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

NCT06142279 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2023-11-21

No results posted yet for this study

Summary

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.

Conditions

  • Certain Disorders Involving the Immune Mechanism

Interventions

BIOLOGICAL

Sampling

At baseline, nasal, salivary and blood sampling will be taken for the participants.

BIOLOGICAL

PCR (polymerase chain reaction) SARS-CoV-2

At baseline, this PCR SARS-CoV-2 will be taken for the participants.

Sponsors & Collaborators

  • University Hospital, Tours

    lead OTHER

Principal Investigators

  • Zoha MAAKAROUN-VERMESSE, MD-PHD · CHRU de TOURS

Study Design

Allocation
NON_RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-11-30
Primary Completion
2024-11-30
Completion
2024-11-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06142279 on ClinicalTrials.gov