Childhood Infection and Immunity Longitudinal Cohort

NCT07815925 | Not Yet Recruiting

• 1 other identifier: K-2026-065-01
• Study Type: observational
• Target: 1,200
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Immunity; Respiratory Infection; Asthma

Keywords

Childhood Immunity; Immune Development; Infectious Disease Surveillance; asthma; respiratory infection

Outcome Measures

Primary Outcomes (2)

• Respiratory infection-related healthcare visit or hospitalization events

  Multiplex respiratory pathogen PCR assay

  From enrollment through 48 months

• Transcriptional profiles of peripheral blood mononuclear cells (PBMCs)

  Single-cell RNA sequencing and analysis will be performed on PBMCs collected at the annual study visits.

  Baseline, 12, 24, 36 and 48 months

Secondary Outcomes (3)

• Vaccine-induced antibody response

  Baseline and 12, 24, 36, and 48 months

• Antibody levels against respiratory pathogens

  Baseline and 12, 24, 36, and 48 months

• Gut Microbiome Diversity

  Baseline and 12, 24, 36, and 48 months

Study Arms (3)

General Community Cohort

Approximately 600 children aged 0-7 years recruited from the general community who have no known serious underlying disease at enrollment. Participants will undergo questionnaires, longitudinal health surveillance, medical and vaccination record collection, and scheduled biospecimen collection. No intervention will be assigned.

Infection Observation Cohort

Approximately 400 children aged 0-7 years who either had an infection-related hospitalization before 3 years of age with documented information on the pathogen, infection site, or clinical diagnosis, or had at least three healthcare visits for respiratory infections during the 12 months before enrollment. Participants will undergo the same observational follow-up and biospecimen collection procedures. No intervention will be assigned.

Childhood Asthma Cohort

Approximately 200 children aged 1 through 7 years with physician-confirmed asthma or highly suspected asthma according to the protocol-defined age-specific clinical criteria. No intervention will be assigned.

Eligibility Criteria

• Age: 0 Days - 7 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

The study population will consist of approximately 1,200 children from birth through 7 years of age who reside in the participating study areas in Zhejiang Province, China, and are available for long-term follow-up. Participants will be recruited from community settings and participating healthcare institutions into three predefined cohorts: approximately 600 children from the general community without known serious underlying disease, 400 children with a history of infection-related hospitalization or recurrent respiratory infections, and 200 children with physician-confirmed asthma. Recruitment targets will be stratified by age, with efforts to maintain reasonable balance by sex and urban or rural residence.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zhejiang Provincial Center for Disease Control and Prevention: lead
• Xiamen University: collaborator
• Xiang An Biomedicine Laboratory: collaborator

Study Sites (2)

Dongyang Center for Disease Control and Prevention

Dongyang, Zhejiang, 322100, China

Location

Yiwu Center for Disease Control and Prevention

Yiwu, Zhejiang, 322000, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

Retained biospecimens will include EDTA-anticoagulated blood, plasma, peripheral blood mononuclear cells (PBMCs), stool, nasopharyngeal swabs, and throat swabs. Blood, stool, and nasopharyngeal swabs will be collected at baseline and annual follow-up visits. During eligible respiratory infection events, blood and nasopharyngeal swabs will be collected during both the acute and recovery phases, and a throat swab will be collected during the acute phase. Samples will generally be stored at -80°C, while PBMCs may be stored in liquid nitrogen for long-term preservation. Retained samples may be used for antibody testing, pathogen detection, microbiome analysis, genomic analysis, and single-cell analyses.

MeSH Terms

Conditions

Respiratory Tract Infections; Asthma

Condition Hierarchy (Ancestors)

Infections; Respiratory Tract Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Jun Zhang, Master

  Xiamen University

  STUDY CHAIR

• Hanqing He, PhD

  Zhejiang Provincial Center for Disease Control and Prevention

  PRINCIPAL INVESTIGATOR

• Tianying Zhang, PhD

  Xiamen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hanqing He, PhD

CONTACT

+86-571-87115170; hanqinghe@cdc.zj.cn

Tianying Zhang, PhD

CONTACT

zhangtianying@xmu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2026
• First Posted: September 11, 2026
• Study Start: September 10, 2026
• Primary Completion (Estimated): December 31, 2036
• Study Completion (Estimated): December 31, 2036
• Last Updated: September 11, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)