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? - COBRA-KAI study

Vrije Universiteit Medisch Centrum0 个研究点目标入组 723 人开始时间: 待定最近更新: 2024年4月9日

适应症

试验速览

暂无简介。

•- 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.

•- 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

发起方