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

RecruitingNAAges 18 Years - 65 YearsAllInstitut Pasteur
NCT05858502 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 th

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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. Exclusion Criteria: * 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
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What it tests

  • Blood sample collection
  • Saliva sample collection
  • Nasopharyngeal and nasal sample collection
  • Exhaled Breath Condensate (EBC)
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Where

1 site
Institut Pasteur - ICAReB-clin
Paris, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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