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

November 28, 2011
January 22, 2013
December 2011
November 2014   (final data collection date for primary outcome measure)
  • 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
  • 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 birth ] [ Designated as safety issue: No ]
    Influenza titers will be measured by on infant serum samples by hemagluttination inhibition assay.
  • 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 hemagluttination inhibition assay.
  • 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 hemagluttination inhibition assay.
Complete list of historical versions of study NCT01496079 on ClinicalTrials.gov Archive Site
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
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 hemagluttination inhibition assay.
Not Provided
Not Provided
 
Maternal Immunization: Giving Immunity For Tomorrow
The Role of Immunizing Pregnant Women In Protecting Young Infants Against Influenza

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
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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

  • Pregnancy
  • Influenza
Not Provided
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
300
November 2014
November 2014   (final data collection date for primary outcome measure)

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
Female
18 Years to 45 Years
No
United States
 
NCT01496079
00051718
No
Julie Shakib, University of Utah
University of Utah
Not Provided
Principal Investigator: Julie H. Shakib, DO, MPH University of Utah
University of Utah
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP