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Brief Title: Immunogenicity of COVID-19 Vaccination in Autologous HSCT or CAR-T Cells Recipients
Official Title: Immunogenicity of COVID-19 Vaccination in Immunocompromised Patients (Auto-COVID-VACC)
Study ID: NCT05597761
Brief Summary: This multicenter, prospective, non-interventional cohort study aims to evaluate data on humoral and cellular immune response generated within the COVID-19 vaccination standard in patients with B-cell non-Hodgkin lymphoma (NHL) or Hodgkin lymphoma (HL) who underwent autologous hematopoietic stem cell transplantation (HSCT) or who were treated with or chimeric-antigen-receptor-T-cells (CAR-T).
Detailed Description: According to the COVID-19 vaccination standard, patients who underwent autologous HSCT or CAR-T cells receive between 3 to 8 anti-SARS-CoV-2 mRNA vaccination in 28-day intervals. The definitive number of vaccinations patients will receive depend on the individual neutralizing antibody response. This study aims to analyze the immune response data generated within the procedures of the standard-of-care COVID-19 vaccination. Additional blood will be drawn from the patients at each visit defined within the vaccination standard by using the same vein puncture as used for blood drawings of routine blood samples. Study related blood samples will be used for evaluation of T and B cell response to COVID-19 vaccinations. For this study, no additional visits or invasive procedures will be performed in addition to the standard interventions.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Klinik für Hämatologie, Onkologie, Hämostaseologie und Stammzelltransplantation (Med. Klinik IV) Uniklinik der RWTH Aachen, Aachen, NRW, Germany
University Hospital of Cologne, Cologne, NRW, Germany
Universitätsklinikum Essen Klinik für Hämatologie und Stammzellentransplantation, Essen, NRW, Germany
Name: Oliver A. Cornely, Prof.
Affiliation: University Hospital of Cologne, Internal Medicine I
Role: PRINCIPAL_INVESTIGATOR