A Phenotypic Study of Safety, Tolerability, Reactogenicity, Immunogenicity, and Virus Shedding With Post-Vaccination Infections of Emergency-Use-Authorized Vaccines Against COVID-19
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 2,000
- 试验地点
- 5
- 主要终点
- Adverse reactions/events
研究概览
简要总结
During the study, members of different online and offline communities will be followed post COVID-19 vaccination.
Injection-site (local) and systemic reaction data will be assessed on vaccination day and afterwards using either web surveys or personal communication, depending on study participant preference.
Hypothesis to be tested: The safety profile and the magnitude and durability of immune responses to the COVID-19 vaccines as well as adverse reactions depend on health conditions, metabolism and microbiomes.
详细描述
The outbreak of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) was declared a Public Health Emergency of International Concern in January 2020 and upgraded to pandemic in March 2020. First vaccines to prevent COVID-19 were authorized for emergency use in the US in December 2020, but a number of unknowns still remains. One of these unknowns is the relationship of the microbiota, gut dysbiosis and impaired metabolism with active immunity to pathogens and vaccines and tolerance to antigens. Study groups will be based on age, metabolism, donated diagnostic test results and self-reported symptoms. Data will be collected continuously via surveys and investigator-participant interactions, as needed. Statistical methods used will be the ones with the greatest power.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Individuals 18 or older at the time of consent
- •Intention to vaccinate and of being available for entire study period
排除标准
- •Any illness or condition that in the opinion of the investigator may affect the safety of the participant or the evaluation of any study endpoint.
结局指标
主要结局
Adverse reactions/events
时间窗: 10 days after any dose of study intervention.
Percentage of occurrence, types, duration and severity of adverse events occurring within 10 days post-doses 1 and 2
次要结局
- Long-term adverse events(Throughout the study period, until 12 months post-final-dose)
- Incidence of COVID-19 cases(From 14 days after completion of the 2-dose regimen up to 12 months post-final-dose)