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Assessment of Alterations in Immune Function During Pregnancy and Post Parturition

17 octobre 2019 mis à jour par: 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.

Aperçu de l'étude

Statut

Complété

Les conditions

Pregnancy Immune Function

Description détaillée

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.

Type d'étude

Observationnel

Inscription (Réel)

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

États-Unis
- Maryland
  - Bethesda, Maryland, États-Unis, 20892
    - National Institutes of Health Clinical Center, 9000 Rockville Pike

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans à 45 ans (Adulte)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Femelle

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Modèles d'observation: Cas-témoins
Perspectives temporelles: Éventuel

Nombre de groupes / cohortes

Cohortes et interventions

Groupe / Cohorte
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

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats	Description de la mesure	Délai
Changes in lymphocyte and NK cell populations during pregnancy compared to non-pregnant control samples. Délai: 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 Délai: 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 Délai: 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

Mesures de résultats secondaires

Mesure des résultats	Description de la mesure	Délai
Functionality of Toll-like receptors and changes in gene expression Délai: 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 Délai: 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 Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

National Institute of Allergy and Infectious Diseases (NIAID)

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

30 septembre 2011

Achèvement primaire

7 décembre 2022

Achèvement de l'étude

11 octobre 2019

Dates d'inscription aux études

Première soumission

11 septembre 2010

Première soumission répondant aux critères de contrôle qualité

11 septembre 2010

Première publication (Estimation)

14 septembre 2010

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

18 octobre 2019

Dernière mise à jour soumise répondant aux critères de contrôle qualité

17 octobre 2019

Dernière vérification

11 octobre 2019

Plus d'information

Termes liés à cette étude

Mots clés

Autres numéros d'identification d'étude

100205
10-I-0205

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

produit fabriqué et exporté des États-Unis.

Non

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