A Pilot Single Arm Study of High-Dose Influenza Vaccine Immunogenicity in Patients With Central Nervous System Tumors
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 4
- 主要终点
- Estimation of geometric mean titer (GMT) seroconversion, defined as the percentage of patients with at least a four-fold increase in hemagglutinin inhibition (HI) antibodies
研究概览
简要总结
This pilot clinical trial studies high-dose trivalent influenza vaccine in inducing immune response patients with central nervous system tumors. Studying samples of blood in the laboratory from patients receiving trivalent influenza vaccine may help doctors learn more about the effects of trivalent influenza vaccine on cells. It may also help doctors understand how well patients respond to treatment.
详细描述
PRIMARY OBJECTIVES:
I. To estimate the immunogenicity of high-dose influenza vaccination in patients with central nervous system tumors.
SECONDARY OBJECTIVES:
I. To assess the geometric mean titer (GMT) in patients after administration of high-dose influenza vaccination compared to previously determined geometric mean titer (GMT) among 38 patients receiving the standard yearly influenza vaccination.
II. To assess the seroconversion rates (i.e. four-fold rise in titer) compared to previously determined seroconversion following administration of the standard yearly influenza 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
- •Patients must have a clinical diagnosis of a primary central nervous system tumor
- •Patients must be eligible to receive the influenza vaccine
- •Patients must be willing to receive the Fluzone® high-dose seasonal influenza vaccine
- •Patients must be willing and able to sign an Institutional Review Board (IRB)-approved written informed consent document
排除标准
- •Patients unable to receive the high-dose influenza vaccine due to history of allergy to egg proteins, allergy to influenza vaccine component, acute febrile illness at the time of proposed vaccine administration, history of clinically or virologically confirmed influenza infection in the previous 6 months, contraindication to intramuscular injections, Guillain-Barré syndrome, or other contraindication to the vaccine
- •Patients who have received the 2013-2014 annual influenza vaccine prior to being considered for enrollment on this study
研究组 & 干预措施
Basic science (trivalent influenza vaccine)
Patients receive trivalent influenza vaccine on day 1.
干预措施: trivalent influenza vaccine (Biological)
Basic science (trivalent influenza vaccine)
Patients receive trivalent influenza vaccine on day 1.
干预措施: laboratory biomarker analysis (Other)
结局指标
主要结局
Estimation of geometric mean titer (GMT) seroconversion, defined as the percentage of patients with at least a four-fold increase in hemagglutinin inhibition (HI) antibodies
时间窗: Baseline
Estimation of GMT seroconversion, defined as the percentage of patients with at least a four-fold increase in HI antibodies
时间窗: Day 28
次要结局
- GMT(Up to 3 months)
- Seroconversion(Up to 3 months)
- Seroprotection rate, defined as the percentage of patients with a serum HI antibody of at least 1:40(Up to 3 months)