An observational study in Pregnancy Immune Function, sponsored by National Institute of Allergy and Infectious Diseases (NIAID). Completed at 1 site in United States. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2019-10-18.
Sponsored by National Institute of Allergy and Infectious Diseases (NIAID) · Observational
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.
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.
National Institute of Allergy and Infectious Diseases (NIAID) is the lead sponsor of 2,401 studies on the registry; 179 are open to participants now.
Of its 396 completed or terminated interventional studies of FDA-regulated products, 294 (74%) have results posted.
Counted across the registry records on this site, refreshed daily.
All pregnant study subjects must:
Up to twenty pregnant subjects who agree to receive the seasonal influenza vaccine must:
EXCLUSION CRITIERIA:
A subject will be excluded if she:
pregnant women that choose to receive the seasonal flu vaccine
pregnant women that do not receive the flu vaccine
Changes in lymphocyte and NK cell populations during pregnancy compared to non-pregnant control samples.
Changes in lymphocyte and NK cell populations during pregnancy compared to non- pregnant control samples. \[Time Frame: 1st, 2nd, and 3rd trimesters and postpartum and postpartum\]
Time frame: 1st, 2nd, and 3rd trimesters and postpartum and postpartum
Changes in Cytokine profiles during pregnancy
Changes in Cytokine profiles during pregnancy compared to non-pregnant control samples
Time frame: 1st, 2nd, and 3rd trimesters and postpartum and postpartum
Functionality of Toll-like receptors and changes in gene expression
Functionality of Toll-like receptors and changes in gene expression during pregnancy during pregnancy compared to non-pregnant control samples \[Time Frame: 1st, 2nd, and 3rd trimesters and postpartum\]
Time frame: 1st, 2nd, and 3rd trimesters and postpartum and postpartum
Functionality of Toll-like receptors and changes in gene expression
Functionality of Toll-like receptors and changes in gene expression during pregnancy during pregnancy compared to non-pregnant control samples, in a subset of pregnant women \[Time Frame: Before and after the administration of the influenza vaccine in a subset of pregnant women\]
Time frame: Before and after the administration of the influenza vaccine in a subset of pregnant women
Changes in lymphocyte and INK cell populations
Changes in lymphocyte and INK cell populations during pregnancy compared to non-pregnant control samples, in a subset of pregnant women \[Time Frame: Before and after the administration of the influenza vaccine in a subset of pregnant women\]
Time frame: Before and after the administration of the influenza vaccine in a subset of pregnant women
Changes in Cytokine profiles
Changes in Cytokine profiles during pregnancy compared to non-pregnant control samples, in a subset of pregnant women \[Time Frame: Before and after the administration of the influenza vaccine in a subset of pregnant women\]
Time frame: Before and after the administration of the influenza vaccine in a subset of pregnant women
This study is completed, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.
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National Institute of Allergy and Infectious Diseases (NIAID)