hematological malignancies reduced B-cell and T-cell immunity reduced immunity
Conditions
Interventions
One or more (maximum three) booster vaccinations with the same vaccine in the
same dose as applied in the primary schedule (Moderna), administered to
participants who did not respond, or responded p
Sponsors
Vrije Universiteit Medisch Centrum
Eligibility
Age
18 Years to 99 Years
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 in the past 12 months received immune-chemotherapy, currently receive targeted agents, or have received autologous or allogeneic stem cell transplantation no longer than 12 months ago, or have received CAR-T therapy.
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Humoral response (IgG) against SARS-CoV-2 spike antigen +28 days after completion of the COVID-19 vaccination schedule and after each additional vaccination. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.SARS-CoV-2 S1-protein specific antibody neutralization, glycosylation, types and titers after completion of the standard COVID-19 vaccination schedule and after each additional vaccination; 2.Proportion of SARS-CoV-2 S1-protein specific CD4+ and CD8+ T-cells and NK cells and proportion of Th1, Th2 and Th17 of SARS-CoV-2 specific T cells after completion of the standard COVID-19 vaccination schedule and after each additional vaccination; 3.Pre-vaccination baseline leukocyte counts, humoral and cellular immune parameters (including T- and B-cell numbers and NK cell numbers and IgA, IgM, IgG and IgG1-4 levels), demographic parameters and medical history including comorbidities, response evaluation and concomitant medications and prior to each additional vaccination; 4. SAE within 7 days after each vaccination; 5. Incidence of COVID-19, COVID-19 related hospitalization and death after each COVID-19 vaccination. | — |
Countries
Netherlands
Outcome results
None listed