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
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|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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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 :||December 1, 2022|
|Estimated Study Completion Date :||January 1, 2023|
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.
- 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.
- 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).
- 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|
- prior allogeneic hematopoietic stem cell transplantation 3 months to 5 years earlier (any donor type)
- age > or = 18 years at inclusion.
- written informed consent
- HIV seropositivity
- 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
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
|Contact: Frédéric MD Baron, Dr. MD||+3243667201||F.Baron@chuliege.be|
|CHU Liège, Domaine du Sart-Tilman||Recruiting|
|Liège, Belgium, 4000|
|Contact: Frédéric MD Baron, MD +3243667201 F.Baron@chuliege.be|
|Principal Investigator:||Frédéric MD Baron||Centre Hospitalier Universitaire de Liege|
|Responsible Party:||Frédéric Baron, Professor, University of Liege|
|Other Study ID Numbers:||
|First Posted:||July 6, 2021 Key Record Dates|
|Last Update Posted:||May 18, 2022|
|Last Verified:||May 2022|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Respiratory Tract Infections
RNA Virus Infections
Respiratory Tract Diseases
Neoplasms by Site
Physiological Effects of Drugs