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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 : May 18, 2022
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Frédéric Baron, University of Liege

Tracking Information
First Submitted Date  ICMJE June 2, 2021
First Posted Date  ICMJE July 6, 2021
Last Update Posted Date May 18, 2022
Actual Study Start Date  ICMJE March 22, 2021
Estimated Primary Completion Date December 1, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 1, 2021)		 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 1, 2021)
  • 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.
  • 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).
  • 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.
  • 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
  • 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).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: July 1, 2021)		 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.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Impact of the Immune System on Response to Anti-Coronavirus Disease 19 (COVID-19) Vaccine in Allogeneic Stem Cell Recipients (Covid Vaccin Allo)
Official Title  ICMJE Impact of the Immune System on Response to COVID-19 Vaccine in Allogeneic Stem Cell Recipients (Covid Vaccin Allo)
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Coronavirus Disease 2019 (Covid19)
  • Hematopoietic Neoplasms
Intervention  ICMJE 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
Study Arms  ICMJE 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)
Intervention: Drug: anti-COVID19 mRNA-based vaccine (BNT162b2, Comirnaty®, commercialized by Pfizer)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 1, 2021)		 50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 1, 2023
Estimated Primary Completion Date December 1, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 100 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Frédéric MD Baron, Dr. MD +3243667201 F.Baron@chuliege.be
Listed Location Countries  ICMJE Belgium
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04951323
Other Study ID Numbers  ICMJE TJB2101
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Frédéric Baron, University of Liege
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University of Liege
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator: Frédéric MD Baron Centre Hospitalier Universitaire de Liege
PRS Account University of Liege
Verification Date May 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP