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Mucosal and Systemic Immune Responses Induced by an Intranasal Influenza Live Attenuated Vaccine
Sponsor: Jiangsu Province Centers for Disease Control and Prevention
Summary
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.
Official title: Mucosal and Systemic Immune Responses Induced by an Intranasal Influenza Live Attenuated Vaccine: A Single-Center, Open-Label, Single-Arm Clinical Study
Key Details
Gender
All
Age Range
14 Years - 17 Years
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2025-10-12
Completion Date
2026-05-10
Last Updated
2025-11-18
Healthy Volunteers
Yes
Conditions
Interventions
LAIV
This vaccine is produced by Changchun BCHT Biotechnology Co.
Locations (1)
Haizhou District Center for Disease Control and Prevention
Lianyungang, Jiangsu, China