6 months after day 21 ]
    To study the evolution anti-RBD IgG titers from day +49 (day 28 after the second dose) to 6 months after the second dose.

  2. Titration of neutralizing antibodies [ Time Frame: Day 49 and 6 months after Day 21 ]
    To analyze the titer of neutralizing antibodies at Day 49 as well as at 6 months after the second dose (at Day 21).

  3. Clinical factors predicting response to vaccine (defined as detectable specific anti-SARS-CoV-2 RBD specific IgG). [ Time Frame: 49 days after the first dose ]
    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.

  4. Efficacy of the immune response to the vaccine to prevent COVID-19 [ Time Frame: 12 months after first dose (Day 0) ]
    Incidence of SARS-CoV-2 infection occurring after vaccination

  5. Assessment of T cell and B cell response to the vaccine [ Time Frame: Day 7 and Day 49 ]
    Measuring SARS-Cov2 specific T cells (by intracellular cytokine staining) and B cells (by Elispot).


Other Outcome Measures:
  1. Number of participants with treatment-related adverse events as assessed by the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 [ Time Frame: 12 months after first dose (Day 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.



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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04951323


Contacts
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Contact: Frédéric MD Baron, Dr. MD +3243667201 F.Baron@chuliege.be

Locations
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Belgium
CHU Liège, Domaine du Sart-Tilman Recruiting
Liège, Belgium, 4000
Contact: Frédéric MD Baron, MD    +3243667201    F.Baron@chuliege.be   
Sponsors and Collaborators
University of Liege
Pfizer
Investigators
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Principal Investigator: Frédéric MD Baron Centre Hospitalier Universitaire de Liège
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Responsible Party: Frédéric Baron, Professor, University of Liege
ClinicalTrials.gov Identifier: NCT04951323    
Other Study ID Numbers: TJB2101
First Posted: July 6, 2021    Key Record Dates
Last Update Posted: July 6, 2021
Last Verified: July 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Coronavirus Infections
Hematologic Neoplasms
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Neoplasms by Site
Neoplasms
Hematologic Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs