Vaccine Ig Levels in Nasal Mucosa as Measured by Nasal Epithelial Lining Fluid
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 71
- 试验地点
- 1
- 主要终点
- Nasal Mucosal COVID-specific IgA
研究概览
简要总结
This study will measure the levels of nasal mucosal Immunoglobulin A (IgA) and blood serum IgA up to one year after COVID vaccination, as well as examining what factors might affect antibody levels in the nose. This will be done through nasal epithelial lining fluid collection and standard venipuncture.
详细描述
Based on data demonstrating that SARS-CoV-2 infections results in virus-specific nasal IgA levels even in patients with mild infections and no/low serum antibody titers, we hypothesize that COVID vaccinations result in robust nasal IgA levels. Since previous data indicate that SARS-CoV2 specific IgA were transiently present following community-acquired infections, we will follow vaccine-induced nasal IgA levels over time (6-12 months). Our specific aims are as following:
Aim 1: Determine COVID vaccine specific immunoglobulin levels and immune mediator profiles in the nasal mucosa pre- and 14 days post second dose of COVID vaccine.
Aim 2: Determine COVID specific immunoglobulin levels and immune mediator profiles at 3, 6, and 12 months following complete vaccination.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals at least 18 years of age who have or plan to receive a COVID-19 vaccination
- •Able to be seen at UNC Chapel Hill's main campus up to 5 times in the next year
排除标准
- •Individuals unwilling to give consent
结局指标
主要结局
Nasal Mucosal COVID-specific IgA
时间窗: Up to 14 months
Level of COVID-specific antibodies in the nasal mucosa
Serum COVID-specific IgA
时间窗: Up to 14 months
Level of COVID-specific antibodies in the blood serum
次要结局
未报告次要终点