Development and Qualification of Methods for Analyzing the Mucosal Immune Response to COVID-19
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- Analysis of the neutralizing capacity of anti-Spike IgA in nasal secretions
研究概览
简要总结
The pandemic associated with the SARS-CoV-2 coronavirus has affected over 760 million individuals worldwide, resulting in more than 6.9 million deaths. France has also been heavily impacted, with over 39.8 million infections and 167,000 deaths.
SARS-CoV-2 primarily causes an upper respiratory tract infection transmitted through the air. When it reaches the lungs, it leads to a severe acute respiratory illness called COVID-19. The body's response to this viral assault primarily occurs at the level of the respiratory mucosa.
This mucosal response is complex, involving various levels of activity. Mucosal immunity is therefore essential for an adequate and long-term immune response against viral respiratory infections, including SARS-CoV-2 infection.
Infection with SARS-CoV-2 triggers a humoral immune response with the production of antibodies in the blood (serum antibodies) and antibodies in the upper respiratory tract (mucosal antibodies). It also induces a cellular immune response by activating specific blood T lymphocytes.
Tests used to measure the humoral blood response against SARS-CoV-2 and their neutralizing capacity are now well identified, as are tests for assessing the serum cellular T lymphocyte response. However, tests for measuring mucosal immune responses are not routinely used.
Our study aims to develop and qualify methods for analyzing mucosal immunity directed against SARS-CoV-2. These methods will be essential for a more precise analysis of the body's mucosal response to this virus.
Once these analytical methods are validated, they will enable the study of mucosal responses to infection, as well as mucosal responses induced by vaccination against SARS-CoV-2, particularly in the context of future nasal vaccine use.
详细描述
SARS-CoV-2 is initially responsible for an airborne infection of the upper respiratory tract which, on reaching the lungs, causes a severe acute respiratory illness known as COVID-19.
The organism's response to this viral aggression is initially directed at the respiratory mucosa.
This mucosal response is complex, with different levels of activity interacting: mechanical activity, with the secretion of mucus that acts as a barrier to the infectious agent; physico-chemical activity, with the production of enzymes and cytokines that contribute to the degradation of viral particles; and specific humoral immune activity, with the production of secretory IgA-type immunoglobulins at the mucosal level, with neutralizing activity that blocks viral entry into the host cell.
These innate and adaptive immune mechanisms, together with their humoral and cellular components, play an essential role in mucosal barrier function. Mucosal immunity is therefore essential for an adequate, early and long-term immune response against respiratory viral infections.
SARS-CoV-2 is an enveloped virus with a helical capsid and a genome consisting of approximately 30,000 nucleotides. This genome codes for several proteins essential for virion formation, including the S protein for Spike and the N protein for nucleocapsid.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •≥18 years old
- •Participant affiliated with a social security scheme
- •Participant willing to take part in the study and having provided consent
- •Participant in good health or with a stable chronic condition for more than 6 months
排除标准
- •Contraindication for nasopharyngeal sampling
- •Pregnant or breastfeeding women
- •Participants benefiting from a legal protection measure as referred to in articles L1121-5 to L1121-8 of the Public Health Code (guardianship, trusteeship, etc.)
- •Participant with an acute condition unrelated to SARS-CoV-2 infection
- •Participant with an unstable chronic condition
研究组 & 干预措施
COVID +
participant with a positive SARS-CoV-2 PCR test
干预措施: Sampling (Biological)
COVID +
participant with a positive SARS-CoV-2 PCR test
干预措施: PCR (polymerase chain reaction) SARS-CoV-2 (Biological)
COVID -
participant with a negative SARS-CoV-2 PCR test
干预措施: Sampling (Biological)
COVID -
participant with a negative SARS-CoV-2 PCR test
干预措施: PCR (polymerase chain reaction) SARS-CoV-2 (Biological)
结局指标
主要结局
Analysis of the neutralizing capacity of anti-Spike IgA in nasal secretions
时间窗: Baseline - Day 0
The neutralizing capacity of secretory nasal IgA assessed in neutralization titer (PRNT 50).
To study the anti-Spike mucosal humoral immune response by measuring secretory IgA in nasal secretions
时间窗: Baseline - Day 0
The level of secretory IgA (immunoglobulin A) in nasal secretions, expressed in picograms per milliliter equivalent.
次要结局
- Assay serum anti-N IgG(Baseline - Day 0)
- Determination of serum anti-Spike IgG(Baseline - Day 0)
- Study the systemic cellular immune response by measuring interferon-gamma production(Baseline - Day 0)
- Analysis of the neutralizing capacity of anti-Spike IgA in salivary secretions(Baseline - Day 0)
- Determination of secretory anti-Spike IgA in salivary secretions(Baseline - Day 0)
- Analysis of the neutralizing capacity of serum anti-Spike IgG(Baseline - Day 0)