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Influenza IMPRINT Cohort: Defining the Impact of Initial Influenza Exposure on Immunity in Infants

Sponsor
Children's Hospital Medical Center, Cincinnati (Other)
Overall Status
Recruiting
CT.gov ID
NCT05436184
Collaborator
National Institute of Allergy and Infectious Diseases (NIAID) (NIH)
1,500
Enrollment
1
Location
110.5
Anticipated Duration (Months)
13.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The primary aim is to define the immune responses to the infant's initial influenza exposure (vaccine or infection) and how that affects the immune response to subsequent influenza exposures

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Vaccination is a leading public health intervention for reducing morbidity and mortality from influenza worldwide. Vaccine optimization is hampered by lack of understanding the natural history of infection and immunity, including the full complement of maternal immunity imparted to infants. This gap in understanding can be addressed only through a well-designed birth cohort study. Up to 1500 mother-infant pairs will be enrolled at or after week 34 in pregnancy over three flu seasons, up to four years of age depending on birth month, at two sites. Follow-up will occur from the third trimester until the child is three to four years of age, along with medical records review to ascertain outcomes not captured through weekly illness and respiratory surveillance, and medical record review up to 18 years of age. The primary aim is to rigorously document the natural history of infection and immune response to influenza in study infants for at least three entire flu seasons.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    1500 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Influenza IMPRINT Cohort: Defining the Impact of Initial Influenza Exposure on Immunity in Infants
    Actual Study Start Date :
    Oct 17, 2019
    Anticipated Primary Completion Date :
    Dec 31, 2027
    Anticipated Study Completion Date :
    Dec 31, 2028

    Arms and Interventions

    Arm Intervention/Treatment
    Cincinnati IMPRINT birth cohort

    mother-infant pairs enrolled at or after week 34 in pregnancy and followed over three flu seasons, up to four years of age.

    Outcome Measures

    Primary Outcome Measures

    1. Immune response to influenza virus infection [4 years]

      Evaluate the immune response to influenza virus infections due to various subtypes in healthy children from birth to 4 years of age in a maternal-infant birth cohort

    2. Immune response to influenza vaccination [4 years]

      Evaluate the immune response to influenza vaccination in healthy children from 6 months to 4 years of age in a maternal-infant birth cohort

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Mother pregnant and ≥ 34 weeks gestation and ≥ 18 yrs. of age

    • Plans to deliver at local hospital

    • Lives within designated home zip codes:

    • No plans to move outside study area within study timeframe

    • Cell phone that can be used for text messaging

    • Singleton live born infant, born ≥ 34 weeks gestational age (GA)

    Exclusion Criteria:

    • Fetal or infant death prior to maternal hospital discharge

    • Mother known to be infected with HIV based on medical records

    • Major congenital anomalies, prenatally diagnosed or other major disorder or anomaly as determined by the PI

    • Reported use of heroin, cocaine or methamphetamines during pregnancy

    • Adoptive infant

    • Enrolled in any investigational vaccine trial or other interventional randomized, clinical trial involving the mother or infant that the PI's deem to be in conflict with study outcomes

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Cincinnati Children's Hospital Medical Center Cincinnati Ohio United States 45219

    Sponsors and Collaborators

    • Children's Hospital Medical Center, Cincinnati
    • National Institute of Allergy and Infectious Diseases (NIAID)

    Investigators

    • Principal Investigator: Mary Staat, MD,MPH, Children's Hospital Medical Center, Cincinnati

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Children's Hospital Medical Center, Cincinnati
    ClinicalTrials.gov Identifier:
    NCT05436184
    Other Study ID Numbers:
    • 1U01AI144673-01
    • 1U01AI144673-01
    First Posted:
    Jun 29, 2022
    Last Update Posted:
    Jun 29, 2022
    Last Verified:
    Nov 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Children's Hospital Medical Center, Cincinnati
    influenza, birth cohort
    Additional relevant MeSH terms:
    Influenza, Human

    Study Results

    No Results Posted as of Jun 29, 2022