Level of Immunity, Neutralization of the COVID-19 Virus and Reinfections in Residents of 2 Migrant Workers' Residences

SARS-COV-2 Clinical Trial

Official title:

Determination of the Level of Immunity, Neutralization of the SARS-COV-2 Virus and Reinfections in Residents of 2 Migrant Workers' Residences 10 Months Apart

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04932837
• Other study ID #: 811562
• Status: Withdrawn
• Start date: June 14, 2021
• Est. completion date: July 2, 2021

Study information

• Verified date: June 2021
• Source: Epicentre
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

A previous seroprevalence survey showed very high seroprevalence levels among residents of the two among the residents of the two migrant workers' hostels surveyed, indicating a high level of circulation of the virus SARS-COV-2 during the 1st wave of COVID-19. The constitution of a cohort after the event would be an opportunity to obtain opportunity to obtain answers to crucial questions: duration of immunity, potential reinfections potential reinfections, potential re-clustering. Going back to check the serological status seems feasible, especiallyespecially in the Foyers de Travailleurs Migrants (high probability of finding the participants).

There is an obvious scientific interest around the duration of immunity and reinfections in a population highly exposed during the first wave. Several articles document the decline of IgG antibodies in the months following an infection, but very few infection, but very few evaluate the protective character in the medium term (>=6 months), especially in asymptomatic individuals. We are also concerned about the circulation of We are also concerned about the circulation of new variants and the immunity acquired after infection in residents.

To date, no study on the duration of immunity has been conducted in migrant worker's residences.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 2, 2021
• Est. primary completion date: June 25, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• All individuals who consented to participate in the 1st study and who consent to participate in this study

• All individuals 18 years of age or older not residing in the 2 MWRs in July 2020 and permanently living in the MWR since September 2020 who consent to participate in this study

Exclusion Criteria:

• Unwillingness to provide informed consent

• Unwillingness to provide blood

• Contraindication to venepuncture

Related Conditions & MeSH terms

• SARS-COV-2

Intervention

Biological:
• Blood and Saliva collection
Serological, viral RNA and antigenic test

Locations

Country	Name	City	State
France	Foyer de travailleurs migrants	Montreuil	Ile De France
France	Foyer de travailleurs migrants	Villemomble	Ile De France

Sponsors (4)

Lead Sponsor	Collaborator
Epicentre	Agence Regionale de Sante d'Ile de France, Institut Pasteur, Medecins Sans Frontieres, Netherlands

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Level and quality of current humoral immune protection in the residents of the two migrant workers' residences	To assess the level and quality of current humoral immune protection in the residents of the two migrant workers' residences in Villemomble and Montreuil who were included in the 1st seroprevalence study in July 2020, approximately 10 months later (May 2021)	15 days
Secondary	Immunity and protection	Identify potential reinfections (reported symptoms confirmed by positive PCR tests) or resurgence of symptoms (long COVID) among residents who were seropositive in July 2020; Assess the evolution of antibodies (IgA, IgM, IgG) approximately 10 months after the first test in Sars-CoV-2 seropositive individuals in July; To evaluate the neutralizing and therefore protective activity of the re-measured antibodies, and their level of affinity maturation to SARS-COV-2 as well as their efficacy against the mainly circulating variants: B.1.1.7 (UK), B.1.351 (South Africa) and P.1 (Brazil)	15 days
Secondary	New infections and screening	Estimate the proportion of infections (reported symptoms and/or positive PCR tests)/exposure to the virus in people newly arrived since September 2020; In case of SARS-COV-2 RNA detection, characterize the virus subtype (genomic sequencing); Document the turnover in MWR populations to guide MSF activities in the future	15 days
Secondary	COVID Vaccination	Assess the proportion of participants already vaccinated or interested in the future COVID vaccination campaign and document the reasons for those who express doubts or plan to refuse vaccination; To evaluate the performance of the LuLISA technique for the response to SARS-CoV-2 N and S proteins; To evaluate the performance of a rapid serological test on strip, LuLISA Stripe developed by the Institute Pasteur by comparison to the LuLISA technique; To evaluate the performance of a rapid N and S antigenic test on saliva, LuLISA Flash, developed by the Institut Pasteur, by comparing it to the RT-PCR method; To evaluate the performance of an alternative antigenic test on saliva with very high sensitivity, LuLISA Stick, developed by Institute Pasteur, by comparing it to the RT-PCR method; Evaluate the performance of a rapid molecular RT-LAMP test developed by Institute Pasteur (depending on availability) by comparing it to the RT-PCR method	15 days