Study of the Neutralizing Power of Serum Antibodies - 2 (PNAS-2)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Serum neutralizing antibody evolution (anti-SARS-CoV-2 and anti-MPXV) over time
研究概览
简要总结
Severe forms of COVID-19 and Monkeypox affect immunocompromised and comorbid individuals. Vaccination and monoclonal antibody therapies induce neutralizing antibodies. This neutralizing power is recognized as a correlate of protection against a new infection. This study aims to describe the neutralizing power of serum and nasal antibodies over time, in relation to SARS-CoV-2 and MPXV vaccines or treatments received.
详细描述
This is a monocentric, longitudinal, descriptive study aiming to measure and describe the evolution of the humoral immune response (serum and nasal) to SARS-CoV-2 and MPXV, following any vaccination or administration of monoclonal antibodies. Samples are collected over a maximum 60-month period per participant to assess the durability of neutralizing activity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
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
- •Adults (≥18 years)
- •Patients receiving or scheduled to receive anti-SARS-CoV-2 and/or anti-MPXV vaccines or monoclonal antibodies
- •Patients have provided written informed consent
排除标准
- •Persons under guardianship or curatorship
- •Persons under legal protection,
- •Persons persons deprived of liberty
- •Persons not affiliated to a social security scheme
- •Pregnant or breastfeeding women
结局指标
主要结局
Serum neutralizing antibody evolution (anti-SARS-CoV-2 and anti-MPXV) over time
时间窗: Up to 60 months
S-Fuse and S-Flow tests performed on collected serum samples at each visit
Serum neutralizing antibody evolution (anti-SARS-CoV-2 and anti-MPXV) over time
时间窗: Up to 60 months
S-Fuse and S-Flow tests performed on collected serum samples at each visit
次要结局
- Mucosal (nasal) neutralizing antibody response and SARS-CoV-2 serology over time(Up to 60 months)
- Mucosal (nasal) neutralizing antibody response and MPXV serology over time(Up to 60 months)
- Mucosal (nasal) neutralizing antibody response and MPXV serology over time(Up to 60 months)
- Mucosal (nasal) neutralizing antibody response and SARS-CoV-2 serology over time(Up to 60 months)