Study of High-dose Influenza Vaccine Efficacy by Repeated Dosing IN Gammopathy Patients (SHIVERING Trial)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- Rate of Disease Control
研究概览
简要总结
A Pilot Study utilizing high dose trivalent influenza vaccine dose in a booster dosing schedule for patients with monoclonal gammopathies stratified by disease status
详细描述
In this study, we will administer Fluzone® High-Dose vaccine with a planned booster to patients with monoclonal gammopathies (stratified by requirement for therapy) irrespective of age. All patients will receive an initial vaccine followed by a booster vaccine 30 days (+/- 7 days) later and will then be followed for outcomes until the end of flu season.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Understand and voluntarily sign an informed consent document
- •Age >= 18 years at the time of signing the informed consent form
- •Diagnosis of any monoclonal gammopathy; Monoclonal Gammopathy of Undetermined Significance (MGUS), asymptomatic/ active multiple myeloma, asymptomatic / active Waldenstrom Macroglobulinemia (WM)
排除标准
- •An serious egg allergy or prior serious adverse reaction to an influenza vaccine
- •Use of any other influenza vaccine for the 2014 to 2015 flu season
- •Women who are pregnant or plan to become pregnant in the study period
研究组 & 干预措施
Early Disease
Patients not requiring anti-tumor therapy
干预措施: Fluzone (Drug)
Disease Requiring Anti-tumor therapy
Patients that have disease requiring anti-tumor therapy at any time
干预措施: Fluzone (Drug)
结局指标
主要结局
Rate of Disease Control
时间窗: up to 10 months
Lack of disease progression requiring therapy as measured by International Myeloma Working Group criteria
次要结局
- Influenza related morbidity rate(up to 10 months)
- Serologic Protection Rate after initial vaccine(30 days post booster)
- T cell response(30 day post booster)