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OpenTrials
Completed

NCT Number: NCT06609811

The Interaction Between Mucosal Microbiota Colonization and the Immune Response to an Intranasal Influenza Live Attenuated Vaccine

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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Key information

Conditions

Influenza Infections Influenza, Human Orthomyxoviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

6 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Haizhou District Center for Disease Control and Prevention

Lianyungang, Jiangsu, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Intranasal Influenza Live Attenuated Vaccine

Biological

This vaccine is produced by Changchun BCHT Biotechnology Co.

Primary outcomes

  1. The responses of sIgA antibodies against the vaccine strain in the nasal mucosal secretions 28 days post-vaccination.

    Time frame: Day 28 post-vaccination

    Measured by Meso Scale Discovery

  2. Changes in the density of nasal mucosal bacterial colonization (CFU/mL) compared to baseline

    Time frame: Day 28 post-vaccination

    Measured by 16s RNA or metagenomic analysis

  3. Changes in the abundance (α Diversity and β Diversity) of nasal mucosal bacterial colonization compared to baseline

    Time frame: Day 28 post-vaccination

    Measured by 16s RNA or metagenomic analysis

Secondary outcomes

  1. The level of HI antibodies against the vaccine strain in serum at 28 days post-vaccination

    Time frame: Day 28 post-vaccination

    Measured by HI

  2. Changes in the density of gut bacterial colonization (CFU/mL) compared to baseline

    Time frame: Day 28 post-vaccination

    Measured by 16s RNA or metagenomic analysis

  3. Changes in the abundance (α Diversity and β Diversity) of gut bacterial colonization compared to baseline

    Time frame: Day 28 post-vaccination

    Measured by 16s RNA or metagenomic analysis

  4. The incidence of adverse reactions within 28 days post-vaccination

    Time frame: within 28 days post-vaccination

  5. 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)

    Time frame: Day 28 post-vaccination

    The number of IFN-γ secreting cells will be quantified using an ELISpot assay.

  6. Frequency of activated T-cell subsets in nasal mucosal epithelial cells at Day 28 post-vaccination (Exploratory)

    Time frame: Day 28 post-vaccination

    The phenotype and activation status of local mucosal T-cell subsets were measured by flow cytometry.

Sponsors and collaborators

Lead sponsor

Jiangsu Province Centers for Disease Control and Prevention

Network

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Sep 24, 2024
Registry last updated
Apr 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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