Antibodies Production After Covid-19 Vaccination Among Patients With Medical History of Cancer and Anti-CD-20 Treatment
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Primary Objective
研究概览
简要总结
This is a Phase II study designed to investigate if the Covid 19 vaccines are capable of eliciting production of antibodies against S protein of Sar-S-Cov-2 virus among patients with medical history of cancer previously treated with monoclonal anti CD-20 antibodies. The antibody production is defined based on the detection of antibodies in the serologic Covid-19 rapid test against S protein or with semiquantitative assay when it becomes available.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients either diagnosed with cancer or with HIV positivity or treated with an antineoplastic regimen including anti CD-20 after Covid-19 vaccine will be registered on the study regardless of their type of cancer or type of antineoplastic regimen.
- •Patients 21 years or older diagnosed with cancer treated with antineoplastic regimen or anti CD-20, or with HIV infection vaccinated with 2 doses of anti Covid-19 vaccine.
- •Eligible patients will be registered on study after a Covid -19 vaccine has been scheduled.
- •In order to be screened for Covid 19 antibodies, they must be tested at least two weeks after the second dose of Covid-19 vaccination.
排除标准
- •Anyone who has not been treated with anti-CD20 antibodies or with chemotherapy who doesn't have HIV infection or who has not received chemotherapy for cancer.
结局指标
主要结局
Primary Objective
时间窗: Two weeks after full dose vaccination.
To determine if patients with cancer history or HIV positivity previously treated with monoclonal anti CD-20 are able to produce antibodies after Covid-19 vaccination. a. Antibody Production defined as: 1. Positive serologic Covid-19 antibodies rapid test against S protein.
次要结局
- Secondary objective 1(Two weeks after full dose vaccination.)
- Secondary objective 2(Two weeks after full dose vaccination.)
研究者
Fernando Cabanillas
Fernando Cabanillas, MD
Auxilio Mutuo Cancer Center