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临床试验/NCT00371878
NCT00371878已完成4 期

Open Label Study of Lung and Serum Immunoglobulin Responses to 7-Valent Pneumococcal Conjugate Vaccine in HIV Infected and Non-HIV Infected Malawian Adults

Royal Liverpool University Hospital2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2003年2月最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
入组人数
40
试验地点
2
主要终点
Immunoglobulin titres in bronchoalveolar fluid

研究概览

简要总结

Lung immune responses are regulated independently of systemic responses. Injected vaccines may induce optimal responses in blood but not at mucosal surfaces. We compared the responses in serum and lung fluid to injected pneumococcal conjugate vaccine.

详细描述

We tested the hypothesis that conjugate vaccine offered less protection against pneumonia due to a reduced mucosal response compared to serum. We further hypothesized that this response would be further compromised with HIV co-infection[32] due to lack of local CD4 lymphocyte support and an altered alveolar milieu. We measured pneumococcal capsular specific immunoglobulin responses to 7-valent conjugate vaccine in both lung fluid and serum from healthy HIV infected and uninfected volunteers, together with flow cytometric assessment of the relative numbers and phenotypes of BAL T lymphocyte, B lymphocyte and macrophages.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
17 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • healthy volunteer adults

排除标准

  • pregnant, recent illness, previous vaccination, asthma

结局指标

主要结局

Immunoglobulin titres in bronchoalveolar fluid

次要结局

  • Immunoglobulin titres in serum
  • Lung lymphocyte phenotype
  • HIV viral load

研究者

申办方类型
Other Gov

研究点 (2)

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