Trivalent Influenza Vaccine in Preventing Flu in Patients With Central Nervous System Tumors
A Pilot Study of Influenza Vaccine Efficacy in Patients With Central Nervous System Tumors
研究概览
详细说明
PRIMARY OBJECTIVES:
I. The primary objective of this pilot study is to assess the efficacy of influenza vaccination in patients with central nervous system tumors as defined by a four-fold increase in hemagglutinin inhibition (HI) titers from the pre-vaccination baseline.
SECONDARY OBJECTIVES:
I. A secondary objective of this pilot study is to assess the efficacy of influenza vaccination in patients with central nervous system tumors as defined by a serum post-vaccination HI titer of at least 1:40.
II. The secondary objectives of this pilot study include an assessment of the relationship between a variety of clinical factors and seroconversion following influenza vaccination.
III. Subgroup analyses will include an investigation of seroconversion and treatment (actively receiving chemotherapy, radiation therapy or both), disease status (active treatment vs long term followup), and use and dose of glucocorticoids.
TERTIARY OBJECTIVES:
I. An additional area of interest which will be further explored in this pilot study is an assessment of the relationship between serologic markers of immune function and response to vaccination.
OUTLINE:
Patients receive trivalent influenza vaccine intramuscularly (IM) on day 0.
After completion of study treatment, patients are followed up at 14 days, 21 days, and 3 and/or 6 months.
研究类型
注册 (实际的)
联系人和位置
学习地点
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North Carolina
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Winston-Salem、North Carolina、美国、27157
- Wake Forest University Health Sciences
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- 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 able to provide written informed consent
Exclusion Criteria:
- Patients unable to receive the 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, Guillan-Barré syndrome, or other contraindication to the vaccine
- Patients who have received the 2011-2012 annual influenza vaccine prior to being considered for enrollment on this study
学习计划
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
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Supportive care (vaccine therapy)
Patients receive trivalent influenza vaccine IM on day 0.
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相关研究
给定即时消息
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Efficacy of influenza vaccination in patients with central nervous system tumors as defined by a four-fold increase in HI titers from the pre-vaccination baseline
大体时间：6 months
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Seroconversion rate will be defined as the percentage of patients with at least a four-fold increase in HI antibodies between baseline and follow up.
Seroprotection rate will be defined as the percentage of patients with a serum HI antibody of at least 1:40.
The relationship between seroconversion and various clinical variables including therapy status (active vs longterm follow-up), glucorticoid dose and immune function will be measured.
Seroconversion and seroprotection rate comparisons will be made to publish normative data for the general population.
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6 months
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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Efficacy of influenza vaccination in patients with central nervous system tumors as defined by a serum post-vaccination HI titer of at least 1:40
大体时间：6 months
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6 months
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Relationship between a variety of clinical factors and seroconversion following influenza vaccination
大体时间：6 months
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6 months
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Relationship between serologic markers of immune function and response to vaccination
大体时间：6 months
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6 months
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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