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Assessment of Alterations in Immune Function During Pregnancy and Post Parturition

17. oktober 2019 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Detaljert beskrivelse

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.

Studietype

Observasjonsmessig

Registrering (Faktiske)

41

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • Maryland
      • Bethesda, Maryland, Forente stater, 20892
        • National Institutes of Health Clinical Center, 9000 Rockville Pike

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 45 år (Voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Hunn

Beskrivelse

  • 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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Observasjonsmodeller: Case-Control
  • Tidsperspektiver: Potensielle

Kohorter og intervensjoner

Gruppe / Kohort
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

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Changes in lymphocyte and NK cell populations during pregnancy compared to non-pregnant control samples.
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Functionality of Toll-like receptors and changes in gene expression
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

30. september 2011

Primær fullføring

7. desember 2022

Studiet fullført

11. oktober 2019

Datoer for studieregistrering

Først innsendt

11. september 2010

Først innsendt som oppfylte QC-kriteriene

11. september 2010

Først lagt ut (Anslag)

14. september 2010

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

18. oktober 2019

Siste oppdatering sendt inn som oppfylte QC-kriteriene

17. oktober 2019

Sist bekreftet

11. oktober 2019

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Andre studie-ID-numre

  • 100205
  • 10-I-0205

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

produkt produsert i og eksportert fra USA

Nei

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