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This is a single-center, randomized, open-label trial designed to explore the interaction between mucosal microbiota colonization in the nasal cavity and gut and the immune response to an intranasal live attenuated influenza vaccine (LAIV). The study plans to enroll 200 children and adolescents aged 6-17 years, with approximately 50% in the 6-11 years age group and 50% in the 12-17 years age group. Participants and their guardians must be able and willing to comply with the clinical trial protocol and provide informed consent. Eligible participants will be randomly assigned in a 1:1 ratio, stratified by age groups, to either the immediate vaccination group or the delayed vaccination group. Nasal swabs will be collected for all participants of both the immediate vaccination group or the delayed vaccination group after randomization for the detection of nasal and gut microbiota. Then, the immediate vaccination group will receive one dose of 0.2 mL of LAIV 28 days after randomization, while the delayed vaccination group will receive one dose of 0.2 mL of LAIV 56 days after randomization. Blood and mucosal samples (nasal stool) will be collected on the day before vaccination and on 28 days after vaccination for humoral and mucosal immunogenicity analysis. Moreover, the occurrence of adverse events within 28 days after vaccination will be collected.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| The immediate vaccination group. | Experimental | Participants are assigned to receive one dose of 0.2 mL of intranasal live attenuated influenza vaccine immediately (Day 0) |
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| The delayed vaccination group | Experimental | Participants are assigned to receive one dose of 0.2 mL of intranasal live attenuated influenza vaccine after a delay (Day 28). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intranasal Influenza Live Attenuated Vaccine | Biological | This vaccine is produced by Changchun BCHT Biotechnology Co. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The responses of sIgA antibodies against the vaccine strain in the nasal mucosal secretions 28 days post-vaccination. | Measured by Meso Scale Discovery | Day 28 post-vaccination |
| Changes in the density of nasal mucosal bacterial colonization (CFU/mL) compared to baseline | Measured by 16s RNA or metagenomic analysis | Day 28 post-vaccination |
| Changes in the abundance (α Diversity and β Diversity) of nasal mucosal bacterial colonization compared to baseline | Measured by 16s RNA or metagenomic analysis | Day 28 post-vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| The level of HI antibodies against the vaccine strain in serum at 28 days post-vaccination | Measured by HI | Day 28 post-vaccination |
| Changes in the density of gut bacterial colonization (CFU/mL) compared to baseline |
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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 |
| Jiangsu Provincial Center for Diseases Control and Prevention | Jiangsu Provincial Center for Diseases Control and Prevention | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Haizhou District Center for Disease Control and Prevention | Lianyungang | Jiangsu | China |
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| Intranasal Influenza Live Attenuated Vaccine | Biological | This vaccine is produced by Changchun BCHT Biotechnology Co. |
|
Measured by 16s RNA or metagenomic analysis
| Day 28 post-vaccination |
| Changes in the abundance (α Diversity and β Diversity) of gut bacterial colonization compared to baseline | Measured by 16s RNA or metagenomic analysis | Day 28 post-vaccination |
| The incidence of adverse reactions within 28 days post-vaccination | within 28 days post-vaccination |
| Number of IFN-γ secreting cells in nasal mucosal epithelial cells in response to influenza virus-based synthetic peptide pools at Day 28 post-vaccination (Exploratory) | The number of IFN-γ secreting cells will be quantified using an ELISpot assay. | Day 28 post-vaccination |
| Frequency of activated T-cell subsets in nasal mucosal epithelial cells at Day 28 post-vaccination (Exploratory) | The phenotype and activation status of local mucosal T-cell subsets were measured by flow cytometry. | Day 28 post-vaccination |
| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D007252 | Influenza Vaccines |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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