Evaluating Immune Response to COVID-19 Vaccines in Patients With Cancer, Transplant or Cellular Therapy Recipients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 5
- 主要终点
- Proportion of participants with immunogenicity following full vaccination (6 months after last dose).
研究概览
简要总结
This study is being done because the investigators would like to learn more about how well the COVID-19 vaccine works in participants with cancer or those who have received a transplant or cellular therapy.
Primary Objective
Assess the immunogenicity to COVID-19 vaccination in patients with cancer and/or transplant and cellular therapy (TCT) recipients.
Secondary Objectives
- Evaluate the antibodies response to COVID-19 vaccination in immunocompromised patients.
- Evaluate the T cell response to COVID-19 vaccination in immunocompromised patients.
Exploratory Objectives
- Assess incidence and severity of COVID-19 infections by 6 months following immunization with a SARS CoV-2 vaccine.
- Assess the durability immune response to COVID-19 vaccination.
- Assess the immunogenicity of COVID-19 vaccination in immunocompetent children and adolescents without cancer and have not undergone transplant or received cellular therapy.
详细描述
The investigator will collect a blood sample (about 1 teaspoon each time) from the participant when the participant receive the COVID-19 vaccine(s) as well as an additional blood samples 6 months after the last COVID-19 vaccine.
The participant will be on the study for about 6 months after the last vaccine. After the six-month blood sample is collected, the participant will be off study.
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
- — 至 24 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient receiving care at St. Jude Children's Hospital or Le Bonheur Children's Hospital
- •Less than 24 years old at the time of enrollment (Day 0)
- •Planning to receive a COVID-19 vaccine as part of clinical care
- •Patient is one of the following:
- •Diagnosed with a Hematological Malignancy (Group A), or
- •Received a hematopoietic cell transplant or cellular therapy (Group B), or
- •Diagnosed with a solid tumor malignancy (Group C).
- •Received a solid organ transplant (Group D), or
- •Does not have cancer and has not received any type of transplant (Group E)
- •Willing and able to provide informed consent
排除标准
- •Received a COVID-19 vaccine prior to enrollment (Day 0).
结局指标
主要结局
Proportion of participants with immunogenicity following full vaccination (6 months after last dose).
时间窗: 6 months after the last vaccine dose
The primary endpoint is immunogenicity response following full vaccination measured at 6 months after the last vaccine dose. Immunogenicity is defined as a ≥4-fold rise in the GMT of SARS-CoV-2 binding antibody to the spike protein RBD compared to the pre-vaccine baseline level or from a non-detectable GMT at the baseline to a detectable GMT after fully vaccinated. The proportion of participants with immunogenicity following full vaccination (6 months after last dose) will be described for all enrolled patients and for each disease stratum with 95% CIs. Only patients who provide a viable blood sample to evaluate immunogenicity at these time-points following completion of vaccine series will be included in this estimation.
次要结局
- Mean and median T cell response to COVID-19 vaccination in immunocompromised patients at day 0, second dose, third dose and post last dose (day 180).(6 months after the last vaccine dose)
- Mean and median antibodies response to COVID-19 vaccination in immunocompromised patients at day 0, second dose, third dose, post last dose (day 180).(6 months after the last vaccine dose)