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

NCT06609811 | Completed Phase 4

• 1 other identifier: JSJKYMS001
• Study Type: interventional
• Target: 201
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Influenza

Keywords

Intranasal Influenza Live Attenuated Vaccine; Nasal Microbiota; Gut Microbiota; Colonization; Mucosal Immunity

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (6)

• The level of HI antibodies 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

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

  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

Study Arms (2)

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)

Biological: Intranasal Influenza Live Attenuated Vaccine

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).

Biological: Intranasal Influenza Live Attenuated Vaccine

Interventions

Intranasal Influenza Live Attenuated Vaccine BIOLOGICAL

This vaccine is produced by Changchun BCHT Biotechnology Co.

The delayed vaccination group

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jiangsu Province Centers for Disease Control and Prevention: lead

Study Sites (1)

Haizhou District Center for Disease Control and Prevention

Lianyungang, Jiangsu, China

Location

MeSH Terms

Conditions

Influenza, Human

Interventions

Influenza Vaccines

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• 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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2024
• First Posted: September 24, 2024
• Study Start: September 21, 2024
• Primary Completion: December 31, 2024
• Study Completion: January 17, 2025
• Last Updated: April 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)