Influenza Vaccine Responses in the Setting of Melanoma Treatment
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Neutralizing antibody response
研究概览
简要总结
Influenza vaccination is indicated for all adults, but the immunogenicity of vaccination has not been assessed in all situations. We are conducting a prospective unblinded study of influenza vaccine recipients.
详细描述
Influenza vaccination is indicated for all adults, but the immunogenicity of vaccination has not been assessed in all situations. In particular, immune responses following influenza vaccination have not been studied in the setting of advanced melanoma and in the context of various anti-tumor treatments. In this study, we will look at the immune response of subjects receiving vaccination.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 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
- •adults capable of providing consent
- •have a diagnosis of locally advanced or metastatic melanoma
排除标准
- •are allergic to influenza vaccination
- •have received influenza vaccination within the past 6 months
- •require prednisone, methotrexate, or other immunosuppressing medications
- •have HIV infection
- •have a history of solid organ or bone marrow transplant
- •require combination immunotherapy
- •are on other studies requiring blood draws that might exceed 450 mL total during the period of the influenza vaccine study
研究组 & 干预措施
Influenza vaccination cohort
Subjects will receive one dose of seasonal quadrivalent inactivated influenza vaccine intramuscularly for standard of care for prevention of influenza infection.
干预措施: Inactivated influenza vaccine (Biological)
结局指标
主要结局
Neutralizing antibody response
时间窗: 21-42 days
The neutralizing antibody titer will be assessed by measurement of the hemagglutinin-inhibition titer before and after influenza vaccination in order to determine the seroconversion rate. The late blood draw may occur between days 21-42 following vaccination.
次要结局
未报告次要终点