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

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

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.

Study Overview

• Status: Withdrawn
• Conditions: SARS-COV-2
• Intervention / Treatment: Biological: Blood and Saliva collection

• Study Type: Observational

Contacts and Locations

Study Locations

• France
  • Ile De France
    • Montreuil, Ile De France, France, 93
      • Foyer de travailleurs migrants
    • Villemomble, Ile De France, France, 93
      • Foyer de travailleurs migrants

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

residents of 2 Migrant Workers

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Ecologic or Community
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
migrant worker residents; The target population will be the 124 residents in the 2 migrant worker residences who were included in the previous seroprevalence study and those who arrived at the 2 residences since September 1st, 2020	Biological: Blood and Saliva collection; Serological, viral RNA and antigenic test

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Epicentre
• Collaborators: Institut Pasteur; Agence Regionale de Sante d'Ile de France; Medecins Sans Frontieres, Netherlands
• Investigators: Principal Investigator: Elisabeth POULET, MD, Epicentre

Study record dates

Study Major Dates

• Study Start (Anticipated): June 14, 2021
• Primary Completion (Anticipated): June 25, 2021
• Study Completion (Anticipated): July 2, 2021

Study Registration Dates

• First Submitted: June 1, 2021
• First Submitted That Met QC Criteria: June 17, 2021
• First Posted (Actual): June 21, 2021

Study Record Updates

• Last Update Posted (Actual): June 21, 2021
• Last Update Submitted That Met QC Criteria: June 17, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: COVID-19; Immunity; migrant workers' residences; protection
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Recurrence; Reinfection
• Other Study ID Numbers: 811562

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes

IPD Plan Description

The research team will develop a range of activities to disseminate the study findings. These dissemination activities will be coordinated by MSF and Epicentre. The results will be presented in an internal report and an external report for the Ministry of Health (MoH), the French National Public Health Agency and Institute Pasteur.

An abstract of the findings will be submitted for presentation at a scientific conference, and at least one manuscript will be submitted for publication in a peer-reviewed scientific journal.

The findings of the survey will also be used for advocacy purposes, in coordination with community leaders of participating communities.

The results of the survey (lay version of the report), and their possible use for advocacy / communication, will be shared with the staff, resident representatives and residents of the MWRs, whether or not they actually participated in the study.

• IPD Sharing Supporting Information Type: Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No