A National, Multicentric, Observational, Prospective Study to Assess Immune Response to COVID-19 Vaccine in Frail Patients (VAX4FRAIL).
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 747
- 试验地点
- 12
- 主要终点
- SARS-CoV-2 vaccine immunization
研究概览
简要总结
This is a multicentre observational study with the aim of evaluating the antibody and cellular response after vaccination for SARS-CoV-2 with Pfizer-BioNTech or Moderna vaccines in frail subjects with impaired immuno-competence, due to their underlying diseases or ongoing therapies.
详细描述
The immune response to COVID-19 vaccination will be assessed at the following time points:
T0: the day of vaccination T1: the day of the booster dose according to the schedule of the two vaccines (Pfizer/BioNTech or Moderna) T2: between 5 and 7 weeks after T0 for those vaccinated with Pfizer/BioNTech and between 6 and 8 weeks after T0 for those vaccinated with Moderna.
- T3: 12 (± 1) weeks after T0
- T4: 24 (± 2) weeks from T0
- T5: 52 (± 2) weeks from T0 Prevention of SARS-CoV-2 infection will be assessed in terms of incidence of SARS-CoV-2 infections (NF molecular swab positive), and of SARS-CoV-2 infections requiring hospitalisation.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Any subject undergoing SARS-CoV-2 vaccination with Pfizer-BioNTech or Moderna vaccines may be included in the study if they belong to at least one of the subgroups listed below:
- •Hematological tumors
- •Solid tumors
- •Rheumatological diseases
- •Neurological diseases
排除标准
- 未提供
研究组 & 干预措施
HEMATOLOGICAL MALIGNANCIES
1a. Newly diagnosed patients with ANY haematological malignancy requiring treatment (No.=100).
1b. Patients with ongoing treatments or with treatments completed within 6 months (chemotherapy and target therapies) other than antibodies. More specifically: patients with ongoing or completed chemotherapy (No.=50) or patients with ongoing or completed Ibrutinib (No.=50) or patients with ongoing or completed ruxolitinib (No.=50)
1c. Patients treated with anti-CD19 or CD20 or CD22 or CD30 or anti-PD1 antibodies with or without chemotherapy OR patients receiving CAR-T cells: patients treated anti-B-cell (No.=50) or patients treated anti-CD30 (No.=50) or patients treated anti-PD1 (No.=50).
1d. Patients at three months after autologous or allogeneic transplantation without active immune suppressive therapy: after autologous transplantation (No.=50) or after allogenic transplantation (No.=50).
干预措施: COVID-19 vaccines (Biological)
SOLID TUMORS
2a. Chemotherapy in adjuvant therapy. All patients with a diagnosis of solid tumors apart resected basal-cell or squamous-cell carcinoma of the skin, melanoma in situ, carcinoma in situ of the cervix, and carcinoma in situ of the Breast. Under curative surgery (stage II-III) for the solid tumor or hemotherapy alone or in combination with target therapies or radiotherapy (No.=100).
2b. Chemotherapy in metastatic Disease. All patients with a diagnosis of solid tumors with Metastatic disease (stage IV), undergoing chemotherapy alone or in combination with immunotherapy or target therapy (No.=100).
2c. Immunotherapy in metastatic Disease. All patients with a diagnosis of solid tumors with Metastatic disease (stage IV), undergoing immunotherapy alone (No.=100).
2d. Target therapies in metastatic Disease. All patients with a diagnosis of solid tumors with Metastatic disease (stage IV), Undergoing target therapy alone (No.=100)
干预措施: COVID-19 vaccines (Biological)
IMMUNORHEUMATOLOGICAL DISEASES
3a. Patients with ANCA-associated vasculitis classified according to Chapel Hill Consensus Conference nomenclature, treated with immunodepressants agents with/without glucocorticoids (No.=50) or treated with RTX with/without glucocorticoids (No.=50) 3b. Interstitial Lung Disease in Autoimmune Conditions. Patients with a diagnosis of a specific CTD, myositis or rheumatoid arthritis based on validated classification criteria, and clinically significant ILD defined as disease treated with traditional immunodepressants or rituximab and fibrotic and/or inflammatory changes on chest CT not attributable to infection, and no evidence of obstructive lung disease. Patients treated with traditional immunodepressive agents with/without glucocorticoidspatients (No.=50) or patients treated with rituximab with/without glucocorticoids (No.=50)
干预措施: COVID-19 vaccines (Biological)
NEUROLOGICAL DISEASES
4a. Patients with a diagnosis of multiple sclerosis, age < 60 years with relapsing-remitting MS on Ocrelizumab (anti-CD20 monoclonal antibody) (No.=50) or with secondary/primary progressive MS on Ocrelizumab (anti-CD20 monoclonal antibody) (No.=50).
4b. Generalized Myasthenia Gravis, on immunosuppressive polytherapies or on B-cell targeted biological treatments, with lymphocytes count < 1 cell/microliter, or with thymoma (No.=100)
干预措施: COVID-19 vaccines (Biological)
结局指标
主要结局
SARS-CoV-2 vaccine immunization
时间窗: 5-7 weeks after T0 for Pfizer/BioNTech vaccination; 6-8 weeks after T0 for Moderna vaccination
For assessing the immunologic response to the COVID-19 vaccination, the anti-S antibodies levels in the fragile population will be quantified at T2 and compared with the anti-S antibodies levels quantified at the same time point in a population of healthy subjects.
次要结局
- T cell immunological response(at 6 times points T0 before vaccine administration, T1 before the second dose of the vaccine and at times T2, T3, T4 and T5 which correspond to 5-7 weeks (Pfizer-BioNTech) or 6-8 weeks (Moderna), 12 weeks, 24 weeks and 52 weeks after the first dose)
- immunological response in different subgroups(1 year)
- anti-S antibodies immunological response(at 6 times points T0 before vaccine administration, T1 before the second dose of the vaccine and at times T2, T3, T4 and T5 which correspond to 5-7 weeks (Pfizer-BioNTech) or 6-8 weeks (Moderna), 12 weeks, 24 weeks and 52 weeks after the first dose)
- impact of COVID-19 vaccination on patient health status(1 weeks after frist dose and 1 week after second dose)
- incidence of SARS-CoV-2 infection.(all 52 weeks)
