SMART (Smallpox Vaccine for Mpox Post-Exposure Prophylaxis: A Cluster Randomized Controlled Trial)
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 3,000
- 试验地点
- 17
- 主要终点
- PCR-confirmed Mpox
研究概览
简要总结
A cluster randomized controlled trial to determine if smallpox vaccine reduces secondary cases and symptom severity in persons exposed to mpox.
详细描述
A pragmatic, adaptive, multi-site, cluster randomized trial where households with one or more persons confirmed to have mpox will be randomized to smallpox vaccine or control. The co-primary outcomes are RT-PCR confirmed mpox and symptom severity.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Participants will not know which vaccine they receive until after the study is completed.
入排标准
- 年龄范围
- 2 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Household member of person with laboratory confirmed mpox
- •Age ≥ 2 years
- •Within 14 days of onset of illness in mpox index case
排除标准
- •Breastfeeding
- •Past serious allergic reaction to study vaccine components
- •Previous smallpox vaccination
- •Current or planned use of another investigational drug at any point during study participation
研究组 & 干预措施
Typhoid vaccine
Participants will receive the Typhim Vi® typhoid vaccine 0.5 ml single-dose
干预措施: Typhoid VI Polysaccharide Vaccine Injectable Solution (Drug)
Smallpox vaccine
Participants will receive the Bavarian Nordic smallpox vaccine 0.5 ml single-dose
干预措施: Bavarian Nordic smallpox vaccine (Drug)
结局指标
主要结局
PCR-confirmed Mpox
时间窗: 8 weeks
To evaluate if smallpox vaccine vs control prevents RT-PCR confirmed mpox
Symptom severity
时间窗: 8 weeks
To evaluate if smallpox vaccine vs control affects symptom severity
次要结局
- Mpox Pain(8 weeks)
- Hospitalization(8 weeks)
- Mortality(8 weeks)
- Number of skin lesions(8 weeks)
- Resolution of skin lesions(8 weeks)
- Self-reported Quality of Life(8 weeks)
- Mpox complications(8 weeks)