COVID-19 Vaccine Response and Durability In Patients With Chronic Respiratory and Medical Disorders
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 360
- 试验地点
- 1
- 主要终点
- Antibody response
研究概览
简要总结
The investigators will assess the antibody, T cell and B cell responses to SARS-CoV-2 vaccination before and every 3 months for 18 months after the initial vaccination or subsequent vaccinations (boosters) in adults and children including patients with chronic medical conditions.
详细描述
HYPOTHESES
- Patients with chronic respiratory diseases will have a lower antibody response to SARS-CoV-2 virus after vaccination and shorter durability of the response than control subjects without chronic disorders.
- Patients on corticosteroids and other immunomodulator medications for chronic medical disorders will have a lower antibody response to SARS-CoV-2 after vaccination and shorter durability of the response than subjects with chronic disorders who are not being treated with corticosteroids and immunomodulator medications.
SPECIFIC AIMS
-
Enroll up to 1,000 patients receiving a SARS-CoV-2 vaccination (initial or subsequent vaccinations) in an observational study to determine vaccine antibody response and durability.
-
Obtain blood samples to measure antibody assess the antibody, T cell and B cell responses to SARS-CoV-2 vaccination before and every 3 months for 18 months after the initial vaccination or subsequent vaccinations (boosters) .
-
Categorize patients by their age, gender, race, ethnicity, underlying chronic disease, disease severity, medical therapy and comorbidities.
-
Assess the clinical effectiveness of the vaccine to prevent COVID-19 infections.
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
- 是
入选标准
- •Receipt of a SARS-CoV-2 vaccination
排除标准
- 未提供
研究组 & 干预措施
Interstitial lung disease
Adults and children age 5 and over.
干预措施: COVID-19 vaccine (Biological)
Cystic fibrosis
Adults and children age 5 and over.
干预措施: COVID-19 vaccine (Biological)
Previous COVID infection
Adults and children age 5 and over.
干预措施: COVID-19 vaccine (Biological)
Asthma receiving immunomodulator medications
Adults and children age 5 and over.
干预措施: COVID-19 vaccine (Biological)
Controls - who are NOT in any of the groups listed below
Adults and children age 5 and over.
干预措施: COVID-19 vaccine (Biological)
Asthma - NOT receiving immunomodulator medications or chronic oral steroids
Adults and children age 5 and over.
干预措施: COVID-19 vaccine (Biological)
Asthma receiving chronic oral steroids
Adults and children age 5 and over.
干预措施: COVID-19 vaccine (Biological)
Cancer patients receiving chemotherapy
Adults and children age 5 and over.
干预措施: COVID-19 vaccine (Biological)
Bronchiectasis
Adults and children age 5 and over.
干预措施: COVID-19 vaccine (Biological)
Chronic Obstructive Pulmonary Disease (COPD
Adults
干预措施: COVID-19 vaccine (Biological)
Rheumatoid Arthritis receiving immunomodulator medications
Adults and children age 5 and over.
干预措施: COVID-19 vaccine (Biological)
Rheumatoid Arthritis NOT receiving immunomodulator medications
Adults and children age 5 and over.
干预措施: COVID-19 vaccine (Biological)
结局指标
主要结局
Antibody response
时间窗: after SARS-CoV-2 vaccinations
quantitative spike protein antibody, binding antibody units (BAU)
次要结局
- Antibody change(Change 18 months after vaccinations)
- Antibody change(Change 3 months after vaccinations)
- Antibody change(Change 6 months after vaccinations)
- Antibody change(Change 9 months after vaccinations)
- Antibody change(Change 12 months after vaccinations)
研究者
Barry Make
Professor of Medicine
National Jewish Health