EUCTR2021-002348-57-AT进行中（未招募）1 期
A Randomized, Parallel Group, Single-Blind, Phase 2 Study to Evaluate the immune response of two classes of SARS-Cov-2 Vaccines employed as Third Vaccination in Patients under current Rituximab Therapy and no humoral response after standard mRNA vaccination - Immune response after three dosis of SARS-CoV-2 (COVID-19) vaccination
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 68
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Male and female subjects will be eligible for participation in this study if they:
- •1.Are =18 years on the day of screening
- •2.Have a chronic condition and have been treated with a B-cell depleting therapy (rituximab) within the last 12 months
- •3.Received mRNA SARS-CoV-2 (Biontech/Pfizer or Moderna) vaccine
- •4.Did not develop humoral immunity 4 weeks after second mRNA vaccination to SARS-CoV-2 (analyzed during the study Characterization of immune responsiveness after mRNA SARS-CoV-2 Vaccination in patients with immunodeficiency or immunosuppressive therapy”, EK-Nr. 1073/2021, EudraCT Nr. 2021-000291-11)
- •5.A maximum of 6 months after second vaccination
- •6.Have an understanding of the study, agree to its provisions, and give written informed consent before study entry
- •7.If female and capable of bearing children – have a negative urine pregnancy test result at study entry and agree to employ adequate birth control measures for the duration of the study
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 34
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 34
排除标准
- •Subjects will be excluded from participation in this study if they:
- •1.Have shown humoral response to the SARS-CoV-2 vaccination
- •2.Had grade 3 adverse effects from the mRNA vaccination reported
- •3.Pregnancy and breast feeding
- •4.Signs of SARS-CoV-2 infection (including previous positive PCR testing)
- •5.Any other contraindication to any of the study compounds
- •6.Urgent need for next rituximab application
研究者
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