EUCTR2021-002693-10-AT进行中（未招募）1 期
A Phase II Study to Evaluate Safety and Efficacy to a Third Vaccination in Immunocompromised Patients with Inadequate Humoral Response after Primary mRNA SARS-CoV-2 (Covid-19) Vaccination - VAC3 SARS-CoV-2 seroconversion study
Medical University of Vienna, Department for Internal Medicine III, Division of Rheumatology0 个研究点目标入组 300 人开始时间: 2021年5月19日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 300
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
- •a) Male and female patients will be eligible for participation in this study if they:
- •1.Are =18 years on the day of screening
- •2.Being immunocompromised (either primary or secondary immunodeficiency or been treated with immunosuppressive therapy within the last 12 months
- •Immunosuppressive therapies include glucocorticoids, cytostatics, antibodies, drugs acting on immunophilins and other treatments like interferons and TNF binding proteins and exclude patients under B cell depleting therapy (like Rituximab, Ocrelicumab, Ofatumumab, Epratuzumab or Obinutuzumab)
- •3.Received two doses of SARS-CoV-2 (Biontech/Pfizer, Moderna) vaccine according to recommendations in the label and/or national guidelines.
- •4.Did develop < 1500 U/ml of SARS-CoV-2 antibodies 4 weeks after second mRNA vaccination (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, or external routine evaluation of humoral response)
- •5.A maximum of 12 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
- •b) Male and female healthy controls will be eligible for participation in this study if they:
- •1.Are =18 years on the day of screening
- •2.Received two doses of SARS-CoV-2 (Biontech/Pfizer, Moderna) vaccine according to recommendations in the label and/or national guidelines.
- •3.Did develop < 1500 U/ml of SARS-CoV-2 antibodies 4 weeks after second mRNA vaccination
- •4.A maximum of 12 months after second vaccination
- •5.Have an understanding of the study, agree to its provisions, and give written informed consent before study entry
- •6.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 150
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 150
排除标准
- •Subjects will be excluded from participation in this study if they:
- •1.Have shown humoral response (> 1500 U/ml) 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 vaccine compounds
- •6.For healthy controls: diagnosis of chronic inflammatory condition including primary or secondary immunodeficiency or ever receiving immunosuppressing therapy as stated above
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