Maternal Immunization: Giving Immunity For Tomorrow

University of Utah166 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

166

Conditions

Pregnancy Influenza

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 Years

Medical Language ↔ Plain English

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

Outcomes

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

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

Time frame: Infant antibody titers at delivery