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This is a single-center, open-label, single-arm clinical trial designed to evaluate the mucosal and systemic immune responses induced by an intranasal influenza live attenuated vaccine, and to explore the correlation between the two. The study plans to recruit 60 healthy volunteers aged 14-17 years, with a male-to-female ratio of 1:1. Participants and their guardians must be able and willing to comply with the clinical trial protocol and provide informed consent. Eligible participants will receive a single 0.2 mL dose of LAIV prior to the influenza season. Information on participants' historical vaccination records, baseline demographic data, and past health status will be collected. Nasal specimens (nasal secretions and nasal mucosal cells) and blood samples (serum and PBMCs) will be collected on Day 0 (before vaccination), Day 7, and Day 28 after vaccination for transcriptome sequencing and immunogenicity analysis. In addition, fecal samples will be collected on Day 0 (before vaccination), Day 7, and Day 28 after vaccination for intestinal microbiota detection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| The vaccination group (Self-Controlled) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LAIV | Biological | This vaccine is produced by Changchun BCHT Biotechnology Co. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The level of IgG antibodies (ng/mL) against the vaccine strain in serum at 28 days post-vaccination. | Measured by Enzyme-Linked Immunosorbent Assay (ELISA) | Day 28 post-vaccination |
| The level of sIgA antibodies (AU/mL) against the vaccine strain in nasal secretions at 28 days post-vaccination. | Measured by Enzyme-Linked Immunosorbent Assay (ELISA) | Day 28 post-vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| The levels of cytokines in serum at 7 days post-vaccination. | Measured by Meso Scale Discovery | Day 7 post-vaccination |
| The levels of cytokines in nasal mucosal secretions at 7 days post-vaccination. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in the abundance of intestinal microbiota compared with baseline (Exploratory). | Measured by 16s RNA or metagenomic analysis | Day 28 post-vaccination |
| Changes in the levels of fecal or serum metabolites compared with baseline (Exploratory) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jing-Xin Li, PhD | Jiangsu Provincial Center for Diseases Control and Prevention | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Haizhou District Center for Disease Control and Prevention | Lianyungang | Jiangsu | China |
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| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
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Measured by Meso Scale Discovery
| Day 7 post-vaccination |
| The levels of cytokines in serum at 28 days post-vaccination. | Measured by Meso Scale Discovery | Day 28 post-vaccination |
| The levels of cytokines in nasal mucosal secretions at 28 days post-vaccination. | Measured by Meso Scale Discovery | Day 28 post-vaccination |
| The level of IgG antibodies (ng/mL) against the vaccine strain in serum at 7 days post-vaccination. | Measured by Enzyme-Linked Immunosorbent Assay (ELISA) | Day 7 post-vaccination |
| The level of neutralizing antibodies (NT50 and IC50, ng/mL) against the vaccine strain in serum at 28 days post-vaccination. | Measured by Neutralization Assay | Day 28 post-vaccination |
| The gene expression levels in PBMCs (Peripheral Blood Mononuclear Cells) at 7 days post-vaccination. | Measured by Bulk Ribonucleic Acid Sequencing. | from baseline (pre-vaccination) to 7 days post-vaccination |
| The gene expression levels in nasal mucosal cells at 7 days post-vaccination. | Measured by Bulk Ribonucleic Acid Sequencing. | from baseline (pre-vaccination) to 7 days post-vaccination |
| The gene expression levels in PBMCs (Peripheral Blood Mononuclear Cells) at 28 days post-vaccination. | Measured by Bulk Ribonucleic Acid Sequencing. | Day 28 post-vaccination |
| The gene expression levels in nasal mucosal cells at 28 days post-vaccination. | Measured by Bulk Ribonucleic Acid Sequencing. | Day 28 post-vaccination |
| The level of sIgA antibodies (AU/mL) against the vaccine strain in nasal secretions at 7 days post-vaccination. | Measured by Enzyme-Linked Immunosorbent Assay (ELISA) | Day 7 post-vaccination |
Ultra-High Performance Liquid Chromatography-Mass Spectrometry
| Day 28 post-vaccination |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |