Efficacy and Safety of the Anti- COVID-19 Vaccin in Clinical Hematology Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- humoral response after COVID19 vaccination
研究概览
简要总结
Coronavirus disease 2019 (COVID-19) is an emerging infectious disease that was first reported in December 2019 in Wuhan, China. Infection with this new coronavirus called SARS-CoV-2 can lead to fatal pneumonia associated with high rates of hospitalization in intensive care units (ICU).
Hospitalized patients with hematologic malignancies have a higher mortality rate than patients without hematologic malignancies (62% vs. 8%). The severity of Covid-19 may be related to their treatment, in particular anti-CD20 used in B lymphoid hemopathies. In fact, anti-CD20 antibodies induce rapid and prolonged depletion of B cells, but they are necessary for development. humoral immune responses.
But currently, no immunogenicity data are known for patients with hemopathy or in those on anti-lymphocyte immunochemotherapy.
详细描述
The aim of this study is to evaluate the humoral response after vaccination against SARS-CoV-2 in a French multicenter cohort of patients with hemopathies. Analysis of hemopathies and immunochemotherapy subgroups will determine whether there is a need to strengthen immunization schedules. In addition, the study wish to assess the safety and clinical efficacy of mRNA vaccines in this cohort.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
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
- •Benign or malignant hemopathy
- •With priority vaccination indication
- •Having benefited from anti-covid-19 mRNA vaccination
排除标准
- •Patients under legal protection
- •Palliative care patients
- •History of known Covid-19 disease (<1 year)
结局指标
主要结局
humoral response after COVID19 vaccination
时间窗: 1 month after vaccination
SARS-CoV-2 Trimeric S IgG titers (BAU/ml)
次要结局
- clinical response after COVID19 vaccination(12 months after vaccination)
- security of mRNA COVID19 vaccine(3 months after vaccination)
- humoral response after COVID19 vaccination(12 months after vaccination)