Clinical trial NCT04355533: Immunity Against SARS-CoV2 in Children and Their Parents / COVID-19
Official title: Seroprevalence and Antibody Profiling Against SARS-CoV2 in Children and Their Parents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COVID-19 Infection
Keywords: Child
COVID-19 infection
immune response
healthy carrier
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Institut National de la Santé Et de la Recherche Médicale, France
name: Commissariat A L'energie Atomique
name: Institut Pasteur
First posted: 2020-04-21
Enrollment: 1056
Sex: ALL
Minimum age (years): 7
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to provide data on the proportion of seroconverted children and their immune status. It will also provide insight into the number of children currently infected at each time point including healthy carriers. Investigators will provide similar data on their parents in an ancillary study.

Detailed description: The fraction of undiagnosed but likely to transmit the virus is a critical epidemiological characteristic that modulates the epidemic potential of SARS-CoV2. To adapt the epidemy control, it is essential to study the immunoprotection of the general population. A crucial question is the study of pauci or asymptomatic subjects, and in particular children who make mild forms, because they could act as a real reservoir for the spread of the virus. The serological study is essential in this context.

The serologic test Abbott will be used to study immunoprevalence. Institut Pasteur has validated test using neutralizing Ab. CEA will used a antibodies and antigen test.

Eligibility criteria: Inclusion Criteria:

For hospitalized children or consulting at hospital

* any child over 7 days old and under 17 years old in consultation or hospitalized for at most 4 days at AP-HP or CH Cayenne; Or any child over 7 days old and under 17 years old with a positive PCR at home, with an attending physician in a participating centre
* Parent's agreement for blood, saliva and stool samples
* Optional parent's agreement for nasopharynx swab
* Optional parent's agreement for follow-up if PCR+
* With an Health insurance

For children with potential COVID disease during the first wave

* Any child over 7 days old and under 17 years, seropositive during the first wave
* Or any child over 7 days old and under 17 years, with a previous inflammatory clinical disease potentially linked to SARS-cov2
* With an Health insurance

Parent of the enrolled child

* One parent of the enrolled child on ped-covid
* Agreement for blood and saliva samples
* Optional agreement for nasopharynx swab
* Optional parent's agreement for follow-up if PCR+
* With an Health insurance

For children SARS-coV2 positive

* any child less then 18 years old
* infected by SARS-coV2
* Parent's agreement for blood, saliva samples
* Optional parent's agreement for nasopharynx swab
* With health insurance

For people living under the same roof of a child included in the study

* any child or adult living under the same roof of a child SARS-coV2 positive and included in the study
* With health insurance

Exclusion Criteria:

For hospitalized children or consulting at hospital

* child younger than 7 days
* Refusal of parent
* Refusal of child
* No health insurance

Primary outcomes:
measure: Seroconversion against SARS-CoV2 in children
timeFrame: at inclusion
Secondary outcomes:
measure: Measure of Ab antiN and Ab anti-S1/2
timeFrame: at inclusion
measure: Neutralization activity
timeFrame: at inclusion
measure: Positive qPCR in children
timeFrame: at inclusion
measure: correlation between different Ab and qPCR and neutralization activity
timeFrame: at inclusion
measure: Protective immunity
timeFrame: Day 3
measure: Protective immunity
timeFrame: Day 7
measure: Protective immunity
timeFrame: Day 15
measure: Protective immunity
timeFrame: Day 45
measure: Protective immunity
timeFrame: At 6 months
measure: Protective immunity
timeFrame: At 12 months
measure: Duration of viral carriage in stool, saliva and or nasopharynx
timeFrame: until 45 days if persistence of positive qPCR
measure: Correlation between antibody profile and viral clearance
timeFrame: until 45 days post onset
measure: Ab profile and memory of immunity
timeFrame: At Day 3
measure: Ab profile and memory of immunity
timeFrame: At Day 7
measure: Ab profile and memory of immunity
timeFrame: At Day 15
measure: Ab profile and memory of immunity
timeFrame: At Day 45
measure: Ab profile and memory of immunity
timeFrame: At 6 months
measure: Ab profile and memory of immunity
timeFrame: At 12 months
measure: saliva biofluid characteristics of COVID-19 infected
timeFrame: Until 1 year follow-up
measure: Presence of the virus
timeFrame: Until 1 year follow-up
measure: Reinfection
timeFrame: Until 1 year follow-up
measure: Transmission of the virus to the family
timeFrame: until 45 days follow-up
measure: Immune response
timeFrame: At inclusion
measure: Mucosal immunity
timeFrame: Until 1 year follow-up
measure: seroconversion against SARS-CoV2 in parents
timeFrame: at inclusion
measure: Measure of Ab antiN and Ab anti-S1 and neutralization activity
timeFrame: at inclusion
measure: Positive qPCR in parents
timeFrame: at inclusion
measure: Correlation between different Ab and qPCR
timeFrame: at inclusion
measure: Correlation between antibody profile and viral clearance
timeFrame: until 45 days post onset
measure: Ab profile and memory of immunity
timeFrame: at Day 3
measure: Ab profile and memory of immunity
timeFrame: at Day 7
measure: Ab profile and memory of immunity
timeFrame: at Day 15
measure: Ab profile and memory of immunity
timeFrame: at Day 45
measure: Ab profile and memory of immunity
timeFrame: at 6 months
measure: Ab profile and memory of immunity
timeFrame: at 12 months
measure: Saliva biofluid characteristics of COVID-19 infected
timeFrame: Until 1 year follow-up
measure: Presence of the virus
timeFrame: Until 45 days follow-up
measure: Mucosal immunity
timeFrame: Until 1 year follow-up
measure: Reinfection
timeFrame: Until 1 year follow-up
Other outcomes:
Locations:
city: ¨Paris
country: France
facility: Hôpital necker Enfants-Malades
Study officials:
affiliation: Assistance Publique-Hôpitaux de Pars
name: Isabelle SERMET-GAUDELUS, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Delaunay-Moisan A, Guilleminot T, Semeraro M, Briand N, Bader-Meunier B, Berthaud R, Morelle G, Quartier P, Galeotti C, Basmaci R, Benoist G, Gajdos V, Lorrot M, Rifai M, Crespin M, M'Sakni Z, Padavia F, Savetier-Leroy C, Lorenzi M, Maurin C, Behillil S, de Pontual L, Elenga N, Bouazza N, Moltrecht B, van der Werf S, Leruez-Ville M, Sermet-Gaudelus I. Saliva for molecular detection of SARS-CoV-2 in pre-school and school-age children. Environ Microbiol. 2022 Oct;24(10):4725-4737. doi: 10.1111/1462-2920.16151. Epub 2022 Aug 12.