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Assessment of Alterations in Immune Function During Pregnancy and Post Parturition

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.

Přehled studie

Postavení

Dokončeno

Detailní popis

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.

Typ studie

Pozorovací

Zápis (Aktuální)

41

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

    • Maryland
      • Bethesda, Maryland, Spojené státy, 20892
        • National Institutes of Health Clinical Center, 9000 Rockville Pike

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let až 45 let (Dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Ženský

Popis

  • INCLUSION CRITERIA:

All pregnant study subjects must:

  • Be between the ages of 18-45 years old.
  • Have a positive pregnancy test (urine).
  • Be of an estimated gestational age of between 10 and 20 weeks either by ultrasound or LMP.
  • Have an identified primary care provider for the pregnancy.
  • Be willing to sign the collaborative study consent form from CHI.
  • Be willing to have samples collected and stored for future research and immunological studies
  • Be willing to sign the collaborative study consent form for normal volunteers from CHI

Up to twenty pregnant subjects who agree to receive the seasonal influenza vaccine must:

  • Have no history of allergic reaction to the vaccine or its contents
  • Not have received the vaccine from other providers this flu season
  • Agree to have an additional 20cc of blood drawn at both Day +1 and Day +7 post-vaccine for immune analysis.

EXCLUSION CRITIERIA:

A subject will be excluded if she:

  • Has an identified underlying chronic medical condition that may adversely affect the immune system (e.g., autoimmune, HIV, or hematologic) or the need for immunomodulating medications (e.g., oral steroids) within 30 days prior to conception for a suspected immune disorder. Oral steroid use for any other reason must have been discontinued for at least 30 days prior to participation.
  • Is found to have a Hemoglobin reading of less than 8g/dL.
  • Has any other medical condition which, in the opinion of the Principal Investigator, poses an unacceptable risk to the subject s participation in the study.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Observační modely: Case-Control
  • Časové perspektivy: Budoucí

Kohorty a intervence

Skupina / kohorta
pregnant flu vaccinated
pregnant women that choose to receive the seasonal flu vaccine
pregnant non-flu vaccinated
pregnant women that do not receive the flu vaccine

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Changes in lymphocyte and NK cell populations during pregnancy compared to non-pregnant control samples.
Časové okno: 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]
1st, 2nd, and 3rd trimesters and postpartum and postpartum
Changes in Cytokine profiles during pregnancy
Časové okno: 1st, 2nd, and 3rd trimesters and postpartum and postpartum
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
Časové okno: 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]
1st, 2nd, and 3rd trimesters and postpartum and postpartum

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Functionality of Toll-like receptors and changes in gene expression
Časové okno: 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 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]
Before and after the administration of the influenza vaccine in a subset of pregnant women
Changes in lymphocyte and INK cell populations
Časové okno: Before and after the administration of the influenza vaccine in a subset of pregnant women
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]
Before and after the administration of the influenza vaccine in a subset of pregnant women
Changes in Cytokine profiles
Časové okno: Before and after the administration of the influenza vaccine in a subset of pregnant women
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]
Before and after the administration of the influenza vaccine in a subset of pregnant women

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia

30. září 2011

Primární dokončení

7. prosince 2022

Dokončení studie

11. října 2019

Termíny zápisu do studia

První předloženo

11. září 2010

První předloženo, které splnilo kritéria kontroly kvality

11. září 2010

První zveřejněno (Odhad)

14. září 2010

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

18. října 2019

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

17. října 2019

Naposledy ověřeno

11. října 2019

Více informací

Termíny související s touto studií

Další identifikační čísla studie

  • 100205
  • 10-I-0205

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

produkt vyrobený a vyvážený z USA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

Klinické studie na Pregnancy Immune Function

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