Coronavirus Disease 2019 (Covid19) Clinical Trial
Official title:
Impact of the Immune System on Response to COVID-19 Vaccine in Allogeneic Stem Cell Recipients (Covid Vaccin Allo)
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.
| Status | Recruiting |
| Enrollment | 50 |
| Est. completion date | January 1, 2023 |
| Est. primary completion date | December 1, 2022 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years to 100 Years |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Belgium | CHU Liège, Domaine du Sart-Tilman | Liège |
| Lead Sponsor | Collaborator |
|---|---|
| University of Liege | Pfizer |
Belgium,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Number of participants with treatment-related adverse events as assessed by the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 | 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. | 12 months after first dose (Day 0) | |
| Primary | 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 | Evolution of anti-SARS-CoV-2 receptor binding domain specific IgG | To study the evolution anti-RBD IgG titers from day +49 (day 28 after the second dose) to 6 months after the second dose. | 6 months after day 21 | |
| Secondary | Titration of neutralizing antibodies | To analyze the titer of neutralizing antibodies at Day 49 as well as at 6 months after the second dose (at Day 21). | Day 49 and 6 months after Day 21 | |
| Secondary | Clinical factors predicting response to vaccine (defined as detectable specific anti-SARS-CoV-2 RBD specific IgG). | 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. | 49 days after the first dose | |
| Secondary | Efficacy of the immune response to the vaccine to prevent COVID-19 | Incidence of SARS-CoV-2 infection occurring after vaccination | 12 months after first dose (Day 0) | |
| Secondary | Assessment of T cell and B cell response to the vaccine | Measuring SARS-Cov2 specific T cells (by intracellular cytokine staining) and B cells (by Elispot). | Day 7 and Day 49 |