Immunity Against SARS-CoV2 in Children and Their Parents / COVID-19

Assistance Publique - Hôpitaux de Paris1,056 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

1,056

Conditions

COVID-19 Infection

Interventions

serology testBIOLOGICAL

volume according to child weight

nasopharyngeal swabBIOLOGICAL

nasopharyngeal swab for PCR

rectal swabBIOLOGICAL

rectal swab for PCR

saliva sample

Eligibility

Sex: ALLMin age: 7 Days

Medical Language ↔ Plain English

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

Locations (1)

Hôpital necker Enfants-Malades

Paris, France

Outcomes

Primary Outcomes

Seroconversion against SARS-CoV2 in children

serology

Time frame: at inclusion

Secondary Outcomes

Measure of Ab antiN and Ab anti-S1/2

Serology in children

Time frame: at inclusion

Neutralization activity

Serology in children

Time frame: at inclusion

Positive qPCR in children

in children, qualitative and quantitative measure , in nasopharynx, saliva and stool

Time frame: at inclusion

correlation between different Ab and qPCR and neutralization activity

in children, qualitative and quantitative measure , in nasopharynx, saliva and stool, Ab anti-N, Ab anti-S1/2, neutralization serum

Time frame: at inclusion

Protective immunity

Serology, measure of Ab in PCR positive children

Time frame: Day 3

Protective immunity

Serology, measure of Ab in PCR positive children

Time frame: Day 7

Protective immunity

Serology, measure of Ab in PCR positive children

Time frame: Day 15

Protective immunity

Serology, measure of Ab in PCR positive children

Data from ClinicalTrials.gov

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Protective immunity

Serology, measure of Ab in PCR positive children

Time frame: At 6 months

Protective immunity

Serology, measure of Ab in PCR positive children

Time frame: At 12 months

Duration of viral carriage in stool, saliva and or nasopharynx

Sars-Cov2 PCR in PCR positive children

Time frame: until 45 days if persistence of positive qPCR

Correlation between antibody profile and viral clearance

Serology in PCR positive children

Time frame: until 45 days post onset

Ab profile and memory of immunity

Immune cells in positive PCR children

Time frame: At Day 3

Ab profile and memory of immunity

Immune cells in positive PCR children

Time frame: At Day 7

Ab profile and memory of immunity

Immune cells in positive PCR children

Time frame: At Day 15

Ab profile and memory of immunity

Immune cells in positive PCR children

Time frame: At Day 45

Ab profile and memory of immunity

Immune cells in positive PCR children

Time frame: At 6 months

Ab profile and memory of immunity

Immune cells in positive PCR children

Time frame: At 12 months

saliva biofluid characteristics of COVID-19 infected

viral content (qPCR and immunodetection); presence of IgG, M, and A

Time frame: Until 1 year follow-up

Presence of the virus

In PCR positive children: nasopharynx, saliva, stool

Time frame: Until 1 year follow-up

Reinfection

In PCR positive children: occurrence of reinfection, immunity responses during reinfection and potential mutations of the virus

Time frame: Until 1 year follow-up

Transmission of the virus to the family

symptomatic, virological and serological follow-up

Time frame: until 45 days follow-up

Immune response

In children COVID+ during the first wave :immune response few months after the infection

Time frame: At inclusion

Mucosal immunity

In PCR positive children: Ab anti-SARS-cov2 in nasopharynx samples

Time frame: Until 1 year follow-up

seroconversion against SARS-CoV2 in parents

Ancillary study: Serology in parents

Time frame: at inclusion

Measure of Ab antiN and Ab anti-S1 and neutralization activity

Ancillary study: Serology in parents

Time frame: at inclusion

Positive qPCR in parents

Ancillary study: in parents, qualitative and quantitative measure , in nasopharynx, saliva

Time frame: at inclusion

Correlation between different Ab and qPCR

Ancillary study: in parents, qualitative and quantitative measure , in nasopharynx, saliva, Ab anti-N, Ab anti-S1, neutralization serum

Time frame: at inclusion

Correlation between antibody profile and viral clearance

Ancillary study: Serology in PCR positive parents

Time frame: until 45 days post onset

Ab profile and memory of immunity

Ancillary study: Immune cells in positive PCR parents

Time frame: at Day 3

Ab profile and memory of immunity

Ancillary study: Immune cells in positive PCR parents

Time frame: at Day 7

Ab profile and memory of immunity

Ancillary study: Immune cells in positive PCR parents

Time frame: at Day 15

Ab profile and memory of immunity

Ancillary study: Immune cells in positive PCR parents

Time frame: at Day 45

Ab profile and memory of immunity

Ancillary study: Immune cells in positive PCR parents

Time frame: at 6 months

Ab profile and memory of immunity

Ancillary study: Immune cells in positive PCR parents

Time frame: at 12 months

Saliva biofluid characteristics of COVID-19 infected

in positive PCR parents: viral content (qPCR and immunodetection); presence of IgG, M, and A

Time frame: Until 1 year follow-up

Presence of the virus

in positive PCR parents: nasopharynx, saliva

Time frame: Until 45 days follow-up

Mucosal immunity

in positive PCR parents: Ab anti-SARS-cov2 in nasopharynx samples

Time frame: Until 1 year follow-up

Reinfection

in positive PCR parents: occurrence of reinfection, immunity responses during reinfection and potential mutations of the virus

Time frame: Until 1 year follow-up