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

NCT ID: NCT06609811

Last Updated: 2025-04-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-21
• Study Completion Date: 2025-01-17

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

The immediate vaccination group.

Participants are assigned to receive one dose of 0.2 mL of intranasal live attenuated influenza vaccine immediately (Day 0)

Group Type: EXPERIMENTAL

Intranasal Influenza Live Attenuated Vaccine

Intervention Type: BIOLOGICAL

This vaccine is produced by Changchun BCHT Biotechnology Co.

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).

Group Type: EXPERIMENTAL

Intranasal Influenza Live Attenuated Vaccine

Intervention Type: BIOLOGICAL

This vaccine is produced by Changchun BCHT Biotechnology Co.

Interventions

Intranasal Influenza Live Attenuated Vaccine

This vaccine is produced by Changchun BCHT Biotechnology Co.

Intervention Type: BIOLOGICAL

Intranasal Influenza Live Attenuated Vaccine

This vaccine is produced by Changchun BCHT Biotechnology Co.

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

1. Individuals aged 6-17 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.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Jiangsu Province Centers for Disease Control and Prevention

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jing-Xin Li, PhD

Role: PRINCIPAL_INVESTIGATOR

Jiangsu Provincial Center for Diseases Control and Prevention

Jiangsu Provincial Center for Diseases Control and Prevention

Role: STUDY_DIRECTOR

Jiangsu Provincial Center for Diseases Control and Prevention

Locations

Haizhou District Center for Disease Control and Prevention

Lianyungang, Jiangsu, China

Countries

China

Other Identifiers

JSJKYMS001

Identifier Type: -

Identifier Source: org_study_id