Development and Qualification of Methods for Analyzing the Mucosal Immune Response to COVID-19

DR230062-MUCOVID

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.

2023-11-01

2024-11-01

2024-11-01

Not yet recruiting

240

Inclusion Criteria: * ≥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 Exclusion Criteria: * 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

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Multicenter cross-sectional study comparing short-term mucosal response in individuals recently infected with SARS-CoV-2 versus recently non-infected individuals. The study will consist of two parts:\n\n1. Part A, which focuses on developing the technique, involves prospective data collection and the collection of biological samples (nasal, salivary, and blood samples).\n2. Part B, which aims to qualify the analysis method, also includes prospective data collection and the collection of biological samples.\n\nOnce the threshold is reached in one of the two groups in Phase A, Phase B will begin concurrently.', 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 240, 'type': 'ESTIMATED'}}

2023-11-21