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临床试验/NCT00769002
NCT00769002终止不适用

Impact of Bilateral Priming on Response to Unilateral Flu Vaccination

Hackensack Meridian Health1 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2008年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
入组人数
18
试验地点
1
主要终点
PET Scan AB Response

研究概览

简要总结

This study is being done to learn how previous flu vaccination or previous infection with flu virus affects the immune response to vaccination.

详细描述

Until recently, all recipients of influenza vaccine received a killed form of virus, typically in the same nondominant arm, each year before flu season. We hypothesize that natural infection, and some forms of vaccination, could allow vaccine induced responses to spread beyond the local lymph nodes near the vaccination site. From a practical perspective, if vaccine induced proliferation of specific immune cells in sites distant from the vaccination site lead to beneficial immune memory, it would suggest vaccination strategies that could be as simple as alternating the injected arm from year to year, or alternating inhaled vs. injected forms of vaccine.

This will be a 4 armed prospective study of individuals receiving unilateral FluShield i.m. Healthy adult volunteers 21-55 will be grouped according to the following criteria: I. Documented history of prior natural infection with influenza A or B within the past 5 years (diagnostic test or high titer hemagglutinin HA Ab in absence of vaccination); II. History of FluMist vaccination within the past 2 years; III. History of TIV (Trivalent (Inactivated) Influenza Vaccine) vaccination, any number of times, but only in a single (e.g., non-dominant) arm. Within one month of screening and baseline blood draws for PBMCs (Peripheral blood mononuclear cells) and Ab (antibody) titers, individuals will receive FluShield injections. For those individuals with prior history of unilateral TIV injections, half will receive their shots in the same arm that has always been injected (Group IIIa). The other half of these individuals will receive Flushield in the opposite (dominant) arm (Group IIIb).

Upon entering the study, 50cc of heparinized blood and 10 cc of serum will be drawn by antecubital venipuncture. Within 4 weeks of this blood draw, volunteers will receive a standard dose of i.m. TIV (FluShield). Four-seven days later they will have an FDG PET-CT scan performed after an 8 hour fast.

Additional blood draws of 50cc heparinized blood and 10 cc serum will be obtained at 2, 4, and 6 weeks post vaccination, and at 10-12 months post vaccination. After the last blood draw, volunteers will also be asked questions pertaining to flu-like symptoms during the past 10 months.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
21 Years 至 55 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Men and women 21-55 years old.
  • •Willingness to participate in the study for a full year including multiple blood draws and PET-CT scanning

排除标准

  • •Use of systemic steroids
  • •Pregnancy or unwillingness to practice birth control of some kind through the PET-CT scanning period
  • •Recent vaccination for other reasons (e.g., traveler's vaccines)
  • •Significant intercurrent illness that might interfere with vaccination "take" or interpretation of PET-CT scanning (e.g., chemotherapy for cancer)

研究组 & 干预措施

FluMist

Active Comparator

prior FluMist vaccinated.

干预措施: FluShield (Biological)

FluMist

Active Comparator

prior FluMist vaccinated.

干预措施: Blood Draws (Procedure)

FluMist

Active Comparator

prior FluMist vaccinated.

干预措施: FDG PET-CT Scan (Procedure)

FluShield - influenza positivity2

Active Comparator

prior FluShield contralateral vaccinated

干预措施: Cytokine Profiling (Genetic)

FluShield - influenza positivity2

Active Comparator

prior FluShield contralateral vaccinated

干预措施: Blood Draws (Procedure)

FluShield - influenza positivity2

Active Comparator

prior FluShield contralateral vaccinated

干预措施: FDG PET-CT Scan (Procedure)

Natural Infection

Active Comparator

previously naturally infected

干预措施: FluShield (Biological)

Natural Infection

Active Comparator

previously naturally infected

干预措施: Blood Draws (Procedure)

Natural Infection

Active Comparator

previously naturally infected

干预措施: FDG PET-CT Scan (Procedure)

Natural Infection

Active Comparator

previously naturally infected

干预措施: Cytokine Profiling (Genetic)

FluShield - influenza positivity

Active Comparator

prior FluShield ipsilateral vaccinated

干预措施: FluShield (Biological)

FluShield - influenza positivity

Active Comparator

prior FluShield ipsilateral vaccinated

干预措施: FluShield - same arm (Biological)

FluShield - influenza positivity

Active Comparator

prior FluShield ipsilateral vaccinated

干预措施: Blood Draws (Procedure)

FluShield - influenza positivity

Active Comparator

prior FluShield ipsilateral vaccinated

干预措施: FDG PET-CT Scan (Procedure)

FluShield - influenza positivity

Active Comparator

prior FluShield ipsilateral vaccinated

干预措施: Cytokine Profiling (Genetic)

FluShield - influenza positivity2

Active Comparator

prior FluShield contralateral vaccinated

干预措施: FluShield (Biological)

FluShield - influenza positivity2

Active Comparator

prior FluShield contralateral vaccinated

干预措施: FluShield - opposite arm (Biological)

FluMist

Active Comparator

prior FluMist vaccinated.

干预措施: Cytokine Profiling (Genetic)

结局指标

主要结局

PET Scan AB Response

时间窗: 4-7 days

Natural infection but not ipsilateral IM injection of FluShield, will prime the host for a specific activation of spleen and bilateral lymph nodes following a subsequent i.m injection of FluShield, as detected by PET-CT performed 4-7 days post- FluShield immunization.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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