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

NCT05436184 | Active Not Recruiting

• 1 other identifier: 1U01AI144673-01
• Study Type: observational
• Target: 1,500
• Locations: 1 country
• Sites: 1

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

Conditions

Influenza

Keywords

influenza, birth cohort

Outcome Measures

Primary Outcomes (2)

• Immune response to influenza virus infection

  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

  4 years

• Immune response to influenza vaccination

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

  4 years

Study Arms (1)

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.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

We will seek to obtain a balanced temporal distribution of the cohort births to account for seasonal variations in influenza transmission patterns. We will seek to enroll 30 eligible women per month by posting advertisements via study flyers and brochures in the maternal clinics, social media, institutional wide emails, and each of the enrollment clinic sites. Our staff will screen pregnant women in clinic settings for inclusion/exclusion criteria and then consent and enroll those eligible to participate.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45219, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Nasal swabs will be obtained weekly and will be tested for influenza A \& B viruses by Real-Time Reverse Transcriptase PCR (RTrtPCR) analysis Respiratory specimens will be stored at 2-8 degrees C and processed within 24-48 hours of collection Serum and whole blood for immune assays will be processed and then frozen at -20 degrees C or in liquid nitrogen until tested in batch assays All blood specimens will be sent to the laboratory for immunologic assays Cheek swabs will be used for HLA typing Saliva specimens will be used for immunologic assays

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Officials

• Mary Staat, MD,MPH

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2022
• First Posted: June 29, 2022
• Study Start: October 17, 2019
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: November 5, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)