The Interaction Between Mucosal Microbiota Colonization in the Nasal Cavity and Gut and the Immune Response to an Intranasal Influenza Live Attenuated Vaccine in Children and Adolescents Aged 6 to 17 Years: A Single-Center, Randomized, Open-Label Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 201
- 试验地点
- 1
- 主要终点
- The level of sIgA antibodies (ng/mL) against the vaccine strain in nasal secretions at 28 days post-vaccination
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Individuals aged 6-17 years.
- •Volunteers and their guardians are able and willing to comply with the requirements of the clinical trial protocol and sign the informed consent form.
排除标准
- •Allergy to any component of the vaccine product, including eggs, excipients, or gentamicin sulfate.
- •Individuals with acute illnesses, severe chronic illnesses, acute exacerbations of chronic illnesses, or fever.
- •Pregnant or lactating women.
- •Individuals with Leigh syndrome who are receiving treatment with aspirin or aspirin-containing medications.
- •Individuals with immunodeficiency, immunosuppression, or those undergoing immunosuppressive therapy.
- •Individuals with uncontrolled epilepsy, other progressive neurological disorders, or a history of Guillain-Barré syndrome.
- •Individuals with rhinitis or asthma.
- •Individuals with a personal or family history of seizures, chronic diseases, epilepsy, or allergic tendencies.
- •Individuals who have received immunoglobulin injections within the last 3 months prior to vaccination.
- •Individuals who have used other live attenuated vaccines within 1 month prior to vaccination.
- •Individuals planning to use antiviral drugs for influenza within 48 hours before or 2 weeks after vaccination.
- •Individuals planning to use any other intranasal medication within 2 days after vaccination.
研究组 & 干预措施
The immediate vaccination group.
Participants are assigned to receive one dose of 0.2 mL of intranasal live attenuated influenza vaccine immediately (Day 0)
干预措施: Intranasal Influenza Live Attenuated Vaccine (Biological)
The delayed vaccination group
Participants are assigned to receive one dose of 0.2 mL of intranasal live attenuated influenza vaccine after a delay (Day 28).
干预措施: Intranasal Influenza Live Attenuated Vaccine (Biological)
结局指标
主要结局
The level of sIgA antibodies (ng/mL) against the vaccine strain in nasal secretions at 28 days post-vaccination
时间窗: Day 28 post-vaccination
Measured by Meso Scale Discovery
Changes in the density of nasal mucosal bacterial colonization (CFU/mL) compared to baseline
时间窗: Day 28 post-vaccination
Measured by 16s RNA or metagenomic analysis
Changes in the abundance (α Diversity and β Diversity) of nasal mucosal bacterial colonization compared to baseline
时间窗: Day 28 post-vaccination
Measured by 16s RNA or metagenomic analysis
The responses of sIgA antibodies against the vaccine strain in the nasal mucosal secretions 28 days post-vaccination.
时间窗: Day 28 post-vaccination
Measured by Meso Scale Discovery
次要结局
- Changes in the abundance (α Diversity and β Diversity) of gut bacterial colonization compared to baseline(Day 28 post-vaccination)
- The incidence of adverse events (AEs) within 28 days post-vaccination(within 28 days post-vaccination)
- The level of neutralizing antibodies (NT50 and IC50, ng/mL) against the vaccine strain in serum at 28 days post-vaccination(Day 28 post-vaccination)
- Changes in the density of gut bacterial colonization (CFU/mL) compared to baseline(Day 28 post-vaccination)
- The level of HI antibodies against the vaccine strain in serum at 28 days post-vaccination(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)(Day 28 post-vaccination)
- Frequency of activated T-cell subsets in nasal mucosal epithelial cells at Day 28 post-vaccination (Exploratory)(Day 28 post-vaccination)