Evaluation of the Immune Response to Sars-Covid-19 (Cov-2) Vaccines in Haematological Patients: Prospective Single Center Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 700
- 试验地点
- 1
- 主要终点
- Rate of seroconversion in hematological patients who received a mRNA SARS-CoV-2 vaccine
研究概览
简要总结
The main objective of this study is to investigate the humoral immune response to COVID-19 vaccines in haematological patients, by testing SARS-CoV-2 seroconversion
详细描述
This single-center prospective study will enroll approximately 700 hematologic patients who access to Haematological Division (San Gerardo Hospital, Monza, Italy) in order to perform their routine blood tests to monitor their hematological conditions. Evaluation of Sars-Cov-2 IgG specific antibodies will be performed on left-over biological material (serum or plasma) collected during routine blood tests run between 30 and 60 days after the administration of the second vaccine dose.
Furthermore, in each patient who has failed seroconversion (absence of specific antibodies for circulation), his cellular immune response will be assessed using an additional blood sample collected during routine blood tests.
These samples will be collected within 9 months of the completion of the vaccination series and will be used to evaluate the plasma INF-γ release using QuantiFERON SARS-CoV-2 test.
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
- •Signed and dated EC-approved informed consent
- •Hematological disease defined according to World Health Organization (WHO) criteria
- •Female or male, 18 years of age or older
- •ECOG performance status 0-3
- •Willingness and ability to comply with routine clinical practice and study procedures
- •Regular vaccination against SARS-CoV-2 according to Italian Haematological Society (SIE) guidelines/recommendations (Version 2.0, 20 April, 2021).
- •Routine blood test planned between 30 and 60 days after administration of the second vaccine dose according to regular hematological follow up.
- •Routine blood test planned no later than 9 months after the completion of the vaccination series (only in case of absence of circulation specific antibodies).
排除标准
- •Preventive vaccination against SARS-CoV-2 not administered according to Italian Haematological Society (SIE) guidelines/recommendations (Version 2.0, 20 April, 2021)
- •Evidence of previous infection with the SARS-Cov-2 virus.
- •Routine blood test not planned between 30 and 60 days after administration of the second vaccine dose.
- •Routine blood test not planned within 9 months after the completion of the vaccination series (only in case of absence of circulation specific antibodies).
结局指标
主要结局
Rate of seroconversion in hematological patients who received a mRNA SARS-CoV-2 vaccine
时间窗: Between 30 and 60 days after the administration of the second vaccine dose
Seroconversion is defined as a post-vaccination SARS-CoV-2 IgG antibody titer \>33.8 Binding Anticorpal Unit (BAU)/ml.
次要结局
- To compare the seroconversion rate in haematological patients versus healthy subjects.(Between 30 and 60 days after the administration of the second vaccine dose)
- To correlate the rate of seroconversion in hematological patients to the specific haematological diseases.(Between 30 and 60 days after the administration of the second vaccine dose)
- To correlate the rate of seroconversion to previous therapies(Between 30 and 60 days after the administration of the second vaccine dose)
- To assess the efficacy of vaccine by estimating how many patients will be infected by SARS-CoV-2 in the 9 months after the administration of the second vaccine dose.(Within 9 months after the administration of the second vaccine dose)
- To analize T-cell response in those patients who will result negative for specific antibodies anti-Sars-Cov-2 after two doses of mRNA SARS-Cov-2 vaccination(Within 9 months after the administration of the second vaccine dose)