Development of a Methodology to Analyze Nasal Tissue-resident Memory Immune Cells and Peripheral Memory Cells Able to Migrate to Airway Tissues (MUCOVAC)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Frequency of resident memory lymphocytes in the nasal mucosa measured by FLOQSwab
研究概览
简要总结
Clinical evaluation of vaccines against respiratory viruses is currently based on the analysis of systemic immune responses, whereas respiratory immunity is the first line of defense against respiratory pathogens. In addition to secretory immunoglobulin A (IgA) in mucosal fluids which are essential to neutralize the pathogens at mucosal surfaces, tissue-resident memory immune cells have been shown to be crucial in protection. Furthermore, memory immune cells in blood able to migrate to airway tissues also play a crucial role. Airway immune responses have not been studied a lot due to the lack of a standardized methodology to evaluate them in humans.
详细描述
The goal of this study is to develop a methodology to collect and analyze nasal tissue-resident memory T and B cells and to evaluate peripheral memory T and B cells expressing airway homing markers in healthy volunteers. Three devices for nasal cell sampling will be compared. Tissue-resident and peripheral memory immune responses will be determined using flow cytometry and correlated with humoral and cellular responses, as well as with gene expression at mucosal and systemic levels. .
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- Single (Participant)
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
- •Affiliated to the Social Security System
- •Signed informed consent form
排除标准
- •History of recurrent nosebleeds or systemic hemorrhages
- •Previous injury or surgery which modified nasal cavity (e.g. deviated nasal septum)
- •Individuals receiving anticoagulant therapy
- •Individuals who experienced a severe respiratory infection leading to hospitalization in the last 6 months
- •Individuals who received an antibiotic therapy for respiratory infection or any other infection in the last 6 months
- •Immunocompromised individuals, or individuals taking immunosuppressed therapy or having a pathology (chronic infection, auto-immune disease) which could impact on immunity based on investigator's opinion
- •Unstable chronic pathology
- •People deprived of liberty or hospitalized without any consent
- •People under guardianship (authorship or curators)
- •Individuals who received a vaccine (any vaccine) in the last 30 days
- •Pregnant or breast-feeding people
- •Individuals experiencing respiratory infection symptoms. Inclusion will be postponed up to 7 days after the symptom resolution
结局指标
主要结局
Frequency of resident memory lymphocytes in the nasal mucosa measured by FLOQSwab
时间窗: At inclusion, one month, two months
This outcome is measured by the three devices : * FLOQSwab * Rhino-Pro Curette * Cervical brush
次要结局
- Visual analog scale for pain(At inclusion, one month, two months)
- Frequencies of resident memory T and B lymphocytes(At inclusion, one month, two months)
- Expression levels of respiratory mucosal migration markers on peripheral memory lymphocytes(At inclusion, one month, two months)