Follow-up of COVID-19 Vaccine Response in Strasbourg University Hospitals
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 800
- 试验地点
- 1
- 主要终点
- Study of the relationship between the serological response to the COVID-19 vaccine and the demographic characteristics of the patient
研究概览
简要总结
Vaccination remains the main promising measure to fight against the COVID-19 pandemic. The presumed efficacy of the vaccines is quite remarkable since it varies between 62 and 95%. There is increasing evidence that sex-specific effects may lead to different outcomes of vaccine safety and efficacy. However, sex-disaggregated data after COVID-19 vaccine are lacking. The first purpose of the study is to determine antibody titers against SARS-CoV-2 spike after COVID-19 vaccination. The secondary purpose is to identify predictor factors of immune response including age, gender and biological factors.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- 否
入选标准
- •Any person, male or female, over 18 years of age who underwent vaccination and
- •anti-SARS-CoV-2 serological test after vaccination
- •having already given their consent for their biological resources to be:
- •stored in a biocollection of the Microbiology Technical Platform (PTM) having received an approval from the CPP Est-IV and declared to the Ministry of Education and Research under reference No. DC2009-1002;
- •subsequently reused, as well as the anonymized associated data, for research purposes
排除标准
- •Inability to give clear information (person in an emergency, difficulty understanding the subject, etc.)
- •Person under safeguard of justice
- •Person under guardianship or curatorship-
结局指标
主要结局
Study of the relationship between the serological response to the COVID-19 vaccine and the demographic characteristics of the patient
时间窗: up to 1 month post-vaccination
次要结局
未报告次要终点