Comparative Immunologic Mechanisms and Microbiome Interactions Following Different Influenza Vaccine Formulations in Older Adults
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 121
- 试验地点
- 1
- 主要终点
- Seroconversion Rate
研究概览
简要总结
This prospective, randomized, open-label clinical study aims to evaluate the immunogenicity and underlying immune mechanisms of different influenza vaccine formulations in adults aged ≥65 years. Additionally, the study investigates the role of the gut microbiome in modulating vaccine-induced immune responses and durability.
详细描述
Despite high influenza vaccination coverage among older adults in Korea, vaccine effectiveness remains suboptimal, even during well-matched seasons. Immunosenescence and microbiome dysbiosis are believed to contribute to reduced vaccine responsiveness.
This study will:
- Compare immune responses induced by standard-dose, MF59-adjuvanted, and high-dose influenza vaccines
- Characterize cellular and humoral immune mechanisms
- Analyze gut microbiome composition and function using metagenomic approaches
- Identify microbiome-derived biomarkers associated with vaccine responsiveness and durability
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age ≥65 years
- •Able and willing to provide informed consent
排除标准
- •Influenza vaccination within the past 6 months
- •Laboratory-confirmed influenza infection within the past 6 months
- •Immunocompromised status
- •Uncontrolled chronic medical conditions
研究组 & 干预措施
Standard-Dose Influenza Vaccine
Intervention: Standard-dose quadrivalent influenza vaccine (Vaxigrip®) Dose: 0.5 mL intramuscular injection, single dose
干预措施: Standard-Dose Influenza Vaccine (Biological)
High-Dose Influenza Vaccine
Intervention: High-dose influenza vaccine (Efluelda®) Dose: 0.7 mL intramuscular injection, single dose
干预措施: High-Dose Influenza Vaccine (Biological)
MF59-Adjuvanted Influenza Vaccine
Intervention: MF59-adjuvanted vaccine (FLUAD®) Dose: 0.5 mL intramuscular injection, single dose
干预措施: MF59-Adjuvanted Influenza Vaccine (Biological)
结局指标
主要结局
Seroconversion Rate
时间窗: 4 weeks post-vaccination
≥4-fold increase in hemagglutination inhibition (HI) antibody titers
次要结局
- Geometric Mean Titers(Baseline, Day 7, Week 4, Month 6)
- Cellular Immune Responses(Baseline, Day 7, Week 4)
- B Cell Responses(Baseline, Day 7, Week 4)
- Microbiome Diversity and Composition(Baseline and Week 4)
- Microbiome Biomarker Identification(Baseline, Week 4)
- Durability of Immune Response(Baseline, Week 4, Month 6)
- Safety Outcomes(Day 7, Day 30)
研究者
Joon Young Song
Professor
Korea University Guro Hospital