We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05436184
Recruitment Status : Recruiting
First Posted : June 29, 2022
Last Update Posted : June 29, 2022
Sponsor:
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
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

Condition or disease
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.

Layout table for study information
Study Type : Observational
Estimated 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 : October 17, 2019
Estimated Primary Completion Date : December 31, 2027
Estimated Study Completion Date : December 31, 2028

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

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.



Primary Outcome Measures :
  1. Immune response to influenza virus infection [ Time Frame: 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 [ Time Frame: 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


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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05436184


Contacts
Layout table for location contacts
Contact: Nancy Back, RN,MPH 513-636-2479 Nancy.Back@cchmc.org
Contact: Chelsea Rohlfs, MBA 513-636-0393 Chelsea.Rohlfs@cchmc.org

Locations
Layout table for location information
United States, Ohio
Cincinnati Children's Hospital Medical Center Recruiting
Cincinnati, Ohio, United States, 45219
Contact: Nancy Back, RN, MPH    513-636-2479    nancy.back@cchmc.org   
Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
Layout table for investigator information
Principal Investigator: Mary Staat, MD,MPH Children's Hospital Medical Center, Cincinnati
Layout table for additonal information
Responsible Party: Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT05436184    
Other Study ID Numbers: 1U01AI144673-01 ( U.S. NIH Grant/Contract )
1U01AI144673-01 ( U.S. NIH Grant/Contract )
First Posted: June 29, 2022    Key Record Dates
Last Update Posted: June 29, 2022
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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:
Layout table for MeSH terms
Influenza, Human
Respiratory Tract Infections
Infections
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Diseases