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Assessment of Alterations in Immune Function During Pregnancy and Post Parturition

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) )
ClinicalTrials.gov Identifier:
NCT01200979
First received: September 11, 2010
Last updated: November 11, 2014
Last verified: April 2014
  Purpose

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....


Condition
Pregnancy
Immune Function

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Assessment of Alterations in Immune Function During Pregnancy and Post Parturition

Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:
  • Changes in lymphocyte and NK cell populations duringpregnancy compared to non-pregnant control samples [ Time Frame: 1st, 2nd, and 3rd trimesters and postpartumand postpartum ] [ Designated as safety issue: No ]
  • Changes in Cytokine profiles during pregnancy compared to non-pregnant control samples [ Time Frame: 1st, 2nd, and 3rd trimesters and postpartum ] [ Designated as safety issue: No ]
  • Functionality of Toll-like receptors and changes in gene expression during pregnancy during pregnancy comparedto non-pregnant control samples [ Time Frame: 1st, 2nd, and 3rd trimesters and postpartum ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 womenn ] [ Designated as safety issue: No ]
  • 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 influenzavaccine in a subset of pregnant women ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: September 2010
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01200979

Contacts
Contact: Lisa A Barnhart, R.N. (301) 496-5270 lbarnhart@niaid.nih.gov
Contact: Christa S Zerbe, M.D. (301) 594-5932 zerbech@niaid.nih.gov

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL)    800-411-1222 ext TTY8664111010    prpl@mail.cc.nih.gov   
Sponsors and Collaborators
Investigators
Principal Investigator: Christa S Zerbe, M.D. National Institute of Allergy and Infectious Diseases (NIAID)
  More Information

Additional Information:
Publications:
Responsible Party: National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) )
ClinicalTrials.gov Identifier: NCT01200979     History of Changes
Other Study ID Numbers: 100205, 10-I-0205
Study First Received: September 11, 2010
Last Updated: November 11, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Cytokine
Lymphocyte
Toll-Like Receptor
NK Cell
Innate Immunity
Pregnancy
Immune Function

ClinicalTrials.gov processed this record on November 25, 2014