Hematological Diseases
Conditions
Interventions
All participants will be invited for blood sampling prior to vaccination. They will return for blood sampling prior to the 2nd vaccination and 4 weeks after completion of the COVID-19 vaccinationsched
Sponsors
AUMC location VUmc
Eligibility
Inclusion criteria
Inclusion criteria: Age =16 years - The following patient cohorts will be included: Acute lymphoblastic leukemia (ALL), 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 12 months, or currently receive targeted agents, or have received autologous or allogeneic stem cell transplantation no longer than 12 months prior, or have received CART 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 < 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 |
|---|---|
| To identify subcategories of hematology patients with A) sufficient protection against COVID-19, +28 days after completion of the standard COVID-19 vaccination schedule (responders: seroconversion), B) insufficient protection, who may benefit from boostervaccinations (low-responders: antibody response but no seroconversion) and C) insufficient protection (non-responders: no seroconversion, no antibody response). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To characterize the humoral responses (including kinetics and persistence of antibodies, role of previous exposure to SARS-CoV2 infection) after vaccination; 2. To characterize the cellular immune response (i.e. CD4 and CD8 T-cell responses including Th1 skewing of CD4 T-cells) after COVID-19 vaccination. 3. To identify immune parameters associated with responses to COVID-19 vaccination 4. To identify clinical parameters (e.g. hematologic diagnosis, current and past therapies, date of last therapy) associated with responses to COVID-19 vaccination. 5. To monitor serious adverse events (SAE) < 7 days after each COVID-19 vaccination 6. To monitor SARS-CoV-2 infection and severity (including death) after COVID-19 vaccination | — |
Contacts
Public ContactEdith van Dijkman
Amsterdam UMC, location AMC
Outcome results
None listed