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

Phase

N/A

Condition

Influenza

Treatment

N/A

Clinical Study ID

NCT05436184

1U01AI144673-01

All Genders
Accepts Healthy Volunteers

Study 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

Eligibility Criteria

Inclusion

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

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 anomalyas 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 conflictwith study outcomes

Study Design

October 17, 2019

December 31, 2028

Study 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.

Connect with a study center

Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio 45219
United States
Site Not Available
Cincinnati Children's Hospital Medical Center
Cincinnati 4508722, Ohio 5165418 45219
United States
Site Not Available

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