SafeTy and Efficacy of Preventative CoVID Vaccines
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 1,286
- 试验地点
- 1
- 主要终点
- COviD-19 vaccine specific antibody levels
研究概览
简要总结
The STOPCoV study is a decentralized study comparing COVID-19 vaccine specific antibody levels at 24 weeks after final vaccine dose. We plan to study the safety and immunogenicity of COVID-19 vaccine(s) in community dwelling persons 70 years and over relative to a younger group (aged 30 - 50 years).
详细描述
This is a prospective observational study of a cohort of individuals aged 30-50 years and a cohort of individuals aged 70 years and over receiving the COVID-19 vaccine.
Participants will complete a questionnaire to determine eligibility. Eligible participants will complete and sign an e-consent and then be provided with a participant ID, log in information and password to the database portal, and then be enrolled into the study.
Participants will complete the study assessments (baseline questionnaire, post vaccine symptom e-diary monthly, check-in questionnaire and dried blood spot specimens)
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Must be a resident of Ontario
- •Individuals aged 70 and over
- •Speak, read and understand English (or have a trusted individual to help with study procedures)
- •Will receive a first or second dose of a COVID-19 vaccine at an Ontario vaccine distribution center. Individuals reaching the minimum age requirement by end of the recruitment calendar year are allowed to participate.
- •Individuals between age 30-50 years
- •Speak, read and understand English (or have a trusted individual to help with study procedures)
- •Receive a first or second dose of a COVID-19 vaccine at an Ontario vaccine distribution center.
排除标准
- •Not a resident of Ontario
- •Individuals who are < 30 years or those 51-69 years.
- •Those who are unable to complete the study protocols in English either alone or with the assistance of a trusted individual with an electronic device.
- •Participants who do not receive any dose of the vaccine
- •Participants who have already received both doses of the vaccine prior to enrolment.
结局指标
主要结局
COviD-19 vaccine specific antibody levels
时间窗: 24 weeks after the final vaccination.
The ratio-normalized levels of anti-spike and anti-RBD IgG antibodies
次要结局
- Antibody Levels at different timepoints(48 Weeks)
- Safety of COVID-19 Vaccines(48 weeks)