COVID-19 trials registries data warehouse

https://trialregister.nl/trial/9553

Edith van Dijkman

hemat.metc@amsterdamumc.nl

2021-06-07

Not recruiting

nonRCT

Non-randomized

Single group assignment

Open label

multi-center

Prevention

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

1

AUMC location VUmc

16

100

Netherlands

High risk patients

N/A

850

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).

Not reported

[{"arm_notes": "", "treatment_id": 1923, "treatment_name": "Inactivated sars-cov-2 vaccine (vero cell)", "treatment_type": "Inactivated virus", "pharmacological_treatment": "Vaccine"}]