Maternal Immunization: Giving Immunity For Tomorrow

NCT01496079 | Completed

• 1 other identifier: 00051718
• Study Type: observational
• Target: 166
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pregnancy; Influenza

Keywords

Maternal immunization; Infant immunization; Influenza vaccine; Passive transfer of immunity

Outcome Measures

Primary Outcomes (1)

• 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

  Infant antibody titers at delivery

Study Arms (2)

Inactivated influenza vaccine in pregnancy

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

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

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

University of Utah Health Sciences Center

Salt Lake City, Utah, 84108, United States

Location

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Officials

• Julie H. Shakib, DO, MS, MPH

  University of Utah

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Pediatrics, Principal Investigator

Study Record Dates

• First Submitted: November 28, 2011
• First Posted: December 21, 2011
• Study Start: December 1, 2011
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: April 14, 2017

Record last verified: 2017-04

Locations

US (1)