Childhood Infection and Immunity Longitudinal Cohort
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age0-7
SponsorZhejiang Provincial Center for Disease Control and Prevention
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
1,200 Participants
are grouped into 3 trial groupsGroup A: General Community Cohort
Group B: Infection Observation Cohort
Group C: Childhood Asthma Cohort
Trial outcomes
Primary outcomes
1
Respiratory infection-related healthcare visit or hospitalization events
Multiplex respiratory pathogen PCR assay
Time frame
From enrollment through 48 months2
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.
Time frame
Baseline, 12, 24, 36 and 48 monthsSecondary outcomes
1
Vaccine-induced antibody response
Antibody levels against hepatitis B, pertussis, and varicella vaccine antigens will be measured in samples collected at the annual study visits.
Time frame
Baseline and 12, 24, 36, and 48 months2
Antibody levels against respiratory pathogens
Respiratory syncytial virus (RSV) neutralizing antibodies, Humanmetapneumovirus (HMPV) neutralizing antibodies, Parainfluenza virus (PIV) neutralizing antibodies, and Mycoplasma pneumoniae IgG will be measured in samples collected at the annual study visits.
Time frame
Baseline and 12, 24, 36, and 48 months3
Gut Microbiome Diversity
Metagenomic sequencing will be performed on stool samples collected at the annual study visits.
Time frame
Baseline and 12, 24, 36, and 48 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Zhejiang Provincial Center for Disease Control and Prevention
Lead sponsor
Xiamen University
Collaborator
Xiang An Biomedicine Laboratory
Collaborator
Source ClinicalTrials.gov
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