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

ConditionCOVID-19
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorInstitut Pasteur

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Blood sample collection

    Biological/Vaccine

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

  • Saliva sample collection

    Other intervention

    Saliva sample collection between inclusion and 3 months

  • Nasopharyngeal and nasal sample collection

    Other intervention

    Nasopharyngeal and nasal sample collection between inclusion and 3 months

  • Exhaled Breath Condensate (EBC)

    Other intervention

    Exhaled Breath Condensate (EBC) between inclusion and 3 months

Treatment groups

No treatment groups listed

Trial outcomes

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.

Time frame
12 months

Secondary outcomes

1

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.

Measurement of the capacity of the biomarkers to characterize the different stages, severity and prognosis of the infection, or theranostic potential.

Time frame
12 months
2

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

Kinetics of virological evolution and immune response in different compartments (blood, upper and lower respiratory)

Time frame
12 months
3

To develop tools to assess the contamination capacity of subjects.

Measurement of viral load in exhaled air condensates

Time frame
12 months
4

To characterization of mucosal and humoral immunity.

Measurement and comparison of mucosal and humoral immunity parameters

Time frame
12 months

Other outcomes

Sponsors and contacts

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Institut Pasteur

Lead sponsor

Biogroup Laboratoire de biologie médicale

Collaborator