Maternal Immunization: Giving Immunity For Tomorrow

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

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

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Key information

Conditions

Pregnancy Infections Influenza Influenza, Human Orthomyxoviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

University of Utah Health Sciences Center

Salt Lake City, Utah, 84108, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Influenza antibody titer levels in infants born to women who receive inactivated influenza vaccine in early pregnancy compared with late pregnancy and no immunization

Time frame: Infant antibody titers at delivery

Influenza titers will be measured on infant serum and breast milk samples by HAI assay and on maternal colostrum or breast milk if available by ELISA and neutralization assay

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Registry information

Official study title

The Role of Immunizing Pregnant Women In Protecting Young Infants Against Influenza

Acronym: MI GIFT

Important dates

Study start: 2011
Primary completion: 2015
Study completion: 2015
First posted: Dec 21, 2011
Registry last updated: Apr 14, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed