Clinical trial NCT04951323: 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: Impact of the Immune System on Response to COVID-19 Vaccine in Allogeneic Stem Cell Recipients (Covid Vaccin Allo)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Coronavirus Disease 2019 (Covid19)
Hematopoietic Neoplasms
Lead sponsor: University of Liege
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2021-07-06
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

Eligibility 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

Primary outcomes:
measure: Quantification of anti-SARS-CoV-2 receptor binding domain specific IgG
timeFrame: Day 49 after first injection (D0)
Secondary outcomes:
measure: Evolution of anti-SARS-CoV-2 receptor binding domain specific IgG
timeFrame: 6 months after day 21
measure: Titration of neutralizing antibodies
timeFrame: Day 49 and 6 months after Day 21
measure: Clinical factors predicting response to vaccine (defined as detectable specific anti-SARS-CoV-2 RBD specific IgG).
timeFrame: 49 days after the first dose
measure: Efficacy of the immune response to the vaccine to prevent COVID-19
timeFrame: 12 months after first dose (Day 0)
measure: Assessment of T cell and B cell response to the vaccine
timeFrame: Day 7 and Day 49
Other outcomes:
measure: Number of participants with treatment-related adverse events as assessed by the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
timeFrame: 12 months after first dose (Day 0)
Locations:
city: Liège
country: Belgium
facility: CHU Liège, Domaine du Sart-Tilman
Study officials:
affiliation: Centre Hospitalier Universitaire de Liege
name: Frédéric MD Baron
role: PRINCIPAL_INVESTIGATOR
References: