COBRA-KAI study: 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?

Completed

Conditions: hematological malignancies
reduced B-cell and T-cell immunity
reduced immunity
10047954

Registration Number: NL-OMON51241

Lead Sponsor: Vrije Universiteit Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 723

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

- 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: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Humoral response (IgG) against SARS-CoV-2 spike antigen +28 days after<br /><br>completion of the COVID-19 vaccination schedule and after each additional<br /><br>vaccination.</p><br>

Secondary Outcome Measures