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临床试验/NCT01200979
NCT01200979已完成不适用

Assessment of Alterations in Immune Function During Pregnancy and Post Parturition

National Institute of Allergy and Infectious Diseases (NIAID)1 个研究点 分布在 1 个国家目标入组 41 人开始时间: 2011年9月30日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
41
试验地点
1
主要终点
Changes in Cytokine profiles during pregnancy

研究概览

简要总结

Traditionally, it has been suggested that pregnancy causes an immunosuppressive state that would facilitate fetal tolerance and result in an increased susceptibility to infection. Although the suppression has been characterized as a global T-cell defect, the observation that the increase in susceptibility is restricted only to specific intracellular bacteria and viruses is consistent with a down regulation of only certain components of the innate immune system. Progress in the treatment and management of infections during pregnancy will require further understanding of the changes to the immune system that occur during pregnancy. It is hypothesized that there is a fundamental down-regulation in the innate immune system that occurs during pregnancy and remains until delivery and that changes in serum cytokines influence na(SqrRoot) ve CD4 differentiation to different subpopulations. To that end, this study will evaluate blood samples drawn from pregnant women during early, mid, and late pregnancy and post-partum for changes in the innate immune system and compare them to those of healthy, non-pregnant women. Changes in the cytokine profile and in the lymphocyte and natural killer (NK) cell populations will be identified. A comparison of any observed changes will be made with those previously reported for in vitro and in vivo studies.

详细描述

Traditionally, it has been suggested that pregnancy causes an immunosuppressive state that would facilitate fetal tolerance and result in an increased susceptibility to infection. Although the suppression has been characterized as a global T-cell defect, the observation that the increase in susceptibility is restricted only to specific intracellular bacteria and viruses is consistent with a down regulation of only certain components of the innate immune system. Progress in the treatment and management of infections during pregnancy will require further understanding of the changes to the immune system that occur during pregnancy. It is hypothesized that there is a fundamental down-regulation in the innate immune system that occurs during pregnancy and remains until delivery and that changes in serum cytokines influence na(SqrRoot) ve CD4 differentiation to different subpopulations. To that end, this study will evaluate blood samples drawn from pregnant women during early, mid, and late pregnancy and post-partum for changes in the innate immune system and compare them to data on a similar cohort of women of childbearing age from an existing database of healthy, non-pregnant women. Changes in the cytokine profile, gene expression by microarray, and in the lymphocyte and natural killer (NK) cell populations will be identified. We may perform neutrophil analysis. We will evaluate toll-like receptors functionality, and any changes in PBMC throughout pregnancy.

We also plan to evaluate serum cytokine panels, PBMC by flow cytometry, and PBMC for microarray of gene expression, before and after administration of the influenza vaccine in up to 20 of the 40 pregnant subjects. Antibody levels will be measured as well.

A comparison of any observed changes will be made with those previously reported for in vitro and in vivo studies.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Changes in Cytokine profiles during pregnancy

时间窗: 1st, 2nd, and 3rd trimesters and postpartum and postpartum

Changes in Cytokine profiles during pregnancy compared to non-pregnant control samples

Functionality of Toll-like receptors and changes in gene expression

时间窗: 1st, 2nd, and 3rd trimesters and postpartum and postpartum

Functionality of Toll-like receptors and changes in gene expression during pregnancy during pregnancy compared to non-pregnant control samples \[Time Frame: 1st, 2nd, and 3rd trimesters and postpartum\]

Changes in lymphocyte and NK cell populations during pregnancy compared to non-pregnant control samples.

时间窗: 1st, 2nd, and 3rd trimesters and postpartum and postpartum

Changes in lymphocyte and NK cell populations during pregnancy compared to non- pregnant control samples. \[Time Frame: 1st, 2nd, and 3rd trimesters and postpartum and postpartum\]

次要结局

  • Changes in Cytokine profiles(Before and after the administration of the influenza vaccine in a subset of pregnant women)
  • Changes in lymphocyte and INK cell populations(Before and after the administration of the influenza vaccine in a subset of pregnant women)
  • Functionality of Toll-like receptors and changes in gene expression(Before and after the administration of the influenza vaccine in a subset of pregnant women)

研究者

申办方类型
Nih
责任方
Sponsor

研究点 (1)

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