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临床试验/DRKS00027372
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Immune response to COVID-19 vaccination in hemato-oncology patients - ImV-HOng

Krukenberg Krebszentrum Halle0 个研究点目标入组 398 人开始时间: 2022年1月11日最近更新:
适应症

试验速览

阶段
未知
状态
已完成
发起方
入组人数
398

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Non-randomized controlled study
盲法
Open (masking not used)

入排标准

年龄范围
18 Years 至 one(—)
性别
All

入选标准

  • 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

排除标准

  • 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

研究者

发起方
Krukenberg Krebszentrum Halle

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