Ezt az oldalt automatikusan lefordították, és a fordítás pontossága nem garantált. Kérjük, olvassa el a angol verzió forrásszöveghez.

Assessment of Alterations in Immune Function During Pregnancy and Post Parturition

2019. október 17. frissítette: National Institute of Allergy and Infectious Diseases (NIAID)

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.

A tanulmány áttekintése

Állapot

Befejezve

Körülmények

Pregnancy Immune Function

Részletes leírás

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.

Tanulmány típusa

Megfigyelő

Beiratkozás (Tényleges)

Kapcsolatok és helyek

Ez a rész a vizsgálatot végzők elérhetőségeit, valamint a vizsgálat lefolytatásának helyére vonatkozó információkat tartalmazza.

Tanulmányi helyek

Egyesült Államok
- Maryland
  - Bethesda, Maryland, Egyesült Államok, 20892
    - National Institutes of Health Clinical Center, 9000 Rockville Pike

Részvételi kritériumok

A kutatók olyan embereket keresnek, akik megfelelnek egy bizonyos leírásnak, az úgynevezett jogosultsági kritériumoknak. Néhány példa ezekre a kritériumokra a személy általános egészségi állapota vagy a korábbi kezelések.

Jogosultsági kritériumok

Tanulmányozható életkorok

18 év (Felnőtt)

Egészséges önkénteseket fogad

Nem

Tanulmányozható nemek

Női

Leírás

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.

Tanulási terv

Ez a rész a vizsgálati terv részleteit tartalmazza, beleértve a vizsgálat megtervezését és a vizsgálat mérését.

Hogyan készül a tanulmány?

Tervezési részletek

Megfigyelési modellek: Case-Control
Időperspektívák: Leendő

Csoportok/kohorszok száma

Kohorszok és beavatkozások

Csoport / Kohorsz
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

Mit mér a tanulmány?

Elsődleges eredményintézkedések

Eredménymérő	Intézkedés leírása	Időkeret
Changes in lymphocyte and NK cell populations during pregnancy compared to non-pregnant control samples. Időkeret: 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 Időkeret: 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 Időkeret: 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

Másodlagos eredményintézkedések

Eredménymérő	Intézkedés leírása	Időkeret
Functionality of Toll-like receptors and changes in gene expression Időkeret: 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 Időkeret: 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 Időkeret: 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

Együttműködők és nyomozók

Itt találhatja meg a tanulmányban érintett személyeket és szervezeteket.

Szponzor

National Institute of Allergy and Infectious Diseases (NIAID)

Publikációk és hasznos linkek

A vizsgálattal kapcsolatos információk beviteléért felelős személy önkéntesen bocsátja rendelkezésre ezeket a kiadványokat. Ezek bármiről szólhatnak, ami a tanulmányhoz kapcsolódik.

Általános kiadványok

Tanulmányi rekorddátumok

Ezek a dátumok nyomon követik a ClinicalTrials.gov webhelyre benyújtott vizsgálati rekordok és összefoglaló eredmények benyújtásának folyamatát. A vizsgálati feljegyzéseket és a jelentett eredményeket a Nemzeti Orvostudományi Könyvtár (NLM) felülvizsgálja, hogy megbizonyosodjon arról, hogy megfelelnek-e az adott minőség-ellenőrzési szabványoknak, mielőtt közzéteszik őket a nyilvános weboldalon.

Tanulmány főbb dátumok

Tanulmány kezdete

2011. szeptember 30.

Elsődleges befejezés

2022. december 7.

A tanulmány befejezése

2019. október 11.

Tanulmányi regisztráció dátumai

Először benyújtva

2010. szeptember 11.

Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak