A Prospective Observational Study on the Immune-response to SARS-CoV-2 Vaccination in Cancer Patients - the IOSI-COVID-19-001 Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 177
- 试验地点
- 1
- 主要终点
- Immune response to SARS-CoV-2 vaccine in cancer patients
研究概览
简要总结
This is a single centre prospective observational study to assess the immune response to SARS-CoV-2 vaccines in cancer patients receiving active treatment or in follow-up at the IOSI and in non-cancer patients (age and gender matched).
详细描述
This study will be conducted on 7 cohorts of cancer patients and 1 cohort of non-cancer subjects (age and gender matched) with a sample size of 30 patients in each cohort:
All enrolled patients will be asked to provide blood samples (2 x 10cc Heparin Tubes) at the following time points:
- Baseline: before the administration of the first dose of the SARS-CoV-2 vaccine (within 4 weeks).
- Before the second dose of the SARS-CoV-2 vaccine (within 7 days).
- Follow-up: after 3, 6, 9 and 12 months after the second dose of the SARS-CoV-2 vaccine. A +/- 14 days window is allowed at each follow-up time point.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male of Female age at least 18 years
- •Patients with a diagnosis of malignancy (solid tumors or hematological malignancies) according to the defined cohorts. Only for cohorts 1-7
- •Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
- •Absence of known immune deficiency (other than cancer for cohorts 1-7)
- •Ability to understand the patient information and study consent. Signed and dated written informed consent must be available before performing any study-related procedure
- •Willing and able to comply with the study procedures.
- •Willing to receive an mRNA anti-SARS-CoV-2 vaccine.
排除标准
- 未提供
结局指标
主要结局
Immune response to SARS-CoV-2 vaccine in cancer patients
时间窗: 3, 6, 9 and 12 months following vaccination
to determine the changes in the titer of serum antibodies (IgM, IgG and IgA) targeting SARS-CoV-2 antigens in 7 cohorts of cancer patients who have received the SARS-CoV-2 vaccination. A cohort of non-cancer subjects will be used as control group.
次要结局
- changes in serum antibodies anti SARS-CoV-2 after vaccination(3, 6, 9 and 12 months following vaccination)
- Cellular immune response to SARS-CoV-2 vaccine(3, 6, 9 and 12 months following vaccination)
- Immune response to SARS-CoV-2 vaccine according tumor and treatment type(3, 6, 9 and 12 months following vaccination)
研究者
Ilaria Colombo
Principal Investigator
Oncology Institute of Southern Switzerland