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

NCT06142279 | Unknown

• 1 other identifier: DR230062-MUCOVID
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• To study the anti-Spike mucosal humoral immune response by measuring secretory IgA in nasal secretions

  The level of secretory IgA (immunoglobulin A) in nasal secretions, expressed in picograms per milliliter equivalent.

  Baseline - Day 0

• Analysis of the neutralizing capacity of anti-Spike IgA in nasal secretions

  The neutralizing capacity of secretory nasal IgA assessed in neutralization titer (PRNT 50).

  Baseline - Day 0

Secondary Outcomes (6)

• Determination of secretory anti-Spike IgA in salivary secretions

  Baseline - Day 0

• Analysis of the neutralizing capacity of anti-Spike IgA in salivary secretions

  Baseline - Day 0

• Determination of serum anti-Spike IgG

  Baseline - Day 0

• Analysis of the neutralizing capacity of serum anti-Spike IgG

  Baseline - Day 0

• Assay serum anti-N IgG

  Baseline - Day 0

Study Arms (2)

COVID +

OTHER

participant with a positive SARS-CoV-2 PCR test

Biological: Sampling; Biological: PCR (polymerase chain reaction) SARS-CoV-2

COVID -

OTHER

participant with a negative SARS-CoV-2 PCR test

Biological: Sampling; Biological: PCR (polymerase chain reaction) SARS-CoV-2

Interventions

Sampling BIOLOGICAL

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

COVID +; COVID -

PCR (polymerase chain reaction) SARS-CoV-2 BIOLOGICAL

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

COVID +; COVID -

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Tours: lead

Study Sites (1)

CHRU de Tours

Tours, 37044, France

Location

Related Publications (9)

• Haute autorité de santé. Aspect immunologiques et virologiques de l'infection par le SARS-CoV-2 ; Rapport HAS 25 Novembre 2020

  BACKGROUND

• Alu A, Chen L, Lei H, Wei Y, Tian X, Wei X. Intranasal COVID-19 vaccines: From bench to bed. EBioMedicine. 2022 Feb;76:103841. doi: 10.1016/j.ebiom.2022.103841. Epub 2022 Jan 24.

  PMID: 35085851 BACKGROUND

• Y. Jouan · M. Si-Tahar · A. Guillon. Immunité de la muqueuse respiratoire : physiologie et implications en réanimation. Méd. Intensive Réa 2017 ; 26 :11-20

  BACKGROUND

• Smith N, Goncalves P, Charbit B, Grzelak L, Beretta M, Planchais C, Bruel T, Rouilly V, Bondet V, Hadjadj J, Yatim N, Pere H, Merkling SH, Ghozlane A, Kerneis S, Rieux-Laucat F, Terrier B, Schwartz O, Mouquet H, Duffy D, Di Santo JP. Distinct systemic and mucosal immune responses during acute SARS-CoV-2 infection. Nat Immunol. 2021 Nov;22(11):1428-1439. doi: 10.1038/s41590-021-01028-7. Epub 2021 Sep 1.

  PMID: 34471264 BACKGROUND

• Chavda VP, Vora LK, Pandya AK, Patravale VB. Intranasal vaccines for SARS-CoV-2: From challenges to potential in COVID-19 management. Drug Discov Today. 2021 Nov;26(11):2619-2636. doi: 10.1016/j.drudis.2021.07.021. Epub 2021 Jul 29.

  PMID: 34332100 BACKGROUND

• Denis F, Alain S, Hantz S, Lagrange P. [Antiviral vaccination and respiratory mucosal immunity: still disappointing results from a seductive idea]. Presse Med. 2005 Oct 8;34(17):1245-53. doi: 10.1016/s0755-4982(05)84165-x. French.

  PMID: 16230967 BACKGROUND

• Russell MW, Mestecky J. Mucosal immunity: The missing link in comprehending SARS-CoV-2 infection and transmission. Front Immunol. 2022 Aug 17;13:957107. doi: 10.3389/fimmu.2022.957107. eCollection 2022.

  PMID: 36059541 BACKGROUND

• Tang J, Zeng C, Cox TM, Li C, Son YM, Cheon IS, Wu Y, Behl S, Taylor JJ, Chakaraborty R, Johnson AJ, Shiavo DN, Utz JP, Reisenauer JS, Midthun DE, Mullon JJ, Edell ES, Alameh MG, Borish L, Teague WG, Kaplan MH, Weissman D, Kern R, Hu H, Vassallo R, Liu SL, Sun J. Respiratory mucosal immunity against SARS-CoV-2 after mRNA vaccination. Sci Immunol. 2022 Oct 28;7(76):eadd4853. doi: 10.1126/sciimmunol.add4853. Epub 2022 Oct 21.

  PMID: 35857583 BACKGROUND

• Yaugel-Novoa M, Bourlet T, Paul S. Role of the humoral immune response during COVID-19: guilty or not guilty? Mucosal Immunol. 2022 Jun;15(6):1170-1180. doi: 10.1038/s41385-022-00569-w. Epub 2022 Oct 4.

  PMID: 36195658 BACKGROUND

MeSH Terms

Interventions

Polymerase Chain Reaction

Intervention Hierarchy (Ancestors)

Nucleic Acid Amplification Techniques; Genetic Techniques; Investigative Techniques

Study Officials

• Zoha MAAKAROUN-VERMESSE, MD-PHD

  CHRU de TOURS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zoha MAAKAROUN-VERMESSE, MD-PHD

CONTACT

0247476972; z.maakaroun-vermesse@chu-tours.fr

Valérie Gissot, MD-PHD

CONTACT

0247476972; valerie.gissot@univ-tours.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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: 1. Part A, which focuses on developing the technique, involves prospective data collection and the collection of biological samples (nasal, salivary, and blood samples). 2. Part B, which aims to qualify the analysis method, also includes prospective data collection and the collection of biological samples. Once the threshold is reached in one of the two groups in Phase A, Phase B will begin concurrently.

Study Record Dates

• First Submitted: November 14, 2023
• First Posted: November 21, 2023
• Study Start: November 1, 2023
• Primary Completion: November 1, 2024
• Study Completion: November 1, 2024
• Last Updated: November 21, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)