COVID-19 vaccination in patients with reduced B-cell and T-cell immunity: response after vaccination of a kaleidoscopic group hematological patients, what’s the impact?
- Conditions
- Hematological Diseases
- Registration Number
- NL-OMON24355
- Lead Sponsor
- AUMC location VUmc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 850
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.
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 1. To characterize the humoral responses (including kinetics and persistence of antibodies, role of previous exposure to SARS-CoV2 infection) after vaccination;<br>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.<br>3. To identify immune parameters associated with responses to COVID-19 vaccination<br>4. To identify clinical parameters (e.g. hematologic diagnosis, current and past therapies, date of last therapy) associated with responses to COVID-19 vaccination.<br>5. To monitor serious adverse events (SAE) < 7 days after each COVID-19 vaccination<br>6. To monitor SARS-CoV-2 infection and severity (including death) after COVID-19 vaccination