Monitoring of Physiologic Changes Associated With Immune System Activation Associated With Vaccination Against the SARS-CoV-2 Virus: Vaccine-Induced Inflammation Identification
试验速览
- 阶段
- 不适用
- 发起方
- physIQ, Inc.
- 入组人数
- 130
- 试验地点
- 2
- 主要终点
- Collect bio signal data before and after vaccination in ~100 individuals using one or more wearable biosensors.
研究概览
简要总结
The study's objective is to test the hypothesis that immune system activation and subsequent systemic inflammation can be detected through continuously tracking multiple bio signals including physiologic variables (ECG, skin temperature and their derivatives) and behavioral variables (activity and sleep from accelerometers) collected during routine activities of daily living using wearable biosensors. In the sub-study, the objective is to explore the association between these objectively measured physiologic changes and vaccine-induced humoral and T-cell responses.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Is 18 years of age or older.
- •Is able to speak and read English.
- •Plan to receive either the Moderna or Pfizer vaccine (mRNA vaccine).
- •No known prior COVID-19 infection.
排除标准
- •Known allergy to the adhesive used on the VitalPatch.
结局指标
主要结局
Collect bio signal data before and after vaccination in ~100 individuals using one or more wearable biosensors.
时间窗: December, 2022
Evaluate the relationship between the MCI and individual bio signals parameters and the subjective symptoms experienced by participants.
时间窗: December, 2022
Explore the association between these objectively measured physiologic changes and vaccine-induced humoral and T-cell responses.
时间窗: December, 2022
次要结局
未报告次要终点