Understanding the Determinants of Mucosal Immunity and Optimizing the Diagnosis of Infection With SARS-CoV-2 Variants

NCT05858502 | Recruiting

• 2 other identifiers: 2021-0792022-A02703-40
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

One of the current health challenges in the face of the COVID-19 pandemic that started in Wuhan in 2019, and still responsible for successive waves, is to better understand and diagnose the infection. The new variants - delta, then omicron, which appeared in November 2021 and then their sub-variants BA.2, then BA.4 and 5, and more recently BQ.1 and the sub-variant XBB.1.5 are increasingly transmissible and responsible for some degree of immune escape. Hence the importance of a better understanding of infection- or vaccine-induced immunity in order to optimize existing prophylactic or therapeutic strategies, or even to develop new, more effective ones. Mucosal immunity could play a particularly important role in interrupting the infection cycle at the entry point of the virus. The key role of innate immunity has been demonstrated in particular, via interferons and the composition of the microbiota. Humoral immunity is the best documented. However, it tends to be eroded within a few months. On the other hand, cellular immunity is more stable over time and would largely explain the decrease in severe forms of the disease in vaccinated individuals. The collection of biological resources that will be built up during this study will also allow us to optimize or develop new diagnostic methods, necessary as a complement to vaccination, to effectively slow down the spread of the pandemic and reduce the severity of its impact on the population. The improvement of diagnostic methods will in turn improve the understanding of the infection by providing increasingly reliable information on the characteristics of an infection, its quantification, its dynamics, and its resolution, especially since these parameters will be compared, at any time during the study, with reference methods and the immunological status of the subject. The main significant improvements expected in the field of SARS-CoV-2 diagnosis are notably the improvement of performance (reduction of false negatives in RT-PCR on nasopharyngeal samples), acceptability, simplicity of implementation in the field, and the capacity to test transmission. The objective of this study is to identify and characterize SARS-CoV-2 infection and host response, particularly mucosal immunity.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

• To characterize SARS-CoV-2 infection and host response, particularly mucosal immunity.

  Measurement of mucosal anti-SARS-CoV-2 antibody levels and cytokines, composition of the local microbiota of the upper respiratory tract.

  12 months

Secondary Outcomes (5)

• To characterize biomarkers of infection (stage, severity, prognosis) with new innovative direct or indirect diagnostic methods for SARS-CoV-2 and identify potential theranostic biomarkers.

  12 months

• To characterize the dynamics of infection and immunological response from the date of suspected infection and up to 3 months post-infection, or later, during the first year

  12 months

• To develop tools to assess the contamination capacity of subjects.

  12 months

• To characterization of mucosal and humoral immunity.

  12 months

• To optimize sampling techniques and calibrate the detection of viral components by artificial contamination on samples taken during the 1st visit of uninfected subjects.

  12 months

Interventions

Blood sample collection BIOLOGICAL

Blood sample collection between inclusion and 3 months max 55 ml at each visit

Saliva sample collection OTHER

Saliva sample collection between inclusion and 3 months

Nasopharyngeal and nasal sample collection OTHER

Nasopharyngeal and nasal sample collection between inclusion and 3 months

Exhaled Breath Condensate (EBC) OTHER

Exhaled Breath Condensate (EBC) between inclusion and 3 months

Eligibility Criteria

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

You may qualify if:

• Common criteria for all subjects:
• Aged between 18 and 65 years included
• Whose weight is greater than or equal to 50 kg and whose state of health is compatible with the collection of 55 ml of blood at one time and 111 ml in 28 days
• Residing in the Ile-de-France region and able to travel to the 15th arrondissement of Paris for visits to ICAReB-Clin
• Having given their consent to participate in the study
• Benefiting from a Social Security scheme except for the Aide Médicale d'Etat
• Criteria for the SARS-CoV-2 infected participant group:
• Subject tested positive for SARS-CoV-2 by RT-PCR in one of the participating laboratories for less than 72 hours
• Asymptomatic or with symptoms not requiring hospitalization regardless of previous vaccination or infection status for SARS-CoV-2.
• Criteria for the SARS-CoV-2 uninfected group:
• Having tested negative for SARS-CoV-2 by RT-PCR
• Subject with no more than 3 co-morbidities listed by the HAS.

You may not qualify if:

• Criteria common to all subjects :
• Subject under a protective measure (e.g., guardianship)
• Participant in another biomedical research
• For women: pregnant or breastfeeding women (declarative)
• Subject with another acute infectious disease
• SARS-CoV-2 RT-PCR result older than 3 days
• Existence of at least 3 co-morbidities known to be factors of severity (and therefore representing risks of hospitalisation during follow-up)
• Existence of a previous known SARS-CoV-2 positivity less than 1 month old (whatever the method used: RT-PCR or antigenic test)
• SARS-CoV-2 infected participant group criteria:
• \- For symptomatic subjects: onset of symptoms more than 4 days ago
• SARS-CoV-2 uninfected participant group criteria:
• Known history of infection and/or COVID-19 vaccination, within the previous 3 months

Sponsors & Collaborators

• Institut Pasteur: lead
• Biogroup Laboratoire de biologie médicale: collaborator

Study Sites (1)

Institut Pasteur - ICAReB-clin

Paris, 75015, France

RECRUITING

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Hélène Laude, MD

  Institut Pasteur

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hélène Laude, MD

CONTACT

33145688394; helene.laude@pasteur.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2023
• First Posted: May 15, 2023
• Study Start: December 15, 2023
• Primary Completion: March 15, 2026
• Study Completion (Estimated): June 18, 2026
• Last Updated: May 14, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)