Maternal Immunization: Giving Immunity For Tomorrow (MI GIFT)

Utah System of Higher Education (USHE)

Status: Completed

Conditions: Influenza; Pregnancy

Study type: Observational

Funder types: Other

Identifiers

NCT01496079

00051718

Details and patient eligibility

About

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

Enrollment: 166 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

166 participants in 2 patient groups

Inactivated influenza vaccine in pregnancy

Description:

Healthy pregnant women who elect to receive inactivated influenza vaccine in early pregnancy (\< 20 weeks gestation) and their infants

No inactivated influenza vaccine during pregnancy

Description:

Healthy pregnant women who decline inactivated influenza vaccine in pregnancy and their infants