hematological diseases MedDRA version: 20.0 Level: LLT Classification code 10019426 Term: Hematologic disorder System Organ Class: 100000004851 MedDRA version: 21.1 Level: LLT Classification code 10066481 Term: Hematological malignancy System Organ Class: 100000004864 MedDRA version: 20.1 Level: LLT Classification code 10069761 Term: Hematological infection System Organ Class: 100000004862 MedDRA version: 20.0 Level: LLT Classification code 10072113 Term: Congenital hematological disorder Sy
Conditions
Interventions
Trade Name: Comirnaty concentrate for dispension for injection COVID-19 mRNA vaccine (nucleoside modified)
Pharmaceutical Form: Solution for injection
Trade Name: COVID-19 Vaccine Moderna dispersion
Sponsors
Amsterdam UMC location VUmc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Age =18 years - The following patient cohorts will be included: B-cell non Hodgkin lymphoma, multiple myeloma, chronic lymphocytic leukemia (CLL), acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), myeloproliferative diseases (MPN), patients with hemoglobinopathies (sickle cell disease and thalassemia), patients who received cell therapy (autologous HCT, allogeneic HCT or CAR T-cell therapy) AND - Patients must either currently receive immuno-chemotherapy or have received such therapy in the past 6 months, or currently receive targeted agents, or have received autologous or allogeneic stem cell transplantation no longer than 6 months prior, or have received CAR-T therapy. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 600 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 250
Exclusion criteria
Exclusion criteria: - Unwilling or unable to give informed consent - Known allergy to one of the components of the vaccine - Patients with a life expectancy of < 12 months - Of note: although we will investigate serologic evidence of prior infection with SARS-CoV-2 in all participants, seropositivity is not an exclusion criterion. The main reasons for this are first that we expect seroprevalence to be well below 5%, because of the stringent isolation measures that are already in place in this patient population; second, a test-first-strategy for seroprevalence would seriously hamper the speed of vaccination rollout, whereas vaccination of seropositive patients is indicated nonetheless, according to the national vaccination guidelines
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate COVID-19 vaccine responses in patients with hematologic diseases, in particular those patients who are considered immunocompromised, either due to the hematologic condition, or as a result of immunosuppressive therapy.;Secondary Objective: not applicable;Primary end point(s): Humoral response (IgG) against SARS-CoV-2 spike antigen +28 days after completion of the COVID-19 vaccination schedule.;Timepoint(s) of evaluation of this end point: +28 days after completion of the COVID-19 vaccination schedule. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. SARS-CoV-2 S-protein specific antibody neutralization, glycosylation, types and titers up to 12 months after completion of the COVID-19 vaccination schedule 2. Proportion of Th1 and Th2 T-cells and proportion of SARS-CoV-2 S-protein specific CD4+ and CD8+ T-cells up to 12 months after completion of the COVID vaccination schedule. 3. Pre-vaccination baseline leukocyte counts, humoral and cellular immune parameters (including T- and B-cell numbers and IgA, IgM, IgG and IgG1-4 levels), demographic parameters and medical history including comorbidities and concomitant medications. 4. SAE within 7 days after both vaccinations. 5. Incidence of COVID-19, COVID-19 related hospitalization and death during and following completion of the COVID-19 vaccination schedule ;Timepoint(s) of evaluation of this end point: After last patient last visit | — |
Countries
Netherlands
Contacts
Public ContactClinical Trial Office Hematology
Amsterdam UMC location VUmc
Outcome results
None listed