Mucosal and Systemic Immune Responses Induced by an Intranasal Influenza Live Attenuated Vaccine

November 14, 2025 updated by: Jiangsu Province Centers for Disease Control and Prevention

Mucosal and Systemic Immune Responses Induced by an Intranasal Influenza Live Attenuated Vaccine: A Single-Center, Open-Label, Single-Arm Clinical Study

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangsu
      • Lianyungang, Jiangsu, China
        • Haizhou District Center for Disease Control and Prevention

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Individuals aged 14-17 years.
  2. 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:

  1. Allergy to any component of the vaccine product, including eggs, excipients, or gentamicin sulfate.
  2. Individuals with acute illnesses, severe chronic illnesses, acute exacerbations of chronic illnesses, or fever.
  3. Pregnant or lactating women.
  4. Individuals with Leigh syndrome who are receiving treatment with aspirin or aspirin-containing medications.
  5. Individuals with immunodeficiency, immunosuppression, or those undergoing immunosuppressive therapy.
  6. Individuals with uncontrolled epilepsy, other progressive neurological disorders, or a history of Guillain-Barré syndrome.
  7. Individuals with rhinitis or asthma.
  8. Individuals with a personal or family history of seizures, chronic diseases, epilepsy, or allergic tendencies.
  9. Individuals who have received immunoglobulin injections within the last 3 months prior to vaccination.
  10. Individuals who have used other live attenuated vaccines within 1 month prior to vaccination.
  11. Individuals planning to use antiviral drugs for influenza within 48 hours before or 2 weeks after vaccination.
  12. Individuals planning to use any other intranasal medication within 2 days after vaccination.
  13. Subjects with underlying gastrointestinal diseases, including but not limited to inflammatory bowel disease (IBD), irritable bowel syndrome (IBS), chronic diarrhea, peptic ulcer, and intestinal polyps.
  14. Subjects with metabolic diseases, such as diabetes mellitus, obesity (BMI ≥ 25.9 kg/m²), hyperlipidemia, or metabolic syndrome.
  15. Subjects who have used antibiotics, probiotics, or other drugs that may affect the intestinal microbiota within the past 3 months.
  16. Other circumstances in which the subject is deemed unsuitable for participation in the study by the investigator.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: The vaccination group (Self-Controlled)
Biological: LAIV
This vaccine is produced by Changchun BCHT Biotechnology Co.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The level of IgG antibodies (ng/mL) against the vaccine strain in serum at 28 days post-vaccination.
Time Frame: Day 28 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.
Time Frame: Day 28 post-vaccination
Measured by Enzyme-Linked Immunosorbent Assay (ELISA)
Day 28 post-vaccination

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The levels of cytokines in serum at 7 days post-vaccination.
Time Frame: Day 7 post-vaccination
Measured by Meso Scale Discovery
Day 7 post-vaccination
The levels of cytokines in nasal mucosal secretions at 7 days post-vaccination.
Time Frame: Day 7 post-vaccination
Measured by Meso Scale Discovery
Day 7 post-vaccination
The levels of cytokines in serum at 28 days post-vaccination.
Time Frame: Day 28 post-vaccination
Measured by Meso Scale Discovery
Day 28 post-vaccination
The levels of cytokines in nasal mucosal secretions at 28 days post-vaccination.
Time Frame: Day 28 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.
Time Frame: Day 7 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.
Time Frame: Day 28 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.
Time Frame: from baseline (pre-vaccination) to 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.
Time Frame: from baseline (pre-vaccination) to 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.
Time Frame: Day 28 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.
Time Frame: Day 28 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.
Time Frame: Day 7 post-vaccination
Measured by Enzyme-Linked Immunosorbent Assay (ELISA)
Day 7 post-vaccination

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Changes in the abundance of intestinal microbiota compared with baseline (Exploratory).
Time Frame: Day 28 post-vaccination
Measured by 16s RNA or metagenomic analysis
Day 28 post-vaccination
Changes in the levels of fecal or serum metabolites compared with baseline (Exploratory)
Time Frame: Day 28 post-vaccination
Ultra-High Performance Liquid Chromatography-Mass Spectrometry
Day 28 post-vaccination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Jiangsu Province Centers for Disease Control and Prevention

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jing-Xin Li, PhD, Jiangsu Provincial Center for Diseases Control and Prevention

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 12, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 10, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 10, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 14, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 14, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 18, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 18, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 14, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • JSJKYMS002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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