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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Seroprevalence and Antibody Profiling Against SARS-CoV2 in Children and Their Parents

Conditions
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COVID-19 Infection

Intervention / Treatment
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* Biological: serology test
* Biological: nasopharyngeal swab
* Biological: rectal swab
* Biological: saliva sample


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 7 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hospitalized children or consulting at hospital<br> | Biological: serology test<br>* volume according to child weight<br>Biological: nasopharyngeal swab<br>* nasopharyngeal swab for PCR<br>Biological: rectal swab<br>* rectal swab for PCR<br>Biological: saliva sample<br>* for biocollection<br>|
| Experimental: Parents of one included child<br> | Biological: serology test<br>* volume according to child weight<br>Biological: nasopharyngeal swab<br>* nasopharyngeal swab for PCR<br>Biological: saliva sample<br>* for biocollection<br>|
| Experimental: Children with potential COVID disease during the first wave<br> | Biological: serology test<br>* volume according to child weight<br>Biological: nasopharyngeal swab<br>* nasopharyngeal swab for PCR<br>Biological: rectal swab<br>* rectal swab for PCR<br>Biological: saliva sample<br>* for biocollection<br>|
| Experimental: Children SARS-coV2 positive<br> | Biological: serology test<br>* volume according to child weight<br>Biological: nasopharyngeal swab<br>* nasopharyngeal swab for PCR<br>Biological: rectal swab<br>* rectal swab for PCR<br>Biological: saliva sample<br>* for biocollection<br>|
| Experimental: Person living under the same roof as children included in the study<br> | Biological: serology test<br>* volume according to child weight<br>Biological: nasopharyngeal swab<br>* nasopharyngeal swab for PCR<br>Biological: rectal swab<br>* rectal swab for PCR<br>Biological: saliva sample<br>* for biocollection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Seroconversion against SARS-CoV2 in children | serology | at inclusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure of Ab antiN and Ab anti-S1/2 | Serology in children | at inclusion | 
| Neutralization activity | Serology in children | at inclusion | 
| Positive qPCR in children | in children, qualitative and quantitative measure , in nasopharynx, saliva and stool | 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 | at inclusion | 
| Protective immunity | Serology, measure of Ab in PCR positive children | Day 3 | 
| Protective immunity | Serology, measure of Ab in PCR positive children | Day 7 | 
| Protective immunity | Serology, measure of Ab in PCR positive children | Day 15 | 
| Protective immunity | Serology, measure of Ab in PCR positive children | Day 45 | 
| Protective immunity | Serology, measure of Ab in PCR positive children | At 6 months | 
| Protective immunity | Serology, measure of Ab in PCR positive children | At 12 months | 
| Duration of viral carriage in stool, saliva and or nasopharynx | Sars-Cov2 PCR in PCR positive children | until 45 days if persistence of positive qPCR | 
| Correlation between antibody profile and viral clearance | Serology in PCR positive children | until 45 days post onset | 
| Ab profile and memory of immunity | Immune cells in positive PCR children | At Day 3 | 
| Ab profile and memory of immunity | Immune cells in positive PCR children | At Day 7 | 
| Ab profile and memory of immunity | Immune cells in positive PCR children | At Day 15 | 
| Ab profile and memory of immunity | Immune cells in positive PCR children | At Day 45 | 
| Ab profile and memory of immunity | Immune cells in positive PCR children | At 6 months | 
| Ab profile and memory of immunity | Immune cells in positive PCR children | At 12 months | 
| saliva biofluid characteristics of COVID-19 infected | viral content (qPCR and immunodetection); presence of IgG, M, and A | Until 1 year follow-up | 
| Presence of the virus | In PCR positive children: nasopharynx, saliva, stool | Until 1 year follow-up | 
| Reinfection | In PCR positive children: occurrence of reinfection, immunity responses during reinfection and potential mutations of the virus | Until 1 year follow-up | 
| Transmission of the virus to the family | symptomatic, virological and serological follow-up | until 45 days follow-up | 
| Immune response | In children COVID+ during the first wave :immune response few months after the infection | At inclusion | 
| Mucosal immunity | In PCR positive children: Ab anti-SARS-cov2 in nasopharynx samples | Until 1 year follow-up | 
| seroconversion against SARS-CoV2 in parents | Ancillary study: Serology in parents | at inclusion | 
| Measure of Ab antiN and Ab anti-S1 and neutralization activity | Ancillary study: Serology in parents | at inclusion | 
| Positive qPCR in parents | Ancillary study: in parents, qualitative and quantitative measure , in nasopharynx, saliva | 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 | at inclusion | 
| Correlation between antibody profile and viral clearance | Ancillary study: Serology in PCR positive parents | until 45 days post onset | 
| Ab profile and memory of immunity | Ancillary study: Immune cells in positive PCR parents | at Day 3 | 
| Ab profile and memory of immunity | Ancillary study: Immune cells in positive PCR parents | at Day 7 | 
| Ab profile and memory of immunity | Ancillary study: Immune cells in positive PCR parents | at Day 15 | 
| Ab profile and memory of immunity | Ancillary study: Immune cells in positive PCR parents | at Day 45 | 
| Ab profile and memory of immunity | Ancillary study: Immune cells in positive PCR parents | at 6 months | 
| Ab profile and memory of immunity | Ancillary study: Immune cells in positive PCR parents | 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 | Until 1 year follow-up | 
| Presence of the virus | in positive PCR parents: nasopharynx, saliva | Until 45 days follow-up | 
| Mucosal immunity | in positive PCR parents: Ab anti-SARS-cov2 in nasopharynx samples | Until 1 year follow-up | 
| Reinfection | in positive PCR parents: occurrence of reinfection, immunity responses during reinfection and potential mutations of the virus | Until 1 year follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Child, COVID-19 infection, immune response, healthy carrier