Childhood Infection and Immunity Longitudinal Cohort

NCT07815925 · tracked via the Priya Life Science China tracker

Sponsor

Zhejiang Provincial Center for Disease Control and Prevention

Phase

Observational

Started

2026-09-10

Last updated

2026-09-11

Condition(s) studied

ImmunityRespiratory InfectionAsthma

Study summary

This prospective observational study will enroll approximately 1,200 children from birth through 7 years of age in Zhejiang Province, China. Participants will include general healthy children from the community, children with a history of serious or recurrent infections, and children with confirmed or highly suspected asthma. No treatment will be assigned by the researchers.

Health information will be collected through questionnaires, vaccination and medical records, regular follow-up, and active surveillance of respiratory infections. Blood, stool, and nasopharyngeal swab samples will be collected at enrollment and annual visits. Additional blood and respiratory samples will be collected during selected respiratory infection events.

Laboratory assessments may include antibody, pathogen, microbiome, and single-cell analyses. The study aims to characterize biomarkers of anti-infective immunity in children and assess their risk of infection.

Xiamen University, Zhejiang Provincial Center for Disease Control and Prevention, and Xiang An Biomedicine Laboratory are the co-sponsors of this study. Hanqing He (Zhejiang Provincial CDC) and Tianying Zhang (Xiamen University) serve as the co-principal investigators.

Eligibility

Sex

ALL

Min age

0 Days

Max age

7 Years

Healthy volunteers

Accepted

Inclusion Criteria: * Children from birth through 7 years of age (younger than 8 years at enrollment). * The participant's parent or legal guardian is able to understand the study, voluntarily agrees to participation, and provides written informed consent. * The participant resides in the study area and is expected to be available for long-term follow-up. * For the General Community Cohort: no known serious underlying disease before enrollment. * For the Infection Observation Cohort: either a history of hospitalization for an infectious disease before 3 years of age, with documented information on the pathogen, infection site, or clinical diagnosis; or at least three healthcare visits for respiratory infections during the 12 months before enrollment. * For the Childhood Asthma Cohort: physician-confirmed asthma or highly suspected asthma according to the protocol-defined age-specific criteria. Children younger than 1 year will not be included in this cohort. Exclusion Criteria: * An acute illness within 14 days before enrollment, including respiratory, gastrointestinal, dermatologic, or urinary symptoms or conditions specified in the protocol. * Known primary immunodeficiency, malignant tumor, serious congenital disorder, or another condition that may substantially alter immune status. * Long-term use of immunosuppressive or other immunomodulatory medications, defined as continuous or intermittent use for a cumulative duration of at least 3 months. * A diagnosed coagulation abnormality or bleeding disorder, including coagulation factor deficiency, other coagulation disorders, or platelet abnormalities. * Any other condition that, in the investigator's judgment, makes the child unsuitable for participation.

Primary outcome measure(s)

Respiratory infection-related healthcare visit or hospitalization events — From enrollment through 48 months
Multiplex respiratory pathogen PCR assay
Transcriptional profiles of peripheral blood mononuclear cells (PBMCs) — Baseline, 12, 24, 36 and 48 months
Single-cell RNA sequencing and analysis will be performed on PBMCs collected at the annual study visits.

Trial sites (2)

Facility	City	Region	Status
Dongyang Center for Disease Control and Prevention	Dongyang	Zhejiang
Yiwu Center for Disease Control and Prevention	Yiwu	Zhejiang

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07815925 on ClinicalTrials.gov ↗ ← All trials in China