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Influenza Immunity Against Pandemic Respiratory Virus

Influenza Immunity: Protective Mechanisms Against a Pandemic Respiratory Virus

Sixty adults, ages 18-49, will be randomly assigned to receive either FluMist or Fluzone. Some of the subjects will have participated in previous studies for these 2 vaccines. The study will last 4 months with subject participation being 28 days. The purpose of this study is to measure immune response to the vaccinations.

研究概览

地位

完全的

条件

详细说明

This is a Phase 4, single-center, study of the immune responses of adults to one of two licensed influenza vaccines (either inactivated vaccine given IM or live, attenuated vaccine given intranasally). The study will enroll up to 60 adults, ages 18-49, some of whom were immunized in the Years 1 and 2 studies. This study began Year 1 of this grant with a protocol testing the two vaccine products in their age-approved populations. FluMist is approved for use in healthy children and adolescents, 5-17 years of age, and healthy adults 18-49 years of age. Fluzone is approved for all age groups starting at 6 months of age. To match for age and to study the youngest children possible, the age cohorts of 5-9 and 18-49 years were chosen for initial Year 1 study. In 2003, 70 adults and 16 children were enrolled, randomized 1:1 to receive either FluMist or Fluzone and immunized. In 2004, 44 of the original 70 adults were re-immunized with the same preparation they received in 2003. In addition, studies were conducted in twenty-eight 6mos to 5yo children who all received Fluzone and in thirty-nine 5-9 yo children who were randomized 1:1 to receive either FluMist or Fluzone. For 2005, we propose to study in this protocol, adults from last year who agree to a third immunization plus as many new adults to add up to a total of 60. Blood samples will also be taken at Days 0, 7-9 and 28 to be analyzed for CD4 and CD8 T-cell, B-cell, NK-cell and homing receptor responses.

研究类型

介入性

注册

60

阶段

  • 第四阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • California
      • Stanford、California、美国、94305
        • Stanford University

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 49年 (成人)

接受健康志愿者

是的

有资格学习的性别

全部

描述

Inclusion Criteria:

  1. Healthy adult, aged 18-49 years who have or have not participated in the Year 1 protocol.
  2. Willing to sign informed consent.
  3. Availability for follow-up for the planned duration of the study at least 4 weeks after immunization.
  4. Acceptable medical history by screening evaluation and brief clinical assessment.
  5. Negative urine or serum pregnancy test for women of childbearing potential.
  6. If the subject is female and of childbearing potential, she must use an acceptable contraception and not become pregnant for the duration of the study. (Acceptable contraception includes implants, injectables, combined oral contraceptives, effective intrauterine devices (IUDs), sexual abstinence, or a vasectomized partner).

Exclusion Criteria:

  1. History of immunodeficiency.
  2. Known or suspected impairment of immunologic function including, but not limited to, clinically significant liver disease; diabetes mellitus; moderate to severe kidney impairment.
  3. History of Guillain-Barré syndrome.
  4. Malignancy, other than squamous cell or basal cell skin cancer.
  5. Autoimmune disease.
  6. History of asthma or reactive airways disease.
  7. Chronic cardiovascular and pulmonary disorder.
  8. Chronic metabolic diseases (including diabetes), renal dysfunction or hemoglobinopathies requiring regular medical follow-up or hospitalization during the preceding year.
  9. Use of immunosuppressive medication. Corticosteroid nasal sprays are permissible.
  10. Medical or psychiatric condition or occupational responsibilities that preclude subject compliance with the protocol.
  11. Inactivated vaccine 14 days prior to vaccination.
  12. Live, attenuated vaccines within 60 days of study.
  13. Use of investigational agents within 30 days prior to study.
  14. Receipt of blood products or immunoglobulin in the past 6 months.
  15. Donation of the equivalent of a unit of blood within 6 weeks prior to enrollment.
  16. Acute febrile illness on the day of vaccination.
  17. Pregnant or lactating women.
  18. Known allergies to any component of the vaccine, including thimerosal.
  19. History of allergy to eggs or egg products.
  20. Any condition that, in the opinion of the investigator, might interfere with study objectives.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:预防
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

初级完成 (实际的)

2005年11月1日

研究完成 (实际的)

2006年1月1日

研究注册日期

首次提交

2005年8月26日

首先提交符合 QC 标准的

2005年8月26日

首次发布 (估计)

2005年8月30日

研究记录更新

最后更新发布 (估计)

2010年8月27日

上次提交的符合 QC 标准的更新

2010年8月26日

最后验证

2010年3月1日

更多信息

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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