Sponsor study identifier
Secondary identifiers
observational
41
1 country
1
Study Start
September 30, 2011
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
Not reported
Date not reportedStudy Completion
October 11, 2019
Date type not reportedThis date has not been verified as actual or estimated.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 11, 2019
Date type not reportedThis date has not been verified as actual or estimated.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 11, 2010
Actual (reported)September 14, 2010
Actual (reported)September 30, 2011
Date type not reportedThis date has not been verified as actual or estimated.
October 11, 2019
Date type not reportedThis date has not been verified as actual or estimated.
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. \[Time Frame: 1st, 2nd, and 3rd trimesters and postpartum and postpartum\]
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
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 \[Time Frame: 1st, 2nd, and 3rd trimesters and postpartum\]
1st, 2nd, and 3rd trimesters and postpartum and postpartum
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
Changes in lymphocyte and INK cell populations
Before and after the administration of the influenza vaccine in a subset of pregnant women
Changes in Cytokine profiles
Before and after the administration of the influenza vaccine in a subset of pregnant women
pregnant women that choose to receive the seasonal flu vaccine
pregnant women that do not receive the flu vaccine
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892, United States
Pejcic-Karapetrovic B, Gurnani K, Russell MS, Finlay BB, Sad S, Krishnan L. Pregnancy impairs the innate immune resistance to Salmonella typhimurium leading to rapid fatal infection. J Immunol. 2007 Nov 1;179(9):6088-96. doi: 10.4049/jimmunol.179.9.6088.
Luppi P. How immune mechanisms are affected by pregnancy. Vaccine. 2003 Jul 28;21(24):3352-7. doi: 10.1016/s0264-410x(03)00331-1.
Zhao J, Lei Z, Liu Y, Li B, Zhang L, Fang H, Song C, Wang X, Zhang GM, Feng ZH, Huang B. Human pregnancy up-regulates Tim-3 in innate immune cells for systemic immunity. J Immunol. 2009 May 15;182(10):6618-24. doi: 10.4049/jimmunol.0803876.
Christa S Zerbe, M.D.
National Institute of Allergy and Infectious Diseases (NIAID)
41 participants (actual enrollment reported by the registry).
First Submitted
September 11, 2010
First Posted
September 14, 2010
Study Start
September 30, 2011
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Study Completion
October 11, 2019
Date type not reportedThis date has not been verified as actual or estimated.
Last Updated
October 18, 2019
Record last verified: 2019-10-11
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Source: ClinicalTrials.gov.
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