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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.

Visão geral do estudo

Status

Concluído

Descrição detalhada

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.

Tipo de estudo

Observacional

Inscrição (Real)

41

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

    • Maryland
      • Bethesda, Maryland, Estados Unidos, 20892
        • National Institutes of Health Clinical Center, 9000 Rockville Pike

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos a 45 anos (Adulto)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Fêmea

Descrição

  • 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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Modelos de observação: Controle de caso
  • Perspectivas de Tempo: Prospectivo

Coortes e Intervenções

Grupo / Coorte
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

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Changes in lymphocyte and NK cell populations during pregnancy compared to non-pregnant control samples.
Prazo: 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
Prazo: 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
Prazo: 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

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Functionality of Toll-like receptors and changes in gene expression
Prazo: 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
Prazo: 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
Prazo: 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

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Publicações e links úteis

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Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo

30 de setembro de 2011

Conclusão Primária

7 de dezembro de 2022

Conclusão do estudo

11 de outubro de 2019

Datas de inscrição no estudo

Enviado pela primeira vez

11 de setembro de 2010

Enviado pela primeira vez que atendeu aos critérios de CQ

11 de setembro de 2010

Primeira postagem (Estimativa)

14 de setembro de 2010

Atualizações de registro de estudo

Última Atualização Postada (Real)

18 de outubro de 2019

Última atualização enviada que atendeu aos critérios de controle de qualidade

17 de outubro de 2019

Última verificação

11 de outubro de 2019

Mais Informações

Termos relacionados a este estudo

Outros números de identificação do estudo

  • 100205
  • 10-I-0205

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

produto fabricado e exportado dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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