Immune response to COVID-19 vaccination in hemato-oncology patients
- Conditions
- hematooncological diseases
- Registration Number
- DRKS00027372
- Lead Sponsor
- Krukenberg Krebszentrum Halle
- Brief Summary
The kinetics of SARS-CoV-2 spike-protein antibodies and the cellular immune landscape following vaccination in patients with hematologic neoplasms are poorly understood. The aim of our prospective and longitudinal study, which included 398 adults, was to compare day 35 and day 120 anti-spike-IgG antibody and day 120 SARS-CoV-2-specific T-cell responses in patients with hematologic malignancies to a reference cohort. Although day 35 seroconversion in controls (98%) was higher compared to patients with myeloid (82%) and lymphoid (48%) neoplasms, substantial increases in day 120 seroconversion were seen in both the myeloid (97%) and lymphoid (66%) cohorts. Remarkably, spike-specific CD4+- and CD8+-cells in the lymphoid (71%/31%) and control (74%/42%) cohorts were comparable. We provide strong evidence of vaccine-elicited immunogenicity in most patients with hematologic malignancies. Both kinetics of seroconversion and cellular responses are crucial to determine which patients with hematologic malignancies will generate immunity. The findings have implications on public health policy regarding recommendations for SARS-CoV-2 booster doses.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 398
patients
• age = 18 years
• one of the following malignant diagnoses:
- myeloid disorders (AML, MPN, or MDS)
- lymphatic disorders (CLL, lymphoma, or MM)
- malignant diseases treated with checkpoint inhibitors
healthy subjects
• age = 18 Jahre
• willingness to or present appointment for covid-19 vaccination
patients
• patients not willing to or unable to get vaccinated
• patients with a duration of remission of = 5 years
• patients unable to give consent
healthy subjects
• subjects not willing to or unable to get vaccinated according to recommendations of the Robert-Koch-Institut
• subjects with a malignant disease and a duration of remission of < 5 years
• subjects unable to give consent
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method humoral immune response to the covid-19 vaccine of patients with hemato-oncological diseases compared to healthy subjects on day 35 (+7) after initial vaccination
- Secondary Outcome Measures
Name Time Method • humoral immune status:<br>- before covid-19 vaccination (day 0 to -21)<br>- day 120 (+14) after initial vaccination<br>• cellular immune status before, on day 35 (+7) and day 120 (+14) after initial vaccination<br>• immune response of hemato-oncological diseases:<br>- myeloid disorders [acute myeloid leukemia (AML), myeloproliferative neoplasms (MPN) and myelodysplastic syndromes (MDS)]<br>- lymphatic disorders [chronic lymphocytic leukemia (CLL), lymphoma, multiple myeloma (MM)]<br>- patients currently treated with checkpoint inhibitors<br>• immune response of therapy versus „watch and wait<br>• impact of patient and disease related factors on immune response<br>• CRP and lymphocyte count in peripheral blood<br>• post-marketing surveillance for collection of safety and tolerability data of the covid-19 vaccine in patients with hemato-oncological diseases and healthy subjects