Maternal Immunization: Giving Immunity For Tomorrow (MI GIFT)
This study is currently recruiting participants.
Verified January 2013 by University of Utah
Sponsor:
University of Utah
Information provided by (Responsible Party):
Julie Shakib, University of Utah
ClinicalTrials.gov Identifier:
NCT01496079
First received: November 28, 2011
Last updated: January 22, 2013
Last verified: January 2013
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Purpose
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
| Condition |
|---|
|
Pregnancy Influenza |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | The Role of Immunizing Pregnant Women In Protecting Young Infants Against Influenza |
Resource links provided by NLM:
MedlinePlus related topics:
Flu
Drug Information available for:
Influenza Vaccines
U.S. FDA Resources
Further study details as provided by University of Utah:
Primary Outcome Measures:
- Influenza antibody titer levels in infants born to women who receive trivalent inactivated influenza vaccine in early pregnancy compared to late pregnancy [ Time Frame: Infant antibody titers at delivery ] [ Designated as safety issue: No ]Influenza titers will be measured on infant serum samples by HAI assay and on maternal colostrum or breast milk if available by ELISA
- Influenza antibody titer levels in infants born to women who receive trivalent inactivated influenza vaccine in early pregnancy compared to late pregnancy [ Time Frame: Infant antibody titers at 2 months ] [ Designated as safety issue: No ]Influenza titers will be measured by on infant serum samples by HAI assay and on maternal colostrum or breast milk if available by ELISA
- Influenza antibody titer levels in infants born to women who receive trivalent inactivated influenza vaccine in early pregnancy compared to late pregnancy [ Time Frame: Infant antibody titers at 6 months ] [ Designated as safety issue: No ]Influenza titers will be measured by on infant serum samples by hemagglutination inhibition assay and on maternal colostrum or breast milk if available by ELISA
Secondary Outcome Measures:
- Proportion of infants achieving seroconversion following active immunization with trivalent inactivated influenza vaccine [ Time Frame: Infant antibody titers at 6, 7, and 8 months of age ] [ Designated as safety issue: No ]Influenza titers will be measured by on infant serum samples by HAI
| Estimated Enrollment: | 300 |
| Study Start Date: | December 2011 |
| Estimated Study Completion Date: | November 2014 |
| Estimated Primary Completion Date: | November 2014 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
TIV in early pregnancy
50 healthy pregnant women who elect to receive trivalent inactivated influenza vaccine in early pregnancy (< 20 weeks gestation) and their infants
|
|
TIV in late pregnancy
50 healthy pregnant women who elect to receive trivalent inactivated influenza vaccine in late pregnancy (20 or more weeks gestation) and their infants
|
|
No TIV during pregnancy
50 healthy pregnant women who decline trivalent inactivated influenza vaccine in pregnancy and their infants
|
Eligibility| Ages Eligible for Study: | 18 Years to 45 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
| 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.
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01496079
Locations
| United States, Utah | |
| University of Utah Health Sciences Center | Recruiting |
| Salt Lake City, Utah, United States, 84108 | |
| Contact: Julie H. Shakib, DO, MPH julie.shakib@hsc.utah.edu | |
Sponsors and Collaborators
University of Utah
Investigators
| Principal Investigator: | Julie H. Shakib, DO, MPH | University of Utah |
More Information
No publications provided
| Responsible Party: | Julie Shakib, Assistant Professor of Pediatrics, Principal Investigator, University of Utah |
| ClinicalTrials.gov Identifier: | NCT01496079 History of Changes |
| Other Study ID Numbers: | 00051718 |
| Study First Received: | November 28, 2011 |
| Last Updated: | January 22, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Utah:
|
Maternal immunization Infant immunization Influenza vaccine Passive transfer of immunity |
Additional relevant MeSH terms:
|
Influenza, Human Orthomyxoviridae Infections RNA Virus Infections |
Virus Diseases Respiratory Tract Infections Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on June 18, 2013