Clinical trial NCT05436184: Influenza IMPRINT Cohort: Defining the Impact of Initial Influenza Exposure on Immunity in Infants
Official title: Influenza IMPRINT Cohort: Defining the Impact of Initial Influenza Exposure on Immunity in Infants
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Influenza
Keywords: influenza, birth cohort
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
Collaborators: name: National Institute of Allergy and Infectious Diseases (NIAID)
First posted: 2022-06-29
Enrollment: 1500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility 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

Primary outcomes:
measure: Immune response to influenza virus infection
timeFrame: 4 years
measure: Immune response to influenza vaccination
timeFrame: 4 years
Secondary outcomes:
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
Study officials:
affiliation: Children's Hospital Medical Center, Cincinnati
name: Mary Staat, MD,MPH
role: PRINCIPAL_INVESTIGATOR
References: