Longitudinal Follow-up of a Population Cohort in a French City With High SARS-CoV-2 Circulation, in Early 2020 [COVID-19] (COVID-OISE)

Longitudinal Follow-up of a Population Cohort in a French City With High SARS-CoV-2 Circulation in Early 2020

An initial retrospective epidemiological investigation was conducted in a city north of France after the diagnosis of the first case of COVID-19 on February 2020. Sero-epidemiological studies were conducted in this town by the Institut Pasteur in early 2020 among families, teachers and non-teaching staff of the high and elementary schools.

The goal of this new project is to better characterize the specific immunity generated by the infection within this community. The specific immune response to the SARS-CoV-2 virus will be followed for a period of 2 years from the initial circulation of the virus, within a large cohort of participants covering all age groups from 5 years-old onwards. The study will focus on systemic humoral and cell responses, immunity of the nasopharyngeal mucosa and the humoral response present in saliva. Follow-up of participants in this cohort and monitoring of the virus circulation within this community would help to determine the protective character against re-infection of the natural immunity generated by SARS-CoV-2.

Study Overview

• Status: Completed
• Conditions: Covid19; SARS (Severe Acute Respiratory Syndrome)
• Intervention / Treatment: Other: Human biological samples

Detailed Description

An initial retrospective epidemiological investigation was conducted in a city north of France after the diagnosis of the first case of COVID-19 on February 2020. Sero-epidemiological studies were conducted in this town by the Institut Pasteur in early 2020 among families, teachers and non-teaching staff of the high and elementary schools.

These surveys have documented the circulation of SARS-CoV-2 in one of the first French COVID-19 outbreaks and this study proposes to better characterize the specific immunity generated by the infection among this community. Indeed, the nature of this immunity and its persistence over time are crucial information. The goal of this new project is to explore the specific immune response to the SARS CoV 2 virus for a period of 2 years from the initial circulation of the virus in this north of France city, within a large cohort of participants in the general population covering all age groups from 5 years of age but also in patients and residents of retirement homes in this city. It is expected that the immune response conferred by natural infection or vaccination will differ according to age.

This study will focus on systemic humoral and cell responses, immunity of the nasopharyngeal mucosa and the humoral response present in saliva. The genetic basis of the diversity of humoral responses induced by SARS-CoV-2 and those related to the multiplicity of clinical manifestations of COVID-19 will also be investigated. This would provide initial evidence to determine the protective character against re-infection of the natural immunity generated by CoV-2-SARS. Finally, these data will be used to model the intra-family transmission of the virus.

• Study Type: Observational
• Enrollment (Actual): 1000

Contacts and Locations

• Study Contact: Name: Sandrine Fernandes Pellerin; Phone Number: +33145688179; Email: sandrine.fernandes-pellerin@pasteur.fr
• Study Contact Backup: Name: Laurie Pinaud; Email: laurie.pinaud@pasteur.fr

Study Locations

• France
  • Crépy-en-Valois, France, 60800
    • Hôpital de Crépy en Valois
  • Paris, France, 75724
    • Institut Pasteur

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Pupils, their parents and siblings, as well as teachers and non-teaching staff of a high and elementary schools located in a city north of France.

Description

Inclusion Criteria:

• Adultes and minors from 5 years old
• Affiliated with or benefiting from a Social Security system
• State of health compatible with a blood sample as defined in the protocol

Exclusion Criteria:

• Person benefiting from a legal protection measure or unable to express informed consent to participation and for which the legal representative or tutor person could not be contacted.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Housolds; Pupils, teachers and non-teaching staff who attended schools of the city during the 2019-2020 school year and members of their households	Other: Human biological samples; Blood , saliva, nasopharyngeal mucosa
Subjects hospitalized or residing in health care facilities; Residents and patients from retirement homes and long-term care units	Other: Human biological samples; Blood , saliva, nasopharyngeal mucosa
Staff of health care institutions	Other: Human biological samples; Blood , saliva, nasopharyngeal mucosa

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Presence of specific anti-SARS-CoV-2 antibodies in the different study groups.	Description of the serological status of individuals	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Presence of specific T cell response to the SARS-CoV-2	Detection over time the specific T cell response to the SARS-CoV-2 virus.	2 years

Collaborators and Investigators

• Sponsor: Institut Pasteur
• Investigators: Principal Investigator: Marie-Noëlle Ungeheuer, Dr, Institut Pasteur

Study record dates

Study Major Dates

• Study Start (Actual): November 13, 2020
• Primary Completion (Actual): June 30, 2022
• Study Completion (Actual): July 1, 2023

Study Registration Dates

• First Submitted: November 18, 2020
• First Submitted That Met QC Criteria: November 23, 2020
• First Posted (Actual): November 25, 2020

Study Record Updates

• Last Update Posted (Actual): July 7, 2023
• Last Update Submitted That Met QC Criteria: July 6, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Severe Acute Respiratory Syndrome; COVID-19
• Other Study ID Numbers: 2020-060

Plan for Individual participant data (IPD)

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

Drug and device information, study documents

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