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Maternal Immunization: Giving Immunity For Tomorrow (MI GIFT)

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by University of Utah
Sponsor:
Information provided by (Responsible Party):
Julie Shakib, University of Utah
ClinicalTrials.gov Identifier:
NCT01496079
First received: November 28, 2011
Last updated: January 22, 2013
Last verified: January 2013
  Purpose

Study objectives are to compare

  • influenza antibody levels in infant sera and maternal colostrum or breast milk at delivery, 2, and 6 months women who receive influenza immunization in early pregnancy, late pregnancy, or no influenza immunization during pregnancy and their infants
  • immune response to infant influenza immunization in infant sera at 6 and 7 months in infants with and without preexisting influenza antibody.

Study hypotheses are that infants born to pregnant women who receive influenza immunization in late pregnancy will have

  • higher levels and a longer serum influenza antibody duration in sera (hemagglutination inhibition (HAI) titers) and colostrum/breast milk (influenza-specific IgA and IgG by enzyme-linked immunosorbent assay (ELISA) than infants of women immunized in early pregnancy or not immunized
  • fewer infants with preexisting antibody will have protective influenza antibody levels after they are immunized against influenza at 6 and 7 months compared with those without preexisting influenza antibody

Condition
Pregnancy
Influenza

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Role of Immunizing Pregnant Women In Protecting Young Infants Against Influenza

Resource links provided by NLM:


Further study details as provided by University of Utah:

Primary Outcome Measures:
  • Influenza antibody titer levels in infants born to women who receive trivalent inactivated influenza vaccine in early pregnancy compared to late pregnancy [ Time Frame: Infant antibody titers at delivery ] [ Designated as safety issue: No ]
    Influenza titers will be measured on infant serum samples by HAI assay and on maternal colostrum or breast milk if available by ELISA

  • Influenza antibody titer levels in infants born to women who receive trivalent inactivated influenza vaccine in early pregnancy compared to late pregnancy [ Time Frame: Infant antibody titers at 2 months ] [ Designated as safety issue: No ]
    Influenza titers will be measured by on infant serum samples by HAI assay and on maternal colostrum or breast milk if available by ELISA

  • Influenza antibody titer levels in infants born to women who receive trivalent inactivated influenza vaccine in early pregnancy compared to late pregnancy [ Time Frame: Infant antibody titers at 6 months ] [ Designated as safety issue: No ]
    Influenza titers will be measured by on infant serum samples by hemagglutination inhibition assay and on maternal colostrum or breast milk if available by ELISA


Secondary Outcome Measures:
  • Proportion of infants achieving seroconversion following active immunization with trivalent inactivated influenza vaccine [ Time Frame: Infant antibody titers at 6, 7, and 8 months of age ] [ Designated as safety issue: No ]
    Influenza titers will be measured by on infant serum samples by HAI


Estimated Enrollment: 300
Study Start Date: December 2011
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
TIV in early pregnancy
50 healthy pregnant women who elect to receive trivalent inactivated influenza vaccine in early pregnancy (< 20 weeks gestation) and their infants
TIV in late pregnancy
50 healthy pregnant women who elect to receive trivalent inactivated influenza vaccine in late pregnancy (20 or more weeks gestation) and their infants
No TIV during pregnancy
50 healthy pregnant women who decline trivalent inactivated influenza vaccine in pregnancy and their infants

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Pregnant women and their infants receiving care at University of Utah Health Sciences (UUHS) will be recruited and followed.

Criteria

Inclusion Criteria:

Pregnant women 18-45 years of age from 8-36 weeks gestation in good health as determined by medical history and recent physical exam who

  • receive prenatal care at the UUHS Obstetrics and Gynecology Clinics and their infants
  • plan to seek care for their infant at the UUHS affiliated Pediatric Clinics (UUHS or SMC Pediatric Clinics)
  • plan for their infant to receive influenza immunization at 6 and 7 months of age

Exclusion Criteria:

  • maternal history of either a congenital or acquired immunodeficiency including infection (e.g. HIV), chronic steroid use, or malignancy
  • serious underlying neurological, cardiac, renal, or pulmonary disease in either the mother or infant
  • multiple gestation
  • antenatal or postnatal detection at delivery of any major birth defect in the infant
  • delivery of the infant before 37 weeks
  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: NCT01496079

Locations
United States, Utah
University of Utah Health Sciences Center Recruiting
Salt Lake City, Utah, United States, 84108
Contact: Julie H. Shakib, DO, MPH       julie.shakib@hsc.utah.edu   
Sponsors and Collaborators
University of Utah
Investigators
Principal Investigator: Julie H. Shakib, DO, MPH University of Utah
  More Information

No publications provided

Responsible Party: Julie Shakib, Assistant Professor of Pediatrics, Principal Investigator, University of Utah
ClinicalTrials.gov Identifier: NCT01496079     History of Changes
Other Study ID Numbers: 00051718
Study First Received: November 28, 2011
Last Updated: January 22, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Utah:
Maternal immunization
Infant immunization
Influenza vaccine
Passive transfer of immunity

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Respiratory Tract Diseases
Respiratory Tract Infections
Virus Diseases

ClinicalTrials.gov processed this record on November 20, 2014