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.
This is a prospective, longitudinal, descriptive study that will include adult participants infected and uninfected with Sars-CoV-2 at the time of recruitment. Participants will be divided into 3 groups of 30 evaluable subjects: * uninfected, * asymptomatically infected, * symptomatically infected. The participants will be identified within the Ile-de-France medical analysis laboratories partners of the project. Study with sample collection: \- For participants infected with SARS-CoV-2: Inclusion visit V0, ≤ 3 days after PCR test Follow-up visit V1, 7 d ± 1 d after V0 Follow-up visit V2, 31 d ± 2 d after V0 V3 follow-up visit, 91 d ± 5 d after V0 \- For participants not infected with SARS-CoV-2 : Inclusion visit V0, ≤ 3 days after PCR test V1' visit, no more than 96 d after V0.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
90
Blood sample collection between inclusion and 3 months max 55 ml at each visit
Saliva sample collection between inclusion and 3 months
Nasopharyngeal and nasal sample collection between inclusion and 3 months
Exhaled Breath Condensate (EBC) between inclusion and 3 months
Institut Pasteur - ICAReB-clin
Paris, France
RECRUITINGTo 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
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
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
To develop tools to assess the contamination capacity of subjects.
Measurement of viral load in exhaled air condensates
Time frame: 12 months
To characterization of mucosal and humoral immunity.
Measurement and comparison of mucosal and humoral immunity parameters
Time frame: 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.
Measurement of viral detection calibration results on the 1st visit samples of uninfected subjects
Time frame: 12 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.