Immune Development in Early Life (IDEaL) longitudinal cohort study protocol: Identifying biomarkers of vaccine responsiveness, respiratory infection, and asthma

Authors

Donato Amodio, Clinical and Research Unit of Clinical Immunology and Vaccinology, Bambino Gesù Children's Hospital, Istituto Di Ricovero e Cura a Carattere Scientifico (IRCCS), Rome, Italy.
Chiara Rossetti, Clinical and Research Unit of Clinical Immunology and Vaccinology, Bambino Gesù Children's Hospital, Istituto Di Ricovero e Cura a Carattere Scientifico (IRCCS), Rome, Italy.
Asimenia Angelidou, Precision Vaccines Program, Department of Pediatrics, Boston Children's Hospital, Boston, Mass.
Marco Sanna, Clinical and Research Unit of Clinical Immunology and Vaccinology, Bambino Gesù Children's Hospital, Istituto Di Ricovero e Cura a Carattere Scientifico (IRCCS), Rome, Italy.
Silvia Cellini, Clinical and Research Unit of Clinical Immunology and Vaccinology, Bambino Gesù Children's Hospital, Istituto Di Ricovero e Cura a Carattere Scientifico (IRCCS), Rome, Italy.
Maria Carla Marrero Cabrera, Clinical and Research Unit of Clinical Immunology and Vaccinology, Bambino Gesù Children's Hospital, Istituto Di Ricovero e Cura a Carattere Scientifico (IRCCS), Rome, Italy.
Martina Acciaccarelli, Clinical and Research Unit of Clinical Immunology and Vaccinology, Bambino Gesù Children's Hospital, Istituto Di Ricovero e Cura a Carattere Scientifico (IRCCS), Rome, Italy.
Alessia Neri, Clinical and Research Unit of Clinical Immunology and Vaccinology, Bambino Gesù Children's Hospital, Istituto Di Ricovero e Cura a Carattere Scientifico (IRCCS), Rome, Italy.
Giuseppe Pontrelli, Center for Clinical Research and Pediatric Drug Development, IRCCS Bambino Gesù Children's Hospital, Rome, Italy.
Marco Roversi, PhD Program in Immunology, Molecular Medicine and Applied Biotechnology, Tor Vergata University, Rome, Italy.
Herbet Carmelo Carlo Valensise, Department of Surgical Sciences, Tor Vergata University, Rome, Italy.
Daniele Farsetti, Department of Surgical Sciences, Tor Vergata University, Rome, Italy.
Sanya Thomas, Precision Vaccines Program, Department of Pediatrics, Boston Children's Hospital, Boston, Mass.
Annmarie Hoch, Precision Vaccines Program, Department of Pediatrics, Boston Children's Hospital, Boston, Mass.
Caitlin Syphurs, Precision Vaccines Program, Department of Pediatrics, Boston Children's Hospital, Boston, Mass.
Ravinder Kaur, Rochester Regional HealthFollow
Kinga K. Smolen, Precision Vaccines Program, Department of Pediatrics, Boston Children's Hospital, Boston, Mass.
Simon van Haren, Precision Vaccines Program, Department of Pediatrics, Boston Children's Hospital, Boston, Mass.
Hanno Steen, Precision Vaccines Program, Department of Pediatrics, Boston Children's Hospital, Boston, Mass.
Joann Diray-Arce, Precision Vaccines Program, Department of Pediatrics, Boston Children's Hospital, Boston, Mass.

Department

Research

Document Type

Article

Publication Title

The Journal of Allergy and Clinical Immunology. Global

Abstract

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.

First Page

100517

DOI

10.1016/j.jacig.2025.100517

Volume

4

Issue

4

Publication Date

11-1-2025

Comments

See full list of authors at journal website.

PubMed ID

40727648

Recommended Citation

Amodio, D., Rossetti, C., Angelidou, A., Sanna, M., Cellini, S., Marrero Cabrera, M. C., Acciaccarelli, M., Neri, A., Pontrelli, G., Roversi, M., Carlo Valensise, H. C., Farsetti, D., Thomas, S., Hoch, A., Syphurs, C., Kaur, R., Smolen, K. K., van Haren, S., Steen, H., & Diray-Arce, J. (2025). Immune Development in Early Life (IDEaL) longitudinal cohort study protocol: Identifying biomarkers of vaccine responsiveness, respiratory infection, and asthma. The Journal of Allergy and Clinical Immunology. Global, 4 (4), 100517. https://doi.org/10.1016/j.jacig.2025.100517