NCT07126652尚未招募不适用
Serological Responses to Adjuvanted Versus Non-adjuvanted Influenza Vaccines Among People With HIV: a Randomized Clinical Trial
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 300
- 主要终点
- SCR
研究概览
简要总结
Until now, the adjuvanted influenza-related studies focused mainly on people at older ages. However, the data on immunocompromised people, who might have suboptimal serological responses when receiving nonadjuvanted vaccines, is scarce. In this study, we aim to compare the immunogenicity and safety to adjuvanted versus nonadjuvanted seasonal influenza vaccines among people with HIV.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •People with HIV aged > 50 years
- •Latest HIV RNA load tested less than 330 IU/mL
排除标准
- •Confirmed serious adverse effect owing to any type of inluenza vaccine
- •severe coagulopathy
- •Have recieved influenza vaccine of 2025-2026 season
研究组 & 干预措施
MF-59
Experimental
干预措施: MF-59 (Drug)
Cell-based
Active Comparator
干预措施: cell-based (Drug)
Egg-based
Active Comparator
干预措施: egg-based (Drug)
结局指标
主要结局
SCR
时间窗: between Day 1 and Day 28±7.
The primary end point includes SCR measured by the change in HI titer in serum against the vaccine strains between Day 1 and Day 28±7.
次要结局
未报告次要终点
研究者
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