COVID-19 trials registries data warehouse

https://www.clinicaltrialsregister.eu/ctr-search/trial/2021-001072-41/NL

Amsterdam UMC location VUmc - Clinical Trial Office Hematology

cobra-kai@amsterdamumc.nl

2021-02-27

Completed

nonRCT

Non-randomized

Parallel

Open label

multi-center

Prevention

- 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.

- 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

2

Amsterdam UMC location VUmc

18

100

Netherlands

Healthy volunteers

N/A

850

Humoral response (IgG) against SARS-CoV-2 spike antigen +28 days after completion of the COVID-19 vaccination schedule.

Dose 2

Phase 4

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