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Immune Development in Early Life (IDEaL) longitudinal cohort study protocol: Identifying biomarkers of vaccine
Donato Amodio1,2, Chiara Rossetti1, Asimenia Angelidou3,4,5
1Clinical and Research Unit of Clinical Immunology and Vaccinology, Bambino Gesù Children's Hospital, Istituto Di Ricovero e Cura a Carattere Scientifico (IRCCS), Rome, Italy.
Insights
This study identifies immune system markers in children to predict respiratory infections and asthma. Findings aim to enable early interventions for better long-term health outcomes.
Area of Science:
- Pediatric immunology and respiratory health.
- Longitudinal cohort studies in early life development.
Background:
- Early-life immune development influences childhood respiratory infections, asthma, and vaccine responses.
- Identifying specific immune endotypes can predict susceptibility and inform interventions.
- The IDEaL-Rome cohort is a prospective study investigating immune trajectories in children.
Purpose of the Study:
- To discover molecular biomarkers for predicting susceptibility to respiratory infections, asthma, and poor vaccine response in early childhood.
- To establish immune profiles for early intervention strategies.
- To guide interventions aimed at modifying adverse immune development pathways.
Main Methods:
- Prospective enrollment of mothers during pregnancy and infants at delivery.
- Collection of biosamples (blood, stool, nasal swabs, cord blood) and clinical data over 6 visits up to age 5.
- Integration of multiomic data (cytokines, proteomics, microbiome) with clinical information.
Main Results:
- 273 participants enrolled with 100% completion rate.
- Clinical and multiomic data integrated over 2 years to analyze immune trajectories.
- Detailed outcome data will be reported as longitudinal analysis progresses.
Conclusions:
- The IDEaL-Rome study aims to identify biomarkers for immune development trajectories.
- Findings may facilitate early interventions to improve infant health outcomes.
- Further research is needed to validate biomarkers and refine predictive models for clinical use.
Background:
Early-life immune development is a critical factor in predicting the risk of childhood respiratory infections, asthma, and poor vaccine responses. Identifying immune endotypes that predispose children to these conditions could lead to the development of predictive biomarkers and early interventions, potentially improving long-term health outcomes. The IDEaL (Immune Development in Early Life)-Rome prospective pediatric cohort, based at Children's Hospital Bambino Gesù (Rome, Italy), is part of a National Institutes of Health/National Institute of Allergy and Infectious Diseases-supported longitudinal observational study.
Objectives:
To identify molecular biomarkers associated with increased susceptibility to respiratory infections, asthma, and poor vaccine responsiveness in early childhood. The study aims to establish predictive immune profiles that could guide interventions to redirect harmful immune trajectories.
Methods:
Mothers are approached during pregnancy prospectively and eligible infants are enrolled at delivery. The study includes 6 planned visits up to 5 years of age. Biosamples (blood, stool, nasal swabs, and cord blood for a subset) were collected at each visit for multiomic data (cytokines, proteomics, microbiome), alongside clinical data on vaccination, infections, and wheezing.
Results:
The study included 273 participants (100% enrollment completion rate). Over 2 years, clinical and multiomic data were integrated to investigate immune trajectories related to clinical outcomes. Specific data on the outcomes will be provided in future reports as longitudinal analysis continues.
Conclusions:
The IDEaL-Rome cohort study seeks to identify biomarkers predicting immune development trajectories. These findings could enable early interventions to redirect harmful immune trajectories in infancy and improve health outcomes, though further studies are required to validate biomarkers and refine predictive models for clinical application.
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