Efficacy and Safety of COVID-19 Vaccine in Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 89
- 试验地点
- 1
- 主要终点
- Antibody response to COVID-19 vaccine after vaccination in cancer patients and health individuals
研究概览
简要总结
This study gathers information about how a cancer patient responds to COVID-19 vaccine during cancer treatment compared to healthy individuals. The information gained may help determine how effective currently available COVID-19 vaccines are in cancer patients receiving chemotherapy and learn more regarding how long an immune response will last compared to healthy individuals.
详细描述
PRIMARY OBJECTIVES:
I. To determine the antibody response to COVID-19 vaccine after vaccination. II. To assess the adverse events of COVID-19 vaccines in cancer patients. III. To determine the incidence and severity of COVID-19 infection after the vaccination.
OUTLINE:
Patients undergo blood sample collection at baseline (prior to first COVID-19 vaccination), prior to second vaccination, 1, 6, and 12 months after the last vaccination. Patients receiving a booster vaccine will undergo blood collection prior to and 1-3 months after vaccination. Patients who receive the types of COVID-19 vaccines that do not require the second injection skip blood sample collection at this time point. This study will collect information regarding the type of COVID-19 vaccine received, date of vaccine injection, and any side effects associated with the COVID-19 vaccine that trial participant encountered. This study will also review the medical record for outcomes and information related to the blood testing.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Other
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
- •Willing to receive COVID-19 vaccination as per standard of care or has already received one or both COVID-19 vaccine injections as long as it has not been longer than three months since their second injection (or the only injection if they receive the types of COVID019 vaccines that do not require the second injection)
- •Willing and able to provide research blood samples
- •Capable of providing valid informed consent
- •For cancer patient cohort:
- •Male or female age >= 18 years
- •Histologically confirmed solid malignancy on or will be starting on systemic cytotoxic chemotherapy
- •For healthy individual cohort:
- •Male or female age >= 18 years
- •No history of active malignancy =< 3 years
- •EXCEPTIONS: Adequately treated non-melanotic skin cancer (adequate wound healing is required prior to study entry) or carcinoma-in-situ of the cervix
- •NOTE: If there is a history of prior solid tumor malignancy, it must have been treated curatively with no evidence of recurrence =< 3 years
- •PATIENTS WITH PREVIOUS COVID-19 INFECTION: Willing and able to provide research blood samples
- •PATIENTS WITH PREVIOUS COVID-19 INFECTION: Capable of providing valid informed consent
- •PATIENTS WITH PREVIOUS COVID-19 INFECTION: Male or female age >= 18 years
- •PATIENTS WITH PREVIOUS COVID-19 INFECTION: Previous history of COVID-19 infection with positive SARS-CoV-2 ribonucleic acid (RNA) by polymerase chain reaction (PCR) or anti-SARS-CoV-2 nucleocapsid antibody
排除标准
- •Immunocompromised patients including patients known to be human immunodeficiency virus (HIV) positive or those on immunosuppressive therapy other than chemotherapy in the judgment of the investigator
结局指标
主要结局
Antibody response to COVID-19 vaccine after vaccination in cancer patients and health individuals
时间窗: Up to 12 months
Wilcoxon rank sum test will be used to compare between baseline and other 3 time points (before the second vaccination, 3 months, and 12 months after the second vaccination).
次要结局
- Adverse events of COVID-19 vaccines in cancer patients and health individuals(Up to 12 months)
- T cell response to COVID-19 vaccine after vaccination in cancer patients and health individuals(Up to 12 months)