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

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

Study Overview

• Status: Recruiting
• Conditions: Influenza

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 Type: Observational
• Enrollment (Estimated): 1500

Contacts and Locations

• Study Contact: Name: Nancy Back, RN,MPH; Phone Number: 513-636-2479; Email: Nancy.Back@cchmc.org
• Study Contact Backup: Name: Chelsea Rohlfs, MBA; Phone Number: 513-636-0393; Email: Chelsea.Rohlfs@cchmc.org

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • Recruiting
      • Cincinnati Children's Hospital Medical Center
      • Contact: Nancy Back, RN, MPH; Phone Number: 513-636-2479; Email: nancy.back@cchmc.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Children's Hospital Medical Center, Cincinnati
• Collaborators: National Institute of Allergy and Infectious Diseases (NIAID)
• Investigators: Principal Investigator: Mary Staat, MD,MPH, Children's Hospital Medical Center, Cincinnati

Study record dates

Study Major Dates

• Study Start (Actual): October 17, 2019
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: June 23, 2022
• First Submitted That Met QC Criteria: June 23, 2022
• First Posted (Actual): June 29, 2022

Study Record Updates

• Last Update Posted (Estimated): December 14, 2023
• Last Update Submitted That Met QC Criteria: December 13, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: influenza, birth cohort
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Orthomyxoviridae Infections; Influenza, Human
• Other Study ID Numbers: 1U01AI144673-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No