Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Titration of neutralizing antibodies |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Frédéric MD Baron, Dr. MD | Contact | +3243667201 | F.Baron@chuliege.be |
| Name | Affiliation | Role |
|---|---|---|
| Frédéric MD Baron | Centre Hospitalier Universitaire de Liege | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Liège, Domaine du Sart-Tilman | Recruiting | Liège | 4000 | Belgium |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
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 |
| 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 |
| 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) |
| 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 |
| 12 months after first dose (Day 0) |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D019337 | Hematologic Neoplasms |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000090982 | BNT162 Vaccine |
| C000722934 | CVnCoV COVID-19 vaccine |
| ID | Term |
|---|---|
| D000087503 | mRNA Vaccines |
| D000087504 | Nucleic Acid-Based Vaccines |
| D014614 | Vaccines, Synthetic |
| D011994 | Recombinant Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D000086663 | COVID-19 Vaccines |
| D014765 | Viral Vaccines |
| D000941 | Antigens |
| D001685 | Biological Factors |
Not provided
Not provided