Response to Influenza Vaccination in Pediatric Oncology Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Proportion of participants with immunogenicity 3 to 5 weeks following vaccination.
研究概览
简要总结
Influenza infection occurring during oncologic treatment or following hematopoietic cell transplantation (HCT) is associated with increased risk of morbidity in the form of lower respiratory tract infection (LRTI) and mortality relative to otherwise healthy patients. The study participants have been diagnosed with a hematological malignancy and are eligible to receive the current seasonal influenza (Flu) vaccine.
Primary Objective
- To determine the feasibility of opening a longitudinal prospective study of IIV immunogenicity in pediatric leukemia patients.
- To describe the immunogenicity, as measured by the development of cell- and/or antibody-mediated influenza specific responses 3 to 5 weeks following vaccination, in a cohort of pediatric leukemia patients.
Secondary Objectives
- To describe whether an immune response, as measured by development of cell- and/or antibody-mediated influenza specific responses, is detectable 1-2 weeks following vaccination in a cohort of pediatric leukemia patients.
- To describe the durability of immunogenicity by measuring cell - and antibody- mediated influenza specific responses at 6 months and 1 year following vaccination in a cohort of pediatric leukemia patients.
Exploratory Objectives
- To estimate the clinical effectiveness of influenza vaccine in this cohort by monitoring for the development of clinical diagnosis of influenza in the cohort of enrolled pediatric oncology patients.
- To correlate results of immune cell frequency in blood, as measured by complete blood count with differential, with development of an immune response to IIV.
详细描述
This is a prospective, 2-stage, non-therapeutic study to characterize the immunogenicity of influenza vaccination among pediatric oncology patients at St. Jude. The first stage of the study will consist of a feasibility phase to assess the feasibility of opening a longitudinal prospective study of IIV immunogenicity in pediatric leukemia patients. The second stage will assess the immunogenicity of IIV among pediatric leukemia patients in a larger samples size. The investigator will collect about one teaspoon of blood from the study participant up to 6 times over a year for a total of 6 teaspoons a year. The investigator will also collect some information about the study participant's underlying condition, flu testing and overall health from the medical record during this time.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient ≤ 18 years old at the time of consent receiving care at St. Jude Children's Research Hospital
- •Diagnosed with a hematological malignancy
- •Eligible to receive the current seasonal influenza vaccine
排除标准
- •Previously received at least one dose of the current seasonal influenza vaccine.
研究组 & 干预措施
Pediatric Influenza Vaccine Recipients
Pediatric patients eligible to receive seasonal influenza vaccine.
结局指标
主要结局
Proportion of participants with immunogenicity 3 to 5 weeks following vaccination.
时间窗: 3 years
Immunogenecity will be measured by the development of cell- and antibody-mediated influenza specific responses 3 to 5 weeks following vaccination. Immunogenicity is estimated as the proportion of evaluable patients whose cell- (as measured by development of any detectable specific T cell responses) and antibody-mediated influenza specific responses (as measured by detectable post vaccination antibody titers) 3 to 5 weeks following vaccination. 95% confidence intervals will be provided.
Proportion of evaluable participants.
时间窗: 3 years
Feasibility is estimated as the proportion of evaluable patients who provide a baseline and Day +35 sample. A 95% confidence interval will be provided.
次要结局
- Proportion of participants with an immune response 1 to 2 weeks following vaccination.(3 years)
- Proportion of participants with durability of immunogenicity at 6 months and 1 year post-vaccination.(3 years)