Immunity Against SARS-CoV2 in Children and Their Parents / COVID-19
- Conditions
- COVID-19 Infection
- Interventions
- Biological: serology testBiological: nasopharyngeal swabBiological: rectal swabBiological: saliva sample
- Registration Number
- NCT04355533
- Lead Sponsor
- Assistance Publique - Hôpitaux de Paris
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1056
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
For hospitalized children or consulting at hospital
- child younger than 7 days
- Refusal of parent
- Refusal of child
- No health insurance
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Children with potential COVID disease during the first wave nasopharyngeal swab - Children with potential COVID disease during the first wave saliva sample - Children SARS-coV2 positive nasopharyngeal swab - Person living under the same roof as children included in the study rectal swab - Person living under the same roof as children included in the study saliva sample - Parents of one included child nasopharyngeal swab - Hospitalized children or consulting at hospital serology test - Hospitalized children or consulting at hospital nasopharyngeal swab - Hospitalized children or consulting at hospital saliva sample - Parents of one included child serology test - Children with potential COVID disease during the first wave rectal swab - Hospitalized children or consulting at hospital rectal swab - Children SARS-coV2 positive rectal swab - Person living under the same roof as children included in the study nasopharyngeal swab - Children SARS-coV2 positive serology test - Children SARS-coV2 positive saliva sample - Person living under the same roof as children included in the study serology test - Parents of one included child saliva sample - Children with potential COVID disease during the first wave serology test -
- Primary Outcome Measures
Name Time Method Seroconversion against SARS-CoV2 in children at inclusion serology
- Secondary Outcome Measures
Name Time Method Neutralization activity at inclusion Serology in children
Measure of Ab antiN and Ab anti-S1/2 at inclusion Serology in children
Protective immunity At 12 months Serology, measure of Ab in PCR positive children
Reinfection Until 1 year follow-up in positive PCR parents: occurrence of reinfection, immunity responses during reinfection and potential mutations of the virus
Transmission of the virus to the family until 45 days follow-up symptomatic, virological and serological follow-up
Saliva biofluid characteristics of COVID-19 infected Until 1 year follow-up in positive PCR parents: viral content (qPCR and immunodetection); presence of IgG, M, and A
seroconversion against SARS-CoV2 in parents at inclusion Ancillary study: Serology in parents
Positive qPCR in children at inclusion in children, qualitative and quantitative measure , in nasopharynx, saliva and stool
correlation between different Ab and qPCR and neutralization activity at inclusion in children, qualitative and quantitative measure , in nasopharynx, saliva and stool, Ab anti-N, Ab anti-S1/2, neutralization serum
Presence of the virus Until 45 days follow-up in positive PCR parents: nasopharynx, saliva
Positive qPCR in parents at inclusion Ancillary study: in parents, qualitative and quantitative measure , in nasopharynx, saliva
Correlation between different Ab and qPCR at inclusion Ancillary study: in parents, qualitative and quantitative measure , in nasopharynx, saliva, Ab anti-N, Ab anti-S1, neutralization serum
Ab profile and memory of immunity at 12 months Ancillary study: Immune cells in positive PCR parents
Measure of Ab antiN and Ab anti-S1 and neutralization activity at inclusion Ancillary study: Serology in parents
Duration of viral carriage in stool, saliva and or nasopharynx until 45 days if persistence of positive qPCR Sars-Cov2 PCR in PCR positive children
Correlation between antibody profile and viral clearance until 45 days post onset Ancillary study: Serology in PCR positive parents
saliva biofluid characteristics of COVID-19 infected Until 1 year follow-up viral content (qPCR and immunodetection); presence of IgG, M, and A
Immune response At inclusion In children COVID+ during the first wave :immune response few months after the infection
Mucosal immunity Until 1 year follow-up in positive PCR parents: Ab anti-SARS-cov2 in nasopharynx samples
Trial Locations
- Locations (1)
Hôpital necker Enfants-Malades
🇫🇷¨Paris, France