EUCTR2021-003710-39-PT进行中（未招募）1 期
COVID-19: Immune response in patients with cancer undergoing mRNA vaccination against SARS-CoV-2. I-SPARC study - I-SPARC
INSTITUT JULES BORDET0 个研究点目标入组 525 人开始时间: 2022年1月24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
- 525
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
- •Subjects must meet all of the following criteria in order to be eligible for this study:
- •1) Age = 18 years old
- •2) ECOG performance status = 2
- •3) Subjects with histologically or cytologically confirmed cancer diagnosis (invasive solid tumour or haematological malignancy)
- •undergoing active systemic cancer treatment at the time of 1st dose of the anti-SARS-CoV-2 mRNA vaccine (such as chemotherapy, immunotherapy, targeted agents, endocrine therapy) in
- •- non-metastatic setting or
- •- metastatic setting (only 1st line therapy )
- •or undergoing follow-up after confirmed cancer complete remission without active cancer treatment for the last 12 months at the time of 1st dose of the anti-SARS-CoV-2 mRNA vaccine
- •4) Life expectancy > 6 months
- •5) Subjects who received the 2nd dose of mRNA platform vaccination against SARS-CoV-2 as per local guidelines within 6 months (maximum until 6 months and 3 weeks) prior to registration.
- •6) Urine pregnancy test negative for all female subjects of childbearing potential within 7 days prior to subject enrolment.
- •7) Signed Informed Consent form (ICF) obtained prior to any study related procedure.
- •8) Subject is willing and able to comply with the protocol for the duration of the study including treatment and scheduled visits and examinations.
- •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 265
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 265
排除标准
- •Subjects meeting one of the following criteria are not eligible for this study:
- •1) Known pregnant and/or lactating women.
- •2) Subject with a significant medical, neuro-psychiatric, or surgical condition, currently uncontrolled by treatment, which, in the principal investigator’s opinion, may interfere with completion of the study.
- •3) Subjects with active diagnosis of acute leukaemia.
- •4) Subjects treated with bone marrow transplant < 90 days before received vaccination against SARS-CoV-2.
- •5) Subjects with a known history of HIV infection.
- •6) COVID-19 infection in the last 28 days before receiving first dose of vaccination against SARS-CoV-2 and up to subject enrolment.
- •7) Subjects receiving prolonged and/or high doses of systemic immunosuppressive therapies including corticosteroids during the last 28 days before receiving first dose of vaccination against SARS-CoV-2 and up to subject enrolment.8) Subjects who, for any reason, did not receive the 2nd dose of the anti-SARS-CoV-2 mRNA vaccine.
- •9) Subjects that received the 3rd dose of anti-SARS-CoV-2 mRNA vaccine prior to study entry.
- •10) Subject that received any dose of non-mRNA anti-SARS-CoV-2 vaccine platform.
- •11) Subjects with a known or suspected history of severe adverse reactions associated with a vaccine and/or with severe allergic reaction to vaccine components or anaphylaxis in the past.
- •12) Subjects who have received any other licensed vaccines for other indications within 28 days prior to the 3rd dose, or who are planning to receive any other vaccine up to 14 days after the 3rd dose of the mRNA anti-SARS-CoV-2 vaccine (28 days for live attenuated vaccines). For influenza vaccination, a shorter interval or simultaneous administration is acceptable.
研究者
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