Maternal Immunization: Giving Immunity For Tomorrow
| Status: | Completed |
|---|---|
| Conditions: | Influenza, Women's Studies |
| Therapuetic Areas: | Immunology / Infectious Diseases, Reproductive |
| Healthy: | No |
| Age Range: | 18 - 45 |
| Updated: | 4/2/2016 |
| Start Date: | December 2011 |
| End Date: | November 2014 |
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
- 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
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
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