Monitoring of Anti-SARS-CoV-2 (COVID 19) and Encapsulated Vaccination in a Cohort of Patients With Thalassemic and Falcemic Syndromes
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,000
- 试验地点
- 9
- 主要终点
- Evaluate the presence and extent of the response to previous vaccinations to encapsulated bacteria.
研究概览
简要总结
There is an urgent need to rapidly evaluate anti-Covid 19 vaccination treatments, in terms of immune response (humoral and cell-mediated) together with the verification of the effectiveness of the vaccine in preventing SARS-CoV-2 infection in thalassemic subjects.
It is also necessary to increase scientific knowledge in order to improve clinical practice to have presence responses and maintenance extent of the response to vaccinations against encapsulated bacteria carried out previously.
The objectives of the main study are:
- Evaluate the appearance, extent, and duration of humoral response (antibodies) to the anti-SARS-CoV-2 vaccine;
- Assess the incidence of positive cases after vaccination.
The objective of the first sub-study is:
- Evaluate the appearance, extent, and duration of cellular response (T lymphocytes and B lymphocytes) to the anti-SARS-CoV-2 vaccine based on age groups and the presence/absence of hypo/asplenia.
The objective of the second sub-study is:
- Evaluate the presence and extent of the response to previous vaccinations to encapsulated bacteria.
详细描述
This is a non-profit multicenter observational study, coordinated by the Department of OncoHematology,Cell Therapy, Gene Therapies and Hematopoietic Transplantation of the Bambino Gesù Children'sHospital, IRCCS which provides for the collectionof clinical data of patients with an established diagnosis of TDT and SCD after the administration of the anti-SARS-CoV-2vaccine.
As this is a prospective study for medium-term assessments, it is expected to last no less than 18 months. The duration of the prospective observation will start from April 2021 for the duration of 12 months.
Setting
The following will be enrolled:
- for the main study patients diagnosed with TDT and SCD even if they have previously contracted SARS-CoV-2 infection;
- for the first substudy, patients with TDT and SCD diagnosis will be enrolled, divided by presence/absence of hypo/asplenia;
- for the second substudy, patients diagnosed with TDT and hypo/asplenic SCD will be enrolled.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Inclusion criteria
- •Main study and first substudy:
- •Patients with advancedTDT and SCD diagnosis, age > 18 years
- •signature of informed consent.
- •Second substudy:
- •Splenectomized patients withTDT and SCD diagnosed, age > 18 years
- •signature of informed consent.
排除标准
- •No signature informed consent.
结局指标
主要结局
Evaluate the presence and extent of the response to previous vaccinations to encapsulated bacteria.
时间窗: through study completion, an average of 1 year
Evaluate the appearance, extent, and duration of humoral response (antibodies) to the anti-SARS-CoV-2 vaccine;
时间窗: through study completion, an average of 1 year
Assess the incidence of positive cases after vaccination.
时间窗: through study completion, an average of 1 year
- Evaluate the appearance, extent and duration of cellular response (T lymphocytes and B lymphocytes) to the anti-SARS-CoV-2 vaccine based on age groups and the presence/absence of hypo/asplenia
时间窗: through study completion, an average of 1 year
次要结局
未报告次要终点