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

Recruiting

• Conditions: Influenza

• Registration Number: NCT05436184
• Lead Sponsor: Children's Hospital Medical Center, Cincinnati

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

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 Timeline

• Study Start: 2019-10-17
• Study First Submitted: 2022-06-23
• Study First Submitted QC: 2022-06-23
• Study First Posted: 2022-06-29
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-21
• Last Update Posted: 2024-08-22
• Primary Completion: 2027-12-31
• Study Completion: 2028-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1500

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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
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

Trial Locations

Locations (1)

Cincinnati Children's Hospital Medical Center; 🇺🇸 Cincinnati, Ohio, United States