Serologic Response to the SARS-CoV-2 MRNA-1273 Vaccine in Select Subsets of Oncology Patients - a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Immunological response to the vaccine
研究概览
简要总结
To explore the immune response to the COVID-19 vaccine in cancer patients and compare to the general population.
详细描述
The purpose of this study is to measure the immune response to the COVID-19 vaccine in cancer patients and compare to the general population. This information can help optimize the timing of the mRNA-1273 vaccine relative to starting treatment for cancer, adding booster immunizations or incorporation of medications that to enhance the immune response.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects are between 50 and 75 years of age;
- •Have not had known or suspected infection with SARS-CoV-2 at any time;
- •Subjects must fall into one of the following subsets of cancer patients:
- •Localized prostate cancer on radiotherapy or have completed radiotherapy in the last three months
- •Prostate cancer on androgen-deprivation therapy for biochemical recurrence
- •Colon cancer on adjuvant chemotherapy for stage III disease
- •CLL on a BTK inhibitor as a first-line single agent for at least 3 months
- •Melanoma patients on adjuvant immunotherapy with PD-1 checkpoint inhibitors for at least 3 months
- •Have received both doses of SARS-CoV-2 mRNA-1273 vaccine with proof of vaccination or are scheduled to do so;
- •Have at least a one-year life expectancy;
- •Prior radiation therapy is allowed, as long as it was completed more than 6 months prior to vaccination
排除标准
- •Subjects have a known hypersensitivity to a vaccine component;
- •Have had known or suspected infection with SARS-CoV-2 at any time;
- •Are organ transplant recipient on immunosuppression;
- •Had received or are scheduled to receive a live virus vaccine in the period from 4 weeks prior to Dose 1 through 28 days post second dose;
- •Had received or are scheduled to receive an inactivated vaccine in the period ranging from 7 days prior to Dose 1 through 7 days post second dose;
- •Received high-dose corticosteroids at any time after receiving the vaccine;
- •Are unable to give informed consent;
- •Are receiving treatment for CLL with another agent (such as rituximab) in addition to a BTK inhibitor
结局指标
主要结局
Immunological response to the vaccine
时间窗: 1 year
Vaccine response, as determined by blood concentrations of serum IgG reactive to the RBD domain of spike protein from the original SARS-CoV-2 virus will be measured by ELISA
次要结局
未报告次要终点
研究者
Deepak Sahasrabudhe
Professor - Department of Medicine , Hematology/Oncology (SMD)
University of Rochester