EUCTR2021-003710-39-BE进行中（未招募）1 期
COVID-19 : Immune response in patients with cancer undergoing vaccination against SARS-CoV-2 - I-SPARC
INSTITUT JULES BORDET0 个研究点目标入组 440 人开始时间: 2021年10月7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
- 440
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •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 the last dose (before ICF signature) of the anti-SARS-CoV-2 mRNA vaccine (such as chemotherapy, immunotherapy, targeted agents, endocrine therapy) in
- •-non-metastatic/curative setting or
- •-metastatic/palliative setting
- •or undergoing follow-up after confirmed cancer complete remission without active cancer treatment for the last 12 months at the time of the last dose (before ICF signature) of the anti-SARS-CoV-2 mRNA vaccine.
- •4)Life expectancy > 6 months
- •5)Subjects who received at least 2 doses of mRNA platform vaccination against SARS-CoV-2 as per local guidelines, with the last dose being given between 3 and 12 months prior to baseline assessment.
- •6)Urine/serum 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 220
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 220
排除标准
- •1)Known pregnant and/or lactating women.
- •2)Subject with a known 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 the last dose of vaccination against SARS-CoV-2 received before ICF signature.
- •5)Subjects with a known history of HIV infection.
- •6)COVID-19 infection in the last 28 days prior 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. Exclusion criterion number 9 is only applicable for previous versions of the protocol and is not applicable for protocol version 3.0 and subsequent versions.
- •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 planned to receive any other licensed vaccines for other indications within 28 days prior to the first booster dose after ICF signature, or who are planning to receive any other vaccine up to 14 days after the first booster dose of the mRNA anti-SARS-CoV-2 vaccine after ICF signature (28 days for live attenuated vaccines). For influenza vaccination, a shorter interval or simultaneous administration is acceptable.
- •13)Subjects who have planned to receive a booster dose after ICF signature but before the baseline assessment.
- •14)Subjects who received COVID-19 pre-exposure prophylactic monoclonal antibodies or who have been treated with anti-SARS-CoV-2 monoclonal antibodies or COVID-19 convalescent plasma during the last 6 months before ICF signature.
研究者
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