Prospective Cohort Study to Evaluate Immunologic Response Following COVID-19 Vaccination in Children, Adolescents and Young Adults With Cancer
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 549
- 试验地点
- 124
- 主要终点
- Seroprevalence of SARS-CoV-2-specific protective antibodies
研究概览
简要总结
This study evaluates immunologic response following COVID-19 vaccination in children, adolescents, and young adults with cancer. Vaccines work by stimulating the body's immune cells to respond against a specific disease. The immune response produces protection from that disease. Effects from cancer and from treatments for cancer can reduce the body's natural disease fighting ability (called immunity). Factors such as vaccine type, timing of vaccine dosing related to treatment for cancer and number of vaccine doses or "boosts" (extra vaccine shots) may strengthen or diminish the body's protective immune response. This study may help researchers learn more about how the body's immune system responds to the COVID-19 vaccine when the vaccination is given during or after cancer treatment.
详细描述
PRIMARY OBJECTIVE:
I. Characterize the immunologic response following severe acute respiratory syndrome (SARS)-coronavirus (CoV)-2 vaccination in children, adolescents, and young adults with cancer who are currently receiving or who recently completed treatment with immunosuppressive therapy.
EXPLORATORY OBJECTIVES:
I. Describe the rate of post-vaccination symptomatic SARS-CoV-2 infections. II. Assess the durability of immune response to SARS-CoV-2 vaccine over 2 years.
III. Describe the longer-term impacts of vaccine immune response including subsequent COVID-19-related serious illness.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
入排标准
- 年龄范围
- 6 Months 至 37 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •>= 6 months and =< 37 years of age at time of enrollment
- •Patient plans to receive their first COVID-19 vaccine dose one of the food and drug administration (FDA) approved/FDA-emergency use authorization (EUA) approved COVID-19 vaccines OR patient already received their first COVID-19 vaccine dose =< 24 months prior to enrollment using one of the FDA approved/FDA-EUA approved COVID-19 vaccines.
- •Note: for this observational study, the decision to vaccinate is according to local discretion and should be made prior to consideration of enrollment
- •Must have a diagnosis of cancer
- •Patient must be undergoing or have previously received one of the following cancer treatments within 12 months before their first COVID-19 vaccine dose:
- •Dosing with chemotherapy or immunotherapy agent, including tyrosine kinase inhibitors and small molecule inhibitors targeting cancer
- •Dosing with monoclonal antibodies targeting B-cell antigens (e.g., Rituximab), or Bruton tyrosine kinase inhibitors or Janus Kinase inhibitors
- •Stem cell infusion for bone marrow transplant or CAR-T infusion for cellular therapy
- •A patient enrolling prior to their first COVID-19 vaccine dose is eligible only if it is feasible to collect required baseline study specimens within protocol mandated time period prior to the initial COVID-19 vaccine dose; or a patient who already received a COVID-19 vaccine is eligible only if feasible to collect at least one post-first-dose follow-up specimen (i.e., at minimum, collection of the 24m PFD follow-up specimen must be feasible as per timing requirements
- •Note: for this observational study, the vaccine timing and regimen will proceed according to local discretion. Patients enrolled prior to their first COVID-19 vaccine dose who do not receive initial vaccine dose within 3 months after enrollment will be taken off study
- •All patients and/or their parents or legal guardians must sign a written informed consent
- •All institutional, FDA, and National Cancer Institute (NCI) requirements for human studies must be met
排除标准
- •Documented SARS-CoV-2 monoclonal antibody infusion or convalescent plasma after COVID-19 infection within last 90 days
- •Note: patients with previous COVID-19 infection are eligible as long as requirements are met. Patients receiving intravenous immunoglobulin therapy (IVIG) therapy (i.e., post bone marrow transplantation [BMT] or chimeric antigen receptor [CAR]-T) are eligible
- •Patients undergoing radiation therapy only are ineligible
- •Reminder: before the planned initial COVID-19 vaccine dose, patient must be undergoing or have received cancer treatments
研究组 & 干预措施
Observational (survey, biospecimen collection)
Patients receive COVID-19 vaccine per standard of care. Patients also complete a survey at 1 month and undergo collection of blood samples at 1, 3, 6, 12, 18, and 24 months. Patients may complete an additional survey at 1 month after each vaccine boost and undergo collection of blood samples before each vaccine boost, 1 month after each vaccine boost, and at the time of COVID-19 infection.
干预措施: Biospecimen Collection (Procedure)
Observational (survey, biospecimen collection)
Patients receive COVID-19 vaccine per standard of care. Patients also complete a survey at 1 month and undergo collection of blood samples at 1, 3, 6, 12, 18, and 24 months. Patients may complete an additional survey at 1 month after each vaccine boost and undergo collection of blood samples before each vaccine boost, 1 month after each vaccine boost, and at the time of COVID-19 infection.
干预措施: Survey Administration (Other)
结局指标
主要结局
Seroprevalence of SARS-CoV-2-specific protective antibodies
时间窗: 24 months following initial vaccination with a protocol-approved COVID-19 vaccine
Will report the proportion of patients with a serologic response to a protocol-approved COVID-19 vaccine, captured using a test for SARS-CoV-2-specific antibodies via immunoassay, and will report a corresponding 95% confidence interval.
次要结局
未报告次要终点