Impact of the Immune System on Response to Anti-Coronavirus Disease 19 (COVID-19) Vaccine in Allogeneic Stem Cell Recipients (Covid Vaccin Allo)

NCT04951323 | Unknown Phase 3

• 1 other identifier: TJB2101
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronavirus Disease 2019 (Covid19); Hematopoietic Neoplasms

Outcome Measures

Primary Outcomes (1)

• 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.

  Day 49 after first injection (D0)

Secondary Outcomes (5)

• 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

Other Outcomes (1)

• Number of participants with treatment-related adverse events as assessed by the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0

  12 months after first dose (Day 0)

Study Arms (1)

Injection of anti-COVID19 mRNA-based vaccine (BNT162b2, Comirnaty®, commercialized by Pfizer)

EXPERIMENTAL

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)

Interventions

anti-COVID19 mRNA-based vaccine (BNT162b2, Comirnaty®, commercialized by Pfizer) DRUG

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

Injection of anti-COVID19 mRNA-based vaccine (BNT162b2, Comirnaty®, commercialized by Pfizer)

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• prior allogeneic hematopoietic stem cell transplantation 3 months to 5 years earlier (any donor type)
• written informed consent

You may not qualify if:

• HIV seropositivity
• Pregnancy
• 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.
• Prior documented COVID-19 infection

Sponsors & Collaborators

• University of Liege: lead
• Pfizer: collaborator

Study Sites (1)

CHU Liège, Domaine du Sart-Tilman

Liège, 4000, Belgium

RECRUITING

MeSH Terms

Conditions

COVID-19; Hematologic Neoplasms

Interventions

BNT162 Vaccine; CVnCoV COVID-19 vaccine

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

mRNA Vaccines; Nucleic Acid-Based Vaccines; Vaccines, Synthetic; Recombinant Proteins; Proteins; Amino Acids, Peptides, and Proteins; Vaccines; Biological Products; Complex Mixtures; COVID-19 Vaccines; Viral Vaccines; Antigens; Biological Factors

Study Officials

• Frédéric MD Baron

  Centre Hospitalier Universitaire de Liege

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Frédéric MD Baron, Dr. MD

CONTACT

+3243667201; F.Baron@chuliege.be

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 2, 2021
• First Posted: July 6, 2021
• Study Start: March 22, 2021
• Primary Completion: December 1, 2022
• Study Completion: January 1, 2023
• Last Updated: May 18, 2022

Record last verified: 2022-05

Locations

BE (1)