Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
Healthy Volunteers
NCT05858502

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

Led by Institut Pasteur · Updated on 2025-05-14

90

Participants Needed

1

Research Sites

130 weeks

Total Duration

On this page

Sponsors

I

Institut Pasteur

Lead Sponsor

B

Biogroup Laboratoire de biologie médicale

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 65Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged between 18 and 65 years
  • Weigh at least 50 kg and be healthy enough to provide up to 55 ml of blood at one time and 111 ml within 28 days
  • Reside in the Ile-de-France region and be able to travel to the 15th arrondissement of Paris for study visits
  • Have given consent to participate in the study
  • Have Social Security coverage (except Aide Médicale d'Etat)
  • For infected participants: tested positive for SARS-CoV-2 by PCR within 72 hours and be asymptomatic or have symptoms not requiring hospitalization
  • For uninfected participants: tested negative for SARS-CoV-2 by PCR and have no more than 3 co-morbidities listed by the HAS
Not Eligible

You will not qualify if you...

  • Under any protective legal measure (e.g., guardianship)
  • Participating in another biomedical research study
  • Pregnant or breastfeeding women
  • Have another acute infectious disease
  • SARS-CoV-2 PCR result older than 3 days
  • Have at least 3 co-morbidities known to increase severity and risk of hospitalization
  • Had a known SARS-CoV-2 positive test less than 1 month ago
  • For symptomatic infected participants: symptoms began more than 4 days ago
  • For uninfected participants: history of infection or COVID-19 vaccination within the last 3 months

AI-Screening

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Trial Site Locations

Total: 1 location

1

Institut Pasteur - ICAReB-clin

Paris, France, 75015

Actively Recruiting

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Research Team

H

Hélène Laude, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

BASIC_SCIENCE

Number of Arms

0

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